Catheter and catheter-based intra-cavity navigation method

Abstract

The invention provides a catheter and a catheter-based intra-cavity navigation method, and relates to the field of medical instruments. A catheter body of the catheter comprises a visual section provided with a forward visual module and a circumferential visual module. The visual section is arranged at the tail end of the far end of the catheter body; the forward vision module faces the extension direction of the tail end of the vision section, and the circumferential vision module is arranged in the circumferential direction of the vision section; wherein the forward vision module is configured to obtain vision information in the advancing direction of the catheter, and the circumferential vision module is configured to obtain vision information in the circumferential direction of the vision section. By using the catheter provided by the embodiment of the invention, non-radiative visual imaging in a cavity can be realized, and a doctor and a patient can send an instrument to a target position in the cavity in a non-radiative environment.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular, to a catheter and a catheter-based intraluminal navigation method. Background Art

[0002] Endovascular interventional procedures have replaced most open surgeries in the peripheral, cardiac, and cardiovascular fields due to their advantages of minimal trauma and fewer complications. Currently, interventional therapies typically involve delivering instruments to the target location within the blood vessel under real-time X-ray guidance using a digital subtraction angiography (DSA) system.

[0003] Currently, the device needs to use at least one auxiliary access device to enter the target position of the blood vessel cavity. When faced with complex lesion locations or tortuous blood vessels with many branches, the operator may need to repeatedly adjust the device. The operation is difficult and time-consuming, which increases the exposure time of doctors and patients to the radiation environment. Therefore, the efficiency and effectiveness of the operation need to be improved. Summary of the Invention

[0004] The purpose of the embodiments of the present application is to provide a catheter and a catheter-based intraluminal navigation method, which can achieve radiation-free intraluminal visualization imaging and enable doctors and patients to deliver instruments to the target position in the cavity in a radiation-free environment.

[0005] In a first aspect, an embodiment of the present application provides a catheter, wherein the catheter body includes a visual segment having a forward visual module and a circumferential visual module; the visual segment is arranged at the distal end of the catheter body; the forward visual module extends toward the distal end of the catheter body, and the circumferential visual module is arranged in the circumferential direction of the visual segment; wherein the forward visual module is configured to obtain visual information of the forward direction of the catheter, and the circumferential visual module is configured to obtain visual information of the circumferential direction of the visual segment.

[0006] In the above implementation process, the catheter structure provided by the embodiment of the present application provides comprehensive visual information of the distal end of the catheter through the combination of the forward vision module and the circumferential vision module; and the catheter provided by the embodiment of the present application can achieve all-round high-quality imaging in the cavity, and no longer requires real-time X-ray guidance of DSA, which can significantly improve the navigation accuracy and safety of the catheter in the cavity.

[0007] Optionally, in an embodiment of the present application, the forward vision module includes multiple forward vision units, and the circumferential vision module includes multiple circumferential vision units; the multiple circumferential vision units are evenly arranged on the outer wall of the vision segment, and the circumferential vision units are evenly arranged at the end of the vision segment.

[0008] In the above-mentioned implementation process, the forward and circumferential visual units adopted in the embodiment of the present application can be ultrasonic transducers, which realize all-round and multi-angle ultrasonic imaging. The forward ultrasonic transducer provides a longitudinal image of the forward path to help the operator navigate and make better choices for tortuous blood vessels with more branches; the circumferential ultrasonic transducer provides a cross-sectional or oblique field of view of the surrounding blood vessel wall through vertical or oblique imaging to help evaluate the nature of the lesion and the position of the instrument. The setting of the imaging segment of the catheter provided in the embodiment of the present application not only improves the comprehensiveness and accuracy of the imaging, but also significantly enhances the operational safety and efficiency of the instrument in a complex vascular environment. Through multi-angle ultrasonic coverage, the operator can obtain high-resolution vascular structure and lesion information in real time, reduce surgical risks, shorten operation time, and provide strong technical support for minimally invasive interventional surgery.

[0009] Optionally, in an embodiment of the present application, the forward vision unit and the circumferential vision unit include ultrasonic transducers.

[0010] In the above-mentioned implementation process, the forward and circumferential visual units adopted in the embodiment of the present application can be ultrasonic transducers, which realize all-round and multi-angle ultrasonic imaging. The forward ultrasonic transducer provides a longitudinal image of the forward path to help the operator navigate and make better choices for tortuous blood vessels with more branches; the circumferential ultrasonic transducer provides a cross-sectional or oblique field of view of the surrounding blood vessel wall through vertical or oblique imaging to help evaluate the nature of the lesion and the position of the instrument. The setting of the imaging segment of the catheter provided in the embodiment of the present application not only improves the comprehensiveness and accuracy of the imaging, but also significantly enhances the operational safety and efficiency of the instrument in a complex vascular environment. Through multi-angle ultrasonic coverage, the operator can obtain high-resolution vascular structure and lesion information in real time, reduce surgical risks, shorten operation time, and provide strong technical support for minimally invasive interventional surgery.

[0011] Optionally, in an embodiment of the present application, the catheter also includes a connecting wire and a handle with a visual connection module; the connecting wire is arranged between the inner wall and the outer wall of the tube body, and is configured to connect the forward vision module and the visual connection module, and to connect the circumferential vision module and the visual connection module; the visual connection module is configured to realize electrical connection between the forward vision module and the circumferential vision module and the external controller.

[0012] In the above implementation process, the present embodiment of the present invention electrically connects the forward and circumferential vision modules to an external controller by installing connecting wires and a visual connection module within the catheter. The visual connection module facilitates the operator's connection to external devices and real-time acquisition of visual information, significantly improving data transmission stability and operational convenience, enabling the operator to obtain high-resolution images of the blood vessels in real time.

[0013] Optionally, in an embodiment of the present application, the catheter also includes a bending adjustment wire and an adjustable bending section with a wire fixing member; the handle also includes a bending adjustment control member; the wire fixing member is fixed to the distal circumferential direction of the adjustable bending section and is configured to fix the bending adjustment wire; the bending adjustment wire is fixedly connected to the wire fixing member and is connected to the bending adjustment control member through a passage between the inner wall and the outer wall of the tube body; the bending control member is configured to control the posture change of the adjustable bending section by transmitting force to the bending adjustment wire, and the bending adjustment wire is configured to transmit force from the bending control member.

[0014] In the above-mentioned implementation process, the embodiment of the present application realizes the precise control of the distal end posture of the catheter through the coordinated work of the bending control part, the bending pull wire and the adjustable bending section. The operator adjusts the posture of the distal end of the catheter in real time through the bending control part, so that it adapts to the direction of the blood vessel and makes better selections for tortuous blood vessels with more branches. If the catheter is equipped with a visual module (such as a forward and / or circumferential ultrasonic transducer), the operator can further optimize the posture adjustment through real-time image feedback. When resetting or reverse adjustment is required, the operator reversely operates the bending control part, relaxes the currently tightened bending pull wire, and tightens the pull wire on the other side to restore the adjustable bending section to a straight state or bend in the opposite direction. The catheter provided by the embodiment of the present application can flexibly adapt to complex vascular paths, significantly improves the navigation accuracy and operating efficiency of the operation, and at the same time, combined with the real-time feedback of the visual module, provides strong technical support for the treatment of complex lesions.

[0015] Optionally, in an embodiment of the present application, the adjustable bend section includes a first adjustable bend section and a second adjustable bend section, the pull wire fixing piece includes a first pull wire fixing piece and a second pull wire fixing piece, and the bending adjustment pull wire includes a first bending adjustment pull wire and a second bending adjustment pull wire; the first pull wire fixing piece is fixed to the distal circumferential direction of the first adjustable bend section, and the second pull wire fixing piece is fixed to the distal circumferential direction of the second adjustable bend section; the first bending adjustment pull wire is connected to the first pull wire fixing piece, and the second bending adjustment pull wire is connected to the second pull wire fixing piece; the first bending adjustment pull wire and the second bending adjustment pull wire are arranged on the tube body along different axial paths, and the projections of the first bending adjustment pull wire and the second bending adjustment pull wire on the cross section of the catheter respectively form an angle greater than or equal to 90° with the line connecting the center points of the catheter.

[0016] In the above implementation process, the embodiment of the present application realizes multi-segment independent bending control of the distal end of the catheter by setting a first adjustable bend section and a second adjustable bend section, respectively equipped with a first bend adjustment wire and a second bend adjustment wire. The two bend adjustment wires are set along different axial paths, and the angle formed by their projections and the line connecting the center points of the catheter is greater than or equal to 90°, ensuring that the two adjustable bend sections can achieve coordinated or independent bending adjustment. This enables it to better adapt to complex vascular paths. In combination with the visual module of the catheter of the embodiment of the present application, it can improve the navigation accuracy and operational efficiency of the surgery.

[0017] Optionally, in an embodiment of the present application, the first bending adjustment cable includes a first bending control cable and a first return bending cable, and the second bending adjustment cable includes a second bending control cable and a second return bending cable; the first bending control cable and the first return bending cable are connected to the first cable fixing piece, and the second bending control cable and the second return bending cable are connected to the second cable fixing piece; wherein, the first bending control cable is configured to control the bending of the first adjustable bending section by transmitting the force from the bending control piece to the first cable fixing piece, and the second bending control cable is configured to control the bending of the second adjustable bending section by transmitting the force from the bending control piece to the second cable fixing piece; the first return bending cable is configured to control the first adjustable bending section to restore its deformation by transmitting the force from the bending control piece to the first cable fixing piece, and the second return bending cable is configured to control the second adjustable bending section to restore its deformation by transmitting the force from the bending control piece to the second cable fixing piece.

[0018] In the aforementioned implementation, the adjustable bend section of the catheter provided in this embodiment can be controlled by dual pull-wire configurations. Bend control lines and return lines are configured for both the first and second adjustable bend sections, enabling independent and precise bending control of multiple sections at the distal end of the catheter. The two-section configuration, combined with dual pull-wire configurations, enables the catheter to achieve complex two-dimensional or three-dimensional bends, such as "S" shapes, adapting to various vascular anatomies.

[0019] Optionally, in an embodiment of the present application, the first bending control line and the first bending line are arranged on the tube body along different axial paths, and the angles formed by the projections of the first bending control line and the first bending line on the cross-section of the catheter and the line connecting the center points of the catheter are greater than or equal to 90°; the second bending control line and the second bending line are arranged on the tube body along different axial paths, and the angles formed by the projections of the second bending control line and the second bending line on the cross-section of the catheter and the line connecting the center points of the catheter are greater than or equal to 90°; the angles formed by the projections of the first bending adjustment line and the second bending adjustment line on the cross-section of the catheter and the line connecting the center points of the catheter do not coincide.

[0020] In the above implementation process, the catheter provided in the embodiment of the present application has multiple adjustable bending sections, and when a bending control line and a bending adjustment line are set corresponding to an adjustable bending section, the setting of the bending adjustment lines corresponding to different adjustable bending sections can be offset in the circumferential direction of the tube body corresponding to the central angle, thereby realizing the adjustable posture of the distal end of the catheter in multiple directions without increasing the volume of the tube body.

[0021] Optionally, in an embodiment of the present application, the bending adjustment pull wire includes a first direction bending adjustment pull wire, a second direction bending adjustment pull wire, a third direction bending adjustment pull wire and a fourth direction bending adjustment pull wire; the first direction bending adjustment pull wire, the second direction bending adjustment pull wire, the third direction bending adjustment pull wire and the fourth direction bending adjustment pull wire are fixedly connected to the pull wire fixing member; the projections of the first direction bending adjustment pull wire, the second direction bending adjustment pull wire, the third direction bending adjustment pull wire and the fourth direction bending adjustment pull wire on the cross section of the catheter respectively form an angle of 90°±5° with the line connecting the center points of the catheter.

[0022] Optionally, in an embodiment of the present application, path planning is performed on the catheter based on the physiological information and the structural information, including: outputting an operation guide using an image-operation matching model based on the physiological information and the structural information.

[0023] Optionally, in an embodiment of the present application, the method for obtaining the image-operation matching model includes: constructing an image-operation matching database based on historical surgical operations and image information corresponding to the historical surgical operations; wherein the image information includes circumferential visual information and forward visual information; using the image-operation matching database to train the image-operation matching model; and optimizing the image-operation matching model based on real-time surgical operations and image information corresponding to the real-time surgical operations.

[0024] Optionally, in an embodiment of the present application, the method of constructing the image-operation matching database includes: controlling the catheter to enter the target access blood vessel and collecting image information of the access blood vessel; obtaining the operator's operation corresponding to the image information, determining multiple image-operation matching relationships, and forming an image-operation matching database; wherein the image-matching operation relationship includes stop operation-vascular abnormality image, stop operation-reaching target position image, turning operation-vascular branch opening image and no operation-normal advancement image.

[0025] In the aforementioned implementation process, the present application achieves precise, all-around control of the catheter in three-dimensional space by providing four symmetrically distributed bend adjustment wires, combined with wire fixtures. This design enables the catheter to bend in all directions, including forward and backward, and left and right. In some embodiments, this design, combined with a handle, also enables the catheter to bend at any angle, including forward and backward, left and right, and any combination thereof. The orthogonal arrangement of the four wires eliminates control blind spots and, combined with the handle, enables the operator to precisely perform complex movements within the blood vessel, such as "forward-backward" and "left-right turn," making it particularly suitable for navigating complex anatomical structures such as bifurcated vessels.

[0026] In a second aspect, an embodiment of the present application provides a catheter-based intraluminal navigation method, which includes: obtaining circumferential visual information and forward visual information in the lumen; determining structural information and physiological information in the lumen based on the circumferential visual information and forward visual information; and planning the path of the catheter based on the physiological information and structural information; wherein the circumferential visual information and forward visual information are obtained based on the catheter in any one of the first aspects of the present application.

[0027] In the above-mentioned implementation process, the catheter-based intracavitary navigation method provided in the embodiment of the present application, and the navigation method based on the catheter and the intracavitary channel, significantly reduce the dependence on X-rays in puncture interventional surgery, and effectively reduce the radiation exposure time of both doctors and patients. Through real-time image guidance, the accuracy of establishing vascular access is significantly improved, making it easier for the operator to locate the target blood vessel or tissue. The system that integrates the catheter-based navigation method and the catheter provided in the embodiment of the present application is mainly suitable for peripheral vascular interventional treatment (such as renal artery, hepatic artery, splenic artery, etc.) and cardiac surgery or examination, and innovatively integrates dual-mode imaging functions, including basic B-ultrasound mode and advanced 4D color Doppler mode, to provide optimized imaging support for different clinical scenarios.

[0028] In a third aspect, an embodiment of the present application provides an electronic device, comprising a memory and a processor, wherein the memory stores program instructions, and when the processor reads and runs the program instructions, it executes the steps in the implementation method of the above-mentioned second aspect.

[0029] In a fourth aspect, an embodiment of the present application further provides a computer-readable storage medium, wherein the computer program instructions are stored in the computer-readable storage medium. When the computer program instructions are read and executed by a processor, the steps in the implementation method of the second aspect are executed.

[0030] In a fifth aspect, an embodiment of the present application further provides a computer program product, wherein the computer program product includes a computer program / instruction, and when the computer program / instruction is executed by a processor, the steps in the implementation method of the above-mentioned second aspect are executed. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0032] Figure 1 A first schematic diagram of a catheter body provided in an embodiment of the present application;

[0033] Figure 2 A second schematic diagram of a catheter body provided in an embodiment of the present application;

[0034] Figure 3 A schematic structural diagram of a catheter provided in an embodiment of the present application;

[0035] Figure 4 A schematic diagram of the configuration of the circumferential vision module provided in an embodiment of the present application;

[0036] Figure 5 A third schematic diagram of a catheter body provided in an embodiment of the present application;

[0037] Figure 6 An example diagram of a wire fixing member provided in an embodiment of the present application;

[0038] Figure 7 A schematic diagram of a bending control member provided in an embodiment of the present application;

[0039] Figure 8 A fourth schematic diagram of a catheter body provided in an embodiment of the present application;

[0040] Figure 9 Provided in the embodiments of this application Figure 8 AA cross-sectional diagram of ;

[0041] Figure 10 Provided in the embodiments of this application Figure 8 BB cross-section diagram;

[0042] Figure 11 Provided in the embodiments of this application Figure 8 Schematic diagram of CC cross section;

[0043] Figure 12 Provided in the embodiments of this application Figure 8 DD cross-sectional diagram;

[0044] Figure 13 A fifth schematic diagram of a catheter body provided in an embodiment of the present application;

[0045] Figure 14 Provided in the embodiments of this application Figure 13 AA cross-sectional diagram of ;

[0046] Figure 15 Provided in the embodiments of this application Figure 13 BB cross-section diagram;

[0047] Figure 16 Provided in the embodiments of this application Figure 13 Schematic diagram of CC cross section;

[0048] Figure 17 Provided in the embodiments of this application Figure 13 DD cross-sectional diagram;

[0049] Figure 18 A schematic cross-sectional view of another design of a catheter body provided in an embodiment of the present application;

[0050] Figure 19 A schematic diagram of another tube structure provided in an embodiment of the present application;

[0051] Figure 20 Provided in the embodiments of this application Figure 19 Schematic cross-section diagram of ;

[0052] Figure 21 A flowchart of a catheter-based intraluminal navigation method provided in an embodiment of the present application;

[0053] Figure 22 A flowchart for constructing an image-operation matching model provided in an embodiment of the present application;

[0054] Figure 23 A schematic diagram of constructing an image-operator matching database provided in an embodiment of the present application;

[0055] Figure 24 A schematic diagram of the structure of an electronic device provided in an embodiment of the present application.

[0056] Icons: Catheter 1000; Tube 100; Tube Distal End S; Circumferential Direction C; Vision Segment 110; Forward Vision Module 111; Circumferential Vision Module 112; Forward Vision Unit a; Circumferential Vision Unit b; Handle 200; Vision Connection Module 210; Bending Control Component 220; Connecting Wire 300; Bending Wire 400; First Bending Wire 411; Second Bending Wire 412; First Bending Control Line-421; first bending line-422; second bending control line-431; second bending line-432; first direction bending adjustment line-441; second direction bending adjustment line-442; third direction bending adjustment line-443; fourth direction bending adjustment line-444; adjustable bending section-120; first adjustable bending section-121; second adjustable bending section-122; line fixing member-130; first line fixing member-131; second line fixing member-132. DETAILED DESCRIPTION

[0057] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of them. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0058] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the embodiments of the present application claimed for protection, but merely represents selected embodiments of the present application. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present application without making creative efforts are within the scope of protection of the embodiments of the present application.

[0059] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0060] In the description of the embodiments of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the embodiment of the application is usually placed when in use. They are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0061] Furthermore, terms such as "horizontal" and "vertical" do not necessarily mean that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0062] In the description of the embodiments of the present application, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in the embodiments of the present application based on the specific circumstances.

[0063] Endovascular interventional surgery, a minimally invasive treatment technique, has made significant progress in the treatment of peripheral vascular, cardiac, and cardiovascular and cerebrovascular diseases in recent years. Due to its advantages of minimal trauma, rapid recovery, and few complications, it has gradually replaced most traditional open surgeries and become the preferred treatment for many vascular diseases. Interventional surgery involves inserting catheters, guidewires, balloons, stents, and other devices into the blood vessels through tiny incisions in the skin, directly reaching the affected area, achieving precise treatment for lesions such as stenosis, occlusion, and aneurysms.

[0064] Currently, interventional procedures often rely on real-time guidance from digital subtraction angiography (DSA). Using X-ray imaging technology, DSA can clearly display the anatomical structure of blood vessels and the location of lesions, helping operators observe the path of instruments within the vessels in real time and accurately locate the target location.

[0065] However, the inventors found that during this process, although DSA technology provides important visualization support for interventional surgery, its reliance on X-rays also brings about radiation exposure problems. Especially for patients with complex lesions or tortuous blood vessels with many branches, the operation time may be longer, and the exposure time of both doctors and patients to the radiation environment also increases accordingly.

[0066] Based on this, this application proposes a catheter and a catheter-based intraluminal navigation method. The catheter integrates a forward-facing and lateral-facing vision module. By positioning the vision module at the end of the catheter, the catheter is accurately positioned, which facilitates the planning of the catheter's movement path. This achieves radiation-free intravascular visualization, enabling doctors and patients to insert instruments into blood vessels in a radiation-free environment, making interventional procedures safer and more efficient.

[0067] Please see Figure 1 , Figure 1 This is a first schematic diagram of a catheter body provided in an embodiment of the present application; the present application provides a catheter 1000 , wherein the body 100 of the catheter 1000 includes a visual segment 110 having a forward visual module 111 and a circumferential visual module 112 .

[0068] like Figure 1 As shown, the visual segment 110 is disposed at the distal end S of the tube body. The forward visual module 111 is directed toward the extension direction of the distal end S of the tube body, and the circumferential visual module 112 is disposed in the circumferential direction C of the visual segment 110 .

[0069] The forward visual module 111 is mainly used to obtain forward visual information of the forward or backward movement of the distal end of the catheter 1000. The forward visual module 111 in the embodiment of the present application can be set on the distal end surface of the visual segment 110, or the forward visual module 111 is set in the circumferential direction C of the distal end of the visual segment 110, and its direction is the extension direction of the distal end S of the tube body.

[0070] In an embodiment of the present application, the forward vision module 111 is configured to obtain visual information of the forward direction of the catheter 1000, mainly used to obtain forward visual information when the catheter 1000 moves forward or backward, which helps the operator navigate during the operation and make better selections for tortuous blood vessels with more branches.

[0071] The circumferential vision module 112 is configured to obtain visual information in the circumferential direction C of the visual segment 110 and provide visual information of the environment surrounding the catheter 1000, which can help the operator understand the state of the inner wall of the cavity, the location of the lesion, and the contact between the instrument and the cavity.

[0072] pass Figure 1 It can be seen that the structure of the catheter 1000 provided in the embodiment of the present application provides comprehensive visual information of the distal end of the catheter 1000 through the combination of the forward vision module 111 and the circumferential vision module 112; and the catheter 1000 provided in the embodiment of the present application can achieve all-round high-quality imaging in the cavity, and no longer requires real-time X-ray guidance of DSA, which can significantly improve the navigation accuracy and safety of the catheter 1000 in the cavity.

[0073] Please see Figure 2 , Figure 2 A second schematic diagram of a catheter body provided in an embodiment of the present application; in an embodiment of the present application, the forward vision module 111 includes a plurality of forward vision units a, and the circumferential vision module 112 includes a plurality of circumferential vision units b;

[0074] A plurality of circumferential vision units b are evenly arranged on the outer wall of the vision segment 110 , and the circumferential vision units b are evenly arranged at the end of the vision segment 110 .

[0075] like Figure 2 As shown, the forward vision module 111 has a plurality of forward vision units a, and the circumferential vision module 112 has a plurality of circumferential vision units b; the plurality of forward vision units a and the plurality of circumferential vision units b are evenly distributed at the distal end of the catheter 1000 .

[0076] The forward vision unit a and the circumferential vision unit b can be, for example, optical fiber sensors, infrared imaging units, etc.

[0077] pass Figure 2 It can be seen that the visual segment 110 of the catheter 1000 provided in the embodiment of the present application uses evenly distributed visual units, so that the operator can obtain high-resolution images or signals, accurately identify the location of the lesion, and evaluate the status within the cavity, providing strong technical support for minimally invasive interventional surgery.

[0078] Please continue to see Figure 2 In an optional implementation manner of the embodiment of the present application, the forward vision unit a and the circumferential vision unit b include ultrasonic transducers.

[0079] In the embodiment of the present application, both the forward vision unit a and the circumferential vision unit b can be ultrasonic transducers, namely, a forward ultrasonic transducer and a circumferential ultrasonic transducer. The forward ultrasonic transducer can transmit ultrasonic waves and receive echoes in a direction parallel to the axial direction of the tube body 100, while the circumferential ultrasonic transducer can transmit ultrasonic waves and receive echoes in a direction perpendicular to the circumference of the tube body 100, or in a direction at an angle of 20° to 80° to the axial direction of the tube body 100.

[0080] In this implementation, the ultrasonic transducer converts electrical energy into mechanical energy, emitting high-frequency sound waves (typically 1-20 MHz). These sound waves propagate through tissue and are reflected when encountering tissue interfaces with different acoustic impedances. The reflected sound waves (echoes) are received by the ultrasonic transducer and converted into electrical signals. By calculating the propagation time and intensity of the sound waves, an ultrasonic image of the tissue can be generated.

[0081] The forward-facing ultrasound transducer generates longitudinal images along the axis of the tube 100, showing the vascular structure and lesions along the forward path. The circumferential ultrasound transducer generates cross-sectional or oblique images perpendicular to the axis of the tube 100, revealing details of the surrounding vascular wall. The circumferential ultrasound transducer design provides a more comprehensive (20° to 80°) field of view, making it particularly suitable for tortuous vessels with numerous branches or complex lesions.

[0082] It can be seen that the forward and circumferential visual units b adopted in the embodiment of the present application can be ultrasonic transducers, which realize all-round and multi-angle ultrasonic imaging. The forward ultrasonic transducer provides a longitudinal image of the forward path to help the operator navigate and make better choices for tortuous blood vessels with more branches; the circumferential ultrasonic transducer provides a cross-sectional or oblique field of view of the surrounding blood vessel wall through vertical or oblique imaging to help evaluate the nature of the lesion and the position of the instrument. The setting of the imaging segment of the catheter 1000 provided in the embodiment of the present application not only improves the comprehensiveness and accuracy of the imaging, but also significantly enhances the operational safety and efficiency of the instrument in a complex vascular environment. Through multi-angle ultrasonic coverage, the operator can obtain high-resolution vascular structure and lesion information in real time, reduce surgical risks, shorten operation time, and provide strong technical support for minimally invasive interventional surgery.

[0083] Please Figure 2 See the basis of Figure 3 and Figure 4 , Figure 3 A schematic structural diagram of a catheter provided in an embodiment of the present application; Figure 4 This is a schematic diagram of the configuration of the circumferential visual module provided in an embodiment of the present application. In an optional implementation of the embodiment of the present application, the catheter 1000 further includes a connecting line 300 and a handle 200 having a visual connection module 210 .

[0084] The connecting line 300 is disposed between the inner wall and the outer wall of the tube body 100 and is configured to connect the forward vision module 111 and the vision connection module 210 , and to connect the circumferential vision module 112 and the vision connection module 210 .

[0085] The vision connection module 210 is configured to realize electrical connection between the forward vision module 111 and the circumferential vision module 112 and an external controller.

[0086] In the above implementation process, the visual module and the visual connection module 210 are connected by the connecting line 300 provided between the inner wall and the outer wall of the tube body 100 , and the image data and control signals collected by the visual module are transmitted through the connecting line 300 .

[0087] The visual connection module 210 of the handle 200 can be easily connected to external devices, and the image information collected by the visual module can be transmitted to the external controller to monitor and process the information provided by the visual module in real time; and control instructions can be transmitted to the visual connection module 210 to achieve control of the visual module.

[0088] pass Figure 3 and Figure 4 As can be seen, the present embodiment of the present invention achieves electrical connection between the forward vision module 111 and the circumferential vision module 112 and an external controller by providing a connecting wire 300 and a visual connection module 210 in the catheter 1000. The visual connection module 210 facilitates the operator to connect to external devices and obtain visual information in real time, significantly improving the stability of data transmission and the ease of operation, enabling the operator to obtain high-resolution images of the blood vessels in real time.

[0089] Please see Figures 5 to 8 , Figure 5 A third schematic diagram of a catheter body provided in an embodiment of the present application; Figure 6 An example diagram of a wire fixing member provided in an embodiment of the present application; Figure 7 A schematic diagram of a bending control member provided in an embodiment of the present application; Figure 8 This is a fourth schematic diagram of the catheter body provided in an embodiment of the present application; in an optional implementation of the embodiment of the present application, the catheter further includes a bending adjustment wire and an adjustable bending section with a wire fixing member; the handle further includes a bending adjustment control member.

[0090] The wire fixing member 130 is fixed to the distal circumferential direction C of the adjustable bending section 120 and is configured to fix the bending adjustment wire 400. The bending adjustment wire 400 is fixedly connected to the wire fixing member 130 ( Figure 5 ) and connected to the bending control member 220 through the passage between the inner wall and the outer wall of the tube body 100 ( Figure 7); the bending control member 220 is configured to control the posture change of the adjustable bending section 120 by transmitting force to the bending wire 400, and the bending wire 400 is configured to transmit force from the bending control member 220.

[0091] like Figure 5 As shown, the catheter body 100 of the catheter 1000 provided in the embodiment of the present application further includes an adjustable bend section 120. The adjustable bend section 120 can adjust the position of the catheter 1000 by being pulled by a bend adjustment wire 400, and can adapt to complex vascular pathways.

[0092] Figure 5 The red line located between the inner and outer walls of the tube body 100 is the bend adjustment cable 400. The bend adjustment cable 400 extends from the cable fixture 130, passes through the passage between the inner and outer walls of the tube body 100, and ultimately connects to the bend control member 220 of the handle 200. The bend adjustment cable 400 transmits the tension from the bend control member 220 to control the bending direction and angle of the adjustable bend section 120.

[0093] In the embodiment of the present application, the bending wire 400 is generally made of a high-strength, low-ductility material (such as stainless steel wire, nickel-titanium alloy or polymer fiber) to ensure efficient force transmission.

[0094] In the embodiment of the present application, the material of the visual segment 110 is Pebax or PU (polyurethane), and the material of the adjustable bend segment 120 is Pebax (polyether block amide) or PU (polyurethane). The material of the tube body 100 excluding the visual segment 110 and the adjustable bend segment 120 is nylon. Preferably, in actual application, the flexibility of the visual segment 110, the flexibility of the adjustable bend segment 120, and the flexibility of the remaining portion after removing the visual segment and the adjustable bend segment 120 show a basically decreasing trend. The wire fixing part 130 is an element provided on the tube body 100 for fixing the bend adjustment wire 400. It is usually fixed to the tube body 100 in a ring-shaped or point-shaped fixing manner. For example, as Figure 6 As shown, the pull wire fixing member 130 is annular and can be fixed to the tube body 100 by laser welding. The bending adjustment wire 400 is fixedly connected to the pull wire fixing member 130 and is connected to the adjustable bending control member 220 through the passage between the inner wall and the outer wall of the tube body 100.

[0095] The bend control element 220 is integrated into the handle 200, allowing for direct operator control. In this embodiment, the bend control element 220 applies force to the bend wire 400 mechanically or electronically to control the position of the adjustable bend section 120. For example, it can be in the form of a knob, slider, or button, enabling precise adjustment.

[0096] Please refer to Figure 7The structure of the knob-type bending control component 220 generally includes a rotating handle 200, an internal gear or pulley system, and a transmission mechanism connected to the bending adjustment cable 400. The knob drives the internal gear or pulley by rotation, and the gear or pulley is connected to the bending adjustment cable 400, converting the rotational motion into linear tension. The bending adjustment cable 400 passes through the passage between the inner wall and the outer wall of the tube body 100 and is finally connected to the cable fixing part 130 of the adjustable bending section 120. The rotation direction of the knob (clockwise or counterclockwise) determines the tightening or loosening of the cable, thereby controlling the bending direction and angle of the adjustable bending section 120. When the operator rotates the knob, the internal mechanism transmits the rotational force to the bending adjustment cable 400, and the cable acts on the cable fixing part 130 of the adjustable bending section 120 through tension, causing the adjustable bending section 120 to bend. The operator can achieve precise posture control by fine-tuning the knob. For example, clockwise rotation may cause the adjustable bending section 120 to bend to the left, while counterclockwise rotation may cause it to bend to the right.

[0097] Please see Figures 5 to 8 In the embodiment of the present application, the operator applies force or displacement through the bending control member 220 (such as a knob, slider or button) on the handle 200, and the movement of the bending control member 220 transmits the force to the bending wire 400 through the internal mechanical structure (such as a gear, pulley or connecting rod). The bending wire 400 transmits force to the distal end along the passage between the inner wall and the outer wall of the tube body 100, acting on the wire fixing member 130 fixed at the distal end of the adjustable bending section 120 in the circumferential direction C. Since the adjustable bending section 120 is flexible, the tension of the wire causes it to bend, and the angle and direction of the bending are determined by the operating force of the bending control member 220 and the distribution of the wire. For example, tightening the wire on one side can cause the adjustable bending section 120 to bend to that side, while multi-sided wires can achieve bending in more directions. In some embodiments, the coordinated work of multi-sided wires can also achieve complex two-dimensional bending or three-dimensional bending, preferably achieving two-dimensional bending.

[0098] pass Figures 5 to 8It can be seen that the embodiment of the present application achieves precise control of the distal posture of the catheter 1000 through the coordinated work of the bending control part 220, the bending adjustment wire 400 and the adjustable bending section 120. The operator adjusts the posture of the distal end of the catheter 1000 in real time through the bending control part 220 so that it can adapt to tortuous blood vessels with more branches. If the catheter 1000 is equipped with a visual module (such as a forward and / or circumferential ultrasonic transducer), the operator can further optimize the posture adjustment through real-time image feedback. When resetting or reverse adjustment is required, the operator reversely operates the bending control part 220, relaxes the currently tightened bending adjustment wire 400, and tightens the wire on the other side to restore the adjustable bending section 120 to a straight state or bend in the opposite direction. The catheter 1000 provided in the embodiment of the present application can flexibly adapt to complex vascular pathways, significantly improves the navigation accuracy and operating efficiency of the operation, and at the same time, combined with the real-time feedback of the visual module, provides strong technical support for the treatment of complex lesions.

[0099] Please see Figures 8 to 12 , Figure 8 A fourth schematic diagram of a catheter body provided in an embodiment of the present application; Figure 9 Provided in the embodiments of this application Figure 8 AA cross-sectional diagram of ; Figure 10 Provided in the embodiments of this application Figure 8 BB cross-section diagram; Figure 11 Provided in the embodiments of this application Figure 8 Schematic diagram of CC cross section; Figure 12 Provided in the embodiments of this application Figure 8 DD cross-sectional schematic diagram; in an optional implementation manner of an embodiment of the present application, the adjustable bending section 120 includes a first adjustable bending section 121 and a second adjustable bending section 122, the wire fixing member 130 includes a first wire fixing member 131 and a second wire fixing member 132, and the bending adjustment wire 400 includes a first bending adjustment wire 411 and a second bending adjustment wire 412.

[0100] The first cable fixing member 131 is fixed to the distal circumferential direction C of the first adjustable bend section 121 , and the second cable fixing member 132 is fixed to the distal circumferential direction C of the second adjustable bend section 122 . The first bending adjustment cable 411 is connected to the first cable fixing member 131 , and the second bending adjustment cable 412 is connected to the second cable fixing member 132 .

[0101] The first bending adjustment wire 411 and the second bending adjustment wire 412 are arranged on the tube body 100 along different axial paths, and the angles formed by the projections of the first bending adjustment wire 411 and the second bending adjustment wire 412 on the cross section of the catheter 1000 and the lines connecting the center points of the catheter 1000 are greater than 90°.

[0102] like Figure 8As shown, AA to CC is the first adjustable bend section 121, CC to DD is the second adjustable bend section 122; the first pull wire fixture 131 is set at the distal end of the first adjustable bend section 121, and the first bend adjustment wire 411 extends from the first pull wire fixture 131 to the handle 200 side; the second pull wire is set at the distal end of the second adjustable bend section 122, and the second bend adjustment wire 412 extends from the second pull wire fixture 132 to the handle 200 side. Figure 9 As shown in the AA section schematic diagram, Figure 6 The first pull wire fixing member 131 of the structure shown is arranged in the tube body 100; and Figure 11 As shown in the CC section schematic diagram, Figure 6 The second pull wire fixing member 132 of the structure shown is arranged in the tube body 100; and it can be seen that the size of the first pull wire fixing member 131 is larger than the size of the second pull wire fixing member 132. In actual application, the size of the second pull wire fixing member 132 can also be set to be larger than the size of the first pull wire fixing member 131; the purpose of setting the size of the first pull wire fixing member 131 and the second pull wire fixing member 132 to different sizes is to allow the first bending adjustment wire 411 and the second bending adjustment wire 412 to extend to the handle 200 through different paths; of course, the size of the second pull wire fixing member 132 can also be set to be the same as the size of the first pull wire fixing member 131. At this time, a groove can be opened on the second pull wire fixing member 132 (for example, annular), and the groove can allow the first bending adjustment wire 411 connected to the first pull wire fixing member 131 to pass through.

[0103] Please refer to Figure 10 The BB cross-section diagram shown and Figure 12 DD cross-sectional schematic diagram shown; in the example provided in the embodiment of the present application, the angle between the first bending adjustment wire 411 and the second bending adjustment wire 412 and the line connecting the center point of the catheter 1000 is 180°, that is, they are set on the opposite side; it should be noted that the 180° setting is only exemplary. In actual applications, the first bending adjustment wire 411 and the second bending adjustment wire 412 should be extended to the handle 200 through different paths, and the first bending adjustment wire 411 and the second bending adjustment wire 412 should be able to adjust the adjustable bending section 120 to different angles or postures; at least the projections of the first bending adjustment wire 411 and the second bending adjustment wire 412 on the cross section of the catheter 1000 should be controlled to form an angle greater than or equal to 90° with the line connecting the center points of the catheter 1000.

[0104] The first and second bending wires 411, 412 can be tightened or loosened respectively by the bending control member 220 (e.g., a knob or slider) on the handle 200. The first and second bending wires 411, 412 can be bent independently or in conjunction with each other as needed to achieve two-dimensional or three-dimensional position adjustment, preferably achieving two-dimensional position adjustment.

[0105] pass Figures 8 to 12 As can be seen, the embodiment of the present application achieves multi-segment independent bending control of the distal end of the catheter 1000 by providing a first adjustable bend section 121 and a second adjustable bend section 122, respectively equipped with a first bend adjustment wire 411 and a second bend adjustment wire 412. The two bend adjustment wires 400 are arranged along different axial paths, and the angle formed by their projections and the line connecting the center points of the catheter 1000 is greater than or equal to 90°, ensuring that the two adjustable bend sections 120 can achieve coordinated or independent bending adjustment. This allows it to better adapt to complex vascular pathways. In combination with the visual module of the catheter 1000 in the embodiment of the present application, it can improve the navigation accuracy and operational efficiency of the surgery.

[0106] Please see Figures 13 to 17 , Figure 13 A fifth schematic diagram of a catheter body provided in an embodiment of the present application; Figure 14 Provided in the embodiments of this application Figure 13 AA cross-sectional diagram of ; Figure 15 Provided in the embodiments of this application Figure 13 BB cross-section diagram; Figure 16 Provided in the embodiments of this application Figure 13 Schematic diagram of CC cross section; Figure 17 Provided in the embodiments of this application Figure 13 DD cross-sectional schematic diagram; in an optional implementation manner of an embodiment of the present application, the first bending adjustment wire 411 includes a first bending control wire 421 and a first return bending wire 422, and the second bending adjustment wire 412 includes a second bending control wire 431 and a second return bending wire 432.

[0107] like Figure 13 As shown, AA to CC is the first adjustable bending section 121, and CC to DD is the second adjustable bending section 122; the first bending control line 421 and the first return bending line 422 are connected to the first pull wire fixing piece 131, and the second bending control line 431 and the second return bending line 432 are connected to the second pull wire fixing piece 132.

[0108] Among them, the first bending control line 421 is configured to control the bending of the first adjustable bending section 121 by transmitting the force from the bending control component 220 to the first wire fixing component 131, and the second bending control line 431 is configured to control the bending of the second adjustable bending section 122 by transmitting the force from the bending control component 220 to the second wire fixing component 132; the first return bending line 422 is configured to control the first adjustable bending section 121 to restore its deformation by transmitting the force from the bending control component 220 to the first wire fixing component 131, and the second return bending line 432 is configured to control the second adjustable bending section 122 to restore its deformation by transmitting the force from the bending control component 220 to the first wire fixing component 131.

[0109] like Figure 14 As shown in the AA section schematic diagram, Figure 6 The first pull wire fixing member 131 of the structure shown is arranged in the tube body 100; and Figure 16 As shown in the CC section schematic diagram, Figure 6 The second pull wire fixing member 132 of the structure shown is arranged in the tube body 100; and it can be seen that the size of the first pull wire fixing member 131 is larger than the size of the second pull wire fixing member 132. In actual application, the size of the second pull wire fixing member 132 can also be set to be larger than the size of the first pull wire fixing member 131; the purpose of setting the size of the first pull wire fixing member 131 and the second pull wire fixing member 132 to different sizes is to allow the first bending control line 421, the second bending control line 431, the first return bending line 422 and the second return bending line 432 to extend to the handle 200 through different paths; of course, the size of the second pull wire fixing member 132 can also be set to be the same as the size of the first pull wire fixing member 131. At this time, a groove can be opened on the second pull wire fixing member 132 (for example, annular), and the groove can allow the first bending control line 411 connected to the first pull wire fixing member 131 to pass through.

[0110] Please refer to Figure 15 The BB cross-section diagram shown and Figure 17DD cross-sectional schematic diagram shown; in the example provided in the embodiment of the present application, the angle between the first control bending line 421 and the first return bending line 422 and the center point of the catheter 1000 is 180°, and the angle between the second control bending line 431 and the second return bending line 432 and the center point of the catheter 1000 is 180°, that is, the first control bending line 421 and the first return bending line 422 are set on opposite sides, and the second control bending line 431 and the second return bending line 432 are set on opposite sides; it should be noted that the 180° setting is only exemplary. In actual application, it should be ensured that the first control bending line 421, the first return bending line 422, the second control bending line 431 and the second return bending line 432 extend to the handle 200 through different paths, and the first control bending line 421 and the second control bending line 431, the first return bending line 422 and the second return bending line 432 can achieve the adjustment of different angles or postures of the adjustable bend section 120. Please refer to Figure 17 ,pass Figure 17 It can be seen that the first bending control line 421 and the second bending control line 431 (or, the second bending line 432) are set on the same radial path, and the first bending line 422 and the second bending line 432 (or, the second bending control line 431) are set on the same radial path. Figure 17 The setting is only exemplary, and there are many other setting methods in actual applications.

[0111] In the embodiment of the present application, the first bending control line 421 and the second bending control line 431 are bending control lines that respectively control the posture changes of the first adjustable bending segment 121 and the second adjustable bending segment 122. They can realize active deformation control of the first adjustable bending segment 121 and the second adjustable bending segment 122 by applying positive force (transmitting force from the bending control component 220, and the direction of the force is from the proximal end to the distal end).

[0112] In the embodiment of the present application, the first bending line 422 and the second bending line 432 are bending lines that respectively control the first adjustable bending section 121 and the second adjustable bending section 122 to restore their deformation, and can also achieve reset control of the first adjustable section and the second adjustable bending section 122 by applying a positive force (transmitting force from the bending control component 220, and the direction of the force is also from the proximal end to the distal end).

[0113] For example, when the knob on the handle 200 is rotated clockwise, the first bending control line 421 is pulled toward the handle 200, and the tension is transmitted through the first wire fixing ring, causing the AA to CC section of the tube body 100 (the first adjustable bend section 121) to tilt toward the bending control line. At this time, the first return bending line 422 is synchronously released and relaxed, allowing the tube body 100 section to bend freely. As the knob rotation angle increases, the tension of the bending control line gradually increases, and the bending angle of the tube body 100 increases accordingly, forming a stable arc bend. During the bending process, the inclination angle of the wire fixing ring reflects the bending state of the tube body 100 in real time, achieving precise angle control.

[0114] For example, when the knob on handle 200 is rotated counterclockwise, the first return bend wire 422 is pulled toward handle 200, while the first bending control wire 421 is simultaneously released and rebounded. The return bend wire exerts a reverse tension through the wire retaining ring, gradually pulling the curved section AA to CC of the tube body 100 (the first adjustable bend section 121) back to the central axis. When the knob is rotated back to its initial position, the bending control wire is completely relaxed, and the tension of the return bend wire causes the tube body 100 to fully return to a straight state. The entire reset process is achieved through the coordinated action of the two pull wires.

[0115] pass Figures 13 to 17 As can be seen, the adjustable bend section 120 of the catheter body 100 provided in this embodiment of the present application can be controlled by a dual pull-wire configuration. Bend control lines and return lines are provided for both the first and second adjustable bend sections 121, 122, respectively, enabling independent and precise bending control of multiple sections at the distal end of the catheter 1000. This two-section configuration, combined with the dual pull-wire configuration, enables the catheter 1000 to achieve complex two-dimensional or three-dimensional bends, such as "S" shapes, adapting to various vascular anatomies.

[0116] Please see Figure 18 , Figure 18 A schematic cross-sectional view of another design of the catheter body provided in an embodiment of the present application; in an optional embodiment of the embodiment of the present application, the first bending control line 421 and the first return bend line 422 are arranged along different axial paths on the tube body 100, and the projections of the first bending control line 421 and the first return bend line 422 on the cross section of the catheter 1000 respectively form an angle greater than or equal to 90° with the line connecting the center points of the catheter 1000 (e.g., Figures 13 to 17 The design shown is an angle of 180°).

[0117] The second bending control line 431 and the second bending line 432 are arranged on the tube body 100 along different axial paths. The angles formed by the projections of the second bending control line 431 and the second bending line 432 on the cross section of the catheter 1000 and the lines connecting the center points of the catheter 1000 are greater than or equal to 90°.

[0118] The angles formed by the projections of the first bending adjustment wire 411 and the second bending adjustment wire 412 on the cross section of the catheter 1000 and the line connecting the center points of the catheter 1000 do not overlap.

[0119] In the embodiment of the present application, the first bending control line 421, the second bending control line 431, the first return bending line 422 and the second return bending line 432 are offset at the corresponding central angles in the circumferential direction of the tube body 100, which can be 90° or any other deflection angle, such as Figure 18 shown.

[0120] pass Figure 18It can be seen that the catheter 1000 provided in the embodiment of the present application has multiple adjustable bend sections 120, and when a control bend line and a bend adjustment line are set corresponding to one adjustable bend section 120, the setting of the bend adjustment wires 400 corresponding to different adjustable bend sections 120 can be offset in the circumferential direction of the tube body 100 corresponding to the central angle, thereby achieving adjustable posture in multiple directions of the distal end of the catheter 100 without increasing the volume of the tube body 100.

[0121] Please see Figure 19 and Figure 20 , Figure 19 A schematic diagram of another tube structure provided in an embodiment of the present application; Figure 20 Provided in the embodiments of this application Figure 19 In an optional embodiment of the present application, the bending adjustment wire 400 includes a first direction bending adjustment wire 441, a second direction bending adjustment wire 442, a third direction bending adjustment wire 443 and a fourth direction bending adjustment wire 444.

[0122] The first direction bending adjustment wire 441, the second direction bending adjustment wire 442, the third direction bending adjustment wire 443, and the fourth direction bending adjustment wire 444 are fixedly connected to the wire fixing member 130. The projections of the first direction bending adjustment wire 441, the second direction bending adjustment wire 442, the third direction bending adjustment wire 443, and the fourth direction bending adjustment wire 444 on the cross section of the catheter 1000 form an angle of 90°±5° with the line connecting the center points of the catheter 1000.

[0123] like Figure 19 As shown, the first direction bend adjustment wire 441, the second direction bend adjustment wire 442, the third direction bend adjustment wire 443, and the fourth direction bend adjustment wire 444 are fixed to a wire fixing member 130. The four direction bend adjustment wires 400 are symmetrically distributed in a cross shape on the cross section of the catheter body 1000 (in actual application, they may not be strictly symmetrical). The four wires extend to the handle 200 side through independent paths, so that the four wires do not interfere with each other during operation.

[0124] pass Figure 19 and Figure 20As can be seen, the present application achieves precise, all-around control of the catheter 1000 in three-dimensional space by providing four symmetrically distributed bend adjustment wires 400, in conjunction with the wire fixture 130. This design enables the catheter 1000 to bend in all directions, including forward and backward, and left and right. In some embodiments, this design, in conjunction with the handle 200, also enables the catheter 1000 to bend at any angle, including forward and backward, left and right, or any combination thereof, at different times. The orthogonal arrangement of the four wires eliminates control blind spots and, in conjunction with the handle 200, enables the operator to precisely perform complex movements within the blood vessel, such as "forward-backward" and "left-right turn," making it particularly suitable for navigating complex anatomical structures such as bifurcated vessels.

[0125] Please see Figure 21 , Figure 21 A flowchart of a catheter-based intraluminal navigation method provided in an embodiment of the present application; the present application provides a catheter-based intraluminal navigation method, which includes the following steps:

[0126] The following describes the intraluminal navigation method provided by the present application using intravascular navigation as an example, wherein the circumferential visual information and the forward visual information are obtained based on the catheter in the first aspect of the present application.

[0127] Step S100: Acquire circumferential visual information and forward visual information in the cavity.

[0128] In S100 , the catheter provided by the embodiment of the present application is inserted into the target blood vessel through interventional surgery. The catheter provided by the embodiment of the present application obtains circumferential visual information based on the circumferential visual module and obtains forward visual information based on the forward visual module in the target blood vessel.

[0129] Step S200: Determine the intraluminal structural information and physiological information based on the circumferential visual information and the forward visual information.

[0130] In the above step S200, it is determined whether a blood vessel branch and a blood vessel opening are detected based on the circumferential visual information and the forward visual information acquired by the catheter in the target blood vessel.

[0131] Optionally, if no branches or vessel openings are detected, the current position of the catheter in the vessel is determined based on the forward visual information and the circumferential visual information, and the vascular intima, media, and adventitia are identified and segmented, and the vessel wall thickness, lumen area, and shape are calculated in real time.

[0132] Optionally, based on forward visual information and circumferential visual information, a vascular abnormality recognition model is used to identify lesions such as vascular calcification and fibrosis in real time, and to identify abnormalities such as plaques and vascular stenosis; if the above lesions and symptoms are identified, a vascular abnormality prompt message is generated, and the doctor decides whether to continue the operation.

[0133] Step S300: planning a path for the catheter based on the physiological information and the structural information.

[0134] In the above step S300, if no abnormal information of the blood vessel is identified, the angle between the current advancing direction of the distal end of the catheter and the direction of the blood vessel lumen is determined based on the physiological information and the structural information.

[0135] Based on the current position of the catheter and the angle between the current distal end of the catheter and the direction of the vascular lumen, a determination is made as to whether direction adjustment is necessary. If adjustment is necessary, the direction and path of the catheter are determined; otherwise, the catheter continues to be advanced.

[0136] Repeat the above steps S100 to S300 to perform operations such as image acquisition, recognition, judgment, and adjustment until the target position is reached; the target position can be a set distance into the branch or a set distance between the trunk and the branch; the target position can be a number of points set in advance on the trunk and branches; the target position can be autonomously planned by the system's built-in model based on the set number of ablation points.

[0137] In an optional embodiment, step S300 includes outputting operation guidance based on physiological and structural information using an image-operation matching model. Specifically, during the operation, the operator is automatically provided with feedback on the next operation based on the image-operation matching model, based on forward and circumferential visual information.

[0138] Please refer to Figure 22 , Figure 22 A flowchart for constructing an image-operation matching model provided in an embodiment of the present application; the above-mentioned image-operation matching model can be obtained by the following steps:

[0139] Step S310: constructing an image-operation matching database based on historical surgical operations and image information corresponding to the historical surgical operations; wherein the image information includes circumferential visual information and forward visual information.

[0140] In the above step S310, an image-operator matching database is constructed based on the historical surgical operations and the image information corresponding to the historical surgical operations. Figure 23 , Figure 23 Schematic diagram of constructing an image-operator matching database provided in an embodiment of the present application; illustratively, images are automatically collected and stored during historical surgical procedures, and corresponding catheter operation marks are matched to construct an image-operation matching database.

[0141] like Figure 23As shown in the figure, the specific process includes: controlling the catheter to enter the target access vessel and collecting image information of the access vessel; selecting the access vessel (such as the femoral artery or radial artery) before the operation, and collecting forward and circumferential ultrasound images (i.e., forward visual information and circumferential visual information) in real time during the operation. The operator's operation corresponding to the image information is obtained, multiple image-operation matching relationships are determined, and an image-operation matching database is formed; that is, according to the catheter operation (advance, turn, stop), the corresponding label (normal advance, turn, vascular abnormality or target position) is matched. After the background screens and confirms the data, four types of image-matching operation relationships are finally formed, namely, stop operation-vascular abnormality image, stop operation-reach target position image, turn operation-vascular branch opening image and no operation-normal advance image, which are used for subsequent model training.

[0142] Step S320: Using the image-operation matching database, train the image-operation matching model.

[0143] Step S330: Optimizing the image-operation matching model according to the real-time surgical operation and the image information corresponding to the real-time surgical operation.

[0144] In the above steps S320 to S330, the target model is trained using the data in the image-operation matching database obtained in the above step S310 to obtain an image-operator matching model; and the model is continuously optimized during real-time use. Exemplarily, the target model can use a convolutional neural network (CNN) to train a multi-classification model for real-time image classification and display results. When the operator's operation is inconsistent with the model prompt, the image and operation will be recorded to optimize the model. The regional convolutional neural network (RCNN) is used to achieve refined marking of the blood vessel wall, branch opening and abnormal location; and the image sequence of the entire surgical process is combined with the operation sequence, and the features are extracted using the pre-trained CNN and then input into the Transformer network to construct a time series model that can predict the next operation. At each moment, the model outputs the next operation based on all the image feature sequences extracted before that moment, and displays it on the screen or directly sends corresponding instructions to control the catheter movement.

[0145] In the above implementation, the base layer of the image-operation matching model performs image classification, the enhancement layer performs object detection, and the advanced layer predicts operation instructions through time series modeling. This layered design ensures real-time performance (CNN fast classification) while improving spatial accuracy (RCNN positioning) and temporal coherence (Transformer sequence prediction), forming a closed-loop learning system. While the model guides operations, manual feedback continuously optimizes model performance.

[0146] It can be seen from this that the catheter-based intraluminal navigation method provided in the embodiment of the present application, and the navigation method based on the catheter and the intraluminal cavity, significantly reduce the dependence on X-rays in puncture interventional surgery, and effectively reduce the radiation exposure time of both doctors and patients. Through real-time image guidance, the accuracy of establishing vascular access is significantly improved, making it easier for the operator to locate the target blood vessel or tissue. The system that integrates the catheter-based navigation method and the catheter provided in the embodiment of the present application is mainly suitable for peripheral vascular interventional treatment (such as renal artery, hepatic artery, splenic artery, etc.) and cardiac surgery or examination, and innovatively integrates dual-mode imaging functions, including basic B-ultrasound mode and advanced 4D color Doppler mode, to provide optimized imaging support for different clinical scenarios.

[0147] See Figure 24 , Figure 24 This is a schematic diagram of the structure of an electronic device provided in an embodiment of the present application. An electronic device 600 provided in an embodiment of the present application includes: a processor 601 and a memory 602, wherein the memory 602 stores machine-readable instructions executable by the processor 601, and when the machine-readable instructions are executed by the processor 601, the above method is performed.

[0148] Based on the same inventive concept, an embodiment of the present application further provides a computer program product, wherein the computer program product includes a computer program / instruction, which, when executed by a processor, executes the steps in any implementation of the above-mentioned catheter-based intraluminal navigation method.

[0149] Based on the same inventive concept, an embodiment of the present application also provides a computer-readable storage medium, in which computer program instructions are stored. When the computer program instructions are read and run by a processor, the steps in any implementation method of the above-mentioned catheter-based intraluminal navigation method are executed.

[0150] The computer-readable storage medium can be a random access memory (RAM), a read-only memory (ROM), a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), or other media that can store program code.

[0151] In this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising..." does not exclude the presence of additional identical elements in the process, method, article, or device comprising the elements.

[0152] The above description is merely an embodiment of the present application and is not intended to limit the scope of protection of the present application. For those skilled in the art, various modifications and variations of the present application are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A catheter, characterized in that: The tube body of the catheter includes a vision segment having a forward vision module and a circumferential vision module; The visual segment is provided at the distal end of the tube body; The forward vision module is directed toward the extension direction of the distal end of the tube body, and the circumferential vision module is arranged in the circumferential direction of the vision segment; The forward vision module is configured to obtain visual information of the advancing direction of the catheter, and the circumferential vision module is configured to obtain visual information of the circumferential direction of the visual segment.

2. The catheter according to claim 1, wherein The forward vision module includes a plurality of forward vision units, and the circumferential vision module includes a plurality of circumferential vision units; A plurality of the circumferential vision units are evenly arranged on the outer wall of the vision segment, and the circumferential vision units are evenly arranged at the end of the vision segment.

3. The catheter according to claim 2, characterized in that The forward vision unit and the circumferential vision unit include ultrasonic transducers.

4. The catheter according to any one of claims 1 to 3, characterized in that The catheter also includes a connection line and a handle with a visual connection module; The connecting line is provided between the inner wall and the outer wall of the tube body and is configured to connect the forward vision module and the vision connection module, and to connect the circumferential vision module and the vision connection module; The vision connection module is configured to realize electrical connection between the forward vision module and the circumferential vision module and an external controller.

5. The catheter according to claim 4, characterized in that The catheter further comprises a bending adjustment wire and an adjustable bending section having a wire fixing member; the handle further comprises a bending adjustment control member; The pull wire fixing member is fixed to the distal circumferential direction of the adjustable bending section and is configured to fix the bending adjustment pull wire; The bending adjustment wire is fixedly connected to the wire fixing part, and is connected to the bending adjustment control part through the passage between the inner wall and the outer wall of the tube body; the bending adjustment control part is configured to control the posture change of the adjustable bending section by transmitting force to the bending adjustment wire, and the bending adjustment wire is configured to transmit force from the bending adjustment control part.

6. The catheter according to claim 5, characterized in that The adjustable bending section includes a first adjustable bending section and a second adjustable bending section, the wire fixing member includes a first wire fixing member and a second wire fixing member, and the bending adjustment wire includes a first bending adjustment wire and a second bending adjustment wire; The first pull wire fixing member is fixed to the distal circumferential direction of the first adjustable bending section, and the second pull wire fixing member is fixed to the distal circumferential direction of the second adjustable bending section; The first bending adjustment wire is connected to the first wire fixing piece, and the second bending adjustment wire is connected to the second wire fixing piece; The first bending adjustment wire and the second bending adjustment wire are arranged on the tube body along different axial paths, and the angles formed by the projections of the first bending adjustment wire and the second bending adjustment wire on the cross section of the catheter and the lines connecting the center points of the catheter are greater than or equal to 90°.

7. The catheter according to claim 6, characterized in that The first bending adjustment cable includes a first bending control cable and a first return bending cable, and the second bending adjustment cable includes a second bending control cable and a second return bending cable; The first bending control line and the first return bending line are connected to the first wire fixing member, and the second bending control line and the second return bending line are connected to the second wire fixing member; In which, the first bending control line is configured to control the bending of the first adjustable bending section by transmitting the force from the bending control component to the first wire fixing component, and the second bending control line is configured to control the bending of the second adjustable bending section by transmitting the force from the bending control component to the second wire fixing component; the first return bending line is configured to control the first adjustable bending section to restore its deformation by transmitting the force from the bending control component to the first wire fixing component, and the second return bending line is configured to control the second adjustable bending section to restore its deformation by transmitting the force from the bending control component to the second wire fixing component.

8. The catheter according to claim 7, characterized in that The first bending control line and the first return bend line are arranged on the tube body along different axial paths, and the angles formed by the projections of the first bending control line and the first return bend line on the cross section of the tube and the line connecting the center points of the tube are greater than or equal to 90°; The second bending control line and the second bending line are arranged on the tube body along different axial paths, and the angles formed by the projections of the second bending control line and the second bending line on the cross section of the tube and the line connecting the center points of the tube are greater than or equal to 90°; The angles formed by the projections of the first bending adjustment wire and the second bending adjustment wire on the cross section of the catheter and the line connecting the center points of the catheter do not overlap.

9. The catheter according to claim 5, characterized in that The bending adjustment cables include a first direction bending adjustment cable, a second direction bending adjustment cable, a third direction bending adjustment cable and a fourth direction bending adjustment cable; The first direction bending adjustment cable, the second direction bending adjustment cable, the third direction bending adjustment cable and the fourth direction bending adjustment cable are fixedly connected to the cable fixing member; The included angles formed by the projections of the first direction bending adjustment wire, the second direction bending adjustment wire, the third direction bending adjustment wire and the fourth direction bending adjustment wire on the cross section of the catheter and the line connecting the center points of the catheter are 90°±5°.

10. A catheter-based intraluminal navigation method, characterized in that: The intracavitary navigation method comprises: Acquiring circumferential visual information and forward visual information within the cavity; Determining intraluminal structural information and physiological information based on the circumferential visual information and the forward visual information; performing path planning for the catheter based on the physiological information and the structural information; The circumferential visual information and the forward visual information are obtained based on the catheter as described in any one of claims 1-9.

11. The intracavitary navigation method according to claim 10, characterized in that: The performing path planning for the catheter based on the physiological information and the structural information includes: outputting an operation guide using an image-operation matching model based on the physiological information and the structural information.

12. The intracavitary navigation method according to claim 11, characterized in that: in, The image-operation matching model is obtained by: Building an image-operation matching database based on historical surgical operations and image information corresponding to the historical surgical operations; wherein the image information includes circumferential visual information and forward visual information; Using the image-operation matching database, training an image-operation matching model; The image-operation matching model is optimized according to the real-time surgical operation and the image information corresponding to the real-time surgical operation.

13. The intracavitary navigation method according to claim 12, characterized in that: in, The image-operation matching database is constructed in the following manner: controlling the catheter to enter a target access blood vessel and acquiring image information of the access blood vessel; The operator operation corresponding to the image information is obtained, multiple image-operation matching relationships are determined, and the image-operation matching database is formed; wherein the image-matching operation relationship includes a stop operation-vascular abnormality image, a stop operation-reaching the target position image, a turn operation-vascular branch opening image, and a no operation-normal progress image.

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