Interventional diagnosis and treatment catheter, assembly method, and ultrasonic apparatus
Through innovative design of interventional diagnostic catheters, stable bending and independent rotation control of the catheter are achieved, solving the problems of insufficient weld fixation strength and unstable deflection and rotation in existing ultrasound catheters during the catheter manufacturing process, and improving the simplicity of catheter manufacturing and the stability of imaging.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- ACOUSTIC LIFE SCIENCE CO LTD
- Filing Date
- 2025-12-16
- Publication Date
- 2026-06-25
AI Technical Summary
Existing ultrasonic catheters suffer from problems such as insufficient weld strength, increased length of the hard section, increased outer diameter, and damage to functional components during the catheter manufacturing process. Furthermore, they are difficult to balance deflection and rotation functions, resulting in cumbersome and unstable operation of the ultrasonic probe when it is bent.
Design an interventional diagnostic catheter, including a functional segment, a transmission segment, a connecting segment, and a pull wire. By setting the pull wires in groups, the pull wires are independently driven by the handle to rotate and pull within the suture channel, thereby changing the spatial orientation of the probe's working surface. Combined with the independent control of the deflection segment and the second fitting, the catheter can be stably bent and rotated.
This improves the ease of catheter manufacturing, ensures non-destructive assembly, and enhances bending durability, allowing the ultrasound probe to rotate in multiple directions while in a stable bending state, thereby improving imaging stability and surgical precision.
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Figure CN2025142980_25062026_PF_FP_ABST
Abstract
Description
An interventional diagnostic and therapeutic catheter, assembly method, and ultrasound device
[0001] This application claims priority to Chinese Patent Application No. 202511384190.6, filed on September 25, 2025, entitled "A Traction Bending Conduit and its Assembly Method", and Chinese Patent Application No. 202411857064.3, filed on December 16, 2024, entitled "An Ultrasonic Conduit and Ultrasonic Device", the entire contents of which are incorporated herein by reference. Technical Field
[0002] This application relates to the field of interventional medical devices / medical equipment technology, and more specifically, to an interventional diagnostic and therapeutic catheter, an assembly method, and an ultrasound device. Background Technology
[0003] Ultrasonic catheters utilize ultrasound technology, enabling doctors to perform imaging or therapeutic functions during interventional procedures.
[0004] Currently, many interventional diagnostic and therapeutic catheters require directional bending. Specifically, the catheter usually needs to be equipped with a pull cord inside. The proximal end of the pull cord is fixed at the handle, and the distal end of the pull cord is fixedly connected to the bending section at the distal end of the catheter. The individual pull cords are controlled by the handle to achieve directional bending of the catheter.
[0005] Correspondingly, special processes and methods are required to fix the pull wire during the conduit manufacturing process. For example, the pull wire can be fixed by welding or connected to a special fastener located at the distal end of the conduit. However, the welding method has high process requirements and is prone to insufficient connection strength at the distal end of the pull wire, which can lead to pull-out during repeated pulling and bending. The fastener increases the length of the hard section of the pull wire connection and the outer diameter of the conduit. Furthermore, the fastener needs to be encapsulated and fixed inside the conduit through high-temperature welding, which can easily cause deformation or performance damage to the functional components at the distal end of the conduit.
[0006] Furthermore, in practice, the inventors discovered that existing ultrasonic catheters have at least the following drawbacks: Existing ultrasonic interventional catheters struggle to simultaneously perform deflection and rotation functions. When the ultrasonic probe of the catheter needs to rotate in a bent state to change its working direction, existing ultrasonic catheters typically involve first returning the catheter to its zero position (i.e., its natural state when not being operated on, generally with a bending angle close to 0°), then rotating the catheter as a whole by a certain angle, and finally readjusting the catheter from the zero position to a bent state to achieve the switching of the ultrasonic probe's orientation. This process is cumbersome, and because catheter rotation and deflection are not independent, catheter movement is usually accompanied by bending, movement, and rotation, causing the ultrasonic probe to oscillate. This can lead to target loss or instability, making it difficult to maintain the bent shape of the ultrasonic catheter and control the ultrasonic probe's working surface to face multiple different directions in this state.
[0007] In summary, how to improve the ease of manufacturing, non-destructive assembly, bending durability, and / or control of the ultrasound catheter to obtain a stable bending shape and rotate in a stable bending state to perform imaging or treatment functions in different directions of the target space, thereby ensuring that the distal probe of the catheter can produce stable and clear images, is an urgent problem to be solved in this field. Summary of the Invention
[0008] In view of this, this application provides an interventional diagnostic and therapeutic catheter, which aims to solve at least one of the technical problems mentioned in the background of this application.
[0009] An interventional diagnostic and therapeutic catheter, comprising:
[0010] The functional tube section includes a probe and a power-transmitting tube sleeved outside the probe;
[0011] A transmission pipe segment, connected to the proximal end of the functional pipe segment, is provided with an even number of threading cavities, and each of the threading cavities is connected along the length of the transmission pipe segment and separated from each other.
[0012] A connecting section is disposed between the functional pipe section and the transmission pipe section;
[0013] The pull wires are an even number, and the far ends of the pull wires are respectively threaded into the threading channel and fixed to the connecting section;
[0014] A handle is installed at the proximal end of the transmission tube section and connected to the proximal end of the pull wire. The handle can drive the connecting section to rotate circumferentially and / or pull the pull wire in the threading cavity, so as to drive the working surface of the probe to change its spatial orientation.
[0015] In view of this, the purpose of this application is to provide an interventional diagnostic and therapeutic catheter that is simple to manufacture, non-destructive to assemble, and durable in terms of bending.
[0016] To achieve the above objectives, this application further provides the following technical solutions: In some embodiments, the pull wires are arranged in groups, the interventional catheter is a traction and bending catheter, each group of pull wires has a common end and two free ends, and the number of free ends of the pull wires is even; the connecting section includes a connecting platform, the common end is embedded in the connecting platform, and the fixed position of the common end on the connecting platform is staggered from the threading cavity, the two free ends of each group of pull wires are connected to the handle through different threading cavities, and each free end is independently driven by the handle.
[0017] In some embodiments, the transmission tube segment is provided with a central cavity, the central cavity being used to accommodate the communication core connected to the probe, and a plurality of the wire-passing cavities are distributed around the central cavity;
[0018] The connecting platform is set at an angle to the threading cavity, and any set of the pull wires is bent at the connecting platform to extend into the threading cavity.
[0019] In some embodiments, the two free ends of the pull wire are respectively inserted into the first cavity and the second cavity;
[0020] The common end of the pull wire is fixed between the first cavity and the second cavity, and the pull wires are staggered on the connecting platform; or, the common end of the pull wire is fixed on the opposite side of the first cavity and the second cavity, any one of the pull wires is arranged to semi-enclose the communication core on the connecting platform, and the pull wires are crisscrossed on the connecting platform.
[0021] In some embodiments, the connecting platform is provided with a mounting groove for receiving the pull wire, the mounting groove being disposed around the central cavity.
[0022] In some embodiments, the common end of the pull wire is formed by an anti-detachment structure, and the maximum width of the threading cavity is smaller than the width of the anti-detachment knot.
[0023] In some embodiments, the connecting platform includes a hardened pipe section and a transition pipe section. The hardened pipe section and the transition pipe section are sequentially arranged between the transmission pipe section and the energy-transmitting pipe. The hardened pipe section is provided with a channel communicating with the threading cavity and the central cavity. The transition pipe section is provided with a cavity communicating with the central cavity. The common end is embedded between the hardened pipe section and the transition pipe section.
[0024] In some embodiments, the hardness of the hardened tube segment is greater than the hardness of the transmission tube segment and greater than the hardness of the transmissive tube, and the hardness of the transition tube segment is between the hardness of the hardened tube segment and the hardness of the transmissive tube. In some embodiments, the interventional catheter is an ultrasound catheter, the probe is an ultrasound probe, and the ultrasound catheter includes a first tube and a second tube arranged coaxially. The first tube includes a transmission tube segment, the distal end of which includes a deflection segment that can be controlled to bend by pulling a cable with a handle. The proximal end of the second tube segment is connected to the handle, and the second tube segment can be driven to rotate circumferentially by the handle. The connecting segment includes a first portion connected to the distal end of the first tube segment and a second portion connected to the distal end of the second tube segment. The second portion is connected to the functional tube segment and can rotate relative to the first portion. The ultrasound probe emits ultrasound waves in multiple directions in the spatial orientation as the first tube segment bends and the second tube segment rotates.
[0025] In some embodiments, the interventional catheter further includes a limiting mechanism disposed between the first fitting and the second fitting, the limiting mechanism allowing the second fitting to rotate relative to the first fitting and limiting axial displacement between the first fitting and the second fitting.
[0026] In some embodiments, the first pipe and the second pipe are arranged side by side, and the second pipe is provided with a deflection compliance section at a position close to the deflection section, the deflection compliance section being able to bend synchronously with the deflection section; one side of the limiting mechanism is connected to the deflection section, and the other side of the limiting mechanism is connected to the deflection compliance section.
[0027] In some embodiments, the limiting mechanism includes a first limiting member and a second limiting member, wherein the first limiting member is disposed circumferentially along the first tube and the second limiting member is disposed circumferentially along the second tube; the first limiting member and the second limiting member block each other along the axial direction of the interventional catheter, or one of the first limiting member and the second limiting member is internally rotatably connected to the other.
[0028] In some embodiments, the limiting mechanism includes a first limiting member, a second limiting member, and an intermediate member; the first limiting member is disposed on the first pipe, the second limiting member is disposed on the second pipe, and the intermediate member is disposed between the first limiting member and the second limiting member to reduce the contact area and / or coefficient of friction between the second limiting member and the second limiting member.
[0029] In some embodiments, the handle includes a rotating mechanism fixedly connected to the proximal end of the second tube, the rotating mechanism driving the second tube to rotate to drive the ultrasound probe to rotate; the handle is also provided with a limiting groove, the rotating mechanism is provided with a first knob and a rotating rod connected together, the first knob can be turned to rotate, and the rotating rod extends into the limiting groove of the handle; the rotating rod is provided with a protrusion that cooperates with the limiting groove to realize the circumferential and axial limiting of the rotating mechanism.
[0030] In some embodiments, the handle includes a bending body, the bending body including a second knob and a transmission member, the second knob being operable to rotate, the second knob and the transmission member being geared, the proximal end of the pull cable being connected to either the second knob or the transmission member, the second knob being rotated to change the winding length of the pull cable on the bending body to adjust the degree of bending of the transmission tube segment.
[0031] In some embodiments, the second tube is sleeved outside the first tube, or the first tube is sleeved outside the second tube and the distal end of the second tube extends outward relative to the distal end of the first tube and the ultrasonic probe is installed thereon; and the pull wires are circumferentially symmetrically distributed relative to the deflection segment.
[0032] This application also provides an ultrasound device, including an ultrasound system and the aforementioned interventional catheter, wherein the ultrasound system is signal-connected to the interventional catheter, and the ultrasound probe is excited to collect image information or emit ablation energy in multiple directions of spatial orientation.
[0033] This application also provides a method for assembling an interventional diagnostic catheter, applied to an interventional diagnostic catheter including any of the above-described methods, the assembly method comprising: assembling a probe inside the permeable tube;
[0034] Insert the pull wires into each of the even-numbered threading channels of the transmission tube section, and connect the proximal end of the transmission tube section to the handle.
[0035] Connect the far end of the pull line to the connector section and the near end of the pull line to the handle;
[0036] Ensure that the handle can rotate the connecting section circumferentially and / or pull the wire in the threading cavity, so as to change the spatial orientation of the probe's working surface.
[0037] In some embodiments, inserting pull wires into the even number of wire-passing cavities of the transmission pipe segment includes: connecting pull wires in groups, with the first free end of the pull wire positioned outside the proximal end of the transmission pipe segment; inserting the second free end of the pull wire into the first cavity to the distal end of the transmission pipe segment; inserting the second free end of the pull wire into the second cavity and exposing it outside the proximal end of the transmission pipe segment; knotting the pull wires at the distal end of the transmission pipe segment to form a common end; fixing the common end in the connecting platform between the energy-transmitting tube and the transmission pipe segment; and connecting the first free end and the second free end of the pull wire to the handle respectively.
[0038] In some embodiments, a hardened pipe section is connected to the distal end of the transmission pipe section; a transition pipe section is connected to the proximal end of the functional pipe section; the first free end of the pull wire is placed outside the proximal end of the transmission pipe section, and the second free end of the pull wire is inserted into a first cavity to the distal end of the hardened pipe section. The pull wire is knotted at the distal end of the hardened pipe section to form a common end, and then the second free end is inserted into a second cavity and exposed at the proximal end of the transmission pipe section. The hardened pipe section and the transition pipe section are fused to form the connecting platform, so that the common end is fixedly embedded in the connecting platform.
[0039] In some embodiments, before the common end is fixedly embedded in the connecting platform between the energy-transmitting tube and the transmission tube segment, the following steps are included: pulling the common end of the pull wire to the opposite side of the first cavity and the second cavity, and then installing the communication core in the central cavity, such that the pull wire is arranged to semi-enclose the communication core at the far end of the transmission tube segment.
[0040] In this application, an interventional diagnostic catheter has a functional segment at its distal end along its length. A probe is a device capable of emitting and receiving detection signals to achieve in vivo imaging. A permeable tube allows the signals emitted by the probe to pass through, and the probe is housed inside the permeable tube to protect it. The probe contacts the patient through the outer surface of the permeable tube. Thus, this interventional diagnostic catheter can be inserted into the patient's body to achieve imaging or ablation through probe detection. A transmission segment is located in the middle of the interventional diagnostic catheter for inserting the probe cable and pull wire. A handle is located at the proximal end of the interventional diagnostic catheter, which, together with the pull wire, allows the interventional diagnostic catheter to be steered during its journey through complex physiological environments such as the heart. The handle can drive the connecting segment to rotate circumferentially and / or pull the pull wire within the suture channel, thereby changing the spatial orientation of the probe's working surface and facilitating the adjustment of the probe's field of view or ablation location.
[0041] Correspondingly, a set of pull wires is arranged in a U-shape and V-shape on the distal end of the transmission tube section, with its two segments passing through two independent lumens. Since each of the equipped pull wires is a complete and continuous pull wire, folded in half at the distal end of the transmission tube section, and the common end is directly embedded inside the connecting platform, compared with related technologies, the interventional catheter in this application has both ease of assembly and the ability to adjust the catheter to bend in different directions. Furthermore, the direct embedding of the common end eliminates the need for custom-made fasteners, which helps to shorten the hard section length of the pull wire connection and reduce the outer diameter of the catheter. The process is simple, the assembly is non-destructive, and the bending durability is high, with smaller stress changes and higher bending capability.
[0042] Compared to the aforementioned background technology, the ultrasonic catheter provided in this application mainly includes a tube body and an ultrasonic probe. The ultrasonic probe is connected to the distal end of the tube body. The tube body includes a first tube and a second tube. The distal end of the first tube includes a deflection section, which can be controlled to bend to change the spatial orientation of the working surface of the ultrasonic probe. The second tube is coaxially arranged with the first tube and can be driven to rotate circumferentially to rotate the working surface of the ultrasonic probe relative to the first tube. The ultrasonic probe emits ultrasonic waves in multiple spatial directions as the first tube bends and the second tube rotates.
[0043] As mentioned in the background section, existing ultrasound catheters often suffer from unnecessary bending or movement during ultrasound probe rotation, causing probe oscillation and resulting in target loss or image instability. This coupled operation limits catheter flexibility and control precision, particularly in cardiac interventional surgeries requiring precise control and stable imaging. To address this issue, the ultrasound catheter solution provided in this application employs an innovative design to achieve independent operation of bending controlled by a deflection segment and rotation controlled by a second component. Specifically, the ultrasound catheter includes a tube body and an ultrasound probe, with the tube body composed of a first component and a second component. The distal end of the first component has a deflection segment that can be independently controlled to bend, thereby changing the spatial orientation of the ultrasound probe's working surface without being affected by the movement of other parts of the catheter. The second component is coaxially arranged with the first component and can rotate independently in the circumferential direction, further adjusting the ultrasound probe's working surface to rotate relative to the first component, enabling the emission of ultrasound waves in multiple directions.
[0044] This design allows the ultrasound catheter to maintain a certain curved shape while stably controlling the orientation of the ultrasound probe's working surface, solving the problem of existing catheters' inability to simultaneously manage deflection and rotation functions. By independently controlling the deflection section and the second fitting, the ultrasound catheter can reduce ultrasound probe wobbling caused by catheter movement, lowering the risk of target loss or image instability, and improving imaging stability and surgical precision. Therefore, this technical solution not only provides an ultrasound catheter that can stably maintain a curved shape but also precisely control the orientation of the ultrasound probe's working surface in multiple different directions, significantly improving surgical adaptability and effectiveness, and meeting the medical field's demand for high-precision ultrasound catheters. It can be seen that this ultrasound catheter has at least the following beneficial effects: by controlling bending through the deflection section and controlling rotation through the second fitting, it effectively solves the problem of existing ultrasound catheters' inability to simultaneously manage deflection and rotation functions, providing an ultrasound catheter that can stably maintain a curved shape and control the orientation of the ultrasound probe's working surface in multiple different directions, thereby improving imaging stability and surgical precision. Attached Figure Description
[0045] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.
[0046] Figure 1 is a schematic diagram of the overall structure of a specific embodiment provided by the present invention;
[0047] Figure 2 is a partial structural schematic diagram of a specific embodiment provided by the present invention;
[0048] Figure 3 is a partial structural cross-sectional view of a specific embodiment provided by the present invention;
[0049] Figure 4 is another partial structural cross-sectional view of a specific embodiment provided by the present invention;
[0050] Figure 5 is a schematic diagram of AA in Figure 4;
[0051] Figure 6 is a schematic diagram of the non-crossing state of the double-group pull wires according to a specific embodiment of the present invention;
[0052] Figure 7 is a second schematic diagram of AA in Figure 4;
[0053] Figure 8 is a schematic diagram of the double-sided crossover state of the double-group pull wires according to a specific embodiment of the present invention;
[0054] Figure 9 is a schematic diagram from another angle of the double-group pull wires crossing state on both sides in a specific embodiment provided by the present invention;
[0055] Figure 10 is a schematic diagram of AA in Figure 4;
[0056] Figure 11 is a schematic diagram of AA in Figure 4;
[0057] Figure 12 is a schematic diagram of AA in Figure 4;
[0058] Figure 13 is a schematic diagram of the ultrasonic catheter provided in an embodiment of this application;
[0059] Figure 14 is a schematic diagram of the tube provided in an embodiment of this application;
[0060] Figure 15 is a schematic diagram of AA in Figure 14;
[0061] Figure 16 is a schematic diagram of BB in Figure 14;
[0062] Figure 17 is a schematic diagram of the handle provided in an embodiment of this application;
[0063] Figure 18 is a schematic diagram of the ultrasonic probe provided in the embodiment of this application. Detailed Implementation
[0064] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.
[0065] In the specific embodiments, the distal end refers to the part of the corresponding component that is farther away from the surgeon or operator, usually the end where the component enters the patient's body or surgical area. The proximal end is the part of the corresponding component that is closer to the surgeon or operator, usually the end that the surgeon or operator holds or manipulates. For a single component, the end closer to the surgeon or operator is the proximal end, and the end farther away from the surgeon or operator is the distal end. Furthermore, in this invention, unless otherwise explicitly specified and limited, the terms "installed," "connected," "linked," "fixed," and "communicated," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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 between two components. For example, the connection between the first tube and the probe mentioned in this application specification is indirect, and the connection between the second tube and the probe can also be indirect, but this does not preclude the description in the specification as "connected" for ease of understanding. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.
[0066] It should be noted that relational terms such as "first" and "second" used below are only used to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities; the terms "upper surface," "lower surface," "top," and "bottom" as well as the directional terms "upper," "lower," "left," and "right" used below are defined based on the accompanying drawings in the specification.
[0067] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.
[0068] The interventional diagnostic and therapeutic catheter and its assembly method provided in this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core ideas of this application. It should be noted that those skilled in the art can make several improvements and modifications to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of this application.
[0069] The primary function of ultrasound technology in interventional surgery is to use ultrasound probes as imaging probes or as ablation elements to perform imaging or therapeutic functions within the human body. For applications requiring continuous ablation or dynamic imaging, it is necessary to be able to continuously adjust the orientation of the working surface of the ultrasound probe. Simultaneously, to reach the location of interest to the operator, especially in areas with complex anatomical structures, the catheter needs to bend into a specific shape, and the ultrasound probe needs to be rotated while maintaining this bending shape to obtain multi-directional image information of the location of interest or to perform continuous ablation. The following example uses intracardiac ultrasound. Those skilled in the art should understand that applying the ultrasound catheter of this application to the field of ablation, or to imaging other human tissue structures, does not exceed the scope of protection of this application, and those skilled in the art can directly apply this ultrasound catheter without inventive effort.
[0070] In intracardiac ultrasound, the ultrasound catheter described in this application allows for independent bending and rotation of the catheter body. It enables real-time dynamic imaging by maintaining the catheter in a bent position while simultaneously rotating it at a specific target location. This avoids distal catheter oscillation at the target position, ensuring clear images can be acquired from different angles and positions. Operators can then observe cardiac structures from multiple planes at locations of interest, obtaining more comprehensive imaging information. This multi-angle imaging not only improves image resolution but also better identifies fine cardiac structures and lesions, thereby enhancing diagnostic accuracy.
[0071] The core of this application is to provide an interventional diagnostic catheter and ultrasound device, which features high levels of simplicity in manufacturing, non-destructive assembly, and durability in terms of bending adaptability. Another core aspect of this application is to provide an assembly method for the aforementioned interventional diagnostic catheter.
[0072] This application provides an interventional diagnostic catheter, as shown in Figures 1-18, comprising: a functional tube segment 1, including a probe 11 and a permeable tube 12 sleeved outside the probe 11; a transmission tube segment 2, connected to the proximal end of the functional tube segment 1, having an even number of suture channels 201, each suture channel 201 extending along the length of the transmission tube segment 2 and separated from each other; a connecting segment, disposed between the functional tube segment 1 and the transmission tube segment 2; pull wires 4, an even number, the distal ends of the pull wires 4 respectively passing through the suture channels 201 and fixed to the connecting segment; and a handle 6, installed at the proximal end of the transmission tube segment 2, and connected to the proximal end of the pull wires 4, the handle 6 being able to drive the connecting segment to rotate circumferentially and / or pull the pull wires 4 within the suture channels 201, thereby causing the working surface of the probe 11 to change its spatial orientation.
[0073] In some embodiments, the pull wires 4 can be arranged in groups, as shown in Figures 4-12, including a functional tube segment 1, a transmission tube segment 2, a handle 6, and several groups of pull wires 4 (one or more groups of pull wires 4); wherein, the functional tube segment 1 includes a probe 11 and a transmission tube 12 sleeved outside the probe 11; the transmission tube segment 2 is connected to the proximal end of the functional tube segment 1, and it is provided with an even number of threading cavities 201, and each threading cavity 201 is connected along the length direction of the transmission tube segment 2 and separated from each other; the handle 6 is connected to the proximal end of the transmission tube segment 2; any group of pull wires 4 has a common end and two free ends, the common end is embedded in the connecting platform 3 between the transmission tube 12 and the transmission tube segment 2, and the fixed position of the common end on the connecting platform 3 is staggered from the threading cavity 201, and the two free ends of any group of pull wires 4 are connected to the handle 6 through different threading cavities 201, and each free end is driven independently by the handle 6.
[0074] Referring to Figures 1-3, the interventional catheter has a functional segment 1 at its left end along its length. The probe 11 is a device that emits and receives detection signals to achieve in vivo imaging. Correspondingly, a permeable tube 12 is a flexible tube through which the signal emitted by the probe 11 can pass. The permeable tube 12 has internal cavities with a circular or rectangular cross-section. The probe 11 is placed within the internal cavity of the permeable tube 12 to protect it. The patient is contacted through the outer surface of the permeable tube 12, allowing the interventional catheter to be inserted into the patient's body and to achieve imaging through the probe 11, such as ultrasound or OCT imaging. The middle section of the interventional catheter is a transmission segment 2, used to insert the probe 11 cable and pull wire 4. The right end of the interventional catheter is a handle 6, which, together with the pull wire 4, controls the direction of the interventional catheter as it travels through complex physiological environments such as the heart.
[0075] Referring to Figures 6, 8, and 9, the number of wiring cavities 201 opened in the transmission pipe section 2 is an even number. The wiring cavities 201 run through the transmission pipe section 2 along its length. One end of the wiring cavity 201 is located at the left end face of the transmission pipe section 2, and the other end is located at the right end face of the transmission pipe section 2. Correspondingly, a set of pull wires 4 are arranged in a U-shape and a V-shape on the far end face of the transmission pipe section 2, and its two parts pass through two independent wiring cavities 201.
[0076] In this set of pull wires 4, the common end is located outside the left end of the transmission pipe segment 2 and where the two parts of the wires are connected or closed. The common end of the pull wire 4 is embedded inside the connecting platform 3 between the left end of the transmission pipe segment 2 and the functional pipe segment 1. The connecting platform 3 is a structure for connecting the left end of the transmission pipe segment 2 and the right end of the functional pipe segment 1. The pull wire 4 is fixed by embedding the common end inside the connecting platform 3. Since the two wire passages 201 into which the two parts of the wires 4 are inserted are arranged at intervals, the parts of the two parts of the wires 4 extending from the port of the wire passage 201 at the left end of the transmission pipe segment 2 need to extend close to each other in order to connect or close. Therefore, the fixed position of the common end of the pull wire 4 on the connecting platform 3 is staggered from the wire passage 201.
[0077] It should be noted that the type of connecting platform 3 is not limited, as long as it can accommodate the fixed end of the pull wire 4. For example, the connecting platform 3 can have two pipe sections, with the fixed end of the pull wire 4 located between the two pipe sections, and the two pipe sections are connected by bonding or welding. Alternatively, the connecting platform 3 can be a molten mixture generated during the process of fixing the transmission pipe section 2 and the energy-transmitting pipe 12 by fusion welding, with the molten mixture wrapping around the fixed end of the pull wire 4. With this configuration, there is no need to design and process holes and grooves to fix the common end of the pull wire 4. Alternatively, the connecting platform 3 can be a structure for bonding between the transmission pipe section 2 and the energy-transmitting pipe 12.
[0078] In a set of pull wires 4, the two ends located on the outer right side of the transmission pipe section 2 are called free ends or open ends. The number of free ends of the pull wires is even. The free ends of the pull wires 4 are connected to the handle 6, so that the position of the pull wires 4 can be positioned by manipulating the two free ends of the pull wires 4. When a pull wire 4 is pulled, the conduit bends in the direction of the pull wire 4. Since the common end is embedded inside the connecting platform 3, even if one of the free ends of a set of pull wires 4 and the pull wire 4 on that side are pulled, the pull wire 4 on the other side will not move into the threading cavity 201 where the pull wire 4 on that side is pulled. Therefore, the adjustment of bending at each free end of the pull wire 4 in this application is independent of each other.
[0079] Generally, in the portion of the bending catheter connected distal to the pull suture 4 (i.e., the connecting platform 3 of this application), a shorter rigid segment at this distal connection is more beneficial for the flexibility of the distal catheter, providing better propulsion through tortuous tissues. Simultaneously, a shorter rigid segment allows for more direct and rapid force transmission when the pull suture 4 pulls the bending segment, enabling more accurate control of the bending angle and shape, thus meeting the intraoperative requirements for catheter positioning accuracy. Therefore, the above approach effectively shortens the required rigid segment, resulting in a shorter connecting platform 3, while ensuring a strong connection between the pull suture 4 and the connecting platform 3.
[0080] Since each of the several sets of pull wires 4 is a complete and continuous pull wire 4, and is folded in half at the distal end of the transmission tube section 2, and since the common end is directly embedded inside the connecting platform 3, compared with related technologies, the interventional catheter in this application has both convenient assembly and the ability to ensure the controllability of the catheter bending in different directions. Furthermore, the method of directly embedding the common end does not require the use of custom-made fasteners, which is beneficial to shorten the hard section length of the pull wire 4 connection part and reduce the outer diameter of the catheter. The process is simple, the assembly is non-destructive, and the bending durability is high, and the stress change is small, with a high bending capability.
[0081] It is understood that although the accompanying drawings of this application primarily illustrate specific embodiments with two or more sets of guy wires 4 to explain implementations in more complex situations, this application can also be applied to cases with only one set of guy wires 4, correspondingly, to bending in two directions (such as forward / backward bending or left / right bending), as shown in Figure 12. Furthermore, this application does not exclude the possibility of combining guy wire bending with other bending methods to achieve multi-directional bending, such as using the bidirectional bending method shown in Figure 12 (as shown in Figure 14) combined with other methods to achieve four-directional bending.
[0082] In some embodiments, optionally, the transmission tube segment 2 is provided with a central cavity 202, which is used to accommodate the communication core 5 connected to the probe 11, and multiple wire-threading channels 201 are distributed around the central cavity 202; the connecting platform 3 is set at an angle to the wire-threading channels 201, and any group of pull wires 4 is bent at the connecting platform 3 to extend into the wire-threading channel 201.
[0083] Referring to Figures 3, 4, 5, 6, 7, 8, and 9, the transmission tube segment 2 has an independent central cavity 202 and the aforementioned threading channels 201. Both the central cavity 202 and the threading channels 201 extend and penetrate along the length of the transmission tube segment 2, with the central cavity 202 located at the center of the transmission tube segment 2. Several threading channels 201 are arranged around the central cavity 202. A communication core 5 is inserted into the central cavity 202. The cross-sectional shape of the communication core 5 can be circular or rectangular, etc., to connect to the probe 11 and meet its working requirements. Pull wires 4 are inserted into the several threading channels 201 to meet the bending requirements of the functional tube segment 1. In this embodiment, the arrangement of the central cavity 202 and the several threading channels 201 is beneficial to enhancing the bending control accuracy and stability of the interventional diagnostic catheter.
[0084] Furthermore, as mentioned above, the threading cavity 201 extends along the length of the transmission tube segment 2, while the connecting platform 3 is a disc-shaped structure formed by welding the left end of the transmission tube segment 2 to the right end of the functional tube segment 1. Its expansion direction in all directions has a non-zero angle with the length of the threading cavity 201 and covers the opening of the threading cavity 201 at the left end of the transmission tube segment 2. The structure of any set of pull wires 4 located inside the connecting platform 3 needs to be bent relative to the length of the threading cavity 201, that is, extend along the width of the conduit. Only then can the two segments of a set of pull wires 4 passing through the two threading cavities 201 close together or connect to form a common end. The structure of a set of pull wires 4 located inside the connecting platform 3 extends along the curved or straight segment of the threading cavity 201 into which its two free ends are inserted, while the free end of the pull wire 4 extends along the length of the threading cavity 201 and connects to the handle 6.
[0085] In some embodiments, the two free ends of the pull wire 4 are respectively inserted into the first cavity 201a and the second cavity 201b; the common end of the pull wire 4 is fixed between the first cavity 201a and the second cavity 201b, and the pull wires 4 are staggered on the connecting platform 3; or, the common end of the pull wire 4 is fixed on the opposite side of the first cavity 201a and the second cavity 201b, any pull wire 4 is semi-enclosed around the communication core 5 on the connecting platform 3, and the pull wires 4 are crisscrossed on the connecting platform 3.
[0086] In this embodiment, the threading cavity 201 between a common end of a set of pull wires 4 and a free end is defined as the first cavity 201a, and the threading cavity 201 between a common end and another free end is defined as the second cavity 201b. Then, the transmission pipe section 2 is provided with at least one set of the above-mentioned first cavity 201a and second cavity 201b.
[0087] Optionally, referring to Figures 5 and 6, the pull wires 4 can be arranged in a non-crossing manner. Specifically, the first cavity 201a and the second cavity 201b for inserting a set of pull wires 4 are located on the same side of the central cavity 202. Correspondingly, the common end of the same set of pull wires 4 is located in the area between the first cavity 201a and the second cavity 201b into which they are inserted. In particular, the common end of a set of pull wires 4 and the first cavity 201a and the second cavity 201b into which they are inserted are both located on the same side of the central cavity 202. Furthermore, the transmission pipe section 2 has a plurality of threading cavities 201 arranged sequentially around the central cavity 202. The first cavity 201a and the second cavity 201b into which a set of pull wires 4 are inserted are two adjacent ones among the plurality of threading cavities 201 arranged around the central cavity 202, thereby making the pull wires 4 staggered on the connecting platform 3.
[0088] Optionally, referring to Figures 7, 8, and 9, the pull wires 4 can be arranged in a double-sided crisscross pattern. Specifically, the first cavity 201a and the second cavity 201b used to insert a set of pull wires 4 are located on the same side of the central cavity 202. However, the structure of the set of pull wires 4 inside the connecting platform 3 is arranged in a semi-enclosed manner around the communication core 5. That is, the segments of the pull wires 4 that pass through the first cavity 201a and the segments that pass through the second cavity 201b, after extending from the port at the far end of the transmission tube section 2, need to extend along the width direction of the conduit towards the other side of the central cavity 202 so as to connect on the opposite side of the first cavity 201a and the second cavity 201b where the pull wires 4 are inserted. Then, the common end of the set of pull wires 4 is fixed to the first cavity 201a and the second cavity 201b where they are inserted. On the opposite side, since several sets of pull wires 4 are located inside the connecting platform 3 and are arranged in a semi-encircling manner around the communication core 5 (a set of pull wires 4 is in a bent state in the connecting platform 3 and the central angle corresponding to the arc segment is not less than 180 degrees), the first cavity 201a and the second cavity 201b into which the same set of pull wires 4 are inserted are arranged either adjacently or with at least one wire passage 201 between them. The structure of each pull wire 4 inside the connecting platform 3 is distributed in a double-sided cross manner. Since a set of pull wires 4 bypasses the communication core 5, the force transmitted by the pull wires 4 can be decomposed into two directions, horizontal and vertical, which effectively reduces the force value of the pull wires 4 in a single direction. This allows the pull wires 4 to withstand greater tension while ensuring that they are not pulled out, and also improves the fixing strength of the common end of the pull wires 4.
[0089] It should be noted that, in order to facilitate understanding of the winding method of the double-sided cross arrangement of the guy wires 4 in Figure 9, the two sets of guy wires 4 are arranged such that the outer diameter of one set of guy wires 4 is larger than that of the other set of guy wires 4. However, it should be noted that this application does not limit the outer diameter of several sets of guy wires 4. Several sets of guy wires 4 can have the same outer diameter, or several sets of guy wires 4 can have different outer diameters, or even some sets of guy wires 4 can have the same outer diameter and the remaining sets of guy wires 4 can have different outer diameters, etc. The differences in the physical characteristics of each guy wire 4 should not be construed as falling outside the scope of protection of this application.
[0090] In some embodiments, the structure of the pull wire 4 inside the connecting platform 3 is further configured such that, regardless of whether the structure is arranged in a double-sided crossing manner or a non-crossing manner, the common end of the pull wire 4 is located on the axis of symmetry of the first cavity 201a and the second cavity 201b, which are inserted into the two free ends of a set of pull wires 4, at the left end (i.e., the far end) port of the transmission pipe section 2. Specifically, a set of pull wires 4 extends from the first cavity 201a and is laid on the connecting platform 3. The section extending from the first cavity 201a to the common end is called segment a, and the section extending from the second cavity 201b to the common end is called segment b, as shown in Figures 5, 6, 7 and 8. The lengths of segment a and segment b are equal in the initial state (before the bending begins), and segment a and segment b are symmetrical with respect to the line connecting the common end and the axis in the initial state, thereby ensuring that the structures in the connecting platform have good symmetry and stability.
[0091] It should be noted that the arrangement of several sets of pull wires 4 is not limited to the above-mentioned optional methods. As long as the requirements for fixing and adjusting the pull wires 4 can be met, it is acceptable. For example, in some embodiments, there is a wire-passing cavity 201 between the first cavity 201a and the second cavity 201b through which a set of pull wires 4 passes. Optionally, as shown in Figure 10, at least two sets of adjacent pull wires 4 are distributed in a cross-shaped manner on the same side of the central cavity 202. In this case, the structure of each pull wire 4 inside the connecting platform 3 adopts a single-sided cross-shaped distribution. Alternatively, as shown in Figure 11, the structure of each pull wire 4 inside the connecting platform 3 adopts a double-sided cross-shaped distribution. The above double-sided cross-shaped distribution refers to the line segments of a set of pull wires 4 located on both sides of the common end crossing with the line segments of at least another set of pull wires 4 located on both sides of the common end.
[0092] In some embodiments, the connecting platform 3 is provided with a mounting groove for accommodating the pull wire 4, the mounting groove being disposed around the central cavity 202.
[0093] Referring to Figures 3, 4, 5, and 7, in order to accommodate the pull wire 4 and fix the common end, the connection platform 3 has an installation groove inside to better ensure the accuracy of the fixed position of the common end. The port of the wire passage 201 located at the far end of the transmission pipe section 2 is opened in the installation groove. Then, the common end of the pull wire 4 and the part of the wire from the common end to the port of the wire passage 201 located at the far end of the transmission pipe section 2 can be presented in the state of passing through the installation groove of the connection platform 3. Since several wire passages 201 are arranged around the central cavity 202, the connecting line segment of the pull wire 4 with the common end between the two wire passages 201 through which it passes is set around the central cavity 202. Therefore, the installation groove used to accommodate the above-mentioned connecting line segment of the pull wire 4 is also set around the central cavity 202.
[0094] In some embodiments, the common end of the pull wire 4 is composed of an anti-knot 41, that is, the anti-knot 41 includes a knotted part and two ends connected to the knotted part and arranged on the connecting platform, and the maximum width of the threading cavity 201 is less than the width of the anti-knot 41.
[0095] Referring to Figures 5, 6, 7, 8, and 9, the common end of the pull wire 4 is the anti-detachment knot 41 shown in the figure. The anti-detachment knot 41 can be a single knot, a double single knot, or a single figure-eight knot, or it can be achieved by adhesive or attachment. The anti-detachment knot 41 ensures that the maximum width of the common end of the pull wire 4 is greater than the maximum width of the threading cavity 201, thereby preventing the common end of the pull wire 4 from sliding and being dragged into the threading cavity 201 during bending. Furthermore, the maximum width of the anti-detachment knot 41 is at least less than the outer diameter of the tube wall at its location, so as to prevent the anti-detachment knot 41 from being exposed outside the conduit.
[0096] In some embodiments, the connecting platform 3 includes a hardened pipe section 31 and a transition pipe section 32. The hardened pipe section 31 and the transition pipe section 32 are sequentially arranged between the transmission pipe section 2 and the energy-transmitting pipe 12. The hardened pipe section 31 is provided with a channel communicating with the wire-passing cavity 201 and the central cavity 202. The transition pipe section 32 is provided with a cavity communicating with the central cavity 202. The common end is embedded between the hardened pipe section 31 and the transition pipe section 32.
[0097] Referring to Figure 3, the connecting platform 3 for connecting the transmission pipe section 2 and the functional pipe section 1 consists of two pipe sections. The part adjacent to and connected to the transmission pipe section 2 is the hardened pipe section 31, and the part adjacent to and connected to the functional pipe section 1 is the transition pipe section 32. Optionally, the length of the transition pipe section 32 ranges from 1 to 5 mm, and the end of the transition pipe section 32 is connected to the end of the hardened pipe section 31 that is close to it. Furthermore, the hardened pipe section 31 has several channels arranged in the same way as the central cavity 202 and the threading cavity 201 of the transmission pipe section 2. Among the several channels of the hardened pipe section 31, one channel located at the center is connected to the central cavity 202 of the transmission pipe section 2. The communication core 5 is connected, and the remaining channels are arranged around the center position and connected to the corresponding wiring cavity 201 of the transmission tube section 2, so that the pull wire 4 can be passed through. The transition tube section 32 only has a channel at the center position, so that it can be connected to the center cavity 202 of the transmission tube section 2 through the channel at the center position of the hardened tube section 31, so that the communication core 5 can be passed through, but the pull wire 4 cannot pass through. The pull wire 4 is bent relative to the length direction of the wiring cavity 201 at the position between the hardened tube section 31 and the transition tube section 32, and the common end is embedded between the hardened tube section 31 and the transition tube section 32.
[0098] Based on the above embodiments, the hardness of the hardened pipe section 31 is greater than the hardness of the transmission pipe section 2 and greater than the hardness of the energy-transmitting pipe 12. The hardness of the transition pipe section 32 is between the hardness of the hardened pipe section 31 and the hardness of the energy-transmitting pipe 12. That is, in this embodiment, as shown in Figure 3, the hardness of the energy-transmitting pipe 12, the transition pipe section 32 and the hardened pipe section 31 arranged and connected from right to left increases sequentially. Moreover, the hardness of the hardened pipe section 31 is also greater than the hardness of the transmission pipe section 2.
[0099] In some embodiments, the transition pipe section 32 is a pipe section structure that has been connected to the near end of the energy-transmitting pipe 12 before the connecting platform 3 is welded to the energy-transmitting pipe 12. It is particularly suitable for a scheme in which several sets of pull wires 4 are located inside the connecting platform 3 and are arranged in a double-sided cross manner. Even in extreme cases, if the pull wires 4 are pulled off or slipped during bending, each set of pull wires 4 is arranged around the communication core 5. Since the communication core 5 can share part of the tension on the pull wires 4, the pull wires 4 will not break, and thus the bending control will not fail. In other words, this application simplifies the fixation of the far end of the pull wire 4 by embedding the common end of each pull wire 4 into the connecting platform 3. Combined with the fact that the common end is set up in a semi-enclosed manner around the communication core 5 at the far end of the conduit (U-shaped, V-shaped, etc.), it helps that when the embedded structure (i.e., the connecting platform 3) at the far end of the pull wire 4 is damaged and the position of the common end cannot be maintained, each pull wire 4 can still be tightly wrapped around the communication core 5 at the far end of the conduit, making the pull wire 4 less likely to be broken and still able to achieve the bending adjustment function, thus providing dual protection for the bending resistance and safety.
[0100] In other embodiments, the transition section 32 is a molten structure formed by the hardened section 31 of the connecting platform 3 during the welding process with the energy-transmitting tube 12. The transition section 32 is a hybrid structure formed by the cooling of a portion of the molten material of the energy-transmitting tube 12 and a portion of the molten material of the hardened section 31. In order to ensure good energy transmission effect, the energy-transmitting tube 12 needs to adopt a structure with low hardness. However, in order to ensure that the pull wire 4 does not pull off or slip during bending, the hardened section 31 needs to have high hardness. Therefore, the hardness of the transition section 32 formed by the partial melting of the energy-transmitting section and the hardened section 31 is between that of the energy-transmitting section and the hardened section 31.
[0101] The above-mentioned connection platform 3 setting promotes a gradual change in hardness from the connection platform 3 to the energy-transmitting tube 12, which is beneficial to ensuring the conformability of the distal end of the conduit, especially avoiding bending at undesirable locations (such as the connection between the connection platform 3 and the energy-transmitting tube 12) during the bending process caused by sudden changes in hardness, ensuring that the distal end of the conduit remains intact as expected and has good bending control performance. When the energy-transmitting tube 12 is made of a softer material and there are higher requirements for the regularity of the shape of the energy-transmitting tube 12, it is preferable that the connection platform 3 includes a transition tube section 32 with different hardness and a hardened tube section 31. This shortens the length of the hardened section of the connection platform 3, which is beneficial to ensuring the pushing performance and the accuracy of bending. On the other hand, directly fusion-connecting the hardened tube section 31 and the energy-transmitting tube 12, due to the different hardness, results in a large difference in melting temperature. Direct fusion requires raising the temperature above the melting temperature of the hardened tube section 31. As a result, the melting degree of the energy-transmitting tube 12 is intensified, making it difficult to maintain its own regularity of shape. The design of section 32 avoids the problem of direct fusion connection between the hardened tube section 31 and the energy-transmitting tube 12. Welding the transition tube section 32 and the energy-transmitting tube 12 first reduces the impact on the shape of the energy-transmitting tube 12 because the difference in hardness and melting temperature between the two is smaller. Welding the transition tube section 32 and the hardened tube section 31 then makes it easier to embed and fix the common end in them because the difference in melting temperature is smaller. Thus, through the overall ingenious design, the common end is firmly fixed, the length of the hardened section is reduced to facilitate the adjustment of bending, and the energy-transmitting tube 12 basically maintains its original shape during the connection process, cleverly balancing multiple practical needs.
[0102] Based on the above embodiment, probe 11 is an ultrasonic probe, and the energy-transmitting tube 12 is a sound-transmitting flexible tube. The handle 6 pulls the pull wire 4 inside the wire-passing cavity 201 to drive the transmission tube section 2 to adjust the imaging field of the ultrasonic probe. When the ultrasonic probe acquires image information by rotating and / or retracting, it is especially necessary to ensure the consistency of the inner cavity of the energy-transmitting tube 12 to ensure the normal operation of the ultrasonic probe.
[0103] The probe 11 is an ultrasound probe 11 with signal generation and recovery functions, and the communication core 5 connected to the probe 11 is a cable capable of transmitting ultrasound signals. Correspondingly, the sound-transmitting tube 12 is a sound-transmitting flexible tube, which serves as a sound-transmitting window. Thus, the interventional diagnostic catheter can achieve ultrasound imaging.
[0104] Furthermore, the connection point between the proximal end of the permeable tube 12 and the distal end of the transmission tube segment 2 serves as the distal fixed point of the pull wire 4, while the two connections of the pull wire 4 to the free end of the handle 6 serve as the proximal movable points of the pull wire 4. When it is necessary to adjust the imaging field of the probe 11, that is, when it is necessary to bend the interventional catheter, the handle 6 is operated to pull the corresponding pull wire 4. The pull wire 4 causes the bendable tube segment in the transmission tube segment 2 to tilt toward the side of the pulled pull wire 4. At this time, the structure of the bendable tube segment in the transmission tube segment 2 on the side where the pulled pull wire 4 is located undergoes contraction deformation, while the structure of the bendable tube segment in the transmission tube segment 2 on the opposite side of the pulled pull wire 4 undergoes expansion deformation.
[0105] In some embodiments, the transmission pipe segment 2 includes a bending pipe segment 21 and a non-bending main pipe segment 22. The proximal end of the energy-transmitting pipe 12 is connected to the distal end of the bending pipe segment 21 via a connecting platform 3, and the proximal end of the bending pipe segment 21 is connected to the distal end of the non-bending main pipe segment 22 to form a complete transmission pipe segment 2. Further, the transmission pipe segment 2 also includes a connecting pipe segment 23, which is the connection point between the proximal end of the bending pipe segment 21 (equivalent to the deflection segment 1110 in other embodiments) and the distal end of the non-bending main pipe segment 22. It should be noted that the transmission tube segment 2 may not be made of a uniform material. To facilitate bending of the distal end of the catheter, the transmission tube segment 2 may be segmented as mentioned above or have a structure where the hardness gradually increases from the distal end to the proximal end. The part of the transmission tube segment 2 closer to the connecting platform 3 has a lower material hardness. That is, this segment is connected to the hardened tube segment 31. Thus, when the handle 6 drives the pull wire 4, the pull wire 4 is connected to the hardened tube segment 31 and causes the catheter to bend. This bending is more likely to occur in the transmission tube segment 2 near the connection with the hardened tube segment 31, thereby enabling the distal end of the catheter to bend according to the control to drive the probe 11 to collect tissue information in the required direction.
[0106] For example, as shown in Figures 5, 6, 7, 8, and 9, in some embodiments, there are two pull wires 4. Correspondingly, the transmission pipe section 2 has four threading cavities 201 inside. These four parallel threading cavities 201 are evenly arranged around the center line of the transmission pipe section 2, meaning the central angle between any two adjacent threading cavities 201 is 90 degrees. In some embodiments, the four threading cavities 201 are arranged in a rectangle, i.e., they are respectively arranged at the apex of a rectangular area. Correspondingly, the two pull wires 4 have a total of [missing information - likely referring to a specific feature or function]. There are four free ends, which are respectively inserted into the corresponding threading cavity 201. Thus, the central angle between any two adjacent free ends is 90 degrees. The common end of the two free ends connected to the same pull wire 4 is located outside the left end of the transmission tube section 2. After the left end of the transmission tube section 2 is welded to the right end of the functional tube section 1 to form a connecting platform 3, the common end can be wrapped and fixed inside the connecting platform 3. In the above embodiment with two sets of pull wires 4, the interventional catheter can be bent in four adjacent directions with an included angle of 90 degrees.
[0107] Of course, there is no limit to the number of pull lines 4; there can be three or four sets, as long as the bending requirements are met.
[0108] In some embodiments, the interventional catheter further includes a sheath 7 and a connector 8. The distal end of the sheath 7 is connected to the proximal end of the handle 6, and the sheath 7 is fitted over the outside of the communication core 5 for protection. The connector 8 is connected to the proximal end of the sheath 7, and the communication core 5 is signal-connected to the connector 8. In use, the connector 8 is connected to the imaging system, which enables the signal transmitted back from the communication core 5 to be transmitted to the imaging system for processing.
[0109] In some embodiments, the handle 6 includes an outer rotating mechanism 61 (similar to the rotating mechanism 410 in other embodiments), an inner bending control mechanism 62 (similar to the bending adjustment body 4320 in other embodiments), and a handle body 63. The outer rotating mechanism 61 and the inner bending control mechanism 62 are both movably disposed on the handle body 63. The outer rotating mechanism 61 is connected to the proximal end of the transmission tube segment 2 and is used to control the rotational movement of the outer conduit, which includes the energy-permeable tube 12 and the transmission tube segment 2. The inner bending control mechanism 62 is connected to the pull wire 4 and is used to pull the pull wire 4 to achieve bending control of the conduit.
[0110] In addition to the aforementioned interventional catheters, this application also provides an assembly method for the interventional catheters disclosed in the above embodiments. The assembly method includes the following steps: assembling a probe inside a permeable tube; threading a pull wire into each of the even-numbered lumens of the transmission tube segment, and connecting the proximal end of the transmission tube segment to a handle; connecting the distal end of the pull wire to a connecting section, and connecting the proximal end of the pull wire to a handle; ensuring that the handle can drive the connecting section to rotate circumferentially and / or pull the pull wire in the lumens to change the spatial orientation of the probe's working surface.
[0111] In some specific embodiments, step S1 is included: assembling the probe 11 inside the energy-transmitting tube 12; it can be understood that the probe 11 is first assembled inside the energy-transmitting tube 12 to complete the assembly of the functional tube segment 1.
[0112] The first free end of the pull wire 4 is placed outside the proximal end of the transmission pipe section 2. The second free end of the pull wire 4 is inserted into the first cavity 201a to the distal end of the transmission pipe section 2. The second free end of the pull wire 4 is inserted into the second cavity 201b and exposed outside the proximal end of the transmission pipe section 2. The pull wire 4 is knotted at the distal end of the transmission pipe section 2 to form a common end. This is used to complete the assembly of the pull wire 4 and the transmission pipe section 2, so as to complete the assembly work required for the transmission pipe section 2 before assembly with the energy-transmitting tube 12. The two free ends of a set of pull wires 4 are defined as the first free end and the second free end, respectively, for easy distinction. The specific process of assembling a set of pull wires 4 is as follows: take the second free end of the pull wire 4 and insert it from the proximal end of one of the threading cavities 201 of the transmission pipe section 2. The pull wire 4 is inserted into the open end until the second free end extends to the outer side of the distal end of the transmission pipe section 2, leaving a target length on the outer side of the distal end of the transmission pipe section 2. Then, a knot is tied at the target length position of the pull wire 4 to form a common end. The second free end is then inserted into the open end of the other threading cavity 201 of the transmission pipe section 2 until the second free end of the pull wire 4 extends to the outer side of the proximal end of the transmission pipe section 2. The position of the pull wire 4 is then finely adjusted so that the anti-loosening knot 41 is located at the target position at the distal end of the transmission pipe section 2, such as the center position between the first cavity 201a and the second cavity 201b (the knot can be tied first and then inserted into the second cavity 201b, or it can be inserted from the proximal end of the second cavity 201b first and then tied). Furthermore, each group of pull wires 4 repeats the above specific assembly process for one group of pull wires 4 in sequence, that is, the assembly of the pull wire 4 and the transmission pipe section 2 is realized.
[0113] Optionally, before assembling the pull wire 4 and the transmission tube segment 2, the end of the traction wire is connected to the second free end of the pull wire 4 by means of adhesive bonding or heat shrink tubing; during the assembly process of the pull wire 4 and the transmission tube segment 2, the free end of the traction wire is inserted into the transmission tube segment 2 through the proximal opening of one of the threading channels 201, and the free end of the traction wire is inserted into the transmission tube segment 2 through the distal opening of the other threading channel 201.
[0114] It should be noted that in step S1 above, the operation of assembling the probe 11 to the energy-transmitting tube 12 and the operation of assembling the pull wire 4 to the transmission tube segment 2 can be performed simultaneously, or either one can be performed first and the other later.
[0115] Step S2: The common end is fixedly embedded in the connecting platform 3 between the energy-transmitting tube 12 and the transmission tube segment 2. It can be understood that the connecting platform 3 connects the distal end of the transmission tube segment 2 and the proximal end of the energy-transmitting tube 12, with the common end of the pull wire 4 embedded inside the connecting platform 3. For example, the distal end of the transmission tube segment 2 and the proximal end of the energy-transmitting tube 12 are directly connected and fixed using fusion welding. The connecting platform 3 is the part of the tube structure where the fused structure of the distal end of the transmission tube segment 2 and the fused structure of the proximal end of the energy-transmitting tube 12 are mixed and solidified.
[0116] Connect the first and second free ends of the pull cable 4 to the handle 6 respectively. It can be understood that by connecting both free ends of the pull cable 4 to the handle 6, the first and second free ends can be pulled respectively by operating the handle 6, thereby achieving bending.
[0117] It should be noted that in step S2 above, the operation of assembling the energy-transmitting tube 12 and the transmission tube segment 2 and the operation of connecting the pull wire 4 and the handle 6 can be performed simultaneously, or either one can be performed first and the other later.
[0118] Based on the above embodiment, in step S1, the first free end of the pull wire 4 is placed outside the proximal end of the transmission pipe section 2, the second free end of the pull wire 4 is inserted into the first cavity 201a to the distal end of the transmission pipe section 2, the second free end of the pull wire 4 is inserted into the second cavity 201b and exposed outside the proximal end of the transmission pipe section 2, and the pull wire 4 is knotted at the distal end of the transmission pipe section 2 to form a common end, including the following steps:
[0119] Step S11: Connect the hardened tube section 31 at the distal end of the transmission tube section 2; it can be understood that the hardened tube section 31 is connected at the distal end of the transmission tube section 2 by bonding or welding to form a complete cavity or path for the pull wire 4 to pass through the conduit. The complete cavity required for the pull wire 4 to pass through the conduit is the threading cavity 201 in the transmission tube section 2 and the channel in the hardened tube section 31 that communicates with the threading cavity 201, and forms the main body of the cavity for the communication core 5 to pass through the conduit. The main body of the cavity required for the communication core 5 to pass through the conduit is the central cavity 202 in the transmission tube section 2 and the channel in the hardened tube section 31 that communicates with the central cavity 202.
[0120] Step S12: Place the first free end of the pull wire 4 outside the proximal end of the transmission pipe section 2, insert the second free end of the pull wire 4 into the first cavity 201a to the distal end of the hardened pipe section 31, insert the second free end of the pull wire 4 into the second cavity 201b and expose it outside the proximal end of the transmission pipe section 2, and tie the pull wire 4 at the distal end of the hardened pipe section 31 to form a common end;
[0121] Understandably, after forming the complete drawstring 4 through step S11 and inserting it into the required cavity inside the catheter, this step involves assembling the drawstring 4. Specifically, the second free end of the drawstring 4 is taken and inserted into the proximal opening of the first cavity 201a of the transfer tube segment 2 until the second free end of the drawstring 4 extends to the distal outer side of the hardened tube segment 31 after passing through the channel corresponding to the first cavity 201a. Then, the second free end is inserted into the distal opening of the channel corresponding to the target second cavity 201b in the transfer tube segment 2 until the second free end of the drawstring 4 extends to the proximal outer side of the transfer tube segment 2. A knot is then tied at the target length position of the drawstring 4 to form a common end (the knot can be tied first and then inserted into the second cavity 201b, or it can be passed out from the proximal end of the second cavity 201b first and then tied).
[0122] Correspondingly, before step S2, the following steps are included, or step S1 may include the following steps: connecting the transition segment 32 to the proximal end of the functional segment 1. It is understood that, in order to prepare the interventional catheter including the hardened segment 31 and the transition segment 32 for the connecting platform 3, steps S11 and S12 have already completed the relevant preparation work for the hardened segment 31. This step requires the preparation work for the transition segment 32, that is, connecting the distal end of the transition segment 32 to the proximal end of the permeable tube 12 by bonding or welding. It should be noted that this step can be performed simultaneously with either step S11 or step S12, or before or after either of them.
[0123] In step S2 above, the common end is fixedly embedded in the connecting platform 3 between the energy-transmitting tube 12 and the transmission tube segment 2; this includes the following steps:
[0124] The molten hardened pipe section 31 and the transition pipe section 32 form a connecting platform 3, so that the common end is fixedly embedded in the connecting platform 3. It can be understood that the far end of the molten hardened pipe section 31 and the near end of the transition pipe section 32 form a connecting platform 3, and the fixed end of the pull wire 4, which is passed through to the outside of the far end of the hardened pipe section 31 through the above step S12, is embedded inside the connecting platform 3.
[0125] Based on the above embodiments, before fixing the common end in the connecting platform 3 between the energy-transmitting tube 12 and the transmission tube segment 2 in step S2, the following steps are included:
[0126] Pull the common end of the pull wire 4 to the opposite side of the first cavity 201a and the second cavity 201b, and then install the communication core 5 in the central cavity 202, so that the pull wire 4 is semi-enclosed around the communication core 5 at the distal end of the transmission tube segment 2. It can be understood that in order to prepare several sets of interventional catheters with pull wires 4 arranged in the above-mentioned bilateral cross-shaped manner, in this step, after assembling the pull wire 4 to the transmission tube segment 2 in step S1, pull the common end of the pull wire 4 to the opposite side of the first cavity 201a and the second cavity 201b, and then install the communication core 5 into the transmission tube segment 2. This can be done by inserting the communication core 5 into the proximal opening of the central cavity 202 until the communication core 5 protrudes to the distal end of the transmission channel, so that the communication core 5 is located in the semi-enclosed area of the pull wire 4, that is, the pull wire 4 is semi-enclosed around the communication core 5 at the distal end of the transmission tube segment 2.
[0127] This application also provides an implementation method in which the interventional diagnostic catheter is directly used as an ultrasound catheter. Please refer to Figures 13 and 14, where Figure 13 is a schematic diagram of the ultrasound catheter provided in the embodiment of this application, and Figure 14 is a schematic diagram of the tube body provided in the embodiment of this application.
[0128] In one specific embodiment, the ultrasonic catheter provided by the present application mainly includes a tube body 10 and an ultrasonic probe 20. The ultrasonic catheter includes a first tube 110 and a second tube 120 arranged coaxially. The first tube 110 includes a transmission tube segment 2. The distal end of the transmission tube segment 2 includes a deflection segment 1110. The deflection segment 1110 can be controlled to bend by the pull wire 4 pulled by the handle 6.
[0129] The proximal end of the second tube 120 is connected to the handle 6, and the second tube 120 can be driven to rotate circumferentially by the handle 6;
[0130] The connecting section includes a first part connected to the distal end of the first tube 110 and a second part connected to the distal end of the second tube 120. The second part is connected to the functional tube segment 1 and can rotate relative to the first part. It can be understood that after the working surface of the probe is oriented to a certain position by pulling the wire, rotating the second tube 120 can rotate the probe to a certain angle in the current position. Of course, it is also possible to return to the zero position and then rotate the second tube 120 according to the needs or preferences. This application does not limit the operation to changing the spatial orientation of the working surface in a certain way, but only to provide support for clinical operations that continuously obtain the nearby field of view or expand the field of view under the current field of view after rotating a certain angle.
[0131] In other words, regarding adjusting the working surface of the probe to change its spatial orientation, the connecting section in the previously mentioned embodiments is an integrated design. By setting one or more sets of pull wires, the working surface of the probe can be adjusted to face multiple directions, and the pull wires are firmly embedded in the connecting platform of the connecting section. In contrast, the embodiments described now mainly adopt a split connecting section, in which two-way bending is achieved by the traction member 4310 (i.e., pull wires), and the implementation of further adjusting the working surface to face other directions is achieved by rotating the second pipe 120 to drive the probe to rotate. There are certain differences between the two.
[0132] It should be understood that the two are not mutually exclusive. The implementation method described here can be a combination of the implementation methods described above. For example, two free ends of a set of pull wires or two independent pull wires without a common end are used to pass through the upper and lower or left and right pull channels of the first tube 110 (that is, the transmission tube segment 2 mentioned in the previous embodiment). (This description is only for ease of understanding. In reality, it is sufficient to ensure that the pull wires pass through the two opposite pull channels and can be adjusted.) The pull wires drive the working surface of the probe to face one of the two opposite directions. For example, the pull wires drive the probe to bend to the left and the working surface faces the left side of the tissue at the current position to obtain a field of view containing the image of the left side of the tissue. By rotating the first tube 110, the image of the tissue adjacent to the left side of the tissue can be obtained, thereby realizing continuous image acquisition and obtaining more targeted large-scale tissue graphics. This helps the operator or surgeon to quickly capture the images and dynamics of the tissue of interest for clinical identification and decision-making.
[0133] For ease of description, the first part and the second tube 120 can be collectively referred to as tube body 10. The ultrasonic probe 20 is connected to the distal end of tube body 10. The distal end of the first tube 110 includes a deflection section 1110, which can be controlled to bend to change the spatial orientation of the working surface of the ultrasonic probe 20. The second tube 120 is coaxially arranged with the first tube 110 and can be driven to rotate circumferentially to rotate the working surface of the ultrasonic probe 20 relative to the first tube 110. The ultrasonic probe 20 emits ultrasonic waves in multiple spatial directions as the first tube 110 bends and the second tube 120 rotates.
[0134] As mentioned in the background section, existing ultrasound catheters often suffer from unnecessary bending or movement during the rotation of the ultrasound probe 20, causing the probe 20 to oscillate and resulting in loss of the imaging target or image instability. This coupled operation method limits the flexibility and precision of catheter manipulation, a problem that is particularly prominent in cardiac interventional procedures requiring precise manipulation and stable imaging.
[0135] To address this issue, the ultrasonic catheter technology solution provided in this application achieves independent operation of the bending controlled by the deflection section 1110 and the rotation controlled by the second tube 120 through innovative design. Specifically, the ultrasonic catheter includes a tube body 10 and an ultrasonic probe 20, wherein the tube body 10 is composed of a first tube 110 and a second tube 120. The distal end of the first tube 110 is provided with a deflection section 1110, which can be independently controlled to bend, thereby changing the spatial orientation of the working surface of the ultrasonic probe 20 without being affected by the movement of other parts of the catheter. The second tube 120 is coaxially arranged with the first tube 110 and can independently rotate circumferentially, further adjusting the working surface of the ultrasonic probe 20 so that it can rotate relative to the first tube 110, realizing the emission of ultrasonic waves in multiple different directions.
[0136] This design reduces interference between bending and rotational movements, allowing the ultrasound catheter to maintain a certain bending shape while stably controlling the orientation of the working surface of the ultrasound probe 20. This solves the problem in existing technologies where catheters struggle to simultaneously handle deflection and rotation. By independently controlling the deflection section 1110 and the second fitting 120, the ultrasound catheter can reduce the oscillation of the ultrasound probe 20 caused by catheter movement, lowering the risk of target loss or image instability, and improving imaging stability and surgical precision. Therefore, this technical solution not only provides an ultrasound catheter that can stably maintain a bending shape but also precisely control the orientation of the working surface of the ultrasound probe 20 in multiple different directions within this bending state, significantly improving surgical adaptability and effectiveness, and meeting the medical field's demand for high-precision ultrasound catheters.
[0137] Based on the above structural and process descriptions, it can be seen that the ultrasonic catheter has at least the following beneficial effects: the ultrasonic catheter controls bending through the deflection section 1110 and rotation through the second tube 120, effectively solving the problem that ultrasonic catheters in the prior art are difficult to balance deflection and rotation functions. It provides an ultrasonic catheter that can stably maintain the bending shape and control the working surface of the ultrasonic probe 20 to face multiple different directions in this state, thereby improving the stability of imaging and the accuracy of surgery.
[0138] In this application, the ultrasound probe 20 can function as both a detection imaging device and an ablation therapy device. Specifically, the following description will focus on the imaging function as the application scenario.
[0139] An ultrasound probe 20 is connected to the distal end of a tube 10, which includes a first tube 110 and a second tube 120. The distal end of the first tube 110 includes a deflection section 1110, which can be controlled to bend, thereby changing the spatial orientation of the working surface of the ultrasound probe 20 and achieving precise imaging of internal structures such as the heart. The second tube 120 is coaxially arranged with the first tube 110 and can be driven to rotate circumferentially, causing the working surface of the ultrasound probe 20 to rotate relative to the first tube 110. This allows the ultrasound probe 20 to emit ultrasound waves in multiple spatial directions for omnidirectional imaging. This design allows the ultrasound catheter to maintain a certain bending shape while stably controlling the orientation of the working surface of the ultrasound probe 20, solving the problem in existing technologies where catheters cannot simultaneously achieve deflection and rotation functions, thus improving imaging stability and surgical precision.
[0140] Please continue to refer to Figure 14. In some embodiments, a limiting mechanism 30 is also provided between the first pipe 110 and the second pipe 120. The limiting mechanism 30 allows the second pipe 120 to rotate relative to the first pipe 110 and restricts the axial displacement between the first pipe 110 and the second pipe 120.
[0141] In this embodiment, a limiting mechanism 30 is specially added to the technical solution. This mechanism is set between the first pipe fitting 110 and the second pipe fitting 120 and plays a key auxiliary role.
[0142] The main function of the limiting mechanism 30 is to allow the second tube 120 to rotate relative to the first tube 110 while limiting the axial displacement between the two. This design ensures that the ultrasonic probe 20 can flexibly adjust the orientation of its working surface without unwanted axial movement, which is crucial for precise control of the position and orientation of the ultrasonic probe 20.
[0143] It should be understood that this mechanism of the limiting mechanism 30 can enhance the operational stability and reliability of the ultrasound catheter, especially during complex interventional procedures, ensuring that the ultrasound probe 20 is kept in the correct position and orientation, thereby improving the accuracy and safety of the procedure.
[0144] It should be noted that axial displacement refers to the positional change of the first tube 110 and the second tube 120 along the axis of the ultrasonic catheter. The design of the limiting mechanism 30 allows for two different axial displacement control methods: one is to completely restrict the axial displacement between the first tube 110 and the second tube 120, ensuring that the two tubes are fixed in the axial direction; the other is to allow limited axial movement between the two tubes to adapt to different usage requirements. This flexible design ensures both the accuracy of catheter operation and provides the necessary adjustment space.
[0145] Please continue to refer to Figure 14. In some embodiments, the first pipe 110 and the second pipe 120 are arranged side by side. The second pipe 120 is provided with a deflection compliance section 1210 at a position close to the deflection section 1110. The deflection compliance section 1210 can bend synchronously with the deflection section 1110.
[0146] One side of the limiting mechanism 30 is connected to the deflection section 1110, and the other side of the limiting mechanism 30 is connected to the deflection compliance section 1210. Furthermore, one side of the limiting mechanism 30 is connected to the distal end of the deflection section 1110, and the other side of the limiting mechanism 30 is connected to the distal end of the deflection compliance section 1210. The working surface of the ultrasonic probe is positioned between the distal end of the tube and the deflection section 1110. Thus, the limiting mechanism 30 is positioned at the distal ends of the deflection section 1110 and the deflection compliance section 1210. The limiting mechanism 30 is close to the ultrasonic probe, allowing it to receive both bending and rotational forces, and ensuring a more stable force transmitted to the ultrasonic probe, preventing probe oscillation and improving the imaging or ablation effect of the ultrasonic probe's working surface.
[0147] In some embodiments, the first tube 110 and the second tube 120 are arranged side by side. This arrangement allows the two tubes to fit together tightly in space, improving the stability of the overall structure and the flexibility of operation. Specifically, the second tube 120 has a deflection compliant section 1210 specifically designed near the deflection section 1110. The important function of this deflection compliant section 1210 is to bend synchronously with the deflection section 1110, ensuring that the second tube 120 can adapt to the bending changes of the first tube 110 when the working surface of the ultrasonic probe 20 is adjusted in space, maintaining overall coordination and consistency. Furthermore, the limiting mechanism 30 is connected to the deflection section 1110 on one side and to the deflection compliant section 1210 on the other side. This not only limits the axial displacement between the first tube 110 and the second tube 120 but also provides stable support when the two tubes rotate or bend relative to each other. With this connection method, the limiting mechanism 30 is set in the bendable part of the tube body 10, which fully mobilizes the deflection conforming section 1210 to bend synchronously with the deflection section 1110, ensuring the accuracy and reliability of the ultrasonic catheter during the bending process. At the same time, the setting of the limiting mechanism 3 leaves a gap between the first tube 110 and the second tube 120, thereby ensuring that the second tube 120 does not affect the first tube 110 when it rotates, and also protects the internal ultrasonic probe 20. This sophisticated design fully considers that intracardiac ultrasound catheters, which are typically around 1 meter in length due to their need to probe cardiac tissue, require appropriate limiting structures. Furthermore, if there is a gap between the first tube 110 and the second tube 120, external manipulation by the operator at the proximal end of the catheter can easily lead to relative movement between the first and second tubes. This makes it difficult to ensure that the two tubes maintain a consistent bending shape, thus hindering the achievement of the operator's desired distal bending shape. Simultaneously, if the distal ends of the two tubes are not mutually restrained, the first tube 110 can bend independently under distal drive. Friction and the gap between the first and second tubes can cause excessive bending of the first tube 110 to drive the second tube 120 to bend. In this case, the first tube 110 is prone to bending and damage, leading to distal catheter movement failure and reduced catheter lifespan.Therefore, by setting the limiting mechanism 30 on the bendable part of the tube body 10, the synchronous bending requirements and separate control requirements of the first tube 110 and the second tube 120 are well balanced. This ensures that the tube body has a consistent degree and shape of bending at least at and near the location of the limiting mechanism 30, thereby achieving stable bending shape control of the ultrasound catheter. The limiting mechanism 30, as a design to ensure the starting point of bending, allows the operator's bending control at the proximal end to be better transmitted to the distal end of the catheter, reducing the transmission distortion rate. It also ensures the separate movement of the first tube 110 and the second tube 120. The ultrasound probe rotates in a stable bending state, thereby performing imaging or treatment functions in different directions of the target space. This allows the ultrasound catheter to be operated more stably, flexibly, and safely in the human body.
[0148] The connection between the aforementioned limiting mechanism 30 and the first pipe fitting 110 and the second pipe fitting 120 can be by bonding, welding or other stable connection methods.
[0149] To improve the synchronicity and consistency of the bending of the deflection section 1110 of the first fitting 110 and the deflection compliance section 1210 of the second fitting 120, in some cases, the deflection section 1110 of the first fitting 110 and the deflection compliance section 1210 of the second fitting 120 are made of relatively soft materials, while other parts of the first fitting 110 and the second fitting 120 are made of relatively hard materials. In other cases, the first fitting 110, as the inner tube, is set to have a greater thickness than the second fitting 120, which can provide greater bending stress when the conduit is bent, thereby driving the deflection compliance section 1210 of the second fitting 120 to bend.
[0150] Please refer to Figures 15 and 16. Figure 15 is a schematic diagram of AA in Figure 14, and Figure 16 is a schematic diagram of BB in Figure 14.
[0151] In some embodiments, the limiting mechanism 30 includes a first limiting member 310 and a second limiting member 320, wherein the first limiting member 310 is disposed along the circumferential direction of the first tube 110 and the second limiting member 320 is disposed along the circumferential direction of the second tube 120.
[0152] The first limiting member 310 and the second limiting member 320 block each other along the axial direction of the tube body 10, or one of the first limiting member 310 and the second limiting member 320 is internally rotatably connected to the other.
[0153] In this embodiment, the limiting mechanism 30 consists of a first limiting member 310 and a second limiting member 320, which are respectively arranged along the circumference of the first tube 110 and the second tube 120. This arrangement allows the first limiting member 310 and the second limiting member 320 to rotate circumferentially in the tube body 1 and to block each other axially, thereby limiting the axial displacement between the first tube 110 and the second tube 120 and ensuring a rotatable connection between them. Furthermore, the first limiting member 310 and the second limiting member 320 can be internally rotatably connected; for example, a circumferential slide rail (not shown) is provided on one of them, and a boss (not shown) extending into the slide rail is provided on the other. This design allows for a certain degree of rotational freedom while still maintaining control over axial displacement. This structure ensures sufficient stability while providing the necessary flexibility to adapt to different surgical procedures and catheter position adjustment needs.
[0154] It should be noted that the first limiting member 310 and the second limiting member 320 mentioned in the design of the limiting mechanism 30 are arranged circumferentially along the first pipe 110 and the second pipe 120, and are not limited to a specific geometric shape. This means that the first limiting member 310 and the second limiting member 320 can be arranged as closed rings or as open rings. Regardless of whether the design is closed or open, the key is that they can provide the necessary limiting function along the circumferential direction of the pipe. This design flexibility allows the most suitable configuration to be selected according to specific application requirements and manufacturing convenience, ensuring that the limiting mechanism 30 can effectively restrict the relative movement of the first pipe 110 and the second pipe 120 along the axial direction of the pipe body 10, or allow a certain degree of rotational engagement between them to adapt to different operating conditions.
[0155] In some embodiments, the limiting mechanism 30 includes a first limiting member 310, a second limiting member 320, and an intermediate member 330; the first limiting member 310 is disposed on the first pipe 110, the second limiting member 320 is disposed on the second pipe 120, and the intermediate member 330 is disposed between the first limiting member 310 and the second limiting member 320 to reduce the contact area and / or coefficient of friction between the second limiting member 320 and the second limiting member 320.
[0156] In this embodiment, as shown in Figure 15, the design of the limiting mechanism 30 is further refined, including a first limiting member 310, a second limiting member 320, and a newly introduced intermediate member 330. The first limiting member 310 is mounted on the first tube 110, while the second limiting member 320 is mounted on the second tube 120. The intermediate member 330 is cleverly positioned between the first limiting member 310 and the second limiting member 320. The main advantage of this configuration is that the intermediate member 330 can effectively reduce the contact area between the first limiting member 310 and / or the second limiting member 320 and itself or other components, or reduce the coefficient of friction through material adjustment. By reducing the contact area and the coefficient of friction, the limiting mechanism 30 can operate more smoothly, reduce wear, extend the service life of the ultrasonic catheter, and improve operational flexibility and precision. This ingenious design demonstrates how to improve overall performance through detailed optimization while maintaining structural stability.
[0157] In some cases, the intermediate component 330 can be a washer or a ball bearing.
[0158] Please refer to Figure 17, which is a schematic diagram of the handle provided in an embodiment of this application.
[0159] In some embodiments, a handle 40 is also included, which includes a rotating mechanism 410 fixedly connected to the proximal end of the second tube 120. The rotating mechanism 410 drives the second tube 120 to rotate so as to rotate the ultrasound probe 20.
[0160] In this embodiment, the ultrasound catheter system includes a handle 40 equipped with a rotating mechanism 410, which is fixedly connected to the proximal end of the second tubing 120. The main function of the rotating mechanism 410 is to drive the second tubing 120 to rotate. This rotational motion is transmitted to the ultrasound probe 20 connected to the distal end of the tubing, allowing the ultrasound probe 20 to rotate around its axis. This design allows the operator to precisely control the rotation of the ultrasound probe 20 via the rotating mechanism 410 on the handle 40, thereby adjusting the orientation of the probe's working surface to suit different imaging or treatment needs. This handle design provides a simple and direct method to control the direction of the ultrasound probe 20, enhancing flexibility and control precision during surgery.
[0161] In some embodiments, the handle 40 is also provided with a limiting groove 420;
[0162] The rotating mechanism 410 is provided with a first knob 4110 and a rotating rod 4120 connected together. The first knob 4110 can be turned to rotate, and the rotating rod 4120 extends into the limiting groove 420 of the handle 40.
[0163] The rotating rod 4120 is provided with a protrusion 41210 that cooperates with the limiting groove 420 to realize the circumferential and axial limiting of the rotating mechanism 410.
[0164] In this embodiment, the design of the handle 40 is further enhanced by adding a new feature: a limiting groove 420. The rotating mechanism 410 consists of a first knob 4110 and a rotating rod 4120, wherein the first knob 4110 can be turned by the operator to achieve rotation, and the rotating rod 4120 extends and inserts into the limiting groove 420 of the handle 40. This design allows the rotating mechanism 410 to be precisely limited in both the circumferential and axial directions.
[0165] The rotating rod 4120 is specially designed with a protrusion 41210, which cooperates with the limiting groove 420 to ensure that the rotating mechanism 410 can stably maintain its current position during rotation, preventing unwanted movement or displacement of the rotating mechanism 410 during operation. The function of the protrusion 41210 is to provide restraint for the rotating mechanism 410 in the circumferential and axial directions, enhancing the operational stability and reliability of the ultrasonic catheter, and making the rotation control of the ultrasonic probe 20 more precise and smooth.
[0166] In some embodiments, a handle 40 is also included, with the proximal end of the first tube 110 connected to the handle 40. The handle 40 includes a bending mechanism 430, which includes a traction member 4310 and a bending body 4320. The proximal end of the traction member 4310 is connected to the bending body 4320, and the distal end of the traction member 4310 passes through the first tube 110 and is connected to the deflection section 1110. The bending body 4320 pulls the traction member 4310 to drive the deflection section 1110 to bend.
[0167] In this embodiment, the handle 40 is not only connected to the proximal end of the first tube 110, but also integrates a bending mechanism 430 for controlling the bending of the deflection segment 1110 in the ultrasonic catheter. The bending mechanism 430 consists of a traction member 4310 and a bending body 4320. One end of the traction member 4310 is connected to the bending body 4320, and the other end extends through the first tube 110 and is finally connected to the deflection segment 1110. By operating the bending body 4320, the traction member 4310 can be stretched or relaxed, thereby achieving precise control over the bending of the deflection segment 1110.
[0168] This design allows the operator to directly control the degree of bending of the deflection section 1110 via the bending adjustment mechanism 430 on the handle 40, thereby adjusting the spatial orientation of the ultrasound probe 20 to adapt to different surgical needs and target areas. This mechanical connection of the traction member 4310 provides a direct and effective means of adjusting the curvature of the catheter, enhancing flexibility and control precision during the surgical process, and contributing to improved surgical accuracy and efficiency.
[0169] In some embodiments, the bending body 4320 includes a second knob 43210 and a transmission member 43220. The second knob 43210 can be turned to rotate. There is gear transmission between the second knob 43210 and the transmission member 43220. The traction member 4310 is a pull cable. The proximal end of the pull cable is connected to either the second knob 43210 or the transmission member 43220. The second knob 43210 changes the winding length of the pull cable on the bending body 4320 by rotation to adjust the degree of bending of the deflection section 1110.
[0170] In this embodiment, the bending body 4320 includes a second knob 43210 and a transmission component 43220. The second knob 43210 is a manually operable component, allowing the operator to control the transmission component 43220 by rotation. These two components are connected via gear transmission, ensuring precise transmission of rotational movements. The traction component 4310 is designed as a pull cable, with its proximal end connected to either the second knob 43210 or the transmission component 43220. This connection allows adjustment of the bending degree of the deflection segment 1110 by changing the winding length of the pull cable.
[0171] Specifically, when the second knob 43210 is rotated, the gear transmission mechanism drives the transmission component 43220, thereby adjusting the tension and length of the pull cable. As the length of the pull cable wound on the bending body 4320 changes, the degree of bending of the deflection section 1110 is adjusted accordingly. This design allows the operator to precisely control the bending shape of the ultrasound catheter to adapt to different surgical needs and target areas. By finely adjusting the bending of the deflection section 1110, the positioning of the ultrasound probe 20 can be optimized, improving the flexibility and accuracy during the surgical procedure.
[0172] Specifically, the transmission component 43220 adopts a gear rod, and the second knob 43210 is connected to the transmission gear 43230, with the gear rod meshing with the transmission gear 43230.
[0173] In some embodiments, the deflection segment 1110 is connected to the traction member 4310 (similar to the pull wire 4 in some other embodiments) and is controlled to bend by the traction member 4310. The number of traction members 4310 is 2N, where N is a positive integer. The traction members 4310 are circumferentially symmetrically distributed relative to the deflection segment 1110.
[0174] In this embodiment, the bending operation of the deflection segment 1110 is achieved through the traction member 4310, which is connected to and controls the bending of the deflection segment 1110. The number of traction members 4310 is 2N, where N is a positive integer, meaning that the traction members 4310 exist in pairs, ensuring that the deflection segment 1110 can be bent uniformly and precisely in multiple directions. This design of the traction members 4310 allows for fine control of the deflection segment 1110 because they are circumferentially symmetrically distributed relative to the deflection segment 1110, making the bending of the deflection segment 1110 more flexible, stable, and controllable.
[0175] This symmetrically distributed traction element 4310 design provides precise control over the bending direction and angle of the deflection segment 1110, which is crucial for the accurate positioning of the ultrasound probe 20. By adjusting the tension of the traction element 4310, the bending state of the deflection segment 1110 can be changed, thereby adjusting the spatial orientation of the ultrasound probe 20 so that it can be aligned with the target area for imaging or treatment. This design enhances the operational flexibility of the ultrasound catheter, enabling it to adapt to complex internal environments and diverse surgical needs.
[0176] Specifically, there are two sets of transmission components 43220 and pull wires, which are symmetrically arranged. When the second knob 43210 is rotated, it drives the transmission components 43220 on both sides to rotate. The two transmission components 43220 rotate in opposite directions, which tightens the pull wire on one side and loosens the pull wire on the other side. By changing the rotation direction of the second knob 43210, the bidirectional bending of the ultrasonic catheter can be achieved.
[0177] In some cases, the pull wires and deflection section 1110 can be fixed by embedding, welding, or gluing. The number of pull wires can be selected as 1-4 or more, evenly distributed around the circumference of the inner conduit. In use, bending in the corresponding direction can be achieved by pulling the pull wires. In addition, the bending profile can be controlled by adjusting the length ratio of the deflection section 1110 in the first pipe fitting 110.
[0178] In some embodiments, the first pipe fitting 110 and the second pipe fitting 120 are arranged side by side, wherein,
[0179] The second fitting 120 is sleeved outside the first fitting 110, and the second fitting 120 is connected to the ultrasonic probe 20. Alternatively, the first fitting 110 is sleeved outside the second fitting 120, and the distal end of the second fitting 120 extends outward relative to the distal end of the first fitting 110 and is fitted with the ultrasonic probe 20.
[0180] In this embodiment, the first tube 110 and the second tube 120 are arranged side-by-side, providing two different configuration options to adapt to different application scenarios. In the first configuration, the second tube 120 is fitted over the first tube 110. This design protects the inner first tube 110 while allowing the second tube 120 to operate independently. In the second configuration, the first tube 110 is fitted over the second tube 120, and the distal end of the second tube 120 extends outward relative to the distal end of the first tube 110. This arrangement allows the ultrasound probe 20 to be mounted on the extended portion of the second tube 120, facilitating imaging or treatment functions.
[0181] This flexible tubing configuration not only enhances the mechanical stability and operational flexibility of the ultrasound catheter but also allows for adjustments to the position and orientation of the ultrasound probe 20 according to specific clinical needs. Whether the second tubing 120 is fitted externally for protection or the first tubing 110 is fitted externally for easy installation of the ultrasound probe 20, these designs are intended to optimize the performance of the ultrasound catheter, ensuring its effectiveness and reliability during surgery. In this way, the ultrasound probe 20 can be precisely positioned to the target area when needed to perform the required medical procedures.
[0182] In some embodiments, as shown in FIG17, the bending mechanism 430 and the rotating mechanism 410 on the handle 40 are arranged coaxially, or the first knob 4110 and the second knob 43210 are distributed coaxially, so as to make the space compact and easy to operate with one hand.
[0183] Please continue referring to Figure 13. In some cases, the ultrasonic catheter also includes a sheath and a connector, which are connected to the tail end of the handle 40. Conversely, the proximal end of the handle 40 is connected to the tube body 10. During use, the handle 40 is convenient for the operator to hold and operate. The core wire of the ultrasonic probe 20 passes through the sheath, and the connector is the interface part that connects to the tail wire of the corresponding device.
[0184] Please refer to Figure 18, which is a schematic diagram of the ultrasonic probe provided in the embodiment of this application.
[0185] In some cases, the ultrasound probe 20 includes a transducer sheath 210, a transducer 220, and a core wire 230. The transducer sheath 210 is made of a material with good sound transmission properties, has a cylindrical shape and a flat inner hole. Taking the second tube 120 fitted over the first tube 110 as an example, the outer dimensions of the transducer sheath 210 match the outer diameter of the second tube 120, and the inner hole matches the outer dimensions of the transducer 220, facilitating the insertion of the transducer 220 and protecting its ultrasonic emitting surface. The ultrasonic transducer 220 has a working surface capable of emitting and receiving ultrasonic signals to obtain image information at the corresponding location. When the ultrasonic transducer 220 is used for ablation to perform therapeutic functions, this working surface is used to emit ultrasonic energy. The core wire 230 is connected to the transducer 220 and can export the signals received by the transducer 220 to the system end.
[0186] In some cases, continuing with the example of the second fitting 120 being fitted outside the first fitting 110, the interior of the first fitting 110 can be provided with a through hole for a pull wire. Simultaneously, sufficient gaps are reserved between the inner and outer layers to ensure that the inner layer is not affected when the outer layer rotates, thus not affecting the overall bending direction of the conduit during bending control.
[0187] This application also provides an ultrasound device, including an ultrasound system and the aforementioned ultrasound catheter, wherein the ultrasound system is signal connected to the ultrasound catheter, and the ultrasound probe 20 is excited to collect image information or emit ablation energy in multiple directions of spatial orientation.
[0188] The ultrasound device includes the aforementioned ultrasound catheter and should possess all the beneficial technical effects of the aforementioned ultrasound catheter, which will not be elaborated here.
[0189] The ultrasonic device mentioned in this application is an integrated system that includes not only the ultrasonic conduit described in detail above, but also an ultrasonic system. This ultrasonic system is connected to the ultrasonic conduit via a signal link, ensuring effective data transmission and communication between the two. In this configuration, the ultrasonic probe 20, as an important component of the ultrasonic conduit, can be excited by the ultrasonic system to emit ultrasonic waves in multiple directions in space.
[0190] These ultrasound waves can penetrate biological tissue, and the reflected signals are received by the ultrasound probe 20, converted into image information, or used to deliver ablation energy for treatment. In imaging mode, the ultrasound system processes these collected signals and converts them into images that can be analyzed and interpreted by the doctor. This integrated ultrasound device design allows doctors to obtain clear image information in real time during surgery or to precisely apply ablation energy, improving the accuracy and safety of the procedure. Furthermore, this design simplifies the operation of the ultrasound device and improves surgical efficiency.
[0191] Based on the above two types of implementation methods, the following explanations are needed regarding the various technical features: Among them, "traction element 4310" is equivalent to "pull wire 4" in some other implementation methods, and "ultrasonic probe 20" is equivalent to the specific selection of "probe 11" in some other implementation methods;
[0192] The following is an explanation of the combination relationship between the two types of implementation methods mentioned above:
[0193] In some preferred embodiments, the specific embodiment described above, which states that "only one set of pull wires 4 is used for bending in two directions (such as bending forward and backward or bending left and right, as shown in Figure 12), can be directly combined with the specific embodiment described above in other embodiments, which includes the second tube 120 and the limiting mechanism 30, to obtain an ultrasonic catheter that can be bent in multiple directions.
[0194] In addition, in some optional embodiments, the specific embodiment in Embodiment 1 with a configuration of more than or equal to two sets of pull wires 4 can also be combined with the specific embodiment in Embodiment 2 that includes the second pipe fitting 120 and the limiting mechanism 30.
Claims
1. An interventional catheter, characterized in that include: The functional tube section includes a probe and a power-transmitting tube sleeved outside the probe; A transmission pipe segment, connected to the proximal end of the functional pipe segment, is provided with an even number of threading cavities, and each of the threading cavities is connected along the length of the transmission pipe segment and separated from each other. A connecting section is disposed between the functional pipe section and the transmission pipe section; The pull wires are an even number, and the far ends of the pull wires are respectively threaded into the threading channel and fixed to the connecting section; A handle is installed at the proximal end of the transmission tube section and connected to the proximal end of the pull wire. The handle can drive the connecting section to rotate circumferentially and / or pull the pull wire in the threading cavity, so as to drive the working surface of the probe to change its spatial orientation.
2. The interventional catheter of claim 1, wherein, The pull wires are arranged in groups, and the interventional catheter is a traction and bending catheter. Each group of pull wires has one common end and two free ends, and the number of free ends of the pull wires is an even number. The connecting section includes a connecting platform, the common end is embedded in the connecting platform, and the fixed position of the common end on the connecting platform is staggered from the threading cavity. The two free ends of any group of pull wires are connected to the handle through different threading cavities, and any free end is driven independently by the handle.
3. The interventional catheter according to claim 2, characterized in that, The transmission tube section is provided with a central cavity, which is used to house the communication core connected to the probe, and a plurality of the wire-passing cavities are distributed around the central cavity; The connecting platform is set at an angle to the threading cavity, and any set of the pull wires is bent at the connecting platform to extend into the threading cavity.
4. The interventional catheter according to claim 3, characterized in that, The two free ends of the pull wire are respectively inserted into the first cavity and the second cavity; The common end of the pull wire is fixed between the first cavity and the second cavity, and the pull wires are staggered on the connecting platform; or, the common end of the pull wire is fixed on the opposite side of the first cavity and the second cavity, any one of the pull wires is arranged to semi-enclose the communication core on the connecting platform, and the pull wires are crisscrossed on the connecting platform.
5. The interventional catheter according to claim 3, characterized in that, The connecting platform is provided with a mounting groove for accommodating the pull wire, and the mounting groove is arranged around the central cavity.
6. The interventional catheter according to claim 2, characterized in that, The common end of the pull wire is made of an anti-detachment structure, and the maximum width of the threading cavity is less than the width of the anti-detachment knot.
7. The interventional catheter according to claim 3, characterized in that, The connecting platform includes a hardened pipe section and a transition pipe section. The hardened pipe section and the transition pipe section are sequentially arranged between the transmission pipe section and the energy-transmitting pipe. The hardened pipe section is provided with a channel communicating with the wire-passing cavity and the central cavity. The transition pipe section is provided with a cavity communicating with the central cavity. The common end is embedded between the hardened pipe section and the transition pipe section.
8. The interventional catheter according to claim 7, characterized in that, The hardness of the hardened pipe section is greater than that of the transmission pipe section and greater than that of the energy-permeable pipe, while the hardness of the transition pipe section is between that of the hardened pipe section and that of the energy-permeable pipe.
9. The interventional catheter according to claim 1, characterized in that, The interventional catheter is an ultrasound catheter, and the probe is an ultrasound probe. The ultrasound catheter includes a first tube and a second tube arranged coaxially. The first tube includes a transmission tube segment, and the distal end of the transmission tube segment includes a deflection segment. The deflection segment can be controlled to bend by pulling the cable with the handle. The proximal end of the second tube is connected to the handle, and the second tube can be driven to rotate circumferentially by the handle; The connecting section includes a first part connected to the distal end of the first pipe fitting and a second part connected to the distal end of the second pipe fitting. The second part is connected to the functional pipe segment and is rotatable relative to the first part. The ultrasonic probe emits ultrasonic waves in multiple directions in the spatial orientation as the first tube bends and the second tube rotates.
10. The interventional catheter according to claim 9, characterized in that, The interventional catheter also includes a limiting mechanism disposed between the first tube and the second tube, the limiting mechanism allowing the second tube to rotate relative to the first tube and limiting the axial displacement between the first tube and the second tube.
11. The interventional catheter according to claim 10, characterized in that, The first pipe fitting and the second pipe fitting are arranged side by side. The second pipe fitting is provided with a deflection compliance section at a position close to the deflection section. The deflection compliance section can bend synchronously with the deflection section. One side of the limiting mechanism is connected to the deflection section, and the other side of the limiting mechanism is connected to the deflection compliance section.
12. The interventional catheter according to claim 10, characterized in that, The limiting mechanism includes a first limiting member and a second limiting member, wherein the first limiting member is arranged along the circumference of the first pipe and the second limiting member is arranged along the circumference of the second pipe. The first limiting member and the second limiting member block each other along the axial direction of the interventional catheter, or one of the first limiting member and the second limiting member is internally rotatably connected to the other.
13. The interventional catheter according to claim 10, characterized in that, The limiting mechanism includes a first limiting member, a second limiting member, and an intermediate member; the first limiting member is disposed on the first pipe fitting, the second limiting member is disposed on the second pipe fitting, and the intermediate member is disposed between the first limiting member and the second limiting member to reduce the contact area and / or coefficient of friction between the second limiting member and the second limiting member.
14. The interventional catheter according to any one of claims 9 to 13, characterized in that, The handle includes a rotating mechanism fixedly connected to the proximal end of the second tube, the rotating mechanism driving the second tube to rotate so as to drive the ultrasound probe to rotate; The handle is also provided with a limiting groove, and the rotating mechanism is provided with a first knob and a rotating rod connected together. The first knob can be turned to rotate, and the rotating rod extends into the limiting groove of the handle. The rotating rod is provided with a protrusion that cooperates with the limiting groove to achieve circumferential and axial limiting of the rotating mechanism.
15. The interventional catheter according to any one of claims 9 to 13, characterized in that, The handle includes a bending body, which includes a second knob and a transmission component. The second knob can be turned to rotate, and there is gear transmission between the second knob and the transmission component. The proximal end of the pull cable is connected to either the second knob or the transmission component. The second knob changes the winding length of the pull cable on the bending body by rotating to adjust the degree of bending of the transmission tube segment.
16. The interventional catheter according to any one of claims 9 to 13, characterized in that, The second tube is sleeved outside the first tube, or the first tube is sleeved outside the second tube and the distal end of the second tube extends outward relative to the distal end of the first tube and the ultrasonic probe is installed thereon; and, The pull wires are circumferentially symmetrically distributed relative to the deflection segment.
17. An ultrasonic device, characterized in that, The device includes an ultrasound system and an interventional catheter as described in any one of claims 1 to 16, wherein the ultrasound system is signal-connected to the interventional catheter, and the ultrasound probe is excited to collect image information or emit ablation energy in multiple directions of spatial orientation.
18. A method for assembling an interventional diagnostic and therapeutic catheter, characterized in that, Applied to the interventional diagnostic and therapeutic catheter according to any one of claims 1-8, the assembly method includes: Assemble the probe inside the energy-transmitting tube; Insert the pull wires into each of the even-numbered threading channels of the transmission tube section, and connect the proximal end of the transmission tube section to the handle. Connect the far end of the pull line to the connector section and the near end of the pull line to the handle; Ensure that the handle can rotate the connecting section circumferentially and / or pull the wire in the threading cavity, so as to change the spatial orientation of the probe's working surface.
19. The assembly method according to claim 18, characterized in that, The process of threading pull wires into each of the even-numbered threading cavities of the transmission pipe section includes: A group of pull wires are connected, with the first free end of the pull wire placed outside the proximal end of the transmission pipe section, the second free end of the pull wire inserted into the first cavity to the distal end of the transmission pipe section, the second free end of the pull wire inserted into the second cavity and exposed outside the proximal end of the transmission pipe section, and the pull wires are knotted at the distal end of the transmission pipe section to form a common end. The common end is fixedly embedded in the connecting platform between the energy-transmitting tube and the transmission tube segment; Connect the first and second free ends of the pull wire to the handle, respectively.
20. The assembly method according to claim 19, characterized in that, The step of connecting the distal end of the pull wire to the connecting section includes: A hardened pipe section is connected to the far end of the transmission pipe section; A transition pipe section is connected to the proximal end of the functional pipe section; The first free end of the pull wire is placed outside the proximal end of the transmission pipe section, and the second free end of the pull wire is inserted into the first cavity to the distal end of the hardened pipe section. The pull wire is knotted at the distal end of the hardened pipe section to form a common end, and then the second free end is inserted into the second cavity and exposed outside the proximal end of the transmission pipe section. The hardened pipe section and the transition pipe section are fused together to form a connecting platform, so that the common end is fixedly embedded in the connecting platform.
21. The assembly method according to claim 19, characterized in that, Before the common end is fixedly embedded in the connecting platform between the energy-transmitting tube and the transmission tube segment, the following steps are included: The common end of the pull wire is pulled to the opposite side of the first cavity and the second cavity, and then the communication core is installed in the central cavity, so that the pull wire is arranged to semi-enclose the communication core at the far end of the transmission tube section.