Ablation catheter

Abstract

The application provides an ablation catheter, and relates to the field of medical devices. The ablation catheter comprises an inner tube, a flexible transition section and an inner tube covering structure with an outer tube tube body and an ablation support body; the flexible transition section is fixedly connected to the distal end of the inner tube and the distal end of the ablation support body and is configured to flexibly transition the ablation catheter and a target tissue; and the inner tube covering structure covers the inner tube; wherein the ablation support body is configured to ablate the target region. The ablation catheter provided by the application embodiment can control the catheter to smoothly enter a target branch blood vessel, and is beneficial to improving the efficiency and treatment effect of an interventional operation.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more specifically, to an ablation catheter. Background Technology

[0002] Interventional surgery is a minimally invasive surgical procedure that, under the precise guidance of medical imaging equipment, uses sophisticated instruments such as catheters and guidewires to enter the body through natural cavities or tiny incisions to accurately diagnose and treat lesions. Interventional surgery is applicable to the treatment of diseases in many fields, including cardiovascular diseases, cerebrovascular diseases, tumors, hypertension, and peripheral vascular diseases.

[0003] Taking RDN surgery (renal artery sympathectomy) as an example, the ablation energy release unit for ablation of the target area is surgically inserted into the renal artery via catheter insertion. The doctor inserts a flexible catheter into the vascular system from the femoral or radial artery through minimally invasive puncture, and then, under imaging guidance, advances the catheter along the vascular path into the renal artery, so that the electrode follows the catheter into the renal artery.

[0004] Due to structural deficiencies, the ablation catheters used in existing technologies cannot guarantee that they will reach the designated target vascular branch location, and may even pose a risk of tissue damage. This not only reduces the efficiency of interventional surgery, but also poses a potential threat to the patient's health. Summary of the Invention

[0005] In view of the above problems, the purpose of this application is to provide an ablation catheter. By designing the inner tube, the inner tube covering structure and the flexible transition section, the catheter can be controlled to smoothly enter the target branch blood vessel, which is beneficial to improving the efficiency and treatment effect of interventional surgery.

[0006] In a first aspect, embodiments of this application provide an ablation catheter, which includes an inner tube, a flexible transition section, and an inner tube covering structure having an outer tube body and an ablation support; the flexible transition section is fixedly connected to the distal end of the inner tube and the distal end of the ablation support, and is configured as a flexible transition ablation catheter to the target tissue; the inner tube covering structure covers the inner tube; wherein, the ablation support is configured as the ablation target area.

[0007] In the above-described implementation process, the ablation catheter provided in this application, through its inner tube, inner tube covering structure (including the outer tube body and ablation support), and flexible transition section, allows the physician to flexibly adjust the position and posture of the ablation support to adapt to the vascular anatomy of different patients, thereby improving the accuracy and safety of ablation treatment. Furthermore, the design of the flexible transition section in this application fully considers the complexity and variability of the vascular environment, helping to reduce damage to the vascular wall during catheter advancement, while improving the stability and operability of the catheter within the blood vessel. In summary, the ablation catheter provided in this application possesses an ingenious structural design and an efficient working mechanism, enabling its use in complex vascular environments and contributing to improved accuracy and safety of ablation procedures.

[0008] Optionally, in this embodiment, the ablation support is disposed between the outer tube and the inner tube.

[0009] In the above implementation process, the ablation support body of the ablation catheter provided in this application embodiment, such as an ablation stent, can be placed between the outer tube and the inner tube, and other wires are also provided. Through reasonable arrangement, it is ensured that when the outer tube and the inner tube of the ablation catheter undergo relative displacement, the other structural components can smoothly perform their respective functions. In addition, space is reserved for the inner tube to facilitate axial displacement or circumferential rotation of the inner tube. Thus, the diameter of the ablation catheter is minimized while ensuring the accuracy of the ablation operation.

[0010] Optionally, in this embodiment, the outer tube includes a central channel distributed along the axial direction of the tube and multiple uniformly distributed circumferential channels; the ablation support includes multiple sets of filamentous components; and the inner tube covering structure includes multiple sets of wires. The inner tube is disposed in the central channel; and the multiple sets of filamentous components and multiple sets of wires are disposed in the multiple circumferential channels.

[0011] In the above implementation process, the multiple sets of filamentous components and multiple sets of wires of the ablation catheter provided in this application embodiment can be respectively arranged in the circumferential channel. Each target ablation point corresponds to an independent energy transmission wire and ablation parameter measurement wire, and the corresponding energy transmission wire and ablation parameter measurement wire are arranged in a circumferential channel. The wires corresponding to different target ablation points are separated, which can greatly avoid cable damage caused by irregular entanglement of multiple cables and the resulting creepage effect.

[0012] Optionally, in this embodiment, the number of circumferential channels is the same as the number of ablation energy release units; each circumferential channel is provided with a set of wires and a set of filamentous components.

[0013] In the above implementation process, the outer tube of the ablation catheter provided in this application embodiment is a multi-channel tube structure, including a central channel and a circumferential channel. By reasonably setting the arrangement and combination of cables in each circumferential channel, the diameter of the ablation catheter is reduced as much as possible while ensuring the normal operation of each cable.

[0014] Optionally, in the embodiments of this application, the number of circumferential channels is less than the number of ablation energy release units; each circumferential channel is provided with at least two sets of wires and two sets of filamentous components, arranged in a filamentous component-wire-filamentous component arrangement.

[0015] In the above implementation process, the ablation catheter provided in this application embodiment can combine multiple cables and proposes improvements in processing technology; while improving the phenomenon of cable entanglement damage in the tube body, it reduces the number of independent cavities in the outer tube body, ultimately reducing the diameter of the ablation catheter body. This helps to reduce trauma to the puncture site when patients undergo interventional surgery, thereby effectively reducing the risk of complications from interventional surgery.

[0016] Optionally, in this embodiment, the flexible transition section includes a flexible bending section; the flexible bending section is a bendable continuous structure.

[0017] Optionally, in the embodiments of this application, the flexible continuous structure includes a straight groove shape, a snake bone shape, or a spring shape continuous structure; the hollow inner tube is indirectly connected to the ablation support body through a first connecting section or a second connecting section; wherein, the first connecting section covers part of the central inner tube in the axial direction, and the second connecting section covers the flexible bending section and part of the hollow inner tube in the axial direction; or, the hollow inner tube is directly connected to the ablation support body.

[0018] Optionally, in this embodiment, the flexible bending section includes an inner tube, an outer tube, and a spring; the outer tube is connected to the outer tube body, and the inner tube is connected to the inner tube; the inner tube and the outer tube have a non-overlapping area in the axial direction, the inner tube covers part of the hollow inner tube in the axial direction, and the flexibility of the outer tube is greater than that of the inner tube; the spring is disposed between the inner tube and the outer tube.

[0019] Optionally, in an embodiment of this application, the proximal end of the spring has a minimum pitch, and the distal end of the spring has a maximum pitch.

[0020] Optionally, in this embodiment, the flexible bending section includes a channel and multiple rings, multiple openings, and connectors; the channel extends through the flexible transition section in the axial direction and is configured to allow the passage of a target interventional device or a target liquid; the rings are arranged in the axial direction along the inner tube covering structure, and adjacent rings are connected by openings.

[0021] In the above implementation process, the flexible bending segment of the embodiment of this application can be achieved through flexible circumferential groove carving, snake bone shape (spiral groove shape) imitation or spring shape design, etc. Combined with the softness and fixation method of polymer material, as well as the material optimization of the inner and outer sides, the structure achieves high flexibility, strong resilience and good biocompatibility, effectively improving the operation performance and safety of ablation catheter in complex vascular environment.

[0022] Optionally, in this embodiment, the flexible transition section further includes an open conical transition distal end; the transition distal end is fixedly connected to the flexible bending section.

[0023] In the above implementation process, the distal transition end of the ablation catheter provided in this application adopts an open conical structure (e.g., multi-flap processing, conical tube assembly, etc.), which achieves a gradual decrease in diameter from the proximal to the distal end, facilitating the guidance of the ablation catheter into the branch. Simultaneously, various designs, such as coatings, heat-shrinkable flexible polymer materials, or direct fixation of conical polymer materials, are employed to prevent thrombosis and improve operational performance. Furthermore, a PTFE liner is placed on the inner wall of the central channel to ensure smooth guidewire insertion and removal, thus optimizing the overall flexibility and practicality of the distal stent.

[0024] Optionally, in this embodiment, the ablation support is provided with ablation energy release units; wherein, the ablation energy release units are arranged in a positive spiral arrangement, a negative spiral arrangement, or an alternating arrangement. The ablation energy release units are, for example, electrodes, including cylindrical electrodes, flat tubular electrodes, U-shaped electrodes, or sheet electrodes; the electrodes are configured to deliver ablation energy to the target area.

[0025] In the above implementation process, the ablation catheter provided in this application embodiment has electrodes fixedly disposed on the ablation support (stent wire). The electrodes are arranged in various forms, such as tubular or sheet-like. While ensuring good wall adhesion performance of multiple electrodes, the overall diameter of the stent is controlled to be small, which helps to reduce vascular trauma and improve surgical safety and postoperative recovery.

[0026] Optionally, in embodiments of this application, the inner tube is configured to infuse a target fluid into a target tissue via a target interventional device.

[0027] In the above implementation process, the hollow inner tube structure of the ablation catheter provided in this application embodiment can not only be accurately guided to the target branch blood vessel in the body through the target interventional device (such as the guide wire), improving the accuracy and safety of the operation, but also infuse the target tissue with a variety of target liquids (such as cold saline, contrast agent, heparin, liquid drugs, etc.) to achieve specific therapeutic effects. Moreover, the inner tube is made of various materials, including polymer materials, metal materials and metal-polymer composite materials, to meet the needs of different application scenarios and greatly improve the functionality and applicability of the ablation catheter.

[0028] Optionally, in this embodiment of the application, the ablation catheter further includes a control handle; the control handle is connected to the inner tube and the inner tube covering structure, and is configured to control the position of the inner tube and the shape of the ablation support.

[0029] In the above implementation process, the ablation catheter provided in this application embodiment is also equipped with a control handle. The control handle is connected to and controls the inner tube and the inner tube covering structure to realize the adjustment of the inner tube position and the shape change of the ablation support (such as a basket or stent), including expansion and retraction. It is also equipped with a Luer connector or sealing valve connector structure to facilitate the smooth entry of interventional instruments into the inner tube channel, thereby improving the convenience of operation and the functionality of the catheter.

[0030] This application provides an ablation catheter with a structural design including an inner tube, an inner tube covering structure, and a flexible transition section. The inner tube serves as an independent channel for inserting a guidewire or injecting target fluid into the target tissue. After the ablation catheter enters the main renal artery through the access device, the guidewire can be rotated / moved to enter the target branch, and then the ablation catheter can be advanced along the guidewire into the target branch. Once the ablation catheter has entered the target branch, the guidewire can be moved backward, and the ablation catheter can be advanced again to deliver the ablation catheter to the distal end of the branch. The ablation catheter provided in this application has an ingenious structural design and an efficient working mechanism, enabling it to operate in complex vascular environments, which helps improve the accuracy and safety of ablation procedures.

[0031] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, specific embodiments are described below in conjunction with the accompanying drawings. Attached Figure Description

[0032] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a first schematic diagram of the structure of the ablation catheter provided in the embodiments of this application;

[0034] Figure 2 This is a first schematic diagram of the cross-section of the ablation catheter provided in an embodiment of this application;

[0035] Figure 3 This is a second schematic diagram of the cross-section of the ablation catheter provided in an embodiment of this application;

[0036] Figure 4This is a third schematic diagram of the cross-section of the ablation catheter provided in an embodiment of this application;

[0037] Figure 5 This is a schematic diagram of two thermocouples in parallel provided in an embodiment of this application;

[0038] Figure 6 This is a schematic diagram of three thermocouples connected in parallel, provided in an embodiment of this application.

[0039] Figure 7 This is a first schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application;

[0040] Figure 8 This is a fifth schematic diagram of the structure of the flexible transition segment provided in the embodiments of this application;

[0041] Figure 9 Provided for the embodiments of this application Figure 8 A first example diagram showing the radial distribution of the central opening in the annulus;

[0042] Figure 10 Provided for the embodiments of this application Figure 8 A second example diagram showing the radial distribution of the central opening in the annulus;

[0043] Figure 11 Provided for the embodiments of this application Figure 8 A third example diagram showing the radial distribution of the central opening in the annulus;

[0044] Figure 12 This is a schematic diagram showing an unfolded flexible transition segment provided in an embodiment of this application;

[0045] Figure 13 Another schematic diagram showing the unfolding of the flexible transition segment provided in the embodiments of this application;

[0046] Figure 14 This is a second schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application;

[0047] Figure 15 This is a third schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application;

[0048] Figure 16 This is a fourth schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application;

[0049] Figure 17 This is a second schematic diagram of the structure of the ablation catheter provided in the embodiments of this application;

[0050] Figure 18 Example of a first cross-sectional view of the ablation catheter provided for the implementation of this application;

[0051] Figure 19A second cross-sectional example of the ablation catheter provided in an embodiment of this application;

[0052] Figure 20 A third cross-sectional example of the ablation catheter provided in an embodiment of this application;

[0053] Figure 21 A fourth cross-sectional example of the ablation catheter provided in the embodiments of this application;

[0054] Figure 22 A schematic diagram of a flexible spring transition section provided in an embodiment of this application;

[0055] Reference numerals: Axial - X; Circumferential - C; Ablation catheter - 1000; Inner tube - 100; Inner tube covering structure - 200; Outer tube body - 210; Central channel - 211; Circumferential channel - 212; Ablation support - 220; Filamentous component - 221; Lead wire - 230; Flexible transition section - 300; Flexible bending section - 310; Ring body - 311; Opening - 312; Channel - 315; Insert - 316; Transition distal end - 320; First connecting section - 330; Second connecting section - 340; Inner tube - 301; Outer tube - 302; Spring - 303; Guide wire - S. Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, 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. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0057] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0058] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0059] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this application is in use. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0060] Furthermore, terms such as "horizontal" and "vertical" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0061] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0062] Interventional surgery, as a highly advanced medical technology, represents the forefront of minimally invasive treatment in modern medicine. It cleverly combines the precise guidance of medical imaging with the flexible operation of sophisticated instruments, enabling non-invasive or minimally invasive precise intervention on lesions inside the body. Guided by medical imaging equipment such as X-rays, CT (computed tomography), MRI (magnetic resonance imaging), and ultrasound, doctors can clearly observe the internal condition, providing the "eyes" for the surgery.

[0063] Using catheters, guidewires, and other miniature instruments, interventional surgery enters the body through natural cavities (such as blood vessels, urethra, and digestive tract) or through small incisions, avoiding the extensive tissue incisions of traditional open surgery. This significantly reduces surgical trauma, blood loss, and postoperative recovery time. Interventional surgery is particularly suitable for cardiovascular diseases (such as coronary heart disease, valvular heart disease, and congenital heart disease), cerebrovascular diseases (such as aneurysms and cerebral vascular stenosis), tumors (such as local ablation therapy for liver cancer and lung cancer), interventional treatment of hypertension (such as renal artery sympathetic nerve ablation), and peripheral vascular diseases (such as lower extremity arteriosclerosis obliterans and varicose veins), providing new treatment options and better prognoses for many patients.

[0064] Ablation is a medical technique that uses physical or chemical means to destroy or remove body tissue. Ablation techniques can be used to treat abnormal tissues, such as tumors, conductive tissues with abnormal heart rhythms, or other lesions. Currently, there are various ablation methods, such as radiofrequency ablation, ultrasound ablation, laser ablation, cryoablation, and chemical ablation.

[0065] Taking endovascular ablation surgery as an example (e.g., RDN surgery), currently, access devices (generally guiding catheters) can only enter the main trunk opening area of ​​the blood vessel; subsequently, the ablation catheter 1000 enters the main trunk of the blood vessel through this access. However, when the ablation catheter 1000 needs to be further extended to distal branch vessels, it depends heavily on the patient's vascular condition, and it cannot be guaranteed that the ablation catheter 1000 can accurately reach the designated target branch location.

[0066] To address the issue of the ablation catheter 1000's difficulty in entering branch vessels, existing technologies include a soft-segment guidewire structure at the distal end of the ablation catheter 1000. (Note: In this embodiment, "distal" refers to the end of the interventional medical device (such as a catheter, guidewire, sheath, etc.) that is furthest from the operator during surgery; "proximal" refers to the end of the interventional medical device (such as a catheter, guidewire, sheath, etc.) that is closest to the operator during surgery. Furthermore, the use of "distal" or "proximal" to describe the structural location of the ablation catheter 1000 should be understood as meaning that the structural location is proximal or distal when the ablation catheter 1000 is in use.) However, the length of the soft segment of the guidewire, the transition between soft and hard sections, and the transition performance of the distal flexible segment all become limiting factors for the ablation catheter 1000's entry into branch vessels, making accurate entry into the target branch vessel still difficult. Taking the renal artery branch as an example, since the distal end of the renal artery is close to the renal parenchyma, there is a possibility of damaging the renal parenchyma if the soft segment length of the guidewire is not set properly, which further limits the operation capability of the ablation catheter 1000 in complex vascular structures.

[0067] Based on this, the ablation catheter 1000 provided in this application embodiment, through the design of the inner tube 100, the inner tube covering structure 200 and the flexible transition section 300 of the ablation catheter 1000, can send the guide wire into the target branch through the inner tube 100, and the ablation catheter 1000 enters the target branch along the guide wire; after the ablation catheter 1000 enters the target branch, the guide wire can be moved backward, and the ablation catheter 1000 can be sent forward again, so as to accurately send the ablation catheter 1000 into the distal end of the target branch blood vessel.

[0068] Please refer to Figure 1 , Figure 1 This is a first schematic diagram of the structure of the ablation catheter 1000 provided in the embodiment of this application; the embodiment of this application provides an ablation catheter 1000, which includes an inner tube 100, a flexible transition section 300 and an inner tube covering structure 200 having an outer tube body 210 and an ablation support body 220.

[0069] The flexible transition section 300 is fixedly connected to the distal end of the inner tube 100 and the distal end of the ablation support 220, and is configured as a flexible transition between the ablation catheter 1000 and the target tissue. The inner tube covering structure 200 covers the inner tube 100; wherein, the ablation support 220 is configured as the ablation target area.

[0070] In the above process, the inner tube 100 can be understood as a hollow control lever. By controlling the displacement of the control lever in the axial direction (X), the ablation support 220 can be controlled.

[0071] In this embodiment, the ablation support 220 of the ablation catheter 1000 can be a mesh structure, a balloon structure, or a stent structure. Different structural forms help to better conform to the blood vessel wall during the procedure, ensuring full contact between the ablation energy release unit and the target area. The mesh structure provides flexible support and coverage, the balloon structure can evenly distribute pressure through inflation, and the stent structure provides stable support (the structure of the ablation catheter 1000 provided in this embodiment will be described below using the stent structure as an example).

[0072] The flexible transition section 300 connects to the distal end of the inner tube 100, enabling a flexible transition between the inner tube 100 and the lumen diameter, such as the intravascular environment (the target tissue in the above process); the flexible transition section 300 connects to the distal end of the ablation support 220, ensuring that the ablation support 220 is driven by the inner tube 100 to move forward or backward within the blood vessel.

[0073] The inner tube covering structure 200 comprises the outer tube body 210 and the ablation support body 220. When the ablation catheter 1000 provided in this embodiment is not in use, the outer tube body 210 and the ablation support body 220 uniformly cover the outside of the inner tube 100. When the ablation catheter 1000 provided in this embodiment is used for ablation in the body, the outer tube body 210 is separated from other structures, and the displacement of the inner tube 100 in the axial (X) direction can be controlled by an external mechanical structure (e.g., a control handle), thereby controlling the position of the stent, and, when the position is appropriate, controlling the ablation energy release unit (disposed on the stent) to release ablation energy.

[0074] It should be noted that the "coverage" in this embodiment is not an absolute connection and coverage in the traditional sense, but rather that under certain special conditions, the various structures can be separated or can undergo relative displacement.

[0075] Optionally, the inner tube 100 and the inner tube covering structure 200 of the ablation catheter 1000 provided in this application embodiment have a sealing function, which can effectively prevent blood leakage caused by increased intravascular pressure during operation, and ensure the safety and reliability of the surgical procedure.

[0076] pass Figure 1 As can be seen, the ablation catheter 1000 provided in this application embodiment, through its inner tube 100, inner tube covering structure 200 (including outer tube body 210 and ablation support 220), and flexible transition section 300, with the inner tube 100 acting as a hollow control lever, allows doctors to flexibly adjust the position and posture of the ablation support 220 to adapt to the vascular anatomy of different patients, thereby improving the accuracy and safety of ablation treatment. Furthermore, the design of the flexible transition section 300 in this application embodiment fully considers the complexity and variability of the vascular environment, helping to reduce damage to the vascular wall during catheter advancement, while improving the stability and operability of the catheter within the blood vessel. In summary, the ablation catheter 1000 provided in this application embodiment possesses an ingenious structural design and an efficient working mechanism, enabling it to operate in complex vascular environments, thus contributing to improved accuracy and safety of ablation procedures.

[0077] Please refer to Figures 2 to 4 , Figure 2 This is a first schematic diagram of the cross-section of the ablation catheter provided in an embodiment of this application; Figure 3 This is a second schematic diagram of the cross-section of the ablation catheter provided in an embodiment of this application; Figure 4 This is a third schematic diagram of the cross-section of the ablation catheter provided in this application embodiment; the inner tube 100 of the ablation catheter 1000 provided in this application embodiment is configured to infuse target fluid into the target tissue via a target interventional device.

[0078] like Figures 2 to 4It can be seen that the hollow channel in the inner tube 100 is located in the middle of the axial (X) direction of the entire ablation catheter 1000. This hollow channel allows the passage of target interventional instruments, such as guide wire S (please refer to...). Figure 2 ).

[0079] A guidewire (S) is a thin and flexible medical device, mainly made of metal or plastic, used in interventional surgery to guide other instruments or substances to the target area inside the body accurately, improving the precision and safety of the surgery.

[0080] For example, when the guide wire S is inserted into the hollow inner tube 100 of the ablation catheter 1000, and the ablation catheter 1000 enters the main renal artery through the access device, the guide wire S is rotated / moved to enter the target branch vessel. Due to the gradual change in hardness and softness of the distal soft segment and transition segment of the guide wire S, the flexible transition segment 300 of the ablation catheter 1000, and the stent segment, the ablation catheter 1000 can smoothly enter the target branch vessel. After the guidewire S is inserted into the hollow inner tube 100, the guidewire S is moved backward (retracted until the guidewire S is no longer exposed at the distal end of the catheter, or retracted to a state where the guidewire S has not been inserted). The inner tube 100 (operating lever) is advanced distally to straighten the ablation support 220 (e.g., the basket is retracted). The inner tube 100 enters the target location of the blood vessel through the insertion device. After the ablation catheter 1000 enters the target branch blood vessel, the guidewire S can be moved backward again to advance the ablation catheter 1000 forward again so as to advance the ablation catheter 1000 into the distal end of the branch. If it is necessary to enter a lower branch, the above steps can be repeated.

[0081] The central control channel can also be used to infuse target fluids into the target tissue. Examples include cold saline, contrast agents, heparin, or liquid medications. Cold saline can be used to lower the temperature of the target tissue, contrast agents help doctors clearly observe the structure of the target tissue, and heparin has anticoagulant properties to prevent thrombosis.

[0082] Optionally, the inner tube 100 can be made of various materials, including polymers such as polyimide (PI), polyether block amide (PEBAX), and polyether etherketone (PEEK). These polymers can be used alone or in combination with other materials, such as PI or PEBAX with a polytetrafluoroethylene (PTFE) liner. In addition, the inner tube 100 can also be made of metal, such as a spring tube or a snake tube; or it can be a combination of metal and polymer, for example, a combination of an inner PTFE liner, a middle metal braided layer, and an outer PI / PEBAX composite tube.

[0083] Therefore, the hollow structure of the inner tube 100 of the ablation catheter 1000 provided in this application embodiment can not only be accurately guided to the target branch blood vessel in the body through the target interventional device (such as the guide wire S), improving the accuracy and safety of the operation, but also infuse the target tissue with a variety of target liquids (such as cold saline, contrast agent, heparin, liquid drugs, etc.) to achieve specific therapeutic effects. Moreover, the inner tube 100 is made of various materials, including polymer materials, metal materials and metal-polymer composite materials, to meet the needs of different application scenarios, greatly improving the functionality and applicability of the ablation catheter 1000.

[0084] In an optional embodiment, the ablation support 220 is disposed between the outer tube 210 and the inner tube 100.

[0085] An ablation electrode is mounted on an ablation stent. A lead wire 230 is inserted through the catheter along its axial direction. One end of the lead wire 230 is electrically connected to the ablation electrode, and the other end is electrically connected to a handle located proximal to the catheter. The ablation stent is located distal to the catheter, and the ablation electrode is mounted on the ablation stent. After the distal end of the ablation catheter is inserted into a natural body cavity, such as the ablation area of ​​a blood vessel, the expansion of the ablation stent can cause the ablation electrode to contact the blood vessel wall, thereby achieving ablation of the target area.

[0086] Taking the ablation stent as an example, the ablation stent can be set between the outer tube body 210 and the inner tube 100. At the same time, the ablation stent and the outer tube stent are also equipped with ablation parameter measuring wires 230 (e.g., temperature measurement, pressure measurement, etc.) and ablation energy transmission wires 230. In addition, the design needs to leave enough space for the inner tube 100 so that the inner tube 100 can move freely within the outer tube body.

[0087] Optionally, multiple sets of wires 230 are distributed along the circumference of the inner tube 100. The wires 230 corresponding to each ablation electrode are distributed in the circumference of the catheter, which not only makes the distribution of the wires 230 neater and more reasonable, but also reduces the risk of signal interference between the wires 230 corresponding to two electrodes.

[0088] Optionally, the wire 230 is spirally wound around the outer periphery of the inner tube 100. Compared with the wire 230 being arranged in a straight line along the axial direction of the inner tube 100, the spiral wiring method increases the length of the wire 230 and correspondingly increases the distribution density of the wire 230 in the unit area of ​​the inner tube 100, making the outer wall of the conduit more compact and increasing the uniformity and strength of the outer wall of the conduit.

[0089] Optionally, a filler line can be provided between the outer tube body 210 and the inner tube 100. By providing a filler line between two adjacent sets of conductors, the filler line can increase the filling density between the outer tube body 210 and the inner tube 100, thereby increasing the strength of the conduit. For example, the filler line can be made of copper.

[0090] Optionally, the outer tube 210 and inner tube 100 provided in this application embodiment can be made of polymer materials such as PEBAX, polyamide (PA), thermoplastic polyurethane (TPU); in addition, the outer tube 210 and inner tube 100 provided in this application embodiment can also adopt a composite structure design, specifically, the inner layer is made of polymer material, the middle is embedded with a metal braided layer to enhance performance, and the outer layer is covered with polymer material to provide protection.

[0091] Therefore, the ablation support 220 of the ablation catheter 1000 provided in this application embodiment, such as an ablation stent, can be placed between the outer tube body 210 and the inner tube 100, and other wires 230 are also provided. Through reasonable arrangement, it is ensured that when the relative displacement of the outer tube body 210 and the inner tube 100 occurs within the position of the ablation catheter 1000, the other structural components can smoothly perform their respective functions. In addition, the inner tube 100 is provided with a space for movement, which can realize the smooth displacement of the inner tube 100 in the axial (X) direction or the circumferential (C) rotation. Thus, the diameter of the ablation catheter 1000 is minimized while ensuring the accuracy of the ablation operation.

[0092] Please continue reading. Figure 2 and Figure 3 In an optional embodiment, the outer tube 210 includes a central channel 211 distributed along the tube's axial direction (X) and a plurality of uniformly distributed circumferential channels 212. The inner tube 100 (with a guide wire S disposed within it) is disposed in the central channel 211, and a plurality of filamentary components 221 and a plurality of wires 230 are disposed in the plurality of circumferential channels 212.

[0093] The ablation support 220 of the ablation catheter 1000 provided in this embodiment includes multiple sets of filamentous components 221, namely stent wires (the stent is made of multiple filaments woven into a mesh or petal shape). When the inner tube 100 and the outer tube covering structure of the ablation catheter 1000 are not separated, the multiple sets of filamentous components 221 of the ablation support 220, i.e., the ablation stent, are located in the aforementioned circumferential channel 212 (please refer to...). Figure 2 , Figure 3 and Figure 4 The inner tube 100 of the ablation catheter 100 is in a naturally extended state. After the inner tube 100 and the outer tube covering structure of the ablation catheter 1000 are separated, the inner tube 100 is rotated or displaced by the handle of the ablation catheter 1000, causing the ablation stent to expand and retract (please refer to...). Figure 1 ).

[0094] Please continue reading. Figure 2 , Figure 3 and Figure 4 The inner tube covering structure 200 provided in this application embodiment also includes multiple sets of wires 230, such as ablation parameter measurement wires 230 (e.g., temperature measurement, pressure measurement, etc.) and ablation energy transfer wires 230.

[0095] Optionally, the inner tube 100, the filamentous component 221, the lead wire 230, and the outer tube body can be fused together using processes such as heat fusion or thermorheology; thereby further reducing the diameter of the ablation catheter 1000. The use of access devices of the smallest possible size can significantly reduce trauma to the puncture site during interventional surgery, thereby effectively reducing the risk of complications.

[0096] Optionally, such as Figure 2 and Figure 3 As shown, the number of sets of filamentary components 221 and wires 230 is consistent with the number of ablation energy release units. Figure 2 and Figure 3 In this process, each circumferential channel 212 contains a set of filamentary components and a set of wires 230.

[0097] For ablation surgery, the ablation energy is transferred from external equipment to the ablation energy release unit through the energy transfer lead 230. For each target ablation point, in addition to the release of ablation energy, it is also necessary to monitor ablation parameters (e.g., temperature, impedance, etc.); therefore, ablation parameter measurement lead 230 is required.

[0098] Therefore, it can be seen that the multiple sets of filamentous components 221 and multiple sets of wires 230 of the ablation catheter 1000 provided in this application embodiment can be respectively arranged in the circumferential channel 212. Each target ablation point corresponds to an independent energy transmission wire 230 and ablation parameter measurement wire 230, and the corresponding energy transmission wire 230 and ablation parameter measurement wire 230 are arranged in one circumferential channel 212. The wires 230 corresponding to different target ablation points are separated, which can greatly avoid cable damage caused by irregular entanglement of multiple cables and the resulting creepage effect.

[0099] In an alternative embodiment, please continue to refer to Figure 2 and Figure 3 The number of circumferential channels 212 is the same as the number of ablation energy release units. Each circumferential channel 212 is provided with a set of wires 230 and a set of filamentary components 221.

[0100] The following description uses radiofrequency ablation and temperature measurement with temperature sensing lead 230 as examples for non-limiting purposes. Those skilled in the art will understand that the following description is merely exemplary, and similarly, the ablation catheter provided in this application can be adapted to other ablation scenarios such as ultrasonic ablation, laser ablation, cryoablation, and chemical ablation after being adapted based on the application scenario.

[0101] like Figure 2 and Figure 3 As shown, Figure 2 and Figure 3 In the middle, the central position is the central channel 211, and six circumferential channels 212 are evenly arranged around the central channel 211; the central channel 211 is provided with an inner tube 100, and each circumferential channel 212 includes a filamentous component 221 of the ablation stent, a radio frequency wire 230 and a temperature measuring wire 230.

[0102] Figure 2 In the circumferential channel 212, the filamentous component 221 is divided into two parts: one part exists alone in the circumferential channel 212, and the other part is combined with the temperature measuring wire 230 and the radio frequency wire 230 into a single strand in the circumferential channel 212.

[0103] Figure 3 In the circumferential channel 212, the filamentary component 221 is divided into two parts: one part exists alone in the circumferential channel 212, and the other part is combined with the temperature measuring wire 230 and the radio frequency wire 230 into a single strand within the circumferential channel 212. However, with... Figure 2 The difference is that the RF wire 230 shares a single copper wire with the thermocouple (temperature measurement) copper wire, thus enabling... Figure 2 Based on this, the diameter of the ablation catheter was further reduced by 1000.

[0104] pass Figure 2 and Figure 3 As can be seen, the outer tube body 210 of the ablation catheter 1000 provided in this application embodiment is a multi-channel tube structure, including a central channel 211 and a circumferential channel 212. By reasonably setting the arrangement and combination of cables in each circumferential channel 212, the diameter of the ablation catheter 1000 is reduced as much as possible while ensuring the normal operation of each cable.

[0105] In an alternative embodiment, please continue to refer to Figure 4 The number of circumferential channels 212 is less than the number of ablation energy release units. Each circumferential channel 212 is provided with at least two sets of wires 230 and two sets of filamentous components 221, arranged in the manner of filamentous component 221-wires 230-filamentous component 221.

[0106] like Figure 4 As shown, Figure 4In the middle, the central position is the central channel 211, and three circumferential channels 212 are evenly arranged around the central channel 211; the central channel 211 is provided with an inner tube 100, and each circumferential channel 212 includes a filamentous component 221 of the ablation stent, a radio frequency wire 230 and a temperature measuring wire 230.

[0107] and Figure 2 and Figure 3 The difference is that, Figure 4 In the circumferential channel 212, multiple cables are connected in parallel. Please refer to the following: Figure 5 and Figure 6 , Figure 5 This is a schematic diagram of two thermocouples in parallel provided in an embodiment of this application; Figure 6 This diagram illustrates three thermocouples connected in parallel, as provided in an embodiment of this application. This forms a multi-parallel thermocouple configuration, such as two thermocouples connected in parallel or three thermocouples connected in parallel. Please refer to the attached diagram. Figure 5 and Figure 6 , Figure 5 The wires are arranged in the following order: constantan wire - copper wire - copper wire - constantan wire (conductor 1 - conductor 2 - conductor 3 - conductor 4). Figure 6 The order of wires is constantan wire-copper wire-copper wire-constantan wire-constantan wire-copper wire (conductor 1-conductor 2-conductor 3-conductor 4-conductor 5-conductor 6). In practical applications, the arrangement of copper wires and constantan wires can be adjusted as needed.

[0108] Optionally, the ablation catheter 1000 provided in this application embodiment, during production and preparation, is designed to facilitate assembly and save assembly time; Figure 2 , Figure 3 , Figure 4 The multi-lumen tube is divided into an inner tube 100 and an outer tube; after the multi-parallel thermocouple, support wire, inner tube 100 and outer tube are fitted together, the outer tube is subjected to thermorheology to fuse the above parts into one; while reducing the diameter of the ablation catheter 1000 tube body, the various components of the ablation catheter 1000 are more firmly fixed.

[0109] Therefore, the ablation catheter 1000 provided in this application embodiment can combine multiple cables and improves the manufacturing process; while improving the cable entanglement damage in the tube body, it reduces the number of independent cavities in the outer tube body 210, ultimately reducing the diameter of the ablation catheter 1000. This helps reduce trauma to the puncture site during interventional surgery, thereby effectively reducing the risk of complications from interventional procedures.

[0110] Please refer to Figure 7 , Figure 7 This is a first schematic diagram of the structure of the flexible transition section provided in an embodiment of this application; in an optional embodiment of this application, the flexible transition section 300 includes a flexible bending section 310.

[0111] Optionally, the flexible bending segment 310 in this embodiment of the application is a bendable continuous structure.

[0112] Please refer to the following: Figure 8 , Figure 8 This is a fifth schematic diagram of the structure of the flexible transition section provided in the embodiments of this application; the flexible transition section 300 and the inner tube covering structure 200 are made of the same material, but the flexible transition section 300 adopts a bendable and deformable structure. Specifically, combined with Figure 8 As shown, the flexible transition section 300 includes multiple rings 311, multiple openings 312, a connector 313, a distal transition section 320, and a channel 315 penetrating the entire flexible transition section 300. The flexible transition section 300, located between the distal soft section of the central guidewire S and the inner tube covering structure 200, provides a transition region of hardness (i.e., the hardness of the flexible transition section 300 is greater than that of the soft section of the central guidewire S and less than that of the inner tube covering structure 200). Furthermore, the flexible transition section 300 can deviate from the longitudinal direction (axial direction, X direction) of the inner tube covering structure 200 to form different degrees of deflection (i.e., Figure 8 The bending angle shown may vary, in order to access the target branch of the renal artery (with a diameter smaller than that of the renal artery).

[0113] Please refer to the following: Figures 9 to 11 , Figure 9 Provided for the embodiments of this application Figure 8 A first example diagram showing the radial distribution of the central opening in the annulus; Figure 10 Provided for the embodiments of this application Figure 8 A second example diagram showing the radial distribution of the central opening in the annulus; Figure 11 Provided for the embodiments of this application Figure 8 A third example diagram shows the radial distribution of openings in the rings; in one embodiment of the invention, the flexible transition section 300 is composed of multiple rings 311 arranged along the longitudinal direction of the inner tube covering structure 200. Adjacent rings 311 are interconnected by non-closed annular openings 312, with each ring's insert 316 inserted into the opening of an adjacent ring to achieve sequential connection between the rings. The openings 312 are radially distributed in the rings 311 and can be arranged in different ways: such as... Figure 9 As shown, they can be arranged parallel to the longitudinal direction in a line; as Figure 10 They can be distributed along two parallel lines; or as... Figure 11 The openings 312 are distributed along four lines and are staggered, forming an angle rather than a straight line alignment. This achieves uniform distribution while ensuring that the openings of adjacent rings are staggered. This staggered distribution method is particularly preferred because it makes the flexible transition section 300 have the same hardness in all directions, adapting to different cavity shapes.

[0114] The distribution of the openings 312 determines the stiffness characteristics of the flexible transition section 300: it can be anisotropic, i.e., bending along a specific radial direction or multiple directions; or it can achieve isotropic stiffness by arranging each opening 312 uniformly in the circumferential direction. The design of the flexible transition section 300 allows its deflection direction to be unidirectional, bidirectional, multidirectional, or to achieve 360° free bending in a cross-section perpendicular to the longitudinal direction.

[0115] The flexible transition section 300 has interconnected channels 315 to accommodate the guidewire S. A connector 313 is located at the proximal end of the flexible transition section 300 and connects to the distal end of the inner tube covering structure 200, forming an integrated structure. The distal end of the flexible transition section 300 is designed as a spherical or conical conical end section 320. This can be achieved by forming a flexible conical end with a polymer material, or by using a metal material combined with a flexible polymer material for wrapping, to avoid damaging the inner wall of the cavity.

[0116] Through this design, the flexible transition section 300 not only has good flexibility and adaptability, but also enables precise catheter positioning and operation while maintaining structural integrity.

[0117] It should be noted that, regardless of whether the flexible transition section 300 is made of a flexible material or a deformable structure (e.g., by forming an opening in a rigid material to allow the compliant part to bend), it should simultaneously meet the following compliance requirements: 1) The stiffness of the flexible transition section 300 is large enough so that it can move to the distal end when the control handle is pushed from the proximal end; 2) The stiffness of the flexible transition section 300 is small enough so that it will automatically conform to the shape of the cavity when moving forward.

[0118] In this embodiment, the stiffness of the flexible transition section 300 is meticulously designed to adapt to ablation cavities with varying degrees of curvature. The degree of curvature, clinically used to describe the twisting and folding of the cavity in space, can be measured by bending angles, radii, etc. The stiffness of the flexible transition section 300 is specifically designed to be less than the stiffness of the connection between the inner tube covering structure 200 and the flexible transition section 300. This allows the flexible transition section 300 to provide sufficient support while flexibly adapting to changes in the curvature and angle of the cavity. Specifically, when the degree of curvature of the cavity is large, the stiffness of the flexible transition section 300 is correspondingly reduced, enabling the flexible transition section 300 to navigate more smoothly to the target location while preventing unexpected rebound or retraction of the guidewire.

[0119] Optionally, the design of the flexible transition section 300 also takes into account its greater tendency to bend relative to the inner tube covering structure 200 in an unstressed state, as well as its ability to bend in any direction of the cross section or only in a single direction, thereby optimizing the overall performance of the ablation catheter and improving the success rate and safety of the procedure.

[0120] Optionally, the stiffness of the flexible transition segment 300 is inversely related to the degree of bending of the cavity (e.g., blood vessel) to be ablated; that is, the greater the degree of bending, the smaller the stiffness of the flexible transition segment 300, which further enhances the adaptability of the flexible transition segment 300.

[0121] In this embodiment, the design of the ablation catheter takes into account the actual physiological anatomy and angles of the cavity to be ablated, particularly the degree of tortuosity of the cavity. The length of the flexible transition section 300 is a key parameter in the ablation catheter design, carefully designed according to the degree of tortuosity of the cavity. Optionally, the length of the flexible transition section 300 is positively correlated with the degree of tortuosity of the cavity (e.g., a blood vessel): the more severe the tortuosity, the longer the required length of the flexible transition section 300, to ensure that the catheter can smoothly enter and adapt to the branching of the cavity. For example, the length of the flexible transition section 300 is set to 13 mm.

[0122] To accommodate cavities with varying anatomical structures, ablation catheters are available in multiple sizes, each with different compliance lengths or stiffnesses. This design allows physicians to select the most suitable ablation catheter size before the ablation procedure, based on the specific anatomy and degree of curvature of the cavity. Therefore, the flexible transition section 300 is designed with a length range of 3 mm to 60 mm, preferably 6 mm to 12 mm, to cover a wide range of clinical needs.

[0123] In clinical applications, the length of the flexible transition segment 300 needs to be adjusted according to the anatomical characteristics of the specific cavity. For example, when used in the renal artery, the flexible transition segment 300 should not be too long to avoid contact with the renal parenchyma, thereby reducing surgical risks. When used in other blood vessels such as the hepatic artery and splenic artery, the length of the flexible transition segment 300 can be flexibly selected according to the specific anatomical structure of the target ablation site to achieve the best therapeutic effect.

[0124] In addition to length, the design of the ablation catheter needs to ensure a close match with the diameter of the cavity to improve the precision and safety of the procedure. In the renal artery and its branches, the diameter of the flexible transition segment 300 of the ablation catheter is typically controlled within 8 mm, but in special cases, it may need to reach 12 mm. For other cavities, such as the duodenum, a larger diameter may be required. This design allows the ablation catheter to adapt to the needs of different patients and different surgical scenarios, ensuring the smooth progress of the procedure.

[0125] The flexible transition section 300 is a key component of the ablation catheter. Its outer diameter is designed to be smaller than that of the inner tube covering structure 200 to ensure smooth passage of the catheter through the lumen. The flexible transition section 300 has internal through-holes to allow a guidewire to pass through, enabling precise catheter guidance. The dimensions of the flexible transition section 300, including its length, wall thickness, and outer diameter, are carefully designed based on the materials and structure used to meet specific compliance requirements. For example, the flexible transition section 300 should be designed to allow it to enter the renal artery branch in a curved position under the guidance of a guidewire, before the inner tube covering structure 200 has entered the branch. Therefore, the outer diameter of the flexible transition section 300 is preferably between 1 and 2 mm, more preferably between 1.6 and 1.8 mm, and the length is preferably between 6 and 12 mm, more preferably between 10 and 12 mm. These dimensions are chosen based on the specific anatomy and course of the lumen to ensure that the catheter can accurately adapt to and operate in different lumens.

[0126] Optionally, to further enhance the performance and safety of the flexible transition segment 300, a more preferable design is to surround the flexible transition segment 300 with a flexible sheath. This sheath can be made of materials such as Pebax, TPU, or silicone, and has a preset hardness and good elasticity. The flexible sheath can tightly wrap around the flexible transition segment 300, maintaining its wrapping state even under repeated bending and deformation of the catheter, thereby avoiding damage to the inner lining and other tissues of the cavity wall. In addition, the flexible sheath can reduce resistance during delivery with the help of lubricants or hydrophilic coatings, ensuring smooth delivery and operation of the ablation catheter. This comprehensive design not only improves the compliance and safety of the ablation catheter but also optimizes the efficiency and effectiveness of the procedure.

[0127] In the embodiments of this application, the flexible transition segment 300 is made from commonly used metallic materials, including austenitic stainless steels such as 304SS, 316SS, 316L, 316LV, and 316LVM, as well as cobalt-chromium alloys such as L605 and MP35N. Furthermore, titanium-nickel shape memory alloys, particularly Nitinol (containing approximately 50.8 atomic percent nickel), are also among the preferred materials for manufacturing the flexible transition segment 300. Through the application of these materials and processes, it can be ensured that the ablation catheter maintains the necessary flexibility while adapting to different vascular conditions and surgical requirements.

[0128] Optionally, the above-described implementation process utilizes a flexible continuous structure, such as a straight groove shape, a snake-like shape, or a spring-like shape. Please refer to [link / reference needed]. Figure 12 and Figure 13 , Figure 12 A schematic diagram showing the unfolded flexible transition segment provided in an embodiment of this application; Figure 13 This is another schematic diagram showing the unfolding of the flexible transition segment provided in an embodiment of this application.

[0129] like Figure 12 As shown, the flexible bending section 310 is sculpted into a regular circumferential groove shape. For example... Figure 12 As shown in the unfolded structure of the flexible transition section, the flexible bending provided in this application embodiment is achieved by carving out circumferential grooves, wherein the arrangement of the circumferential grooves is not limited.

[0130] The design of circumferential grooves is flexible and versatile. Depending on actual needs, grooves of different lengths and positions can be freely arranged on the circumference. Long or short grooves can be used individually, or they can be combined and staggered to meet the requirements of flexible bending.

[0131] like Figure 13 As shown, the flexible bending segment 310 is carved into a single or multiple spiral filaments, and after processing, it has bending capabilities in multiple directions.

[0132] In practical applications, the flexible bending segment 310 provided in this application embodiment can also be realized through other structural forms.

[0133] For example, the serpentine (spiral) shape mimics the flexible bending and twisting characteristics of a snake's spine. The serpentine shape not only gives the structure the ability to bend freely in multiple directions but also enhances its ability to withstand complex stresses. This allows the structure to maintain strength while adapting to various complex deformation requirements, enabling a smooth transition between the ablation catheter 1000 and the intravascular environment.

[0134] For example, the spring-shaped structure is a structural design based on the principle of elasticity, utilizing the elastic deformation of materials to store and release energy. Springs are typically made of coiled or helical metal wires that undergo elastic deformation when subjected to external forces, such as compression, tension, or torsion. The spring-shaped design allows the structure to maintain a certain degree of elasticity and restoring force while withstanding external forces, thus providing stable support and cushioning. In some embodiments, the spring 303 can be directly used as the inner layer of the flexible bending segment 310 to meet bending requirements. Please... Figure 22 Based on the above, refer to Figure 20 and Figure 21 , Figure 20 A third cross-sectional example of the ablation catheter provided in an embodiment of this application;

[0135] Figure 21 A fourth cross-sectional example of the ablation catheter provided in the embodiments of this application; Figure 22 This is a schematic diagram of the flexible transition section of the spring provided in an embodiment of this application; as shown. Figure 20As shown, the inner layer of the flexible bending section 310 is equipped with an independent spring 303, which is fixedly connected to the ablation support 220 by welding or adhesive bonding. The entire flexible transition section exhibits a gradual change in flexibility, with the furthest end being the most flexible, gradually increasing in hardness to achieve a smooth transition in hardness with the ablation support 220. Figure 21 As shown, spring 303 is disposed between inner tube 301 and outer tube 302, and spring 303 can be set to a fixed pitch. Alternatively, spring 303 can be set to a variable pitch, with the proximal pitch being the smallest and the distal pitch being the largest; to achieve the most flexible end at the distal end, gradually increasing the hardness, so as to achieve a smooth transition with the hardness of the basket section.

[0136] The outer tube 302 is connected to the outer tube body 210, and the inner tube 301 is connected to the inner tube 100. The inner tube 301 and the outer tube 302 have a non-overlapping area in the axial direction (X direction). The inner tube 301 covers part of the hollow inner tube 100 in the axial direction (X direction), and the flexibility of the outer tube 302 is greater than that of the inner tube 301. That is to say, in this embodiment, the inner tube 301 and the outer tube 302 have different degrees of flexibility and staggered lengths, which can achieve a gradual change in hardness at the transition distal end 320.

[0137] Optionally, the flexible transition section 300 in this embodiment may be made of a polymer material that is softer than the inner tube 100 and the outer tube body 210, and may be fixed to the far end of the bracket by means of welding / laser welding or other methods.

[0138] Optionally, the flexible bending segment 310 in this embodiment may be wrapped with molecular material.

[0139] Optionally, the inner side of the flexible bending segment 310 in this embodiment may be lined with a lubricating material, such as a PTFE liner.

[0140] pass Figure 7 and Figure 12 It is understood that the flexible bending segment 310 in this embodiment can be achieved through flexible circumferential groove carving, snake bone shape imitation or spring shape design, etc. Combined with the softness and fixation method of polymer material, as well as the material optimization of the inner and outer sides, the structure achieves high flexibility, strong recovery and good biocompatibility, effectively improving the operation performance and safety of the ablation catheter 1000 in complex vascular environment.

[0141] Please refer to Figure 14 and Figure 15 , Figure 14 This is a second schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application; Figure 15 This is a third schematic diagram of the structure of the flexible transition segment provided in an embodiment of this application;

[0142] Figure 16 The fourth schematic diagram of the structure of the flexible transition section provided in the embodiment of this application is shown. In an optional embodiment, the flexible transition section 300 further includes an open conical structure of the transition distal end 320. The transition distal end 320 is fixedly connected to the flexible bending section 310.

[0143] like Figure 14 As shown, the distal end 320 of the flexible transition segment 300 provided in this embodiment can be configured as a multi-lobed shape or other tapering shape (please refer to the previous section before processing). Figure 7 , Figure 12 and Figure 13 During processing, a jig is used to shape it into a slightly conical or conical arc shape so that the distal end of the ablation catheter 1000 can be guided into the branch; the flexible transition section 300 of the catheter is a gradually changing flexible section, with the distal end being the most flexible and the distal end 320 having an arc transition to avoid damage to the inner wall of the blood vessel.

[0144] Optionally, please refer to the following: Figure 15 and Figure 16 The requirement for a gradual decrease in tube diameter from the proximal to the distal end (320) can be achieved by assembling a section of conical tube through welding, riveting, etc. The processing of one side of the ablation support 220 can be done by... Figures 12 to 13 The shape on the far right is defined as an expanded support structure (e.g.) Figure 15 (As shown in the structure on the right).

[0145] Please refer to Figure 18 and Figure 19 , Figure 18 Example of a first cross-sectional view of the ablation catheter provided for the implementation of this application; Figure 19 This is a second cross-sectional example of the ablation catheter provided in an embodiment of this application; the hollow inner tube 100 is indirectly connected to the ablation support 220 through a first connecting section 330 or a second connecting section 340; wherein, the first connecting section 330 covers part of the central inner tube 100 in the axial direction (X direction), and the second connecting section 340 covers the flexible bending section 310 and part of the hollow inner tube 100 in the axial direction (X direction).

[0146] This application provides two connection methods for the inner tube 100, the ablation support 220, and the flexible transition section 300. Please refer to... Figure 18 ,exist Figure 18 In the section where the flexible bending section 310 intersects with the hollow inner tube 100, the hollow inner tube 100 can be directly connected to the ablation support 220 via bonding or welding. Alternatively, the hollow inner tube 100 can be indirectly bonded or welded to the ablation support 220 (e.g., a mesh support) via the first connecting section 330 (e.g., a short metal ring or polymer tube). Please refer to [link / reference]. Figure 19 ,exist Figure 19In the section where the flexible bending section 310 meets the hollow inner tube 100, the hollow inner tube 100 is indirectly bonded or welded to the ablation support 220 via the second connecting section 340, such as... Figure 19 As shown, the second connecting segment 340 is a longer connecting segment whose length covers part of the inner tube 100 and the flexible bending segment 310; exemplarily, the second connecting segment 340 may be a longer polymer tube.

[0147] Optionally, the distal end 320 of the transition section can employ various designs to prevent thrombosis and improve operational performance. For example, a coating can be applied to prevent thrombosis, or a heat-shrinkable section can be made of a flexible polymer material such as PEBAX 2533, 3533, or TPU. This not only maintains the flexibility of the flexible section but also makes the surface smooth, reducing material adhesion. Other examples (see also...) Figure 16 Alternatively, flexible polymer materials can be directly fixed to the far end of the support, and the end of the material can be designed into a conical shape to achieve a simple and effective design.

[0148] Optionally, the distal end 320 of the ablation catheter 1000 provided in this embodiment may be lined with a PTFE liner on the inner wall of the central channel 211. The PTFE liner material has excellent lubricity, which can ensure that the guidewire S moves more smoothly and freely when entering and exiting, further optimizing the flexible structure of the distal end of the stent.

[0149] pass Figures 14 to 16 As can be seen, the distal transition end 320 of the ablation catheter 1000 provided in this application embodiment, through the adoption of an open conical structure (e.g., multi-flap processing, conical tube assembly, etc.), achieves a gradual decrease in diameter from the proximal to the distal end of the distal transition end 320, facilitating the guidance of the ablation catheter 1000 into the branch. Simultaneously, various designs, such as coatings, heat-shrinkable flexible polymer materials, or direct fixation of conical polymer materials, are employed to prevent thrombosis and improve operational performance. Furthermore, a PTFE liner is provided on the inner wall of the central channel 211 to ensure smooth entry and exit of the guidewire S, thus optimizing the overall flexibility and practicality of the stent distal end.

[0150] Please refer to Figure 17 , Figure 17 This is a second schematic diagram of the structure of the ablation catheter 1000 provided in an embodiment of this application; in an optional embodiment, an ablation energy release unit is provided on the ablation support 220.

[0151] The ablation energy release units are arranged in a spiral arrangement, a spiral arrangement, or an alternating arrangement; the ablation energy release units include, for example, electrodes, which include cylindrical electrodes, flat tubular electrodes, U-shaped electrodes, or sheet electrodes; the electrodes are configured to deliver ablation energy to the target area.

[0152] Alternatively, electrodes and wires 230 can be printed directly on the support wire.

[0153] Optionally, in the embodiments of this application, different stent morphology schemes include conventional mesh stents, whose mesh segments can be woven from multiple round or flat wires, or carved from metal / polymer round tubing. The carved round tube stent can be multi-wire at one end followed by meshing and shaping, or it can be carved as a whole, similar to a vascular stent, or it can have a distal end connected by carved wires while the area near the electrode fixation point has multiple wires, among other forms. For the ablation catheter 1000 requiring electrode loading, if an integrally carved stent is used, an open structure needs to be provided at the electrode loading location for fixation, or the electrode can be designed in a U-shape, sheet shape, or other similar shape and fixed at a designated position on the carved stent.

[0154] pass Figure 17 As can be seen, the ablation support 220 (stent wire) of the ablation catheter 1000 provided in this application embodiment is fixedly provided with electrodes. The arrangement of the electrodes is diverse, and the electrodes can be tubular, sheet, etc. While ensuring that the multiple electrodes have good wall adhesion performance, the overall diameter of the stent is controlled to be small, which is beneficial to reduce vascular trauma, improve surgical safety and postoperative recovery.

[0155] In an optional embodiment, the ablation catheter 1000 also includes a control handle.

[0156] The control handle connects the inner tube 100 and the inner tube covering structure 200, and is configured to control the position of the inner tube 100 and the shape of the ablation support 220.

[0157] In the above process, the control handle can control the hollow inner tube 100 to move or rotate in the axial direction (X), thereby controlling the ablation support 220 (such as a basket or bracket) to expand and retract.

[0158] Optionally, the control handle is also equipped with a Luer connector or a sealing valve connector structure to facilitate the smooth entry of interventional instruments into the inner tube 100 channel.

[0159] Therefore, the ablation catheter 1000 provided in this embodiment is also equipped with a control handle. The control handle is connected to and controls the inner tube 100 and the inner tube covering structure 200 to realize the position adjustment of the inner tube 100 and the shape change of the ablation support 220 (such as a basket or a stent), including expansion and retraction. It is also equipped with a Luer connector or sealing valve connector structure to facilitate the smooth entry of interventional instruments into the inner tube 100 channel, thereby improving the convenience of operation and the functionality of the catheter.

[0160] In summary, the ablation catheter provided in this application, through the design of the inner tube, the inner tube covering structure, and the flexible transition section, can control the catheter to smoothly enter the target branch blood vessel. With its ingenious structural design and efficient working mechanism, it can be used in complex vascular environments, which is conducive to improving the accuracy, safety, and efficiency of interventional surgery.

[0161] The above are merely embodiments of this application and are not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. An ablation catheter, characterized in that, The ablation catheter includes an inner tube, a flexible transition section, and an inner tube covering structure having an outer tube body and an ablation support; The flexible transition section is fixedly connected to the distal end of the inner tube and the distal end of the ablation support, and is configured to flexibly transition the ablation catheter and the target tissue; The inner tube covering structure covers the inner tube; wherein the ablation support is configured to ablate the target area.

2. The ablation catheter according to claim 1, characterized in that, The ablation support is disposed between the outer tube and the inner tube.

3. The ablation catheter according to claim 1, characterized in that, The outer tube body includes a central channel distributed along the axial direction of the tube body and multiple evenly distributed circumferential channels; the ablation support body includes multiple sets of filamentous components; and the inner tube covering structure also includes multiple sets of wires. The inner tube is disposed in the central channel; Multiple sets of the aforementioned filamentous components and multiple sets of the aforementioned wires are disposed in multiple circumferential channels.

4. The ablation catheter according to claim 3, characterized in that, The ablation support is provided with an ablation energy release unit; The ablation energy release units are arranged in a spiral arrangement, a spiral arrangement, or an alternating arrangement, and the ablation energy release units are configured to deliver ablation energy to the target area.

5. The ablation catheter according to claim 4, characterized in that, The number of circumferential channels is the same as the number of ablation energy release units; Each of the circumferential channels is provided with a set of wires and a set of filamentous components.

6. The ablation catheter according to claim 4, characterized in that, The number of circumferential channels is less than the number of ablation energy release units; Each of the circumferential channels is provided with at least two sets of wires and two sets of filamentous components, arranged in a filamentous component-wire-filamentous component arrangement.

7. The ablation catheter according to claim 1, characterized in that, The flexible transition section includes a flexible bending section; The flexible bending segment is a continuous, bendable structure.

8. The ablation catheter according to claim 7, characterized in that, The flexible continuous structure includes a straight groove shape, a snake bone shape, or a spring shape continuous structure; The hollow inner tube is indirectly connected to the ablation support body through a first connecting section or a second connecting section; wherein, the first connecting section covers part of the central inner tube in the axial direction, and the second connecting section covers the flexible bending section and part of the hollow inner tube in the axial direction. Alternatively, the hollow inner tube may be directly connected to the ablation support.

9. The ablation catheter according to claim 7, characterized in that, The flexible transition section also includes an open-conical transition distal end; The transition distal end is fixedly connected to the flexible bending segment.

10. The ablation catheter according to claim 9, characterized in that, The flexible bending section includes an inner tube, an outer tube, and a spring; The outer tube is connected to the outer tube body, and the inner tube is connected to the inner tube; the inner tube and the outer tube have a non-overlapping area in the axial direction, the inner tube covers part of the hollow inner tube in the axial direction, and the flexibility of the outer tube is greater than that of the inner tube. The spring is disposed between the inner tube and the outer tube.

11. The ablation catheter according to claim 10, characterized in that, in, The spring has a minimum pitch at its proximal end and a maximum pitch at its distal end.

12. The ablation catheter according to claim 7, characterized in that, The flexible bending section includes a channel and multiple rings, multiple openings, and connecting bodies; The channel extends axially through the flexible transition section and is configured to allow passage of a target interventional device or a target fluid. The rings are arranged along the axial direction of the inner tube covering structure, and adjacent rings are connected by the opening.

13. The ablation catheter according to claim 1, characterized in that, The inner tube is configured to infuse a target fluid into the target tissue via a target interventional device.

14. The ablation catheter according to claim 1, characterized in that, The ablation catheter also includes a control handle; The control handle is connected to the inner tube and the inner tube covering structure, and is configured to control the position of the inner tube and the shape of the ablation support.

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