A radio frequency catheter capable of gripping tissue

Abstract

The application discloses a radiofrequency catheter capable of clamping tissues, which comprises a handle assembly, an inner tube, a distal electrode assembly, a proximal electrode assembly and an outer tube arranged in sequence from inside to outside; the proximal ends of the inner tube and the outer tube are connected to the handle assembly; the distal electrode assembly comprises a distal stent and a distal electrode; the proximal electrode assembly comprises a proximal stent and a proximal electrode; the distal stent and the proximal stent both have a retracted state of being retracted into the outer tube and an unfolded state of being unfolded and expanded outward after being extended out of the outer tube; when the distal stent and the proximal stent are both in the unfolded state, the distal stent and the proximal stent can clamp the atrial septum tissue on opposite sides of the atrial septum tissue; the distal electrode and the proximal electrode are firmly attached to the atrial septum tissue; during radiofrequency ablation, the distal electrode and the proximal electrode are electrified, the heat ablation effect on the atrial septum tissue is more obvious, and the deep tissue of the atrial septum is necrotic after heat ablation, which helps to delay the closure of the shunt hole and makes the patient benefit for a long time.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a radiofrequency catheter capable of clamping tissue. Background Technology

[0002] The human heart has four chambers: the left atrium and the right atrium, as well as the left ventricle and the right ventricle.

[0003] Heart failure is a common and potentially fatal disease in humans, and despite the best efforts of hospitals, it is often difficult to control and cure in clinical practice. In particular, the incidence of heart failure with preserved ejection fraction (HFpEF) has increased significantly in recent years, but its treatment remains a challenge for clinicians.

[0004] Heart failure with preserved ejection fraction (FEF) is a concept relative to systolic insufficiency. It primarily refers to heart failure characterized by reduced left ventricular diastolic function and relatively normal left ventricular systolic function. This condition is characterized by left ventricular stiffness, accompanied by decreased compliance and impaired relaxation, leading to elevated end-diastolic pressure. Approximately one-third of heart failure patients suffer from FEF with FEF, and there are almost no completely effective drug treatments available.

[0005] Currently, devices used to treat heart failure with preserved ejection fraction fall into two main categories: implantable and interventional. Their fundamental purpose is to create a shunt in the atrial septum between the left and right atria. Patients with heart failure with preserved ejection fraction experience a greater burden on the left ventricle, resulting in higher pressure in the left atrium due to obstructed blood circulation. After creating the shunt, blood flow from the left atrium can be diverted to the right atrium, allowing the right atrium to compensate and alleviate the burden on the left ventricle. While this palliative treatment cannot cure the underlying condition, it effectively relieves cardiac burden and significantly improves the patient's quality of life.

[0006] Compared to interventional devices, implantable devices cannot be removed after surgery. In addition to the many problems associated with implantable materials, it is also inconvenient to handle situations such as reduced or closed shunt holes after surgery.

[0007] Interventional devices typically create shunts by thermally contracting and shaping the atrial septum tissue, offering the advantage of preventing any foreign matter from remaining in the body. However, when using thermal ablation to create shunts, existing interventional devices cannot effectively ensure contact between the ablation electrode and the atrial septum tissue. This results in poor thermal ablation of the atrial septum tissue, failure to ablate and necrose the deeper tissues, and a tendency for the shunts to close again due to tissue regrowth, thus affecting the treatment outcome.

[0008] Application content

[0009] Therefore, the technical problem to be solved by this application is to overcome the defects in the prior art where the ablation electrode on the interventional device has poor contact with the atrial septum tissue when using thermal ablation to create a hole, resulting in poor thermal ablation effect on the atrial septum tissue and easy reclosure of the shunt hole on the atrial septum. This application provides a radiofrequency catheter that can clamp tissue.

[0010] To solve the above-mentioned technical problems, the technical solution of this application is as follows:

[0011] A tissue-clamping radiofrequency catheter includes an inner tube, a distal electrode assembly, a proximal electrode assembly, and an outer tube arranged sequentially from the inside out. The proximal ends of the inner tube and the outer tube are connected to a handle assembly. The distal electrode assembly includes a distal support and a distal electrode disposed on the distal support. The proximal electrode assembly includes a proximal support and a proximal electrode disposed on the proximal support. Both the distal support and the proximal support have a retracted state retracted within the outer tube and an extended state extending outward from the outer tube. When both the distal support and the proximal support are in the extended state, the distal support is located at the distal end of the proximal support. The distal support and the proximal support are adapted to cooperate in clamping the atrial septum tissue so that the distal electrode and the proximal electrode are abutted against the atrial septum tissue.

[0012] Furthermore, the outer wall of the distal stent in its deployed state is adapted to support the puncture site at the intended puncture location in the atrial septum tissue.

[0013] Furthermore, a balloon located at the distal end of the distal electrode assembly is connected to the inner tube. The balloon has a contracted state when no fluid is injected into its inner cavity and an inflated state when the inner cavity is filled with fluid. The distal support has a distal support opening at one end facing the balloon. When the balloon is in the inflated state, the balloon is adapted to extend into the interior of the distal support through the distal support opening.

[0014] Support the distal bracket.

[0015] Furthermore, the distal support is provided with a distal edge protrusion adapted to abut against one side wall of the atrial septum tissue, and the proximal support is provided with a proximal edge protrusion adapted to abut against the other side wall of the atrial septum tissue.

[0016] Furthermore, there are multiple distal edge protrusions and multiple protruding edges, with the distal edge protrusions arranged at intervals along the circumference of the distal support and the multiple protruding edges arranged at intervals along the circumference of the protruding support.

[0017] Furthermore, the distal electrode is disposed on the surface of the distal edge protrusion that contacts the atrial septum tissue, and the proximal electrode is disposed on the surface of the proximal edge protrusion that contacts the atrial septum tissue.

[0018] Furthermore, the distal electrode is provided with a distal insulating structure that partially separates the distal electrode from the atrial septum; the proximal electrode is provided with a proximal insulating structure that partially separates the proximal electrode from the atrial septum.

[0019] Furthermore, the distal support is provided with one or more distal temperature sensors, and the proximal support is provided with one or more proximal temperature sensors.

[0020] Furthermore, the distal electrode assembly further includes a distal support tube located on the outer layer of the inner tube and a distal lead connected to the proximal end of the distal support. The proximal electrode assembly also includes a proximal support tube located on the outer layer of the distal support tube and a proximal lead connected to the proximal end of the proximal support. The distal lead includes a distal electrode lead connected to the distal electrode and a distal sensor lead connected to the distal temperature sensor. The proximal lead includes a proximal electrode lead connected to the proximal electrode and a proximal sensor lead connected to the proximal temperature sensor. The distal lead is connected to the distal support tube, or the distal lead and the distal support tube are an integral structure, or the distal lead passes through the gap between the distal support tube and the proximal support tube. The proximal lead is connected to the proximal support tube, or the proximal lead and the proximal support tube are an integral structure, or the proximal lead passes through the gap between the proximal support tube and the distal support tube.

[0021] Furthermore, the distal support tube and the proximal support tube are an integral structure with a gap between them; or the distal support tube and the proximal support tube are separate double-layer tube structures.

[0022] Furthermore, the distal end of the inner tube is provided with a pointed structure.

[0023] Furthermore, a tee is connected to the proximal end of the inner tube, the tee is provided with a guide wire channel, and a guide wire cavity is provided inside the inner tube, the guide wire cavity being in communication with the guide wire channel.

[0024] Furthermore, the inner tube is provided with an infusion chamber communicating with the inner cavity of the balloon, and the three-way fitting is provided with an infusion channel communicating with the infusion chamber. The infusion channel is adapted to be connected to an infusion device for infusing coolant into the inner cavity of the balloon.

[0025] Furthermore, the surface of the balloon is provided with infusion holes.

[0026] Furthermore, the inner tube has a multi-lumen structure, and both the guidewire lumen and the infusion lumen are lumens within the inner tube.

[0027] Furthermore, the inner tube is provided with a radiopaque ring located inside the balloon.

[0028] Furthermore, the balloon is provided with a protruding structure on its exterior, which is adapted to extend into the gap of the distal stent to position the distal stent.

[0029] Furthermore, the distal electrode and the proximal electrode are either electrically connected or mutually insulated.

[0030] Furthermore, the handle assembly is provided with a curvature adjustment knob for adjusting the curvature of the outer tube, a distal electrode pushing device for pushing the distal electrode assembly, a proximal electrode pushing device for pushing the proximal electrode assembly, and an inner tube pushing device for pushing the inner tube.

[0031] The technical solution of this application has the following advantages:

[0032] 1. The tissue-clamping radiofrequency catheter provided in this application, when both the distal and proximal stents are in the deployed state, can clamp the atrial septum tissue on opposite sides. The distal electrode on the distal stent and the proximal electrode on the proximal stent can be firmly attached to the atrial septum tissue. During radiofrequency ablation, the distal and proximal electrodes are energized, and the thermal ablation effect on the atrial septum tissue is more pronounced. The deep tissue cells of the atrial septum die after thermal ablation. The necrosis of the deep tissue cells helps to prevent or delay the closure of the created shunt orifice, thus providing long-term benefits to the patient.

[0033] 2. The radiofrequency catheter capable of clamping tissue provided in this application, with its distal stent sidewall supported on the puncture site at the expected shunt location in the atrial septum tissue in its deployed state, can ensure that the shunt hole is as circular as possible after ablation, which is beneficial to increasing the flow rate of the shunt hole after thermal ablation and shaping of the atrial septum tissue.

[0034] area.

[0035] 3. The radiofrequency catheter capable of clamping tissue provided in this application allows the balloon to extend from the distal stent opening into the distal stent when the balloon is inflated. The balloon can compensate for the insufficient support of the distal stent for the ostomy site, effectively expanding the ostomy site to the expected size, ensuring both the size and shape of the ostomy site, and making the surgical outcome more controllable.

[0036] 4. The tissue-clamping radiofrequency catheter provided in this application has a distal edge protrusion on the distal stent that is suitable for abutting one side wall of the atrial septum tissue, and a proximal edge protrusion on the proximal stent that is suitable for abutting the other side wall of the atrial septum tissue, which is beneficial for the positioning of the distal stent and the proximal stent on the atrial septum tissue.

[0037] 5. The radiofrequency catheter for clamping tissue provided in this application, with multiple distal edge protrusions and multiple proximal edge protrusions arranged circumferentially, can ensure uniform force distribution at each connection point, which is beneficial to improving the connection reliability between the distal and proximal stents and the interatrial septum tissue and avoiding detachment due to insufficient local force.

[0038] 6. The radiofrequency catheter capable of clamping tissue provided in this application has a distal electrode disposed on the surface of the distal edge protrusion that contacts the atrial septum tissue, and a proximal electrode disposed on the surface of the proximal edge protrusion that contacts the atrial septum tissue, thereby achieving close contact between the distal and proximal electrodes and the atrial septum tissue.

[0039] 7. The radiofrequency catheter capable of clamping tissue provided in this application has a distal electrode with a distal insulating structure that partially separates the distal electrode from the interatrial septum tissue, and a proximal electrode with a proximal insulating structure that partially separates the proximal electrode from the interatrial septum tissue. The distal insulating structure can reduce the contact area between the distal electrode and the interatrial septum tissue, and the proximal insulating structure can reduce the contact area between the proximal electrode and the interatrial septum tissue, which is beneficial for the concentration of radiofrequency current.

[0040] 8. The radiofrequency catheter capable of clamping tissue provided in this application, with one or more distal temperature sensors and one or more proximal temperature sensors, can monitor the real-time temperature of the ablated tissue and its surroundings.

[0041] 9. The radiofrequency catheter capable of clamping tissue provided in this application has an infusion port on the surface of the balloon. During ablation, the coolant can cool the electrode surface through the infusion port, which is conducive to the ablation reaching deeper tissues and increasing the ablation area. The necrosis of deeper tissues helps to prevent or delay the closure of the created shunt port, thus benefiting the patient in the long term.

[0042] 10. The radiofrequency catheter capable of clamping tissue provided in this application has a protruding structure on the outside of the balloon that can provide distal support.

[0043] Positioning the stent helps prevent the distal stent and balloon from separating.

[0044] 11. The radiofrequency conduit that can clamp tissue provided in this application, when the distal electrode and the proximal electrode are interconnected, helps the radiofrequency thermal effect to develop into the deeper tissue. When the distal electrode and the proximal electrode are insulated from each other, the radiofrequency thermal effect is generated faster but the range of action is smaller. Attached Figure Description

[0045] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0046] Figure 1 This is a schematic diagram of the overall structure of the radiofrequency catheter capable of clamping tissue in the embodiments of this application;

[0047] Figure 2 This is a schematic diagram of the structure of the balloon in the inflated state on the inner tube in an embodiment of this application;

[0048] Figure 3 This is a schematic diagram of the structure of the distal electrode assembly in an embodiment of this application;

[0049] Figure 4 This is a schematic diagram of the proximal electrode assembly in an embodiment of this application;

[0050] Figure 5 This is a schematic diagram of the handle assembly in an embodiment of this application;

[0051] Figure 6 This is a schematic diagram of the structure of the catheter distal electrode assembly and proximal electrode assembly in the retrieved state and the balloon in the contracted state in the embodiment of this application.

[0052] Figure 7 This is a schematic diagram of the structure of the distal electrode assembly and proximal electrode assembly on the catheter in the deployed state and the balloon in the inflated state in the embodiment of this application.

[0053] Figure 8 This is a schematic diagram of the distal electrode on the distal support in an embodiment of this application;

[0054] Figure 9 This is a schematic diagram of the proximal electrode on the proximal support in an embodiment of this application;

[0055] Figure 10 This is a schematic diagram of the radio frequency circuit when the distal electrode and the proximal electrode are mutually connected in an embodiment of this application;

[0056] Figure 11 This is a schematic diagram of the radio frequency circuit when the distal electrode and the proximal electrode are mutually insulated in an embodiment of this application.

[0057] Figure 12 for Figure 11 Enlarged view of point A in the image;

[0058] Figure 13 A schematic diagram of puncturing and inserting a guidewire into the interatrial septum tissue;

[0059] Figure 14 A schematic diagram showing the radiofrequency catheter being inserted into the heart along the guidewire and passing through the shunt hole in the atrial septum tissue;

[0060] Figure 15 A schematic diagram showing the distal electrode assembly extending from the outer tube and deploying within the left atrium;

[0061] Figure 16 This is a schematic diagram showing the distal electrode assembly against the left atrial wall after the distal electrode assembly and the outer tube have been withdrawn, and the distal end of the outer tube needs to be withdrawn to the right atrium.

[0062] Figure 17 A schematic diagram showing the proximal electrode assembly extending from the outer tube and abutting against the right atrial wall at the ostomy site;

[0063] Figure 18 This is a schematic diagram of the balloon entering the distal stent after the balloon and inner tube have been retracted in an embodiment of this application.

[0064] Figure 19 This is a schematic diagram of the structure in an embodiment of this application where the distal stent and proximal stent work together to clamp the atrial septum tissue, and the balloon is located inside the distal stent.

[0065] Explanation of reference numerals in the attached diagram: 1. Inner tube; 11. Tip structure; 12. Balloon; 121. Irrigation port; 13. Imaging ring; 141. Pressurization port; 15. Tee; 2. Distal electrode assembly; 21. Distal support; 211. Distal edge protrusion; 212. Distal electrode; 22. Distal support tube; 23. Distal lead; 24. Distal temperature sensor; 3. Proximal electrode assembly; 31. Proximal support; 311. Proximal edge protrusion; 312. Proximal electrode; 32. Proximal support tube; 33. Proximal lead; 34. Proximal temperature sensor; 4. Outer tube; 5. Handle assembly; 51. Curvature adjustment knob; 52. Distal electrode pushing device; 53. Positioning clamping device; 54. Inner tube pushing device; 55. Catheter internal flushing interface; 56. Electrical connector; 6. Atrial septum tissue. Detailed Implementation

[0066] The technical solutions of this application will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. 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.

[0067] In the description of this application, it should be noted that when used to refer to an instrument or component in the following description, the terms "distal" and "proximal" refer to the position or direction relative to the treating clinician. Therefore, "distal" means a position away from or in a direction away from the treating clinician, while the term "proximal" means a position close to or towards the clinician. The terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and 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 of this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0068] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" 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 between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0069] like Figure 1 Figure 9 shows a tissue-clamping radiofrequency catheter, comprising an inner tube 1, a distal electrode assembly 2, a proximal electrode assembly 3, an outer tube 4, and a handle assembly 5. The inner tube 1, distal electrode assembly 2, proximal electrode assembly 3, and outer tube 4 are the portions intended to enter the human body, with the proximal ends of the inner tube 1 and outer tube 4 connected to the handle assembly 5. The inner tube 1, distal electrode assembly 2, proximal electrode assembly 3, and outer tube 4 form a four-layer structure arranged sequentially from the inside out. The distal electrode assembly 2 includes a distal stent 21 and a distal electrode 212 disposed on the distal stent 21. The proximal electrode assembly 3 includes a proximal stent 31 and a proximal electrode 312 disposed on the proximal stent 31. Both the distal stent 21 and the proximal stent 31 have a retracted state that is contracted within the outer tube 4 and an extended state that extends outward after extending outward from the outer tube 4. When both the distal stent 21 and the proximal stent 31 are in the extended state, the distal stent 21 is located at the distal end of the proximal stent 31. The distal stent 21 and the proximal stent 31 are adapted to cooperate in clamping the atrial septum tissue 6 so that the distal electrode 212 and the proximal electrode 312 are in contact with the atrial septum tissue 6.

[0070] This tissue-clamping radiofrequency catheter is used in conjunction with a radiofrequency ablation device, which powers the proximal electrode 312 and the distal electrode 212. When both the distal stent 21 and the proximal stent 31 are in the deployed state, they can clamp the atrial septum 6 on opposite sides. The distal electrode 212 on the distal stent 21 and the proximal electrode 312 on the proximal stent 31...

[0071] It can adhere firmly to the atrial septum tissue 6. After the distal electrode 212 and the proximal electrode 312 are energized, the thermal ablation effect on the atrial septum tissue 6 is more obvious. The deep tissue cells of the atrial septum die after thermal ablation. The necrosis of the deep tissue cells helps to prevent or delay the closure of the created shunt orifice, so that the patient can benefit in the long term.

[0072] like Figure 2 and Figure 7 As shown, the distal end of the inner tube 1 is provided with a tip structure 11, which facilitates the passage of the inner tube 1 through the ostomy site on the atrial septum tissue 6. The inner tube 1 also has a balloon 12 located distal to the distal electrode assembly 2. The balloon 12 has a contracted state when the lumen is empty and an inflated state when the lumen is filled with fluid. The distal stent 21 has an opening at one end facing the balloon 12. When the balloon 12 is inflated, it is adapted to extend into the distal stent 21 through the opening to support it. The balloon 12 on the inner tube 1 compensates for the insufficient support of the distal stent 21 for the ostomy site, effectively expanding the ostomy site to the expected size, ensuring both the size and shape of the ostomy site, and making the surgical outcome more controllable.

[0073] like Figure 2 As shown, the proximal end of the inner tube 1 is connected to a three-way connector 15, which has a guidewire channel and an infusion channel. The inner tube 1 contains a guidewire cavity and an infusion cavity. The guidewire cavity communicates with the guidewire channel, and the infusion cavity communicates with the infusion channel. The guidewire cavity and guidewire channel are adapted for the guidewire to pass through the inner tube 1. The infusion channel is adapted to connect to an infusion device for injecting cooling fluid into the inner cavity of the balloon 12. The inner tube 1 has a pressure port 141 connecting the inner cavity of the balloon 12 and the infusion cavity. The surface of the balloon 12 is machined into a very small infusion port 121. During radiofrequency ablation, the infusion device can inject physiological saline as a coolant into the balloon 12 through the infusion channel. The coolant can cool the surfaces of the distal electrode 212 and the proximal electrode 312 through the infusion port 121, facilitating ablation to deeper tissues, increasing the ablation area, and preventing or delaying the closure of the created shunt, thus providing long-term benefit to the patient.

[0074] Specifically, the inner tube 1 has a multi-lumen structure, with both the guidewire lumen and the infusion lumen being lumens within the inner tube 1. This integrated design of the guidewire lumen and infusion lumen saves space and helps reduce the size of the inner tube 1. The inner tube 1 has a radiopaque ring 13 located inside the balloon 12, which indicates the position of the balloon 12 under X-ray.

[0075] In some embodiments, the balloon 12 has a protruding structure on its exterior, which is adapted to extend into the gap of the distal stent 21 to position the distal stent 21, thereby helping to prevent the distal stent 21 and the balloon from colliding.

[0076] 12 Separation. In alternative embodiments, the exterior of the balloon 12 can also be any other shape that contributes to support.

[0077] like Figure 3 As shown in -4 and 6-9, in the unfolded state, the main bodies of both the distal stent 21 and the proximal stent 31 are cylindrical. The distal electrode assembly 2 also includes a distal support tube 22 located outside the inner tube 1 and a distal lead 23 connected to the proximal end of the distal stent 21. The proximal electrode assembly 3 also includes a proximal support tube 32 located outside the distal support tube 22 and a proximal lead 33 connected to the proximal end of the proximal stent 31. The distal lead 23 includes a distal electrode lead connected to the distal electrode 212 and a distal sensor lead connected to the distal temperature sensor 24. The proximal lead 33 includes a proximal electrode lead connected to the proximal electrode 312 and a proximal sensor lead connected to the proximal temperature sensor 34. The distal lead 23 is connected to the distal support tube 22, and the distal lead 23 and the distal support tube 22 are an integral structure, or the distal lead 23 passes through the gap between the distal support tube 22 and the proximal support tube 32. The proximal lead 33 is connected to the proximal support tube 32, and the proximal lead 33 and the proximal support tube 32 are an integral structure, or the proximal lead 33 passes through the gap between the proximal support tube 32 and the distal support tube 22. When the distal lead 23 and the distal support tube 22 are an integral structure, the distal lead 23 can be fused together with the distal support tube 22, and the distal lead 23 is pre-embedded during the processing of the distal support tube 22. When the proximal lead 33 and the proximal support tube 32 are an integral structure, the proximal lead 33 can be fused together with the proximal support tube 32, and the proximal lead 33 is pre-embedded during the processing of the proximal support tube 32. When both the distal stent 21 and the proximal stent 31 are in the deployed state, the distal stent 21 is located at the distal end of the proximal stent 31. The distal stent 21 and the proximal stent 31 are adapted to cooperate in clamping the atrial septum tissue 6 so that the distal electrode 212 and the proximal electrode 312 are attached to the inner tube 1 of the atrial septum tissue 6. The outer wall of the distal stent 21 in the deployed state is adapted to support the puncture hole at the expected puncture site of the atrial septum tissue 6. This can ensure that the shunt hole after ablation is as circular as possible, which is beneficial to increase the flow area of ​​the shunt hole after the atrial septum tissue 6 is thermally ablated and shaped.

[0078] In some embodiments, the distal support tube 22 and the proximal support tube 32 can be an integral structure with a gap between them, through which the proximal lead 33 and the distal lead 23 pass. In other embodiments, the distal support tube 22 and the proximal support tube 32 are separate double-layer tube structures, through which the proximal lead 33 and the distal lead 23 pass.

[0079] like Figure 8 and Figure 9 As shown, the distal stent 21 has a distal edge protrusion 211 adapted to abut against one side wall of the atrial septum 6, and the proximal stent 31 has a proximal edge protrusion 311 adapted to abut against the other side wall of the atrial septum 6. The distal edge protrusion 211 facilitates the positioning of the distal stent 21 on the atrial septum 6, and the proximal edge protrusion 311 facilitates the positioning of the proximal stent 31 on the atrial septum 6. There are multiple distal edge protrusions 211 and multiple proximal edge protrusions 311, with the distal edge protrusions 211 and proximal edge protrusions 311 arranged at intervals along the circumference of the distal stent 211 and the proximal edge protrusions 311 arranged at intervals along the circumference of the proximal stent 311. The distal electrode 212 is disposed on the surface of the distal edge protrusion 211 that contacts the atrial septum 6, and the proximal electrode 312 is disposed on the surface of the proximal edge protrusion 311 that contacts the atrial septum 6. This configuration ensures that the electrode support is evenly stressed at all connection points, which improves the reliability of the connection between the electrode support and the interatrial septum 6 and prevents detachment due to insufficient local stress. On the other hand, the distal electrode 212 and the proximal electrode 312 can make close contact with the interatrial septum 6, and the even arrangement of the distal electrode 212 and the proximal electrode 312 around the interatrial septum 6 at the pore site ensures that the thermal ablation effect on various parts around the pore site is similar, which helps to ensure the shape of the pore.

[0080] In some embodiments, the distal electrode 212 has a distal insulating structure that partially separates the distal electrode 212 from the atrial septum 6; the proximal electrode 312 has a proximal insulating structure that partially separates the proximal electrode 312 from the atrial septum 6. The distal insulating structure reduces the contact area between the distal electrode 212 and the atrial septum 6, and the proximal insulating structure reduces the contact area between the proximal electrode 312 and the atrial septum 6, which is beneficial for the concentration of radio frequency current. The distal and proximal insulating structures are implemented through coatings or material encapsulation.

[0081] like Figure 3 and Figure 4As shown, the distal stent 21 is equipped with one or more distal temperature sensors 24, and the proximal stent 31 is equipped with one or more proximal temperature sensors 34; the distal temperature sensors 24 and proximal temperature sensors 34 are positioned as close as possible to the ablation site of the atrial septum tissue 6. The distal temperature sensors 24 and proximal temperature sensors 34 can monitor the real-time temperature of the ablated tissue and its surroundings.

[0082] like Figure 5 As shown, the handle assembly 5 includes a clamping and positioning device 53, a curvature adjustment knob 51, a distal electrode pushing device 52, a proximal electrode pushing device 53, an inner tube pushing device 54, a catheter internal flushing interface 55, and an electrical connector 56. The inner tube pushing device 54 is used to push the inner tube 1, and the clamping and positioning device 53 clamps...

[0083] The outer tube 4 is held outside the inner tube pushing device 54. A curvature adjustment knob 51 is used to adjust the curvature of the outer tube 4. A distal electrode pushing device 52 and a proximal electrode pushing device are mounted on the clamping and positioning device 53. The distal electrode pushing device 52 pushes the distal electrode assembly 2, and the proximal electrode pushing device pushes the proximal electrode assembly 3. An electrical connector 56 is electrically connected to the distal electrode 212 and the proximal electrode 312, and is also used for electrical connection to external radio frequency equipment. The handle assembly 5 also has necessary size markings for determining the curvature of the outer tube 4 and indicating the positional relationship between the distal electrode 212, the proximal electrode 312, and the balloon 12.

[0084] Figure 6 This diagram shows the distal electrode assembly 2 and proximal electrode assembly 3 on the catheter in the retrieved state, and the balloon 12 in the contracted state. Figure 7 The diagram shows the distal electrode assembly 2 and proximal electrode assembly 3 on the inner tube 1 in the deployed state, and the balloon 12 in the inflated state. The balloon 12 on the inner tube 1 is located at the distal end, and the distal stent 21 and proximal stent 31 are arranged from distal to proximal to avoid cross-interference. The outer tube 4 serves as the carrier for the first three components.

[0085] Radiofrequency catheters need to be used in conjunction with a radiofrequency ablation device. A dedicated cable connects catheter 1 and the radiofrequency ablation device, which combines radiofrequency ablation and saline infusion functions. Based on the concept of radiofrequency ablation, the catheter electrodes can have two modes: unipolar and bipolar. Figure 10 This is a schematic diagram of the radio frequency circuit when the distal electrode 212 and the proximal electrode 312 are interconnected in single-stage mode. In this case, a neutral electrode needs to be added to the system. The neutral electrode is attached to the back of the human body and connected to the radio frequency ablation device. The radio frequency circuit is as follows: radio frequency ablation device – distal electrode 212 and proximal electrode 312 – human body – neutral electrode – radio frequency ablation device. Figure 11 and Figure 12This is a schematic diagram of the radiofrequency circuit when the distal electrode 212 and the proximal electrode 312 are mutually insulated in bipolar mode. In this case, a neutral electrode is not required in the system, and the radiofrequency circuit is: radiofrequency ablation device – distal electrode 212 – human body – proximal electrode 312 – radiofrequency ablation device. Comparing the two methods above: unipolar mode helps the radiofrequency thermal effect penetrate deeper into the tissue, while bipolar mode generates a thermal effect faster but has a smaller range of action.

[0086] like Figure 13 -19 illustrates the use of this radiofrequency catheter during surgery, which includes the following steps:

[0087] Step S1: See Figure 13 The interatrial septal puncture was completed and a guidewire was inserted;

[0088] Step S2: See Figure 14 The radiofrequency catheter is inserted into the heart along the guidewire, so that the distal tip of the inner tube 1...

[0089] Structure 11 enters the left atrium; this process requires the use of handle assembly 5 to adjust the outer tube 4 so that the outer tube 4 forms a suitable curvature;

[0090] Step S3: See Figure 15 First, push the inner tube 1 inward so that the balloon 12 can fully enter the left atrium; then push the distal electrode assembly 2 inward so that the distal stent 21 can extend out of the outer tube 4 and fully enter the left atrium.

[0091] Step S4: See Figure 16 The outer tube 4 and the distal electrode assembly 2 are withdrawn so that the distal stent 21 rests against the left atrial wall at the site of the atrial septum tissue 6. At the same time, the distal end of the outer tube 4 needs to be withdrawn into the right atrium.

[0092] Step S5: See Figure 17 Push the proximal electrode assembly 3 inward so that the proximal stent 31 rests against the right atrial wall at the site of the atrial septum tissue 6. Use the distal stent 21 and the proximal stent 31 to hold the atrial septum tissue 6 at the expected ablation site in the middle.

[0093] Step S6: See Figure 18 Keeping the position unchanged from the previous step, retract the inner tube 1 so that the balloon 12 enters the interior of the distal stent 21. Connect the interface of the inner tube 1 to the cold saline infusion interface of the radiofrequency ablation device and continuously pressurize and infuse the balloon 12.

[0094] Step S7: See Figure 19 The radiofrequency ablation device is activated, and ablation is performed at appropriate energy and time to cause necrosis of the atrial septum tissue 6 between the distal stent 21 and the proximal stent 31, forming a shunt hole.

[0095] Step S8: After ablation, the proximal stent 31, distal stent 21 and balloon 12 are retrieved into the outer tube 4 in sequence, and the inner tube 1 is safely withdrawn, and the operation is completed.

[0096] During the procedure, a radiofrequency catheter is used to expand and ablate the atrial septum puncture site in the heart, causing tissue necrosis and creating a long-term shunt between the left and right atria. For patients with heart failure, especially those with preserved ejection fraction, this shunts pressure from the left atrium to the right atrium; for patients with pulmonary hypertension, it shunts pressure from the right atrium to the left atrium. This relieves the circulatory burden on the heart and improves the patient's quality of life.

[0097] In summary, the tissue-clamping radiofrequency catheter provided in this application uses a stent-type distal electrode assembly 2 and a proximal electrode assembly 3 to firmly hold the atrial septum tissue 6 in the middle, ensuring that the distal electrode 212 and the proximal electrode 312 are firmly attached to the atrial septum tissue 6. The stronger the attachment, the more obvious the thermal effect of radiofrequency ablation will be. At the same time, in order to compensate for the insufficient support of the stent-type electrode assembly for the pore-forming site, a balloon 12 is additionally provided on the inner tube 1. After the balloon 12 is inflated, it can effectively expand the pore-forming site to the expected size, ensuring both size and shape, making the surgical effect more controllable. Furthermore, an irrigation hole 121 can be processed on the surface of the balloon 12 for cold irrigation, thereby reducing the surface temperature of the distal electrode 212 and the proximal electrode 312. This helps the radiofrequency energy to be effectively transmitted to the deeper tissue, increasing the ablation area and slowing down tissue healing.

[0098] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this application.

Claims

1. A radiofrequency catheter capable of clamping tissue, characterized in that, The assembly includes, from the inside out, an inner tube (1), a distal electrode assembly (2), a proximal electrode assembly (3), and an outer tube (4). The proximal ends of the inner tube (1) and the outer tube (4) are connected to a handle assembly (5). The distal electrode assembly (2) includes a distal support (21) and a distal electrode (212) disposed on the distal support (21). The proximal electrode assembly (3) includes a proximal support (31) and a proximal electrode (312) disposed on the proximal support (31). The proximal stents (31) all have a retracted state that is retracted within the outer tube (4) and an extended state that extends outward after extending outward from the outer tube (4); when both the distal stent (21) and the proximal stent (31) are in the extended state, the distal stent (21) is located at the distal end of the proximal stent (31), and the distal stent (21) and the proximal stent (31) are adapted to cooperate in clamping the atrial septum tissue (6) and to make the distal electrode (212) and the proximal electrode (312) abut against the atrial septum tissue (6); The outer wall of the distal stent (21) in its deployed state is adapted to support the puncture site at the intended puncture location of the atrial septum tissue (6); The inner tube (1) is also connected to a balloon (12) located at the distal end of the distal electrode assembly (2). The balloon (12) has a contracted state when no fluid is injected into the inner cavity and an expanded state when the inner cavity is filled with fluid. The distal stent (21) has a distal stent opening at one end facing the balloon (12). When the balloon (12) is in the expanded state, the balloon (12) is adapted to extend into the interior of the distal stent (21) from the distal stent opening to support the distal stent (21). The distal support (21) is provided with a distal edge protrusion (211) adapted to abut against one side wall of the atrial septum (6), and the proximal support (31) is provided with a proximal edge protrusion (311) adapted to abut against the other side wall of the atrial septum (6).

2. The tissue graspable RF catheter of claim 1, wherein, There are multiple distal edge protrusions (211) and multiple proximal edge protrusions (311). The multiple distal edge protrusions (211) are arranged at intervals along the circumference of the distal support (21), and the multiple proximal edge protrusions (311) are arranged at intervals along the circumference of the proximal support (31).

3. The tissue graspable RF catheter of claim 1, wherein, The distal electrode (212) is disposed on the surface of the distal edge protrusion (211) that contacts the interatrial septum tissue (6), and the proximal electrode (312) is disposed on the surface of the proximal edge protrusion (311) that contacts the interatrial septum tissue (6).

4. The tissue graspable RF catheter of claim 3, wherein, The distal electrode (212) is provided with a distal insulating structure that partially separates the distal electrode (212) from the atrial septum (6); the proximal electrode (312) is provided with a proximal insulating structure that partially separates the proximal electrode (312) from the atrial septum (6).

5. The tissue graspable RF catheter of claim 1, wherein, The distal support (21) is provided with one or more distal temperature sensors (24), and the proximal support (31) is provided with one or more proximal temperature sensors (34).

6. The clampable tissue radiofrequency of claim 5, wherein, The distal electrode assembly (2) further includes a distal support tube (22) located outside the inner tube (1) and a distal lead (23) connected to the proximal end of the distal support (21). The proximal electrode assembly (3) further includes a proximal support tube (32) located outside the distal support tube (22) and a proximal lead (33) connected to the proximal end of the proximal support (31). The distal lead (23) includes a distal electrode lead connected to the distal electrode (212) and a distal sensor lead connected to the distal temperature sensor (24). The proximal lead (33) includes a proximal electrode lead connected to the proximal electrode (312) and a proximal sensor lead connected to the distal temperature sensor (24). The proximal temperature sensor (34) is connected to the proximal sensor lead; the distal lead (23) is connected to the distal support tube (22), or the distal lead (23) and the distal support tube (22) are an integral structure, or the distal lead (23) passes through the gap between the distal support tube (22) and the proximal support tube (32); the proximal lead (33) is connected to the proximal support tube (32), or the proximal lead (33) and the proximal support tube (32) are an integral structure, or the proximal lead (33) passes through the gap between the proximal support tube (32) and the distal support tube (22).

7. The tissue graspable RF catheter of claim 6, wherein, The distal support tube (22) and the proximal support tube (32) are an integral structure with a gap between them; or the distal support tube (22) and the proximal support tube (32) are a separate double-layer tube structure.

8. The grippable tissue radiofrequency catheter of claim 1 wherein, The proximal end of the inner tube (1) is connected to a tee (15), the tee (15) is provided with a guide wire channel, and the inner tube (1) is provided with a guide wire cavity, which is connected to the guide wire channel.

9. The tissue graspable RF catheter of claim 8, wherein, The inner tube (1) is provided with an infusion chamber that communicates with the inner cavity of the balloon (12), and the three-way fitting (15) is also provided with an infusion channel that communicates with the infusion chamber. The infusion channel is adapted to be connected to an infusion device for infusing coolant into the inner cavity of the balloon (12).

10. The tissue graspable RF catheter of claim 9, wherein, The surface of the balloon (12) is provided with an infusion hole (121).

11. The tissue graspable RF catheter of claim 9, wherein, The inner tube (1) has a multi-lumen structure, and the guide wire lumen and the infusion lumen are both lumens within the inner tube (1).

12. The grippable tissue radiofrequency catheter of claim 1 wherein, The balloon (12) has a protruding structure on its exterior, which is adapted to extend into the gap of the distal stent (21) to position the distal stent (21).

13. The grippable tissue radiofrequency catheter of claim 1 wherein, The distal electrode (212) and the proximal electrode (312) are either electrically connected or insulated from each other.

14. The grippable tissue radiofrequency catheter of claim 1 wherein, The handle assembly (5) is provided with a curvature adjustment knob (51) for adjusting the curvature of the outer tube (4), a distal electrode pushing device (52) for pushing the distal electrode assembly (2), a proximal electrode pushing device for pushing the proximal electrode assembly (3), and an inner tube pushing device (54) for pushing the inner tube (1).

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