Pulsed electric field ablation splined catheter and method of ablation

Abstract

The application discloses a pulsed electric field ablation spline type catheter and an ablation method thereof, and relates to the technical field of ablation catheters, wherein the catheter comprises spline electrodes, a main outer tube, an adjusting handle, a main inner tube, a guide wire and a three-dimensional mapping catheter; the spline electrodes are composed of a plurality of radially expandable splines, and each of the splines is provided with an ablation electrode. In a first state, the guide wire is located in a guide wire cavity to navigate the catheter to a target pulmonary vein orifice, and in a second state, the three-dimensional mapping catheter is located in the guide wire cavity, and one end of the three-dimensional mapping catheter extends out of one end of the spline electrodes away from the main outer tube to contact endocardial tissue of a target point area for electrophysiological mapping, the rapid switching of guide wire navigation and three-dimensional mapping catheter mapping can be realized in the same catheter, and special mapping catheters need not be punctured or replaced, so that endocardial electrophysiological signals of the target point area can be directly obtained before ablation.

Description

Technical Field

[0001] This invention relates to the field of ablation catheter technology, and in particular to a pulsed electric field ablation spline catheter and its ablation method. Background Technology

[0002] Pulsed field ablation (PFA) is a non-thermal ablation technique based on the irreversible electroporation mechanism. Due to its advantages such as tissue specificity, high ablation efficiency, and minimal damage to surrounding tissues, it has been widely used in the treatment of arrhythmias such as atrial fibrillation in recent years.

[0003] Currently, intraoperative localization typically relies on indirect imaging techniques such as X-ray fluoroscopy or transesophageal echocardiography to assess the adhesion between the spline electrode and the pulmonary vein orifice. However, these indirect imaging methods cannot directly acquire endocardial electrophysiological signals in the target area, leading to a degree of uncertainty in the determination of the ablation target. If a three-dimensional mapping system is required for precise localization, it often necessitates additional puncture or replacement of a dedicated mapping catheter. This not only increases surgical trauma and the number of instrument exchanges but also prolongs the procedure and increases the risk of X-ray exposure. Summary of the Invention

[0004] The pulsed electric field ablation spline catheter and ablation method provided by this invention can solve the problem that the determination of ablation target points in the prior art is somewhat blind, and if a three-dimensional mapping system is required for precise positioning, it is often necessary to perform a separate puncture or replace it with a dedicated mapping catheter.

[0005] A pulsed electric field ablation spline-type catheter includes a spline electrode, an outer main tube, an adjusting handle, an inner main tube, a guidewire, and a three-dimensional mapping catheter. The spline electrode is composed of multiple radially expandable splines, each spline having an ablation electrode. The outer main tube is connected to one end of the spline electrode. The adjusting handle is connected to the end of the outer main tube away from the spline electrode. One end of the inner main tube is connected to the end of the spline electrode away from the outer main tube, and the other end is connected to the adjusting handle. An internal guidewire cavity is formed within the inner tube, with the distal end of the guidewire cavity opening into... The spline electrode is located at one end away from the main body outer tube; the guidewire is movably disposed within the guidewire lumen; the three-dimensional mapping catheter is movably disposed within the guidewire lumen; the catheter has at least two states: in the first state, the guidewire is located within the guidewire lumen for navigating the catheter to the target pulmonary vein orifice; in the second state, the three-dimensional mapping catheter is located within the guidewire lumen, and one end of the three-dimensional mapping catheter extends beyond the spline electrode at the end away from the main body outer tube for contacting the endocardial tissue of the target area for electrophysiological mapping.

[0006] The present invention provides a pulsed electric field ablation spline-type catheter, which, compared with the prior art, has the following beneficial effects, but is not limited to: This pulsed electric field ablation spline-type catheter navigates to the target pulmonary vein orifice in a first state where the guidewire is positioned within the guidewire lumen. In a second state, a three-dimensional mapping catheter is positioned within the guidewire lumen with one end extending from the spline electrode away from the main outer tube to contact the endocardial tissue of the target area for electrophysiological mapping. This allows for rapid switching between guidewire navigation and three-dimensional mapping within the same catheter, eliminating the need for additional punctures or replacement with a dedicated mapping catheter. This enables direct acquisition of endocardial electrophysiological signals in the target area before ablation, overcoming the blind spots in assessment that exist when relying solely on indirect imaging methods such as X-ray fluoroscopy or transesophageal echocardiography. It improves the accuracy of ablation target determination and reduces surgical trauma, the number of instrument exchanges, surgical time, and the risk of X-ray exposure.

[0007] Furthermore, the adjustment handle includes a handle body, on which an unfolding slider is slidably connected. The unfolding slider is connected to the inner tube of the main body, and the unfolding slider is used to control multiple splines to radially unfold into a predetermined shape when sliding.

[0008] Furthermore, the three-dimensional mapping catheter includes a movable tube and an annular flexible mapping tube, on which multiple mapping electrodes and microelectrodes are disposed.

[0009] Furthermore, the spline is also equipped with a contact force sensor and an impedance detection electrode to determine the contact quality between the spline and the pulmonary vein opening.

[0010] Furthermore, the spline is made of a nickel-titanium shape memory alloy skeleton, and multiple ablation electrodes are segmented on the spline, with their polarity independently controllable.

[0011] Furthermore, the adjusting handle has a first flushing port, a second flushing port, and a cable interface. A first hose is provided in the first flushing port, and a second hose is provided in the second flushing port. A cavity is formed between the outer tube and the inner tube of the main body. The liquid outlet of the first hose is located inside the inner tube of the main body, and the liquid outlet of the second hose is located inside the cavity.

[0012] Furthermore, the adjusting handle has a first suction port and a second suction port. A third hose is provided inside the first suction port, and a fourth hose is provided inside the second suction port. The liquid inlet end of the third hose is located inside the inner tube of the main body, and the liquid inlet end of the fourth hose is located inside the cavity.

[0013] Furthermore, at least four splines are provided, and at least four ablation electrodes are provided on each spline.

[0014] Furthermore, the ablation electrode is wrapped around a spline.

[0015] A pulsed electric field ablation method, based on the aforementioned pulsed electric field ablation spline-type catheter, includes the following steps: S1, placing a guidewire in the guidewire lumen, placing the catheter in a first state; S2, with the support of the guidewire, pushing the catheter to the target pulmonary vein orifice; S3, withdrawing the guidewire, inserting a three-dimensional mapping catheter through the guidewire lumen, so that one end of the three-dimensional mapping catheter extends beyond the spline electrode at the end away from the main outer tube, placing the catheter in a second state; S4, using the three-dimensional mapping catheter to contact the endocardial tissue of the target area for electrophysiological mapping, obtaining mapping results; S5, withdrawing the three-dimensional mapping catheter, adjusting the handle to move the main inner tube relative to the main outer tube, causing multiple splines to expand radially, so that the ablation electrode is close to the target pulmonary vein orifice; S6, based on the mapping results, delivering a pulsed electric field through the ablation electrode for ablation. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the first state of a pulsed electric field ablation spline-type catheter according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the second state of a pulsed electric field ablation spline-type catheter according to an embodiment of the present invention; Figure 3 for Figure 2 A schematic diagram of the end structure of the spline-type catheter in the second state of medium-pulse electric field ablation; Figure 4 This is a cross-sectional view of the second state of a pulsed electric field ablation spline catheter according to an embodiment of the present invention; Figure 5 for Figure 4 Schematic diagram of the structure of the spline electrode; Figure 6 for Figure 4 A schematic diagram of the structure of the adjustment handle; Figure 7 This is a flowchart of a pulsed electric field ablation method according to the present invention.

[0017] Explanation of reference numerals in the attached figures: 1. Spline electrode; 101. Spline; 102. Ablation electrode; 103. Contact force sensor; 104. Impedance detection electrode; 2. Main body outer tube; 3. Adjustment handle; 31. Handle; 32. Deployment slider; 4. Main body inner tube; 5. Guide wire cavity; 6. Guide wire; 7. Three-dimensional mapping catheter; 71. Moving tube; 72. Annular flexible mapping tube; 73. Mapping electrode; 74. Microelectrode; 8. First flushing port; 9. Second flushing port; 10. Cable interface; 11. First flexible tube; 12. Second flexible tube; 13. Cavity; 14. First suction port; 15. Second suction port; 16. Third flexible tube; 17. Fourth flexible tube. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] like Figure 1-4 As shown in the figure, an embodiment of the present invention provides a pulsed electric field ablation spline-type catheter, including a spline electrode 1, an outer main tube 2, an adjusting handle 3, an inner main tube 4, a guidewire 6, and a three-dimensional mapping catheter 7; the spline electrode 1 is composed of multiple radially expandable splines 101, each spline 101 being provided with an ablation electrode 102; the outer main tube 2 is connected to one end of the spline electrode 1; the adjusting handle 3 is connected to the end of the outer main tube 2 away from the spline electrode 1; one end of the inner main tube 4 is connected to the end of the spline electrode 1 away from the outer main tube 2, and the other end is connected to the adjusting handle 3, with an internal shape... The device has a guidewire lumen 5, the distal end of which opens at the end of the spline electrode 1 away from the main body tube 2; a guidewire 6 is movably disposed within the guidewire lumen 5; a three-dimensional mapping catheter 7 is movably disposed within the guidewire lumen 5; the catheter has at least two states: in the first state, the guidewire 6 is located within the guidewire lumen 5, used to navigate the catheter to the target pulmonary vein orifice; in the second state, the three-dimensional mapping catheter 7 is located within the guidewire lumen 5, and one end of the three-dimensional mapping catheter 7 extends beyond the spline electrode 1 away from the main body tube 2, used to contact the endocardial tissue of the target area for electrophysiological mapping.

[0020] In this embodiment, in the first state, the guidewire 6 is located in the guidewire lumen 5 to guide the catheter to the target pulmonary vein orifice. In the second state, the three-dimensional mapping catheter 7 is located in the guidewire lumen 5 with one end extending from the spline electrode 1 away from the main body outer tube 2 to contact the endocardial tissue of the target area for electrophysiological mapping. This allows for rapid switching between guidewire 6 navigation and three-dimensional mapping catheter 7 mapping within the same catheter, without the need for additional puncture or replacement of a dedicated mapping catheter. This enables the direct acquisition of endocardial electrophysiological signals of the target area before ablation, overcoming the blind spots in assessment that exist when relying solely on indirect imaging methods such as X-ray fluoroscopy or transesophageal echocardiography. This improves the accuracy of ablation target determination and reduces surgical trauma, the number of instrument exchanges, surgical time, and the risk of X-ray exposure.

[0021] Specifically, the outer tube 2 and the inner tube 4 are connected to the two ends of the spline electrode 1 and are connected to the adjustment handle 3. The operator can control the movement of the inner tube 4 relative to the outer tube 2 by operating the adjustment handle 3, thereby driving multiple splines 101 to reliably expand or contract radially. This facilitates the smooth delivery of the catheter to the target pulmonary vein orifice in the blood vessel and its stable attachment after it is in place. At the same time, the ablation electrode 102 on each spline 101 can uniformly and controllably deliver a pulsed electric field for ablation. Furthermore, this structure provides the basis for the formation of the guidewire lumen 5 inside the inner tube 4 and the subsequent movable placement of the guidewire 6 and three-dimensional mapping catheter 7 within the guidewire lumen 5. This allows the endocardial electrophysiological signal of the target area to be directly obtained before ablation without the need for additional puncture or replacement of a dedicated mapping catheter.

[0022] The inner diameter of the guidewire lumen 5 is set to 0.040 inches to 0.060 inches, and the outer diameter of the matching three-dimensional mapping catheter 7 is set to 0.035 inches to 0.055 inches. The outer diameter of the three-dimensional mapping catheter 7 is smaller than the inner diameter of the guidewire lumen 5. The wall thickness between the guidewire lumen 5 and the main body outer tube 2 is designed to be 0.05 mm to 0.20 mm. This allows the guidewire lumen 5 to be compatible with the standard 0.035-inch guidewire 6 for navigation, and also enables the matching three-dimensional mapping catheter 7 to be smoothly inserted through the guidewire lumen 5 and extend out to the end of the spline electrode 1 away from the main body outer tube 2 for high-precision electrophysiological mapping.

[0023] like Figure 3 and Figure 6 As shown, the adjustment handle 3 includes a handle body 31, on which an unfolding knob 32 is slidably connected. The unfolding knob 32 is connected to the inner tube 4 of the main body. The unfolding knob 32 is used to control the multiple splines 101 to unfold radially into a predetermined shape when sliding.

[0024] In this embodiment, the movement of the inner tube 4 relative to the outer tube 2 of the main body can be precisely controlled by sliding the unfolding knob 32, thereby enabling the multiple splines 101 to be stably and controllably unfolded radially to a predetermined shape. This ensures that the ablation electrode 102 is evenly attached to the target pulmonary vein opening, avoiding ineffective ablation or damage to adjacent tissues due to incomplete unfolding or poor attachment. Thus, without the need for additional puncture or replacement of the dedicated mapping catheter, the mapping results obtained by the three-dimensional mapping catheter 7 in the guidewire lumen 5 can be used to achieve precise targeted ablation, further improving the accuracy of ablation target determination and surgical safety.

[0025] like Figure 3 and Figure 5 As shown, the three-dimensional mapping catheter 7 includes a movable tube 71 and an annular flexible mapping tube 72, on which multiple mapping electrodes 73 and microelectrodes 74 are disposed.

[0026] In this embodiment, when the three-dimensional mapping catheter 7 is inserted through the guidewire lumen 5 and the annular flexible mapping tube 72 extends from the spline electrode 1 away from the main body outer tube 2, the moving tube 71 can push the annular flexible mapping tube 72 to the target area. The annular flexible mapping tube 72 flexibly adheres to the endocardial tissue, and multiple mapping electrodes 73 and microelectrodes 74 can acquire local electrocardiogram signals at high density and construct a three-dimensional electroanatomical model. Thus, the endocardial electrophysiological signals of the target area can be directly obtained without additional puncture or replacement of the dedicated mapping catheter, thereby improving the accuracy of ablation target determination.

[0027] Specifically, the annular flexible labeling tube 72 is made of flexible material and is annular in shape. It is connected to the moving tube 71 and can move with the moving tube 71 within the guidewire lumen 5. When the three-dimensional mapping catheter 7 is inserted through the guidewire lumen 5, the annular flexible labeling tube 72 extends from the end of the spline electrode 1 away from the main body outer tube 2. With its flexible annular structure, it adaptively adheres to the endocardial tissue of the target area. Multiple mapping electrodes 73 and microelectrodes 74 on the annular flexible labeling tube 72 collect local electrocardiogram signals and transmit them to the external three-dimensional mapping system through the wires in the moving tube 71 and the cable interface 10 on the adjustment handle 3. This constructs a three-dimensional electroanatomical model and guides the ablation electrode 102 to deliver a pulsed electric field for precise ablation. This enables continuous operation of guidewire 6 navigation, three-dimensional mapping, and spline 101 ablation within the same catheter, without the need for separate puncture or replacement of a dedicated mapping catheter.

[0028] like Figure 3 and Figure 5 As shown, a contact force sensor 103 and an impedance detection electrode 104 are also provided on the spline 101 to determine the contact quality between the spline 101 and the pulmonary vein opening.

[0029] In this embodiment, when the surgeon unfolds the spline 101 and places it against the target pulmonary vein opening, the surgeon can obtain the contact force and impedance signals between the spline 101 and the tissue in real time through the contact force sensor 103 and the impedance detection electrode 104. Based on this, the surgeon can accurately determine whether the spline 101 is evenly and stably placed against the pulmonary vein opening, and adjust the position and unfolding state of the spline 101 in a timely manner to avoid ineffective ablation or damage to adjacent tissues due to poor placement.

[0030] like Figure 1 and Figure 5 As shown, the spline 101 is made of a nickel-titanium shape memory alloy skeleton, and multiple ablation electrodes 102 are segmented on the spline 101, and their polarity can be controlled independently.

[0031] In this embodiment, the spline 101, thanks to the shape memory and superelasticity of the nickel-titanium shape memory alloy, can repeatedly and stably expand radially and maintain a predetermined shape, ensuring that the ablation electrode 102 is evenly attached to the target pulmonary vein orifice. At the same time, the multiple ablation electrodes 102 arranged in segments can independently control their polarity, allowing the operator to flexibly adjust the electric field distribution and ablation range according to the endocardial electrophysiological signals of the target area obtained by the three-dimensional mapping catheter 7. This accurately adapts to the anatomical morphology of the pulmonary vein orifice of different patients, avoiding ineffective ablation and damage to adjacent tissues due to poor attachment or improper electric field distribution. Thus, precise targeted ablation can be achieved without the need for additional puncture or replacement of a dedicated mapping catheter.

[0032] Specifically, at least four splines 101 are provided, and at least four ablation electrodes 102 are provided on each spline 101; preferably, six or eight splines 101 are provided, and the number of ablation electrodes 102 on each spline 101 is set to four. The length of the spline 101 is 10-30 mm and the outer diameter is 0.5-2 mm. The ablation electrodes 102 are made of platinum-iridium alloy or gold and are annular or segmented rectangular in shape, with a length of 0.5-5 mm and a width of 1-2 mm. When the spline 101 is fully unfolded, it is petal-shaped or basket-shaped and the maximum outer diameter is 20-4 mm. 0mm, preferably 25-35mm; therefore, this parameter setting allows the spline 101 to adapt to the anatomical morphology of the pulmonary vein orifice of different patients, ensuring that multiple ablation electrodes 102 are evenly attached to the target tissue and form a continuous, transmural ablation foci. At the same time, the nickel-titanium alloy skeleton and polyimide or polyether block amide coating give the spline 101 shape memory, flexibility and insulation. The platinum-iridium alloy or gold electrodes and the ring or segmented rectangular structure improve the uniformity of electric field distribution and high voltage resistance, thereby achieving precise targeted ablation without the need for additional puncture or replacement of a special mapping catheter.

[0033] like Figure 6 As shown, the adjustment handle 3 has a first flushing port 8, a second flushing port 9 and a cable interface 10. A first hose 11 is installed in the first flushing port 8 and a second hose 12 is installed in the second flushing port 9. A cavity 13 is formed between the outer tube 2 and the inner tube 4 of the main body. The liquid outlet end of the first hose 11 is located in the inner tube 4 of the main body and the liquid outlet end of the second hose 12 is located in the cavity 13.

[0034] In this embodiment, heparinized saline solution can be continuously infused into the guidewire lumen 5 within the inner tube 4 of the main body through the first flushing port 8 and the first flexible tube 11, independently flushing the movement channels of the guidewire 6 and the three-dimensional mapping catheter 7 to prevent blood backflow and coagulation, ensuring smooth interchange between the guidewire 6 and the three-dimensional mapping catheter 7 within the guidewire lumen 5. Simultaneously, flushing fluid can be infused into the cavity 13 between the outer tube 2 and the inner tube 4 of the main body through the second flushing port 9 and the second flexible tube 12, independently flushing the cavity 13 to avoid blood stagnation and thrombus formation. The cable interface 10 is used to connect to the pulsed electric field ablation device to realize the transmission of ablation energy. The dual flushing channels flush the guidewire lumen 5 and the cavity 13 respectively without interference, effectively reducing the risk of coagulation and thromboembolism in the catheter lumen during prolonged surgery, reducing instrument jamming caused by coagulation, and improving surgical safety.

[0035] like Figure 6 As shown, the adjusting handle 3 has a first suction port 14 and a second suction port 15. A third hose 16 is installed in the first suction port 14, and a fourth hose 17 is installed in the second suction port 15. The liquid inlet end of the third hose 16 is located in the inner tube 4 of the main body, and the liquid inlet end of the fourth hose 17 is located in the cavity 13.

[0036] In this embodiment, by aspirating the guidewire lumen 5 within the main body inner tube 4 and the cavity 13 between the main body outer tube 2 and the main body inner tube 4 during the replacement of the guidewire 6 and the three-dimensional mapping catheter 7 through the guidewire lumen 5, and before and after ablation, any blood, air bubbles, and debris that may enter are promptly discharged. This prevents blood stagnation and coagulation that could lead to blockage of the guidewire lumen 5 and the cavity 13, ensuring smooth movement and interchange of the guidewire 6 and the three-dimensional mapping catheter 7 within the guidewire lumen 5. Simultaneously, in conjunction with the first flushing port 8 and the second flushing port 9, a flushing method of aspiration followed by continuous perfusion is implemented, further reducing the risk of thrombosis and air embolism, and ensuring that the spline electrode 1 and the ablation electrode 102 are precisely positioned and ablated at the target pulmonary vein opening.

[0037] like Figure 1 and Figure 5 As shown, the ablation electrode 102 is wrapped around the spline 101.

[0038] In this embodiment, the ablation electrode 102 is wrapped around the spline 101, so the ablation electrode 102 is firmly bonded to the spline 101 and is not easy to fall off. It also increases the contact area between the ablation electrode 102 and the target tissue, so that the pulse electric field is evenly distributed along the circumference of the spline 101. This avoids the formation of bubbles or damage to adjacent tissues caused by local current concentration. It ensures that the ablation electrode 102 can stably and evenly deliver the pulse electric field when the spline 101 is close to the pulmonary vein orifice of the target, thereby improving the permeability and safety of ablation.

[0039] Specifically, the pulsed electric field ablation parameters are set to a pulse voltage in the range of 1000V to 4000V, a pulse width in the microsecond range, a frequency in the Hertz to kilohertz range, and a waveform of single-phase or biphase pulse waveform. The discharge combination methods between electrodes include paired discharge of ablation electrodes 102 on adjacent splines 101, paired discharge of different ablation electrodes 102 on the same spline 101, and simultaneous discharge of ablation electrodes 102 on multiple splines 101. Therefore, the operator can flexibly select the pulse voltage, pulse width, frequency, waveform, and electrode discharge combination method according to the endocardial electrophysiological signal of the target area and the anatomical morphology of the pulmonary vein ostium obtained by the three-dimensional mapping catheter 7, so that the pulsed electric field forms a uniform, controllable, and sufficient ablation depth in the target tissue.

[0040] like Figure 7 As shown, a pulsed electric field ablation method, based on the aforementioned pulsed electric field ablation spline-type catheter, includes the following steps: S1, placing the guidewire 6 inside the guidewire lumen 5, placing the catheter in a first state; S2, with the support of the guidewire 6, pushing the catheter to the target pulmonary vein orifice; S3, withdrawing the guidewire 6, inserting the three-dimensional mapping catheter 7 through the guidewire lumen 5, so that one end of the three-dimensional mapping catheter 7 extends beyond the spline electrode 1 away from the main outer tube 2, placing the catheter in a second state; S4, using the three-dimensional mapping catheter 7 to contact the endocardial tissue of the target area for electrophysiological mapping, obtaining mapping results; S5, withdrawing the three-dimensional mapping catheter 7, and adjusting the handle 3 to move the main inner tube 4 relative to the main outer tube 2, causing multiple splines 101 to expand radially, so that the ablation electrode 102 is attached to the target pulmonary vein orifice; S6, based on the mapping results, performing ablation by delivering a pulsed electric field through the ablation electrode 102.

[0041] In this embodiment, the catheter is first placed in the guidewire lumen 5 to achieve a first state. Supported by the guidewire 6, the catheter is pushed to the target pulmonary vein orifice. Then, after withdrawing the guidewire 6, the three-dimensional mapping catheter 7 is inserted through the guidewire lumen 5, with one end of the three-dimensional mapping catheter 7 extending beyond the spline electrode 1 away from the main outer tube 2, thus achieving a second state. Electrophysiological mapping is performed by contacting the endocardial tissue of the target area using the three-dimensional mapping catheter 7, and mapping results are obtained. After withdrawing the three-dimensional mapping catheter 7, the main inner tube 4 is moved relative to the main outer tube 2 by adjusting the handle 3, causing multiple splines 101 to radially expand, allowing the ablation electrode 102 to adhere to the target area. By applying a pulsed electric field through the ablation electrode 102 near the pulmonary vein orifice based on the mapping results, this method can sequentially complete the operation of guidewire navigation 6, three-dimensional mapping catheter 7 mapping, and spline 101 ablation within the same catheter, without the need for additional puncture or replacement of a dedicated mapping catheter. This allows for the direct acquisition of endocardial electrophysiological signals in the target area before ablation, overcoming the blindness of relying solely on indirect imaging methods such as X-ray fluoroscopy or transesophageal echocardiography to assess the contact between the spline electrode and the pulmonary vein orifice, improving the accuracy of ablation target determination, and reducing surgical trauma, number of instrument exchanges, operation time, and X-ray exposure risks.

[0042] Specifically, in step S5, after withdrawing the three-dimensional mapping catheter 7, the guidewire 6 can be reinserted, and the inner tube 4 of the main body can be moved relative to the outer tube 2 of the main body by adjusting the handle 3, which drives the multiple splines 101 to expand radially, so that the ablation electrode 102 is attached to the target pulmonary vein orifice. Therefore, this step can either reinsert the guidewire 6 after withdrawing the three-dimensional mapping catheter 7, and use the guidewire 6 to provide additional support and guidance for the expansion and attachment of the splines 101, reduce the displacement of the splines 101 during cardiac pulsation, and ensure that the ablation electrode 102 is stably attached to the target pulmonary vein orifice, or directly expand the splines 101 with the assistance of the mapping catheter, thereby adapting to the operating habits of different operators and the different anatomical morphologies of the pulmonary vein orifices, and improving the accuracy of the ablation target determination and the ablation safety.

[0043] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A pulsed electric field ablation spline-type catheter, characterized in that, include: The spline electrode (1) is composed of multiple radially expandable splines (101), and each spline (101) is provided with an ablation electrode (102). The outer tube (2) of the main body is connected to one end of the spline electrode (1); Adjusting handle (3) is connected to the end of the outer tube (2) of the main body away from the spline electrode (1); The inner tube (4) of the main body is connected at one end to the spline electrode (1) away from the outer tube (2) of the main body, and at the other end to the adjustment handle (3). A guide wire cavity (5) is formed inside the tube. The distal end of the guide wire cavity (5) opens at the end of the spline electrode (1) away from the outer tube (2). The guidewire (6) is movably disposed within the guidewire cavity (5); A three-dimensional mapping catheter (7) is movably disposed within the guidewire lumen (5); The catheter has at least two states: In the first state, the guidewire (6) is located in the guidewire lumen (5) for navigating the catheter to the target pulmonary vein orifice; In the second state, the three-dimensional mapping catheter (7) is located inside the guidewire lumen (5), and one end of the three-dimensional mapping catheter (7) extends out of the spline electrode (1) away from the main body outer tube (2) for contacting the endocardial tissue of the target area for electrophysiological mapping.

2. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The adjustment handle (3) includes a handle body (31), on which an unfolding knob (32) is slidably connected. The unfolding knob (32) is connected to the inner tube (4) of the main body. The unfolding knob (32) is used to control multiple splines (101) to unfold radially into a predetermined shape when sliding.

3. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The three-dimensional mapping catheter (7) includes a movable tube (71) and an annular flexible label tube (72), on which multiple mapping electrodes (73) and microelectrodes (74) are provided.

4. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The spline (101) is also provided with a contact force sensor (103) and an impedance detection electrode (104) to determine the contact quality between the spline (101) and the pulmonary vein opening.

5. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The spline (101) is made of a nickel-titanium shape memory alloy skeleton, and multiple ablation electrodes (102) are segmented on the spline (101) and their polarity can be controlled independently.

6. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The adjustment handle (3) has a first flushing port (8), a second flushing port (9) and a cable interface (10). A first hose (11) is provided in the first flushing port (8), and a second hose (12) is provided in the second flushing port (9). A cavity (13) is formed between the outer tube (2) of the main body and the inner tube (4) of the main body. The liquid outlet of the first hose (11) is located in the inner tube (4) of the main body, and the liquid outlet of the second hose (12) is located in the cavity (13).

7. The pulsed electric field ablation spline-type catheter as described in claim 6, characterized in that, The adjusting handle (3) has a first suction port (14) and a second suction port (15). A third hose (16) is provided in the first suction port (14), and a fourth hose (17) is provided in the second suction port (15). The liquid inlet end of the third hose (16) is located in the inner tube (4) of the main body, and the liquid inlet end of the fourth hose (17) is located in the cavity (13).

8. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, At least four splines (101) are provided, and at least four ablation electrodes (102) are provided on each spline (101).

9. The pulsed electric field ablation spline-type catheter as described in claim 1, characterized in that, The ablation electrode (102) is wrapped around the spline (101).

10. A pulsed electric field ablation method, characterized in that, The pulsed electric field ablation spline catheter, as described in any one of claims 1-9, comprises the following steps: S1. Place the guidewire (6) inside the guidewire cavity (5) to put the catheter in the first state; S2. With the support of the guidewire (6), the catheter is pushed to the mouth of the target pulmonary vein; S3. Withdraw the guidewire (6) and insert the three-dimensional mapping catheter (7) through the guidewire cavity (5) so that one end of the three-dimensional mapping catheter (7) extends out of the spline electrode (1) away from the outer tube (2) of the main body, so that the catheter is in the second state; S4. Electrophysiological mapping is performed on the endocardial tissue in the target area using the three-dimensional mapping catheter (7) to obtain the mapping results; S5. Withdraw the three-dimensional mapping catheter (7), and move the inner tube (4) of the main body relative to the outer tube (2) through the adjustment handle (3), thereby driving the multiple splines (101) to expand radially, so that the ablation electrode (102) is attached to the mouth of the target pulmonary vein. S6. Based on the measurement results, ablation is performed by emitting a pulsed electric field through the ablation electrode (102).

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