A flexible pulsed electric field ablation catheter and its working method

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to a flexible pulsed electric field ablation catheter. The flexible pulsed electric field ablation catheter includes a multi-lumen catheter. An air passage hose and electrode wires are assembled inside the multi-lumen catheter. An endoscope is fixed at one end of the multi-lumen catheter. An air hole is formed at one end of the multi-lumen catheter close to the endoscope, and the output end of the air passage hose is connected to the air hole. In the present invention, an air pump module is used to make the electrode carrier and the flexible electrode extend synchronously, so that the flexible electrode can fit the target tissue. The cooperation of a plurality of inner support cross arms and outer support cross arms forms support and limitation on both ends of the electrode carrier in the extended state, so that the electrode carrier in the extended state forms a structure similar to a cylinder. Compared with the way that the electrodes are parallel or perpendicular to the catheter axis, through the spiral arrangement of the electrodes, a more uniform distribution of the pulsed electric field is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a flexible pulsed electric field ablation catheter and its working method. Background Art

[0002] Diabetes is a common and highly prevalent disease that affects hundreds of millions of people worldwide. Traditional treatment methods include diet control, increased exercise, oral hypoglycemic drugs, and insulin injection. However, these traditional methods will all reduce the quality of life of patients to a certain extent and bring inconvenience to patients. For example, oral hypoglycemic drugs may cause hypoglycemia, indigestion, weight gain, or other discomforts, and long-term medication may also cause some patients to develop drug resistance.

[0003] Currently, methods for treating chronic diseases such as obesity and diabetes by duodenal intima remodeling have been proposed. However, if the conventional treatment of the duodenum is carried out by electrothermal ablation, there is a risk of overheating, the ablation boundary cannot be accurately controlled, and more duodenal layers (such as the muscular layer) may be damaged than expected, bringing unpredictable risks to the recovery of patients after treatment. Traditional solutions require long-term cooperation from patients, but the final treatment effects are often not satisfactory.

[0004] In view of the above problems, this application document proposes a flexible pulsed electric field ablation catheter and its working method to improve these problems.

[0005] The purpose of the present invention is to provide a flexible pulsed electric field ablation catheter. Through an air pump module, the electrode carrier and the flexible electrode are synchronously stretched, so that the flexible electrode can fit with the target tissue. Through the cooperation of multiple inner support cross arms and outer support cross arms, the two ends of the stretched electrode carrier are supported and limited, so that the stretched electrode carrier forms a structure similar to a cylinder. Compared with the way that the electrodes are parallel or perpendicular to the catheter axis, through the spiral arrangement of the electrodes, a more uniform distribution of the pulsed electric field is achieved.

[0006] The technical solution adopted by the present invention is specifically as follows:

[0007] A flexible pulsed electric field ablation catheter, including a multi-lumen catheter, wherein an air hose and an electrode wire are assembled inside the multi-lumen catheter, an endoscope is fixed at one end of the multi-lumen catheter, air holes are opened at one end of the multi-lumen catheter close to the endoscope, and the output end of the air hose is connected to the air holes. The catheter further includes:

[0008] An electrode carrier, which is arranged at one end of the multi-lumen catheter close to the endoscope, and the electrode carrier is adapted to the air holes;

[0009] A plurality of flexible electrodes, wherein the plurality of flexible electrodes are spirally distributed on the outer side of the electrode carrier, and the flexible electrodes are connected to electrode wires;

[0010] A plurality of first support mechanisms, wherein the plurality of first support mechanisms are all assembled at one end of the multi-lumen catheter close to the endoscope;

[0011] A plurality of second support mechanisms, wherein the plurality of second support mechanisms are all assembled on the outer side of the multi-lumen catheter and located outside the first support mechanisms, and the plurality of second support mechanisms correspond to the plurality of first support mechanisms one by one;

[0012] A handle assembly, which is arranged at the end of the multi-lumen catheter far from the endoscope, and the handle assembly is connected to the first support mechanism and the second support mechanism respectively, and the handle assembly can drive the first support mechanism and the second support mechanism to operate respectively;

[0013] Wherein, in the initial state, the electrode carrier and the flexible electrodes are both in a compressed state. After inputting a gas medium into the electrode carrier through the gas hose, the electrode carrier drives the flexible electrodes to extend until the flexible electrodes are in contact with the target tissue.

[0014] In a preferred solution, the material of the electrode carrier is any one of the following materials: PI, PET, PEEK, PTFE.

[0015] In a preferred solution, the material of the flexible electrode is any one of the following materials: gold, silver, titanium.

[0016] In a preferred solution, the material thickness range of the electrode carrier is 10-60 μm.

[0017] In a preferred solution, a plurality of limiting bosses are fixed at both ends of the plurality of air holes on the outer side of the multi-lumen catheter, and the plurality of limiting bosses correspond to the plurality of first support mechanisms one by one.

[0018] In a preferred solution, the first support mechanism includes a guide plate and a plurality of inner support cross arms. The guide plate is slidably connected to the outer side of the multi-lumen catheter, and the plurality of inner support cross arms are all rotatably connected to the outer side of the guide plate. The guide plate is connected to the handle assembly, and the inner support cross arms are connected to the handle assembly. In the initial state, the plurality of inner support cross arms are attached to each other to form a first tubular structure.

[0019] In a preferred embodiment, the second support mechanism includes a support tube and a plurality of outer support cross arms. The support tube is fixed to the outside of the multi-lumen catheter and is located outside the first support mechanism, and the support tube is fixedly connected to the electrode carrier. A plurality of the outer support cross arms are rotatably connected to one end of the support tube close to the air hole, and the outer support cross arms are connected to the handle assembly. In the initial state, the plurality of outer support cross arms are mutually attached to form a second tubular structure.

[0020] In a preferred embodiment, rotation bosses are provided at one ends of the inner support cross arms and the outer support cross arms away from the air hole, and a right-angle limiting surface is provided on one side of the rotation boss close to the multi-lumen catheter.

[0021] A working method of a flexible pulsed electric field ablation catheter, applicable to the flexible pulsed electric field ablation catheter described in any one of the above, includes the following steps:

[0022] Determine the pulse parameters, where the pulse parameters include pulse power and pulse frequency;

[0023] Release the limit on the second support mechanism through the handle assembly, and then drive the first support mechanism to operate through the handle assembly, so that the first support mechanism changes from the initial state to the extended state, and drive the second support mechanism to change from the initial state to the extended state through the first support mechanism. Support and limit the electrode carrier in the extended state through the cooperation of the first support mechanism and the second support mechanism;

[0024] Input a gas medium into the electrode carrier through the air pump module, so that the electrode carrier and the flexible electrode are synchronously extended;

[0025] Start the pulse generation module, and the flexible electrode releases the ablation electric field.

[0026] The technical effects achieved by the present invention are:

[0027] In the present invention, a gas medium is input into the electrode carrier through the air pump module, so that the electrode carrier and the flexible electrode are synchronously extended, enabling the flexible electrode to fit the target tissue. At the same time, the first support mechanism and the second support mechanism are driven to operate through the handle assembly, and the two ends of the electrode carrier in the extended state are supported and limited through the cooperation of a plurality of inner support cross arms and outer support cross arms. The pulse generation module is started to perform pulsed ablation on the target tissue through the flexible electrode. Compared with the method where the electrodes are parallel or perpendicular to the catheter axis, through the spiral arrangement of the electrodes, a more uniform distribution of the pulsed electric field is achieved;

[0028] The present invention forms support and limit on both ends of the electrode carrier in the extended state through the cooperation of multiple inner support cross arms and outer support cross arms, enabling the electrode carrier in the extended state to form a structure similar to a cylinder. Pulse ablation is performed on the target tissue through a flexible electrode, which can achieve precise boundary ablation. It can be applied to duodenal intima reconstruction to treat chronic diseases such as obesity and diabetes. Compared with the electrothermal ablation method, it avoids phenomena such as overheating and damaging more duodenal layers than expected, provides guarantee for the patient's recovery after treatment, improves the treatment effect, and avoids potential hazards in the medical process. Description of the Drawings

[0029] Figure 1 is the overall structural schematic diagram of the present invention;

[0030] Figure 2 is the partial structural schematic diagram of the present invention;

[0031] Figure 3 is the partial structural cross-sectional view of the present invention;

[0032] Figure 4 is the present invention Figure 3 partial enlarged schematic diagram at position A in;

[0033] Figure 5 is the partial structural schematic diagram of the inner support cross arm of the present invention;

[0034] Figure 6 is the partial structural cross-sectional view of the inner support cross arm of the present invention;

[0035] Figure 7 is the structural schematic diagram of the present invention in the extended state;

[0036] Figure 8 is the structural cross-sectional view of the present invention in the extended state;

[0037] Figure 9 is the pulse electric field distribution diagram in the XOY direction in the simulation analysis of the present invention;

[0038] Figure 10 is the pulse electric field distribution diagram in the XOZ direction in the simulation analysis of the present invention;

[0039] Figure 11 is the pulse electric field distribution diagram in the YOZ direction in the simulation analysis of the present invention.

[0040] In the drawings, the list of components represented by each reference numeral is as follows:

[0041] 10. Multi-lumen catheter; 11. Endoscope; 12. Air hole; 13. Electrode carrier; 14. Flexible electrode; 15. Limiting boss; 20. First support mechanism; 21. Guide plate; 22. Inner support cross arm; 30. Second support mechanism; 31. Support tube; 32. Outer support cross arm; 40. Handle assembly. Detailed implementation manners

[0042] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention with reference to the accompanying drawings of the specification.

[0043] In the following description, many specific details are set forth to fully understand the present invention. However, the present invention can also be implemented in other ways different from those described herein. Those skilled in the art can make similar extensions without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0044] Secondly, the so-called "one embodiment" or "embodiment" herein refers to a specific feature, structure, or characteristic that can be included in at least one implementation manner of the present invention. The phrase "in a preferred implementation manner" that appears in different places in this specification does not necessarily refer to the same embodiment, nor is it a separate or selectively exclusive embodiment from other embodiments.

[0045] Furthermore, the present invention is described in detail with reference to the schematic diagrams. When detailing the embodiments of the present invention, for the convenience of explanation, the cross-sectional views showing the device structure will be enlarged locally not in accordance with the general scale, and the schematic diagrams are only examples and should not limit the scope of protection of the present invention herein. In addition, in actual production, three-dimensional spatial dimensions including length, width, and depth should be included.

[0046] Please refer to the attached Figures 1 to 4 As shown, this is the first embodiment of the present invention. This embodiment provides a flexible pulsed electric field ablation catheter, which includes a multi-lumen catheter 10. An air hose and electrode wires are assembled inside the multi-lumen catheter 10. An endoscope 11 is fixed at one end of the multi-lumen catheter 10. An air hole 12 is opened at one end of the multi-lumen catheter 10 close to the endoscope 11 on the outside, and the output end of the air hose is connected to the air hole 12. It further includes:

[0047] An electrode carrier 13, which is arranged at one end of the multi-lumen catheter 10 close to the endoscope 11 on the outside, and the electrode carrier 13 is adapted to the air hole 12;

[0048] A plurality of flexible electrodes 14, which are spirally distributed on the outside of the electrode carrier 13, and the flexible electrodes 14 are connected to the electrode wires;

[0049] A plurality of first support mechanisms 20, and the plurality of first support mechanisms 20 are all assembled at one end of the multi-lumen catheter 10 close to the endoscope 11 on the outside, and the plurality of first support mechanisms 20 are respectively located at both ends of the electrode carrier 13;

[0050] A plurality of second support mechanisms 30, and the plurality of second support mechanisms 30 are all assembled on the outside of the multi-lumen catheter 10 and are located outside the first support mechanisms 20, and the plurality of second support mechanisms 30 are respectively located at both ends of the electrode carrier 13, and the plurality of second support mechanisms 30 and the plurality of first support mechanisms 20 are in one-to-one correspondence;

[0051] A handle assembly 40, the handle assembly 40 is arranged at one end of the multi-lumen catheter 10 away from the endoscope 11, and the handle assembly 40 is connected to the gas path hose, the handle assembly 40 is connected to the electrode wire, the handle assembly 40 is connected to the first support mechanism 20, and the handle assembly 40 is connected to the second support mechanism 30, and the handle assembly 40 can drive the first support mechanism 20 and the second support mechanism 30 to operate respectively;

[0052] Wherein, in the initial state, the electrode carrier 13 and the flexible electrode 14 are both located inside the second support mechanism 30 and are in a compressed state. After the gas medium is input into the electrode carrier 13 through the gas path hose, the electrode carrier 13 drives the flexible electrode 14 to extend until the flexible electrode 14 is in contact with the target tissue, and the extended electrode carrier 13 can be supported by the cooperation of the plurality of first support mechanisms 20 and the second support mechanisms 30.

[0053] Herein, the number of the flexible electrodes 14 is at least two.

[0054] It should be noted that a plurality of adjusting units are arranged on the handle assembly 40, and the adjusting units are connected to the first support mechanism 20 and the adjusting units are connected to the second support mechanism 30 through the binding wires. In the initial state, the plurality of adjusting units can respectively limit the first support mechanism 20 and the second support mechanism 30 through the binding wires, so as to prevent the first support mechanism 20 and the second support mechanism 30 from operating when ablation is not performed.

[0055] Further, there is also a pulse ablation control system used in conjunction with the device. The pulse ablation control system at least includes a power supply module, a pulse generation module, an impedance detection module, a control module, and a gas pump module. The power supply module is electrically connected to the control module, the power supply module is electrically connected to the pulse generation module, the pulse generation module is electrically connected to the impedance monitoring module, and the pulse generation module is electrically connected to the flexible electrode 14. The gas pump module is connected to the gas path hose. The power supply module is used to provide electrical energy. The pulse generation module is used to send a pulse signal to the flexible electrode 14. The impedance detection module is used to detect the impedance value between multiple pulse electrodes of the electrode, and then determine the impedance value of the target tissue. The control module can receive the impedance value of the lesion tissue detected by the impedance detection module, and determine the ablation parameters (for example: ablation time, pulse voltage, pulse width, pulse frequency, etc.) according to the impedance value of the lesion tissue. The gas pump module can transport or extract a gas medium into the electrode carrier 13. Specifically, the pulse ablation control system is a mature existing application, and will not be elaborated further here.

[0056] In this embodiment, an image of the target tissue is obtained by an imaging device. One end of the multi-lumen catheter 10 far from the handle assembly 40 is delivered to the target tissue. The impedance value of the ablation tissue is obtained by the pulsed ablation control system to determine the pulse parameters. The handle assembly 40 is operated to release the limit on the second support mechanism 30 through the handle assembly 40, and then the handle assembly 40 is used to drive the plurality of first support mechanisms 20 to move towards the direction close to the air hole 12. At the same time, the first support mechanism 20 changes from the initial state to the extended state. During the extension process of the first support mechanism 20, the second support mechanism 30 will be driven to operate synchronously, so that the second support mechanism 30 also changes from the initial state to the extended state. The first support mechanism 20 and the second support mechanism 30 in the extended state cooperate to support and limit the electrode carrier 13 (during this process, the electrode carrier 13 will also undergo partial extension under the drive of the first support mechanism 20, but cannot be fully extended). The air pump module is started, and a gas medium is input into the electrode carrier 13 through the air hose, so that the electrode carrier 13 gradually extends and changes from the initial state to the extended state. At the same time, the electrode carrier 13 drives the flexible electrode 14 to extend until the flexible electrode 14 is in close contact with the target tissue. The pulse generation module is started to send a pulse signal to the flexible electrode 14, and the target tissue is pulsed ablated through the flexible electrode 14. The spiral flexible electrode 14 realizes a more uniform distribution of the pulsed electric field compared with the way that the electrode is parallel or perpendicular to the catheter axis. At the same time, the ablation boundary is controllable, and precise boundary ablation can be achieved. It can be applied to the reconstruction of the duodenal mucosa to treat chronic diseases such as obesity and diabetes. After ablation, the handle assembly 40 drives the first support mechanism 20 to operate in the reverse direction to release the support of the first support mechanism 20 on the electrode carrier 13, so that the first support mechanism 20 changes from the extended state to the initial state. The gas inside the electrode carrier 13 is extracted through the air pump module, so that the electrode carrier 13 and the flexible electrode 14 contract, and the handle assembly 40 is used to drive the two second support mechanisms 30 to operate in the reverse direction, changing from the extended state to the initial state, and the handle assembly 40 forms a limit on the second support mechanism 30. After ablation is completed, the device can be withdrawn from the patient's body.

[0057] In a specific embodiment, please refer to Figures 9 to 11 As shown, taking the unidirectional voltage as an example for simulation analysis to show the pulsed electric field distribution. The applied pulsed voltage is 2000V, the pulse frequency is 1Hz, the pulse width is 100us, the pulsed electric field distribution is uniform, the ablation boundary is controllable, and precise boundary ablation can be achieved. It can be applied to the reconstruction of the duodenal mucosa to treat chronic diseases such as obesity and diabetes. Compared with the electrothermal ablation method, it avoids phenomena such as overheating and damage to more duodenal layers than expected, provides a guarantee for the patient's recovery after treatment, improves the treatment effect, and avoids potential hazards in the medical process.

[0058] In a preferred embodiment, the material of the electrode carrier 13 is any one of the following materials: PI, PET, PEEK, PTFE or other medical polymer materials. The thickness range of the material of the electrode carrier 13 is 10-60 μm. The material of the flexible electrode 14 is any one of the following materials: gold, silver, titanium or other conductive polymer materials. Specifically, in this embodiment, the material of the electrode carrier 13 is preferably PEEK, the thickness of the electrode carrier 13 is preferably 20 μm, and the material of the flexible electrode 14 is preferably titanium.

[0059] In this embodiment, medical polymer materials usually have good biocompatibility, which means they have good compatibility with human tissues and organisms. Such materials can combine with human tissues without causing side effects such as rejection, allergy, corrosion and carcinogenesis.

[0060] Please refer to Figures 3 to 4 As shown, a plurality of limiting bosses 15 are fixed at both ends of the air hole 12 on the outer side of the multi-lumen catheter 10, and the plurality of limiting bosses 15 correspond to the plurality of first support mechanisms 20 one by one.

[0061] In this embodiment, when the first support mechanism 20 is driven by the handle assembly 40 to move in a direction close to each other, the setting of the limiting boss 15 can limit the stroke of the first support mechanism 20, preventing the moving distance of the first support mechanism 20 from being too large to effectively support and limit the electrode carrier 13.

[0062] Please refer to Figures 3 to 4 As shown, the first support mechanism 20 includes a guide plate 21 and a plurality of inner support cross arms 22. The guide plate 21 is slidably connected to the outer side of the multi-lumen catheter 10. The plurality of inner support cross arms 22 are all rotatably connected to the outer side of the guide plate 21, and the guide plate 21 is connected to the handle assembly 40, and the inner support cross arms 22 are also connected to the handle assembly 40. Among them, in the initial state, the plurality of inner support cross arms 22 are mutually attached to form a first tubular structure.

[0063] It should be noted that in this embodiment, the number of the first support mechanism 20 and the second support mechanism 30 is two.

[0064] In this embodiment, when pulsed ablation needs to be performed on the target tissue, the limit on the second support mechanism 30 is released through the handle assembly 40. The guide plates 21 in the two first support mechanisms 20 are driven by the handle assembly 40 to move towards each other. When the guide plates 21 contact the limit bosses 15, the limit bosses 15 limit the guide plates 21. All the inner support cross arms 22 in the two first support mechanisms 20 are driven to rotate by the handle assembly 40. During the rotation of the inner support cross arms 22, the electrode carrier 13 will be locally extended. When the inner support cross arms 22 contact the second support mechanism 30, the inner support cross arms 22 will drive the second support mechanism 30 to operate, so that the second support mechanism 30 changes from the initial state to the extended state (at this time, the electrode carrier 13 is locally clamped between the inner support cross arms 22 and the second support mechanism 30). Through the cooperation of the inner support cross arms 22 and the second support mechanism 30, the electrode carrier 13 is supported and limited. The gas medium is input into the electrode carrier 13 through the air pump module, so that the electrode carrier 13 and the flexible electrode 14 are synchronously extended until the flexible electrode 14 is in close contact with the target tissue. After the pulse generation module is started, pulsed ablation is performed on the target tissue through the flexible electrode 14. The spiral flexible electrode 14 realizes a more uniform distribution of the pulsed electric field compared with the way that the electrodes are parallel or perpendicular to the catheter axis. At the same time, the ablation boundary is controllable, and accurate boundary ablation is realized. After the ablation is completed, the inner support cross arms 22 are driven to reset by the handle assembly 40, and the guide plates 21 inside the two first support mechanisms 20 are moved away from each other, and the support inside the electrode carrier 13 is released. The air pump module and the second support mechanism 30 are operated in reverse, so that the electrode carrier 13, the flexible electrode 14 and the second support mechanism 30 change from the extended state to the initial state, and the handle assembly 40 drives the retraction wire to move and limit the second support mechanism 30 in the initial state.

[0065] Please refer to again Figures 3 to 4 As shown, the second support mechanism 30 includes a support tube 31 and a plurality of outer support cross arms 32. The support tube 31 is fixed on the outer side of the multi-lumen catheter 10 and is located outside the first support mechanism 20. The support tubes 31 in the two second support mechanisms 30 and the two ends of the electrode carrier 13 are respectively fixedly connected. A plurality of outer support cross arms 32 are all rotatably connected to one end of the support tube 31 close to the air hole 12, and the outer support cross arms 32 are connected to the adjustment unit. Among them, in the initial state, the plurality of outer support cross arms 32 are mutually attached to form a second tubular structure.

[0066] It should be noted that the support tubes 31 and the electrode carrier 13 inside the plurality of second support mechanisms 30 form a sealed space, which avoids the overflow of the gas medium when the gas medium is input into the electrode carrier 13 through the air pump module.

[0067] It should be noted that the guide plate 21 is connected to the control unit, the inner support cross arm 22 is connected to the control unit, and the outer support cross arm 32 is connected to the control unit through the converging wire. Specifically, when the control unit adapted to the guide plate 21 rotates forward, the guide plates 21 in the two first support mechanisms 20 move towards each other; when the control unit adapted to the guide plate 21 rotates in the reverse direction, the guide plates 21 in the two first support mechanisms 20 move away from each other; when the control unit adapted to the inner support cross arm 22 rotates forward, the multiple inner support cross arms 22 rotate forward, and the first support mechanism 20 changes from the initial state to the extended state; when the control unit adapted to the inner support cross arm 22 rotates in the reverse direction, the multiple inner support cross arms 22 rotate in the reverse direction, and the first support mechanism 20 changes from the extended state to the initial state; when the control unit adapted to the outer support cross arm 32 rotates forward, the control unit releases the limit on the outer support cross arm 32, and the outer support cross arm 32 can rotate and drive the converging wire connected thereto to move synchronously. At this time, the second support mechanism 30 can change from the initial state to the extended state; when the control unit adapted to the outer support cross arm 32 rotates in the reverse direction, the outer support cross arm 32 can be driven to rotate in the reverse direction for reset through the converging wire. When the outer support cross arm 32 rotates to the reset state, the above-mentioned converging wire is in a taut state, and the outer support cross arm 32 can be limited by the taut converging wire. At the same time, the second support mechanism 30 changes from the extended state to the initial state. Specifically, the handle assembly 40 is a mature existing application, and its specific structure is adaptively adjusted according to the use requirements and use environment. Here, no further elaboration is made.

[0068] Here, the forward rotation and the reverse rotation only represent the operating states of the structural components and do not specifically limit the operating direction.

[0069] In this embodiment, an image of the target tissue is obtained by an imaging device. One end of the multi-lumen catheter 10 away from the handle assembly 40 is delivered to the target tissue. The limit on the outer support cross arm 32 is released through the handle assembly 40, and then the first support mechanism 20 is driven by the handle assembly 40 to change from the initial state to the extended state. Among them, after the rotating inner support cross arm 22 contacts the outer support cross arm 32, it can drive the outer support cross arm 32 to rotate synchronously, and then drive the second support mechanism 30 to change from the initial state to the extended state through the inner support cross arm 22. The electrode carrier 13 is supported and limited by the cooperation of the plurality of inner support cross arms 22 and the plurality of outer support cross arms 32. The air pump module is started to input a gas medium into the electrode carrier 13, so that the electrode carrier 13 and the flexible electrode 14 are extended synchronously. The extended electrode carrier 13 forms a structure similar to a cylinder, so that the flexible electrode 14 is closely attached to the target tissue. The target tissue is ablated through the flexible electrode 14. After ablation, the first support mechanism 20 is driven by a control unit adapted to the first support mechanism 20 to change from the extended state to the initial state. At the same time, the air pump module is started to operate in the reverse direction, and the gas medium inside the electrode carrier 13 is extracted through the air pump module, so that the extended electrode carrier 13 and the flexible electrode 14 contract. The outer support cross arm 32 is driven to rotate in the reverse direction by a control unit adapted to the outer support cross arm 32, so that the second support mechanism 30 changes from the extended state to the initial state, and the outer support cross arm 32 is limited again through the cooperation of the control unit and the retraction wire.

[0070] Please refer to again Figures 5 to 6 As shown, rotating bosses are provided at one ends of the inner support cross arm 22 and the outer support cross arm 32 away from the air hole 12. A shaft rod is provided inside the rotating boss. The guide plate 21 and the inner support cross arm 22, and the support tube 31 and the outer support cross arm 32 are rotationally connected through the rotating boss. A right-angle limiting surface is provided on one side of the rotating boss close to the multi-lumen catheter 10.

[0071] Further, in this embodiment, the angular rotation range of the inner support cross arm 22 and the outer support cross arm 32 is 0-90°.

[0072] In this embodiment, the setting of the right-angle limiting surface can limit the rotation angle of the guide plate 21 and the support tube 31 when the guide plate 21 and the support tube 31 rotate and reset, and prevent the guide plate 21 and the support tube 31 from continuing to rotate after resetting.

[0073] A working method of a flexible pulsed electric field ablation catheter, applicable to a flexible pulsed electric field ablation catheter according to any one of the above, includes the following steps:

[0074] An image of the target tissue is obtained by an imaging device, and one end of the multi-lumen catheter 10 away from the handle assembly 40 is delivered to the target tissue;

[0075] Determine the pulse parameters, where the pulse parameters include pulse power and pulse frequency;

[0076] Release the limit on the outer support cross arm 32 through the handle assembly 40, drive the two guide plates 21 to move towards each other through the handle assembly 40 and drive the inner support cross arm 22 to rotate, drive the outer support cross arm 32 to rotate through the plurality of inner support cross arms 22, and form support and limit on both ends of the electrode carrier 13 in the extended state through the cooperation of the inner support cross arm 22 and the outer support cross arm 32 in the extended state;

[0077] Start the air pump module, input the gas medium into the electrode carrier 13 through the gas path hose, so that the electrode carrier 13 and the flexible electrode 14 are synchronously extended until the flexible electrode 14 is in contact with the target tissue;

[0078] Start the pulse generation module, and the flexible electrode 14 releases the ablation electric field to ablate the target tissue.

[0079] The working principle of the present invention is:

[0080] Please refer to Figures 7 to 8As shown, an image of the target tissue is obtained through an imaging device. The multi-lumen catheter 10 is delivered to the target tissue near one end of the endoscope 11. The impedance value of the ablation tissue is obtained through the pulsed ablation control system to determine the pulse parameters. The handle assembly 40 is operated to release the limit on the outer support cross arm 32 through the handle assembly 40, and the first support mechanism 20 is driven by the handle assembly 40 to change from the initial state to the extended state. During this process, the outer support cross arm 32 is driven to rotate by the inner support cross arm 22, so that the second support mechanism 30 changes from the initial state to the extended state. Through the cooperation of the extended inner support cross arm 22 and the outer support cross arm 32, support and limit are formed on both ends of the extended electrode carrier 13. The air pump module is started to input a gas medium into the electrode carrier 13, so that the electrode carrier 13 and the flexible electrode 14 are synchronously extended, and the electrode carrier 13 forms a structure similar to a cylinder until the flexible electrode 14 is in contact with the target tissue. The pulse generation module is started to send a pulse signal to the flexible electrode 14, and the target tissue is pulsed ablated through the flexible electrode 14. After ablation, the first support mechanism 20 is driven by the control unit adapted to the first support mechanism 20 to change from the extended state to the initial state. At the same time, the air pump module is started to operate in the reverse direction, and the gas medium inside the electrode carrier 13 is extracted through the air pump module, so that the extended electrode carrier 13 and the flexible electrode 14 contract. The outer support cross arm 32 is driven to rotate in the reverse direction by the control unit adapted to the outer support cross arm 32, so that the second support mechanism 30 changes from the extended state to the initial state, and through the cooperation of the control unit and the retraction wire, the outer support cross arm 32 is limited again. When the electrode carrier 13, the flexible electrode 14, the first support mechanism 20, and the second support mechanism 30 are all in the initial state, the device can be withdrawn from the patient's body.

[0081] The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and modifications can be made, and these improvements and modifications should also be regarded as the protection scope of the present invention. The structures, devices, and operation methods not specifically described and explained in the present invention are implemented according to the conventional means in the art without special description and limitation.

Claims

1. A flexible pulsed electric field ablation catheter, characterized in that: Comprising a multi-lumen catheter (10), an air path hose and an electrode wire are internally assembled in the multi-lumen catheter (10), an endoscope (11) is fixed at one end of the multi-lumen catheter (10), air holes (12) are formed in the outer side of the multi-lumen catheter (10) near one end of the endoscope (11), and the output end of the air path hose is connected to the air holes (12). Further comprising: An electrode carrier (13) is arranged on the outer side of the multi-lumen catheter (10) near one end of the endoscope (11), and the electrode carrier (13) is adapted to the air holes (12); A plurality of flexible electrodes (14) are spirally distributed on the outer side of the electrode carrier (13), and the flexible electrodes (14) are connected to the electrode wire; A plurality of first support mechanisms (20) are all assembled on the outer side of the multi-lumen catheter (10) near one end of the endoscope (11); A plurality of second support mechanisms (30) are all assembled on the outer side of the multi-lumen catheter (10) and located on the outer side of the first support mechanisms (20). The plurality of second support mechanisms (30) correspond to the plurality of first support mechanisms (20) one by one; A handle assembly (40) is arranged at the end of the multi-lumen catheter (10) away from the endoscope (11), and the handle assembly (40) is connected to the first support mechanism (20) and the second support mechanism (30) respectively. The handle assembly (40) can drive the first support mechanism (20) and the second support mechanism (30) to operate respectively. By releasing the limit on the second support mechanism (30) through the handle assembly (40), and then driving the first support mechanism (20) to operate through the handle assembly (40), the first support mechanism (20) is changed from the initial state to the extended state, and the second support mechanism (30) is driven by the first support mechanism (20) to be changed from the initial state to the extended state. The extended electrode carrier (13) is supported and limited by the cooperation of the first support mechanism (20) and the second support mechanism (30); Wherein, in the initial state, the electrode carrier (13) and the flexible electrodes (14) are both in a compressed state. After inputting a gas medium into the electrode carrier (13) through an air pump module, the electrode carrier (13) drives the flexible electrodes (14) to extend synchronously until the flexible electrodes (14) are in contact with the target tissue.

2. The flexible pulsed electric field ablation catheter according to claim 1, wherein: The material of the electrode carrier (13) is any one of the following materials: PI, PET, PEEK, PTFE.

3. The flexible pulsed electric field ablation catheter according to claim 1, wherein: The material of the flexible electrode (14) is any one of the following materials: gold, silver, titanium.

4. The flexible pulsed electric field ablation catheter according to claim 1, wherein: The material thickness range of the electrode carrier (13) is 10 - 60 μm.

5. A flexible pulsed electric field ablation catheter according to claim 1, wherein: A plurality of limit bosses (15) are fixed at both ends of the outer side of the multi-lumen catheter (10) where the plurality of air holes (12) are located, and the plurality of limit bosses (15) correspond to the plurality of first support mechanisms (20) one by one.

6. The flexible pulsed electric field ablation catheter according to claim 1, wherein: The first support mechanism (20) includes a guide plate (21) and a plurality of inner support cross arms (22). The guide plate (21) is slidably connected to the outer side of the multi-lumen catheter (10). A plurality of the inner support cross arms (22) are rotatably connected to the outer side of the guide plate (21), and the guide plate (21) is connected to the handle assembly (40), and the inner support cross arms (22) are connected to the handle assembly (40). In the initial state, the plurality of inner support cross arms (22) are attached to each other to form a first tubular structure.

7. The flexible pulsed electric field ablation catheter according to claim 6, wherein: The second support mechanism (30) includes a support tube (31) and a plurality of outer support cross arms (32). The support tube (31) is fixed to the outer side of the multi-lumen catheter (10) and is located outside the first support mechanism (20), and the support tube (31) is fixedly connected to the electrode carrier (13). A plurality of the outer support cross arms (32) are rotatably connected to one end of the support tube (31) close to the air hole (12), and the outer support cross arms (32) are connected to the handle assembly (40). In the initial state, the plurality of outer support cross arms (32) are attached to each other to form a second tubular structure.

8. A flexible pulsed electric field ablation catheter according to claim 7, characterized in that: Rotation bosses are provided at one ends of the inner support cross arms (22) and the outer support cross arms (32) away from the air hole (12), and a right-angle limiting surface is provided on one side of the rotation boss close to the multi-lumen catheter (10).

9. A working method of a flexible pulsed electric field ablation catheter, applicable to a flexible pulsed electric field ablation catheter described in any one of claims 1 to 8, characterized in that: It includes the following steps: Determine the pulse parameters, where the pulse parameters include pulse power and pulse frequency; Start the pulse generation module, and the flexible electrode (14) releases an ablation electric field.

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