Dual energy ring ablation catheter with freeze and pulse

Abstract

The application discloses a double-energy annular ablation catheter with freezing and pulse, relates to the field of ablation, and comprises a main body section, a flexible section, a metal head and a plurality of electrodes. One end of the flexible section is fixedly connected with the main body section, and the other end is an annular part. The plurality of electrodes are arranged on the annular part of the flexible section. The metal head is fixedly connected with the annular part of the flexible section. The main body section, the flexible section and the metal head all have a plurality of cavities inside. The electrodes are used for measuring the electrical signal at the action site. When the action site is ablated, the refrigerant reaches the metal head through the cavities inside the main body section and the flexible section in sequence, so that the action site is subjected to cryoablation. After the cryoablation is completed, the refrigerant is discharged through the cavities inside the metal head, the flexible section and the main body section in sequence. The electrodes are also used for generating a high-voltage pulse electric field when the cryoablation is completed, so that the action site is subjected to pulse ablation. The application improves the ablation efficiency and the safety of ablation.

Description

Technical Field

[0001] This invention relates to the field of ablation, and in particular to a dual-energy annular ablation catheter with both freezing and pulse functions. Background Technology

[0002] In current cryoablation devices, the ablation component is an ablation balloon, which can expand and contract, and achieves cryoablation by circulating a cryo-medium to keep the balloon surface at a low temperature. However, traditional cryoablation balloon ablation requires high tissue adhesion, and ablation is very difficult in areas other than the pulmonary vein orifice, such as the posterior wall of the left atrium, the top line of the left atrium, and the bottom line. Therefore, the success rate of treating persistent atrial fibrillation is low. Traditional cryoablation balloon devices require an additional mapping catheter, which is generally ring-shaped (see Medtronic's Arctic FrontAdvance Pro cryoablation catheter). Due to the variable shape and strong contractility of the atrial wall and the wall at the junction of the atrium and pulmonary veins, and the limited outward expansion ability of the spiral mapping structure, the mapping effect of the spiral mapping component in current cryoablation balloons is unstable and poor.

[0003] Current pulse ablation devices often require higher voltages to reach deeper lesions. Higher voltages can cause electrical sparks between electrodes and lead to skeletal muscle contraction, necessitating deep sedation or general anesthesia. Microbubbles are generated during pulse ablation, which can potentially lead to air embolism. Pulse ablation is effective for ablating myocardial cells, but less effective for ablating heterogeneous tissues. Summary of the Invention

[0004] The purpose of this invention is to provide a dual-energy annular ablation catheter with both cryotherapy and pulsed ablation capabilities, which can improve ablation efficiency and safety.

[0005] To achieve the above objectives, the present invention provides a dual-energy annular ablation catheter with cryotherapy and pulsed ablation capabilities, comprising: a main body segment, a flexible segment, a metal head, and multiple electrodes;

[0006] One end of the flexible segment is fixedly connected to the main body segment; the other end of the flexible segment is an annular portion; multiple electrodes are disposed in the annular portion of the flexible segment; the metal head is fixedly connected to the annular portion of the flexible segment.

[0007] The main body segment, the flexible segment, and the metal head all have multiple cavities inside;

[0008] The electrode is used to measure electrical signals at the site of action; during ablation of the site of action, the cryoprotectant passes sequentially through the cavities inside the main body segment and the flexible segment to reach the metal head to perform cryoablation of the site of action; after cryoablation, the cryoprotectant is discharged sequentially through the cavities inside the metal head, the flexible segment, and the main body segment; the electrode is also used to generate a high-voltage pulsed electric field at the end of cryoablation to perform pulsed ablation of the site of action.

[0009] Optionally, all electrodes are ring electrodes; the multiple ring electrodes are uniformly sleeved on the annular portion of the flexible segment.

[0010] Optionally, the electrode acquires electrical signals before and after ablation of the target site to perform electrical signal mapping at the target site.

[0011] Optionally, a pressure sensor is also provided in the annular portion of the flexible segment; the pressure sensor is used to monitor the pressure inside the annular portion in real time.

[0012] Optionally, a temperature sensor is also provided in the annular portion of the flexible segment; the temperature sensor is used to monitor the temperature of the annular portion in real time during the ablation process, so as to control the flow rate of the refrigerant in the cavity of the main segment and the flexible segment according to the temperature of the annular portion.

[0013] Optionally, the cavities inside the main body segment are: an input pipe, an output pipe, a wire pipe, and a main cavity; the cavities inside the flexible segment and the metal head correspond one-to-one with the cavities inside the main body segment; the input pipe and the output pipe are connected inside the metal head;

[0014] The input pipe is the input channel for the refrigerant, and the output pipe is the return channel for the refrigerant; the wire pipe is provided with wires connected to each ring electrode.

[0015] Optionally, a heat insulation layer is provided on the outside of the input pipe, output pipe, wire pipe and main cavity inside the main body section, the flexible section and the metal head.

[0016] Optionally, the main body segment, the flexible segment, and the metal head each contain multiple input pipes, output pipes, and wire pipes; the multiple input pipes, multiple output pipes, and multiple wire pipes are evenly distributed around the main cavity.

[0017] Optionally, a metal wire is provided in the main cavity of the flexible segment to fix the shape of the flexible segment during the ablation process.

[0018] Optionally, the metal head includes a metal body and a metal round head; one end of the metal body is fixedly connected to the flexible segment, and the other end of the metal body is fixedly connected to the metal round head; the cavities inside the metal body correspond one-to-one with the cavities inside the flexible segment; the input pipe and the output pipe are connected inside the metal round head.

[0019] According to specific embodiments provided by the present invention, the following technical effects are disclosed: The present invention combines cryoablation and pulse ablation. The ice layer formed on the frozen surface can effectively prevent the formation of bubbles due to electrolysis during the pulse process, and reduce or even eliminate the musculoskeletal contraction caused by the current generated by pulse ablation, thereby improving the safety and efficiency of ablation. Furthermore, it can perform real-time electrical signal mapping at the treatment site. Multiple cavities are designed inside the main body, flexible section, and metal head, allowing the cryoprotectant to converge inside the metal head, improving the freezing and rewarming speed of cryoablation, and further enhancing ablation efficiency. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the dual-energy annular ablation catheter with cryotherapy and pulse technology provided by the present invention.

[0022] Figure 2 This is a schematic diagram of the internal structure of the main body section.

[0023] Figure 3 This is a schematic diagram of the junction between the main body section and the flexible section.

[0024] Figure 4 This is a schematic diagram of the cross-section of the flexible segment.

[0025] Figure 5 This is a schematic diagram of the main structure of the flexible segment.

[0026] Figure 6 This is a schematic diagram of the metal head structure.

[0027] Figure 7 This is a schematic diagram showing the junction between the flexible section and the metal head.

[0028] Symbol explanation: 1-Main body section, 2-Flexible section, 3-Metal head, 4-Ring electrode, 5-Input pipe, 6-Output pipe, 7-Wire pipe, 8-Main cavity, 9-Wire, 10-Insulation layer, 11-Outer tube, 12-Inner tube. Detailed Implementation

[0029] 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.

[0030] The purpose of this invention is to provide a dual-energy ring ablation catheter with cryoablation and pulse ablation capabilities for the treatment of atrial fibrillation. By combining ring cryoablation with pulse ablation catheter, the ablation of tissue at the target site can be achieved, thereby improving the mapping effect of atrial disease ablation and the safety of the surgical procedure.

[0031] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0032] like Figure 1 As shown, the dual-energy annular ablation catheter with cryotherapy and pulse provided by the present invention includes: a main body segment 1, a flexible segment 2, a metal head 3, and multiple electrodes.

[0033] One end of the flexible segment 2 is fixedly connected to the main body segment 1. Specifically, the junction between the flexible segment 2 and the main body segment 1 is fixedly bonded with adhesive. The other end of the flexible segment 2 is a ring-shaped portion. That is, the distal end of the dual-energy ring ablation catheter is a ring. The ring shape can be used for pulmonary vein vestibule ablation, left atrial posterior wall ablation, left atrial roof line ablation, and left atrial basal line ablation, thereby improving the success rate of paroxysmal atrial fibrillation ablation and persistent atrial fibrillation treatment.

[0034] The main body segment 1 can also be connected to a handle to control the ablation process.

[0035] Multiple electrodes are disposed in the annular portion of the flexible segment 2. The metal head 3 is fixedly connected to the annular portion of the flexible segment 2.

[0036] In this embodiment, multiple electrodes are all ring electrodes 4. These ring electrodes 4 are uniformly disposed within the annular portion of the flexible segment 2, enabling pulse ablation and the acquisition and transmission of electrical signals at this location.

[0037] The main body segment 1, the flexible segment 2, and the metal head 3 each have multiple cavities inside.

[0038] Specifically, such as Figure 2As shown, the cavities inside the main body segment 1 are: input pipe 5, output pipe 6, wire pipe 7, and main cavity 8. The outermost layer of the main body segment 1 is the outer tube 11, and the inner tube 12 is between the main cavity 8 and the input pipe 5, output pipe 6, and wire pipe 7. The cavities inside the flexible segment 2 and the metal head 3 correspond one-to-one with the cavities inside the main body segment 1. The input pipe 5, output pipe 6, and wire pipe 7 extending from the main body segment 1 are placed into the flexible segment 2, and the joints are fixed and bonded with glue, as shown. Figure 3 As shown. The input pipe 5 and the output pipe 6 are connected inside the metal head 3.

[0039] The input pipe 5 is the refrigerant input channel, and the output pipe 6 is the refrigerant return channel. The wire conduit 7 contains wires 9 connected to each ring electrode 4.

[0040] A heat insulation layer 10 is provided on the outside of the input pipe 5, output pipe 6, wire pipe 7 and main cavity 8 inside the main body section 1, the flexible section 2 and the metal head 3.

[0041] In one specific implementation, the main body segment 1, the flexible segment 2, and the metal head 3 each contain multiple input pipes 5, output pipes 6, and wire pipes 7. These multiple input pipes 5, multiple output pipes 6, and multiple wire pipes are evenly distributed around the main cavity 8.

[0042] The cross-section of flexible segment 2 is as follows Figure 4 As shown, its main structure is as follows Figure 5 As shown. Each cavity is mainly used to connect with the main body segment 1.

[0043] The flexible segment 2 is made of a low-temperature resistant material and is quite flexible, while its shape must not deform during the ablation process. Therefore, a metal wire of the same shape is installed inside the main cavity of the flexible segment 2 to keep the shape of the flexible segment 2 fixed during the ablation process.

[0044] In this embodiment, as Figure 6 As shown, the metal head 3 includes a metal body and a metal round head. One end of the metal body is fixedly connected to the flexible segment 2, and the other end of the metal body is fixedly connected to the metal round head, as shown. Figure 7 As shown. Specifically, the metal body and the flexible segment 2 are bonded and fixed with adhesive, and the rear end face of the metal round head is welded to the correct position of the pipe connection in the metal body. The cavities inside the metal body correspond one-to-one with the cavities inside the flexible segment 2. The input pipe 5 and the output pipe 6 are connected inside the metal round head.

[0045] The electrode is used to map electrical signals at the site of action. Specifically, the electrode acquires electrical signals before and after ablation of the site of action to map the electrical signals at the site of action.

[0046] During ablation of the target area, the cryoprotectant sequentially flows through the cavities inside the main body segment 1 and the flexible segment 2 to the metal head 3 to perform cryoablation on the target area. After cryoablation, the cryoprotectant is discharged sequentially through the cavities inside the metal head 3, the flexible segment 2, and the main body segment 1. The electrode is also used to generate a high-voltage pulsed electric field at the end of cryoablation to perform pulsed ablation on the target area.

[0047] Specifically, the dual-energy annular ablation catheter with cryotherapy and pulsed stimulation provided by this invention can be used for ablation in the following three modes:

[0048] (1) Cryoablation only: The refrigerant reaches the flexible section 2 through the input pipe 5 inside the main body section 1, and finally reaches the metal head 3. During the rewarming stage, the input pipe 5 near the main body section 1 is closed, and no more refrigerant is input. At the same time, the output pipe 6 is opened, and the refrigerant is output through the output pipe 6, and the conduit reaches the required temperature. During the cryoablation process, the temperature and pressure at the corresponding locations are detected in real time by temperature sensors and pressure sensors.

[0049] (2) Pulse ablation only: High voltage pulse electricity reaches the ring electrode 4 through the wire 9, and then generates a high voltage pulse electric field.

[0050] (3) Cryoablation combined with pulse ablation: In mode (1), pulse ablation in mode (2) is performed when the cryoablation process is about to be completed.

[0051] This invention combines cryoablation and pulsed ablation during the ablation process. The ice layer formed on the frozen surface effectively prevents the formation of bubbles due to electrolysis during pulsed ablation, and reduces or even eliminates musculoskeletal contractions caused by the current generated during pulsed ablation. In any heterogeneous tissue, cryoablation can create deeper lesions.

[0052] Furthermore, a pressure sensor is also provided in the annular portion of the flexible segment 2. The pressure sensor is used to monitor the pressure inside the annular portion in real time.

[0053] A temperature sensor is also provided in the annular portion of the flexible segment 2. The temperature sensor is used to monitor the temperature of the annular portion in real time during the ablation process, so as to control the flow rate of cryotherapy in the cavity of the main segment 1 and the flexible segment 2 according to the temperature of the annular portion, thereby improving the efficiency of cryoablation and the safety of the operation.

[0054] The dual-energy loop ablation catheter with cryoablation and pulsed ablation capabilities provided by this invention, in practical use, reaches the left atrium through an adjustable curved sheath, and then maps the electrical signals of the four pulmonary veins. After mapping, ablation begins: first, cryoablation is performed, with the distal end of the dual-energy loop ablation catheter rapidly cooled to the required temperature. The specific freezing time is determined by the operator, but should not be too long. Pulsed ablation is then performed near the end of cryoablation, followed by rewarming of the dual-energy loop ablation catheter. After rewarming, electrical signal mapping is performed on the ablation area to confirm the ablation status. In addition to the four pulmonary vein orifices, the posterior wall of the left atrium, the top line of the left atrium, and the bottom line can be selected for ablation depending on the actual situation. The ablation strategy is similar to that of pulmonary vein ablation. During actual ablation, cryoablation or pulsed ablation can be selected alone, or a combination of both can be used. Finally, after all ablation is completed, all catheters are withdrawn.

[0055] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0056] (1) The present invention can realize the functions of cryoablation and pulse ablation, and at the same time realize the real-time monitoring of temperature and pressure and the mapping function of electrical signals, and can be used for the treatment of paroxysmal, persistent and long-term persistent atrial fibrillation.

[0057] (2) The present invention has designed a refrigerant input pipe 5 and an output pipe 6 inside the main body section 1, the flexible section 2 and the metal head 3. The refrigerant is gathered inside the low-temperature resistant metal head 3, which can realize rapid rewarming after freezing.

[0058] (3) The present invention designs multiple cavities inside the main body section 1, the flexible section 2 and the metal head 3, and opens small holes in the pipe wall at designated locations. The small holes are connected to the channels to realize the entry and exit of gas.

[0059] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0060] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention. Furthermore, those skilled in the art will recognize that, based on the ideas of the present invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A dual-energy annular ablation catheter with both cryotherapy and pulsed ablation capabilities, characterized in that, The dual-energy annular ablation catheter with cryotherapy and pulsed ablation functions includes: a main body segment, a flexible segment, a metal head, and multiple electrodes; One end of the flexible segment is fixedly connected to the main body segment; the other end of the flexible segment is an annular portion; multiple electrodes are disposed in the annular portion of the flexible segment; the metal head is fixedly connected to the annular portion of the flexible segment. The main body segment, the flexible segment, and the metal head all have multiple cavities inside; The cavities inside the main body section are: an input pipe, an output pipe, a wire pipe, and a main cavity; the cavities inside the flexible section and the metal head correspond one-to-one with the cavities inside the main body section; the input pipe and the output pipe are connected inside the metal head; the input pipe is the input channel for the refrigerant, and the output pipe is the return channel for the refrigerant; the wire pipe contains wires connected to each ring electrode; the input pipe, output pipe, wire pipe, and main cavity inside the main body section, the flexible section, and the metal head are all provided with a heat insulation layer; the main cavity of the flexible section contains a metal wire to fix the shape of the flexible section during the ablation process; The metal head includes a metal body and a metal round head; one end of the metal body is fixedly connected to the flexible segment, and the other end of the metal body is fixedly connected to the metal round head; the cavities inside the metal body correspond one-to-one with the cavities inside the flexible segment; the input pipe and the output pipe are connected inside the metal round head. The electrode is used to map electrical signals at the site of action; during ablation of the site of action, the cryoprotectant sequentially passes through the cavities inside the main body segment and the flexible segment to reach the metal head to perform cryoablation of the site of action; after cryoablation, the cryoprotectant is discharged sequentially through the cavities inside the metal head, the flexible segment, and the main body segment; the electrode is also used to generate a high-voltage pulsed electric field at the end of cryoablation to perform pulsed ablation of the site of action; The dual-energy loop ablation catheter with cryotherapy and pulsed ablation functions is used in the following three modes for ablation: Cryoablation only: The refrigerant reaches the flexible section through the input pipe inside the main body section, and finally reaches the metal head; during the rewarming stage, the input pipe near the main body section is closed, and no more refrigerant is input, while the output pipe is opened at the same time, and the refrigerant is output through the output pipe, and the conduit reaches the required temperature; Pulse ablation only: High-voltage pulsed electricity reaches the electrodes through the wires, and then a high-voltage pulsed electric field is generated; Cryoablation combined with pulse ablation: In cryoablation-only mode, pulse ablation is performed when the cryoablation process is about to be completed.

2. The dual-energy annular ablation catheter with cryotherapy and pulsed ablation as described in claim 1, characterized in that, Multiple electrodes are all ring electrodes; multiple ring electrodes are uniformly sleeved on the ring-shaped part of the flexible segment.

3. The dual-energy annular ablation catheter with cryotherapy and pulsed ablation as described in claim 1, characterized in that, The electrode acquires electrical signals before and after ablation of the target site to perform electrical signal mapping at the target site.

4. The dual-energy annular ablation catheter with cryotherapy and pulsed ablation as described in claim 1, characterized in that, The annular portion of the flexible section is also equipped with a pressure sensor; the pressure sensor is used to monitor the pressure inside the annular portion in real time.

5. The dual-energy annular ablation catheter with cryotherapy and pulsed ablation as described in claim 1, characterized in that, The annular portion of the flexible segment is also equipped with a temperature sensor; the temperature sensor is used to monitor the temperature of the annular portion in real time during the ablation process, so as to control the flow rate of the refrigerant in the cavity of the main segment and the flexible segment according to the temperature of the annular portion.

6. The dual-energy annular ablation catheter with cryotherapy and pulsed ablation according to claim 1, characterized in that, The main body section, the flexible section, and the metal head each contain multiple input pipes, output pipes, and wire pipes; these multiple input pipes, multiple output pipes, and multiple wire pipes are evenly distributed around the main cavity.

Images