A cardiac pulse electric field ablation catheter device

Abstract

A cardiac pulse electric field ablation catheter device comprises an operating handle, a bending adjustment component, a guide wire channel component and an ablation component. The ablation component comprises a wire and a plurality of pulse electrodes. At least one annular region can be formed after the ablation component is released. The pulse electrodes are arranged at positions that can be evenly spaced in the annular region. The region where the pulse electrodes can generate an electric field is a working region. The working region of each pulse electrode is arranged at a position where the annular region contacts the target ablation tissue. The pulse electrodes used for transmitting the pulse electric field mainly contact the target ablation region tissue, and the electrode area in contact with the target ablation tissue is not less than the electrode area in contact with the non-target ablation region. The pulse electric field generated by the electrode mainly acts on the target ablation region tissue, rather than on non-target ablation regions such as blood, thereby reducing damage to tissue cells and reducing related complications.

Description

Technical Field

[0001] The present invention relates to the technical field of tissue ablation equipment, and in particular to a cardiac pulse electric field ablation catheter device. Background Art

[0002] Atrial fibrillation (AF) is the most common arrhythmia, with an incidence of about 2%, and its incidence gradually increases with age. The most serious complication of AF is thromboembolism, which can lead to stroke, myocardial infarction, etc. Among them, stroke is the most common complication of death from AF.

[0003] There are two major methods for treating atrial fibrillation, namely drug therapy and non-drug therapy. According to the "Atrial Fibrillation: Current Understanding and Treatment Recommendations-2015" published by the Chinese Medical Association's Electrophysiology and Pacing Branch, the current drug treatment for atrial fibrillation mainly includes: controlling ventricular rate, restoring and maintaining sinus rhythm, and antithrombotic therapy. Drug therapy includes antiarrhythmic therapy and anticoagulant therapy. The purpose of antiarrhythmic therapy is to prevent the occurrence of atrial fibrillation, control the rapid heart rate during atrial fibrillation, and eliminate atrial fibrillation and maintain sinus rhythm. Commonly used drugs include quinidine, digoxin, betaloc, and cordarone. The purpose of anticoagulant therapy is to prevent the formation of mural thrombi in the atrium and to prevent the detachment of mural thrombi in the atrium from causing embolism of other organ columns, especially cerebral embolism. The commonly used drug is warfarin.

[0004] Non-drug treatments for atrial fibrillation include ablation therapy, surgical treatment and pacing therapy, etc., which are suitable for patients whose atrial fibrillation does not respond well to drug treatment or are not suitable for drug treatment. Successful ablation therapy and surgical treatment can cure atrial fibrillation.

[0005] At present, catheter ablation is an effective means to restore and maintain sinus rhythm in patients with atrial fibrillation. Catheter ablation mainly uses radiofrequency energy, but there are also other energy sources (including cryoablation, ultrasound, and laser ablation, etc.). However, these ablations based on heat / cold energy conduction have certain limitations. They lack selectivity in destroying tissues in the ablation area and rely on the adhesion force of the catheter to the ablated tissue, so they may cause damage to the adjacent esophagus, coronary arteries, and phrenic nerves. This leads to certain complications during the perioperative period, and some patients will relapse due to reasons such as the catheter adhesion effect and the depth of the lesion. It is reported that the recurrence rate of radiofrequency ablation is 20-40%, and the recurrence rate of cryoablation is 10-30%;

[0006] In recent years, both at home and abroad, the application of pulsed electric field ablation in the field of cardiac ablation has been explored, and promising results have been achieved. Unlike traditional energy, pulsed electric field energy forms irreversible micropores on the cell membrane through instantaneous discharge, causing cell apoptosis and achieving the purpose of non-thermal ablation, which is also called irreversible electroporation. At present, electroporation ablation has been used as an effective means to destroy malignant tumor tissue. In theory, pulsed electric field ablation can damage myocardial cells without heating the tissue, and has cell / tissue selectivity, protecting key structures around the ablated tissue.

[0007] The principle of pulse ablation is that a short DC high-voltage pulse can form an electric field of several hundred volts within a few centimeters. This electric field can damage the cell membrane and form perforations. If the electric field formed at the cell membrane is greater than the threshold, the electroporation formed is irreversible and the pores remain open. This leads to cell necrosis or apoptosis. Therefore, pulse ablation is a non-thermal biological ablation, which is different from radiofrequency, cryotherapy, microwave, and ultrasound. It can effectively avoid damage to blood vessels, nerves, and esophagus.

[0008] Judging from the existing clinical results and literature reports, pulse ablation has not yet solved the problem of the electric field interference caused by the high-voltage electric field applied to the ablated tissue to the surrounding nerves and other cells. Although the patient will be given general anesthesia during the operation, the patient will still feel pain. In addition, different electric fields need to be applied to different tissues during electric field ablation, and tissue changes during the ablation process also require dynamic adjustment of the electric field energy. At the same time, relevant literature studies have shown that during pulse electric field ablation, the blood in the atrioventricular cavity of the heart has a lower resistance than the myocardial tissue, which leads to a significant increase in the current density in the blood near the catheter. Electrolysis of the blood may cause microbubbles in the blood. This may increase the patient's risk of stroke.

[0009] Therefore, in order to reduce damage to tissue cells and reduce related complications, a new ablation catheter product design is needed that can accurately and effectively control the application of the pulsed electric field to the target myocardial tissue that needs to be ablated. Summary of the invention

[0010] In view of the shortcomings and defects of the prior art, a cardiac pulsed electric field ablation catheter device is provided, the main purpose of which is to make the pulsed electric field generated by the electrode act mainly on the target ablation area tissue, reduce damage to tissue cells and reduce related complications.

[0011] To achieve the above objectives, the present invention provides the following technical solutions.

[0012] A cardiac pulse electric field ablation catheter device comprises an operating handle, a bending adjustment component, a guide wire channel component and an ablation component, wherein the ablation component comprises a wire and a plurality of pulse electrodes connected to the wire, and the ablation component is an ablation component that can form at least one annular area after release, and the pulse electrodes are arranged at positions that can be evenly spaced in the annular area, and the area where the pulse electrodes can generate an electric field is a working area, and the working area of ​​each pulse electrode is arranged at a position where the annular area contacts the target ablation tissue.

[0013] In one embodiment, the ablation component includes at least one wire, each of which is bent into a circular ring after release, and each wire is coaxially arranged. The wire is tubular and is loaded with the pulse electrodes at uniform intervals. Each ring segment of the wire loaded with the pulse electrode is a loading area, and the plurality of pulse electrodes are distributed at intervals along the axial direction of the wire, and the working area of ​​each pulse electrode is smaller than the surface area of ​​the loading area.

[0014] In one of the embodiments, the wires are arranged in the same plane and in the same axis after being released.

[0015] In one embodiment, the circular rings formed by the respective wires after release are arranged in different planes, and from the distal end to the proximal end, the diameter of the circular ring formed by the wires is not greater than the diameter of the circular ring formed by the adjacent wires.

[0016] In one embodiment, the pulse electrode is in a semicircular ring shape and is mounted on the surface of the wire. The curvature of the pulse electrode is less than 2π.

[0017] In one embodiment, the pulse electrode is mounted on the surface of the wire in a circular ring shape, the pulse electrode includes the working area and the non-working area, the surface of the pulse electrode in the non-working area is covered with an insulating layer, and the area of ​​the working area is smaller than that of the non-working area.

[0018] In one embodiment, the pulse electrode is provided in a dot-shaped protrusion on the surface of the wire.

[0019] In one of the embodiments, the loading area is provided with a circular reinforcing tube, and the pulse electrode is protrudingly provided on the surface of the reinforcing tube.

[0020] In one embodiment, the ablation assembly includes an insulating balloon and a plurality of wires, and the pulse electrode is a sheet-shaped pulse electrode, which is arranged at positions evenly spaced and distributed in a circle along the surface of the balloon after the balloon is released.

[0021] In one of the embodiments, the number of pulse electrodes in a circle is not less than two, and the number of pulse electrodes distributed in each circle is not less than two.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows: the ablation component of the present invention, the pulse electrode for transmitting the pulse electric field, mainly contacts the target ablation area tissue, and the electrode area in contact with the target ablation tissue is not less than the electrode area in contact with the non-target ablation area; the pulse electric field generated by the electrode mainly acts on the target ablation area tissue, rather than on non-target ablation areas such as blood, thereby reducing damage to tissue cells and reducing related complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a schematic diagram of the structure of an ablation component of a cardiac pulse electric field ablation catheter device in one embodiment;

[0024] Figure 2 It is a schematic diagram of the structure of an ablation component of a cardiac pulse electric field ablation catheter device in another embodiment;

[0025] Figure 3 It is a schematic structural diagram of an ablation component of a cardiac pulse electric field ablation catheter device in yet another embodiment;

[0026] Figure 4 A schematic diagram of a pulse electrode structure of a cardiac pulse electric field ablation catheter device in one embodiment

[0027] Figure 5 It is a schematic diagram of the pulse electrode structure of a cardiac pulse electric field ablation catheter device in another embodiment;

[0028] Figure 6 It is a schematic diagram of the pulse electrode structure of a cardiac pulse electric field ablation catheter device in yet another embodiment. DETAILED DESCRIPTION

[0029] The technical solution of the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0030] like Figure 1 , 2 As shown in or 3, a cardiac pulse electric field ablation catheter device includes an operating handle, a bending adjustment component, a guide wire channel component and an ablation component, the ablation component includes a wire 10 and a plurality of pulse electrodes 20 connected to the wire 10, the ablation component is an ablation component that can form at least one annular area after release, the pulse electrodes 20 are arranged at positions that can be evenly spaced and distributed in the annular area, the area where the pulse electrodes 20 can generate an electric field is the working area, and the working area of ​​each pulse electrode is arranged at the position where the annular area contacts the target ablation tissue. Wherein, the release is defined as the process of the ablation component entering the working state after vascular puncture.

[0031] The ablation component, which is used to transmit the pulse electrode 20 of the pulse electric field, mainly contacts the target ablation area tissue, and the electrode area in contact with the target ablation tissue is not less than the electrode area in contact with the non-target ablation area; the pulse electric field generated by the electrode mainly acts on the target ablation area tissue, rather than on non-target ablation areas such as blood, thereby reducing damage to tissue cells and reducing related complications.

[0032] like Figure 1 As shown, in one embodiment, the ablation component includes at least one wire 10, each wire 10 is bent into a circular ring, and the wires 10 are coaxially arranged. The wire 10 is tubular and used to load the pulse electrode 20, and each circular ring segment loaded with the pulse electrode 20 is a loading area; the plurality of pulse electrodes 20 are distributed axially at intervals along the wire 10, and the working area of ​​each pulse electrode 20 is smaller than the surface area of ​​the loading area.

[0033] In this embodiment, the circular rings formed by the wires 10 are arranged in different planes, and the diameter of the circular rings formed by the wires 10 from the distal end to the proximal end is not greater than the diameter of the circular rings formed by the adjacent wires 10. The proximal end and the distal end are defined as the distance between the object described and the operator during the catheter surgery, such as the proximal end refers to the end of the catheter closer to the operator, that is, the end closer to the vascular puncture site. The distal end is the end of the catheter farther from the operator, that is, the end away from the vascular puncture site.

[0034] In such Figure 2 In one embodiment shown, the wires 10 are arranged coaxially in the same plane.

[0035] like Figure 4 In one embodiment, the pulse electrode 20a is in a semicircular shape and is attached to the surface of the guide wire 10. The curvature of the pulse electrode 20a is less than 2π. In this way, the missing curvature portion of the pulse electrode 20a does not contact the target ablation tissue, while the remaining curvature portion of the electrode contacts the target ablation tissue. The shape of the pulse electrode 20a can be a semicircular electrode, or other shapes such as a crescent.

[0036] like Figure 5 As shown, in another embodiment, the pulse electrode 20b is mounted on the surface of the wire 10 in a circular ring shape, and the pulse electrode 20b includes the working area and the non-working area. The surface of the pulse electrode 20b in the non-working area is covered with an insulating layer 21, and the area of ​​the working area is smaller than that of the non-working area.

[0037] That is to say, in this embodiment, by insulating part of the surface of the annular pulse electrode 20b, the insulating part of the pulse electrode 20b does not contact the target ablation tissue, and the non-insulating part of the pulse electrode 20b contacts the target ablation tissue, so that the area of ​​the pulse electrode 20b in contact with the tissue to be ablated is not less than the area of ​​the pulse electrode 20b in contact with the blood. For example, a layer of insulating material is added to the position where the pulse electrode 20b needs to be insulated by coating, etc. There are many ways to insulate the pulse electrode 20b, including but not limited to coating a layer of insulating material with good biocompatibility, such as polyester, phenolic resin, melamine resin, epoxy resin, polyimide resin, silicone, organic fluorine resin, ceramics, etc.

[0038] like Figure 6 As shown, in yet another embodiment, the pulse electrode 20c is protruded in a dot shape on the surface of the wire 10.

[0039] In one embodiment, the loading area is provided with a circular reinforcing tube 30, and the pulse electrode 20c is protruded from the surface of the reinforcing tube 30.

[0040] That is to say, in this embodiment, the shape of the pulse electrode 20c can also be a point-shaped or convex electrode, so that the pulse electrode 20c only contacts the target ablation tissue. In order to improve the bonding strength between the pulse electrode 20c and the wire 10, a layer of reinforcing tube 30 can be filled between the wire 10 and the pulse electrode 20c to make the bonding between the wire 10 and the electrode more firm.

[0041] like Figure 3 As shown, in one embodiment, the ablation component includes an insulating balloon 30 and a plurality of wires 10, and the pulse electrode 20 is a sheet-like pulse electrode, which is arranged at a position evenly spaced and distributed in a circle along the surface of the balloon 30 after the balloon 30 is released.

[0042] In this embodiment, the ablation assembly is formed by a balloon 30 and a plurality of pulse electrodes 20, and the pulse electrodes 20 can be designed as sheet electrodes, flexible electrodes, etc. One side of the pulse electrode 20 contacts the target ablation tissue, such as the pulmonary vein vestibule, and the other side contacts the surface of the balloon 30. The balloon 30 used in the present invention can be made of a polymer material with insulating properties such as Pebax, PA, TPU, etc. The electric field generated by the pulse electrode 20 is mainly transmitted in the target ablation tissue, and will not be transmitted in the balloon 30.

[0043] Further, the number of pulse electrodes 20 on the above-mentioned balloon 30 is not less than 4, and the arrangement of the pulse electrodes 20 on the surface of the balloon 3054 is not less than two circles, and the number of pulse electrodes 20 in each circle is not less than 2. The number of circles of the pulse electrodes 20 can be defined as the number of circles in which the pulse electrodes 20 are arranged in the circumferential direction of the surface of the balloon 30 to form a circle. Specifically, the pulse electrodes 20 in each circle should be evenly distributed on the circumferential surface of the balloon 30, and the number of pulse electrodes 20 in each circle is preferably 3 to 6. According to the number of pulse electrodes 20 in each circle, the corresponding number of wings of the balloon 30 is selected for folding, and the number of wings of the folded balloon 30 is equal to the number of pulse electrodes 20 in each circle. If the number of pulse electrodes 20 in each circle is 3, the balloon 30 is folded with three wings; if the number of pulse electrodes 20 in each circle is 6, the balloon 30 is folded with six wings, so that after the balloon 30 is expanded, the pulse electrodes 20 can be evenly distributed on the surface of the balloon 30.

[0044] Furthermore, the corresponding electric field ablation parameters can be selected for ablation according to the spacing of the pulse electrodes 20 on the surface of the balloon 30. Figure 3 The distance between the pulse electrode 203 and the pulse electrode 206 shown in the figure will further increase with the expansion of the balloon 30. Therefore, the parameters of the electric field ablation can be designed to be adjusted according to the compliance of the expansion of the balloon 30 to maintain the pulse electric field intensity emitted by the pulse electrode 20 on the surface of the balloon 30 without a significant decrease with the expansion of the balloon 30. Specifically, the voltage of the pulse electric field ablation can be gradually increased as the pressure of the balloon 30 expands and the distance between the circumferential pulse electrodes 20 on the surface of the balloon 30 increases.

[0045] Furthermore, the direction of the electric field of the electric field ablation can be adjusted according to the distribution of the pulse electrodes 20 on the surface of the balloon 30, so as to achieve electric field ablation in different directions, such as making the electric field along the circumference of the pulmonary vein (such as Figure 3 The pulse electrode 203 and the pulse electrode 206 shown in the figure form a pair of electric fields), or the electric field is along the axial direction of the pulmonary vein (such as the pulse electrode 202 and the pulse electrode 203 form a pair of electric fields), and the ablation direction that makes the electric field form a certain angle with the axial direction of the pulmonary vein (such as the pulse electrode 202 and the pulse electrode 206 form a pair of electric fields). Different ablation directions help increase the probability of cell membranes being electroporated in multiple directions; because electroporation is most likely to occur in the radial direction of the cell membrane that is consistent with the direction of the electric field.

[0046] Furthermore, the above-mentioned ablation parameters can be formed into ablation parameters corresponding to the specifications of the balloon 30 according to the specifications of the balloon 30. Specifically, the distance between the two pulse electrodes 20 forming the electric field on the surface of the balloon 30 is proportional to the amplitude of the pulse voltage applied to the two pulse electrodes 20, that is, when the distance between the pulse electrodes 20 forming the electric field changes, the amplitude of the pulse voltage forming the electric field changes accordingly. This makes the pulse voltage amplitude per unit distance maintain an approximate level.

[0047] The above description is only a preferred embodiment of the present invention, so all equivalent changes or modifications made according to the structure, characteristics and principles described in the scope of the patent application of the present invention are included in the scope of the patent application of the present invention.

Claims

1. A cardiac pulse electric field ablation catheter device, comprising an operating handle, a bending adjustment component, a guide wire channel component and an ablation component, characterized in that: The ablation component includes a wire and a plurality of pulse electrodes connected to the wire. The ablation component is an ablation component that can form a plurality of annular areas after being released. The pulse electrodes are arranged at positions that can be evenly spaced in the annular areas. The area where the pulse electrodes can generate electric fields is the working area. The working area of ​​each pulse electrode is arranged at a position where the annular area contacts the target ablation tissue. The pulse electrode includes the working area and the non-working area. The surface of the pulse electrode in the non-working area is covered with an insulating layer. The area of ​​the working area is smaller than that of the non-working area. The pulse electrode of the ablation component for transmitting the pulse electric field mainly contacts the target ablation area tissue. The electrode area in contact with the target ablation tissue is not less than the electrode area in contact with the non-target ablation area. The pulse electric field generated by the electrode mainly acts on the target ablation area tissue. The ablation component includes multiple wires, each of which is bent into a circular ring after release. The wires are coaxially arranged, and the wires are tubular. The pulse electrodes are evenly loaded with the wires. Each ring segment of the wire loaded with the pulse electrodes is a loading area. The multiple pulse electrodes are distributed at intervals along the axial direction of the wire, and the working area of ​​each pulse electrode is smaller than the surface area of ​​the loading area.

2. A cardiac pulsed electric field ablation catheter device according to claim 1, characterized in that: The wires are arranged coaxially in the same plane after being released.

3. A cardiac pulsed electric field ablation catheter device according to claim 1, characterized in that: The circular rings formed by the wires after release are arranged in different planes, and from the distal end to the proximal end, the diameter of the circular rings formed by the wires is not greater than the diameter of the circular rings formed by the adjacent wires.

4. A cardiac pulse electric field ablation catheter device according to any one of claims 1 to 3, characterized in that: The pulse electrode is in a semicircular ring shape and is mounted on the surface of the wire. The curvature of the pulse electrode is less than 2π.

5. A cardiac pulse electric field ablation catheter device according to any one of claims 1 to 3, characterized in that: The pulse electrode is annularly sleeved and mounted on the surface of the lead.

6. A cardiac pulse electric field ablation catheter device according to any one of claims 1 to 3, characterized in that: The pulse electrode is arranged in a dot-shaped protrusion on the surface of the wire.

7. A cardiac pulse electric field ablation catheter device according to claim 6, characterized in that: The loading area is sleeved with a circular reinforcing tube, and the pulse electrode is convexly arranged on the surface of the reinforcing tube.

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