Electrode, Electrophysiological Catheter and Ablation System

Abstract

The electrode provided by the present invention is used to be arranged at the distal end of a catheter. The electrode includes an electrode proximal portion, an electrode main portion and an electrode distal portion connected in sequence from the proximal end to the distal end. The electrode main portion includes a first section and a second section connected along the axial direction of the catheter; at least one of the electrode proximal portion and the electrode distal portion is used to be movably connected to the catheter; the electrode main portion is configured to switch between a contracted form and a folded form as the electrode proximal portion and the electrode distal portion move relative to each other along the catheter; when the electrode main portion is in the folded form, the electrode main portion expands outwardly along the radial direction of the catheter, so that the first section and the second section are inclined toward each other, forming a dislocated arrangement along the transverse direction of the catheter. By configuring the electrode main portion in the folded form as above, it is possible to avoid the electrode torsional dislocation affecting the contact area between the electrode main portion and the predetermined portion; the contact area between the electrode main portion and the predetermined portion can be increased, the electric field around the predetermined portion can be improved, and the ablation effect can be enhanced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an electrode, an electrophysiological catheter and an ablation system. Background Art

[0002] In the field of electrophysiological treatment, it is a common means to use an electrophysiological catheter to transmit energy for tissue ablation. Specifically, the electrophysiological catheter includes a catheter and an electrode disposed at the head end of the catheter. After inserting the head end of the catheter into the target site to be treated, energy is supplied to the electrode through an energy supply platform, and the electrode is brought into contact with the target site to transfer the energy to the target site, thereby performing ablation. Among them, the commonly used energy is the pulsed electric field of irreversible electroporation, which has cell selectivity and can effectively avoid damage to the esophagus and phrenic nerve, especially during pulmonary vein isolation ablation.

[0003] Commonly, the electrophysiological catheter using pulsed electric field ablation is the Farawave catheter of Farapulse Company. The Farawave catheter includes a traditional polymer material tube / ring electrode. After inserting the pushed head end of the catheter into the target site, the head end of the catheter is twisted to form a misaligned arrangement of the electrodes, so as to maximize the contact of the electrodes with the target site (such as the pulmonary vein). However, the traditional polymer tube / ring electrode structure occupies a large space, and the density of the electrodes is limited, affecting the effective ablation depth.

[0004] In addition, during pulmonary vein isolation ablation, an electrophysiological mapping catheter is often used, such as the INTELLAMAP ORION high-resolution mapping catheter of Boston Scientific Corporation. The mapping catheter uses electrodes disposed on a flexible circuit and can achieve high-density electrophysiological mapping. However, due to the poor anti-torsion performance of the flexible circuit, it is impossible to maximize the contact (maximize the contact area) of the electrodes with the pulmonary vein after the head end of the catheter is twisted, affecting the mapping accuracy. Moreover, the electrodes of the high-resolution mapping catheter are thin-layer electrodes formed by sputtering or electroplating, and cannot effectively contact the target site. Summary of the Invention

[0005] The present invention provides an electrode, an electrophysiological catheter and an ablation system. One of the purposes is to solve the problem in the prior art that the contact area between the electrode and the target site cannot be maximized after the electrode is twisted, thereby affecting the ablation effect; another purpose is to solve the problem in the prior art that the limited density of the electrodes used for twisting affects the ablation depth.

[0006] To solve the above technical problems, based on one aspect of the present invention, the present invention provides an electrode for setting the distal end of a catheter and for transmitting energy between a device and a predetermined site. The electrode includes an electrode proximal end portion, an electrode main body portion, and an electrode distal end portion that are sequentially connected from the proximal end to the distal end. The electrode main body portion includes a first section and a second section that are connected along the axial direction of the catheter; at least one of the electrode proximal end portion and the electrode distal end portion is configured to be movably connected to the catheter;

[0007] The electrode main body portion is configured to be convertible between a contracted form and a folded form as the electrode proximal end portion and the electrode distal end portion move relative to each other along the catheter; when the electrode main body portion is in the contracted form, the electrode main body portion abuts against the catheter radially inward along the catheter; when the electrode main body portion is in the folded form, the electrode main body portion expands radially outward along the catheter, causing the first section and the second section to incline towards each other, forming a staggered arrangement along the transverse direction of the catheter.

[0008] Optionally, the electrode main body portion further includes a folding section that is respectively connected to the first section and the second section. When the electrode main body portion is in the folded form, the first section and the second section are folded and staggered through the folding section.

[0009] Optionally, the folding section has a groove. When the electrode main body portion is in the folded form, the groove is used to accommodate the first section or the second section.

[0010] Optionally, the electrode main body portion is convertible between the contracted form and an intermediate form, and between the intermediate form and the folded form; when the electrode main body portion is in the intermediate form, the projection of the folding section on the catheter is between the electrode proximal end portion and the electrode distal end portion.

[0011] Optionally, when the electrode main body portion is in the contracted form and / or the intermediate form, the first section and the second section are staggered along the transverse direction of the catheter.

[0012] Optionally, the electrode further includes a proximal mounting portion and a distal mounting portion. The proximal mounting portion and the distal mounting portion are respectively parallel to the axial direction of the catheter. The electrode proximal end portion is configured to be connected to the catheter through the proximal mounting portion, and the electrode distal end portion is configured to be connected to the catheter through the distal mounting portion.

[0013] Optionally, at least one of the first section and the second section is arc-shaped or zigzag-shaped.

[0014] Optionally, both the first section and the second section are arc-shaped or zigzag-shaped, and the opening directions of the first section and the second section are opposite to each other in the transverse direction of the catheter.

[0015] Optionally, the electrode includes a substrate and sub-electrodes. Both the first section and the second section are disposed on the substrate, and the sub-electrodes are located on the first section and / or the second section.

[0016] Optionally, the electrode includes a plurality of the sub-electrodes. The plurality of sub-electrodes are spaced apart along the extending direction of the first section on the first section, and / or the plurality of sub-electrodes are spaced apart along the extending direction of the second section on the second section.

[0017] Optionally, the radial dimensions of at least some of the sub-electrodes are non-uniform.

[0018] Optionally, the radial dimension of the sub-electrode located in the middle of the first section is larger than that of the sub-electrodes towards both ends of the first section, and / or the radial dimension of the sub-electrode located in the middle of the second section is larger than that of the sub-electrodes towards both ends of the second section.

[0019] Optionally, the radial dimension of the sub-electrodes on the first section gradually decreases from the middle of the first section towards both ends; and / or the radial dimension of the sub-electrodes on the second section gradually decreases from the middle of the second section towards both ends.

[0020] Optionally, the sub-electrodes protrude from the surface of the substrate for abutting against a predetermined part.

[0021] Optionally, the electrode further includes a transmission line. The sub-electrodes are electrically connected to the transmission line; an insulating layer is provided on the transmission line for insulating the sub-electrodes from each other.

[0022] Optionally, the electrode further includes a transmission line. The sub-electrodes are electrically connected to the transmission line; the sub-electrodes have flanges, and the flanges are covered on the transmission line by a covering layer to limit the positions of the sub-electrodes on the transmission line.

[0023] Optionally, the substrate is filled with an elastic nickel alloy.

[0024] Optionally, the substrate is a strip-shaped member. Both the first section and the second section are provided with the sub-electrodes, and the sub-electrodes on the first section and the sub-electrodes on the second section are radially distributed on two sides of the substrate along the radial direction of the catheter.

[0025] Based on another aspect of the present invention, the present invention further provides an electrophysiological catheter, which includes a catheter and the electrode as described above, and at least one of the proximal electrode end and the distal electrode end of the electrode is movably connected to the catheter; the electrode body part of the electrode is converted between the contracted form and the folded form as the proximal electrode end and the distal electrode end move relative to each other along the catheter.

[0026] Optionally, the electrophysiological catheter includes a plurality of the electrodes, and the plurality of electrodes are arranged circumferentially along the catheter.

[0027] Optionally, the plurality of electrodes are arranged evenly in sequence along the circumferential direction of the catheter.

[0028] Optionally, the electrode includes a plurality of sub - electrodes, and the plurality of sub - electrodes are arranged at intervals along the axial direction of the catheter to form a sub - electrode group; when the electrode body part of the electrode is in the contracted form, the sub - electrode groups on two adjacent electrodes are arranged axially misaligned along the catheter.

[0029] Optionally, the catheter includes an outer tube and a stent shaft, and the stent shaft is movably disposed in the outer tube; the proximal electrode end of the electrode is disposed on the outer tube, and the distal electrode end of the electrode is disposed on the stent shaft.

[0030] Based on still another aspect of the present invention, the present invention further provides an ablation system, which includes the electrophysiological catheter as described above.

[0031] In summary, the electrode provided by the present invention is used to be disposed at the distal end of a catheter. The electrode includes a proximal electrode end, an electrode body part, and a distal electrode end that are connected in sequence from proximal to distal. The electrode body part includes a first section and a second section that are connected axially along the catheter; at least one of the proximal electrode end and the distal electrode end is used to be movably connected to the catheter; the electrode body part is configured to be converted between a contracted form and a folded form as the proximal electrode end and the distal electrode end move relative to each other along the catheter; when the electrode body part is in the contracted form, the electrode body part abuts against the catheter radially inward along the catheter; when the electrode body part is in the folded form, the electrode body part expands radially outward along the catheter, causing the first section and the second section to incline towards each other, forming a misaligned arrangement along the transverse direction of the catheter. By radially expanding the electrode body part to cause the first section and the second section to incline towards each other, thereby forming a misaligned arrangement of the first section and the second section, it is possible to avoid the influence of electrode torsion misalignment on the contact area between the electrode body part and the predetermined part; it is possible to increase the contact area between the electrode body part and the predetermined part, improve the electric field around the predetermined part, and enhance the ablation effect. Description of the Drawings

[0032] Those of ordinary skill in the art should understand that the provided drawings are for better understanding of the present invention and do not constitute any limitation to the scope of the present invention.

[0033] Figure 1 It is a schematic diagram of an electrode according to an embodiment of the present invention.

[0034] Figure 2 It is a schematic diagram of the electrode according to an embodiment of the present invention in a contracted form.

[0035] Figure 3 It is a schematic diagram of the electrode according to another embodiment of the present invention in a contracted form.

[0036] Figure 4 is Figure 3 the developed view of the electrode in

[0037] Figure 5 It is a schematic diagram of the electrode according to an embodiment of the present invention in a folded form.

[0038] Figure 6 It is a schematic diagram of the electrode according to an embodiment of the present invention in an intermediate form.

[0039] Figures 7 - 8 It is a schematic diagram of the electrode according to a preferred embodiment of the present invention.

[0040] Figure 9 It is a schematic diagram of the electrode according to another embodiment of the present invention.

[0041] Figure 10 It is a schematic diagram of a sub - electrode, a substrate and a transmission line according to an embodiment of the present invention.

[0042] In the drawings:

[0043] 100 - electrode; 110 - proximal end portion of the electrode; 120 - main body portion of the electrode; 121 - first section; 122 - second section; 123 - folding section; 130 - distal end portion of the electrode; 140 - proximal mounting portion; 150 - distal mounting portion; 160 - substrate; 170 - sub - electrode; 180 - transmission line; 190 - insulating layer; 200 - catheter; 210 - outer tube; 220 - support shaft. Detailed Description of the Invention

[0044] To make the objectives, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and not drawn to scale, and are only used to facilitate and clearly assist in explaining the objectives of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structures. In particular, the emphasis that each drawing needs to show is different, and sometimes different scales are used.

[0045] As used in the present invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in the sense of including "and / or", the term "several" is generally used in the sense of including "at least one", the term "at least two" is generally used in the sense of including "two or more". In addition, the terms "first", "second", "third" are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first", "second", "third" may explicitly or implicitly include one or at least two of such features, unless the content clearly indicates otherwise.

[0046] As defined herein, "proximal" and "distal" are defined as follows: "Proximal" generally refers to the end of the medical device that is closer to the operator during normal operation, while "distal" generally refers to the end of the medical device that first enters the patient's body during normal operation.

[0047] The present invention provides an electrode, an electrophysiological catheter and an ablation system. One of the purposes is to solve the problem in the prior art that after the electrode is twisted, the contact area between the electrode and the target cannot be maximized, thus affecting the ablation effect; another purpose is to solve the problem in the prior art that the limited density of the electrode used for twisting affects the ablation depth.

[0048] The following description will refer to the accompanying drawings.

[0049] As Figure 1 shown, and with reference to Figure 2 , Figure 1 is a schematic diagram of an electrode according to an embodiment of the present invention. Figure 2 is a schematic diagram of the electrode in a contracted state according to an embodiment of the present invention. This embodiment provides an electrode 100 for setting at the distal end of a catheter and for transmitting energy (such as radio frequency, pulse, ultrasound) between a device (energy supply platform) and a predetermined site (such as a pulmonary vein). The electrode 100 includes an electrode proximal portion 110, an electrode main body portion 120 and an electrode distal portion 130 connected in sequence from proximal to distal. The electrode main body portion 120 includes a first section 121 and a second section 122 connected along the axial direction of the catheter 200. In addition, in this embodiment, the first section 121 and the second section 122 are connected in the direction from proximal to distal. At least one of the electrode proximal portion 110 and the electrode distal portion 130 is configured to be movably connected to the catheter 200. The electrode main body portion 120 is configured to be convertible between a contracted state and a folded state as the electrode proximal portion 110 and the electrode distal portion 130 move relative to each other along the catheter 200. Continuing to refer to Figure 2, when the electrode main body 120 is in the contracted state, the electrode main body 120 abuts against the catheter 200 inwardly along the radial direction of the catheter 200 (abutting against the outer wall of the catheter 20); please refer to Figure 5 , Figure 5 is a schematic diagram of the electrode in the folded state according to an embodiment of the present invention. When the electrode main body 120 is in the folded state, the electrode main body 120 expands outwardly along the radial direction of the catheter 200, causing the first section 121 and the second section 122 to incline towards each other, forming a staggered arrangement along the transverse direction of the catheter 200. It should be understood that when the proximal end portion 110 and the distal end portion 130 of the electrode move, the ends of the first section 121 and the second section 122 facing each other move radially outward along the catheter 200, causing the first section 121 and the second section 122 to be arranged at an angle to the axial direction of the catheter 200; the folded state here refers to the maximum folded state, that is, the first section 121 and the second section 122 are substantially in contact with each other (if there is a slight gap between them, it can be ignored); the first section 121 and the second section 122 incline towards each other means that they each incline towards the other; more specifically, along the transverse direction of the catheter 200, the first section 121 and the second section 122 are arranged at an angle; along the axial direction of the catheter 200, the first section 121 and the second section 122 do not coincide. In this way, both the first section 121 and the second section 122 abut against the predetermined part, increasing the contact area; the transverse direction of the catheter 200 refers to the direction substantially along the cross-section of the catheter 200, and the axial direction of the catheter 200 should be understood as the direction substantially along the extension of the catheter 200 (including the case of bending). Please continue to refer to Figure 1 and refer to in combination Figure 2 , optionally, the electrode 100 further includes a proximal mounting portion 140 and a distal mounting portion 150. The proximal end portion 110 of the electrode is used to connect to the catheter 200 through the proximal mounting portion 140, and the distal end portion 130 of the electrode is used to connect to the catheter 200 through the distal mounting portion 150. Preferably, the proximal mounting portion 140 and the distal mounting portion 150 are respectively parallel to the axial direction of the catheter 200.

[0050] In the prior art, the structure for ablation (the structure is generally similar to the electrode in this embodiment and is generally linear. Hereinafter, the structure for ablation in the prior art is named as ablation electrode) is formed by arranging a plurality of ring electrodes in sequence on a polymer pipe. After the ablation electrode is pushed through the catheter 200, the distal end of the catheter 200 is twisted, so as to realize the twisting of the ablation electrode to form a staggered arrangement in the ablation electrode. In the prior art, the traditional polymer pipe / ring electrode occupies a large space, resulting in limited density of the ablation electrode. In addition, the anti-twisting performance of the twisted ablation electrode is poor, and the area where the ablation electrode can be abutted against the predetermined part cannot be maximized, which affects both the ablation depth and the accuracy of high-density mapping of the ablation electrode. In this embodiment, with the relative movement of the electrode proximal end 110 and the electrode distal end 130, the first section 121 and the second section 122 finally form a folded staggered arrangement, avoiding the influence of electrode twisting on the abutting area between the electrode main body 120 and the predetermined part, thereby improving the electric field around the predetermined part and enhancing the ablation effect.

[0051] Please continue to refer to Figure 5 , the catheter 200 includes an outer tube 210 and a stent shaft 220. The stent shaft 220 is movably inserted through the outer tube 210 (it can be understood that the catheter 200 has elasticity), and the stent shaft 220 extends out of the outer tube 210 towards the distal end. At least one of the electrode proximal end 110 and the electrode distal end 130 is used to be movably connected to the catheter 200. The relative movement of the electrode proximal end 110 and the electrode distal end 130 along the catheter 200 (the relative distance changes), specifically includes one of the following several situations:

[0052] (1) The electrode proximal end 110 and the electrode distal end 130 are both movably arranged on the outer tube 210 or the stent shaft 220. By changing the relative distance after the movement of the electrode proximal end 110 and the electrode distal end 130, the morphological change of the electrode main body 120 is realized;

[0053] (2) One of the electrode proximal end 110 and the electrode distal end 130 is fixed on the catheter 200, and the other is movably arranged on the catheter 200. For example, one of the electrode proximal end 110 and the electrode distal end 130 is fixed on the stent shaft 220, and the other is movably arranged on the stent shaft 220, or one of the electrode proximal end 110 and the electrode distal end 130 is fixed on the outer tube 210, and the other is movably arranged on the outer tube 210;

[0054] (3) Lock the positions of the outer tube 210 and the stent shaft 220 so that they do not slide relative to each other. The electrode proximal end 110 is movably arranged on the outer tube 210, and / or the electrode distal end 130 is movably arranged on the stent shaft 220, and the morphological change of the electrode main body 120 can also be realized;

[0055] (4) The proximal end portion 110 of the electrode is fixed to the outer tube 210, and the distal end portion 130 of the electrode is fixed to the support shaft 220. By the movement of the support shaft 220 passing through the outer tube 210 (the support shaft 220 is pushed distally and the support shaft 220 is retracted proximally), the relative movement between the proximal end portion 110 of the electrode and the distal end portion 130 of the electrode is achieved.

[0056] In the above (1), (2) and (3), a traction wire can be connected to the proximal end portion 110 of the electrode and / or the distal end portion 130 of the electrode respectively to guide the relative movement between the two. It should be noted that Figure 2 in the figure, the electrode 100 is in contact with the support shaft, which is a schematic representation of the catheter. The catheter "200" is marked on the outer tube, and those skilled in the art should not limit the structure of the catheter accordingly.

[0057] Furthermore, the electrode main body portion 120 further includes a folding section 123, the folding section 123 is respectively connected to the first section 121 and the second section 122. When the electrode main body portion 120 is in the folded state, the first section 121 and the second section 122 are arranged in a folded and misaligned manner through the folding section 123. The setting of the folding section 123 can prevent the first section 121 or the second section 122 from being folded and reducing the contact area, which is beneficial to maximizing the folded misalignment between the first section 121 and the second section 122 and reducing the resistance of the first section 121 and the second section 122 to form a folded and misaligned arrangement. Optionally, the folding section 123 can be made of insulating material. Preferably, the folding section 123 has a groove. When the electrode main body portion 120 is in the folded state, the groove is used to accommodate the first section 121 or the second section 122. In this way, when the electrode main body portion 120 is in the folded state, the first section 121 and the second section 122 are substantially on the same plane (curved surface), which is convenient for contacting with the predetermined part.

[0058] Please refer to Figure 6 , Figure 6 which is a schematic diagram of the electrode in the intermediate state in an embodiment of the present invention. In this embodiment, the electrode main body portion 120 is also in an intermediate state. Specifically, the electrode main body portion 120 is converted between the contracted state and the intermediate state, and between the intermediate state and the folded state; when the electrode main body portion 120 is in the intermediate state, the projection of the folding section 123 on the catheter 200 (the projection on the catheter 200 along the radial direction of the catheter 200) is between the proximal end portion 110 of the electrode and the distal end portion 130 of the electrode. It can be understood that when in the intermediate state, the cross-section of the structure formed by the electrode main body portion 120 and the catheter 200 is substantially semi-elliptical. Actually, the electrode main body portion 120 in the intermediate state can be used to perform ablation treatment on the wall of the physiological lumen.

[0059] Optionally, when the electrode main body 120 is in the contracted state and / or the intermediate state, the first section 121 and the second section 122 are arranged in a lateral dislocation along the catheter 200. As described above in detail, when the electrode main body 120 is in the folded state, the first section 121 and the second section 122 are arranged in a lateral dislocation along the catheter 200. In this embodiment, when the electrode main body 120 is in the contracted state, the intermediate state, and the folded state respectively, the arrangement of the first section 121 and the second section 122 includes one of the following several cases:

[0060] (1) In the three states of the contracted state, the intermediate state, and the folded state, the first section 121 and the second section 122 are both arranged in a lateral dislocation along the catheter 200. Among them, when in the contracted state, the first section 121 and the second section 122 are in contact with the catheter 200, and the electrode main body 120 is substantially in a curled shape;

[0061] (2) When the electrode main body 120 is in the contracted state and the intermediate state, the first section 121 and the second section 122 are not arranged in a dislocation (for example, they can be arranged along the axis of the catheter 200), and when in the folded state, the first section 121 and the second section 122 are in a dislocation;

[0062] (3) When the electrode main body 120 is in one of the contracted state and the intermediate state, the first section 121 and the second section 122 are in a dislocation, and when in the other of the contracted state and the intermediate state, the first section 121 and the second section 122 are not in a dislocation. When in the folded state, the first section 121 and the second section 122 are in a dislocation. In this embodiment, when the electrode main body 120 is in the above three states, the first section 121 and the second section 122 are both arranged in a lateral dislocation along the catheter 200.

[0063] Preferably, please continue to refer to Figure 1 and, in combination with reference to Figure 7 and Figure 8 Figure 7 and Figure 8 ​FIG. 0 is a schematic diagram of an electrode according to a preferred embodiment of the present invention. At least one of the first section 121 and the second section 122 is arc-shaped or zigzag-shaped. With such an arrangement, when the electrode main body 120 is in a folded state, the overlapping part of the first section 121 and the second section 122 can be reduced, and the arrangement mode of the two can be optimized. Preferably, both the first section 121 and the second section 122 are arc-shaped or zigzag-shaped, and the opening directions of the first section 121 and the second section 122 are opposite along the transverse direction of the catheter 200. With such a configuration, when the electrode main body 120 is in a contracted state, the electrode main body 120 is generally in an "S" shape. When in a folded state, the lower part of the "S" is folded up and abuts against the upper part, so that the electrode main body 120 is generally in a petal shape. In addition, when in a contracted state, the proximal mounting portion 140 and the distal mounting portion 150 are generally collinear or nearly collinear, which is convenient for technicians to install. Preferably, the centers of the proximal mounting portion 140, the distal mounting portion 150, and the folding section 123 are located on the same axis (i.e., arranged along the axis of the catheter 200), and the first section 121 and the second section 122 are respectively located on both sides of the axis. It should be understood that the zigzag shape here means that several zigzag segments are sequentially connected along the axial direction of the catheter 200, and the connection angle between two adjacent zigzag segments is relatively small and can be ignored (for example, 5°). After several zigzag segments are sequentially connected, it can generally be understood as an arc shape as a whole.

[0064] Please refer to Figure 3 , Figure 4 and Figure 9 , Figure 3 FIG. 11 is a schematic diagram of the electrode according to another embodiment of the present invention when in a contracted state. Figure 4 FIG. Figure 3 is the unfolded view of the electrode in Figure 9 FIG. Figure 9 Of course, in some other embodiments, the first section 121 and the second section 122 can also be linear, generally parallel to the axial direction of the catheter 200, and the two can be transitioned through a curved section ( Figure 4 as shown in FIG. Figure 2 ), or through an inclined section (

[0065] Further, please refer to Figure 10 , Figure 10Schematic diagram of a sub - electrode, a substrate and a transmission line according to an embodiment of the present invention. The electrode 100 includes a substrate 160 and a sub - electrode 170. Both the first section 121 and the second section 122 are disposed on the substrate 160, and the sub - electrode 170 is located on the first section 121 and / or the second section 122. The sub - electrode 170 is used to transmit energy to a predetermined site to achieve the ablation purpose, and the sub - electrode 170 can be made of platinum or gold. Here, for an ablation site with a small area of the pulmonary vein orifice, a sub - electrode 170 with a relatively large radial dimension can be set for ablation treatment, thus saving materials. The present invention does not specifically limit the shape of the sub - electrode 170 (which can be understood as the cross - section of the sub - electrode 1710 here), and it can be circular, oval, polygonal, irregular planar shape, etc.; the radial dimension here can be understood as the maximum radial dimension, that is, the maximum distance between the edges of the sub - electrode 170. When the cross - section of the sub - electrode 170 is circular, it is the diameter. It should be noted that the sub - electrode 170 here is not the ring electrode in the prior art. The sub - electrode 170 is preferably in a sheet shape, generally in a hat - like or screw - like shape, and is embedded in the substrate 160, and the surface of the sub - electrode 170 can be abutted against the predetermined site. Compared with the ring electrode in the prior art, the contact area of the sub - electrode 170 is larger. Preferably, the substrate 160 is made of an insulating material, such as liquid crystal copolymer (LCP), polyimide (PI), polydimethylsiloxane (PDMS); more preferably, the substrate 160 is filled with a nickel - titanium alloy, so as to improve the supporting force of the electrode. Here, the performance of the nickel - titanium alloy is not specifically described, and those skilled in the art can obtain it according to common knowledge. It should be noted that the material used to fill and improve the supporting force of the electrode 100 in this embodiment is not limited to the nickel - titanium alloy, and any material that can improve the supporting force of the electrode 100 and has no side effects on patients can be filled into the substrate 160 described in this embodiment.

[0066] Preferably, the electrode includes a plurality of the sub - electrodes 170. With reference to Figure 7 and Figure 8 , a plurality of the sub - electrodes 170 are arranged at intervals along the extending direction of the first section 121 on the first section 121, and / or a plurality of the sub - electrodes 170 are arranged at intervals along the extending direction of the second section 122 on the second section 122. By adjusting the number of the sub - electrodes 170 to change the density of the electrode, the high - density mapping function of the electrode can also be realized to assist in collecting physiological signals of a predetermined site.

[0067] Preferably, the first section 121 and the second section 122 are both provided with the sub-electrodes 170, which can increase the ablation depth and improve the accuracy of high-density mapping. The substrate 160 is a strip-shaped member, similar to a planar shape (analogous to a rectangle). The sub-electrodes 170 located in the first section 121 and the sub-electrodes 170 located in the second section 122 are distributed on two sides of the substrate 160. In an exemplary embodiment, when in the contracted form, the substrate 160 is perpendicular to the radial direction of the catheter 200. The sub-electrodes 170 located in the first section 121 are distributed on the inner side surface of the substrate 160, and the sub-electrodes 170 located in the second section 122 are distributed on the outer side surface of the substrate 160. When the electrode main body 120 is in the folded form, the sub-electrodes 170 all face the distal end; or the sub-electrodes 170 located in the first section 121 are distributed on the outer side surface of the substrate 160, and the sub-electrodes 170 located in the second section 122 are distributed on the inner side surface of the substrate 160. When the electrode main body 120 is in the folded form, the sub-electrodes 170 all face the proximal end. Here, the inner side surface of the substrate 160 refers to the side of the substrate 160 close to the catheter 200; the outer side surface of the substrate 160 refers to the side of the substrate 160 facing away from the catheter 200. Those skilled in the art can configure the sub-electrodes 170 to be distributed on the outer side surface or the inner side surface of the substrate 160 according to the actual configuration of the predetermined part by the pathologist.

[0068] In some other embodiments, when in the contracted form, it is not limited to the substrate 160 being perpendicular to the radial direction of the catheter. It can also be that the substrate 160 is arranged at an angle with the catheter (including 0°, that is, the substrate 160 extends along the radial direction of the catheter), as long as when in the folded form, the two sides of the substrate 160 face the proximal end and the distal end respectively.

[0069] Furthermore, the radial dimensions of at least some of the sub-electrodes 170 are inconsistent. It can also be understood that the cross-sectional areas of at least some of the sub-electrodes 170 are inconsistent. The radial dimension of the sub-electrode 170 located in the middle of the first section 121 is larger than the radial dimensions of the sub-electrodes 170 facing the two ends of the first section 121, and / or the radial dimension of the sub-electrode 170 located in the middle of the second section 122 is larger than the radial dimensions of the sub-electrodes facing the two ends of the second section 122.. Specifically, please refer to Figure 7 and Figure 8, taking the first section 121 and the second section 122 being arc-shaped as an example, the radial dimension of the sub-electrode 170 in the middle part of the first section 121 / the second section 122 is larger, and then towards the two ends of the first section 121 / the second section 122, the radial dimension of the sub-electrode 170 gradually decreases. When the electrode main body 120 is in a folded state, the distance between the middle parts of the first section 121 and the second section 122 is larger, and sub-electrodes 170 with larger radial dimensions can be arranged. The distance between the two parts towards the two ends is smaller, and sub-electrodes 170 with smaller radial dimensions can be arranged. In this way, the arrangement mode of the sub-electrodes 170 can be optimized, the redundant space can be utilized as much as possible, the area of the electrode for ablation can be increased, and the energy distribution of ablation can also be concentrated.

[0070] Preferably, the radial dimension of the sub-electrode 170 located in the first section 121 gradually decreases from the middle part of the first section 121 towards the two ends respectively; and / or, the radial dimension of the sub-electrode located in the second section 122 gradually decreases from the middle part of the second section 122 towards the two ends respectively. In this way, the arrangement mode of the sub-electrodes can be further optimized. Please continue to refer to Figure 7 and Figure 8 , and with reference to Figure 9 , here, taking at least one of the first section 121 and the second section 122 being arc-shaped as an example for illustration. When one of the first section 121 and the second section 122 is arc-shaped and the other is linear, when the electrode main body 120 is in a folded state, the first section 121 and the second section 122 as a whole generally present a semi-elliptical shape (including a semi-circular shape). When the curvature of the arc is close to an elliptical arc, at this time, the semi-elliptical shape is symmetric about its major axis and minor axis respectively, and the radial dimensions of the sub-electrodes of the first section 121 and the second section 122 can be configured to gradually decrease (decrease) from their respective middle parts towards the two ends; similarly, when both the first section 121 and the second section 122 are arc-shaped and the curvatures of both arcs are close to an elliptical arc, in the folded state, the first section 121 and the second section 122 as a whole present an elliptical shape (including a circular shape), and the radial dimensions of the sub-electrodes of the first section and the second section can also be configured to gradually decrease (decrease) from their respective middle parts towards the two ends. It should be noted that in the above "elliptical shape" and "semi-elliptical shape", the radial dimensions of the two sub-electrodes 170 that are opposite to each other along the minor axis of the first section 121 and the second section 122 (roughly opposite, and there may be some deviations, which are all understood as opposite here) can be equal or unequal. This embodiment does not limit this. In addition, the above "elliptical shape" and "semi-elliptical shape" are only used for illustration and do not limit the present invention in any way.

[0071] Preferably, the sub-electrode 170 protrudes from the surface of the substrate 160 and is used to abut against a predetermined site, which can provide a better abutting effect relative to the ring electrode. With such a configuration, the substrate 160 is prevented from abutting against the predetermined site, the compressive stress on the predetermined site (pulmonary vein) is reduced, the blood in the pulmonary vein can flow normally, and the influence of the thermal effect on the ablation treatment is reduced.

[0072] Optionally, the electrode further includes a transmission line 180, the sub-electrode 170 is electrically connected to the transmission line 180, and the transmission line 180 is used to transmit energy to the sub-electrode 170. The transmission line 180 can be made of materials such as copper and gold. Further, an insulating layer 190 is provided on the transmission line 180 for insulating the sub-electrodes 170 from each other.

[0073] Preferably, the sub-electrode 170 has a flange, and the extension direction of the flange is not specifically limited here. Preferably, the flange extends along the direction of the transmission line 180, and the flange is covered by a covering layer on the transmission line 180 to limit the position of the sub-electrode 170 on the transmission line 180, strengthen the fixation of the sub-electrode 170, prevent it from falling off, and improve safety. Specifically, flanges are formed at both the proximal end and the distal end of the sub-electrode 170, and the cross-section is generally in the shape of "Ω", and the "-" in the "Ω" is the flange. Optionally, the covering layer can be made of polyimide or LCP (liquid crystal polymer).

[0074] Based on the above electrode, the present invention further provides an electrophysiological catheter 200, which includes the catheter 200 as described above and the electrode 100 as described above. At least one of the electrode proximal end portion 110 and the electrode distal end portion 130 of the electrode 100 is movably connected to the catheter 200; the electrode main body portion 120 of the electrode 100 is converted between the contracted form and the folded form as the electrode proximal end portion 110 and the electrode distal end portion 130 move relative to each other along the catheter 200.

[0075] Further, the electrophysiological catheter 200 includes a plurality of the electrodes 100, and the plurality of the electrodes 100 are arranged circumferentially along the catheter 200. Preferably, the plurality of the electrodes are arranged uniformly in sequence along the circumference of the catheter 200 to optimize the arrangement method and make the energy distribution of ablation uniform. Please refer to Figure 5 , after the electrode main body portions 120 of the plurality of electrodes are in the folded form, the whole is generally similar to a petal and fits with the pulmonary vein ostium (the pulmonary vein ostium is generally conical) to perform ablation and collect physiological signals.

[0076] The electrode includes a plurality of sub - electrodes 170, and the plurality of sub - electrodes 170 are arranged at intervals along the axial direction of the catheter 200 to form a sub - electrode group; when the electrode main body portion 120 of the electrode 100 is in the contracted state, the sub - electrode groups on two adjacent electrodes 100 are arranged in a staggered manner along the axial direction of the catheter 200. It can be understood that for two adjacent electrodes 100, when in the contracted state, one sub - electrode 170 of the other electrode is arranged between two adjacent sub - electrodes 170 on one electrode. In this way, redundant space can be saved, so that the number of electrodes 100 arranged on the catheter 200 is large enough, the ablation depth is increased, and a wider ablation lesion is formed.

[0077] In this embodiment, the catheter 200 includes an outer tube 210 and a stent shaft 220 movably disposed in the outer tube 210. In a preferred embodiment, the proximal electrode portion 110 of the electrode 100 is disposed on the outer tube 210, and the distal electrode portion 130 of the electrode 100 is disposed on the stent shaft 220. The morphological change of the electrode main body portion 120 is realized by the movement of the stent shaft 220 through the outer tube 210. Further, the stent shaft 220 includes a wire channel (not shown) that penetrates axially, which is used to place a traction wire (not shown) connected to the proximal electrode portion 110 to guide the electrode to a predetermined position. Preferably, the stent shaft 220 is made of stainless steel or a reinforced plastic tube, and the wire channel is made of polytetrafluoroethylene (PTFE) or high - density ethylene (HDPE) material, and a hydrophilic or hydrophobic super - slippery coating can be further coated in the channel.

[0078] Based on the above - mentioned electrophysiological catheter 200, this embodiment further provides an ablation system, and the ablation system includes the electrophysiological catheter 200 as described above. It should be understood that since the ablation system includes the electrophysiological catheter 200, the ablation system also has the beneficial effects brought by the electrophysiological catheter 200. Here, the working principle and other components of the ablation system are not elaborated in detail. Those skilled in the art can configure them according to the actual situation. For example, the ablation system further includes a control handle (not shown), which is connected to the outer tube 210 to drive the movement of the outer tube 210, so as to realize the relative movement of the stent shaft 220 and the outer tube 210, thereby changing the morphology of the electrode main body portion 120; the ablation system further includes an energy supply platform, which is used to be electrically connected to the electrode 1 and supply energy (such as radio frequency, ultrasound, pulse) to the electrode (specifically referring to the sub - electrode 170) to ablate a predetermined part; the ablation system further includes a temperature sensor and / or a pressure sensor. The temperature sensor is used to detect the thermal effect during the ablation stage, and the pressure sensor is used to detect the degree of contact between the electrode and the predetermined part.

[0079] In summary, the electrode provided by the present invention is used to be disposed at the distal end of a catheter. The electrode includes a proximal electrode portion, a main electrode portion, and a distal electrode portion that are sequentially connected from the proximal end to the distal end. The main electrode portion includes a first section and a second section that are connected along the axial direction of the catheter. At least one of the proximal electrode portion and the distal electrode portion is configured to be movably connected to the catheter. The main electrode portion is configured to be converted between a contracted form and a folded form as the proximal electrode portion and the distal electrode portion move relative to each other along the catheter. When the main electrode portion is in the contracted form, the main electrode portion abuts against the catheter inwardly in the radial direction of the catheter. When the main electrode portion is in the folded form, the main electrode portion expands outwardly in the radial direction of the catheter, causing the first section and the second section to incline towards each other, forming a staggered arrangement along the transverse direction of the catheter. By radially expanding the main electrode portion to cause the first section and the second section to incline towards each other, thereby forming a staggered arrangement of the first section and the second section, it is possible to avoid the influence of electrode torsion misalignment on the contact area between the main electrode portion and the predetermined site; it is possible to increase the contact area between the main electrode portion and the predetermined site, improve the electric field around the predetermined site, and enhance the ablation effect.

[0080] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosure fall within the protection scope of the claims.

Claims

1. An electrode is configured to be disposed at a distal end of a catheter and to transfer energy between a device and a predetermined site. Characterized in that, the electrode includes an electrode proximal portion, an electrode main body portion, and an electrode distal portion that are sequentially connected from the proximal end to the distal end. The electrode main body portion includes a first section and a second section that are connected along the axial direction of the catheter. At least one of the electrode proximal portion and the electrode distal portion is configured to be movably connected to the catheter. The electrode main body portion is configured to be converted between a contracted form and a folded form as the electrode proximal portion and the electrode distal portion move relative to each other along the catheter. When the electrode main body portion is in the contracted form, the electrode main body portion is attached to the catheter radially inward along the radial direction of the catheter. When the electrode main body portion is in the folded form, the electrode main body portion expands radially outward along the radial direction of the catheter, causing the first section and the second section to incline towards each other, forming a staggered arrangement along the transverse direction of the catheter, and the first section and the second section abut against each other. The electrode includes a substrate and sub-electrodes. The sub-electrodes are disposed on the substrate. The substrate is a strip-shaped member. The first section and the second section are both provided with sub-electrodes, and the sub-electrodes located in the first section and the sub-electrodes located in the second section are distributed on two sides of the substrate. The electrode main body portion further includes a folding section that is respectively connected to the first section and the second section. When the electrode main body portion is in the folded form, the first section and the second section are folded and staggered through the folding section. The folding section has a groove. When the electrode main body portion is in the folded form, the groove is configured to accommodate the first section or the second section.

2. The electrode according to claim 1, Characterized in that, the electrode main body portion is converted between the contracted form and an intermediate form, and between the intermediate form and the folded form. When the electrode main body portion is in the intermediate form, the projection of the folding section on the catheter is between the electrode proximal portion and the electrode distal portion.

3. The electrode according to claim 2, Characterized in that, when the electrode main body portion is in the contracted form and / or the intermediate form, the first section and the second section are staggered along the transverse direction of the catheter.

4. The electrode according to claim 1, Characterized in that, the electrode further includes a proximal mounting portion and a distal mounting portion. The proximal mounting portion and the distal mounting portion are respectively parallel to the axial direction of the catheter. The electrode proximal portion is configured to be connected to the catheter through the proximal mounting portion, and the electrode distal portion is configured to be connected to the catheter through the distal mounting portion.

5. The electrode according to claim 1, Characterized in that, at least one of the first section and the second section is arc-shaped or zigzag-shaped.

6. The electrode according to any one of claims 1-5, Characterized in that, both the first section and the second section are arc-shaped or zigzag-shaped, and the opening directions of the first section and the second section are opposite along the transverse direction of the catheter.

7. The electrode according to claim 1, Characterized in that, The electrode includes a plurality of the sub - electrodes, and the plurality of sub - electrodes are arranged at intervals along the extending direction of the first section and are also arranged at intervals along the extending direction of the second section.

8. The electrode according to claim 7, wherein, the radial dimensions of at least some of the sub - electrodes are inconsistent.

9. The electrode according to claim 8, wherein, the radial dimension of the sub - electrode located in the middle of the first section is larger than that of the sub - electrodes towards the two ends of the first section, and / or the radial dimension of the sub - electrode located in the middle of the second section is larger than that of the sub - electrodes towards the two ends of the second section.

10. The electrode according to claim 9, wherein, the radial dimension of the sub - electrodes located in the first section gradually decreases from the middle of the first section towards both ends; and / or the radial dimension of the sub - electrodes located in the second section gradually decreases from the middle of the second section towards both ends.

11. The electrode according to claim 1, wherein, the sub - electrodes protrude from the surface of the substrate and are used to abut against a predetermined part.

12. The electrode according to claim 7, wherein, the electrode further includes a transmission line, and the sub - electrodes are electrically connected to the transmission line; an insulating layer is provided on the transmission line for insulating each of the sub - electrodes from each other.

13. The electrode according to claim 1, wherein, the electrode further includes a transmission line, and the sub - electrodes are electrically connected to the transmission line; the sub - electrodes have flanges, and the flanges are covered by a covering layer on the transmission line to limit the position of the sub - electrodes on the transmission line.

14. The electrode according to claim 1, wherein, the substrate is filled with an elastic nickel alloy.

15. An electrophysiological catheter, wherein, it includes a catheter and the electrode according to any one of claims 1 - 4, and at least one of the proximal electrode end and the distal electrode end of the electrode is movably connected to the catheter; the electrode body part of the electrode is converted between the contracted form and the folded form as the proximal electrode end and the distal electrode end of the electrode move relative to each other along the catheter.

16. The electrophysiological catheter according to claim 15, wherein, the electrophysiological catheter includes a plurality of the electrodes, and the plurality of electrodes are arranged circumferentially along the catheter.

17. The electrophysiological catheter according to claim 16, wherein, the plurality of electrodes are arranged evenly in sequence along the circumference of the catheter.

18. The electrophysiological catheter according to claim 16 or 17, wherein, the electrode includes a plurality of sub - electrodes, and the plurality of sub - electrodes are arranged at intervals along the axial direction of the catheter to form a sub - electrode group; when the electrode body part of the electrode is in the contracted form, the sub - electrode groups on two adjacent electrodes are arranged axially offset along the catheter.

19. The electrophysiological catheter according to any one of claims 15 - 17, wherein, The catheter includes an outer tube and a stent shaft, and the stent shaft is movably disposed in the outer tube; the proximal electrode end of the electrode is disposed on the outer tube, and the distal electrode end of the electrode is disposed on the stent shaft.

20. An ablation system, characterized in that it includes an electrophysiological catheter according to any one of claims 15 to 17.

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