Linear flexible electrode, ablation catheter and method of manufacturing the same, ablation system
By designing a linear flexible electrode, the problems of energy waste and manufacturing complexity associated with ring electrodes in blood have been solved, achieving efficient energy transfer and simplified manufacturing.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHANGHAI ARTECHMED MEDICAL TECH CO LTD
- Filing Date
- 2023-07-06
- Publication Date
- 2026-05-12
Smart Images
Figure CN116672071B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of electrophysiology, and in particular to a linear flexible electrode, an ablation catheter and its manufacturing method, and an ablation system. Background Technology
[0002] Currently, in the field of electrophysiological therapy, using catheters to deliver energy and perform tissue ablation is one of the most common methods. After the tip of the catheter enters the body and reaches the corresponding treatment target, energy (such as radiofrequency, ultrasound, pulsed energy, etc.) is sent through an energy platform connected to the tail end of the catheter. The distal end of the catheter is equipped with an energy delivery electrode, which, after being in contact with the tissue, transfers energy to the tissue, thereby performing tissue ablation.
[0003] Traditional catheters use ring electrodes for energy delivery. When the electrode is placed inside the heart, most of its surface remains submerged in blood when it is against the target tissue. This results in most of the delivered energy being released into the bloodstream, leading to ineffective discharge, increased power consumption of the treatment system, and reduced therapeutic efficacy. Furthermore, the ring electrode itself is a rigid structure; increasing the number of ring electrodes reduces catheter flexibility and hinders surgical procedures.
[0004] Flexible circuits are increasingly used in electrophysiology, offering better flexibility compared to traditional ring electrodes. Furthermore, the electrodes can be oriented to fit against the tissue, effectively reducing power consumption. However, facilitating the assembly of flexible circuit electrodes onto the catheter shaft often involves complex manufacturing processes, leading to increased costs. Summary of the Invention
[0005] The purpose of this invention is to provide a linear flexible electrode, an ablation catheter, a manufacturing method thereof, and an ablation system, in order to solve the problem of increased costs caused by the complex manufacturing process of the flexible circuit electrode in order to facilitate its assembly on the catheter shaft.
[0006] To address the aforementioned technical problems, based on a first aspect of the present invention, the present invention provides a linear flexible electrode applied to an ablation catheter. The ablation catheter includes an outer tube and a catheter shaft movably inserted within the outer tube. The linear flexible electrode includes:
[0007] A connecting unit having an alignment portion;
[0008] Two electrode regions, which extend in a linear direction, are connected by the connecting unit.
[0009] The linear flexible electrode is configured to be mounted on the conduit shaft via the alignment portion and on the outer tube via the end of the electrode region away from the connecting unit.
[0010] Optionally, the alignment portion may be located at the end of the catheter shaft, and the alignment portion may allow the guidewire to pass through; or the alignment portion may be configured as an alignment hole through the connection unit, through which the linear flexible electrode is sleeved on the catheter shaft.
[0011] Optionally, the linear flexible electrode includes an ablation electrode and an electrode carrier extending in a linear direction. The ablation electrode is disposed on the electrode carrier to form two electrode regions, and a portion of the electrode carrier located between the two electrode regions is configured as the alignment portion that allows the guide wire to pass through.
[0012] Optionally, the connecting unit further includes a reinforcement member disposed on the alignment portion.
[0013] Optionally, the reinforcement has a through hole and extensions located on both sides of the through hole, the through hole being arranged around the alignment portion, and the extensions being connected to the electrode carrier in a linear direction.
[0014] Optionally, the electrode region includes two electrode segments arranged at intervals, namely a distal electrode segment and a proximal electrode segment. The distal electrode segment is closer to the connection unit than the proximal electrode segment. The electrode segments extend in a linear direction and are used to release ablation energy.
[0015] Optionally, the electrode region further includes an intermediate bending segment, a distal bending segment, and a proximal bending segment, all of which are bendable and deformable. The distal electrode segment and the proximal electrode segment are connected through the intermediate bending segment. The distal electrode segment is connected to the connecting unit through the distal bending segment, and the proximal bending segment is connected to the proximal electrode segment. The bending point of the distal bending segment is A, the bending point of the intermediate bending segment is B, and the bending point of the proximal bending segment is C. The distance between B and C is greater than the distance between A and B.
[0016] Optionally, the ratio of the distance between A and B to the distance between B and C is greater than or equal to 65% and less than or equal to 95%.
[0017] Optionally, the portion of the electrode region located between B and C has a smaller deformation capacity than the portion of the electrode region located between A and B.
[0018] Optionally, B is located at the midpoint of the intermediate bend segment;
[0019] The end of the distal bending segment that connects to the connecting unit is configured as A;
[0020] The electrode region also includes a free section connected to the proximal bend section, the free section being used to connect to the outer tube, and the end of the proximal bend section connecting to the free section is configured as C.
[0021] Optionally, the electrode segment includes multiple ablation electrodes arranged at intervals. After the distal electrode segment and the proximal electrode segment are brought closer together by a B-bend, the ablation electrodes of the distal electrode segment and the ablation electrodes of the proximal electrode segment are arranged alternately along a linear direction.
[0022] Optionally, in at least one of the two electrode regions, the surface of the distal electrode region that releases the ablation energy and the surface of the proximal electrode region that releases the ablation energy face opposite directions when the electrode region is not bent.
[0023] Optionally, the electrode segment includes a plurality of ablation electrodes arranged at intervals in sequence, and the distance from the ablation electrode closest to the alignment portion in the distal electrode segments corresponding to the two electrode regions is different.
[0024] Optionally, the position of the alignment portion is configured such that after the two electrode regions are folded and overlapped about the alignment portion, the ablation electrodes of the distal electrode segment of one electrode region and the distal electrode segment of the other electrode region are staggered with each other in a linear direction, and / or the ablation electrodes of the proximal electrode segment of one electrode region and the proximal electrode segment of the other electrode region are staggered with each other in a linear direction.
[0025] Optionally, in at least one of the two electrode regions, the distal electrode segment and the proximal electrode segment are staggered and arranged in an S-shape.
[0026] Optionally, the electrode carrier includes a substrate layer, a circuit layer, an insulating layer, and a pad layer. The circuit layer is located between the substrate layer and the insulating layer, the insulating layer is located between the pad layer and the circuit layer, the pad layer is electrically connected to the circuit layer, and the ablation electrode is disposed on the pad layer.
[0027] Optionally, the base layer is provided with an elastic nickel-titanium alloy.
[0028] Based on a second aspect of the present invention, the present invention also provides an ablation catheter, which includes an outer tube, a catheter shaft, and an electrode basket, wherein the electrode basket includes a plurality of linear flexible electrodes as described above, and the plurality of linear flexible electrodes are distributed circumferentially along the catheter shaft.
[0029] The electrode basket transitions between a radially contracting shape and a radially expanding shape as the outer tube and the guide shaft move axially relative to each other.
[0030] Optionally, multiple linear flexible electrodes are evenly arranged circumferentially along the axis of the conduit.
[0031] Optionally, the ablation catheter further includes a fixation component, which is disposed on the catheter shaft to fix the plurality of linear flexible electrodes on the catheter shaft; the fixation component includes a first fixation member and a second fixation member, at least one of the first fixation member and the second fixation member is sleeved on the catheter shaft, the plurality of linear flexible electrodes are located between the first fixation member and the second fixation member, and the first fixation member and the second fixation member cooperate to axially press the plurality of linear flexible electrodes together.
[0032] Optionally, the second fixing member is closer to the distal end of the catheter shaft than the first fixing member. The end of the first fixing member facing the second fixing member is a first clamping end. The first clamping end is protruding and includes a first straight portion and a first rounded corner portion surrounding the first straight portion. The first straight portion is perpendicular to the axial direction of the catheter shaft, and the opening of the first rounded corner portion faces the catheter shaft.
[0033] The end of the second fixing member facing the first fixing member is the second clamping end. The second clamping end is concave and includes a second straight portion and a second rounded corner portion surrounding the second straight portion. The second straight portion is perpendicular to the axial direction of the conduit shaft, and the opening of the second rounded corner portion faces the conduit shaft.
[0034] Wherein, the first clamping end is within the radial range of the second clamping end along the axis of the conduit.
[0035] Optionally, the ablation catheter further includes an angle positioning structure disposed on the catheter shaft and / or the fixation assembly, for limiting the circumferential angle between two adjacent linear flexible electrodes along the catheter shaft.
[0036] Optionally, the angle positioning structure includes multiple positioning slots;
[0037] The positioning slots are recessed along the axial direction of the guide shaft at one end of the first fixing member facing the second fixing member and / or one end of the second fixing member facing the first fixing member, and a plurality of the positioning slots are distributed circumferentially along the guide shaft.
[0038] Alternatively, the ablation catheter includes a hollow component sleeved on the catheter shaft, the positioning grooves being recessed into the hollow component along the axial direction of the catheter shaft, and a plurality of the positioning grooves being distributed circumferentially along the catheter shaft.
[0039] Optionally, the two electrode regions are respectively a first electrode region and a second electrode region; all the first electrode regions and all the second electrode regions are distributed alternately along the circumferential direction of the conduit axis.
[0040] Optionally, the electrode region includes two electrode segments arranged at intervals, namely a distal electrode segment and a proximal electrode segment. The distal electrode segment is closer to the connection unit than the proximal electrode segment. The distance from the nearest ablation electrode to the alignment portion in the distal electrode segment of the first electrode region is different from the distance from the nearest ablation electrode to the alignment portion in the distal electrode segment of the second electrode region.
[0041] Based on a third aspect of the present invention, the present invention also provides a method for manufacturing an ablation catheter, comprising:
[0042] The first fastener is fitted onto and fixed to the guide shaft;
[0043] The second fastener cooperates with the first fastener to clamp and press the multiple linear flexible electrodes stacked between the first fastener and the second fastener;
[0044] The conduit shaft is movably inserted into the outer tube, and both ends of the linear flexible electrode are fixed to the outer tube.
[0045] Optionally, before clamping and pressing multiple stacked linear flexible electrodes located between the first fixation member and the second fixation member, the method of manufacturing the ablation catheter further includes:
[0046] Multiple linear flexible electrodes are sequentially stacked on the guide tube shaft through their respective alignment portions.
[0047] Optionally, the two electrode regions of the linear flexible electrode are a first electrode region and a second electrode region, respectively, and the manufacturing method of the ablation catheter further includes:
[0048] Multiple linear flexible electrodes are stacked and all the first electrode regions and all the second electrode regions are staggered along the circumferential direction of the conduit axis.
[0049] Optionally, before clamping and pressing multiple stacked linear flexible electrodes located between the first fixation member and the second fixation member, the method of manufacturing the ablation catheter further includes:
[0050] The linear flexible electrodes are gathered together, and a hollow component is fitted onto the conduit shaft to limit the circumferential angle between two adjacent linear flexible electrodes along the conduit shaft.
[0051] Based on a fourth aspect of the invention, the invention also provides an ablation system comprising an energy supply platform and an ablation catheter as described above, wherein the energy supply platform is electrically connected to the linear flexible electrode to provide ablation energy to the electrode region of the linear flexible electrode.
[0052] In summary, in the linear flexible electrode, ablation catheter, manufacturing method thereof, and ablation system provided by this invention, the linear flexible electrode includes a connecting unit and two electrode regions. The connecting unit has an alignment portion, the electrode regions extend along a linear direction, and the two electrode regions are connected through the connecting unit. The linear flexible electrode is configured to be mounted on the catheter shaft through the alignment portion and mounted on the outer tube through one end of the electrode region away from the connecting unit.
[0053] With this configuration, the linear flexible electrode of the present invention is provided with an alignment part that mates with the catheter shaft, which facilitates the assembly of the linear flexible electrode onto the catheter shaft and the outer tube, making the fabrication of the ablation catheter simpler and simplifying the manufacturing process of the linear flexible electrode.
[0054] It should be noted that ablation catheters and ablation systems that include the aforementioned linear flexible electrode have the same or corresponding specific technical features as the linear flexible electrode, and also have the beneficial technical effects brought about by the linear flexible electrode, which will not be repeated here. Attached Figure Description
[0055] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:
[0056] Figure 1 This is a schematic diagram of a linear flexible electrode according to an embodiment of the present invention;
[0057] Figure 2 This is a schematic diagram of the electrode basket of the ablation catheter in a radially expanded state according to an embodiment of the present invention.
[0058] Figure 3 This is a schematic diagram of a reinforcement element according to an embodiment of the present invention;
[0059] Figure 4 This is a schematic diagram of each bending point in the electrode region according to an embodiment of the present invention;
[0060] Figure 5 This is a schematic diagram of the staggered arrangement of the distal electrode segment and the proximal electrode segment according to an embodiment of the present invention;
[0061] Figure 6 This is a schematic diagram of the electrode basket of the ablation catheter in a radially contracted state according to an embodiment of the present invention.
[0062] Figure 7 This is a schematic diagram of the electrode basket of the ablation catheter in a folded state according to an embodiment of the present invention.
[0063] Figure 8 This is a schematic diagram of a fixing component clamping a linear flexible electrode according to an embodiment of the present invention;
[0064] Figure 9 This is a schematic diagram of the first fixing member according to an embodiment of the present invention;
[0065] Figure 10 This is a schematic diagram of the second fastener according to an embodiment of the present invention;
[0066] Figure 11 An axial cross-sectional view of the first and second fixing members clamping a linear flexible electrode according to an embodiment of the present invention;
[0067] Figure 12 This is another schematic diagram of a fixing component clamping a linear flexible electrode according to an embodiment of the present invention;
[0068] Figure 13 This is another axial cross-sectional view of the first and second fixing members clamping a linear flexible electrode according to an embodiment of the present invention.
[0069] Figure 14 This is a schematic diagram of a positioning slot according to an embodiment of the present invention;
[0070] Figure 15 This is another schematic diagram of the positioning slot according to an embodiment of the present invention.
[0071] In the attached image:
[0072] 10-Linear flexible electrode; 11-Connecting unit; 110-Alignment hole; 111-Reinforcement; 1111-Through hole; 1112-Extension; 12-Electrode region; 120-Ablation electrode; 121-Distal electrode segment; 122-Proximal electrode segment; 123-Intermediate bending segment; 124-Distal bending segment; 125-Proximal bending segment; 126-Free segment; 13-Electrode carrier;
[0073] 20-Outer tube;
[0074] 30 - Catheter shaft; 31 - Inner shaft; 32 - Cannula;
[0075] 40-Electrode basket;
[0076] 50 - Fixing component; 51 - First fixing member; 511 - First straight portion; 512 - First rounded corner portion; 52 - Second fixing member; 521 - Second straight portion; 522 - Second rounded corner portion;
[0077] 60 - Positioning slot;
[0078] 70 - Hollow component. Detailed Implementation
[0079] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.
[0080] As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature. “One end” and “the other end,” as well as “proximal end” and “distal end,” generally refer to two corresponding parts, including not only endpoints. The terms “installed,” “connected,” and “joined” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral part; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or a connection within two elements or an interaction between two elements. Furthermore, as used in this invention, the phrase "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located arbitrarily inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.
[0081] In this article, "proximal" and "distal" are defined as follows: "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.
[0082] Figure 1 This is a schematic diagram of a linear flexible electrode according to an embodiment of the present invention. Figure 1As shown, an embodiment of the present invention schematically provides a linear flexible electrode 10. The linear flexible electrode 10 extends in a linear direction in the form of a strip or band. The linear flexible electrode 10 includes a connecting unit 11 and two electrode regions 12. The electrode regions 12 extend in a linear direction and can release ablation energy to the lesion area. The two electrode regions 12 are connected by the connecting unit 11, which has an alignment portion. The linear flexible electrode 10 can be installed onto the catheter shaft 30 of the ablation catheter 20 through the alignment portion. In one embodiment, the alignment portion of the connecting unit 11 is configured as a through alignment hole 110. Further, the axial direction of the alignment hole 110 can be understood as the vertical direction of the strip or band-shaped linear flexible electrode 10. Preferably, the two electrode regions 12 and the connecting unit 11 are an integral structure. The linear flexible electrode 10 is applied to an ablation catheter. Figure 2 This is a schematic diagram of the electrode basket of the ablation catheter in a radially expanded state according to an embodiment of the present invention. (See attached diagram.) Figure 2 The ablation catheter includes an outer tube 20 and a catheter shaft 30 movably inserted within the outer tube 20. A linear flexible electrode 10 is configured to be mounted onto the catheter shaft 30 through an alignment hole 110 (i.e., fixed to the catheter shaft 30 via the alignment hole 110) and to be mounted onto the outer tube 20 through an electrode region 12 away from the connecting unit 11, thereby assembling the linear flexible electrode 10 onto the ablation catheter. The linear flexible electrode 10 can release ablation energy (pulse, ultrasound, radiofrequency, etc.) to the lesion area within the patient's body, thereby performing ablation treatment on the patient. Specifically, the ablation energy is released through the electrode region 12.
[0083] In another embodiment, the alignment portion can be located at the end of the catheter shaft 30 (the distal end of the catheter shaft 30), thereby allowing the middle portion of the linear flexible electrode 10 to be positioned at the end of the catheter shaft 30. The alignment portion is solid rather than perforated, but allows a medical guidewire to pass through without affecting its application. For example, the distal end of the catheter shaft 30 has an axially recessed groove, and the alignment portion can be engaged and fixed in the groove of the catheter shaft 30. Alternatively, the distal end of the catheter shaft 30 can be fixedly connected to a fixing component 50, which has a groove. The alignment portion is engaged and fixed in the groove. Further, the fixing component 50 includes a first fixing member 51 and a second fixing member 52. The first fixing member 51 is fixed to the distal end of the catheter shaft 30 and has a recessed groove. The alignment portion of the linear flexible electrode 10 is engaged and fixed in the groove of the first fixing member 51, and then the second fixing member 52 cooperates with the first fixing member 51 to press the alignment portion firmly.
[0084] It should be noted that the linear flexible electrode 10 is flexible and can change its shape. For example, it can be in a straight shape, a curled shape or a folded shape under the action of external force. In this way, after the linear flexible electrode 10 is assembled onto the ablation catheter, it can change its shape based on the relative movement of the outer tube 20 and the catheter shaft 30. Specifically, the shape of each electrode area 12 is changed. Specifically, the opposing movements of the outer tube 20 and the catheter shaft 30 cause the electrode region 12 to gradually straighten and be in a flat state. At this time, the extension direction of the electrode region 12 is roughly parallel to the axial direction of the catheter shaft 30 and roughly attached to the catheter shaft 30. The opposing movements of the outer tube 20 and the catheter shaft 30 cause the electrode region 12 to gradually curl and be in a curled state. That is, the electrode region 12 gradually moves away from the catheter shaft 30 radially outward. Furthermore, when the stroke of the opposing movements of the outer tube 20 and the catheter shaft 30 reaches its maximum, that is, when the distance between the distal end of the outer tube 20 and the distal end of the catheter shaft 30 is closest, the degree of outward expansion of the electrode region 12 radially outward reaches its maximum. At this time, the electrode region 12 is roughly in a folded state, specifically referring to the electrode region 12 being folded at a certain point.
[0085] Regarding the structure of the linear flexible electrode 10, the linear flexible electrode 10 includes an ablation electrode 120 and an electrode carrier extending along a linear direction. The ablation electrode 120 is disposed on the electrode carrier to form two electrode regions 12. In other words, each electrode region 12 includes multiple ablation electrodes 120, and the electrode region 12 releases ablation energy through the ablation electrodes 120. The portion of the electrode carrier located between the two electrode regions 12 does not have an ablation electrode 120, so that the portion of the electrode carrier located between the two electrode regions 12 is configured as an alignment portion, which allows the guide wire to pass through. Alternatively, a through hole is formed in the portion of the electrode carrier located between the two electrode regions 12, and this through hole is configured as an alignment hole 110 for connecting unit 11.
[0086] Figure 3 This is a schematic diagram of a reinforcement member according to an embodiment of the present invention. (See attached diagram.) Figure 3Preferably, the connecting unit 11 further includes a reinforcing member 111, which is disposed on the electrode carrier and connected to the alignment portion to limit the deformation of the alignment portion. Specifically, taking the alignment portion as an alignment hole 10, the reinforcing member 111 is disposed on the electrode carrier to increase the rigidity of the connecting unit 11, thereby enhancing the strength of the alignment hole 110 and preventing deformation of the alignment hole 110, including fracture deformation, compressive and tensile deformation, etc., so that the linear flexible electrode 10 can be more stably installed on the guide shaft 30. In one embodiment, the reinforcing member 111 has a through hole 1111 and extensions 1112 located on both radial sides of the through hole 1111. The through hole 1111 is arranged around the alignment hole 110, and the extensions 1112 are connected to the electrode carrier in a linear direction, that is, the direction of the two extensions 1112 is consistent with the direction of the electrode carrier. Preferably, the through hole 1111 and the alignment hole 110 are coaxial, and the diameter of the through hole 1111 is greater than or equal to the diameter of the alignment hole 110. The material of the reinforcing member 111 is metal. In this way, the through hole 1111 of the reinforcing member 111 facilitates the alignment and installation of the reinforcing member 111 into the alignment hole 110, and the extension 1112 can enhance the strength of the connecting unit 11 and minimize deformation of the alignment hole 110.
[0087] Further reading Figure 1 Electrode region 12 includes two electrode segments arranged at intervals: a distal electrode segment 121 and a proximal electrode segment 122. The distal electrode segment 121 is closer to the connecting unit 11 than the proximal electrode segment 122. The electrode segments extend in a linear direction, and electrode region 12 is used to release ablation energy through the electrode segments. Understandably, each electrode segment includes multiple ablation electrodes 120 to release ablation energy. Understandably, after the linear flexible electrode 10 is mounted on the ablation catheter (specifically, at the distal end of the ablation catheter), the distal electrode segment 121 is located at the distal end of electrode region 12, and the proximal electrode segment 122 is located at the proximal end of electrode region 12. Ablation energy is released through the distal electrode segment 121 and the proximal electrode segment 122.
[0088] Furthermore, electrode region 12 also includes a bendable intermediate bending section 123, through which distal electrode segment 121 and proximal electrode segment 122 are connected. Thus, when electrode region 12 changes shape due to the relative movement of outer tube 20 and conduit shaft 30, the deformation of intermediate bending section 123 allows distal electrode segment 121 and proximal electrode segment 122 to gradually move away, resulting in a roughly straight electrode region 12; or it allows them to gradually move closer, resulting in a roughly curled electrode region 12, and ultimately a folded shape. In the folded shape, distal electrode segment 121 and proximal electrode segment 122 are approximately folded together by the bending deformation of intermediate bending section 123. The bending point of intermediate bending section 123 can be defined as B, and intermediate bending section 123 bends at point B.
[0089] Figure 4 This is a schematic diagram of the bending points in the electrode region according to an embodiment of the present invention. (See attached diagram.) Figure 4 Furthermore, the electrode region 12 also includes a distal bending segment 124 and a proximal bending segment 125, both of which are bendable and deformable. The distal electrode segment 121 is connected to the connecting unit 11 through the distal bending segment 124, and the proximal bending segment 125 is connected to the proximal electrode segment 122. The bending point of the distal bending segment 124 can be defined as A, and the distal bending segment 124 bends at point A. The bending point of the proximal bending segment 125 is defined as C, and the proximal bending point bends at point C. Preferably, the distance between B and C is greater than the distance between A and B. This ensures that when the electrode region 12 is in a curled state, the distal electrode segment 121 and the proximal electrode segment 122 work together to enhance the forward probing effect of the electrode region 12, improve the adhesion between the distal electrode segment 121 and the proximal electrode segment 122 and the tissue of the lesion area, and enhance the ablation treatment effect on the lesion area.
[0090] Through practice, the inventors discovered that if the distance between B and C is much greater than the distance between A and B, the positions of the bending points B and C are prone to change with the shape of the electrode region 12, thus affecting the bending performance of the electrode region 12. To avoid this problem, the inventors found that the ratio of the distance between A and B to the distance between B and C can be set to greater than or equal to 65% and less than or equal to 95%. To further improve the forward probing effect of the electrode region 12, the deformation capacity of the portion of the electrode region 12 located between B and C can be configured to be less than that of the portion of the electrode region 12 located between A and B, that is, the hardness of the electrode region 12 between B and C is greater than that between A and B. Specifically, a reinforcing substrate (such as an elastic nickel-titanium alloy) can be added to the electrode carrier between B and C, or the width and / or thickness of the electrode carrier between B and C can be increased. (Continue reading...) Figure 4Preferably, B is located at the midpoint of the intermediate bend 123, the distal bend 124 is connected to the end of the connecting unit 11 and is configured as A, the electrode region 12 also includes a free section 126 connected to the proximal bend 125, the free section 126 is used to connect to the outer tube 20, specifically the free section 126 is connected to the inner wall of the outer tube 20, and the end of the proximal bend 125 connected to the free section 126 is configured as C.
[0091] Preferably, the electrode segment includes a plurality of ablation electrodes 120 arranged at intervals. After the distal electrode segment 121 and the proximal electrode segment 122 are brought closer together by B-bending, the ablation electrodes 120 of the distal electrode segment 121 and the ablation electrodes 120 of the proximal electrode segment 122 are arranged alternately along a linear direction, which can increase the electrode density and improve the ablation treatment effect.
[0092] Preferably, in at least one of the two electrode regions 12, the surfaces of the distal electrode segment 121 and the proximal electrode segment 122 that release ablation energy are opposite to each other along the bending direction of the intermediate bending section 123. That is, when the electrode region 12 is not bent, the surfaces of the distal electrode segment 121 and the proximal electrode segment 122 that release ablation energy face away from each other. This allows the surfaces of the distal electrode segment 121 and the proximal electrode segment 122 to adhere to the tissue of the lesion area after being bent into a folded state by the intermediate bending section 123. Understandably, the surface of the electrode segment that releases ablation energy is also the end face of the ablation electrode 120 corresponding to the electrode carrier. Specifically, the ablation electrode 120 of the distal electrode segment 121 and the ablation electrode 120 of the proximal electrode segment 122 are located on opposite end faces of the electrode carrier. Typically, when the electrode area 12 is in a flat shape and roughly abuts against the catheter shaft 30, the ablation electrode 120 of the distal electrode segment 121 is located on the outer end face of the electrode carrier, and the ablation electrode 120 of the proximal electrode segment 122 is located on the inner end face of the electrode carrier. When the electrode area 12 is in a folded shape, the ablation electrode 120 of the distal electrode segment 121 and the ablation electrode 120 of the proximal electrode segment 122 both face distally, thus allowing them to abut against the tissue of the lesion area.
[0093] Furthermore, the distances from the nearest ablation electrode 120 to the alignment portion (specifically, the alignment hole 110) in the distal electrode segments 121 corresponding to the two electrode regions 12 are not the same. To clarify, the distance from the nearest ablation electrode 120 to the alignment portion in the distal electrode segment 121 corresponding to one electrode region 12 is a first distance, and the distance from the nearest ablation electrode 120 to the alignment portion in the distal electrode segment 121 corresponding to the other electrode region 12 is a second distance; the first distance and the second distance are not equal.
[0094] Preferably, the positioning of the aligning portion is configured such that after the two electrode regions 12 are folded and overlapped about the aligning portion, the ablation electrodes 120 of the distal electrode segment 121 of one electrode region 12 and the ablation electrodes 120 of the distal electrode segment 121 of the other electrode region 12 are staggered with each other in a linear direction, and / or, the ablation electrodes 120 of the proximal electrode segment 122 of one electrode region 12 and the ablation electrodes 120 of the proximal electrode segment 122 of the other electrode region 12 are staggered with each other in a linear direction. This allows for an increase in the electrode density of the electrode region 12 acting on the tissue after it is folded and attached to the tissue, thereby improving the ablation treatment effect.
[0095] Figure 5 This is a schematic diagram illustrating the staggered arrangement of the distal and proximal electrode segments according to an embodiment of the present invention. (See attached diagram.) Figure 5 Preferably, in at least one of the two electrode regions 12, the distal electrode segment 121 and the proximal electrode segment 122 are staggered in an S-shape. This ensures that after the electrode region 12 is folded, the corresponding distal electrode segment 121 and proximal electrode segment 122 are staggered instead of being folded together as a whole. This ensures that both the distal electrode segment 121 and the proximal electrode segment 122 can adhere to the tissue, thereby increasing the density of the ablation electrode 120 acting on the tissue.
[0096] Regarding the structure of the electrode carrier, the electrode carrier has a multilayer structure, including a base layer, a circuit layer, an insulating layer, and a pad layer (not shown). The circuit layer is located between the base layer and the insulating layer, and the insulating layer is located between the pad layer and the circuit layer. The pad layer is electrically connected to the circuit layer. The ablation electrode 120 is disposed on the pad layer, and ablation energy is transmitted to the ablation electrode 120 located on the pad layer through the circuit layer. Preferably, a reinforcing substrate (such as an elastic nickel-titanium alloy) can be added to the base layer to improve the elasticity and hardness of the overall structure of the linear flexible electrode 10 and improve the support force of the linear flexible electrode 10. The materials of the pad layer and the circuit layer are metals, such as copper or gold, and the materials of the base layer and the insulating layer can be polyimide or LCP (liquid crystal polymer). Based on this, a portion of the electrode carrier located between the two electrode regions 12 is configured as an alignment portion that allows the guide wire to pass through, and the alignment portion also has the above-described multilayer structure.
[0097] Furthermore, the ablation electrodes 120 corresponding to the distal electrode segment 121 and the proximal electrode segment 122 are located on two different end faces of the electrode carrier. The base layer has a circuit layer, an insulating layer and a pad layer on both sides, so that the ablation electrodes 120 can be installed not only on the outer end face of the electrode carrier, but also on the inner end face of the electrode carrier.
[0098] Figure 6 This is a schematic diagram of the electrode basket of an ablation catheter according to an embodiment of the present invention in a radially contracted state. (See attached diagram.) Figure 2 and Figure 6 Based on the aforementioned linear flexible electrode 10, this embodiment also provides an ablation catheter, which includes an outer tube 20, a catheter shaft 30, and an electrode basket 40. The catheter shaft 30 is movably inserted into the outer tube 20. The distal end of the electrode basket 40 is connected to the catheter shaft 30, and the proximal end of the electrode basket 40 is connected to the outer tube 20. The electrode basket 40 oscillates radially as it moves axially relative to the outer tube 20 and the catheter shaft 30. Figure 6 (as shown) and radial expansion morphology ( Figure 2 The electrode basket 40 is switched between the radially contracted and radially expanded states. When the electrode basket 40 is in the radially contracted state, it contracts radially inward along the catheter shaft 30 to abut against the catheter shaft 30. When the electrode basket 40 is in the radially expanded state, it expands radially outward along the catheter shaft 30 to move away from the catheter shaft 30. Figure 7 This is a schematic diagram of the electrode basket of the ablation catheter according to an embodiment of the present invention in a folded state. (See attached diagram.) Figure 7 When the radial expansion of the electrode basket 40 reaches its maximum, the proximal and distal ends of the electrode basket 40 are approximately touching, causing the electrode basket 40 to be in a roughly folded state. Figure 7 As shown, it is roughly umbrella-shaped.
[0099] The electrode basket 40 includes multiple linear flexible electrodes 10 as described above, and these linear flexible electrodes 10 are distributed circumferentially along the conduit shaft 30. The connecting unit 11 of the linear flexible electrodes 10 is mounted on the conduit shaft 30 via an alignment portion. This can be either sleeved onto the conduit shaft 30 in the form of an alignment hole 110, or it can be an alignment portion of a solid body disposed in a groove of the conduit shaft 30. Thus, multiple linear flexible electrodes 10 are stacked sequentially on the conduit shaft 30. The distal end of the electrode basket 40 is the assembly of the connecting units 11 of the multiple linear flexible electrodes 10. The end of the electrode region 12 furthest from the connecting unit 11 is mounted on the outer tube 20, and the proximal end of the electrode basket 40 is the assembly of the end of the electrode region 12 furthest from the connecting unit 11 among the multiple linear flexible electrodes 10.
[0100] Preferably, multiple linear flexible electrodes 10 are evenly arranged along the circumference of the conduit axis 30. For example, three linear flexible electrodes 10 are distributed sequentially along the circumference of the conduit axis 30, and the circumferential angle between two adjacent linear flexible electrodes 10 along the conduit axis 30 is 120°.
[0101] Furthermore, the distances from the nearest ablation electrode 120 to the aligning portion in the distal electrode segments 122 corresponding to the two electrode regions 12 are not the same; the two electrode regions 12 are the first electrode region and the second electrode region, respectively. Therefore, the distance from the nearest ablation electrode 120 to the aligning portion in the distal electrode segment 122 of the first electrode region is different from the distance from the nearest ablation electrode 120 to the aligning portion in the distal electrode segment 122 of the second electrode region. All the first electrode regions and all the second electrode regions are sequentially staggered along the circumference of the catheter axis 30. That is, after all the linear flexible electrodes 10 are assembled onto the catheter axis 30, for all the first and second electrode regions, one first electrode region is arranged between two adjacent second electrode regions and one second electrode region is arranged between two adjacent first electrode regions in the circumference of the catheter axis 30. This increases the density of the ablation electrode 120 adhering to the tissue.
[0102] Further reading Figure 6 and Figure 7 The ablation catheter also includes a fixing component 50, which is disposed on the catheter shaft 30 (specifically, at the distal end of the catheter shaft 30) to fix multiple linear flexible electrodes 10 to the catheter shaft 30. The alignment portion can be installed in a groove of the fixing component 50. In one embodiment, see [reference needed]. Figure 8 , Figure 8This is a schematic diagram of a fixing component clamping a linear flexible electrode according to an embodiment of the present invention. The fixing component 50 includes a first fixing member 51 and a second fixing member 52. One of the first fixing member 51 and the second fixing member 52 is sleeved on the conduit shaft 30. Alternatively, both the first fixing member 51 and the second fixing member 52 can be sleeved on the conduit shaft 30. Multiple linear flexible electrodes 10 are located between the first fixing member 51 and the second fixing member 52. The first fixing member 51 and the second fixing member 52 cooperate to press and clamp the multiple linear flexible electrodes 10 along the axial direction of the conduit shaft 30. The materials of the first fixing member 51 and the second fixing member 52 can be metals with good biocompatibility, such as 304 stainless steel. The first fixing member 51 and the second fixing member 52 can clamp the multiple linear flexible electrodes 10 without gaps, ensuring that the linear flexible electrodes 10 are protected at the structurally weak points near the alignment hole 110 and will not break due to stress concentration during bending. Preferably, the second fixing member 52 is closer to the distal end of the conduit shaft 30 than the first fixing member 51. Both the first fixing member 51 and the second fixing member 52 can be annular cylindrical. It should be noted that the clamping area formed by the first fixing member 51 and the second fixing member 52 for clamping the linear flexible electrode 10 is typically annular, with an inner diameter generally between 1.0mm and 1.6mm and an outer diameter between 2.0mm and 3.0mm. As a further detail of the implementation, the conduit shaft 30 includes an inner shaft 31 and a sleeve 32. The sleeve 32 is fitted onto the distal end of the inner shaft 31, and the first fixing member 51 is fitted onto the sleeve 32. The second fixing member 52 can be threaded to the sleeve 32 or the inner shaft 31, or it can be inserted into a hole-like structure at the distal end of the inner shaft 31. The inner shaft 31 can be a tubular structure, such as a braided mesh, and the material can be a thermoplastic elastomer, such as Pebax, TPU, etc., or an outer layer of polyimide / inner layer of Teflon, with the braided filaments made of stainless steel.
[0103] Figure 9 This is a schematic diagram of the first fixing member according to an embodiment of the present invention. (See attached diagram.) Figure 9 Preferably, the end of the first fixing member 51 facing the second fixing member 52 is the first clamping end. The first clamping end is protruding and includes a first straight portion 511 and a first rounded portion 512 surrounding the first straight portion 511. The first straight portion 511 is perpendicular to the axial direction of the conduit shaft 30, and the opening of the first rounded portion 512 faces the conduit shaft 30. Figure 10 This is a schematic diagram of the second fastener according to an embodiment of the present invention. It should be noted that... Figure 10 The focus is on illustrating the structure of the second fastener 52; the first fastener 51 is not shown. See reference [link to documentation]. Figure 10The end of the second fixing member 52 facing the first fixing member 51 is the second clamping end. The second clamping end is concave and includes a second straight portion 521 and a second rounded portion 522 surrounding the second straight portion 521. The second straight portion 521 is perpendicular to the axial direction of the conduit shaft 30, and the opening of the second rounded portion 522 faces the conduit shaft 30. The first clamping end is positioned within the radial range of the second clamping end along the conduit shaft 30, allowing the protruding first clamping end to enter the concave second clamping end. Figure 11 This is an axial cross-sectional view of the first and second fixing members clamping the linear flexible electrode according to an embodiment of the present invention. With this configuration, the first fixing member 51 and the second fixing member 52 can both be sleeved on the catheter shaft 30, and the first straight portion 511 and the second straight portion 521 can cooperate to clamp the linear flexible electrode 10 at the weak point around the alignment hole 110, so as to protect it. The first rounded portion 512 can guide the transition of the linear flexible electrode 10, so as to avoid damage to the linear flexible electrode 10 when the electrode basket 40 changes shape. The second rounded portion 522 can ensure that the electrode area 12 of the linear flexible electrode 10 converges towards the proximal end of the catheter shaft 30 and is in a gradually straight shape, so as to improve the contraction performance of the ablation catheter through the sheath.
[0104] Figure 12 This is another schematic diagram of a fixing component clamping a linear flexible electrode according to an embodiment of the present invention. Figure 13 This is another axial cross-sectional view of the first and second fixing members clamping a linear flexible electrode according to an embodiment of the present invention. (See also...) Figure 12 and Figure 13 In this embodiment, the first fixing member 51 can be sleeved and fixed to the distal end of the guide shaft 30, and the first fixing member 51 has a groove for accommodating the alignment portion. The second fixing member 52 is axially engaged and fixed to the first fixing member 51. The first fixing member 51 and the second fixing member 52 thereby axially press the alignment portions of the multiple linear flexible electrodes 10 stacked in the groove. Of course, the second fixing member 52 can also be an axially recessed groove for accommodating the alignment portion.
[0105] To meet the angular positioning requirements after multiple linear flexible electrodes 10 are clamped and fixed on the catheter shaft 30, the ablation catheter also includes an angle positioning structure. The angle positioning structure is disposed on the catheter shaft 30 and / or the fixing assembly (disposed on the first fixing member 51 and / or the second fixing member 52). The angle positioning structure is used to limit the circumferential angle between two adjacent linear flexible electrodes 10 along the catheter shaft 30. For example, the circumferential angle between two adjacent linear flexible electrodes 10 along the catheter shaft 30 can be limited to 120°.
[0106] In one embodiment, the angle positioning structure includes a plurality of positioning slots 60. Figure 14This is a schematic diagram of a positioning slot according to an embodiment of the present invention. (See attached diagram.) Figure 11 The positioning slot 60 can be disposed on the second fixing member 52. Specifically, the positioning slot 60 is recessed along the axial direction of the conduit shaft 30 at one end of the second fixing member 52 facing the first fixing member 51, and multiple positioning slots 60 are distributed circumferentially along the conduit shaft 30. In some other embodiments, the positioning slot 60 can also be disposed on the second rounded corner portion 522 of the second fixing member 52. Similarly, the positioning slot 60 can also be disposed on the first fixing member 51. Specifically, the positioning slot 60 is recessed along the axial direction of the conduit shaft 30 at one end of the first fixing member 52 facing the second fixing member 52. Of course, the positioning slot 60 can also be disposed on the first rounded corner portion 512 of the first fixing member 51. Each positioning slot 60 is used to accommodate a segment of electrode region 12. It is understood that, considering that each linear flexible electrode 10 includes two segments of electrode region 12, every two positioning slots 60 are set as a group, and the two positioning slots 60 in a group are located on the same radial direction of the conduit shaft 30. The included angle between two adjacent linear flexible electrodes 10 is limited by the circumferential included angle between the positioning slots 60 along the guide shaft 30.
[0107] Figure 15 This is another schematic diagram of the positioning slot according to an embodiment of the present invention, see reference. Figure 15 In some other embodiments, the ablation catheter includes a hollow part 70 sleeved on the catheter shaft 30, and a positioning groove 60 can be provided on the hollow part 70. Specifically, the positioning groove 60 is recessed in the hollow part 70 along the axial direction of the catheter shaft 30, and multiple positioning grooves 60 are distributed along the circumference of the catheter shaft 30.
[0108] Based on the ablation catheter described above, this embodiment also provides an ablation system, which includes an energy supply platform and the ablation catheter as described above. The energy supply platform is electrically connected to a linear flexible electrode 10 to provide ablation energy to the electrode area 12 of the linear flexible electrode, so that the electrode area 12 releases ablation energy to the tissue of the lesion area through the ablation electrode 120. The ablation energy includes, but is not limited to, pulse, ultrasound, and radiofrequency.
[0109] Accordingly, this embodiment also provides a method for manufacturing an ablation catheter, the method comprising:
[0110] Step 1: Sleeve and fix the first fixing member 51 onto the guide shaft 30. Optionally, before sleeve the first fixing member 51, the sleeve 32 can be sleeved and fixed onto the inner shaft 31 first, and then the first fixing member 51 can be sleeved and fixed onto the sleeve 32. The fixing method can be adhesive bonding or laser welding. Preferably, the sleeve 32 and the inner shaft 31 are bonded together to avoid damage to the inner shaft 31.
[0111] Step 2: The linear flexible electrodes 10 are positioned on the conduit shaft 30 or the first fixing member 51 through their respective alignment portions, so that multiple linear flexible electrodes 10 are sequentially stacked along the axial direction of the conduit shaft 30. For example, multiple linear flexible electrodes can be sequentially stacked on the conduit shaft 30 through their respective alignment portions in the form of alignment holes 110.
[0112] Step 3: The stacked linear flexible electrodes 10 are axially clamped and pressed together by the cooperation of the second fixing member 52 and the first fixing member 51. Specifically, the second fixing member 52 is sleeved on the guide shaft 30 and cooperates with the first fixing member 51 to clamp and press together the multiple linear flexible electrodes 10. The fixing method between the second fixing member 52 and the inner shaft 31 can be adhesive bonding or laser welding. Optionally, before sleeved on the second fixing member 52, an angle positioning structure is used to constrain and position the circumferential angle between two adjacent linear flexible electrodes 10 along the guide shaft 30.
[0113] Step 4: The conduit shaft 30 is movably inserted into the outer tube 20, and both ends of the linear flexible electrode 10 are fixed to the outer tube 20.
[0114] Furthermore, the manufacturing method of the ablation catheter also includes: stacking multiple linear flexible electrodes 10 and making all the first electrode areas and the second electrode areas staggered along the circumferential direction of the catheter axis, thereby increasing the electrode density of the formed basket electrode 40 in contact with the tissue.
[0115] Furthermore, before clamping and pressing multiple stacked linear flexible electrodes 10 located between the first and second fixing members, the manufacturing method of the ablation catheter further includes: radially gathering the linear flexible electrodes 10 and sleeved a hollow member 70 on the catheter shaft 30, thereby limiting the circumferential angle between two adjacent linear flexible electrodes 10 along the catheter shaft 30 by the hollow member 70.
[0116] Existing one-piece flexible basket electrodes result in significant material waste during mass production. Furthermore, when bent, stress concentration points exist between adjacent electrode segments, making them prone to cracking. In contrast, the basket electrode 40 of this invention is formed by sequentially stacking single linear flexible electrodes 10, allowing for a tight arrangement during manufacturing, which helps reduce manufacturing costs. Moreover, when the basket electrode 40 undergoes deformation, stress does not concentrate at a single point, thus preventing cracking.
[0117] While the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the present invention, shall still fall within the scope of protection of the present invention.
Claims
1. A linear flexible electrode applicable to an ablation catheter, the ablation catheter comprising an outer tube and a catheter shaft movably inserted within the outer tube, characterized in that, The linear flexible electrode includes: A connecting unit having an alignment portion; Two electrode regions, which extend in a linear direction, are connected by the connecting unit. The linear flexible electrode is configured to be mounted on the conduit shaft via the alignment portion, and mounted on the outer tube via the end of the electrode region away from the connecting unit; The electrode region includes two electrode segments arranged at intervals, namely a distal electrode segment and a proximal electrode segment. The distal electrode segment is closer to the connection unit than the proximal electrode segment. The electrode segments extend in a linear direction and are used to release ablation energy. The electrode region further includes a bendable intermediate section, a distal section, and a proximal section. The distal electrode section and the proximal electrode section are connected through the intermediate section. The distal electrode section is connected to the connecting unit through the distal section, and the proximal section is connected to the proximal electrode section. The bending point of the distal section is A, the bending point of the intermediate section is B, and the bending point of the proximal section is C. The distance between B and C is greater than the distance between A and B. The ratio of the distance between A and B to the distance between B and C is greater than or equal to 65% and less than or equal to 95%; the deformation capacity of the portion of the electrode region located between B and C is less than the deformation capacity of the portion of the electrode region located between A and B; B is located at the midpoint of the intermediate bend section; the end of the distal bend section connected to the connecting unit is configured as A; the electrode region also includes a free section connected to the proximal bend section, the free section being used to connect to the outer tube; the end of the proximal bend section connected to the free section is configured as C.
2. The linear flexible electrode according to claim 1, characterized in that, The alignment portion may be located at the end of the catheter shaft, and the alignment portion may allow the guidewire to pass through; or the alignment portion may be configured as an alignment hole through the connection unit, through which the linear flexible electrode is sleeved on the catheter shaft.
3. The linear flexible electrode according to claim 1, characterized in that, The linear flexible electrode includes an ablation electrode and an electrode carrier extending in a linear direction. The ablation electrode is disposed on the electrode carrier to form two electrode regions. A portion of the electrode carrier located between the two electrode regions is configured as the alignment portion that allows the guide wire to pass through.
4. The linear flexible electrode according to claim 3, characterized in that, The connecting unit further includes a reinforcing member disposed on the alignment portion.
5. The linear flexible electrode according to claim 4, characterized in that, The reinforcement has a through hole and extensions located on both radial sides of the through hole, the through hole being arranged around the alignment portion, and the extensions being connected to the electrode carrier in a linear direction.
6. The linear flexible electrode according to claim 1, characterized in that, The electrode segment includes multiple ablation electrodes arranged at intervals. After the distal electrode segment and the proximal electrode segment are brought together by a B-bend, the ablation electrodes of the distal electrode segment and the ablation electrodes of the proximal electrode segment are arranged alternately along a linear direction.
7. The linear flexible electrode according to claim 1, characterized in that, In at least one of the two electrode regions, the surface of the distal electrode region that releases the ablation energy and the surface of the proximal electrode region that releases the ablation energy face opposite directions when the electrode region is not bent.
8. The linear flexible electrode according to claim 1, characterized in that, The electrode segment includes a plurality of ablation electrodes arranged at intervals in sequence, and the distance from the ablation electrode closest to the alignment portion in the distal electrode segments corresponding to the two electrode regions is different.
9. The linear flexible electrode according to claim 8, characterized in that, The position of the alignment portion is configured such that after the two electrode regions are folded and overlapped about the alignment portion, the ablation electrodes of the distal electrode segment of one electrode region and the distal electrode segment of the other electrode region are staggered with each other in a linear direction, and / or the ablation electrodes of the proximal electrode segment of one electrode region and the proximal electrode segment of the other electrode region are staggered with each other in a linear direction.
10. The linear flexible electrode according to claim 1, characterized in that, In at least one of the two electrode regions, the distal electrode segment and the proximal electrode segment are staggered and arranged in an S-shape.
11. An ablation catheter, characterized in that, It includes an outer tube, a catheter shaft, and an electrode basket, wherein the electrode basket includes a plurality of linear flexible electrodes as described in any one of claims 1-10, and the plurality of linear flexible electrodes are distributed circumferentially along the catheter shaft; The electrode basket transitions between a radially contracting shape and a radially expanding shape as the outer tube and the guide shaft move axially relative to each other.
12. The ablation catheter according to claim 11, characterized in that, Multiple linear flexible electrodes are evenly arranged circumferentially along the axis of the conduit.
13. The ablation catheter according to claim 11, characterized in that, The ablation catheter also includes a fixation component. The fixing component includes a first fixing member and a second fixing member. At least one of the first fixing member and the second fixing member is sleeved on the guide shaft. Multiple linear flexible electrodes are located between the first fixing member and the second fixing member. The first fixing member and the second fixing member cooperate to press the multiple linear flexible electrodes axially together.
14. The ablation catheter according to claim 13, characterized in that, The second fixing member is closer to the distal end of the catheter shaft than the first fixing member. The end of the first fixing member facing the second fixing member is the first clamping end. The first clamping end is protruding and includes a first straight portion and a first rounded corner portion surrounding the first straight portion. The first straight portion is perpendicular to the axial direction of the catheter shaft, and the opening of the first rounded corner portion faces the catheter shaft. The end of the second fixing member facing the first fixing member is the second clamping end. The second clamping end is concave and includes a second straight portion and a second rounded corner portion surrounding the second straight portion. The second straight portion is perpendicular to the axial direction of the conduit shaft, and the opening of the second rounded corner portion faces the conduit shaft. Wherein, the first clamping end is within the radial range of the second clamping end along the axis of the conduit.
15. The ablation catheter according to any one of claims 13 or 14, characterized in that, The ablation catheter also includes an angle positioning structure, which is disposed on the catheter shaft and / or the fixing component to limit the circumferential angle between two adjacent linear flexible electrodes along the catheter shaft.
16. The ablation catheter according to claim 15, characterized in that, The angle positioning structure includes multiple positioning slots; The positioning slots are recessed along the axial direction of the guide shaft at one end of the first fixing member facing the second fixing member and / or one end of the second fixing member facing the first fixing member, and a plurality of the positioning slots are distributed circumferentially along the guide shaft. Alternatively, the ablation catheter includes a hollow component sleeved on the catheter shaft, the positioning grooves being recessed into the hollow component along the axial direction of the catheter shaft, and a plurality of the positioning grooves being distributed circumferentially along the catheter shaft.
17. The ablation catheter according to claim 11, characterized in that, The two electrode regions are the first electrode region and the second electrode region, respectively; all the first electrode regions and all the second electrode regions are distributed alternately along the circumferential direction of the conduit axis.
18. The ablation catheter according to claim 17, characterized in that, The distance from the nearest ablation electrode to the alignment site in the distal electrode segment of the first electrode region is different from the distance from the nearest ablation electrode to the alignment site in the distal electrode segment of the second electrode region.
19. A method for manufacturing an ablation catheter, applied to the ablation catheter as described in any one of claims 13-18, characterized in that, The method for manufacturing the ablation catheter includes: The first fastener is fitted onto and fixed to the guide shaft; The second fastener cooperates with the first fastener to clamp and press the multiple linear flexible electrodes stacked between the first fastener and the second fastener; The conduit shaft is movably inserted into the outer tube, and both ends of the linear flexible electrode are fixed to the outer tube; Wherein, the second fixing member is closer to the distal end of the catheter shaft than the first fixing member; the end of the first fixing member facing the second fixing member is a first clamping end, which is convex and includes a first straight portion and a first rounded corner portion surrounding the first straight portion; the first straight portion is perpendicular to the axial direction of the catheter shaft, and the opening of the first rounded corner portion faces the catheter shaft; the end of the second fixing member facing the first fixing member is a second clamping end, which is concave and includes a second straight portion and a second rounded corner portion surrounding the second straight portion; the second straight portion is perpendicular to the axial direction of the catheter shaft, and the opening of the second rounded corner portion faces the catheter shaft; the first clamping end is within the radial range of the second clamping end along the catheter shaft.
20. The method for manufacturing the ablation catheter according to claim 19, characterized in that, Before clamping and pressing the multiple stacked linear flexible electrodes located between the first fixation member and the second fixation member, the method of manufacturing the ablation catheter further includes: Multiple linear flexible electrodes are sequentially stacked on the guide tube shaft through their respective alignment portions.
21. The method for manufacturing an ablation catheter according to claim 19 or 20, characterized in that, The two electrode regions of the linear flexible electrode are a first electrode region and a second electrode region, respectively. The manufacturing method of the ablation catheter further includes: Multiple linear flexible electrodes are stacked and all the first electrode regions and all the second electrode regions are staggered along the circumferential direction of the conduit axis.
22. The method for manufacturing the ablation catheter according to claim 21, characterized in that, Before clamping and pressing the multiple stacked linear flexible electrodes located between the first fixation member and the second fixation member, the method of manufacturing the ablation catheter further includes: The linear flexible electrodes are gathered together, and a hollow component is fitted onto the conduit shaft to limit the circumferential angle between two adjacent linear flexible electrodes along the conduit shaft.
23. An ablation system, characterized in that, It includes an energy supply platform and an ablation catheter as described in any one of claims 11-18, wherein the energy supply platform is electrically connected to the linear flexible electrode to provide ablation energy to the electrode region of the linear flexible electrode.