CN-116672071-B - Linear flexible electrode, ablation catheter, manufacturing method of linear flexible electrode and ablation catheter, and ablation system

Abstract

The invention provides a linear flexible electrode, an ablation catheter, a manufacturing method thereof and an ablation system, wherein the linear flexible electrode comprises a connecting unit and two sections of electrode areas, the connecting unit is provided with a counterpoint part, the electrode areas extend along the linear direction, and the two sections of electrode areas are connected through the connecting unit; the linear flexible electrode is configured to be mounted to the catheter shaft through the alignment portion and to the outer tube through an end of the electrode region remote from the connection unit. The linear flexible electrode is provided with the alignment part matched with the catheter shaft, so that the linear flexible electrode can be conveniently assembled on the catheter shaft and the outer tube, and the mode of manufacturing the ablation catheter is simpler and the manufacturing process of the linear flexible electrode is simplified.

Inventors

• ZHOU LEI
• GUO DONGJIE
• SHI SHENGFENG
• XUE WEI

Assignees

• 上海安钛克医疗科技有限公司

Dates

Publication Date

20260512

Application Date

20230706

Claims (20)

1. 1. A linear flexible electrode applicable to an ablation catheter comprising an outer tube and a catheter shaft movably disposed through the outer tube, the linear flexible electrode comprising: a connection unit having an alignment portion; the two sections of electrode areas extend along the linear direction and are connected through the connecting unit; The linear flexible electrode is configured to be mounted to the catheter shaft through the alignment portion and to be mounted to the outer tube through an end of the electrode region remote from the connection unit; The electrode zone comprises two electrode sections which are arranged at intervals, namely a far-end electrode section and a near-end electrode section, the far-end electrode section is closer to the connecting unit relative to the near-end electrode section, the electrode sections extend along the linear direction, and the electrode sections are used for releasing ablation energy; The electrode area further comprises an intermediate bending section, a distal bending section and a proximal bending section which can be bent and deformed, and the distal electrode section and the proximal electrode section are connected through the intermediate bending section; the distal electrode section is connected to the connecting unit through the distal bending section, the proximal bending section is connected with the proximal electrode section, the bending point of the distal bending section is A, the bending point of the middle bending section is B, the bending point of the proximal bending section is C, and the distance between B and C is larger 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 deformability of the portion of the electrode zone between B and C is less than the deformability of the portion of the electrode zone between A and B, B is located at the midpoint of the middle bending section, the end of the distal bending section connected with the connecting unit is configured as A, the electrode zone further comprises a free section connected with the proximal bending section, the free section is used for being connected with the outer tube, and the end of the proximal bending section connected with the free section is configured as C.
2. 2. The linear flexible electrode according to claim 1, wherein the alignment part is located at an end of the catheter shaft and allows the guide wire to pass through, or is configured as an alignment hole penetrating the connection unit, and the linear flexible electrode is sleeved on the catheter shaft through the alignment hole.
3. 3. The linear flexible electrode of claim 1, comprising an ablation electrode and an electrode carrier extending in a linear direction, the ablation electrode being disposed on the electrode carrier so as to form two segments of the electrode region, respectively, a portion of the electrode carrier between the two segments of the electrode region being configured as the alignment portion for allowing passage of a guidewire.
4. 4. The linear flexible electrode of claim 3, wherein the connection unit further comprises a reinforcement member disposed on the alignment portion.
5. 5. The linear flexible electrode according to claim 4, wherein the reinforcement has a through hole therethrough and extension bodies located on both radial sides of the through hole, the through hole being arranged around the alignment portion, the extension bodies being connected to the electrode carrier in a linear direction.
6. 6. The linear flexible electrode of claim 1, wherein the electrode segment comprises a plurality of ablation electrodes arranged at intervals, and the ablation electrodes of the distal electrode segment and the ablation electrodes of the proximal electrode segment are staggered from each other in a linear direction after the distal electrode segment and the proximal electrode segment are brought close together by bending by B.
7. 7. The linear flexible electrode of claim 1, wherein in at least one of the two sections of the electrode zone, the active surface of the distal electrode section that releases the ablative energy and the active surface of the proximal electrode section that releases the ablative energy face away from each other when the electrode zone is not bent.
8. 8. The linear flexible electrode according to claim 1, wherein the electrode section comprises a plurality of ablation electrodes arranged at intervals in sequence, and the distance from the ablation electrode closest to the alignment part in each of the two corresponding distal electrode sections of the electrode area is different.
9. 9. The linear flexible electrode of claim 8, wherein the position of the alignment portion is configured such that, after the two electrode sections are folded in relation to the alignment portion, the ablation electrode of the distal electrode section of one electrode section and the ablation electrode of the distal electrode section of the other electrode section are staggered with each other in the linear direction, and/or the ablation electrode of the proximal electrode section of one electrode section and the ablation electrode of the proximal electrode section of the other electrode section are staggered with each other in the linear direction.
10. 10. The linear flexible electrode of claim 1, wherein in at least one of the two electrode sections, the distal electrode section and the proximal electrode section are arranged in an offset S-shape.
11. 11. An ablation catheter comprising an outer tube, a catheter shaft, and an electrode basket comprising a plurality of the linear flexible electrodes of any one of claims 1-10, the plurality of the linear flexible electrodes being distributed along a circumference of the catheter shaft; wherein the electrode basket transitions between a radially contracted configuration and a radially expanded configuration with axial relative movement between the outer tube and catheter shaft.
12. 12. The ablation catheter of claim 11, wherein a plurality of the linear flexible electrodes are uniformly arranged along a circumference of the catheter shaft.
13. 13. The ablation catheter of claim 11, further comprising a fixation assembly, The fixing assembly comprises a first fixing piece and a second fixing piece, at least one of the first fixing piece and the second fixing piece is sleeved on the catheter shaft, a plurality of linear flexible electrodes are located between the first fixing piece and the second fixing piece, and the first fixing piece and the second fixing piece are matched to axially press the linear flexible electrodes.
14. 14. The ablation catheter of claim 13, wherein the second mount is closer to the distal end of the catheter shaft than the first mount, an end of the first mount facing the second mount is a first gripping end that is convex, the first gripping end includes a first straight portion and a first rounded portion surrounding the first straight portion, the first straight portion being perpendicular to the axial direction of the catheter shaft, the first rounded portion opening toward the catheter shaft; The end, facing the first fixing piece, of the second fixing piece is a second clamping end, the second clamping end is concave, the second clamping end comprises a second straight portion and a second round corner portion surrounding the second straight portion, the second straight portion is perpendicular to the axial direction of the catheter shaft, and an opening of the second round corner portion faces the catheter shaft; Wherein the first gripping end is within a radial extent of the second gripping end along the catheter shaft.
15. 15. The ablation catheter of any of claims 13 or 14, further comprising an angular positioning structure disposed on the catheter shaft and/or the fixation assembly for limiting a circumferential included angle of adjacent two of the linear flexible electrodes along the catheter shaft.
16. 16. The ablation catheter of claim 15, wherein the angular positioning structure comprises a plurality of positioning notches; The positioning notch is concavely formed at one end of the first fixing piece facing the second fixing piece and/or one end of the second fixing piece facing the first fixing piece along the axial direction of the catheter shaft, and a plurality of positioning notches are distributed along the circumferential direction of the catheter shaft; or the ablation catheter comprises a hollow piece sleeved on the catheter shaft, the positioning notch is concavely formed on the hollow piece along the axial direction of the catheter shaft, and a plurality of positioning notches are distributed along the circumferential direction of the catheter shaft.
17. 17. The ablation catheter of claim 11, wherein the two electrode sections are respectively a first electrode section and a second electrode section, and all the first electrode sections and all the second electrode sections are sequentially staggered along the circumferential direction of the catheter shaft.
18. 18. The ablation catheter of claim 17, wherein a distance from an ablation electrode closest to the alignment portion in the distal electrode section of the first electrode section is different from a distance from the ablation electrode closest to the alignment portion in the distal electrode section of the second electrode section.
19. 19. A method of manufacturing an ablation catheter as set forth in any one of claims 13-18, the method for manufacturing the ablation catheter is characterized by comprising the following steps: Sleeving and fixing the first fixing piece on the catheter shaft; a second fixture is matched with the first fixture to clamp and press a plurality of stacked linear flexible electrodes between the first fixture and the second fixture; movably threading the catheter shaft in an outer tube and fixing both ends of the linear flexible electrode to the outer tube; The second fixing piece is closer to the distal end of the catheter shaft than the first fixing piece, one end, facing the second fixing piece, of the first fixing piece is a first clamping end, the first clamping end is in a protruding shape, the first clamping end comprises a first straight portion and a first round angle portion surrounding the first straight portion, the first straight portion is perpendicular to the axial direction of the catheter shaft, an opening of the first round angle portion faces the catheter shaft, one end, facing the first fixing piece, of the second fixing piece is a second clamping end, the second clamping end is in a concave shape, the second clamping end comprises a second straight portion and a second round angle portion surrounding the second straight portion, the second straight portion is perpendicular to the axial direction of the catheter shaft, an opening of the second round angle portion faces the catheter shaft, and the first clamping end is located in the radial range of the second clamping end along the catheter shaft.
20. 20. The method of manufacturing an ablation catheter according to claim 19, wherein prior to clamping the plurality of stacked linear flexible electrodes between the first and second fixtures, the method further comprises: And sequentially sleeving and stacking a plurality of linear flexible electrodes on the catheter shaft through respective alignment parts of the linear flexible electrodes.

Description

Linear flexible electrode, ablation catheter, manufacturing method of linear flexible electrode and ablation catheter, and ablation system Technical Field The invention relates to the technical field of electrophysiology, in particular to a linear flexible electrode, an ablation catheter, a manufacturing method of the linear flexible electrode and the ablation catheter, and an ablation system. Background Currently, in the field of electrophysiological therapy, the use of catheters to deliver energy and perform tissue ablation is one of the most common means. After the head end of the catheter enters the human body and reaches the corresponding treatment target position, energy (such as radio frequency, ultrasonic, pulse and the like) is sent through an energy platform connected with the tail end of the catheter, an energy delivery electrode is arranged at the distal end of the catheter, and the electrode is attached to the tissue and then transfers the energy to the tissue, so that tissue ablation is performed. The energy delivery carrier of the traditional catheter uses an annular electrode structure, when the electrode is positioned in the heart, most of the electrode surface of the annular electrode is still positioned in blood when the annular electrode is abutted against preset tissues, so that most of the delivered energy is released to the blood to form ineffective discharge, the power consumption of a treatment system is improved, and the treatment effect is reduced. Meanwhile, the annular electrode belongs to a rigid structure, and the flexibility of the catheter can be reduced as the number of the annular electrode is increased, so that the operation is not facilitated. The flexible circuit is more and more commonly applied in the electrophysiological field, has better flexibility compared with the traditional annular electrode, and the electrode can be arranged on one side of the tissue in an oriented way, so that the power consumption can be effectively reduced. However, in order to facilitate the assembly of the flexible circuit electrode on the catheter shaft, a complicated manufacturing process of the flexible circuit electrode is often accompanied, resulting in an increase in cost. Disclosure of Invention The invention aims to provide a linear flexible electrode, an ablation catheter, a manufacturing method thereof and an ablation system, which are used for solving the problem that in the prior art, the flexible circuit electrode is assembled on a catheter shaft conveniently and the cost is increased due to the complicated manufacturing process of the flexible circuit electrode. To solve the above-mentioned technical problem, based on a first aspect of the present invention, there is provided a linear flexible electrode applied to an ablation catheter, the ablation catheter including an outer tube and a catheter shaft movably penetrating the outer tube, the linear flexible electrode comprising: a connection unit having an alignment portion; the two sections of electrode areas extend along the linear direction and are connected through the connecting unit; the linear flexible electrode is configured to be mounted to the catheter shaft through the alignment portion and to be mounted to the outer tube through an end of the electrode region remote from the connection unit. Alternatively, the alignment part may be located at an end of the catheter shaft and may allow the guide wire to pass through, or the alignment part may be configured to penetrate through an alignment hole of the connection unit, and the linear flexible electrode is sleeved on the catheter shaft through the alignment hole. Optionally, the linear flexible electrode includes an ablation electrode and an electrode carrier extending in a linear direction, the ablation electrode being disposed on the electrode carrier so as to form two sections of the electrode regions, respectively, a portion of the electrode carrier between the two sections of the electrode regions being configured as the alignment portion allowing passage of a guide wire. Optionally, the connection unit further includes a reinforcing member, where the reinforcing member is disposed on the alignment portion. Optionally, the reinforcement member has a through hole and extension bodies located at both radial sides of the through hole, the through hole being arranged around the alignment portion, the extension bodies being connected to the electrode carrier in a linear direction. Optionally, the electrode area 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 along a linear direction, and the electrode segments are used for releasing ablation energy. Optionally, the electrode area further comprises a middle bending section, a far-end bending section and a near-end ben