CN-121987316-A - Ablation catheter, manufacturing method thereof and ablation system

Abstract

The application relates to an ablation catheter, a manufacturing method thereof and an ablation system. The system catheter comprises a main body tube, a supporting bar, a functional component, an ablation electrode and a first monitoring element, wherein the functional component is positioned at the distal end of the main body tube, the proximal end of the functional component is connected with the main body tube, the distal end of the functional component is connected with the distal end of the supporting bar, the functional component is provided with an unfolding mode and a shrinking mode, the radial dimension of the unfolding mode is larger than that of the shrinking mode, the functional component comprises a plurality of first mounting pieces and at least one second mounting piece, the plurality of first mounting pieces are distributed at intervals along the circumferential direction of the functional component, at least one second mounting piece is arranged between at least two circumferentially adjacent first mounting pieces, at least one ablation electrode is arranged on the at least one first mounting piece, the ablation electrode can release ablation energy to form an energy area, at least one first monitoring element is arranged on the at least one second mounting piece, and the first monitoring element can be used for monitoring the temperature of at least a local energy area.

Inventors

• TAN JIANWEN
• LI JIANYONG
• ZHOU WENFENG

Assignees

• 深圳迈微医疗科技有限公司

Dates

Publication Date

20260508

Application Date

20260331

Claims (20)

1. 1. An ablation catheter, comprising: A main body tube; The supporting bar penetrates through the main body pipe, the distal end of the supporting bar is positioned at one side of the distal end of the main body pipe, and the proximal end of the supporting bar is close to the proximal end of the main body pipe; a functional assembly located at a distal end of the main body tube, a proximal end of the functional assembly being connected to the main body tube, a distal end of the functional assembly being connected to a distal end of the support bar, the functional assembly having an expanded configuration and a contracted configuration, a radial dimension of the expanded configuration being greater than a radial dimension of the contracted configuration; one of the support bar and the main body tube is axially movable relative to the other to transition the functional component between the expanded configuration and the contracted configuration; The functional component comprises a plurality of first mounting pieces and at least one second mounting piece, the plurality of first mounting pieces are distributed at intervals along the circumferential direction of the functional component, and the at least one second mounting piece is arranged between two adjacent first mounting pieces at least partially in the circumferential direction; An ablation electrode, at least one of which is arranged on at least one of the first mounting members, the ablation electrode being capable of releasing ablation energy to form an energy zone, and At least one first monitoring element is arranged on at least one second mounting piece, and the first monitoring element can be used for monitoring the temperature of at least partial energy area.
2. 2. The ablation catheter of claim 1, wherein the energy region comprises at least one of a target tissue region and an environment surrounding the ablation electrode, or wherein the energy region is a target tissue region.
3. 3. The ablation catheter of claim 1, wherein at least one of the ablation electrodes on one of the first mounts has a first polarity and at least one of the ablation electrodes on the other of the first mounts that is circumferentially adjacent has a second polarity, the at least one ablation electrode having the first polarity and the at least one ablation electrode having the second polarity forming an electrode set; The at least one first monitoring element is located between the two first mountings of the electrode group along the circumference of the functional assembly.
4. 4. The ablation catheter of claim 3, wherein the enclosed area of all of the ablation electrodes of the electrode set has a central location and a central area, the central area having an axial length and a radial length, the axial length being defined as the length of the central area extending along a first axis, the first axis being parallel to the axis of the first mount and the central location being on the first axis, the radial length being the length extending along the circumference of the functional assembly, the radial length of the central area being 1% -20% of the spacing between the two first mounts where the electrode set is located; At least one ablation electrode is arranged on each of the plurality of first mounting pieces; at least a portion of at least one of the first monitoring elements is located in the central region between the ablation electrodes of its corresponding electrode set along the circumference of the functional assembly.
5. 5. The ablation catheter of claim 4, wherein the central regions are disposed between the ablation electrodes of the electrode sets formed on any two of the first mounting members adjacent to each other in the circumferential direction of the functional assembly, and at least one of the first monitoring elements is disposed in each of the central regions.
6. 6. The ablation catheter of claim 4, wherein the catheter is configured to receive a catheter, A plurality of ablation electrodes are respectively arranged on the plurality of first mounting pieces, and all the ablation electrodes on the same first mounting piece are distributed at intervals along the axial direction of the first mounting piece; the electrode set includes at least three ablation electrodes; at least a portion of at least one of the first monitoring elements is located in the central region between the ablation electrodes of its corresponding electrode set along the circumference of the functional assembly.
7. 7. The ablation catheter of claim 3, wherein the first polarity and the second polarity are the same or different.
8. 8. The ablation catheter of any of claims 4-7, wherein the electrode set has at least one overlapping electrode set comprising one ablation electrode having the first polarity and one ablation electrode having the second polarity; Projecting along the circumference of the functional component, wherein two ablation electrodes of the overlapping electrode set at least partially overlap; The first monitoring element includes a plurality of exposed segments that are located outside of the second mount and are connected to form a temperature measurement endpoint for monitoring a temperature of at least a portion of the energy region.
9. 9. The ablation catheter of claim 8, wherein the temperature measurement endpoint is located at the central region between the ablation electrodes of the at least one overlapping electrode set along a circumference of the functional assembly.
10. 10. The ablation catheter of claim 8, wherein at least one exposed segment of the first monitoring element is located in the central region between the ablation electrodes of the at least one overlapping electrode set along a circumference of the functional assembly, or The exposed segments of the first monitoring element are each located at the central region between the ablation electrodes of the overlapping electrode set along the circumference of the functional assembly.
11. 11. The ablation catheter of claim 8, wherein the electrode set has a plurality of the overlapping electrode sets, the plurality of overlapping electrode sets being spaced apart along the axis of the functional assembly; In the circumferential direction of the functional assembly, in the first monitoring element, at least one of the exposed segments is located within the central region between the ablation electrodes of one of the overlapping electrode groups, and at least another one of the exposed segments is located within the central region between the ablation electrodes of the other one of the overlapping electrode groups.
12. 12. The ablation catheter of claim 8, wherein in the electrode sets, the overlapping electrode sets are provided in a plurality, the plurality of overlapping electrode sets being spaced apart along the axis of the functional assembly, the plurality of overlapping electrode sets including a distal overlapping electrode set relatively closer to the distal end of the functional assembly and a proximal overlapping electrode set relatively closer to the proximal end of the functional assembly; In the first monitoring element, at least one of the exposed segments is located at the central region between the ablation electrodes of the distal overlapping electrode set and at least another one of the exposed segments is located at the central region between the ablation electrodes of the proximal overlapping electrode set along the circumference of the functional assembly.
13. 13. The ablation catheter of claim 8, wherein the first monitoring element comprises two wires of different materials, both wires being disposed within the second mount, and both wires having a portion of the structure exposed outside of the lumen of the second mount as the exposed section, the exposed sections of wires being connected to form the temperature measurement endpoint.
14. 14. The ablation catheter of claim 13, wherein the second mount is an insulating tube, the second mount having a plurality of mutually independent, axially extending wire lumens; each wire cavity is provided with a wire hole communicated with the outside; Each wire is accommodated in one wire cavity, the part of the wire structure is exposed to the outside of the second mounting piece through the wire hole, and the part of the wire structure exposed to the outside of the second mounting piece at the wire hole forms the exposed section.
15. 15. The ablation catheter of claim 14, wherein the second mount comprises a plurality of insulating tubes having axially extending wire lumens having wire holes in communication with the exterior; Each metal wire is accommodated in a wire cavity of one insulating tube; the partial structure of each wire is exposed to the outside of its corresponding insulating tube through the wire hole, the partial structure of the wire exposed to the outside of the second mount at the wire hole forming the exposed section.
16. 16. The ablation catheter of claim 15, wherein the plurality of insulating tubes are disposed side-by-side against the functional assembly in the same second mount or are spaced apart along the circumference of the functional assembly.
17. 17. The ablation catheter of claim 16, wherein the plurality of insulating tubes are spaced apart circumferentially of the functional assembly in the same second mount, and wherein a spacing between two adjacent insulating tubes is 0.2mm-6mm.
18. 18. The ablation catheter of claim 1, wherein the first monitoring element is configured to detect at least one physiological parameter of chemical activity, light, electrical activity, ph, pressure, fluid flow in the localized energy region.
19. 19. The ablation catheter of any of claims 1-7, further comprising at least one second monitoring element disposed on at least one of the ablation electrodes, the at least one second monitoring element being operable to monitor at least a temperature in an energy region proximate to a corresponding one of the ablation electrodes.
20. 20. The ablation catheter of any of claims 1-7, further comprising at least a second monitoring element disposed on at least one of the first mounts, the second monitoring element being operable to monitor at least a temperature of an energy region proximate to the ablation electrode on the same first mount.

Description

Ablation catheter, manufacturing method thereof and ablation system Technical Field The application relates to the technical field of medical instruments, in particular to an ablation catheter, a manufacturing method thereof and an ablation system. Background The core mechanism of radiofrequency/cryoablation is thermal damage (heating or freezing). The damage is entirely dependent on heating the tissue to a coagulative necrosis temperature (typically >50 ℃) or deep cryogenic freezing. Thus, temperature is the central endpoint parameter that must be monitored in real time. Illustratively, a catheter of the related art is provided at a distal end thereof by temporarily inserting the catheter into a human body, wherein the basket is generally formed of a plurality of splines each having one or more electrodes disposed thereon. In the case that the electrode is used as a carrier for releasing radiofrequency ablation energy to ablate target tissue, a temperature sensor is generally integrated on one spline electrode, or a temperature sensor is arranged among a plurality of electrodes of one spline, so that the temperature of the electrode and the surrounding environment of the electrode in the radiofrequency ablation process is monitored in real time to judge the temperature condition of the target tissue, and damage to the target tissue is reduced or even prevented. Pulsed electric field ablation (Pulsed Fields Ablation, PFA) is an emerging arrhythmia interventional procedure in recent years that relies on the irreversible electroporation (Irreversible Electroporation, IRE) effect to effect myocardial tissue ablation. The electrode is used as a carrier for releasing electric field ablation energy to ablate target tissues, in pulse electric field ablation, the electrode forms an electric field gradient, when the cell membrane of the target tissues is exposed to the electric field, a phospholipid bilayer of the phospholipid bilayer can generate nanoscale pores, if the electric field strength exceeds a threshold value, the pores can irreversibly expand to cause leakage and metabolic disturbance of cell contents, apoptosis or necrosis is finally initiated to form an ablation focus, and finally the purpose of ablation is achieved. However, the inventors have found that PFA treatment may still suffer from focal recurrence due to discontinuous or incomplete ablation sites, or may suffer from damage to non-target tissues. Disclosure of Invention PFA generally claims not to ablate thermally, so the temperature is not an endpoint parameter that it needs to monitor. However, to the inventors' knowledge, during the discharge of the electric field ablation, small tissue temperature rises may occur in the vicinity of the electrode or in the myocardial tissue, and such tissue temperature rises should be controlled in a range where protein denaturation may not occur in the myocardial tissue or in adjacent tissue (e.g., blood temperature exceeding 45 ℃ may cause protein denaturation, esophagus is extremely sensitive to heat, damage may occur for a period of time above 44 ℃ to cause atrial esophageal fistula), so that it is necessary to monitor the tissue temperature rises in real time to reduce or even avoid unexpected consequences, so as to optimize the problem of damage to non-target tissue (e.g., adjacent tissue as mentioned above) during the ablation, and secondly, to monitor the ablation effect of the target tissue by temperature changes (for the case where there may be leakage points, e.g., poor contact between the instrument and the target tissue or insufficient ablation energy to the target tissue, at least feedback from temperature monitoring of part of the leakage points) so as to optimize the problem of discontinuous or incomplete ablation focus causing recurrence of the lesion. In some embodiments, the present application provides an ablation catheter comprising: A main body tube; the supporting bar is penetrated in the main body tube, distal ends of the support bars being located the distal end side of the main body tube, near the support bar The end is close to the proximal end of the main body tube; The functional component is positioned at the distal end of the main body pipe, the proximal end of the functional component is connected with the main body pipe, the distal end of the functional component is connected with the distal end of the supporting bar, the functional component has an unfolding form and a shrinking form, and the radial dimension of the unfolding form is larger than that of the shrinking form; one of the support bar and the main body tube is axially movable relative to the other to switch the functional assembly between the expanded configuration and the contracted configuration; The functional component comprises a plurality of first mounting pieces and at least one second mounting piece, the plurality of first mounting pieces are distributed at intervals along the circumferential direction of