CN213525440U

CN213525440U - Ablation catheter

Info

Publication number: CN213525440U
Application number: CN202021231348.9U
Authority: CN
Inventors: 唐闽; 刘成; 王永胜
Original assignee: Hangzhou Nuomao Medtech Co ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2020-06-29
Filing date: 2020-06-29
Publication date: 2021-06-25
Anticipated expiration: 2030-06-29
Also published as: WO2022001986A1

Abstract

The utility model provides an ablation catheter, which comprises a handle and a bearing rod connected with the far end of the handle. The bearing rod comprises a marking ring and an ablating ring which are arranged at the far end, and the ablating ring is positioned between the marking ring and the handle. The marking ring and the ablating ring are both annular and extend around the axis of the bearing rod. The measuring ring is provided with a measuring electrode, the ablating ring is provided with an ablating electrode, the ablating electrode is used for transmitting ablating energy to the target tissue area, and the measuring electrode is used for transmitting electrophysiological signals in the target tissue area to the handle. The ablation catheter integrates the ablation ring and the mapping ring, so that the ablation catheter can simultaneously detect electrophysiological signals of target tissues and perform ablation on the target tissues, operation is more convenient, and the success rate of the operation is improved.

Description

Ablation catheter

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to an ablation catheter for cardiac ablation.

Background

Atrial Fibrillation (AF), abbreviated as atrial fibrillation, is the most common persistent arrhythmia, and the incidence rate of atrial fibrillation increases with the age, and reaches 10% in people over 75 years old. The exciting frequency of the atria during atrial fibrillation reaches 300-600 times per minute, the heartbeat frequency is often fast and irregular and sometimes reaches 100-160 times per minute, the heartbeat is much faster than that of a normal person and is irregular, and the atria lose effective contraction function. Atrial fibrillation generally increases the risk of acquiring many potentially fatal complications, including thromboembolic stroke, dilated cardiomyopathy, and congestive heart failure, and common symptoms of atrial fibrillation such as palpitations, chest pain, dyspnea, fatigue, and dizziness also affect quality of life. The average incidence of patients with atrial fibrillation is increased five-fold and mortality is increased two-fold compared to normal.

Tissue ablation is commonly used to treat a variety of cardiac arrhythmias, including atrial fibrillation. The principle of tissue ablation treatment is that an electrode catheter is placed into a heart cavity through femoral artery or femoral vein puncture, a focus source of cardiac arrhythmia is determined by means of a mapping guide wire, and then the ablation catheter is guided to perform ablation blocking on a target tissue area. And during ablation therapy, it is also desirable to monitor whether electrophysiological signals in the target tissue region have been isolated using the mapping guidewire. Therefore, the ablation treatment cannot be completed by separately guiding the ablation catheter into the heart cavity, the mapping guide wire needs to be guided into the heart cavity, and two devices, namely the ablation catheter and the mapping guide wire, need to be guided and operated respectively in the operation process, so that the operation steps are complex, the operation time is long, and the cost is high.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to overcome prior art's not enough, provide a collection melts and marks a pipe in melting of an organic whole, specifically include following technical scheme:

an ablation catheter comprises a handle and a bearing rod connected to the distal end of the handle, wherein the bearing rod comprises a marking ring and an ablation ring which are arranged at the distal end of the bearing rod, the ablation ring is located between the marking ring and the handle, the marking ring and the ablation ring are both annular and extend around the axis of the bearing rod, a mapping electrode is arranged on the marking ring, an ablation electrode is arranged on the ablation ring, the ablation electrode is used for transmitting ablation energy to a target tissue area, and the mapping electrode is used for transmitting electrophysiological signals in the target tissue area to the handle.

Wherein the radial dimension of the ablating loop is greater than or equal to the radial dimension of the marking loop.

The bearing rod comprises a proximal end section connected between the handle and the ablating ring, the marking ring and the proximal end section are of an integrally formed structure.

The bearing rod further comprises a connecting section connected between the ablating ring and the measuring ring, the connecting section comprises a first section and a second section, the second section is connected between the first section and the measuring ring, and one end of the second section, which is connected with the first section, is closer to the geometric center of the measuring ring than the other end of the second section, which is connected with the measuring ring; and/or

The proximal section comprises a fourth section and a fifth section, the fifth section is connected between the fourth section and the ablating loop, and one end of the fifth section connected with the fourth section is closer to the geometric center of the ablating loop than the other end connected with the marking loop.

And arc transitions are arranged at the connection part between the proximal section and the ablating ring and the connection part between the connection section and the ablating ring and the marking ring respectively.

Wherein the ablating loop is formed in a first plane and the measuring loop is formed in a second plane.

Wherein the first plane and/or the second plane are perpendicular to the axis of the carrier bar.

The number of the mapping electrodes is multiple, and the multiple mapping electrodes are arranged at intervals along the circumferential direction of the mapping ring; and/or the number of the ablation electrodes is multiple, and the positive electrode and the negative electrode in the multiple ablation electrodes are alternately arranged.

The ablation ring comprises a first ablation ring and a second ablation ring, the second ablation ring is arranged at the near end of the first ablation ring relative to the handle, and ablation electrodes are arranged on the first ablation ring and the second ablation ring.

Wherein the second ablating loop has a radial dimension that is greater than a radial dimension of the first ablating loop.

Wherein the ablation catheter further comprises a connecting section fixed on the handle, the connecting section comprising a detection interface electrically connected with the mapping ring and an energy supply interface electrically connected with the ablation ring.

The ablation catheter is provided with an inner sheath tube between the bearing rod and the handle, a traction piece is arranged in the tube wall of the inner sheath tube along the axial direction, the traction piece is connected between the far end of the inner sheath tube and the handle, and the handle is used for bending the far end of the inner sheath tube to one direction by pulling the traction piece.

The utility model provides an ablation catheter is through the distal end of carrier bar sets up simultaneously mark survey ring with the ablating loop, just be provided with the mark electrode of surveying that is arranged in detecting the electrophysiological signal in the target tissue region on the mark survey ring, be provided with on the ablating loop and be used for melting the electrode to the regional transmission of target tissue, make ablation catheter has possessed the function of surveying the mark and has surveyed simultaneously and the function of melting. Therefore, the ablation ring and the marking and measuring ring are integrated into a whole, so that the operation is more convenient and faster, and the success rate of the operation is favorably improved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural view of an ablation catheter according to a first embodiment of the present invention;

FIG. 2 is a schematic partial structural view of the ablation catheter of FIG. 1;

FIG. 3 is a schematic view of the ablation catheter shown in FIG. 2 after being bent;

FIG. 4 is a schematic view showing an internal structure of the inner sheath shown in FIG. 3;

FIG. 5 is a schematic view of the internal structure of the traction element shown in FIG. 4;

FIG. 6 is a cross-sectional view of the handle of FIG. 1 taken along line VI-VI;

fig. 7 is a partial schematic structural view of an ablation catheter according to a second embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the attached drawing figures and, thus, are used in a better and clearer sense to describe and understand the present invention rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the invention.

Orientation definition: for clarity of description, the end of the procedure that is closer to the operator will be referred to as the "proximal end" and the end that is further from the operator will be referred to as the "distal end". This definition is for convenience of presentation only and should not be construed as limiting the application, with "axial" referring to the axial direction of the load bar or the axial center line of the handle.

Please refer to fig. 1, which is a schematic structural diagram of an ablation catheter 100 according to a first embodiment of the present invention. The ablation catheter 100 provided herein is used for cardiac ablation, such as tissue ablation of the pulmonary veins, left atrial appendage, and heart chambers.

The ablation catheter 100 comprises a handle 10, an inner sheath 50 and a carrier rod 20, wherein the distal end of the handle 10 is fixedly connected with the proximal end of the inner sheath 50, the distal end of the inner sheath 50 is fixedly connected with the proximal end 201 of the carrier rod 20, and the distal end 202 of the carrier rod 20 also extends along the axis 203 thereof in a direction away from the handle 10. The central axis 203 of the present embodiment is the central axis of the carrier rod 20, and coincides with the central axis of the inner sheath tube 50 and the central axis of the handle 10. In other modified embodiments, the central axis of the carrier rod 20 is not limited and coincides with the central axis of the inner sheath tube 50 and the central axis of the handle 10.

The carrier rod 20 includes a proximal section 21, the proximal section 21 includes a proximal end 201, and the proximal section 21 is a rod-like structure. The distal end 202 of the carrier rod 20 is also spaced apart by a gauge ring 40 and an ablating loop 30, with the ablating loop 30 being positioned between the gauge ring 40 and the handle 10. The measuring ring 40 and the ablating ring 30 are both generally annular, and the measuring ring 40 and the ablating ring 30 both extend in a circular rotation around the axis 203 of the carrier rod 20. It can be understood that in the ablation catheter 100 of the present application, the axes of the measuring ring 40 and the ablating ring 30 are coincident with each other, and in practical applications, the measuring ring 40 is used to enter the pulmonary vein or the left atrial appendage and is fitted to the inner wall of the lumen in a circle, so that the axis of the ablating ring 30 is aligned with the center of the mouth of the pulmonary vein or the center of the mouth of the left atrial appendage, and the ablating ring 30 can perform ablation around the mouth of the pulmonary vein or the mouth of the left atrial appendage. In another application scenario, the mapping ring 40 and the ablating ring 30 are used to ablate tissue in the heart chamber. The pulmonary vein ablation is described below as an example, and it is understood that the ablation catheter 100 is also used to ablate other tissues in the heart. In one embodiment, the axes of the mapping 40 and ablating loops 30 are parallel to each other.

The marking ring 40 is provided with a mapping electrode 41, the marking ring 40 detects an electrophysiological signal in the target tissue region through the mapping electrode 41 to achieve a mapping function, and specifically, when the marking ring 40 is attached to the target tissue on the inner wall of the pulmonary vein, the ablation catheter 100 can perform Electromyography (EMG) intracardiac signal detection through the mapping electrode 41 on the marking ring 40. The ablating loop 30 is provided with an ablating electrode 31, and the ablating electrode 31 is used for delivering ablating energy to the target tissue region. And because the ablating loop 30 and the mapping loop 40 are arranged at intervals, when the mapping loop 40 is attached to the target tissue area, the ablating loop 30 can use the ablating electrode 31 to emit pulse energy, radio frequency energy or other energy sources to ablate the target tissue area.

The electrophysiological signals of the target tissue region are detected by the measuring ring 40, so that the ablation energy of the ablating ring 30 can be controlled, and at least part of tissues in the target tissue region are ablated and blocked by the ablation energy emitted by the ablating ring, and because the electrophysiological signals generated by different tissues in the target region are different and the reaction thresholds of the different tissues for the ablation energy are different, the ablating ring 30 can be isolated independently for the target tissues emitting the electrophysiological signals which are not expected to be generated in the target tissue region, thereby avoiding influencing the normal work of other tissues. After ablation, electrophysiological signals generated in the target tissue region meet expectations, and the purpose of eliminating atrial fibrillation is achieved. The ablation catheter 100 of the present application can perform mapping and ablation operations on target tissue by integrating the measuring ring 40 and the ablating ring 30, and the mapping and ablation operations can be performed simultaneously or in time-sharing. Compared with the scene that two devices for ablation and mapping are respectively controlled to perform ablation and mapping in the prior art, the ablation catheter 100 simplifies the operation steps of the operation, enables the operation process to be more convenient and fast, and is also beneficial to improving the success rate of the operation.

In one embodiment, the looped mapping ring 40 has a first radial dimension, the looped ablating ring 30 has a second radial dimension, and the second radial dimension is greater than or equal to the first radial dimension. In the present embodiment, the ablation energy source is a pulse, and the ablating loop 30 can ablate the target tissue in a non-contact manner along the radial direction thereof, and the ablation region formed based on the ablation energy diverges outward in a ring shape along the circumference of the ablating loop 30. The second radial dimension of the ablating loop 30 is set to be larger than or equal to the first radial dimension of the measuring loop 40, so that the ablating loop 30 can form an ablation area around the mouth outside the pulmonary vein, and the ablation area can be adapted to the anatomical structure of the mouth of the pulmonary vein.

In one embodiment, the carrier rod 20 includes a proximal section 21, an ablating loop 30 and a mapping loop 40 in sequence along the direction of the axis 203, and the ablating loop 30, the mapping loop 40 and the proximal section 21 are integrally formed. It will be appreciated that when the ablating loop 30, the mapping loop 40, and the proximal segment 21 are integrally formed, the distal end 202 of the carrier rod 20 is rotationally bent about the axis 203 to sequentially form the ablating loop 30 and the mapping loop 40. The carrier rod 20 needs to be transported and guided to the heart position through an outer sheath (not shown) sleeved outside the carrier rod 20, and the integrally formed carrier rod 20 is linearly accommodated in the outer sheath during the transportation process, and the diameter of the carrier rod can be contracted to a smaller state, so that the carrier rod can be conveniently transported in the outer sheath, and the outer sheath with a smaller diameter can be used conveniently. When released in the heart, the carrier rod 20 may automatically expand to the shape shown in fig. 1, i.e., forming spaced ablating loops 30 and mapping loops 40, for performing mapping and ablating operations of the ablation catheter 100.

Referring to fig. 1 and 2 together, in the ablation catheter 100 of the present application, the carrier rod 20 further includes a connecting section 23 connected between the ablating loop 30 and the mapping loop 40, so as to realize the spaced arrangement between the ablating loop 30 and the mapping loop 40. The connecting segment 23 includes a first segment 231 and a second segment 232, wherein the first segment 231 is connected to a distal end of the second segment 232, and the second segment 232 is connected between the first segment 231 and the mapping ring 40. The second section 232 includes an end 232a connected to the measuring ring 40 and an end 232b connected to the first section 231, and the end 232b of the second section 232 connected to the first section 231 is closer to the geometric center of the measuring ring 40 than the end 232a connected to the measuring ring 40.

In the process of pushing the handle 10 to make the measuring ring 40 enter the pulmonary vein, the pushing force on the handle 10 drives the connecting section 23 and the measuring ring 40 to move towards the pulmonary vein, if the measuring ring 40 is abutted against the tissue at the mouth of the pulmonary vein, the first section 231 is connected to one end 232b of the second section 232 closer to the geometric center of the measuring ring 40, that is, the first section 231 is not connected to the circumferential edge of the measuring ring 40, so that the first section 231 does not contact with the pulmonary vein, which is beneficial to improving the flexibility of movement of the measuring ring 40, and the measuring ring 40 can easily and smoothly enter the pulmonary vein. It can be understood that if the first section 231 of the connecting section 23 is connected to the circumferential edge of the measuring ring 40, in the case that the mapping ring 40 is pressed against the tissue at the ostium of the pulmonary vein, the first section 231 can easily apply a pushing force directly to the tissue region when the measuring ring 40 is pushed continuously, i.e. the pressure is applied to press the measuring ring 40 against the tissue, and the difficulty of sliding the measuring ring 40 into the pulmonary vein is high.

When a portion of the edge of the ring 40 abuts against the tissue at the ostium of the pulmonary vein and the distal end of the first segment 231 of the connecting segment 23 points into the ostium, the ring 40 can more easily enter the pulmonary vein. Further, in the embodiment of fig. 1, the first section 231 extends in the direction of the axis 203, and the indexing ring 40 can more easily enter the pulmonary vein with the first section 231 pointing towards the edge of the mouth of the pulmonary vein.

In this embodiment, the first segment 231 extends axially through the geometric centers of the ablating loop 30 and the measuring loop 40, and in a modified embodiment, the geometric centers of the ablating loop 30 and the measuring loop 40 are not collinear with the axis 203. In modified embodiments, the first segment 231 extends parallel to the axis 203, and in other embodiments, the first segment 231 is in an inclined relationship with respect to the axial direction, such as at an acute or obtuse angle.

The second section 232 extends at least in a radial direction, with positions on the second section 232 that are closer to the proximal end being closer to the geometric center of the target ring 40. In a modified embodiment, the second section 232 extends in both the axial and radial directions.

On the other hand, the connecting section 23 further includes a third section 233, and the third section 233 is connected between the ablating loop 30 and the first section 231. Because the first section 231 extends along the axis 203, the axis 203 passes through the geometric center of the ablating loop 30, and thus the third section 233 is connected between the geometric center and the edge of the ablating loop 30. The third section 233 is beneficial to ensure the position of the first section 231 relative to the measuring ring 40 and the ablating ring 30, so that relative displacement between the ablating ring 30 and the measuring ring 40 is not easy to occur, and the smoothness of movement and the positioning accuracy of the carrier 20 after release in body tissue are improved.

In this embodiment, the third section 233 extends in the radial direction, and one end of the third section 233 is located at the geometric center of the ablating loop 30, in a modified embodiment, the third section 233 extends in the axial direction and in the radial direction, that is, the third section 233 extends in both the axial direction and the radial direction by a predetermined length, and the third section 233 may not pass through the geometric center of the ablating loop 30.

As shown in fig. 2, proximal segment 21 includes a fourth segment 211 and a fifth segment 212, with fourth segment 211 being connected between handle 10 and fifth segment 212, more specifically, fourth segment 211 being connected between inner sheath 50 and fifth segment 212, and fifth segment 212 being connected between fourth segment 211 and ablating loop 30. The end 212b of the fifth section 212 connected to the fourth section 211 is closer to the geometric center of the ablating loop 30 than the end 212a of the ablating loop 30.

In the embodiment of fig. 1 and 2, fourth section 211 extends in the direction of axis 203. The fourth section 211 is coaxial with the first section 231 in the connecting section 23 and extends along the axis 203, so that uniform stress on the ablating loop 30 and the mapping loop 40 is facilitated, the ablating loop 30 and the mapping loop 40 can be smoothly pushed, and the probability of relative deformation of the ablating loop 30 and the mapping loop 40 in the pushing process is reduced. In modified embodiments, the fourth segment 211 is disposed parallel to the axis 203, or forms an obtuse or acute angle with the axis 203.

In this embodiment, the ablating loop 30 and the measuring loop 40 are both in an open-loop structure, so that the ablating loop 30, the measuring loop 40, the connecting section 23 and the proximal section 21 are integrally formed. In the conveying state, the bearing rod 20 is accommodated in the sheath tube linearly, the bearing rod 20 is integrally formed and assembled by multiple sections relative to the bearing rod, connecting joints among the sections arranged on the bearing rod 20 are omitted, the maximum outer diameter of the bearing rod 20 is reduced, the sheath tube with a smaller diameter is convenient to use, the loading, conveying and withdrawing of the bearing part 20 are convenient, and the safety and the reliability of the bearing rod 20 are improved. In modified embodiments, the ablating loop 30, the mapping loop 40 and the proximal section 21 are not limited to being integrally formed, nor are the ablating loop 30, the mapping loop 40, the connecting section 23 and the proximal section 21 integrally formed.

In one embodiment, the connection between the proximal segment 21 and the ablating loop 30, and the connection between the connecting segment 23 and the ablating loop 30 and the mapping loop 40, respectively, are provided with circular arc transitions. The connecting structure with the arc transition can reduce the stress concentration phenomenon of the integrally formed bearing rod 20 at the turning position, avoid cracks or fractures of the bearing rod 20 in the process of bending and forming the ablation ring 30 and the mapping ring 40, and reduce the risk of scratching and puncturing tissues by the bearing rod 20. Accordingly, a circular arc transition may also be provided within the connecting section 23, i.e. between the first section 231 and the second and

third sections

232, 233, respectively, and between the fourth and

fifth sections

211, 212 within the proximal section 21.

Referring to fig. 2, fig. 2 is a partial schematic view of the marker ring 40 and ablating loop 30 of the ablation catheter 100 of the present application. In the illustration of fig. 2, an annular ablating loop 30 is formed in a first plane 101 to facilitate forming an annular ablation region at the ostium of the pulmonary vein; an annular calibration ring 40 is formed in the second plane 102 to facilitate entry of the calibration ring 40 into the pulmonary vein and abutment with the inner wall of the pulmonary vein to position the ablating loop 30 at the ostium of the pulmonary vein in alignment with the center of the pulmonary vein, the first plane 101 is disposed perpendicular to the axis 203 of the carrier rod 20, and the second plane 102 is disposed perpendicular to the axis 203 of the carrier rod 20. In a modified embodiment, the first plane 101 or the second plane 102 is perpendicular to the axis 203 of the support rod 20, and in another modified embodiment, the first plane 101 is not parallel to the second plane 102, and/or the first plane 101 or the second plane 102 is not perpendicular to the axis 203.

In this embodiment, the first plane 101 is parallel to the second plane 102, so as to achieve the same distance between any position on the ablating loop 30 and the corresponding position on the measuring loop 40, that is, the same distance between any position where any plane perpendicular to the first plane 101 and the second plane 102 intersects with the ablating loop 30 and the measuring loop 40, respectively, so as to control the ablating energy output by the ablating loop 30 according to the detection result of the measuring loop 40. And the first plane 101 and the second plane 102 are both arranged perpendicular to the axis 203 of the carrier rod 20 to facilitate positioning of the mapping ring 40 and the ablating ring 30 with the handle 10 during a surgical procedure.

In other embodiments, the ablating loop 30, which is not limited to being annular, is formed in a first plane 101, the marking loop 40, which is annular, is formed in a second plane 102, the first plane 101 is disposed perpendicular to the axis 203 of the carrier rod 20, and the second plane 102 is disposed perpendicular to the axis 203 of the carrier rod 20.

Referring further to fig. 2, the number of the mapping electrodes 41 on the mapping ring 40 is multiple, and the multiple mapping electrodes 41 are spaced apart along the circumference of the mapping ring 40. Preferably, the plurality of mapping electrodes 41 are evenly spaced along the circumference of the mapping ring 40. The multiple mapping electrodes 41 can collect electrophysiological signals from multiple directions for a target tissue region, which is beneficial to quickly and accurately locating a lesion.

The ablation electrode 31 is also plural in number, and the plural ablation electrodes 31 are also provided at intervals in the circumferential direction of the ablating ring 30. Preferably, the plurality of ablation electrodes 31 are evenly spaced along the circumference of the ablating loop 30. The plurality of ablation electrodes 31 can emit ablation energy from a plurality of directions, and the ablation energy emitted from the ablating loop 30 forms a ring shape, which effectively acts on the target tissue region to isolate the lesion.

In this embodiment, the ablation catheter 100 of the present application uses a pulsed energy source for ablation. The ablation of the pulse energy is to use a high-intensity pulse electric field to cause irreversible electric breakdown of a cell membrane, which is called irreversible electroporation (IRE) in the medical field, so that the cell apoptosis is realized to ablate the cell by non-thermal effect without being affected by the heat sink effect. The high-voltage pulse sequence generates less heat, does not need normal saline to wash and cool, and can effectively reduce the occurrence of air explosion, eschar and thrombus. And the treatment time for pulse ablation is short, usually less than 1 minute for a set of pulse sequences, and the total ablation time is usually no more than 5 minutes. Because different target tissues have difference to the response threshold value of the pulse electric field, other adjacent tissues can not be interfered when the cardiac muscle is ablated, and the esophagus and the phrenic nerve tissues adjacent to the pulmonary vein are prevented from being injured by mistake.

On the other hand, pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed in the range of the intensity of the pulse electric field emitted by the ablating ring 30 can be subjected to electroporation, so that the requirement on the pressure of the ablation catheter 100 attached to the target tissues during ablation is reduced. That is, the ablation catheter 100 of the present application need not fully conform the ablating loop 30 to the inner wall of the target tissue after entering the atrium. After the ablation is completed, the intracardiac electrophysiological signals can be monitored in time through the measuring ring 40 to judge whether the target tissue is completely electrically isolated.

For the ablation catheter 100 using the pulse energy, the plurality of ablation electrodes 31 distributed on the ablation ring 30 also need to be arranged with their positive and negative electrodes arranged alternately, so as to ensure that the pulse energy generates a closed-loop injury region through the plurality of ablation electrodes 31.

Referring to fig. 3 and 4, the inner sheath 50 is hollow and has a distal end 202 provided with a bending section 51, and the bending section 51 is adjustable. The bending section 51 is made of an elastic material, and the hardness of the bending section 51 is smaller than that of other sections in the inner sheath 50 so as to facilitate bending. The bending section 51 can be accurately controlled to the specific part of the inner sheath tube 50 which deforms when being bent, so that the relative deformation of the marking ring 40 and the ablating ring 30 is avoided, and the ablating effect of the ablating catheter 100 is further influenced.

At least one pulling element 52 is provided in the wall of the inner sheath 50 in the direction of the axis 203. The pulling member 52 is connected at both ends thereof to the distal end of the bent section 51 and the handle 10, respectively. The pulling member 52 is fixedly connected with the distal end of the bending section 51, the handle 10 is provided with the adjusting knob 11 which is connected with the pulling member 52 and can pull the pulling member 52, at least one pulling member 52 can be tensioned by rotating the angle of the adjusting knob 11 relative to the handle 10, the bending section 51 is further bent towards one direction (as shown in fig. 5), and the corresponding bending angle of the bending section 51 is changed by controlling the rotating angle of the adjusting knob 11. The curved inner sheath 50 can adjust the orientation of the targeting ring 40 and ablating ring 30 to facilitate steering of the targeting ring 40 into the target lumen with the ablating ring 30 mapping and ablating proximate the target tissue region.

Referring to fig. 5, the pulling member 52 includes a pulling tube 521 and a pulling wire 522. The pulling tube 521 is a hollow tube, and the inner cavity of the pulling tube is used for passing the pulling wire 522, and two ends of the pulling wire 522 are used for connecting the distal end of the bending section 51 and the handle 10. The pull wire 522 may be a stainless steel wire, and in one embodiment, the pull wire 522 is a coated stainless steel wire with a smooth surface and good handling properties. The pulling tube 521 may be a spring ring that wraps the stainless steel wire to keep the inner sheath 50 smoothly bent.

In one embodiment, the pulling member 52 omits the provision of the pulling tube 521, i.e., the pulling member 52 is a pulling wire.

In this embodiment, two pulling members 52 are oppositely disposed in the tube wall of the inner sheath tube 50, and the bending of the bending section 51 in two opposite directions is controlled by rotating the adjusting knob 11 (fig. 1) to pull the two pulling members 52, so that the distal end of the ablation catheter 100 can flexibly turn towards 2 directions, thereby improving the operability and convenience of the ablation catheter 100. It will be appreciated that the number of pulling elements 52 can be more than two, so that the curved section 51 of inner sheath 50 can be curved in multiple directions.

Referring to fig. 6, the handle 10 includes a housing 11, an adjusting member 152 disposed in the housing 11, and a driving member 154 for driving the adjusting member 152 to move along the axial direction of the inner sheath 50, two pulling wires 522 slidably disposed in the wall of the inner sheath 50 along the axial direction of the inner sheath 50, and a winding part 1115 disposed in the housing 11, preferably, the winding part 1115 is adjacent to the proximal end of the adjusting member 152. The distal ends of the two pull wires 522 are coupled to the distal end of the curved section 51 (fig. 3), with the proximal end of one pull wire 522 coupled to the adjustment member 152 and the proximal end of the other pull wire 522 coupled to the adjustment member 152 by passing around the wire winding section 1115. Specifically, a distal end of one of the pull wires 522 is secured to the distal end of the curved section 51, and a proximal end of one of the pull wires 522 is directly connected to the adjustment member 152; the distal end of the other pull wire 522 is secured to the distal end of the curved section 51, and the proximal end of the other pull wire 522 is routed around the wire winding 1115 and then attached to the adjustment member 152.

An adjusting knob 11 is fixed on the outer wall of the driving member 154 in the circumferential direction, and the driving member 154 is driven to rotate by the rotation of the adjusting knob 11. The rotation of the driving member 154 drives the adjusting member 152 to move through the internal thread thereof and drives the two pulling wires 522 to slide, so that the bending section 51 of the sheath 23 is bent in different directions, i.e. the bending section 51 can be bent in different directions and elastically reset.

When the inner sheath 50 is bent, the driving member 154 is rotated by operating the adjusting knob 11 to drive the adjusting member 152 to rotate toward the proximal end or the distal end and move axially. In the initial state, when the adjusting member 152 rotates and moves axially in the proximal direction, the pulling wire 522 directly fixed to the adjusting member 152 is driven to slide in the proximal direction, so that the bending section 51 bends toward one side of the pulled pulling wire 522, and during the bending process, the pulling wire 522 connected to the adjusting member 252 after bypassing the winding part 1115 is pulled by the deformation of the bending section 51 to slide in the distal direction, so that the bending section 51 is bent; in the initial state, when the adjusting member 152 rotates and moves axially in the distal direction, the pulling wire 522 connected to the adjusting member 152 after passing around the winding section 1115 is driven by the adjusting member 152 to slide in the proximal direction, so that the bending section 51 bends toward one side of the pulled pulling wire 256, and the bending section 51 drives the pulling wire 522 directly fixed to the adjusting member 152 to slide in the distal direction during the bending process, so that the bending section 51 is bent.

It should be noted that the initial state is the state in which curved section 51 of inner sheath 50 is straightened.

Referring again to fig. 4 and 1, the ablation catheter 100 of the present application further includes a connector 60 connected to the handle 10. In this embodiment, the connector 60 is connected to the handle 10 at a proximal position, and the connector 60 includes a detection interface 61 and an energy supply interface 62. The detection interface 61 is electrically connected to the mapping electrode 41 on the mapping ring 40, and is configured to receive the electrophysiological signals detected by the mapping ring 40. The energy supply interface 62 is electrically connected to the ablation electrode 31 on the ablating loop 30 for delivering external energy to the ablating loop 30 for ablation. The functional interface 62 is used to connect to an external source of pulsed, radio frequency or microwave energy.

The inner sheath 50 has a hollow tubular shape, and a plurality of wires 24 are arranged therein, and the wires 24 are insulated from each other. The detection interface 61 is connected with a plurality of mapping electrodes 41 distributed on the mapping ring 40 through a lead 24, electrophysiological signals detected by each mapping electrode 41 are transmitted to the detection interface 61 through a lead 24, and then the electrophysiological signals are transmitted to an external detection instrument through the detection interface 61; the energy supply interface 62 is conducted with the plurality of ablation electrodes 31 distributed on the ablating loop 30 through the conducting wires 24 distinguished from the detecting interface 61, and the energy supply interface 62 receives external energy and transmits the external energy to each ablation electrode 31, so that the ablation electrodes 31 form ablation energy based on the external energy and act on the target tissue area.

Referring to fig. 7, the ablating loop 70 provided in the second embodiment of the present application is mainly different from the ablating loop 40 in the first embodiment in that the ablating loop 70 includes two sub-ablating loops, namely a first ablating loop 701 and a second ablating loop 702, and the first ablating loop 701 is disposed between the second ablating loop 702 and the mapping loop 40.

The first ablating ring 701 and the second ablating ring 702 are respectively provided with ablating electrodes 71 at intervals, and the first ablating ring 701 and the second ablating ring 702 respectively have the function of emitting ablating energy.

It will be appreciated that when the first ablating loop 701 is operated alone, it forms a different range of action of ablating energy than when the second ablating loop 702 is operated alone, and thus the ablation catheter 100 of the present application is able to cover a larger area of ablation by providing two spaced sub-ablating loops. Moreover, based on the different source positions of the abnormal electrophysiological signals in the target tissue region detected by the measuring ring 40, the ablation catheter 100 of the present application can control different sub-ablation rings to emit ablation energy to act on different target tissue regions for electrical isolation; or controls the two sub-ablating loops to emit the ablating energy at the same time, so as to provide larger ablating energy to shorten the operation time. It is understood that in other embodiments, the number of sub-ablating loops of the ablation catheter 100 can be more than two, so as to further expand the range of action of the ablating loop 70. In one embodiment, the partial electrodes 71 in the first ablating loop 701 are turned on simultaneously with the partial electrodes in the second ablating loop 702 to ablate the designated area.

In the embodiment shown in fig. 7, the radial dimension of the second ablating loop 702 is greater than the radial dimension of the first ablating loop 701. The radial dimension difference of the two sub-ablating loops can form different ablation energy acting ranges. Meanwhile, the smaller the radial dimension of the sub-ablating loop closer to one side of the measuring ring 40, the smaller the radial dimension of the ring structure formed at the distal end of the ablation catheter 100 of the present application is, the first ablating loop 701 or the second ablating loop 702 can be selected to be opened for ablation according to different diameters of target vascular tissues, for example, when the pulmonary vein of a patient is narrow, the ablating electrode 71 on the first ablating loop 701 is selected to be opened, the ablating electrode 71 on the second ablating loop 702 is closed, and the first ablating loop 701 is used to be close to the mouth of the pulmonary vein for ablation; when the pulmonary veins of a patient are wide, the first ablation ring 701 can enter the pulmonary veins, the ablation electrodes 71 on the second ablation ring 702 are selectively opened, the ablation electrodes 71 on the first ablation ring 701 are closed, and ablation is performed by utilizing the second ablation ring 702 to be close to the mouth of the pulmonary veins, so that better attaching and ablation effects of target tissues are realized.

Specifically, the carrying rod is provided with a sixth section 234 between the first ablating loop 701 and the second ablating loop 702, the sixth section 234 can be arranged along a direction parallel to or coincident with the axis, or inclined at an acute angle or an obtuse angle with the axis, and other connecting sections for connecting the first ablating loop 701 and the second ablating loop 702 can be further arranged at two ends of the sixth section 234, so that the sixth section 234 facilitates pushing the first ablating loop 701 and the marking loop 40 to move in the vein.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims

1. An ablation catheter is characterized by comprising a handle and a bearing rod connected to the distal end of the handle, wherein the bearing rod comprises a marking ring and an ablating ring which are arranged at the distal end of the bearing rod, the ablating ring is positioned between the marking ring and the handle, the marking ring and the ablating ring are both annular and extend around the axis of the bearing rod, a mapping electrode is arranged on the marking ring, an ablating electrode is arranged on the ablating ring, the ablating electrode is used for transmitting ablation energy to a target tissue area, and the mapping electrode is used for transmitting electrophysiological signals in the target tissue area to the handle.

2. The ablation catheter of claim 1, wherein a radial dimension of the ablating loop is greater than or equal to a radial dimension of the targeting loop.

3. The ablation catheter of claim 1, wherein the carrier rod includes a proximal section connected between the handle and the ablating loop, the marking loop, and the proximal section being of unitary construction.

4. The ablation catheter of claim 3, wherein the carrier rod further comprises a connecting section connected between the ablating loop and the targeting loop, the connecting section comprising a first section and a second section, the second section connected between the first section and the targeting loop, the second section connected to the first section at an end closer to the geometric center of the targeting loop than to the end connected to the targeting loop; and/or

5. The ablation catheter of claim 1, wherein said ablating loop is formed in a first plane and said measuring loop is formed in a second plane.

6. The ablation catheter of claim 5, wherein the first plane and/or the second plane is perpendicular to an axis of the carrier rod.

7. The ablation catheter of any of claims 1-6, wherein the number of mapping electrodes is multiple, and the multiple mapping electrodes are spaced apart along the circumference of the mapping ring; and/or the number of the ablation electrodes is multiple, and the positive electrode and the negative electrode in the multiple ablation electrodes are alternately arranged.

8. The ablation catheter of any of claims 1-6 wherein said ablating loop comprises a first ablating loop and a second ablating loop, and wherein said second ablating loop is disposed proximally of said first ablating loop relative to said handle, and wherein an ablating electrode is disposed on each of said first ablating loop and said second ablating loop.

9. The ablation catheter of claim 8, wherein a radial dimension of said second ablating loop is greater than a radial dimension of said first ablating loop.

10. The ablation catheter of any of claims 1-6, wherein an inner sheath is disposed between the carrier rod and the handle, and wherein a pulling member is disposed axially within a wall of the inner sheath, the pulling member being connected between a distal end of the inner sheath and the handle, and wherein the handle is configured to bend the distal end of the inner sheath in one direction by pulling the pulling member.