CN118717276B - Double-bending double-basket array electrode PFA mapping ablation catheter - Google Patents

Abstract

The application discloses a double-bending double-basket array electrode PFA mapping ablation catheter, which relates to the medical instrument technology and comprises the following components: one end of the catheter body is led out of the guiding wire outlet, the other end of the catheter body is connected to the catheter handle, and the head end of the catheter body is respectively provided with a first basket and a second basket; the catheter handle is connected with the catheter body, is provided with the flexible wheel of controlling of second basket and the flexible wheel of controlling of first basket on it, the flexible wheel of controlling of second basket and the flexible wheel of controlling of first basket are connected with corresponding traction wire respectively, the catheter handle draw forth corresponding electrode tail with the other end of guiding the seal wire. The present application enables the dual basket of the catheter head to be able to enter and exit the proximal end of the target pulmonary vein and to abut and exit the pulmonary vein vestibule, respectively, by retracting and extending.

Description

Double-bending double-basket array electrode PFA mapping ablation catheter

Technical Field

The application relates to the technical field of medical instruments, in particular to a PFA mapping ablation catheter with double-bending double-basket array electrodes.

Background

Minimally invasive catheter ablation technology is the basic therapy for treating human arrhythmia diseases currently, and the basic principle is as follows: 1. puncture peripheral blood vessel of patient, establish the minimally invasive operation channel of the human cardiovascular system of passing in and out of the electrophysiological apparatus. 2. The treatment electrode, electrode combination or electrode array is precisely positioned at the predetermined focus under the guidance of various imaging and electrophysiology mapping techniques. 3. Various ablative energies are delivered under the guidance of various monitoring and evaluation indexes, and target focuses are destroyed or improved as required, so that the aim of curing arrhythmia diseases is fulfilled. Depending on the ablation energy used, the morphology and characteristics of the ablation electrode employed will vary. For example, when conventional radio frequency energy is applied, a single electrode ablation mode is typically used, and a bipolar ablation mode at a distance of 10-30cm may also be employed in some special cases; when cryoablation energy is used, balloon ablation modes are typically used that can be inflated and deflated; when pulsed electric field energy ablation is employed, either conventional single, bipolar ablation modes or electrode combination or electrode array ablation modes may be employed.

Although the conventional radiofrequency ablation energy release mode has many advantages, such as easy long-distance transmission, quantitative control, simple catheter control and the like, the conventional radiofrequency ablation energy release mode also has very obvious disadvantages, such as no tissue specificity, easy generation of bubbles, eschar and sudden vibration, long single-point ablation time, poor multipolar discharge effect and the like. To overcome the above-described drawbacks of radio frequency energy, pulsed electric field (PFA) ablation energy has been developed. Ablation patterns employing multiple electrode combinations to deliver pulsed electric field energy are particularly useful in the treatment of complex arrhythmic conditions, such as various types of atrial fibrillation. The ablation technology has the advantages of strong tissue selectivity, good operation safety and high ablation efficiency, and is expected to replace the traditional electrode radiofrequency ablation mode.

The existing PFA multipolar catheter mainly comprises PulsedFA annular multipolar catheters and CardiPulse petal-shaped multipolar catheters.

PulsedFA annular multipolar catheter structure is characterized in that: 1. an electrode ring with the diameter of 3-4cm and vertical to the catheter body is arranged at the head end of the catheter. 2. The electrode ring is uniformly provided with 6-8 identical platinum iridium ring electrodes from far to near. The use scheme of the catheter is as follows: 1. the annular multipolar PFA catheter is delivered into the target chamber through an adjustable curved sheath that is pre-positioned in the target chamber. 2. The head end of the adjustable curved sheath tube is controlled to bend, and the PFA catheter is guided to enter the vestibular part of the target pulmonary vein. 3. And verifying and adjusting the position of the PFA electrode ring through a three-dimensional image and electrophysiology mapping technology. 4. And forming an ablation electrode group by two adjacent electrodes, and synchronously distributing PFA energy to complete the ablation process.

CardiPulse petal-shaped multipolar catheter structure is characterized in that: 1. at the head end of the catheter petal-shaped multi-electrode ring. 2. 3 identical ring electrodes are equidistantly arranged at the top end of each ring flap. 3. The catheter has an open lumen throughout for passage of the guide wire. The use scheme of the catheter is as follows: 1. the petal multipolar PFA catheter is delivered into the target chamber through an adjustable curved sheath that is pre-positioned in the target chamber. 2. Under the guidance of perspective or three-dimensional images, the head end of the adjustable curved sheath tube is controlled to bend, and the head end of the guide wire is guided to enter the proximal end of the target pulmonary vein. 3. Under the guidance of perspective or three-dimensional images, a guide wire is fixed, and petal-shaped electrodes are sent into the vestibular part of the target pulmonary vein through the guidance of the head end of the guide wire. 4. And verifying and adjusting the positions of the petal electrode rings through three-dimensional images and electrophysiology mapping technology. 5. Two adjacent electrodes on the petal ring radial line and the latitude line form an ablation electrode group, and PFA energy is synchronously released to complete the ablation process.

The two PFA multi-electrode catheters still have the following defects that as the two multi-electrode catheters are of a single-ring structure, the head ends of the electrode catheters extend into the vestibule of the pulmonary veins, the ablation electrode rings cannot be well coaxial with the vestibule of the pulmonary veins, so that the ablation effect is not ideal, the annular head ends of the two multi-electrode catheters are of fixed sizes, the sizes of the ablation rings cannot be changed along with the diameter changes of different patients or the pulmonary veins of the same patient, so that the ablation electrode groups cannot be well attached to irregular vestibule tissues, and the individual ablation rings cannot be designed according to different forms of the vestibule of different pulmonary veins. Because the two PFA catheters are of annular structures, the upper and lower pulmonary vein combination parts and other linear ablation parts cannot be effectively ablated, the purpose of ablation of the pulmonary vein vestibular macrocycle is achieved, meanwhile, the ablation catheter does not have a head end bending function, the direction and the angle of an electrode ring cannot be changed automatically, and the operation efficiency is low in the use process of an operator.

Disclosure of Invention

The embodiment of the application provides a double-bending double-basket array electrode PFA mapping ablation catheter, which realizes that a double basket at the head of the catheter can enter and exit the proximal end of a target pulmonary vein and lean against and leave the vestibule of the pulmonary vein respectively or simultaneously through recovery and extension, and the double basket can be linearly telescopic and adaptive to the proximal end inner diameter of the target pulmonary vein and the vestibule diameter of the target pulmonary vein respectively or simultaneously.

The embodiment of the application provides a PFA mapping ablation catheter with double-bending double-basket array electrodes, which comprises the following components:

A catheter body 23, one end of which leads out a guide wire 34 from the guide wire outlet 1, and the other end of which is connected to the catheter handle 25, wherein the head end of the catheter body 23 is provided with a first basket and a second basket respectively; wherein,

The first basket comprises a first basket framework 3, a first basket telescopic rod 7 and a first basket framework spring 8, wherein the first basket framework 3 and the first basket telescopic rod 7 are arranged along the direction of the catheter body 23, the first basket framework 3 can move and deform based on the first basket framework spring 8 under the pulling of corresponding pulling wires, the first basket framework 3 is restored to the position after the pulling wires are loosened, and a first basket electrode array 4 is arranged on the first basket framework 3;

The second basket is arranged at intervals from the first basket and comprises a second basket framework 14, a second basket telescopic lantern ring 19 and a second basket framework spring 18, the second basket framework 14 is arranged along the direction of the catheter body 23, the second basket framework 14 can move and deform based on the second basket framework spring 18 under the pulling of corresponding pulling wires, the second basket framework 14 is restored to the position after the pulling wires are pulled back, and a second basket electrode array 15 is arranged on the second basket framework 14;

the catheter handle 25 is connected with the catheter body 23, and is provided with a second basket telescopic control wheel 27 and a first basket telescopic control wheel 28, the second basket telescopic control wheel 27 and the first basket telescopic control wheel 28 are respectively connected with corresponding traction wires, and the catheter handle 25 draws out corresponding electrode tails and the other ends of the guiding wires 34.

Optionally, the first basket frame 3 is not less than 3 basket frames and not shorter than 10mm, a walking wire is formed in the inner cavity of the formed frame, and a first basket electrode array mark 5 is arranged on one basket frame.

Optionally, the first basket electrode array 4 is arranged at one end of the basket framework, which is close to the finger guide wire outlet 1, and is arranged at equal intervals;

the first basket electrode array 4 includes at least 3 ring electrodes.

Optionally, at least 3 ring electrodes of the first basket electrode array 4 are based on the first basket electrode array identifier 5 and are sequentially provided with numbers.

Optionally, the first basket frame spring 8 is a compression rebound working spring, the first basket frame spring 8 is disposed on the first basket telescopic rod 7, one end of the first basket frame spring is fixed at the head end of the first basket telescopic rod 7, the other end of the first basket frame spring is fixed at the basket frame connecting portion 11, and in a normal state, the first basket frame spring 8 is naturally straightened;

One end of the first basket framework 3 far away from the finger guide wire outlet 1 is fixed at one end of the first basket telescopic rod 7 close to the basket framework connecting part 11.

Optionally, the outer diameter of the basket framework connecting portion 11 is not less than 7F, the length of the basket framework connecting portion is not less than 10mm, one end of the basket framework connecting portion is fixed on the catheter body portion 23, and the finger guide wires 34, the first basket telescopic rod 7 and the second basket telescopic collar 19 are sleeved in the inner cavity of the basket framework connecting portion 11 from inside to outside.

Optionally, the second basket frame 14 includes not less than 3 basket frames, and not shorter than 30mm, and has an outer diameter not less than 2F, and a walking wire is formed in an inner cavity of the formed frame, and a second basket electrode array identifier 16 is disposed on one basket frame;

the second basket electrode array 15 is arranged at one end of the basket framework, which is close to the finger guide wire outlet 1, and is arranged at equal intervals;

the second basket electrode array 15 includes at least 3 ring electrodes with gaps left between the ring electrodes without covering electrode material, each electrode face pointing toward the inner wall of the vestibule of the pulmonary vein, and the gap face pointing toward the center of the basket.

Optionally, the second basket frame spring 18 is a stretch rebound working spring, and is disposed on the second basket expansion link, one end of the second basket frame spring is fixed to the basket frame connecting portion 11, and the other end of the second basket frame spring is fixed to the second basket expansion collar 19.

Optionally, the outer diameter of the second basket expansion collar 19 is not less than 6F, the length is not less than 50mm, the inner cavity of the second basket expansion collar 19 is not less than 5F, one end of the second basket expansion collar 19 is movably arranged at the basket frame connecting portion 11, the second basket expansion collar 19 comprises an expansion rod, the expansion rod can slide in the basket frame connecting portion 11 to drive the second basket frame 14 to stretch and recover, and after the second basket frame 14 is completely stretched, at least one electrode of the second basket electrode array 15 is located at the most distal end of the second basket frame 14.

Optionally, at least two visualization electrodes 22 are further disposed on the catheter body 23, and at least two visualization electrodes 22 are disposed at intervals.

The PFA mapping ablation catheter provided by the embodiment of the application can realize that the double basket at the head of the catheter can enter and exit the proximal end of the target pulmonary vein and lean against and leave the vestibule of the pulmonary vein respectively or simultaneously through recovery and extension, and the double basket can be adapted to the proximal end inner diameter of the target pulmonary vein and the vestibule diameter of the target pulmonary vein respectively or simultaneously in a linear expansion mode.

The foregoing description is only an overview of the present application, and is intended to be implemented in accordance with the teachings of the present application in order that the same may be more clearly understood and to make the same and other objects, features and advantages of the present application more readily apparent.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the application. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:

FIG. 1 is a schematic illustration of a partial structure of a double-bend double-basket array electrode PFA mapping ablation catheter in accordance with an embodiment of the present application;

FIG. 2 is an overall schematic of a dual-bend dual-basket array electrode PFA mapping ablation catheter in accordance with an embodiment of the present application;

Fig. 3 and fig. 4 are partial structural illustrations of a catheter handle of a PFA-mapped ablation catheter with a double-bent double-basket array electrode according to an embodiment of the present application;

FIG. 5 is a schematic illustration of a partial structure of a double-bend double-basket array electrode PFA mapping ablation catheter in accordance with an embodiment of the present application;

FIG. 6 is a bending state illustration of a double-bend double-basket array electrode PFA mapping ablation catheter according to an embodiment of the present application;

FIG. 7 is an illustration of an extended state of a dual-bend dual-basket array electrode PFA mapping ablation catheter in accordance with an embodiment of the present application;

FIG. 8 is a schematic cross-sectional view of a PFA mapping ablation catheter with double-bend double-basket array electrodes according to an embodiment of the present application;

fig. 9 is a schematic diagram of the distribution and use of the PFA mapping ablation catheter proximal and distal basket electrodes.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

The embodiment of the application provides a double-bending double-basket array electrode PFA mapping ablation catheter, which is shown in fig. 1 and 2 and comprises the following components:

The catheter body 23, one end of which leads out the guide wire 34 from the guide wire outlet 1, and the other end of which is connected to the catheter handle 25, and the head end of the catheter body 23 is provided with a first basket and a second basket, respectively. In some specific examples, catheter body 23 has an outer diameter of no greater than 8F, a length of no less than 100 cm, a wall thickness of no greater than 0.2mm, and an internal running structure comprising: the device comprises a finger guide wire and catheter flushing lumen, a basket electrode wire lumen, a positioning sensor, a visual electrode wire lumen, a distal basket telescopic rod traction steel wire lumen, a proximal basket telescopic sleeve traction steel wire lumen and a catheter head end bending control steel wire lumen. Wherein, in some specific examples, as shown in fig. 2, the guide wire 34 has an outer diameter of no greater than 0.035 inches and a length of no less than 260cm, is relatively soft at a head end of 30mm and has a preformed protective J-bend of no greater than 10mm in diameter, and is lined at a tail end with an inner core to enhance the support of the body of the guide wire. The surface of the finger guide wire 34 is subjected to heparin anticoagulation and super-slipping treatment.

The first basket comprises a first basket framework 3, a first basket telescopic rod 7 and a first basket framework spring 8, wherein the first basket framework 3 and the first basket telescopic rod 7 are arranged along the direction of the catheter body 23, the first basket framework 3 can move and deform based on the first basket framework spring 8 under the pulling of corresponding pulling wires, and after the pulling wires are loosened, the first basket framework 3 is at a recovery position, and a first basket electrode array 4 is arranged on the first basket framework 3.

The second basket is arranged at intervals with the first basket, and comprises a second basket framework 14, a second basket telescopic lantern ring 19 and a second basket framework spring 18, the second basket framework 14 is arranged along the direction of the catheter body 23, the second basket framework 14 can move and deform based on the second basket framework spring 18 under the pulling of corresponding pulling wires, the second basket framework 14 is restored to the position after the pulling wires are pulled back, and a second basket electrode array 15 is arranged on the second basket framework 14.

The catheter handle 25 is connected with the catheter body 23, and is provided with a second basket telescopic control wheel 27 and a first basket telescopic control wheel 28, the second basket telescopic control wheel 27 and the first basket telescopic control wheel 28 are respectively connected with corresponding traction wires, and the catheter handle 25 draws out corresponding electrode tails and the other ends of the guiding wires 34.

In the embodiments of the present application and the subsequent embodiments, "distal" and "proximal" are used to describe both ends, respectively, for example, one end of the member that is proximal to the operator is the proximal end of the member and the other end is the distal end of the member. In some specific examples, catheter handle 25, as shown in FIG. 2, has an outer diameter of no greater than 20mm and a length of no greater than 70mm, and a head end attached to a tail end of the catheter body, the tail end having a sealing membrane opening with an inner diameter of no less than 0.035 inches for passing a finger guide wire. The tail part of the handle is connected with a catheter flushing pipe, a double basket electrode tail wire, a positioning sensor and a visual electrode tail wire. The inside handle head end is provided with: the outer diameter ratio of the two basket traction steel wire control shafts is the same as the synchronous telescoping ratio of the far basket and the near basket. A double basket linkage separator. The head end of the catheter bends the traction steel wire control shaft. The handle body is provided with a catheter head end bending manipulation wheel, a double basket telescoping manipulation wheel (a second basket telescoping manipulation wheel 27 and a first basket telescoping manipulation wheel 28).

Wherein, as shown in fig. 2, the catheter head end double-bending control wheel 26 is located at the distal end of the handle, and in a specific example, for the damping rotation wheel convenient for control and temporary stop, two traction steel wires are respectively connected with the inner side of the catheter head end in a 180-degree diagonal angle. When the operator rotates the wheel clockwise or anticlockwise, the catheter head end bends 1-135 degrees towards the side where the traction steel wire is located, the purpose of bidirectionally bending the catheter head end is achieved, and the bending degree of the catheter is controlled and determined by the operator. Due to the damping function of the swivel wheel, the catheter tip can temporarily stop at any bending angle (within a maximum full range) required by the operator.

The second basket telescoping control wheel 27 (distal basket telescoping control wheel), which is immediately adjacent to the proximal end of the double bend control wheel, is of a damped swivel wheel design that facilitates control and temporary stop, and is connected to the proximal end of the distal basket telescoping rod by a single traction wire. When the operator rotates the wheel clockwise or anticlockwise, the traction steel wire is driven to retract towards the proximal end of the catheter or loosen towards the distal end, so that the stretching or rebounding of the telescopic spring of the distal basket is controlled, the telescopic control of the distal basket is realized, and the telescopic degree of the basket is controlled and determined by the operator. Due to the damping function of the swivel wheel, the distal basket frame can temporarily stop at any degree of telescoping required by the operator (within the maximum telescoping limits of the distal basket frame).

The first basket telescoping control wheel 28 (proximal basket telescoping control wheel), which is adjacent to the proximal end of the distal basket telescoping control wheel, is of a damped swivel wheel design that facilitates control and temporary stop, and is connected to the proximal end of the proximal basket telescoping wand by a single traction wire. When the operator rotates the wheel clockwise or anticlockwise, the traction steel wire is driven to retract towards the proximal end of the catheter or loosen towards the distal end, so that the stretching or rebounding of the telescopic spring of the proximal basket is controlled, the telescopic control of the proximal basket is realized, and the telescopic degree of the basket is controlled and determined by the operator. Due to the damping function of the swivel wheel, the proximal basket frame may be temporarily stopped at any degree of telescoping required by the operator (within the maximum telescoping limits of the proximal basket frame).

In some specific examples, as shown in fig. 3 and 4, the catheter further comprises a catheter lumen flush tube 29 positioned at the tail of the catheter handle and in communication with the guide wire lumen running inside the catheter, the function of which is to vent residual air from the guide wire lumen and to flush the guide wire lumen continuously.

A distal basket electrode tail 30, located at the tail of the catheter handle, is connected to the leads of the distal basket array electrodes.

A proximal basket electrode tail 31, located at the tail of the catheter handle, is connected to the leads of the proximal basket array electrodes.

The positioning sensor and the visualized electrode tail 32 are positioned at the tail part of the catheter handle and are connected with the basket positioning sensor and the visualized electrode lead.

The tail of the flush handle is referred to as the guidewire inlet (with sealing membrane) 33, which has an inner diameter of no less than 0.035 inches, which communicates with the guidewire lumen of the catheter body, and has sealing membrane at the inlet to prevent air ingress and blood escape.

The PFA mapping ablation catheter provided by the embodiment of the application can realize that the double basket at the head of the catheter can enter and exit the proximal end of the target pulmonary vein and lean against and leave the vestibule of the pulmonary vein respectively or simultaneously through recovery and extension, and the double basket can be adapted to the proximal end inner diameter of the target pulmonary vein and the vestibule diameter of the target pulmonary vein respectively or simultaneously in a linear expansion mode.

In some embodiments, as shown in fig. 1, the first basket frame 3 is not less than 3 basket frames and not shorter than 10mm, a wire is walked in the cavity of the formed frame, and a first basket electrode array identifier 5 is arranged on one basket frame. In some specific examples, as shown in fig. 5, the head of the catheter body 23 is provided with a distal basket skeleton distal fixing point 2, and the distal end of the first basket skeleton 3 (distal basket skeleton) is fixed to the most distal end of the first basket telescoping rod 7 (distal basket telescoping rod) to facilitate the extension and retraction of the distal basket telescoping rod when it is moved back and forth.

As shown in fig. 1, the first basket frame 3 (distal basket frame) is equidistantly spaced from each other; the walking electrode and the sensor wire of skeleton inner chamber, the proximal end of one of them skeleton has first basket electrode array sign 5 (X line ring shape sign) for the sign skeleton serial number, and the skeleton proximal end that corresponds with this skeleton sets up 1 at least distal end basket positioning sensor 6. In a specific example, at least 1 positioning sensor is arranged on a far-end basket framework corresponding to the X-ray identification framework and used for positioning the three-dimensional position of the far-end basket on the three-dimensional image.

In some embodiments, the first basket electrode array 4 is disposed on one end of the basket frame near the finger guide wire outlet 1, and is disposed at equal intervals;

In some embodiments, at least 3 ring electrodes of the first basket electrode array 4 are sequentially numbered based on the first basket electrode array identifier 5. For example, in some examples, the serial numbers of all basket frameworks are sequentially calibrated and identified in a clockwise or counterclockwise direction based on the first basket electrode array identifier 5.

Specifically, as shown in fig. 1, the first basket electrode array 4 includes at least 3 ring electrodes, platinum-iridium alloy materials, the length is not less than 2mm, the thickness is not less than 1mm, and the 3 ring electrodes can be sequentially numbered in sequence with X-ray marks as starting points, so as to facilitate computer identification and distribution.

In some specific examples, the ablation electrode at the top end of the basket frame wraps only 225 ° of the basket frame circumference leaving a 135 ° gap free of electrode material; the electrode surface points to the inner wall of the pulmonary vein, and the gap surface points to the center of the basket, so that the tissue surface directional ablation of PDA energy is realized.

In a specific example, the functions of the first basket electrode array 4 (distal basket electrode array) include: (1) The electrodes positioned in the middle of the skeleton form electrode pairs by every 2 adjacent electrodes in the radial direction of the basket, PFA energy is released to ablate the proximal muscular sleeve of the target pulmonary vein, the pulmonary vein positioning, checking and ablating effect is recorded, and remedial ablation is guided. (2) The electrode groups which are arranged in a straight line or arc line on the two opposite basket frameworks can be independently used for ablation of the front and back crossing parts of the upper and lower pulmonary veins and various linear ablations in the left atrium. (3) When the distal basket is maximally extended, a matrix of all electrodes can be used for three-dimensional modeling and activation mapping.

In some specific examples, the first basket telescoping rod 7 (distal basket telescoping rod) has an outer diameter no greater than 5F, a length no less than 20mm, an inner lumen no less than 0.035 inches, a stiffness sufficient to support full extension and retraction of all of the framework, a distal opening for the passage of a finger guide wire, and a proximal end located within basket framework connection 11 (no less than 10 mm); the proximal end of the distal basket telescoping rod is capable of sliding within the basket frame connection 11, thereby driving the frame to extend and retract. When the scaffold is fully extended, its proximal electrode is located just at the apex of the scaffold.

The function of the telescopic rod of the far-end basket in the embodiment of the application is as follows: (1) The basket framework is completely recovered, so that the head end of the catheter can conveniently enter the target heart cavity through the sheath tube. (2) The basket frame is fully extended to achieve the maximum basket outer diameter. (3) The outer diameter of the basket is adjusted as required so as to be individually adapted to different inner diameters of the proximal end of the target pulmonary vein.

In some specific examples, the first basket frame spring 8 is a compression rebound working spring, the first basket frame spring 8 is disposed on the first basket telescopic rod 7, one end of the first basket frame spring is fixed at the head end of the first basket telescopic rod 7, and the other end of the first basket frame spring is fixed at the basket frame connecting portion 11, and in a normal state, the first basket frame spring 8 is naturally straightened.

One end of the first basket frame 3 far away from the finger guide wire outlet 1 is fixed at one end of the basket frame connecting portion 11 close to the basket frame connecting portion 11.

In some specific examples, as shown in fig. 1, a first basket frame spring 8 (a distal basket frame straightening spring) is preloaded on a distal basket telescoping rod, with its distal end secured to the telescoping rod head end and its proximal end secured to basket frame connection 11. Under normal conditions, the spring is in a natural stretching state, and the length of the spring is consistent with that of the far-end basket framework. As shown in FIG. 6, as the traction wire pulls the distal basket telescoping wand catheter proximally, the spring is compressed while the basket frame is bent into an arc of varying degrees. When the mapping and ablation task of the distal basket is finished, the operator releases the traction steel wire, and the compressed spring gradually returns to the natural length by virtue of elasticity, so that the distal basket framework is straightened again.

As shown in fig. 5, a distal basket frame proximal fixing point 9 is further provided at the distal end of the basket frame connecting portion 11, and the proximal end of the first basket frame 3 is fixed to the distal end of the basket frame connecting portion 11 so that the basket frame can be extended and retracted following the distal basket expansion link when it is moved forward and backward.

As shown in fig. 5, the distal basket telescoping rod traction wire attachment point 10 is located proximal to the distal basket telescoping rod for attachment of a traction wire for manipulating the distal basket telescoping rod.

In some specific examples, the outer diameter of the basket frame connecting portion 11 is not less than 7F, the length of the basket frame connecting portion is not less than 10mm, one end of the basket frame connecting portion is fixed on the catheter body portion 23, and the finger guide wires 34, the first basket telescopic rod 7 and the second basket telescopic collar 19 are sleeved in the inner cavity of the basket frame connecting portion 11 from inside to outside. The basket skeleton connecting portion 11 functions as: (1) providing a mobile fulcrum for the double basket. (2) providing mobile support for the distal basket telescoping pole. (3) providing a proximal fixation point for the distal basket frame. (4) providing mobile support for the proximal basket telescoping collar. (5) providing a distal fixation point for the proximal basket. (6) Providing a lumen for guiding the passage of the guidewire and saline flush catheter.

The telescopic ring is also provided with a far-end fixing point 12 of the near-end basket framework, which is positioned at the near end of the basket framework connecting part 11, and the far end of the near-end basket framework is fixed at the near end of the basket framework connecting part 11, so that the framework of the near-end basket can be stretched and recovered when the telescopic ring of the near-end basket is moved back and forth.

The catheter bending control steel wire distal fixing point 13 is also arranged, is positioned at the catheter body part corresponding to the distal end part of the basket framework connecting part 11, is distributed in 180 degrees opposite directions, and is used for bidirectionally bending the catheter head end by 0-135 degrees.

In some embodiments, the second basket frame 14 includes not less than 3 basket frames, and not shorter than 30mm, and has an outer diameter not less than 2F, and a wire is walked in the cavity of the formed frame, and a second basket electrode array identifier 16 is disposed on one of the basket frames, for example, the second basket electrode array identifier 16 may be an X-wire ring identifier for identifying a frame number; at least 1 proximal basket positioning sensor 17 is provided at the proximal end of the frame corresponding to the frame. The specific near-end basket positioning sensor 17 is that at least 1 positioning sensor is arranged on the near-end basket framework corresponding to the X-ray identification framework, namely the near-end basket positioning sensor 17 is used for positioning the three-dimensional position of the near-end basket on the three-dimensional image. Based on this, the second basket electrode array identifier 16 sequentially indexes and identifies the serial numbers of all basket frameworks in a clockwise or counterclockwise direction.

The second basket electrode array 15 is arranged at one end of the basket framework, which is close to the finger guide wire outlet 1, and is arranged at equal intervals.

The second basket electrode array 15 includes at least 3 ring electrodes with gaps left between the ring electrodes without covering electrode material, each electrode face pointing toward the inner wall of the vestibule of the pulmonary vein, and the gap face pointing toward the center of the basket.

Specifically, as shown in fig. 1, the second basket electrode array 15 (proximal basket electrode array) is provided with at least 3 annular electrodes at equal intervals on the length of 1/2 of the distal end of the proximal basket skeleton, the length of the electrodes is not less than 2mm, the thickness is not less than 1mm, the electrode rings surround the peripheral diameter of 225 degrees of the basket skeleton, and a gap of 135 degrees is reserved without covering the electrode materials; the electrode surface points to the inner wall of the vestibule of the pulmonary vein, and the clearance surface points to the center of the basket, so that the directional ablation of the tissue surface of PFA energy is realized. In a specific example, the electrode arrays are sequentially numbered by taking the X-ray mark as a starting point, so that the computer identification and distribution are facilitated; the proximal electrode is located distally of the central portion of the scaffold so that when the basket scaffold is maximally extended, the electrode is still able to point with its outer electrode surface toward the catheter tip, well in contact with the targeted pulmonary vein vestibule.

The functions of the second basket electrode array 15 include: (1) Adjacent electrodes positioned on the same basket skeleton can form an ablation electrode pair in the weft direction of the basket, then the ablation electrode pair corresponding to the adjacent basket skeleton on the same basket skeleton forms an ablation ring, and PFA energy is synchronously emitted through the electrode pairs distributed in a ring shape, so that the target pulmonary vein vestibule can be ablated. (2) The electrodes at the same positions on the adjacent basket frameworks can form an ablation electrode pair in the radial direction of the basket, a complete ablation ring can be formed by connecting the electrode pairs, and annular ablation of the vestibule of the target pulmonary vein can be completed by synchronously distributing PFA energy through the electrode pairs which are annularly arranged along the radial direction of the basket. (3) Firstly, judging the tissue adhesion degree of all array electrodes by using electrophysiological parameters, then automatically selecting 1 electrode with the best contact quality from each basket framework, connecting the electrodes into an ablation electrode ring according to the radial direction of the basket framework, and finally forming an ablation electrode pair by using adjacent electrodes to finish synchronous annular ablation of the vestibule of a target pulmonary vein.

In some embodiments, the second basket frame spring 18 is a stretch rebound working spring, and is disposed on a second basket expansion link, one end of which is fixed to the basket frame connection portion 11, and the other end of which is fixed to the second basket expansion collar 19. In a specific example, as shown in fig. 1, the second basket frame spring 18 is preloaded onto the proximal basket telescoping rod with its distal end secured to the proximal end of the basket frame connector 11 and its proximal end secured to the distal end of the second basket telescoping collar 19.

Under normal conditions, the second basket frame spring 18 is in a natural compressed state, the length of the second basket frame spring is consistent with the thickness of the distal basket frame after the maximum contraction, and at the moment, the proximal basket is in a disc shape in the maximum contraction state, and can be used for being abutted against the vestibule of a target pulmonary vein to finish mapping and ablation. As shown in FIG. 7, when the operator needs to extend the proximal basket frame, the traction wires can be manipulated to pull the proximal basket telescoping collar toward the proximal end of the catheter, at which time the springs will be gradually stretched while the proximal basket frame is also stretched from the maximally contracted state to the arc of varying degrees desired by the operator until all of the frames are fully straightened, i.e., fully extended. After the mapping and ablation tasks of the proximal basket are finished, the operator can completely straighten the proximal basket skeleton by pulling back the proximal basket traction steel wire, so as to be convenient for repositioning the catheter or completely recovering the catheter into the sheath lumen.

In some embodiments, as shown in fig. 1, the outer diameter of the second basket expansion collar 19 is not less than 6F, the length is not less than 50mm, the inner cavity is not less than 5F, one end of the second basket expansion collar 19 is movably disposed at the basket frame connecting portion 11, the second basket expansion collar 19 includes an expansion rod, and the expansion rod can slide in the basket frame connecting portion 11 to drive the second basket frame 14 to stretch and recover, and after the second basket frame 14 is fully stretched, at least one electrode of the second basket electrode array 15 is located at the most distal end of the second basket frame 14.

In some specific examples, the second basket telescoping collar 19 (proximal basket telescoping collar) is stiff enough to support full extension and retraction of the second basket frame 14; the far end of the net basket frame connecting part is moved inside the net basket frame connecting part 11 (the moving range is not less than 10 mm); the distal end of the second basket expansion link can slide in the basket frame connecting part 11, thereby driving the extension and recovery of the proximal basket frame; when the basket framework is fully extended, its proximal electrode is just distal to the highest point of the framework, with the outer side of the electrode pointing toward the catheter tip.

The function of the second basket telescoping collar 19 is: (1) The basket framework is completely recovered, so that the basket framework can conveniently enter the target heart cavity through the sheath tube. (2) And fully stretching the basket framework to obtain the maximum outer diameter of the basket. (3) The basket outer diameter is adjusted as needed to individually adapt to different target pulmonary vein vestibular diameters.

As shown in fig. 1 and 8, a proximal end fixing point 20 of the proximal basket frame is further provided and located at the proximal end of the proximal basket connecting rod, and the distal end of the proximal basket frame is fixed to the proximal end of the proximal basket connecting rod, so that the basket frame can be stretched and recovered along with the proximal basket telescopic collar when the proximal basket telescopic collar is moved back and forth.

The proximal basket telescoping collar traction wire attachment point 21, located at the proximal end of the sliding collar, is used to pull the sliding collar to move over the catheter body. When the operator releases the traction steel wire completely, the movable lantern ring drives the proximal basket framework to shrink gradually due to the elastic retraction of the stretched working spring until the proximal basket framework takes on a maximum shrinkage disc shape. When the operator pulls back the traction steel wire, the sliding lantern ring moves towards the proximal direction of the catheter, and meanwhile the proximal basket working spring is gradually stretched until the proximal basket framework is in an arc shape required by the operator or reaches a maximum straightening state.

In some embodiments, the catheter body 23 is further provided with at least two visualization electrodes 22, at least two visualization electrodes 22 are disposed at intervals, in some examples, the visualization electrodes 22 are made of platinum iridium alloy materials, the length is 3mm or more, the thickness is not greater than 1mm, the distance from the proximal end of the proximal basket skeleton is at least 10mm, and the wires run in the wire microtubes in the catheter cavity.

The embodiment of the application further provides a use example of the PFA mapping ablation catheter with the double-bending double-basket array electrode, which comprises the following steps:

1. The visualized adjustable bending long sheath tube which can be matched with the catheter is placed in a target heart cavity, and is connected with a normal saline flushing lumen for continuous flushing after sufficient exhaust.

2. Heparin anticoagulation was performed by intravenous injection.

3. And (3) sending a finger guide wire (2.6 m) through the inlet at the tail end of the sheath tube, and controlling the adjustable bent sheath tube to lead the head end of the adjustable bent sheath tube to point to the opening of the target pulmonary vein under the guidance of imaging equipment. If a 1.5m guide wire is used, the guide wire is preloaded in place while the catheter is being prepared (the guide wire tip extends 3-5cm beyond the catheter tip).

4. Under the guidance of a perspective image or a three-dimensional image, the end of the thread guiding head is sent into the primary branch of the target pulmonary vein and the position of the thread guiding head is kept stable.

5. Preparing a double-bending double-basket array electrode multifunctional catheter: and completely recovering 2 electrode baskets, wetting the catheter body part by using normal saline, fully exhausting the flushing pipe, connecting the flushing pipe with the normal saline, and completely recovering the 2 electrode baskets into the guide sheath. If a 1.5m guide wire is used, the guide wire is preloaded into place from the guide wire inlet at the tail of the catheter (the guide wire tip extends 3-5cm beyond the catheter tip).

6. The 2 basket electrode tails, the basket position sensor and the visualized electrode tail are respectively connected with an electrophysiology host. This step may also be accomplished after the catheter tip has entered the target heart chamber.

7. Under the protection of the basket electrode guiding sheath, the head end of the catheter is sent to the tail inlet of the adjustable bent sheath tube through the finger guide wire, passes through the tail inlet sealing film and is sent to the middle section of the sheath tube.

8. Intracardiac multi-electrode activation mapping and three-dimensional modeling: (1) Under the guidance of a perspective image or a three-dimensional image, the distal basket of the catheter is sent out of the sheath tube through a finger guide wire (the basket framework is in a completely straightened state). (2) The operator rotates the distal basket control wheel on the control catheter handle, compresses the distal basket under the guidance of three-dimensional or two-dimensional images, so that the framework of the distal basket is fully unfolded, and the outer diameter of the basket reaches the maximum. (3) The operator controls the catheter handle and the bending control wheel to finish intracavity activation mapping and three-dimensional modeling through the electrode array on the far-end basket.

9. The catheter tip enters the target pulmonary vein: under the guidance of a perspective image or a three-dimensional image, the distal basket of the catheter is sent out of the sheath tube through the finger guide wire and slowly enters the proximal end of the target pulmonary vein.

10. Distal basket is opened at the proximal end of the target pulmonary vein: the operator refers to the inner diameter of the proximal end of the target pulmonary vein, and increases the outer diameter of the distal basket as required, so that the proximal electrode positioned at the vertex of the basket framework is completely abutted against the inner wall of the proximal end of the target pulmonary vein. The index of good close contact of the proximal basket electrode to the proximal inner wall of the target pulmonary vein is: (1) the position of the basket is stable. (2) the pulmonary vein positioning recorded by each electrode is stable. (3) the electrode impedance value is stable. (4) basket outer diameter exhibits characteristic compressive deformation.

11. The proximal basket of the catheter is extended to the desired size under the direction of the fluoroscopic or three-dimensional image. The reference indexes for determining the extension degree of the proximal basket are as follows: the distal basket actually stretches an outer diameter of +6mm.

12. The catheter is forwarded under the protection of the guide wire and the far-end basket, the abutting pressure of the near-end basket electrode and the target pulmonary vein vestibular tissue is increased, and the good abutting index of the basket electrode and the pulmonary vein vestibular tissue is judged as follows: (1) the proximal basket is stable in position. (2) the recorded vestibular potential is stable. (3) electrode impedance is stable. (4) The distance between the proximal basket edge and the distal basket edge is enlarged. (5) The front portion of the proximal basket exhibits a characteristic rearward deformation.

13. Target pulmonary vein proximal muscular sleeve ablation technique: and forming an ablation electrode pair (every 2 adjacent electrodes form 1 ablation electrode pair) by an electrode at the top of the far-end basket framework along the radial direction of the basket, synchronously discharging and ablating the near-end muscular sleeve of the target pulmonary vein by PFA energy, and simultaneously monitoring the ablation effect by the discharge ablated basket electrodes.

14. Target pulmonary vein vestibular ablation technique: the electrophysiology host automatically judges the abutting quality of the proximal basket matrix electrode and the target pulmonary vein vestibular tissue, 1 electrode with the best abutting degree is selected from each basket skeleton to serve as a main ablation electrode, and then PFA energy is sequentially synchronized for ablation in the following mode: (1) synchronous ablation of basket skeleton weft electrode pairs. The synchronous ablation is performed by forming an ablation electrode pair by all main ablation electrodes and electrodes at the proximal end of the main ablation electrodes, and then forming an ablation electrode pair by all main ablation electrodes and electrodes at the distal end of the main ablation electrodes. (2) synchronous ablation of mesh basket skeleton radial line electrode pairs: the main ablation electrode forms an ablation electrode pair along the radial direction of the basket to perform synchronous ablation, the electrode at the near end of the main ablation electrode forms an ablation electrode pair along the radial direction of the basket to perform synchronous ablation, and the electrode at the far end of the main ablation electrode forms an ablation electrode pair along the radial direction of the basket to perform synchronous ablation. While the ablation effect is monitored by the ablation electrodes.

15. The proximal muscular cuff and vestibular annular movement ablation technique of the target pulmonary vein is as shown in fig. 9: (1) The first ablation of the proximal muscular sleeve and vestibule of the target pulmonary vein is accomplished separately or simultaneously, according to steps 12, 13. (2) And evaluating the ablation effect of the first ablation part to determine whether in-situ re-ablation is needed. (3) reducing the outer diameter of the distal end and/or the proximal end basket by more than 50 percent. (4) The catheter is rotated in situ 30 deg. -45 deg. clockwise or counter-clockwise. (5) The operator stretches the distal and/or proximal basket to the target outer diameter depending on the application requirements. (6) The electrophysiology and image parameters of the new part are evaluated to meet the requirements, and fine adjustment is performed if necessary. (7) Advancing the catheter and adjusting the outer diameter of the distal basket until a characteristic distal and proximal basket deformation occurs, achieving an ideal pressure abutment between the electrode and tissue. (8) And respectively or synchronously releasing PFA ablation energy to complete the ablation of the proximal muscular sleeve of the target pulmonary vein and the newly selected part of the vestibule. (9) And evaluating the ablation effect of the newly selected part, and confirming whether the newly selected part needs to be ablated again in situ. (10) The method is transferred to the next adjacent site ablation according to steps (1) - (10) until complete electrical isolation of the target pulmonary vein is achieved.

16. Anterior-posterior crossing large ring isolation ablation of the vestibule of the superior and inferior pulmonary veins, as shown in fig. 9: (1) fully retrieving the proximal basket. (2) The distal basket is withdrawn from the ostium of the pulmonary vein through the finger guide wire. (3) The guide wire is withdrawn until its head end enters the catheter body. (4) fully extending the distal basket. (5) The head end of the sheath tube is adjusted to point to the vestibular intersection of the pulmonary vein. (6) The catheter is advanced and its head end curvature adjusted as needed until the center of the distal basket top is at the pulmonary vein vestibular intersection. (7) The advancing distal basket ensures good apposition of the intimal tissue at the top of the basket at the vestibule intersection. (8) The electrophysiology host selects basket electrodes to form linear or arc ablation lines according to the vestibular crossing walking. (9) After the electrodes are combined into 1 ablation electrode pair according to every 2 adjacent electrodes, PFA energy ablation is synchronously emitted. (10) And after the position of the distal basket is adjusted, repeating the ablation operation until the ablation of the front and rear crossing of the vestibule of the pulmonary vein is completed. (11) And (5) moving the distal basket electrode into the ablation large ring, and checking the ablation effect of the pulmonary vein vestibule and the proximal muscle sleeve thereof.

To sum up, the dual basket of the catheter head of the PFA mapping ablation catheter of the present application is capable of being retracted and extended into and out of the proximal end of the target pulmonary vein and against and out of the vestibule of the pulmonary vein, respectively or simultaneously. The PFA mapping ablation catheter double basket can be respectively or simultaneously linearly telescopic to adapt to the inner diameter of the proximal end of the target pulmonary vein and the vestibular diameter of the target pulmonary vein, and the distal basket can be coaxial with the proximal end of the target pulmonary vein through a finger guide wire. The proximal basket of the present application can be coaxial to the vestibule of the targeted pulmonary vein by a finger guide wire and the distal basket in an extended state.

The abutting pressure between the near-end basket and the vestibule of the target pulmonary vein of the PFA mapping ablation catheter can be adjusted as required, and the far-end basket can be independently used as a three-dimensional modeling and exciting mapping catheter.

The PFA mapping ablation catheter proximal basket electrode array can design a personalized target pulmonary vein ablation ring in real time through identification and combination of respective electrophysiology parameters. The PFA mapping ablation catheter double-basket electrode array can simultaneously and respectively ablate the proximal muscle sleeve and the vestibule of a target pulmonary vein, and can complete the large ring isolation of the vestibule of the upper and lower pulmonary veins and various linear ablations in the left atrium by matching with the linear electrode combination of the distal basket, and the electrode array of the proximal basket can synchronously ablate the electrode combination in the longitude and latitude directions.

It should be noted that, in various embodiments of the present application, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

The foregoing embodiment numbers of the present application are merely for the purpose of description, and do not represent the advantages or disadvantages of the embodiments.

The embodiments of the present application have been described above with reference to the accompanying drawings, but the present application is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present application and the scope of the claims, which are to be protected by the present application.

Claims (7)

1. A double-bend double-basket array electrode PFA mapping ablation catheter, comprising:

A catheter body (23) with one end leading out a guide wire (34) from the guide wire outlet (1) and the other end connected to a catheter handle (25), wherein the head end of the catheter body (23) is respectively provided with a first basket and a second basket; wherein,

The first basket comprises a first basket framework (3), a first basket telescopic rod (7) and a first basket framework spring (8), wherein the first basket framework (3) and the first basket telescopic rod (7) are arranged along the direction of the catheter body (23), the first basket framework (3) can move and deform based on the first basket framework spring (8) under the pulling of corresponding pulling wires, and after the pulling wires are loosened, the first basket framework (3) is restored to the position, and a first basket electrode array (4) is arranged on the first basket framework (3);

The second basket is arranged at intervals with the first basket and comprises a second basket framework (14), a second basket telescopic sleeve ring (19) and a second basket framework spring (18), the second basket framework (14) is arranged along the direction of the catheter body (23), the second basket framework (14) can move and deform under the pulling of corresponding pulling wires based on the second basket framework spring (18), and the second basket framework (14) is at a recovery position after the pulling wires are pulled back, and a second basket electrode array (15) is arranged on the second basket framework (14);

The catheter handle (25) is connected with the catheter body (23), a second basket telescopic control wheel (27) and a first basket telescopic control wheel (28) are arranged on the catheter handle, the second basket telescopic control wheel (27) and the first basket telescopic control wheel (28) are respectively connected with corresponding traction wires, and the catheter handle (25) is led out of corresponding electrode tail wires and the other end of the guiding guide wire (34);

The first basket framework spring (8) is a compression rebound working spring, the first basket framework spring (8) is arranged on the first basket telescopic rod (7), one end of the first basket framework spring is fixed at the head end of the first basket telescopic rod (7), the other end of the first basket framework spring is fixed at the basket framework connecting part (11), under a normal state, the first basket framework spring (8) is naturally straightened, and the proximal end of the first basket telescopic rod (7) can slide in the basket framework connecting part (11);

the device is also provided with a far-end basket framework near-end fixed point (9) which is positioned at the far end of the basket framework connecting part (11), the near end of the first basket framework (3) is fixed at the far end of the basket framework connecting part (11), and the far end of the first basket framework (3) is fixed at the far end of the first basket telescopic rod (7);

The outer diameter of the second basket expansion sleeve ring (19) is not smaller than 6F, the length is not shorter than 50mm, the inner cavity of the second basket expansion sleeve ring is not smaller than 5F, one end of the second basket expansion sleeve ring (19) is movably arranged at the basket framework connecting part (11), the second basket expansion sleeve ring (19) comprises a second basket expansion rod, the second basket expansion rod can slide in the basket framework connecting part (11) to drive the second basket framework (14) to stretch and recover, after the second basket framework (14) is fully stretched, at least one electrode of the second basket electrode array (15) is positioned at the most far end of the second basket framework (14), the far end of the second basket framework is fixed at the near end of the basket framework connecting part (11), and the near end of the second basket framework is fixed at the near end of the second basket expansion rod;

The second basket framework spring (18) is a stretching rebound working spring and is arranged on the second basket telescopic rod, one end of the second basket framework spring is fixed on the basket framework connecting part (11), and the other end of the second basket framework spring is fixed with the second basket telescopic lantern ring (19).

2. The double-bending double-basket array electrode PFA mapping ablation catheter according to claim 1, wherein the first basket frameworks (3) are not less than 3 basket frameworks and not shorter than 10mm, a walking wire is arranged in the cavity of the formed frameworks, and a first basket electrode array identifier (5) is arranged on one basket framework.

3. The double-bending double-basket array electrode PFA mapping ablation catheter according to claim 2, wherein the first basket electrode array (4) is arranged at one end of the basket framework close to the finger guide wire outlet (1) and at equal intervals;

The first basket electrode array (4) includes at least 3 ring electrodes.

4. A double-bend double-basket array electrode PFA mapping ablation catheter according to claim 3, characterized in that at least 3 ring electrodes of the first basket electrode array (4) are provided with numbers sequentially based on the first basket electrode array identification (5).

5. The double-bending double-basket array electrode PFA mapping ablation catheter according to claim 1, wherein the outer diameter of the basket framework connecting part (11) is not less than 7F, the length of the basket framework connecting part is not less than 10mm, one end of the basket framework connecting part is fixed on the catheter body (23), and the guide wire (34), the first basket telescopic rod (7) and the second basket telescopic sleeve ring (19) are sleeved in the inner cavity of the basket framework connecting part (11) from inside to outside.

6. The double-bent double-basket array electrode PFA mapping ablation catheter according to claim 5, wherein the second basket framework (14) comprises not less than 3 basket frameworks, is not shorter than 30mm, has an outer diameter not less than 2F, walks on a wire in an inner cavity of the formed framework, and a second basket electrode array identifier (16) is arranged on one basket framework;

the second basket electrode array (15) is arranged at one end, close to the finger guide wire outlet (1), of the basket framework and is arranged at equal intervals;

The second basket electrode array (15) comprises at least 3 annular electrodes, gaps are reserved on the annular electrodes and are not covered by electrode materials, each electrode face points to the inner wall of the vestibule of a pulmonary vein, and the clearance face points to the center of the basket.

7. The double-bending double-basket array electrode PFA mapping ablation catheter according to claim 1, wherein at least two visualization electrodes (22) are further arranged on the catheter body (23), and at least two visualization electrodes (22) are arranged at intervals.