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

Abstract

The utility model discloses a double-bend double-basket array electrode PFA (perfluoroalkoxy) mapping ablation catheter, which relates to the technology of medical instruments and comprises a catheter body, one end of the catheter body leads out a guide wire from a guide wire outlet, the other end of the catheter body is connected to a catheter handle, and a first basket and a second basket are respectively arranged at the head end of the catheter body; and the catheter handle is connected with the catheter body part, a second mesh basket telescopic control wheel and a first mesh basket telescopic control wheel are arranged on the catheter handle, the second mesh basket telescopic control wheel and the first mesh basket telescopic control wheel are respectively connected with the corresponding traction wires, and the catheter handle leads out corresponding electrode tail wires and the other ends of the guide wires. According to the utility model, the double net baskets at the head part of the catheter can respectively or simultaneously enter and exit from the near end of the target pulmonary vein and cling to and leave from the vestibule of the pulmonary vein through retraction and extension.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a double-bent double-basket array electrode PFA mapping and ablation catheter. Background Technique

[0002] Minimally invasive catheter ablation technology is the basic therapy for treating human arrhythmia diseases at present. Its basic principle is as follows: 1. Puncture the peripheral blood vessels of the patient to establish a minimally invasive surgical channel for electrophysiological instruments to enter and exit the human cardiovascular system. 2. Under the guidance of various imaging and electrophysiological mapping technologies, accurately position the treatment electrode, electrode combination or electrode array at the predetermined lesion. 3. Under the guidance of various monitoring and evaluation indicators, deliver various ablation energies to damage or modify the target lesion as needed, so as to achieve the purpose of curing arrhythmia diseases. According to the different ablation energies used, the forms and characteristics of the ablation electrodes adopted are different. For example, when applying traditional radiofrequency energy, a single-electrode ablation mode is usually used, and in some special cases, a bipolar ablation mode with a distance of 10-30 cm can also be adopted; when using cryoablation energy, a balloon ablation mode that can be filled and emptied is usually adopted; when using pulsed electric field energy ablation, both traditional single- and bipolar ablation modes can be used, or an electrode combination or electrode array ablation mode can be adopted.

[0003] Although the traditional radiofrequency ablation energy delivery mode has many advantages, such as easy long-distance transmission, quantitative control, simple catheter manipulation, etc., it also has very obvious deficiencies, such as lack of tissue specificity, easy generation of bubbles, eschar and shock, long single-point ablation time, poor multi-pole discharge effect, etc. In order to overcome the above defects of radiofrequency energy, pulsed electric field (PFA) ablation energy came into being. The ablation mode of using a multi-electrode combination to deliver pulsed electric field energy is particularly suitable for treating complex arrhythmia diseases, such as various types of atrial fibrillation. Because of the strong tissue selectivity, good operation safety and high ablation efficiency of this ablation technology, it is expected to replace the traditional electrode radiofrequency ablation mode.

[0004] The existing PFA multi-pole catheters mainly include PulsedFA annular multi-pole catheters and CardiPulse petal-shaped multi-pole catheters.

[0005] The structural features of the PulsedFA annular multi-polar catheter are as follows: 1. An electrode ring with a diameter of 3 - 4 cm perpendicular to the catheter body is provided at the catheter tip. 2. Six to eight identical platinum-iridium annular electrodes are evenly arranged on the electrode ring from far to near. The usage scheme of this catheter is as follows: 1. The annular multi-polar PFA catheter is sent into the target cardiac chamber through an adjustable bending sheath tube pre-placed in the target cardiac chamber. 2. Manipulate the tip of the adjustable bending sheath tube to bend and guide the PFA catheter into the target pulmonary vein vestibule area. 3. Then, verify and adjust the position of the PFA electrode ring through three-dimensional imaging and electrophysiological mapping techniques. 4. Use two adjacent electrodes to form an ablation electrode group and synchronously deliver PFA energy to complete the ablation process.

[0006] The structural features of the CardiPulse petal-shaped multi-polar catheter are as follows: 1. A petal-shaped multi-electrode ring is provided at the catheter tip. 2. Three identical annular electrodes are equidistantly arranged at the top of each petal lobe. 3. The catheter has an open lumen throughout for passing a guide wire. The usage scheme of this catheter is as follows: 1. The petal-shaped multi-polar PFA catheter is sent into the target cardiac chamber through an adjustable bending sheath tube pre-placed in the target cardiac chamber. 2. Under fluoroscopy or three-dimensional imaging guidance, manipulate the tip of the adjustable bending sheath tube to bend and guide the tip of the guide wire into the proximal part of the target pulmonary vein. 3. Under fluoroscopy or three-dimensional imaging guidance, fix the guide wire and, guided by the tip of the guide wire, send the petal-shaped electrode into the vestibule area of the target pulmonary vein. 4. Verify and adjust the position of the petal electrode ring through three-dimensional imaging and electrophysiological mapping techniques. 5. Use two adjacent electrodes on the radial and circumferential lines of the petal ring to form an ablation electrode group and synchronously deliver PFA energy to complete the ablation process.

[0007] The above two PFA multi-electrode catheters still have the following defects. Since both of the above two multi-electrode catheters have a single-ring structure, during the process of the electrode catheter tip extending into the pulmonary vein vestibule, the ablation electrode ring cannot be well coaxial with the pulmonary vein vestibule, resulting in an unsatisfactory ablation effect. Moreover, the annular tips of the above two multi-electrode catheters have fixed sizes and cannot change the size of the ablation ring according to the diameter changes of different patients or different positions of the pulmonary veins of the same patient, resulting in the ablation electrode group not being able to closely adhere to the irregular vestibular tissue and unable to design an individualized ablation ring according to the different morphologies of different pulmonary vein vestibules. Since both of the above two PFA catheters have an annular structure, they cannot effectively ablate linear ablation sites such as the junction of the upper and lower pulmonary veins to achieve the purpose of ablating the large ring of the pulmonary vein vestibule. At the same time, the above ablation catheter does not have the function of tip bending and cannot change the pointing and angle of the electrode ring by itself, resulting in a low operation efficiency during the use by the operator. Summary of the Invention

[0008] An embodiment of the present utility model provides a double-bend double-basket array electrode PFA mapping and ablation catheter, enabling the double baskets at the catheter head to enter and exit the proximal end of the target pulmonary vein respectively or simultaneously, and to be in contact with and away from the pulmonary vein vestibule through recovery and extension, and the double baskets can linearly expand and contract respectively or simultaneously to adapt to the inner diameter of the proximal end of the target pulmonary vein and the diameter of the pulmonary vein vestibule.

[0009] An embodiment of the present utility model provides a double-bend double-basket array electrode PFA mapping and ablation catheter, comprising:

[0010] A catheter body 23, one end of which leads out a guide wire 34 from the guide wire outlet 1, and the other end is connected to a catheter handle 25. At the head end of the catheter body 23, a first basket and a second basket are respectively arranged; wherein,

[0011] The first basket includes a first basket framework 3, a first basket telescopic rod 7 and a first basket framework spring 8. 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 the corresponding traction wire, and the first basket framework 3 restores its position after the traction wire is relaxed. A first basket electrode array 4 is arranged on the first basket framework 3;

[0012] The second basket is arranged at an interval from the first basket, and includes a second basket framework 14, a second basket telescopic sleeve 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 the corresponding traction wire, and the second basket framework 14 restores its position after the traction wire is pulled back. A second basket electrode array 15 is arranged on the second basket framework 14;

[0013] A catheter handle 25, connected to the catheter body 23, on which a double-bend control wheel 26 for the catheter head end, a second basket telescopic control wheel 27 and a first basket telescopic control wheel 28 are arranged. The double-bend control wheel 26 for the catheter head end is connected to the inner side of the catheter wall at the catheter head end through a traction wire for bending the catheter head end. The second basket telescopic control wheel 27 and the first basket telescopic control wheel 28 are respectively connected to the corresponding traction wires, and the catheter handle 25 leads out the corresponding electrode tail wires and the other end of the guide wire 34.

[0014] Optionally, the first basket framework 3 has no less than 3 basket frameworks and is no shorter than 10 mm. A wire is routed through the inner cavity of the formed framework, and a first basket electrode array identifier 5 is arranged on one of the basket frameworks.

[0015] Optionally, the first basket electrode array 4 is disposed at one end of the basket skeleton close to the guide wire outlet 1 and is arranged at equal intervals;

[0016] The first basket electrode array 4 includes at least three ring electrodes.

[0017] Optionally, at least three ring electrodes of the first basket electrode array 4 are numbered in sequence based on the first basket electrode array identifier 5.

[0018] Optionally, the first basket skeleton spring 8 is a compression and rebound working spring. The first basket skeleton spring 8 is disposed on the first basket telescopic rod 7, with one end fixed to the head end of the first basket telescopic rod 7 and the other end fixed to the basket skeleton connection part 11. In the normal state, the first basket skeleton spring 8 is naturally straightened;

[0019] One end of the first basket skeleton 3 far from the guide wire outlet 1 is fixed to one end of the first basket telescopic rod 7 close to the basket skeleton connection part 11.

[0020] Optionally, the outer diameter of the basket skeleton connection part 11 is not less than 7F and the length is not shorter than 10 mm. One end of it is fixed to the catheter body part 23. The inner cavity of the basket skeleton connection part 11 is sleeved with the guide wire 34, the first basket telescopic rod 7, and the second basket telescopic collar 19 from inside to outside.

[0021] Optionally, the second basket skeleton 14 includes not less than three basket skeletons, and is not shorter than 30 mm. Its outer diameter is not less than 2F. Conducting wires run in the formed skeleton inner cavity, and a second basket electrode array identifier 16 is provided on one of the basket skeletons.

[0022] The second basket electrode array 15 is disposed at one end of the basket skeleton close to the guide wire outlet 1 and is arranged at equal intervals;

[0023] The second basket electrode array 15 includes at least three ring electrodes, and the ring electrodes have gaps and do not cover the electrode material. Each electrode surface points to the inner wall of the pulmonary vein vestibule, and the gap surface points to the center of the basket.

[0024] Optionally, the second basket skeleton spring 18 is a tension and rebound working spring. It is disposed on the second basket telescopic rod, with one end fixed to the basket skeleton connection part 11 and the other end fixed to the second basket telescopic collar 19.

[0025] Optionally, the outer diameter of the second basket telescopic collar 19 is not less than 6F, the length is not shorter than 50 mm, its inner cavity is not less than 5F, one end of the second basket telescopic collar 19 is movably arranged at the basket frame connecting part 11, the second basket telescopic collar 19 includes a telescopic rod, and the telescopic rod can slide in the basket frame connecting part 11 to drive the extension and retraction of the second basket frame 14, and after the second basket frame 14 is fully extended, at least one electrode of the second basket electrode array 15 is located at the farthest end of the second basket frame 14.

[0026] Optionally, at least two visualization electrodes 22 are further arranged on the catheter body part 23, and the at least two visualization electrodes 22 are arranged at intervals.

[0027] The PFA mapping and ablation catheter of the embodiment of the present invention can enable the double baskets at the catheter head to enter and exit the proximal end of the target pulmonary vein respectively or simultaneously and abut against and leave the pulmonary vein vestibule by retraction and extension, and the double baskets can linearly expand and contract respectively or simultaneously to adapt to the inner diameter of the proximal end of the target pulmonary vein and the diameter of the pulmonary vein vestibule.

[0028] The above description is only an overview of the technical solution of the present invention. In order to be able to understand the technical means of the present invention more clearly, it can be implemented according to the content of the specification, and in order to make the above and other purposes, features and advantages of the present invention more obvious and understandable, the following specifically illustrates the specific embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0030] Figure 1 It is a partial structural schematic diagram of the double-bend double-basket array electrode PFA mapping and ablation catheter of the embodiment of the present invention;

[0031] Figure 2 It is an overall structural schematic diagram of the double-bend double-basket array electrode PFA mapping and ablation catheter of the embodiment of the present invention;

[0032] Figure 3 、 Figure 4 It is a partial structural schematic diagram of the catheter handle of the double-bend double-basket array electrode PFA mapping and ablation catheter of the embodiment of the present invention;

[0033] Figure 5 It is a partial structural schematic diagram of the double-bend double-basket array electrode PFA mapping and ablation catheter of the embodiment of the present invention;

[0034] Figure 6 Schematic diagram of the bending state of the double-bend double-basket array electrode PFA mapping and ablation catheter according to an embodiment of the present invention;

[0035] Figure 7 Schematic diagram of the extended state of the double-bend double-basket array electrode PFA mapping and ablation catheter according to an embodiment of the present invention;

[0036] Figure 8 Schematic diagram of the cross-sectional structure of the double-bend double-basket array electrode PFA mapping and ablation catheter according to an embodiment of the present invention. Detailed implementation manners

[0037] Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be completely conveyed to those skilled in the art.

[0038] An embodiment of the present invention provides a double-bend double-basket array electrode PFA mapping and ablation catheter, as Figure 1 , Figure 2 shown, including:

[0039] A catheter body 23, one end of which leads out a guide wire 34 from the guide wire outlet 1, and the other end is connected to a catheter handle 25. A first basket and a second basket are respectively provided at the head end of the catheter body 23. In some specific examples, the outer diameter of the catheter body 23 is not greater than 8F, the length is not shorter than 100 cm, the wall thickness is not greater than 0.2 mm, and the internal running structure includes: a guide wire and a catheter flushing lumen, a basket electrode wire lumen, a positioning sensor and a visualization electrode wire lumen, a distal basket telescopic rod traction wire lumen, a proximal basket telescopic sleeve traction wire lumen, and a catheter head end bending control wire lumen. Among them, in some specific examples, as Figure 2 shown, the outer diameter of the guide wire 34 is not greater than 0.035 inches, the length is not shorter than 260 cm, the head end 30 mm is relatively soft and has a prefabricated protective J bend, the diameter of the J bend is not greater than 10 mm, and its tail is lined with an inner core to enhance the support ability of the guide wire body. The surface of the guide wire 34 is heparin anticoagulated and super-slippery treated.

[0040] The first wire basket includes a first wire basket framework 3, a first wire basket telescopic rod 7, and a first wire basket framework spring 8. The first wire basket framework 3 and the first wire basket telescopic rod 7 are arranged along the direction of the catheter body portion 23. The first wire basket framework 3 can move and deform based on the first wire basket framework spring 8 under the pulling of the corresponding traction wire, and the first wire basket framework 3 resumes its position after the traction wire is relaxed. A first wire basket electrode array 4 is arranged on the first wire basket framework 3.

[0041] The second wire basket is arranged at an interval from the first wire basket, and includes a second wire basket framework 14, a second wire basket telescopic collar 19, and a second wire basket framework spring 18. The second wire basket framework 14 is arranged along the direction of the catheter body portion 23. The second wire basket framework 14 can move and deform based on the second wire basket framework spring 18 under the pulling of the corresponding traction wire, and the second wire basket framework 14 resumes its position after the traction wire is pulled back. A second wire basket electrode array 15 is arranged on the second wire basket framework 14.

[0042] The catheter handle 25 is connected to the catheter body portion 23, and is provided with a double-bend control wheel 26 at the head end of the catheter, a second wire basket telescopic control wheel 27, and a first wire basket telescopic control wheel 28. The double-bend control wheel 26 at the head end of the catheter is connected to the inner side of the tube wall at the head end of the catheter through a traction wire, and is used for bending the head end of the catheter. The second wire basket telescopic control wheel 27 and the first wire basket telescopic control wheel 28 are respectively connected to the corresponding traction wires. The catheter handle 25 leads out the corresponding electrode tail wires and the other end of the guide wire 34.

[0043] In the embodiments of the present invention and subsequent embodiments, "distal end" and "proximal end" are respectively used to describe the two ends. For example, the end of a component closer to the operator is the proximal end of the component, and the other end is the distal end of the component. In some specific examples, the catheter handle 25, as Figure 2 shown, has an outer diameter not greater than 20 mm, a length not greater than 70 mm, the head end is connected to the tail end of the catheter body portion, and the tail end has a sealed membrane opening with an inner diameter not less than 0.035 inches for passing the guide wire. The handle tail is connected with a catheter flushing tube, double-wire basket electrode tail wires, a positioning sensor, and a visualization electrode tail wire. Inside the head end of the handle, there are provided: two wire basket traction wire control shafts, and the outer diameter ratio of the two is the same as the synchronous telescopic ratio of the far and near wire baskets. A double-wire basket linkage separator. A catheter head end bending traction wire control shaft. On the body portion of the handle, there are provided a catheter head end bending control wheel and double-wire basket telescopic control wheels (the second wire basket telescopic control wheel 27 and the first wire basket telescopic control wheel 28).

[0044] Among them, as Figure 2As shown, the double-bend control wheel 26 at the distal end of the catheter is located at the distal end of the handle. In a specific example, it is a damping rotary wheel for easy operation and temporary stopping. It is diagonally connected to the inner side of the catheter wall at the distal end of the catheter by two traction wires at an angle of 180°. When the operator rotates the wheel clockwise or counterclockwise, the distal end of the catheter bends 1° to 135° towards the side where the traction wire is located, achieving the purpose of two-way bending adjustment of the distal end of the catheter. The bending degree of the catheter is determined by the operator's control. Due to the damping function of the rotary wheel, the distal end of the catheter can be temporarily stopped at any bending angle (within the maximum full range) required by the operator.

[0045] The second basket telescopic control wheel 27 (distal basket telescopic control wheel), adjacent to the proximal end of the double-bend control wheel, adopts a damping rotary wheel design for easy operation and temporary stopping. It is connected to the proximal end of the distal basket telescopic rod by a single traction wire. When the operator rotates the wheel clockwise or counterclockwise, it drives the traction wire to retract towards the proximal end of the catheter or loosen towards the distal end, thereby controlling the stretching or rebound of the distal basket telescopic spring and achieving the telescopic control of the distal basket. The telescopic degree of the basket is determined by the operator's control. Due to the damping function of the rotary wheel, the distal basket skeleton can be temporarily stopped at any telescopic degree (within the maximum telescopic limit of the distal basket skeleton) required by the operator.

[0046] The first basket telescopic control wheel 28 (proximal basket telescopic control wheel), adjacent to the proximal end of the distal basket telescopic control wheel, adopts a damping rotary wheel design for easy operation and temporary stopping. It is connected to the proximal end of the proximal basket telescopic rod by a single traction wire. When the operator rotates the wheel clockwise or counterclockwise, it drives the traction wire to retract towards the proximal end of the catheter or loosen towards the distal end, thereby controlling the stretching or rebound of the proximal basket telescopic spring and achieving the telescopic control of the proximal basket. The telescopic degree of the basket is determined by the operator's control. Due to the damping function of the rotary wheel, the proximal basket skeleton can be temporarily stopped at any telescopic degree (within the maximum telescopic limit of the proximal basket skeleton) required by the operator.

[0047] In some specific examples, such as Figure 3 、 Figure 4 shown, it also includes a catheter lumen flushing tube 29, located at the tail of the catheter handle, communicating with the guide wire lumen running inside the catheter. Its function is to discharge the residual air in the guide wire lumen and continuously flush the guide wire lumen.

[0048] The distal basket electrode tail wire 30 is located at the tail of the catheter handle and is connected to the wires of the distal basket array electrodes.

[0049] The proximal basket electrode tail wire 31 is located at the tail of the catheter handle and is connected to the wires of the proximal basket array electrodes.

[0050] The positioning sensor and visualization electrode tail wire 32 is located at the tail of the catheter handle and is connected to the wires of the basket positioning sensor and visualization electrodes.

[0051] The guiding wire inlet at the tail of the impact handle (with a sealing film) 33 has an inner diameter of not less than 0.035 inches and is communicated with the guiding wire lumen of the catheter body. A sealing film is provided at the inlet to prevent air from entering and blood from overflowing.

[0052] The PFA mapping and ablation catheter of the embodiment of the present utility model can enable the double wire baskets at the head of the catheter to enter and exit the proximal end of the target pulmonary vein respectively or simultaneously and abut against and leave the pulmonary vein vestibule by recovery and extension, and the double wire baskets can linearly expand and contract respectively or simultaneously to adapt to the inner diameter of the proximal end of the target pulmonary vein and the diameter of the pulmonary vein vestibule.

[0053] In some embodiments, such as Figure 1 shown, the first wire basket skeleton 3 has no less than 3 wire basket skeletons and is not shorter than 10 mm. A wire is walked in the inner cavity of the formed skeleton, and a first wire basket electrode array identifier 5 is provided on one of the wire basket skeletons. In some specific examples, such as Figure 5 shown, at the head of the catheter body 23, a distal fixed point 2 of the distal wire basket skeleton is provided, and the distal end of the first wire basket skeleton 3 (distal wire basket skeleton) is fixed to the most distal end of the first wire basket telescopic rod 7 (distal wire basket telescopic rod), so as to facilitate the extension and recovery of its wire basket skeleton when the distal wire basket telescopic rod moves forward and backward.

[0054] Such as Figure 1 shown, the first wire basket skeletons 3 (distal wire basket skeletons) are spaced at equal intervals from each other; electrodes and sensor wires are walked in the inner cavity of the skeleton. At the proximal end of one of the skeletons, there is a first wire basket electrode array identifier 5 (X-ray annular identifier) for identifying the skeleton serial number, and at least 1 distal wire basket positioning sensor 6 is provided at the proximal end of the skeleton corresponding to this skeleton. In a specific example, at least 1 positioning sensor is provided on the distal wire basket skeleton corresponding to the X-ray identification skeleton for positioning the three-dimensional position of the distal wire basket on the three-dimensional image.

[0055] In some embodiments, the first wire basket electrode array 4 is provided at one end of the wire basket skeleton close to the guiding wire outlet 1 and is arranged at equal intervals;

[0056] In some embodiments, at least 3 annular electrodes of the first wire basket electrode array 4 are numbered in sequence based on the first wire basket electrode array identifier 5. For example, in some examples, the serial numbers of all wire basket skeletons are sequentially calibrated and identified in a clockwise or counterclockwise direction based on the first wire basket electrode array identifier 5.

[0057] Specifically, such as Figure 1As shown, the first basket electrode array 4 includes at least 3 ring electrodes made of platinum-iridium alloy material, with a length of not less than 2 mm and a thickness of not less than 1 mm. The 3 ring electrodes can be specifically numbered in sequence starting from the X-ray mark for the convenience of computer recognition and allocation.

[0058] In some specific examples, the ablation electrode at the top of the basket skeleton only wraps 225° of the circumference of the basket skeleton, leaving a 135° gap without covering the 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 as to achieve tissue surface directional ablation of PDA energy.

[0059] In specific examples, the functions of the first basket electrode array 4 (distal basket electrode array) include: (1) The electrodes in the middle of the skeleton, with every 2 electrodes adjacent in the basket diameter direction forming an electrode pair, emitting PFA energy to ablate the proximal muscle sleeve of the target pulmonary vein, recording the pulmonary vein positioning to test the ablation effect, and guiding remedial ablation. (2) The electrode groups arranged in a straight line or arc on two opposite basket skeletons can be used alone for ablation at 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 fully extended, the matrix composed of all electrodes can be used for three-dimensional modeling and activation mapping.

[0060] In some specific examples, the first basket telescopic rod 7 (distal basket telescopic rod) has an outer diameter of not more than 5F, a length of not less than 20 mm, an inner cavity of not less than 0.035 inches, and a hardness sufficient to support the full extension and recovery of all skeletons. Its distal opening is used for the guide wire to pass through, and its proximal end is located within the basket skeleton connection part 11 (not less than 10 mm); the proximal end of the distal basket telescopic rod can slide within the basket skeleton connection part 11, thereby driving the skeleton to extend and recover. When the skeleton is fully extended, its proximal electrode is exactly located at the vertex of the skeleton.

[0061] The functions of the distal basket telescopic rod in the embodiment of the present utility model are: (1) Fully retract the basket skeleton to facilitate the catheter tip to enter the target heart cavity through the sheath. (2) Fully extend the basket skeleton to obtain the maximum basket outer diameter. (3) Adjust the basket outer diameter as needed to adapt to different proximal inner diameters of the target pulmonary veins in a personalized manner.

[0062] In some specific examples, the first basket skeleton spring 8 is a compression and rebound working spring. The first basket skeleton spring 8 is arranged on the first basket telescopic rod 7, with one end fixed to the head end of the first basket telescopic rod 7 and the other end fixed to the basket skeleton connection part 11. In the normal state, the first basket skeleton spring 8 is naturally straightened.

[0063] One end of the first basket skeleton 3 far from the guide wire outlet 1 is fixed to one end of the first basket telescopic rod 7 close to the basket skeleton connection part 11.

[0064] In some specific examples, such as Figure 1 shown, the first basket frame spring 8 (distal basket frame straightening spring) is pre-installed on the distal basket telescopic rod, with its distal end fixed to the head end of the telescopic rod and its proximal end fixed to the proximal-distal basket connection part. Under normal circumstances, the spring is in a natural stretched state, and its length is the same as that of the distal basket frame. As Figure 6 shown, when the traction wire pulls the proximal end of the distal basket telescopic rod catheter to move, the spring is compressed, and at the same time, the basket frame is bent into arcs of different degrees. When the mapping and ablation tasks of the distal basket are completed and the operator releases the traction wire, the compressed spring gradually returns to its natural length by relying on its elasticity, so as to straighten the distal basket frame again.

[0065] As Figure 5 shown, there is also a proximal fixed point 9 of the distal basket frame, located at the distal end of the proximal-distal basket connecting rod, fixing the proximal end of the first basket frame 3 to the distal end of the basket frame connection part 11, so that when the basket frame connection part 11 moves back and forth, its basket frame can follow its extension and retraction.

[0066] As Figure 5 shown, the traction wire fixed point 10 of the distal basket telescopic rod is located at the proximal end of the distal basket telescopic rod and is used to connect the traction wire for controlling the distal basket telescopic rod.

[0067] In some specific examples, the outer diameter of the basket frame connection part 11 is not less than 7F, and the length is not less than 10 mm. One end of it is fixed to the catheter body 23. The inner cavity of the basket frame connection part 11 is sleeved with the guide wire 34, the first basket telescopic rod 7, and the second basket telescopic collar 19 from the inside to the outside. The functions of the basket frame connection part 11 are: (1) providing a moving fulcrum for the double basket; (2) providing moving support for the distal basket telescopic rod; (3) providing a proximal fixed point for the distal basket frame; (4) providing moving support for the proximal basket telescopic collar; (5) providing a distal fixed point for the proximal basket; (6) providing an inner cavity for the guide wire to pass through and the saline flushing catheter.

[0068] There is also a distal fixed point 12 of the proximal basket frame, located at the proximal end of the basket frame connection part 11, fixing the distal end of the proximal basket frame to the proximal end of the basket frame connection part 11, so as to facilitate the extension and retraction of the proximal basket frame when the proximal basket telescopic collar moves back and forth.

[0069] There is also a distal fixed point 13 of the catheter bending control wire, located at the catheter body corresponding to the distal part of the basket frame connection part 11, with the number not less than 2 and distributed in a 180° opposite direction, for bending the catheter head end in two directions of 0° to 135°.

[0070] In some embodiments, the second basket skeleton 14 includes no less than 3 basket skeletons, with a length of no less than 30 mm, an outer diameter of no less than 2F. Wires are routed through the inner cavity of the formed skeleton. A second basket electrode array identifier 16 is provided on one of the basket skeletons. For example, the second basket electrode array identifier 16 can be an X-ray annular identifier for identifying the skeleton serial number. At least 1 proximal basket positioning sensor 17 is provided at the proximal end of the skeleton corresponding to this skeleton. Specifically, for the proximal basket positioning sensor 17, at least 1 positioning sensor is provided on the proximal basket skeleton corresponding to the X-ray marked skeleton, which is the proximal basket positioning sensor 17, used to locate the three-dimensional position of the proximal basket on the three-dimensional image. Based on this, the second basket electrode array identifier 16 sequentially calibrates and identifies the serial numbers of all basket skeletons in a clockwise or counterclockwise direction.

[0071] The second basket electrode array 15 is provided at one end of the basket skeleton close to the guide wire outlet 1 and is arranged at equal intervals.

[0072] The second basket electrode array 15 includes at least 3 annular electrodes, and the annular electrodes have gaps that do not cover the electrode material. Each electrode surface points to the inner wall of the pulmonary vein vestibule, and the gap surface points to the center of the basket.

[0073] Specifically, as Figure 1 shown, the second basket electrode array 15 (proximal basket electrode array) has at least 3 annular electrodes equidistantly arranged on the distal 1 / 2 length of the proximal basket skeleton. The material is platinum-iridium alloy. The electrode length is not less than 2 mm, and the thickness is not less than 1 mm. The electrode ring surrounds 225° of the circumference of the basket skeleton, leaving a 135° gap that does not cover the electrode material. The electrode surface points to the inner wall of the pulmonary vein vestibule, and the gap surface points to the center of the basket, thereby realizing tissue surface-directed ablation of PFA energy. In a specific example, starting from the X-ray identifier, the electrode array is sequentially numbered to facilitate computer recognition and allocation. The proximal electrode is located in the middle and towards the distal side of the skeleton so that when the basket skeleton is fully extended, this electrode can still point its outer electrode surface towards the catheter tip and make good contact with the target pulmonary vein vestibule.

[0074] The functions of the second basket electrode array 15 include: (1) Adjacent electrodes located on the same basket skeleton can form ablation electrode pairs in the weft direction of the basket. Then, they can form an ablation ring with the corresponding electrode pairs on the adjacent basket skeletons. By synchronously delivering PFA energy through these annularly distributed electrode pairs, ablation of the target pulmonary vein vestibule can be completed. (2) Electrodes at the same position on adjacent basket skeletons can form ablation electrode pairs in the radial direction of the basket. Connecting the electrode pairs can form a complete ablation ring. By synchronously delivering PFA energy through the electrode pairs arranged annularly along the radial direction of the basket, annular ablation of the target pulmonary vein vestibule can be completed. (3) First, determine the tissue apposition degree of all array electrodes based on electrophysiological parameters. Then, automatically select 1 electrode with the best contact quality from each basket skeleton. An ablation electrode ring can be formed by connecting them along the radial direction of the basket skeleton. Finally, adjacent electrodes form ablation electrode pairs to complete synchronous annular ablation of the target pulmonary vein vestibule.

[0075] In some embodiments, the second basket skeleton spring 18 is a tensile and resilient working spring, which is arranged on the second basket telescopic rod. One end of it is fixed to the basket skeleton connection part 11, and the other end is fixed to the second basket telescopic collar 19. In a specific example, as Figure 1 shown, the second basket skeleton spring 18 is pre-installed on the proximal basket telescopic rod. Its distal end is fixed to the proximal end of the basket skeleton connection part 11, and the proximal end is fixed to the distal end of the second basket telescopic collar 19.

[0076] Under normal circumstances, the second basket skeleton spring 18 is in a natural compressed state, and its length is consistent with the thickness of the distal basket skeleton after maximum contraction. At this time, the proximal basket is in a disk shape in the maximum contracted state, which can be used to appose the target pulmonary vein vestibule to complete mapping and ablation. As Figure 7 shown, when the operator needs to extend the proximal basket skeleton, the traction wire can be manipulated to pull the proximal basket telescopic collar towards the proximal end of the catheter. At this time, the spring will be gradually stretched, and at the same time, the proximal basket skeleton will be stretched from the maximum contracted state into arcs of different degrees required by the operator until all skeletons are fully straightened, that is, in the fully extended state. When the mapping and ablation tasks of the proximal basket are completed, the operator can retract the proximal basket traction wire to fully straighten the proximal basket skeleton, which is convenient for repositioning the catheter or completely withdrawing the catheter into the sheath lumen.

[0077] In some embodiments, as Figure 1As shown, the outer diameter of the second basket telescopic collar 19 is not less than 6F, the length is not shorter than 50 mm, and its inner cavity is not less than 5F. One end of the second basket telescopic collar 19 is movably arranged at the basket frame connecting part 11. The second basket telescopic collar 19 includes a telescopic rod, and the telescopic rod can slide within the basket frame connecting part 11 to drive the extension and retraction of the second basket frame 14. After the second basket frame 14 is fully extended, at least one electrode of the second basket electrode array 15 is located at the outermost end of the second basket frame 14.

[0078] In some specific examples, the second basket telescopic collar 19 (proximal basket telescopic collar) has sufficient hardness to support the full extension and retraction of the second basket frame 14; its distal end moves inside the basket frame connecting part 11 (the moving range is not less than 10 mm); the distal end of the second basket telescopic rod can slide within the basket frame connecting part 11, thereby driving the extension and retraction of the proximal basket frame; when the basket frame is fully extended, its proximal electrode is exactly located at the distal end of the highest point of the frame, and the outer side of the electrode points to the distal end of the catheter.

[0079] The functions of the second basket telescopic collar 19 are: (1) fully retract the basket frame to facilitate entry into the target heart cavity through the sheath tube. (2) fully extend the basket frame to obtain the maximum basket outer diameter. (3) adjust the basket outer diameter as needed to individually adapt to different diameters of the target pulmonary vein vestibule.

[0080] As Figure 1 、 Figure 8 As shown, there is also a proximal fixed point 20 of the proximal basket frame, located at the proximal end of the proximal and distal basket connecting rod, fixing the distal end of the proximal basket frame to the proximal end of the proximal and distal basket connecting rod, so that when the proximal basket telescopic collar moves back and forth, its basket frame can follow its extension and retraction.

[0081] The traction wire fixing point 21 of the proximal basket telescopic collar is located at the proximal end of the sliding collar and is used to traction the sliding collar to move within the catheter body. When the operator fully releases the traction wire, the moving collar will drive the proximal basket frame to gradually contract due to the elastic retraction of the stretched working spring until it becomes a disk shape with the maximum contraction. When the operator pulls back the traction wire, the sliding collar will move towards the proximal end of the catheter, and at the same time gradually stretch the proximal basket working spring until the proximal basket frame presents the arc required by the operator or reaches the maximum straight state.

[0082] In some embodiments, at least two visualization electrodes 22 are further provided on the catheter body 23. The at least two visualization electrodes 22 are spaced apart. In some examples, the visualization electrode 22 is made of platinum-iridium alloy material, with a length of more than 3 mm, a thickness of not more than 1 mm, and a distance of at least 10 mm from the proximal fixed point of the proximal basket frame. The wire runs within the wire microtube in the catheter cavity.

[0083] In summary, the double wire baskets at the catheter head of the PFA mapping and ablation catheter of the present utility model can enter and exit the proximal end of the target pulmonary vein respectively or simultaneously through recovery and extension, and can be in contact with and separated from the pulmonary vein vestibule. The double wire baskets of the PFA mapping and ablation catheter of the present utility model can linearly expand and contract respectively or simultaneously to adapt to the inner diameter of the proximal end of the target pulmonary vein and the diameter of the pulmonary vein vestibule. The distal wire basket of the present utility model can be coaxial with the proximal end of the target pulmonary vein through a guide wire. The proximal wire basket of the present utility model can be coaxial with the pulmonary vein vestibule through a guide wire and the distal wire basket in the extended state.

[0084] The contact pressure between the proximal wire basket of the PFA mapping and ablation catheter of the present utility model and the pulmonary vein vestibule can be adjusted as needed, and the distal wire basket can be used alone as a three-dimensional modeling and activation mapping catheter.

[0085] The electrode array of the proximal wire basket of the PFA mapping and ablation catheter of the present utility model can design a personalized target pulmonary vein ablation ring in real time through the identification and combination of their respective electrophysiological parameters. The double wire basket electrode arrays of the PFA mapping and ablation catheter of the present utility model can simultaneously and separately complete the ablation of the proximal muscle sleeve and the vestibular part of the target pulmonary vein. Cooperating with the linear electrode combination of the distal wire basket, it can complete the large ring isolation of the upper and lower pulmonary vein vestibules and various linear ablations in the left atrium. The electrode array of the proximal wire basket can synchronously achieve the electrode combination ablation in the longitude and latitude directions.

[0086] It should be noted that in each embodiment of the present utility model, the terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "including one..." does not exclude the existence of another identical element in the process, method, article or device including the element.

[0087] The serial numbers of the above embodiments of the present utility model are only for description and do not represent the advantages or disadvantages of the embodiments.

[0088] The embodiments of the present utility model have been described above in conjunction with the accompanying drawings. However, the present utility model is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the present utility model, those of ordinary skill in the art can also make many forms without departing from the purpose and scope protected by the claims of the present utility model. These all fall within the protection scope of the present utility model.

Claims

1. A double-bend double-mesh basket array electrode PFA mapping and ablation catheter, characterized in that, Comprising: A catheter body portion (23) with one end leading out a guide wire (34) from a guide wire outlet (1) and the other end connected to a catheter handle (25). At the head end of the catheter body portion (23), a first basket and a second basket are respectively provided; wherein, The first basket includes a first basket skeleton (3), a first basket telescopic rod (7) and a first basket skeleton spring (8). The first basket skeleton (3) and the first basket telescopic rod (7) are arranged along the direction of the catheter body portion (23). The first basket skeleton (3) can move and deform based on the first basket skeleton spring (8) under the pulling of a corresponding traction wire, and the first basket skeleton (3) resumes its position after the traction wire is relaxed. A first basket electrode array (4) is provided on the first basket skeleton (3); The second basket is arranged at an interval from the first basket and includes a second basket skeleton (14), a second basket telescopic collar (19) and a second basket skeleton spring (18). The second basket skeleton (14) is arranged along the direction of the catheter body portion (23). The second basket skeleton (14) can move and deform based on the second basket skeleton spring (18) under the pulling of a corresponding traction wire, and the second basket skeleton (14) resumes its position after the traction wire is pulled back. A second basket electrode array (15) is provided on the second basket skeleton (14); A catheter handle (25) is connected to the catheter body portion (23) and is provided with a catheter head end double-bend control wheel (26), a second basket telescopic control wheel (27) and a first basket telescopic control wheel (28). The catheter head end double-bend control wheel (26) is connected to the inner side of the tube wall at the catheter head end through a traction wire for bending the catheter head end. The second basket telescopic control wheel (27) and the first basket telescopic control wheel (28) are respectively connected to corresponding traction wires. The catheter handle (25) leads out corresponding electrode tail wires and the other end of the guide wire (34).

2. The double-bend double-mesh basket array electrode PFA mapping and ablation catheter according to claim 1, characterized in that, The first basket skeleton (3) has no less than 3 basket skeletons and is no shorter than 10 mm. Wires are walked in the formed skeleton inner cavity, and a first basket electrode array mark (5) is provided on one of the basket skeletons; 3. The double-bend double-mesh basket array electrode PFA mapping and ablation catheter according to claim 2, wherein The first basket electrode array (4) is provided at one end of the basket skeleton close to the guide wire outlet (1) and is arranged at equal intervals; The first basket electrode array (4) includes at least 3 ring electrodes; 4. The double-bend double-mesh basket array electrode PFA mapping and ablation catheter according to claim 3, wherein, At least 3 ring electrodes of the first basket electrode array (4) are sequentially numbered based on the first basket electrode array mark (5); 5. The double-bend double-net basket array electrode PFA mapping and ablation catheter according to claim 1, characterized in that, The first basket skeleton spring (8) is a compression and rebound working spring. The first basket skeleton spring (8) is arranged on the first basket telescopic rod (7), with one end fixed at the head end of the first basket telescopic rod (7) and the other end fixed at the basket skeleton connection part (11). In the normal state, the first basket skeleton spring (8) is naturally straightened; One end of the first basket framework (3) far from the guide wire outlet (1) is fixed to one end of the first basket telescopic rod (7) close to the basket framework connection part (11).

6. The double-bend double-net basket array electrode PFA mapping and ablation catheter according to claim 5, wherein, The basket framework connection part (11) has an outer diameter not less than 7F and a length not shorter than 10 mm. One end of it is fixed to the catheter body part (23). The inner cavity of the basket framework connection part (11) is sleeved with the guide wire (34), the first basket telescopic rod (7), and the second basket telescopic collar (19) from inside to outside.

7. The double-bend double-mesh basket array electrode PFA mapping and ablation catheter according to claim 6, characterized in that, The second basket framework (14) includes not less than 3 basket frameworks and is not shorter than 30 mm. Its outer diameter is not less than 2F. Conducting wires run in the formed framework inner cavity. A second basket electrode array mark (16) is provided on one of the basket frameworks. The second basket electrode array (15) is arranged at one end of the basket framework close to the guide wire outlet (1) and is arranged at equal intervals. The second basket electrode array (15) includes at least 3 ring-shaped electrodes, and the ring-shaped electrodes have gaps that do not cover the electrode material. Each electrode surface points to the inner wall of the pulmonary vein vestibule, and the gap surface points to the center of the basket.

8. The double-bend double-mesh basket array electrode PFA mapping and ablation catheter according to claim 7, characterized in that, The second basket framework spring (18) is a tensile and resilient working spring, which is arranged on the second basket telescopic rod. One end of it is fixed to the basket framework connection part (11), and the other end is fixed to the second basket telescopic collar (19).

9. The double-bend double-net basket array electrode PFA mapping and ablation catheter according to claim 8, characterized in that, The outer diameter of the second basket telescopic collar (19) is not less than 6F, and the length is not shorter than 50 mm. Its inner cavity is not less than 5F. One end of the second basket telescopic collar (19) is movably arranged on the basket framework connection part (11). The second basket telescopic collar (19) includes a telescopic rod, and the telescopic rod can slide in the basket framework connection part (11) to drive the extension and retraction of the second basket framework (14). After the second basket framework (14) is fully extended, at least one electrode of the second basket electrode array (15) is located at the outermost end of the second basket framework (14).

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

Images