Petal type pulsed electric field ablation catheter

Abstract

The utility model discloses a petal type pulsed electric field ablation catheter, which relates to the medical instrument technology, and comprises a catheter body part, a guide wire is arranged in the catheter body part, the guide wire is led out from a guide wire outlet at one end of the catheter body part, and the other end of the catheter body part is connected with a catheter tail handle; the petal skeleton comprises a plurality of skeleton branches and one end, arranged at the guide wire outlet of the catheter body part, of the skeleton branches, each skeleton branch comprises a free end, each free end can be stretched and separated based on the one end of the guide wire outlet and can be bent, and each free end can be folded into a bundle shape based on the led-out guide wire; a plurality of electrodes and positioning sensors are arranged on the skeleton branches at intervals; a bending control knob is arranged on the catheter tail handle, and the bending control knob is connected to the catheter head end through a bending traction steel wire. The petal skeleton is large in deformation range, and double-insurance ablation of the pulmonary vein open muscle sleeve and the vestibular tissue can be achieved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a petal-shaped pulsed electric field ablation catheter. Background Art

[0002] Currently, several pulsed electric field ablation (PEF) catheters are in clinical use both domestically and internationally. There are two main types of domestically produced PEF catheters: annular multipolar catheters and petal-shaped multipolar catheters.

[0003] The annular multipolar pulsed electric field catheter has the following features: 1. A single electrode ring with a diameter of 3-4 cm and perpendicular to the catheter body is set at the tip of the catheter. 2. 6-8 identical platinum-iridium ring electrodes are evenly arranged on the electrode ring from far to near. 3. Every two adjacent electrodes can form an electrode pair for ablation. The method of using this catheter is: first, the annular multipolar pulsed electric field catheter is guided into the heart cavity where the lesion of the electrocardiogram disease is located through a long sheath. Then, the operator controls the device on the handle of the multipolar catheter to complete the required degree of bending of the catheter tip, and advances the catheter so that the electrode ring of the catheter reaches the vestibule of the target pulmonary vein. The position of the pulsed electric field electrode ring is then fine-tuned through three-dimensional imaging and mapping technology. Finally, the adjacent electrodes are paired and the pulsed electric field energy is released synchronously to complete the ablation.

[0004] The aforementioned PFA multi-electrode catheter still has the following drawbacks: 1. The ablation electrode ring is not perfectly coaxial with the target pulmonary vein vestibule. 2. The outer diameter of the electrode ring or mesh basket does not adjust with the diameter of the pulmonary vein vestibule. 3. The ablation electrode group cannot actively deform to properly adhere to irregular vestibular tissue. 4. It cannot ablate the junction of the upper and lower pulmonary veins to achieve isolation of the large loop of the pulmonary vein vestibule. 5. It cannot ablate the pulmonary vein vestibule and proximal end simultaneously or sequentially. Summary of the Invention

[0005] An embodiment of the present application provides a petal-shaped pulsed electric field ablation catheter, which is used to propose a petal-shaped ablation catheter. The petal skeleton has a large deformation range and can achieve double-insurance ablation of the pulmonary vein opening muscle sleeve and vestibular tissue. The catheter petal skeleton is soft and supported by a guide wire, and is easy to operate.

[0006] The present embodiment provides a petal-shaped pulsed electric field ablation catheter, comprising:

[0007] A catheter body 12, in which a guide wire 20 is passed, the guide wire 20 is led out from a guide wire outlet 1 at one end of the catheter body 12, and the other end of the guide wire 20 is connected to a catheter tail handle 15;

[0008] The petal skeleton 2 includes a plurality of skeleton branches, which are arranged at one end of the guide wire outlet 1 of the catheter body 12. The plurality of skeleton branches include free ends, each of which can be stretched and separated based on one end of the guide wire outlet 1 and can be bent. Each free end can be contracted into a bundle based on the guided wire 20 led out. A plurality of electrodes and positioning sensors 6 are arranged at intervals on the skeleton branches;

[0009] The catheter tail handle 15 is provided with a bending control knob 16 , which is connected to the catheter head end through a bending traction wire 13 , and the bending traction wire 13 runs in the microtube of the catheter body 12 .

[0010] Optionally, it also includes: a loading guide sleeve 14, which has a loading and unloading seam, so that the loading guide sleeve 14 can be mounted on the catheter body 12 based on the loading and unloading seam, and the loading guide sleeve 14 can slide based on the catheter body 12 to load and recover the petal skeleton 2.

[0011] Optionally, one end of the petal skeleton 2 is fixed to the catheter head end;

[0012] Each skeleton branch of the petal skeleton 2 is prefabricated with a proximal bend and a distal bend, with a folded length of not less than 10 mm, an outer diameter of not more than 0.5 mm, and a number of not less than 3, which are evenly distributed around the catheter head end.

[0013] Optionally, the multiple electrodes spaced apart on the skeleton branch include: an outer electrode 5, a middle electrode 7, and an inner electrode 8, wherein the outer electrode 5 is located at the free end of the skeleton branch, and the middle electrode 7 and the inner electrode 8 are located at the curved section of the skeleton branch, and each electrode forms an electrode array after the petal skeleton 2 stretches and separates.

[0014] Optionally, the catheter head end of the catheter body 12 is further provided with visualization electrodes 11, the number of the visualization electrodes 11 is not less than 2, the electrode length is not greater than 3 mm, and the electrode spacing is not less than 10 mm.

[0015] Optionally, an electrode marker 9 is further provided on one of the skeleton branches of the petal skeleton 2 .

[0016] Optionally, one end of the catheter tail handle 15 further leads to a flushing connector 18 and a tail wire connector 19;

[0017] The flushing connector 18 is in communication with the central lumen of the catheter and is used to achieve suction within the central lumen;

[0018] The tail wire connector 19 is used to lead out the electrode and sensor tail wires.

[0019] Optionally, one end of the catheter tail handle 15 is further provided with a finger guide wire entrance sealing membrane 17 for passing the finger guide wire 20 and preventing air from entering the catheter.

[0020] The embodiment of the present application further provides a pulsed electric field ablation system, including the petal-shaped pulsed electric field ablation catheter as described above.

[0021] The petal-shaped ablation catheter of the embodiment of the present application has a large deformation range of the petal skeleton, which can achieve double-safety ablation of the pulmonary vein opening muscle sleeve and vestibular tissue. The catheter petal skeleton is soft and supported by a guide wire, and is easy to operate.

[0022] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application, it can be implemented in accordance with the contents of the specification. In order to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are listed below. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present application. The same reference symbols are used throughout the drawings to represent the same components. In the drawings:

[0024] Figure 1 A partial schematic diagram of the catheter body of a petal-shaped pulsed electric field ablation catheter according to an embodiment of the present application;

[0025] Figure 2 This is a diagram illustrating the petal skeleton of the petal-shaped pulsed electric field ablation catheter of the embodiment of the present application in an unfolded state;

[0026] Figure 3 This is a schematic diagram of the petal-shaped pulsed electric field ablation catheter of the embodiment of the present application in a bent state with the petal skeleton in contact with the pulmonary vein;

[0027] Figure 4 This is a schematic diagram of the catheter tail structure of a petal-shaped pulsed electric field ablation catheter according to an embodiment of the present application;

[0028] Figure 5 This is a schematic diagram of the electrode array of the petal-shaped pulsed electric field ablation catheter according to an embodiment of the present application;

[0029] Figure 6 This is a schematic diagram of the cross-sectional structure of the tail portion of the petal-shaped pulsed electric field ablation catheter of an embodiment of the present application;

[0030] Figure 7 This is a diagram illustrating the collapsed state of the petal skeleton of the petal-shaped pulsed electric field ablation catheter according to an embodiment of the present application;

[0031] Figure 8 This is a schematic diagram of the bent state of the petal-shaped pulsed electric field ablation catheter according to an embodiment of the present application. DETAILED DESCRIPTION

[0032] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying 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. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0033] The present embodiment provides a petal-shaped pulsed electric field ablation catheter, comprising:

[0034] The catheter body 12 has a guide wire 20 running inside it, which is led out from the guide wire outlet 1 at one end of the catheter body 12, and the other end of the catheter body 12 is connected to the catheter tail handle 15. Figure 1 As shown, the finger guide wire outlet 1 is located in the center of the catheter head end, and the catheter head end is also one end of the catheter body. In some examples, the inner diameter of the catheter head end is no more than 0.035 inches (0.88 mm), and is used to guide the finger guide wire in and out of the catheter lumen. In a specific example, the finger guide wire 20 runs in the central lumen of the catheter, has an outer diameter no more than 0.5 mm, and is not part of the catheter structure. The finger guide wire 20 can be used to find and locate the target pulmonary vein opening, and is used to guide the pulmonary vein bend of the catheter petals to approach, abut and enter the pulmonary vein opening, and to support the petal skeleton located in the pulmonary vein opening to be coaxial with the pulmonary vein opening, and to support the petal skeleton to extend forward and be retracted backward into the sheath. It is also used to restore the array electrode mapping function of the petal skeleton and the linear ablation task of the linearly arranged electrodes after it is completely recovered into the catheter body.

[0035] The petal skeleton 2 includes multiple skeleton branches, which are arranged at one end of the guide wire outlet 1 of the catheter body 12. The multiple skeleton branches include free ends, each of which can be stretched and separated based on one end of the guide wire outlet 1 and can be bent. Each free end can be contracted into a bundle based on the guided wire 20. Figure 1 As shown, the proximal end (the end close to the operator) of the petal skeleton 2 is fixed to the catheter head, and the distal end (the end away from the operator) is free.

[0036] A plurality of electrodes and positioning sensors 6 are spaced apart on the skeleton branches. In some implementations, the plurality of electrodes are spread out to form an electrode array for realizing array electrode activation mapping and three-dimensional modeling.

[0037] In specific applications, such as Figure 2 、 Figure 3As shown, the softness and bending elasticity of the petal skeleton 2 are designed to achieve bidirectional softness adaptation between the petals and the tissue. When the operator advances the catheter to make the petal skeleton gradually approach and stick to the target pulmonary vein structure, the petal skeleton and the pulmonary vein structure can maintain bidirectional softness adaptation, especially the proximal end of the petal skeleton adapts to the pulmonary vein opening structure, and the distal end of the petal skeleton adapts to the pulmonary vein vestibule structure.

[0038] The catheter tail handle 15 is provided with a bending control knob 16, which is connected to the catheter head end through the bending traction wire 13. The catheter tail handle 15 is located at the tail of the guide cannula and can be used to hold the guide cannula with one hand.

[0039] The petal-shaped ablation catheter of the embodiment of the present application has a large deformation range of the petal skeleton, which can achieve double-safety ablation of the pulmonary vein opening muscle sleeve and vestibular tissue. The catheter petal skeleton is soft and supported by a guide wire, and is easy to operate.

[0040] In some embodiments, it further comprises: a loading guide sleeve 14 having a loading and unloading seam, so that the loading guide sleeve 14 can be sleeved on the catheter body 12 based on the loading and unloading seam, and the loading guide sleeve 14 can slide based on the catheter body 12 to load and recover the petal skeleton 2. Figure 4 As shown in the specific example, the loading guide sleeve 14 is located in the catheter body. It is made of medical plastic, has a wall thickness of no more than 0.2mm, an outer diameter slightly larger than the outer diameter of the catheter, and is no less than 10mm long, and can slide freely within the catheter body. The loading and unloading seam is used to load and remove the guide sleeve from the catheter body 12. That is, when it is necessary to load and retrieve the petal skeleton, the sleeve can be installed in the catheter body through this side seam for use; when it is necessary to manipulate the catheter, the sleeve can be removed from the catheter body through this side seam to meet the length requirements of the catheter advancing and retreating from the sheath.

[0041] In some embodiments, as Figure 1 As shown, one end of the petal skeleton 2 is fixed to the catheter head end;

[0042] Each branch of the petal skeleton 2 is prefabricated with a proximal bend and a distal bend, has a collapsed length of no less than 10 mm, an outer diameter of no more than 0.5 mm, and is at least three in number and evenly distributed around the catheter tip. In some specific examples, the branches of the petal skeleton 2 can be made of medical polyurethane material, with the two bends in opposite directions, and when deployed, the branches can be oriented perpendicular to the long axis of the catheter.

[0043] In a specific example, the petal skeleton 2 can be prefabricated with two bends from the inside to the outside, which are divided into a proximal bend and a distal bend. The proximal bend points to the front of the catheter. In some specific applications, the bending angle is not less than 90°, which is called the proximal bend of the skeleton or the pulmonary vein opening bend; the distal bend points to the back of the catheter, and the bending angle is not greater than 135°, which is called the distal bend of the skeleton or the pulmonary vein vestibule bend.

[0044] In some other examples, such as Figure 2 、 Figure 3 As shown, the proximal bend of the petal skeleton 2 is also known as the pulmonary vein opening bend. This bend points forward of the catheter, has an angle of no less than 90°, a length of no less than 10 mm, and a minimum distance of ±3 mm between the highest and lowest points of the bend from the catheter tip plane. The elastic force of the proximal bend of the petal skeleton is comparable to that of myocardial tissue and is no greater than 50 g.

[0045] The unstressed length of the proximal bend of the petal frame 2 is no less than 10 mm and may be designated identically to the catheter model. This designation allows for pulsed electric field ablation of target pulmonary vein openings with an inner diameter smaller than or equal to that of the model. Catheter model design is primarily based on the proximal bend of the petal frame, with the fundamental principle being to cover at least 98% of the diameters of normal adult pulmonary vein openings with a minimum number of models.

[0046] In some specific applications, the proximal bending of the petal skeleton 2 can be used to:

[0047] a. Coaxiality with the target pulmonary vein opening: Keep the center of the catheter coaxial with the target pulmonary vein opening.

[0048] b. Squeezing inward deformation: When the operator advances the catheter, the bend undergoes inward elastic deformation (moving closer to the long axis of the catheter) and gradually enters the opening of the pulmonary vein.

[0049] c. The middle / inner electrode is stably attached to the inner wall of the pulmonary vein opening: that is, the middle and / or inner electrode is stably attached to the inner wall of the pulmonary vein opening due to the elasticity of the bend.

[0050] d. Active pressure contact by extrusion deformation: As the proximal end of the skeleton bends, it is compressed by the inner wall tissue of the pulmonary vein opening and deforms inward, causing the middle and / or inner electrodes to actively form elastic contact with the inner wall tissue of the pulmonary vein opening. The more obvious the deformation of the bend due to extrusion, the greater the contact pressure of the electrode on the tissue.

[0051] e. Electrode displacement observable in two-dimensional images: When the operator gradually advances the catheter, the bend moves forward and gradually enters the pulmonary vein opening. On the other hand, it is gradually compressed by the inner wall tissue of the pulmonary vein opening and deformed. The characteristics of electrode displacement observable in two-dimensional images are: the inner electrode shifts forward, the middle electrode shifts inward, and the outer electrode shifts outward.

[0052] f. Two-dimensional image-guided catheter manipulation: By observing and recording the degree of electrode displacement and their mutual relationship on a two-dimensional image, it can be used to intuitively guide catheter operation, precisely locate the petal position, and accurately determine the degree of electrode adhesion.

[0053] like Figure 2 、 Figure 3 As shown, the distal bend of the petal skeleton 2 is also known as the pulmonary vein vestibular bend. This bend points toward the rear of the catheter. In specific applications, the distal bend has an angle no greater than 135° and a length no less than 3 mm. The highest and lowest points of the bend are no less than ±3 mm from the plane of the catheter tip. The elastic force of the distal bend of the petal skeleton is comparable to that of the vestibular tissue and is no more than 50 g.

[0054] The unstressed length of the distal bend of the petal skeleton is no less than 3mm. It is located in the pulmonary vein vestibule outside the pulmonary vein opening (except when the catheter size is too small or the pulmonary vein opening is too large), coaxial with the center of the pulmonary vein opening, and its distance from the outer edge of the pulmonary vein opening is related to the degree of stress deformation of the bend. This bend is fixed to the catheter size, maintaining a relatively fixed value regardless of the catheter size.

[0055] The function of the distal curvature of the petal skeleton is:

[0056] a. Target pulmonary vein vestibule coaxiality: that is, keep the outer electrode coaxial with the pulmonary vein opening.

[0057] b. Squeezing outward deformation: When the operator advances the catheter, the bend undergoes outward elastic deformation (away from the long axis of the catheter) and gradually shifts toward the outside of the pulmonary vein vestibule.

[0058] c. The outer electrode is stably attached to the inner wall of the pulmonary vein vestibule: that is, the outer electrode is stably attached to the inner wall of the pulmonary vein vestibule due to the elasticity of the bend.

[0059] d. Pulmonary vein vestibule morphology adaptation: Because the outermost side of the bend is designed as a free end, and the petal skeleton has prefabricated bending and soft characteristics, the outer electrode can adapt to the individualized natural or random variations in the pulmonary vein vestibule morphology at different heights or planes, and can maintain stable contact and active elastic pressure against the vestibular tissue in this variation state.

[0060] e. Active pressure adhesion with resistance deformation: that is, when the operator advances the catheter, as the proximal bend of the skeleton gradually enters the pulmonary vein opening and is gradually compressed by the inner wall tissue of the pulmonary vein opening and deforms inward, the distal bend of the petal skeleton also gradually and closely contacts the pulmonary vein vestibule tissue; at this time, due to the resistance of the vestibular tissue to the distal bend, the outer electrode is gradually displaced toward the outside of the vestibule while being subjected to increasing vestibular resistance. This resistance is simultaneously converted into active elastic pressure adhesion of the outer electrode to the vestibular tissue. The more obvious the deformation of the distal bend caused by the resistance, the greater the adhesion pressure of the outer electrode on the vestibular tissue.

[0061] f. Electrode displacement observable in two-dimensional images: When the operator gradually advances the catheter, on the one hand, the distal bend gradually moves backward, and on the other hand, its outer electrode also gradually shifts outward. The characteristics of electrode displacement observable in two-dimensional images are: the inner electrode shifts forward, the middle electrode shifts inward, and the outer electrode shifts outward.

[0062] g. Two-dimensional image-guided catheter manipulation: By observing and recording the degree of electrode displacement and their mutual relationship on a two-dimensional image, it can be used to intuitively guide catheter operation, precisely locate the petal position, and accurately determine the degree of electrode adhesion.

[0063] In some embodiments, the plurality of electrodes spaced apart on the skeleton branch include: an outer electrode 5, a middle electrode 7, and an inner electrode 8, wherein the outer electrode 5 is located at the free end of the skeleton branch, and the middle electrode 7 and the inner electrode 8 are located at the curved section of the skeleton branch. Each electrode forms an electrode array as the petal skeleton 2 stretches and separates. In a specific application, after the operator completely retracts the finger guide wire into the catheter body, the inner electrode 8 at the proximal end of the petal skeleton 2 and the outer electrode 5 at the distal end can form a mapping electrode array to complete the functions of excitation mapping and three-dimensional modeling.

[0064] like Figure 5 As shown, the electrode array includes: (1) a mapping electrode array. The inner and outer electrodes on the petals can be combined to form a mapping electrode array to complete the catheter modeling and excitation mapping functions. (2) a linear ablation electrode group. The inner and outer electrodes on the two petal skeletons 2 arranged at 180 degrees relative to each other can form a linear ablation electrode group. Two adjacent electrodes can form a linear ablation electrode pair to emit a pulsed electric field, thereby realizing the linear ablation function of the catheter.

[0065] In specific applications, the distal curved section of the petal skeleton 2 is provided with at least one pulmonary vein vestibular electrode, of which the outermost electrode is located at the outermost free end of the petal skeleton, i.e., the outer electrode 5. The outer electrode 5 can be a cylindrical electrode, not less than 2 mm in length, made of platinum-iridium alloy, and spaced not less than 2 mm from the middle electrode. Its functions include pulmonary vein vestibular potential mapping, pulmonary vein vestibular ring ablation, and forming a mapping electrode array in combination with the proximal electrode.

[0066] Two ring electrodes, middle electrode 7 and inner electrode 8, are positioned inward from the outside of the proximal bend of the two petal frames. Middle electrode 7 is located at the outermost edge of the proximal bend of the petal frame, forming the beginning of the distal bend. The electrodes are no less than 2 mm long and no more than 0.2 mm thick, with the lead wires routed within the petal frame. They are primarily used for pulmonary vein ostium potential mapping, pulmonary vein ostium circular ablation, pulmonary vein ostium location guidance, and assessment of pulmonary vein ostium electrode contact.

[0067] In specific applications, as shown in Table 1, the unstressed length of the proximal bend of the petal frame where the mid-layer electrode resides is no less than 10 mm, corresponding to the catheter model designation. This allows for pulsed electric field ablation of target pulmonary vein ostia with an inner diameter smaller than or equal to that of the model. Catheter model design is primarily based on the proximal bend of the petal frame, with the fundamental principle being to cover at least 98% of the normal adult pulmonary vein ostia with a minimum number of models.

[0068] Table 1 Model parameters of petal pulse electric field catheter

[0069]

[0070] The inner electrode 8, two ring electrodes arranged from the outside to the inside of the proximal bend of the petal skeleton 2, is located just outside the proximal bend of the petal skeleton and inside the middle electrode, forming the starting point of the distal bend. The distance from the middle electrode is no less than 2 mm, the electrode length is no less than 2 mm, and the thickness is no more than 0.2 mm. The wire runs within the petal skeleton. Its functions include: pulmonary vein ostium potential mapping, pulmonary vein ostium circular ablation, pulmonary vein ostium positioning guidance, and determination of pulmonary vein ostium electrode contact. The parameters of the petal skeleton 2, skeleton curvature, and electrodes are shown in Table 2.

[0071] Table 2 Model parameters of petal pulse electric field catheter

[0072] Catheter model Lung V diameter Petal diameter Petal thickness Skeleton length Lung V-bend length Length of vestibular bend Small 35 45 5.0 24.5 17.5 5.0 middle 40 50 5.0 27.0 20.0 5.0 big 45 55 5.0 29.5 22.5 5.0

[0073] In the array electrode, the inner electrodes 8 and outer electrodes 5 on every two oppositely arranged skeleton branches can be combined into a linear electrode group consisting of four electrodes connected in series to complete various linear pulse electric field ablation tasks.

[0074] In the specific example, the positioning sensor 6 is located at the proximal end of one or more petal skeletons, and the wire runs inside the skeleton.

[0075] In some embodiments, an electrode marker 9 is further provided on one of the skeleton branches of the petal skeleton 2. In a specific example, the electrode marker 9 is located at the proximal end of the selected petal skeleton and is an X-ray-proof annular marker with a length of not less than 2 mm. It is used to define and identify the serial number of the petal skeleton electrode array under X-ray fluoroscopy. Examples of specific identification methods: (1) Identify the petal skeleton: Starting from the skeleton where the identification mark is located, the skeletons are sorted in a clockwise direction, and the skeletons can be calibrated as skeleton 1 to skeleton N (S1~Sn). (2) Identify the skeleton electrode: The electrodes on a single skeleton are calibrated from inside to outside as electrode 1 to electrode N (E1~En). (3) Identify the electrode array: Combined with the above calibration results, the electrode array can be calibrated as: inner electrode group S1E1~SnEn, middle electrode group S2E2~S2En, outer electrode group S3E3~S3En. The inner and middle electrode groups are the pulmonary vein opening electrode groups, the outer electrode group is the pulmonary vein vestibule electrode group, and the inner and outer electrode groups are the mapping electrode groups.

[0076] In some examples, the catheter tail handle 15 is provided with a bending control knob 16, and the bending control knob 16 is connected to the catheter head end by bending the traction wire 13. Figure 6 、 Figure 7 As shown, the bending traction wire 13 of the bending control knob 16 can be connected to the bending traction wire distal end fixing point 10 at the catheter tip. The bending traction wire distal end fixing point 10 can be set to correspond to the bending traction wire 13. The two fixing points 10 can be arranged at 180 degrees to each other, with a distance of no less than 10 mm from the catheter tip. The two traction wires are respectively routed within the traction wire microtubes in the catheter body, and the proximal ends are connected to the control device in the tail handle. When the operator rotates the tail handle control knob clockwise or counterclockwise, the catheter tip bends to the same side or the opposite side, respectively.

[0077] The bending traction wire 13, which can be two in number, runs in a dedicated microtube in the catheter body. The distal end ends at the catheter tip fixed point, and the proximal end ends at the tail handle control device. When the operator rotates the bending control knob 16 of the tail handle, the traction wire is caused to expand and contract, thereby causing the catheter tip to bend. The direction and degree of bending are determined by the operator's control action. In some application examples, for example Figure 8 As shown, by rotating the control wheel on the catheter tail handle clockwise or counterclockwise, the operator can form a bidirectional bend on the catheter tip, with a maximum bending diameter of 30 mm and a maximum bending angle of 135°.

[0078] In some embodiments, the catheter body 12 is further provided with a visualization electrode 11 at the catheter tip. The number of the visualization electrodes 11 is no less than 2, the electrode length is no more than 3 mm, and the inter-electrode spacing is no less than 10 mm. In a specific example, the outer diameter of the catheter body 12 is no less than 7 French and the length is no less than 80 mm. The microtubules running in the catheter body include:

[0079] I. The central lumen, with an inner diameter no larger than 0.5 mm, is used for guiding the guidewire. Its distal outlet is located at the catheter tip, and its proximal inlet is at the end of the caudal peduncle. A lateral tube within the caudal peduncle connects to the caudal peduncle irrigation tube. A sealing membrane is located at the caudal peduncle guidewire inlet to prevent bleeding and air ingress.

[0080] II. Wire microtubes, used to route various electrodes and sensor wires.

[0081] III. Traction wire microtubes: There is one on each side of the catheter wall, which is used to bend the traction wire at the tip of the running catheter.

[0082] In some embodiments, one end of the catheter tail handle 15 also leads to a flushing connector 18 and a tail wire connector 19. Figure 6 As shown, the catheter tail handle 15 is located at the proximal end of the catheter, has an outer diameter of not less than 10 mm, a length of not less than 50 mm, and is connected to the catheter body at the distal end. A bending control knob 16 is provided at the catheter head end for the operator to control the bending direction and angle of the catheter head end.

[0083] The flush connector 18 communicates with the central lumen of the catheter and is used to aspirate the central lumen. In a specific embodiment, the flush connector 18 is located at the distal end of the catheter stem, with its distal end communicating with the central lumen at the end of the stem and a proximal end having a three-way connector. The flush connector 18 is used to aspirate and remove any bubbles and microthrombi within the central lumen of the catheter, as well as to continuously flush the central lumen with heparinized saline to prevent thrombosis from interfering with the advancement and withdrawal of the guidewire.

[0084] The tail wire connector 19 is used to lead out the electrode and sensor tail wires. The tail wire connector 19 is specifically used to connect the electrophysiological electrode wires on the petal skeleton to the electrophysiological host and ablation device. It also connects the positioning sensor wire to the electrophysiological host and the visualization electrode wire to the electrophysiological host.

[0085] In some embodiments, one end of the catheter tail handle 15 is further provided with a guidewire inlet sealing membrane 17 for passing the guidewire 20 and preventing air from entering the catheter. The guidewire inlet sealing membrane 17 is also used to prevent bleeding.

[0086] It should be noted that, in the various embodiments of the present application, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

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

[0088] The embodiments of the present application are described above in conjunction with the accompanying drawings, but the present application is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of this application, ordinary technicians in this field can also make many forms without departing from the purpose of this application and the scope of protection of the claims, all of which are protected by this application.

Claims

1. A petal-shaped pulsed electric field ablation catheter, characterized in that: include: A catheter body (12) having a guide wire (20) running therein, the guide wire (20) being led out from a guide wire outlet (1) at one end of the catheter body (12), and the other end of the catheter body (12) being connected to a catheter tail handle (15); A petal skeleton (2) includes a plurality of skeleton branches, which are arranged at one end of the finger guide wire outlet (1) of the catheter body (12), and the plurality of skeleton branches include free ends, each of which can be stretched and separated based on one end of the finger guide wire outlet (1) and can be bent, and each of which can be gathered into a bundle based on the led finger guide wire (20), and a plurality of electrodes and positioning sensors (6) are arranged at intervals on the skeleton branches; The catheter tail handle (15) is provided with a bending control knob (16), and the bending control knob (16) is connected to the catheter head end through a bending traction wire (13), and the bending traction wire (13) runs in the microtube of the catheter body (12).

2. The petal-shaped pulsed electric field ablation catheter according to claim 1, characterized in that: Also includes: A loading guide sleeve (14) is provided with a loading and unloading seam so that the loading guide sleeve (14) can be sleeved on the catheter body (12) based on the loading and unloading seam. The loading guide sleeve (14) can slide based on the catheter body (12) to load and recover the petal skeleton (2).

3. The petal-shaped pulsed electric field ablation catheter according to claim 2, characterized in that: One end of the petal skeleton (2) is fixed to the catheter head end; Each skeleton branch of the petal skeleton (2) is prefabricated with a proximal bend and a distal bend, has a folded length of not less than 10 mm, an outer diameter of not more than 0.5 mm, and is not less than 3 in number and evenly distributed around the catheter head end.

4. The petal-shaped pulsed electric field ablation catheter according to claim 1, characterized in that: The plurality of electrodes spaced apart on the skeleton branch include: an outer electrode (5), a middle electrode (7), and an inner electrode (8), wherein the outer electrode (5) is located at the free end of the skeleton branch, and the middle electrode (7) and the inner electrode (8) are located at the curved section of the skeleton branch. The electrodes form an electrode array as the petal skeleton (2) stretches and separates.

5. The petal-shaped pulsed electric field ablation catheter according to claim 1, characterized in that: The catheter head end of the catheter body (12) is further provided with a visualization electrode (11), the number of the visualization electrodes (11) is not less than 2, the electrode length is not greater than 3 mm, and the electrode spacing is not less than 10 mm.

6. The petal-shaped pulsed electric field ablation catheter according to claim 5, characterized in that: An electrode marker (9) is also provided on one of the skeleton branches of the petal skeleton (2).

7. The petal-shaped pulsed electric field ablation catheter according to claim 1, characterized in that: One end of the catheter tail handle (15) is also provided with a flushing connector (18) and a tail wire connector (19); The flushing connector (18) is in communication with the central lumen of the catheter and is used to achieve suction in the central lumen; The tail wire connector (19) is used to lead out the electrode and sensor tail wires.

8. The petal-shaped pulsed electric field ablation catheter according to claim 1, characterized in that: One end of the catheter tail handle (15) is also provided with a finger guide wire entrance sealing membrane (17) for passing the finger guide wire (20) and preventing air from entering the catheter.

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