Controllable windmill-shaped PFA catheter and remote catheter ablation device

Abstract

The utility model discloses a controllable windmill-shaped PFA catheter, and relates to the technical field of catheter ablation and medical instruments, the controllable windmill-shaped PFA catheter comprises a catheter (1), the catheter (1) is led out from a catheter body (2), the head end of the catheter is of a windmill structure, a magnetic sensor and a plurality of electrodes are arranged on a framework of the windmill structure, and the windmill structure can be contained in a sheath tube; one end of the catheter body (2) is led out of the catheter (1), and the catheter body (2) is arranged in the sheathing canal; one end of the catheter handle (3) is led out of the catheter body (2), the catheter handle (3) is matched with a gear assembly of an electrophysiological interventional instrument, and the gear assembly at least comprises three sets of gears used for achieving corresponding operation actions. According to the windmill-shaped PFA ablation catheter, the electrodes are evenly distributed on the windmill-shaped framework, even electrode distribution is formed on the target pulmonary vein, and an operator can conduct ablation without replacing the catheter while completing three-dimensional point mapping dissection.

Description

Technical Field

[0001] The present application relates to the field of catheter ablation and medical device technology, and in particular to a controllable windmill-shaped PFA catheter and a remote catheter ablation device. Background Art

[0002] Catheter ablation, the most widely used procedure in clinical practice, usually uses radiofrequency energy. However, because radiofrequency thermal ablation is prone to serious complications such as cardiac perforation, esophageal injury, phrenic nerve injury, and pulmonary vein stenosis, clinical practitioners are gradually using pulsed field energy as a new ablation energy source. Clinically, it has many advantages, such as strong tissue selectivity, no significant damage to tissue structure, no generation of bubbles, eschars and detonations, and the ability to discharge synchronously with multiple poles.

[0003] At present, there are many types of pulsed electric field ablation (pulsed electric field) catheters that have entered clinical practice at home and abroad. There are mainly two types of domestic pulsed electric field catheters: ring-shaped multi-polar catheters and petal-shaped multi-polar catheters. The above-mentioned pulsed electric field multi-electrode catheters have the following defects: 1. The ablation electrode rings are distributed on a single electrode skeleton, which cannot form a uniform electrode distribution with the target pulmonary vein, which easily causes uneven distances between electrodes, and seriously causes short circuits and arcs; 2. The petal / basket-shaped electrode catheters are supported by multiple skeletons at the front end of the catheter, thus forming a catheter tip, which easily brings the risk of sticking in the heart cavity, and seriously causes the risk of cardiac perforation, and cannot complete rapid three-dimensional mapping. 3. The existing electrode ring or basket PFA cannot complete three-dimensional mapping and impedance monitoring of local cardiac anatomical parts, and thus cannot be adapted to two-dimensional DSA and three-dimensional electroanatomy at the same time. 4. With existing electrode ring or basket PFA, surgeons cannot control and complete remote ablation surgery, cannot automatically plan ablation on the surgical robot platform, and cannot achieve remote control. As a result, they have to operate under a large amount of X-rays and bear the trouble of weight-bearing lead clothing. At the same time, it is impossible to improve the level of intelligent surgery and popularize the standardization of surgery. Utility Model Content

[0004] An embodiment of the present application provides a controllable windmill-shaped PFA catheter and a remote catheter ablation device, which is used to propose a windmill-shaped PFA ablation catheter, in which electrodes are evenly distributed on the windmill-shaped skeleton, forming a uniform electrode distribution in the target pulmonary vein, and multiple electrodes and magnetic positioning sensors are evenly distributed on the windmill-shaped electrode skeleton, integrating three-dimensional high-density mapping, impedance monitoring and PFA ablation functions, so that the operator can perform ablation without changing the catheter while completing three-dimensional point mapping and dissection.

[0005] The present application provides a controllable windmill-shaped PFA conduit, comprising:

[0006] The catheter 1 is led out from the catheter body 2, and the catheter tip is in a windmill structure. A magnetic sensor and multiple electrodes are provided on the frame of the windmill structure. The windmill structure can be stored in a sheath.

[0007] The catheter body 2 is led out from the catheter handle 3, and the other end leads out of the catheter 1;

[0008] The catheter handle 3 has one end extending from the catheter body 2. The catheter handle 3 is adapted to a gear assembly for an electrophysiological interventional instrument. The gear assembly includes at least three sets of gears for implementing corresponding surgical actions, wherein the first gear is used to adjust the windmill diameter of the windmill structure at the catheter head end, the second gear is used to adjust the rotation of the catheter, and the third gear is used to push the J-bend guidewire.

[0009] Optionally, the windmill structure at the catheter head end of the catheter 1 includes a combined support frame 11 and an electrode frame 12, wherein:

[0010] The support frame 11 is a bilateral support structure in the shape of petals. The ends of the petal-shaped support frame 11 serve as connection points for the electrode frame 12. A first fixed end 111 is provided in the middle of the petal-shaped support frame.

[0011] The electrode skeleton 12 is provided with at least 6 sub-skeletons based on the connection points of the petal-shaped support skeleton, at least 3 annular microelectrodes are provided on any sub-skeleton, and magnetic positioning sensors are provided on the spaced sub-skeletons. Each sub-skeleton 123 is formed with a second fixed end 121 at one end corresponding to the first fixed end 111. The first fixed end 111 and the second fixed end 121 are used to fix the windmill structure of the catheter head end to the catheter body 2.

[0012] Optionally, each sub-skeleton is provided with a skeleton protection tube at one end connected to the petal-shaped support skeleton, and the fixing point of any sub-skeleton is arranged at a preset angle with the connection point of the support skeleton 11 in the circumferential direction.

[0013] Optionally, the catheter tube body 2 includes an inner lumen tube body and an outer lumen tube body, and the inner lumen tube body is slidably disposed in the outer lumen tube body;

[0014] The inner tube body is fixed to the second fixed end 121, and the outer tube body is fixed to the first fixed end 111, so as to control the windmill diameter of the windmill structure based on the relative movement of the inner tube body and the outer tube body;

[0015] The inner lumen tube body has a guide wire routing hole and a J-bend guide wire cavity distributed on its head end;

[0016] The outer cavity tube body is provided with a bending anchor hole at the head end thereof for pulling and bending the traction wire.

[0017] Optionally, the outer cavity tube body comprises a multi-layer structure, the outer cavity tube body comprises an inner lining tube and an outer braided tube, and the outer braided tube is coated with a layer of clear water coating;

[0018] The inner cavity tube body is an integrally formed tube made of a polymer material. A plurality of tube wiring grooves are provided in the inner cavity tube body to lead out electrode wires and magnetic positioning sensor wires based on the tube wiring grooves.

[0019] Optionally, the catheter handle 3 includes the gear assembly, the bending and fixing slider, and the saline pipeline, wherein:

[0020] The bending and fixing slider is arranged at one end of the catheter handle 3. The bending and fixing slider is provided with a bending traction wire anchor hole for connecting the bending traction wire for mechanical transmission of the catheter tip bending;

[0021] The third gear is used for pushing the J-bend guide wire, wherein the J-bend guide wire is fixed by a J-bend guide wire fixing valve.

[0022] Optionally, the catheter handle 3 further includes an inner cavity sliding module, and a threaded slider is fixed inside the inner cavity J-bend guide wire, wherein,

[0023] The inner cavity sliding module 38 includes an inner cavity sliding thread sliding block provided with an external thread. The inner cavity sliding thread sliding block can be slidably arranged in the tube body of the catheter handle 3. A circumferential limiting structure is provided between the inner cavity sliding thread sliding block and the tube body.

[0024] Optionally, the inner wall of the first gear is provided with an internal thread, and the internal thread is adapted to the inner cavity sliding thread sliding block, so that the sliding block can be controlled to slide in the inner cavity by rotating the first gear to adjust the windmill diameter of the windmill structure at the catheter head end.

[0025] Optionally, the J-bend guide wire is connected to a fixed threaded slider 39 inside the J-bend guide wire, the fixed slider inside the J-bend guide wire is provided with an external thread, and the external sleeve is provided with an internal threaded sleeve adapted to the external thread, and a circumferential limiting structure is provided between the fixed threaded slider 39 inside the J-bend guide wire and the internal threaded sleeve, and the internal threaded sleeve is driven to rotate by the rotation of the third gear 37, so as to control the axial movement of the fixed threaded slider under the transmission of the internal and external threads of the internal threaded sleeve and the fixed slider to control the axial push and retreat of the J-bend guide wire 4.

[0026] The windmill-shaped PFA ablation catheter proposed in the embodiment of the present application has electrodes evenly distributed on the windmill-shaped skeleton, forming a uniform electrode distribution in the target pulmonary vein, and multiple electrodes and magnetic positioning sensors are evenly distributed on the windmill-shaped electrode skeleton, integrating three-dimensional high-density mapping, impedance monitoring and PFA ablation functions, which allows the surgeon to perform ablation without changing the catheter while completing three-dimensional point mapping and dissection.

[0027] 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

[0028] 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:

[0029] Figure 1 This is a schematic diagram of the overall structure of the controllable windmill-shaped PFA conduit according to an embodiment of the present application;

[0030] Figure 2 This is a schematic diagram of the windmill skeleton structure of the controllable windmill-shaped PFA duct according to an embodiment of the present application;

[0031] Figure 3 This is another schematic diagram of the controllable windmill-shaped PFA duct windmill skeleton structure according to an embodiment of the present application;

[0032] Figure 4 This is a schematic diagram of the expanded structure of the controllable windmill-shaped PFA duct windmill skeleton according to an embodiment of the present application;

[0033] Figure 5 This is a schematic diagram of the catheter cavity structure of the controllable windmill-shaped PFA catheter in an embodiment of the present application;

[0034] Figure 6 This is a schematic diagram of the windmill skeleton of the controllable windmill-shaped PFA catheter in the embodiment of the present application being retracted into the sheath;

[0035] Figure 7 Schematic diagram of the catheter handle structure of the controllable windmill-shaped PFA catheter in the embodiment of the present application

[0036] Figure 8 Schematic diagram of the explosion of the catheter handle of the controllable windmill-shaped PFA catheter according to an embodiment of the present application. DETAILED DESCRIPTION

[0037] 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.

[0038] The embodiment of the present application provides a controllable windmill-shaped PFA conduit, such as Figure 1 Shown, including:

[0039] Catheter 1 extends from catheter body 2, and its tip is shaped like a pinwheel. A magnetic sensor and multiple electrodes are mounted on the pinwheel structure's skeleton, and the pinwheel structure can be retracted into a sheath. In this embodiment, the pinwheel structure at the tip of catheter 1 serves as an electrode for PFA ablation. The spherical radial diameter is adjustable, thereby controlling the diameter of the pinwheel surface at the tip to accommodate pulmonary vein ostia of varying sizes, achieving optimal therapeutic effects.

[0040] In a specific example, the pinwheel-shaped PFA catheter is an adjustable bend tube, and the handle end can be used to control the bidirectional bending of the tip of the catheter 1, thereby adjusting the pinwheel-shaped tip of the catheter to be coaxial with the target pulmonary vein, thereby improving the contact between the ablation electrode at the pinwheel-shaped tip of the catheter and the pulmonary vein tissue.

[0041] The catheter body 2 is led out from the catheter handle 3, and the other end leads out of the catheter 1. In some examples, the catheter body 2 can be set in the sheath.

[0042] The catheter handle 3 has one end extending from the catheter body 2. The catheter handle 3 is adapted to a gear assembly for the electrophysiological interventional instrument. The gear assembly includes at least three sets of gears for implementing corresponding surgical actions, wherein the first gear is used to adjust the windmill diameter of the windmill structure of the catheter head end, the second gear is used to adjust the rotation of the catheter, and the third gear is used to push the J-bend guide wire 4.

[0043] The controllable catheter proximal handle of this application is used to adapt to the electrophysiological interventional device control system to remotely control the windmill-shaped PFA catheter. The windmill-shaped PFA ablation catheter proposed in the embodiment of this application has electrodes evenly distributed on the windmill-shaped skeleton, forming a uniform electrode distribution in the target pulmonary vein. In addition, multiple electrodes and magnetic positioning sensors are evenly distributed on the windmill-shaped electrode skeleton, integrating three-dimensional high-density mapping, impedance monitoring and PFA ablation functions, allowing the operator to perform ablation without changing the catheter while completing three-dimensional point mapping and dissection.

[0044] In some embodiments, as Figure 2 As shown, the windmill structure of the catheter head end of the catheter 1 includes a combined support frame 11 and an electrode frame 12, wherein:

[0045] The support frame 11 is a bilateral support structure in the shape of petals. The ends of the petal-shaped support frame 11 serve as connection points for the electrode frame 12 . A first fixed end 111 is provided in the middle of the petal-shaped support frame.

[0046] The electrode skeleton 12, such as Figure 3 、 Figure 4As shown, at least 6 sub-skeletons 123 are provided at the connection points of the petal-shaped support skeleton, at least 3 annular microelectrodes 124 are provided on any sub-skeleton 123, and a magnetic positioning sensor 125 is provided on the spaced sub-skeletons 123. A second fixed end 121 is formed at one end of each sub-skeleton 123 corresponding to the first fixed end 111, and the first fixed end 111 and the second fixed end 121 are used to fix the windmill structure of the catheter head end to the catheter body 2.

[0047] In the specific example, the support skeleton 11 is a bilateral support structure, and each sub-skeleton 123 is supported by the bottom skeletons on both sides, so as to provide good circumferential support for each sub-skeleton 123, prevent the electrode skeleton from circumferential displacement, and ensure that the electrodes are evenly distributed close to the target tissue in the cardiac cavity to the greatest extent, thereby improving the ablation quality and reducing the recurrence rate.

[0048] In some embodiments, each sub-frame 123 is provided with a frame protection tube 122 at one end connected to the petal-shaped support frame. The fixing point of each sub-frame 123 is circumferentially arranged at a preset angle to the connection point of the support frame 11. In a specific example, the frame protection tube 122 is used to smooth the connection between the electrode frame 12 and the support frame to improve the passability of the catheter tip during intracardiac movement and avoid damage to myocardial tissue. The entire windmill structure frame is cut from nickel-titanium alloy and pre-formed to the maximum diameter of the windmill.

[0049] like Figure 3 As shown, the fixing point at the front end of each sub-skeleton 123 and the connection point between the electrode skeleton 12 and the support skeleton 11 are set at a certain angle in the circumferential direction, so that each electrode skeleton is always in a semi-spiral state in the expanded state, so as to increase the contact stability between the electrode skeleton and the pulmonary vein orifice, while reducing the electrode spacing between two adjacent electrode skeletons and increasing the electrode surface ratio in the circumferential direction of the catheter.

[0050] In some embodiments, as Figure 5 As shown, the catheter tube body 2 includes an inner cavity tube body 21 and an outer cavity tube body 22, and the inner cavity tube body 21 can be slidably disposed in the outer cavity tube body 22;

[0051] The inner tube body 21 is fixed to the second fixed end 121 , and the outer tube body 22 is fixed to the first fixed end 111 , so that the windmill diameter of the windmill structure is controlled based on the relative movement of the inner tube body 21 and the outer tube body 22 ;

[0052] The inner tube body 21 has a guide wire routing hole 23 and a J-bend guide wire cavity 24 distributed on its head end;

[0053] The outer cavity tube body 22 has a bend anchor hole 25 at its head end for pulling and bending the traction wire. In a specific example, the outer cavity tube body 22 also has a frame fixing hole 26 at its head end for receiving the first fixing end 111 of the support frame 11.

[0054] In this specific example, the distance between the first fixed end 111 and the second fixed end 121 of the windmill structure framework is controlled by the relative axial movement of the inner and outer tubes 21, 22, thereby regulating the shape of the windmill structure at the catheter tip. By pushing the inner tube 21 back and forth, the diameter of the windmill structure at the catheter tip is adjusted to accommodate different pulmonary vein orifices and vestibules. When entering the pulmonary vein orifice, the blood vessel gradually narrows, and the elliptical windmill shape achieves better alignment.

[0055] In some specific examples, the tip of the inner tube body 21 is provided with a guidewire routing hole 23 and a J-bend guidewire cavity 24. The tip of the fixed outer tube body 22 is also provided with a bend adjustment anchor hole 25 for pulling and bending the traction wire. Alternatively, the diameter of the windmill-shaped catheter tip can be adjusted by pushing the outer tube body forward and backward. The diameter adjustment of the windmill structure can be achieved through the relative axial movement of the inner and outer tube bodies 21, 22. This application will subsequently illustrate this first approach.

[0056] In some embodiments, the outer lumen tube body 22 includes a multi-layer structure, and the outer lumen tube body 22 includes an inner lining tube and an outer braided tube. The outer braided tube is coated with a layer of clear water coating to form a smooth tube body, reducing the risk of damage to peripheral blood vessels.

[0057] The inner cavity tube body 21 is an integrally formed tube made of a polymer material. A plurality of tube wiring grooves are provided in the inner cavity tube body 21 to lead out electrode wires and magnetic positioning sensor wires based on the tube wiring grooves.

[0058] See further Figure 4 , showing the overall structure of the windmill-shaped PFA catheter ablation tip of the present application, including: an inner cavity tube body 21, an outer cavity tube body 22, a support skeleton 11, an electrode skeleton 12, annular microelectrodes 124 with fixed spacing, a magnetic positioning sensor 125, and a middle cavity J-bend coaxial guide wire 4.

[0059] The windmill's diameter is adjusted through axial movement of the inner tube 21. As the catheter lumen advances, the windmill framework stretches radially, forming an elliptical windmill ablation pattern. The inner tube 21 retracts to its full extent, achieving the windmill's maximum deployed diameter. The windmill's radial adjustment range is 40-60mm (within the inner tube's retraction range), ensuring complete alignment with the pulmonary vein vestibule. During 3D mapping, the maximum-diameter catheter tip allows for rapid heart modeling. The expanded diameter of the catheter tip ranges from 30-40mm to accommodate diverse cardiac anatomy.

[0060] Each sub-skeleton is equipped with an independent electrode to complete impedance monitoring, thereby determining the adhesion effect of the catheter. The inner cavity tube body 21 can pass through a 0.035" guide wire. When it is adhered to the pulmonary vein orifice, the operator can enter the pulmonary vein through the J-bend guide wire 4, and then advance the catheter as a whole along the pulmonary vein. The impedance monitoring of the electrode determines the adhesion stability. When part of the skeleton fails to form a suitable adhesion at the pulmonary vein orifice, the ablation device can selectively discharge between the skeletons with better adhesion, thereby reducing ineffective discharge in the blood, reducing damage to the blood, and avoiding complications.

[0061] The electrode skeleton 12 is covered with a polymer protective sheath, and the annular microelectrode 124 and the magnetic positioning sensor 125 are arranged outside the protective sheath. In a specific example, the present application is provided with six electrode skeletons, each of which is evenly spaced with three annular electrodes. Three of the skeletons are loaded with magnetic positioning sensors at the front end, and the three skeletons with magnetic positioning sensors are spaced two by two to form an annular coverage.

[0062] The windmill structure at the catheter tip can be retracted into the sheath as a whole. The shape after retraction is shown in the figure below. During operation, the retraction steps include:

[0063] First, the inner tube body 21 is controlled to retreat to form the largest diameter windmill, and the windmill frame is restored to the largest diameter and horizontally expanded. Then the catheter is controlled to be withdrawn into the sheath tube as a whole, and the windmill head end is recovered into the sheath tube as a whole. Under the compression of the inner wall of the sheath tube 5, the windmill frame is deformed and retracted into the sheath tube 5. The final state is as follows Figure 6 shown.

[0064] In some embodiments, as Figure 7 As shown, the catheter handle 3 includes the gear assembly, a bending and fixing slider 34 , and a saline pipeline 32 , wherein the gear assembly includes a first gear 35 , a second gear 36 and a third gear 37 .

[0065] The bending fixed slider 34 is provided at one end of the catheter handle 3. The bending fixed slider is provided with a bending traction wire anchor hole for connecting the bending traction wire for mechanical transmission of the catheter tip bending.

[0066] The third gear 37 is used to push the J-bend guide wire 4, wherein the J-bend guide wire 4 is fixed by a J-bend guide wire fixing valve.

[0067] In a specific example, Figure 7 As shown, the electrode tail wire 33 is used for signal transmission of the electrode at the catheter head end, the saline pipeline 32 is used for saline perfusion at the catheter head end, the bending fixed slider 34 is used for the mechanical arm transmission of the catheter head end bending, the first gear 35 is used for the mechanical transmission of the axial movement of the catheter inner cavity tube body, and the diameter change of the windmill-shaped skeleton at the catheter head end is controlled by the relative axial displacement of the catheter inner cavity tube body relative to the catheter outer cavity tube body, the second gear 36 is used for the mechanical transmission of the catheter rotation, and the third gear 37 is used for the mechanical transmission of the axial push of the J-bend guidewire, which controls the axial movement of the J-bend guidewire. The J-bend guidewire fixing valve 310 is used to fix the J-bend guidewire 4 and prevent blood backflow into the inner cavity.

[0068] In some embodiments, as Figure 8 As shown, the catheter handle 3 also includes an inner cavity sliding module, and a threaded slider is fixed inside the inner cavity J-bend guide wire, wherein,

[0069] The inner cavity sliding module 38 includes an inner cavity sliding thread sliding block provided with an external thread. The inner cavity sliding thread sliding block can be slidably arranged in the tube body of the catheter handle 3, and a circumferential limiting structure is provided between the inner cavity sliding thread sliding block and the tube body.

[0070] Specific as Figure 8 As shown, the internal structure of the catheter handle 3 mainly includes: a bending and fixing slider 34, an inner cavity sliding module 38, a second gear 36, and an inner cavity J-bend guide wire internal fixing thread slider 39.

[0071] The bending and fixing slider 34 has a built-in anchor hole for the bending traction wire, which is connected to the bending anchor hole 25 at the tip of the catheter's outer lumen body 22 via the traction wire. The bending operation is completed by the forward and backward controlled movement of the bending and fixing slider 34. The inner lumen sliding module 38 includes an inner lumen sliding threaded sliding block with external threads. The inner lumen sliding threaded sliding block is slidably mounted within the tube body, and a circumferential limit structure is provided between the inner lumen sliding threaded sliding block and the tube body.

[0072] In some embodiments, the inner wall of the first gear is provided with an internal thread, and the internal thread is adapted to the inner cavity sliding thread sliding block, so that the sliding block can be controlled to slide in the inner cavity by rotating the first gear to adjust the windmill diameter of the windmill structure of the catheter head end.

[0073] Specifically, the inner wall of the first gear 35 is provided with an internal thread, and the internal thread is adapted to the external thread of the sliding block of the inner cavity sliding thread. The rotation of the second gear 36 can control the sliding block to move axially in the inner cavity, thereby driving the inner cavity tube body to move axially and controlling the diameter size of the windmill structure at the catheter head end.

[0074] The second gear 36 is used to drive the entire catheter body to rotate.

[0075] In some embodiments, the J-bend guidewire is connected to a fixed threaded slider 39 inside the J-bend guidewire. The fixed slider inside the J-bend guidewire is provided with an external thread and is covered with an internal threaded sleeve that matches the external thread. A circumferential limit structure is provided between the fixed threaded slider 39 inside the J-bend guidewire and the internal threaded sleeve. The rotation of the third gear 37 drives the internal threaded sleeve to rotate. Under the transmission of the internal and external threads of the internal threaded sleeve and the fixed slider, the axial movement of the fixed threaded slider is controlled to control the axial push and retraction of the J-bend guidewire 4. In a specific example, the transmission method of the fixed threaded slider 39 inside the inner cavity of the J-bend guidewire is similar to that of the inner cavity sliding module 38. The J-bend guidewire is fixedly connected to the fixed threaded slider 39 inside the J-bend guidewire. The fixed threaded slider 39 inside the J-bend guidewire is provided with an external thread and is covered with an internal threaded sleeve that matches the external thread. The rotation of the third gear 37 drives the internal threaded sleeve to rotate. Under the transmission of the internal and external threads, the fixed threaded slider 39 inside the J-bend guidewire moves axially, thereby controlling the axial push and retraction of the J-bend guidewire 4. A J-bend guidewire is placed in the lumen of the catheter to achieve better coaxial adhesion of the catheter to the target pulmonary vein.

[0076] The controllable windmill-shaped PFA catheter electrodes in this embodiment are evenly distributed within the windmill-shaped framework, creating a uniform electrode distribution within the target pulmonary vein, addressing the short-circuiting and arcing issues caused by the release of pulsed electric field energy. The windmill-shaped PFA ablation catheter in this application features a circular spherical surface at the front, creating a better fit within the heart and addressing the potential for damage to the endocardium caused by the raised tip of the catheter during insertion, which can lead to severe cardiac perforation.

[0077] The pinwheel-shaped electrode framework of this application evenly distributes multiple electrodes and magnetic positioning sensors, enabling integrated 3D high-density mapping, impedance monitoring, and PFA ablation. This allows physicians to simultaneously complete 3D anatomical mapping without switching catheters for PFA ablation. The unique bifurcated diameter control structure allows for optimal alignment with the proximal end of the target pulmonary vein ostium and the vestibule, improving catheter adaptability.

[0078] The catheter handle of the present application integrates a multi-degree-of-freedom control structure of the catheter, including five degree-of-freedom control structures: ablation ring diameter, catheter rotation, catheter bending, advance and retreat of the J-bend guidewire in the lumen, and overall advance and retreat of the catheter. It can be controlled and operated through the auxiliary control system of cardiac interventional equipment to solve the problems of zero-ray radiation and remote surgery.

[0079] 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.

[0080] 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.

[0081] 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 controllable windmill-shaped PFA catheter, characterized in that: include: The catheter (1) is led out from the catheter body (2), and the catheter head end is in a windmill structure. A magnetic sensor and a plurality of electrodes are provided on the frame of the windmill structure, and the windmill structure can be received in a sheath tube; The catheter body (2) is led out from the catheter handle (3), and the other end leads out of the catheter (1); A catheter handle (3) is provided, one end of which leads out the catheter body (2); the catheter handle (3) is connected to a gear assembly adapted to an electrophysiological interventional instrument; the gear assembly comprises at least three groups of gears for implementing corresponding surgical actions; the gear assembly comprises at least three groups of gears for implementing corresponding surgical actions, wherein the first gear is used to adjust the windmill diameter of the windmill structure of the catheter head end, the second gear is used to adjust the rotation of the catheter, and the third gear is used to push the J-bend guide wire.

2. The controllable windmill-shaped PFA conduit according to claim 1, characterized in that: The windmill structure at the catheter head end of the catheter (1) comprises a combined support frame (11) and an electrode frame (12), wherein: The support frame (11) is a bilateral support structure in the shape of petals, the ends of the petal-shaped support frame (11) serving as connection points for the electrode frame (12), and a first fixed end (111) is provided in the middle of the petal-shaped support frame; The electrode skeleton (12) is provided with at least 6 sub-skeletons based on the connection points of the petal-shaped support skeleton, at least 3 annular microelectrodes (124) are provided on any sub-skeleton (123), and magnetic positioning sensors (125) are provided on the spaced sub-skeletons. A second fixed end (121) is formed at one end of each sub-skeleton (123) corresponding to the first fixed end (111), and the first fixed end (111) and the second fixed end (121) are used to fix the windmill structure of the catheter head end to the catheter body (2).

3. The controllable windmill-shaped PFA conduit according to claim 2, characterized in that: Each sub-frame (123) is provided with a frame protection tube (122) at one end connected to the petal-shaped support frame, and the fixing point of any sub-frame is arranged at a preset angle with the connection point of the support frame (11) in the circumferential direction.

4. The controllable windmill-shaped PFA conduit according to claim 2, characterized in that: The catheter tube body (2) comprises an inner cavity tube body (21) and an outer cavity tube body (22), wherein the inner cavity tube body (21) is slidably disposed in the outer cavity tube body (22); The inner cavity tube body (21) is fixed to the second fixed end (121), and the outer cavity tube body (22) is fixed to the first fixed end (111), so as to control the windmill diameter of the windmill structure based on the relative movement of the inner cavity tube body (21) and the outer cavity tube body (22); The inner cavity tube body (21) has a guide wire routing hole and a J-bend guide wire cavity distributed on its head end; The outer cavity tube body (22) is provided with a bending anchor hole at its head end for pulling and bending the traction wire.

5. The controllable windmill-shaped PFA conduit according to claim 4, characterized in that: The outer cavity tube body (22) comprises a multi-layer structure, and the outer cavity tube body (22) comprises an inner lining tube and an outer braided tube, and the outer braided tube is coated with a layer of clear water coating; The inner cavity tube body (21) is an integrally formed tube made of a polymer material, and a plurality of tube body wiring grooves are provided in the inner cavity tube body to lead out electrode wires and magnetic positioning sensor wires based on the tube body wiring grooves.

6. The controllable windmill-shaped PFA conduit according to claim 1, wherein: The catheter handle (3) comprises the gear assembly, a bending and fixing slider (34), and a saline pipeline (32), wherein: The bending fixing slider (34) is arranged at one end of the catheter handle (3), and a bending traction wire anchoring hole is provided on the bending fixing slider (34) for connecting the bending traction wire and for mechanical transmission of the bending of the catheter head end; The third gear (37) is used for pushing the J-bend guide wire (4), wherein the J-bend guide wire (4) is fixed by a J-bend guide wire fixing valve (310).

7. The controllable windmill-shaped PFA conduit according to claim 6, characterized in that: The catheter handle (3) further comprises an inner cavity sliding module (38), wherein: The inner cavity sliding module (38) includes an inner cavity sliding thread sliding block provided with an external thread, the inner cavity sliding thread sliding block can be slidably arranged in the tube body of the catheter handle (3), and a circumferential limiting structure is provided between the inner cavity sliding thread sliding block and the tube body.

8. The controllable windmill-shaped PFA conduit according to claim 7, wherein: The first gear (35) has an inner wall provided with an internal thread, which is adapted to the inner cavity sliding thread sliding block, so that the sliding block is controlled to slide in the inner cavity by rotating the first gear (35) to adjust the windmill diameter of the windmill structure at the catheter head end.

9. The controllable windmill-shaped PFA conduit according to claim 6, wherein: The J-bend guide wire is connected to a fixed threaded slider (39) inside the J-bend guide wire. The fixed slider inside the J-bend guide wire is provided with an external thread, and an internal threaded sleeve adapted to the external thread is provided on the outside. A circumferential limiting structure is provided between the fixed threaded slider (39) inside the J-bend guide wire and the internal threaded sleeve. The internal threaded sleeve is driven to rotate by the rotation of the third gear (37), so that the axial movement of the fixed threaded slider is controlled under the transmission of the internal and external threads of the internal threaded sleeve and the fixed slider to control the axial pushing and retreat of the J-bend guide wire (4).

10. A remote catheter ablation device, characterized in that: It comprises an electrophysiological interventional robot and a controllable windmill-shaped PFA catheter as described in any one of claims 1 to 9, wherein the actuator of the electrophysiological interventional robot is adapted to the gear assembly of the catheter handle of the controllable windmill-shaped PFA catheter to perform corresponding surgical actions according to control instructions.

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