Controllable windmill-shaped PFA catheter and remote catheter ablation device

Abstract

The invention discloses a controllable windmill-shaped PFA catheter and a remote catheter ablation device, and relates to the technical field of catheter ablation and medical instruments, the controllable windmill-shaped PFA catheter comprises a catheter, the catheter is led out of a catheter body, 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 is led out of the catheter, and the catheter body is arranged in the sheath tube; one end of the catheter handle is led out of the catheter body, the catheter handle is matched with a gear assembly of an electrophysiology 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] The most widely used catheter ablation in clinical practice usually uses radiofrequency energy. However, because radiofrequency thermal ablation is easily accompanied by 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, eschar and detonation, and the ability to discharge simultaneously with multiple poles.

[0003] At present, there are many pulsed electric field ablation (pulsed electric field) catheters in clinical practice at home and abroad. There are two main types of domestic pulsed electric field catheters: ring-shaped multipolar catheters and petal-shaped multipolar catheters. The above-mentioned pulsed electric field multi-electrode catheters have the following defects: 1. The ablation electrode ring is 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 to form the catheter tip, which easily brings the risk of sticking in the heart cavity, and seriously forms 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 adapt to two-dimensional DSA and three-dimensional electroanatomy at the same time. 4. With the existing electrode ring or basket PFA, the surgeon cannot control and complete remote ablation surgery, cannot plan automatic ablation on the surgical robot platform, and cannot achieve remote control. As a result, the surgeon has to perform surgery 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. Summary of the invention

[0004] The embodiments of the present application provide a controllable windmill-shaped PFA catheter and a remote catheter ablation device, which are used to propose a windmill-shaped PFA ablation catheter, wherein electrodes are evenly distributed on a windmill-shaped skeleton, forming a uniform electrode distribution on 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 embodiment provides a controllable windmill-shaped PFA conduit, comprising: 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 arranged on the framework of the windmill structure, and the windmill structure can be put into the 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 with the catheter body 2 at one end. The catheter handle 3 is adapted to a gear assembly of an electrophysiological interventional instrument. The gear assembly includes at least three groups of gears for realizing corresponding surgical actions.

[0006] 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: The support frame 11 is a bilateral support structure in the shape of a petal. The end of the petal-shaped support frame 11 serves as a connection point for the electrode frame 12. A first fixed end 111 is disposed 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 supporting 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. 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.

[0007] Optionally, each sub-skeleton 123 is provided with a skeleton protection tube 122 at one end connected to the petal-shaped supporting skeleton, and the fixing point of any sub-skeleton is arranged at a preset angle with the connection point of the supporting skeleton 11 in the circumferential direction.

[0008] Optionally, the catheter body 2 includes an inner lumen body 21 and an outer lumen body 22, and the inner lumen body 21 can be slidably disposed in the outer lumen 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 has a bending adjustment anchor hole at its head end for pulling and bending the traction wire.

[0009] Optionally, the outer cavity tube body 22 comprises a multi-layer structure, 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 polymer material, and a plurality of tube body wiring grooves are arranged in the inner cavity tube body to lead out electrode wires and magnetic positioning sensor wires based on the tube body wiring grooves.

[0010] Optionally, the catheter handle 3 includes the gear assembly, a bending and fixing slider 34, and a saline pipeline 32, wherein: The bending and fixing slider 34 is arranged at one end of the catheter handle 3, and a bending and fixing wire anchoring hole is arranged on the bending and fixing slider 34 for connecting the bending and fixing wire, which is used for mechanical transmission of the bending of the catheter head end; The third gear 37 of the gear assembly 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 .

[0011] Optionally, the catheter handle 3 further includes an inner cavity sliding module 38, wherein: The inner cavity sliding module 38 includes an inner cavity sliding threaded sliding block provided with an external thread. The inner cavity sliding threaded sliding block can be slidably arranged in the tube body of the catheter handle 3, and a circumferential limiting structure is arranged between the inner cavity sliding threaded sliding block and the tube body.

[0012] Optionally, the first gear 35 of the gear assembly 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 can be 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.

[0013] 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 an external sleeve is provided with an internal threaded sleeve that matches 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, so as to control the axial push and withdrawal of the J-bend guide wire 4.

[0014] An embodiment of the present application also proposes a remote catheter ablation device, including an electrophysiological interventional robot and a controllable windmill-shaped PFA catheter as described above, 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.

[0015] 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, so that the operator can perform ablation without changing the catheter while completing the three-dimensional point mapping and dissection.

[0016] 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

[0017] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present application. Also, the same reference symbols are used throughout the accompanying drawings to represent the same components. In the accompanying drawings: Figure 1 The overall structure of the controllable windmill-shaped PFA conduit according to an embodiment of the present application is schematically shown; Figure 2 This is a schematic diagram of the windmill skeleton structure of a controllable windmill-shaped PFA duct according to an embodiment of the present application; Figure 3 Another schematic diagram of the controllable windmill-shaped PFA duct windmill skeleton structure of the embodiment of the present application; Figure 4a This is a schematic diagram of the unfolded structure of the windmill skeleton of the controllable windmill-shaped PFA duct according to an embodiment of the present application; Figure 4b It is a partial enlarged schematic diagram of the unfolded structure of the windmill skeleton of the controllable windmill-shaped PFA duct in the embodiment of the present application; Figure 5 A schematic diagram of the catheter cavity structure of a controllable windmill-shaped PFA catheter in an embodiment of the present application; 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; Figure 7 Schematic diagram of the catheter handle structure of the controllable windmill-shaped PFA catheter of the present application embodiment 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

[0018] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the 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. On the contrary, 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.

[0019] The present application embodiment provides a controllable windmill-shaped PFA conduit, such as Figure 1 As shown, including: The catheter 1 is led out from the catheter body 2, and the catheter tip is in a windmill structure. A magnetic sensor and a plurality of electrodes are arranged on the frame of the windmill structure, and the windmill structure can be received in the sheath. In the embodiment of the present application, the windmill structure at the tip of the catheter 1 is used as the electrode PFA ablation tip, and the spherical radial diameter is adjustable, thereby controlling the diameter of the windmill surface at the tip of the catheter to adapt to pulmonary vein orifices of different sizes, thereby achieving a better treatment effect.

[0020] In a specific example, the pinwheel structure 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, so as to adjust the pinwheel structure 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.

[0021] 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.

[0022] A catheter handle 3, one end of which leads out the catheter body 2, and the catheter handle 3 is adapted to a gear assembly of an electrophysiological interventional instrument, wherein the gear assembly includes at least three sets of gears for realizing 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.

[0023] The controllable catheter proximal handle of the present application is used to adapt 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 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 facilitates the operator to perform ablation without changing the catheter while completing the three-dimensional point mapping and dissection.

[0024] In some embodiments, 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: 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 disposed in the middle of the petal-shaped support frame.

[0025] The electrode skeleton 12, such as Figure 3 , Figure 4aAs shown, at least 6 sub-skeletons 123 are arranged at the connection points based on the petal-shaped support skeleton, at least 3 annular microelectrodes 124 are arranged on any sub-skeleton 123, and a magnetic positioning sensor 125 is arranged 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.

[0026] 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 circumferential displacement of the electrode skeleton, and ensure that the electrodes are evenly distributed close to the target tissue of the cardiac cavity to the greatest extent, thereby improving the quality of ablation and reducing the recurrence rate.

[0027] 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, and the fixing point of any sub-frame 123 is set at a preset angle with the connection point of the support frame 11 in the circumferential direction. In a specific example, the frame protection tube 122 is used for the smooth treatment of the connection between the electrode frame 12 and the support frame to improve the passability of the catheter tip when it moves in the heart cavity, avoiding damage to the myocardial tissue. The frame of the entire windmill structure is completed by integral cutting of nickel-titanium alloy and preformed to the maximum diameter of the windmill.

[0028] 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, and at the same time reduce the electrode spacing between two adjacent electrode skeletons, thereby increasing the electrode surface ratio in the circumferential direction of the catheter.

[0029] In some embodiments, Figure 5 As shown, the catheter body 2 includes an inner cavity body 21 and an outer cavity body 22, and the inner cavity body 21 can be slidably disposed in the outer cavity 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 23 and a J-bend guide wire cavity 24 on its head end; The outer cavity tube body 22 has a bending 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 connecting the first fixing end 111 of the supporting frame 11.

[0030] In a specific example, the distance between the first fixed end 111 and the second fixed end 121 of the windmill structure skeleton is controlled by the relative axial movement of the inner cavity tube body 21 and the outer cavity tube body 22, thereby adjusting the shape of the windmill structure at the catheter head end. The diameter of the windmill structure at the catheter head end is adjusted by pushing the inner cavity tube body 21 forward and backward, so as to adapt to different pulmonary vein orifices and vestibules. When entering the pulmonary vein orifice, the blood vessel gradually narrows, and a better fit is achieved through the elliptical windmill shape.

[0031] In some specific examples, the guide wire routing hole 23 and the J-bend guide wire cavity 24 are distributed on the head end of the inner cavity tube body 21, and the head end of the fixed outer cavity tube body 22 is also built with a bending anchor hole 25 for pulling and bending the traction wire. As another solution, the diameter of the windmill-shaped catheter head end can be adjusted by pushing the outer cavity tube body forward and backward, and the diameter adjustment of the windmill structure can be completed by the relative axial movement of the inner cavity tube body 21 and the outer cavity tube body 22. This application will be described later using the first solution as an example.

[0032] 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, thereby reducing the risk of damage to peripheral blood vessels.

[0033] The inner cavity tube body 21 is an integrally formed tube made of polymer material. A plurality of tube wiring grooves are arranged in the inner cavity tube body 21 to lead out electrode wires and magnetic positioning sensor wires based on the tube wiring grooves.

[0034] See also Figure 4b , 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.

[0035] The diameter of the windmill is adjusted by the axial movement of the inner cavity tube 21. When the inner cavity of the catheter is pushed forward, the windmill frame can be stretched radially as a whole, thereby forming an elliptical windmill ablation shape. The inner cavity tube 21 is withdrawn to the bottom to form the maximum expansion diameter of the windmill. The radial adjustment distance of the windmill is 40-60mm (the withdrawal distance range of the inner cavity tube body), which can be completely attached to the pulmonary vein vestibule. At the same time, during three-dimensional mapping, the front end of the catheter with the largest diameter can form a rapid model of the heart. The diameter of the catheter head is expanded to 30-40mm to adapt to the heart anatomical structure of different patients.

[0036] Each sub-skeleton is provided 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 a J-bend guide wire 4, and then the catheter is pushed forward as a whole, moving forward along the pulmonary vein. The adhesion stability is determined by the impedance monitoring of the electrode. 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 effects, thereby reducing ineffective discharges in the blood, reducing damage to the blood, and avoiding complications.

[0037] The electrode skeleton 12 is covered with a polymer protective sleeve, and the annular microelectrode 124 and the magnetic positioning sensor 125 are arranged outside the protective sleeve. In a specific example, the present application is provided with 6 electrode skeletons, and 3 annular electrodes are evenly spaced on each electrode skeleton, and the front ends of 3 skeletons are loaded with magnetic positioning sensors, and the 3 skeletons with magnetic positioning sensors are spaced in pairs to form an annular coverage.

[0038] The windmill structure at the catheter tip can be integrated into the sheath tube. Figure 6 As shown, during the working process, the storage steps include: First, the inner cavity tube body 21 is controlled to withdraw to form a windmill with the largest diameter, and the windmill frame is restored to the maximum diameter and horizontally expanded. Then the catheter is controlled to withdraw as a whole into the sheath tube, and the windmill head end is recovered as a whole into the sheath tube. 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.

[0039] In some embodiments, 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 .

[0040] The bending and fixing slider 34 is arranged at one end of the catheter handle 3, and a bending and fixing wire anchoring hole is arranged on the bending and fixing slider for connecting the bending and fixing wire, which is used 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.

[0041] In a specific example, Figure 7 As shown, the electrode tail line 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, the third gear 37 is used for the mechanical transmission of the axial push of the J-bend guidewire, and the axial movement of the J-bend guidewire is controlled. The J-bend guidewire fixing valve 310 is used to fix the J-bend guidewire 4 and prevent blood return from the inner cavity.

[0042] In some embodiments, 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, The inner cavity sliding module 38 includes an inner cavity sliding threaded sliding block provided with an external thread. The inner cavity sliding threaded sliding block can be slidably arranged in the tube body of the catheter handle 3, and a circumferential limiting structure is arranged between the inner cavity sliding threaded sliding block and the tube body.

[0043] 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.

[0044] The bending fixed slider 34 has a built-in bending traction wire anchor hole, which is connected to the bending adjustment anchor hole 25 at the head end of the catheter outer cavity tube body 22 through the traction wire, and the bending operation is completed by controlling the forward and backward movement of the bending fixed slider 34. The inner cavity sliding module 38 includes an inner cavity sliding threaded sliding block provided with an external thread, the inner cavity sliding threaded sliding block can be slidably arranged in the tube body, and a circumferential limiting structure is arranged between the inner cavity sliding threaded sliding block and the tube body.

[0045] 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 at the catheter head end.

[0046] Specifically, the inner wall of the first gear 35 is provided with an internal thread, and its internal thread is adapted to the external thread of the inner cavity sliding thread sliding block. 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.

[0047] The second gear 36 is used to drive the entire catheter body to rotate.

[0048] In some embodiments, the J-bend guide wire is connected to the fixed thread 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 thread sleeve matching the external thread is provided on the outside. A circumferential limit structure is provided between the fixed thread slider 39 inside the J-bend guide wire and the internal thread sleeve, and the internal thread sleeve is driven to rotate by the rotation of the third gear 37, so as to control the axial movement of the fixed thread slider under the transmission of the internal and external threads of the internal thread sleeve and the fixed slider to control the axial push and retreat of the J-bend guide wire 4. In a specific example, the transmission mode of the fixed thread slider 39 inside the inner cavity J-bend guide wire is similar to that of the inner cavity sliding module 38. The J-bend guide wire is fixedly connected to the fixed thread slider inside the J-bend guide wire, the fixed thread slider 39 inside the J-bend guide wire is provided with an external thread, and an internal thread sleeve matching the external thread is provided on the outside. The internal thread sleeve is driven to rotate by the rotation of the third gear 37, and the fixed thread slider 39 inside the J-bend guide wire moves axially under the transmission of the internal and external threads, thereby controlling the axial push and retreat of the J-bend guide wire 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.

[0049] The controllable windmill-shaped PFA catheter electrodes of the embodiment of the present application are evenly distributed on the windmill-shaped frame, forming a uniform electrode distribution in the target pulmonary vein, solving the short circuit and arc problems caused during the release of pulsed electric field energy. The windmill-shaped PFA ablation catheter of the present application has a circular arc spherical surface at the front, which forms a better fit in the heart, solving the potential damage to the endocardium caused by the raised tip of the front end of the catheter during the placement of the existing petal-shaped catheter, which may cause the risk of heart perforation in severe cases.

[0050] The pinwheel-shaped electrode skeleton of the present application evenly distributes multiple electrodes and magnetic positioning sensors to complete integrated three-dimensional high-density mapping, impedance monitoring and PFA ablation, which facilitates doctors to complete PFA ablation without switching catheters while completing three-dimensional mapping and dissection. The unique split-body diameter control structure can form a suitable fit at the proximal end of different target pulmonary vein orifices and vestibules, improving the adaptability of the catheter.

[0051] 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, advancement and withdrawal of the J-bend guidewire in the lumen, and advancement and withdrawal of the catheter as a whole. 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.

[0052] An embodiment of the present application also proposes a remote catheter ablation device, including an electrophysiological interventional robot and a controllable windmill-shaped PFA catheter as described above, 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.

[0053] It should be noted that in the various embodiments of the present application, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "includes a ..." does not exclude the presence of other identical elements in the process, method, article or device including the element.

[0054] The serial numbers of the above-mentioned embodiments of the present application are for description only and do not represent the advantages or disadvantages of the embodiments.

[0055] 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 the present application, ordinary technicians in this field can also make many forms without departing from the purpose of the present application and the scope of protection of the claims, all of which are within the protection of the present 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 arranged on the framework of the windmill structure, and the windmill structure can be received in a sheath tube; A catheter body (2) is led out from a catheter handle (3), and the other end leads out of the catheter (1); A catheter handle (3) has one end leading out of the catheter body (2); the catheter handle (3) is a gear assembly adapted to the electrophysiological interventional instrument, and the gear assembly comprises at least three groups of gears for realizing corresponding surgical actions.

2. The controllable windmill-shaped PFA conduit according to claim 1, characterized in that: The catheter (1), wherein the windmill structure at the catheter head end 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 a petal, 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 a magnetic positioning sensor (125) is 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 a fixing point of any sub-frame is arranged at a preset angle with a 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 lumen tube body (21) and an outer lumen tube body (22), wherein the inner lumen tube body (21) can be slidably disposed in the outer lumen 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 adjustment 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, 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 polymer material, and a plurality of tube body wiring grooves are arranged 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, characterized in that: The catheter handle (3) comprises the gear assembly, a bending and fixing slider (34), and a saline pipeline (32), wherein: The bending and fixing slider (34) is arranged at one end of the catheter handle (3), and a bending and fixing wire anchoring hole is arranged on the bending and fixing slider (34) for connecting the bending and fixing wire, and for mechanical transmission of the bending of the catheter tip; The third gear (37) of the gear assembly is used for pushing the J-bend guide wire (4), wherein the circumferential position of the J-bend guide wire (4) is limited by the 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) comprises an inner cavity sliding threaded sliding block provided with an external thread, the inner cavity sliding threaded sliding block can be slidably arranged in the tube body of the catheter handle (3), and a circumferential limiting structure is arranged between the inner cavity sliding threaded sliding block and the tube body.

8. The controllable windmill-shaped PFA conduit according to claim 7, characterized in that: The first gear (35) of the gear assembly 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 can be 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, characterized in that: 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 matching 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, so as to control the axial pushing and retreating of the J-bend guide wire (4).

10. A remote catheter ablation device, characterized in that: It comprises an electrophysiological intervention robot and a controllable windmill-shaped PFA catheter as described in any one of claims 1 to 9, wherein the actuator of the electrophysiological intervention 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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