Ablation catheter

Abstract

The invention relates to the technical field of medical instruments, and provides an ablation catheter which comprises an outer tube and an inner tube. The near end of the inner tube assembly can be movably inserted into the outer tube in the axial direction of the outer tube; the mesh basket electrode assembly comprises a plurality of electrode arms, and the plurality of electrode arms are emitted from the far end of the inner tube assembly and are gathered together at the far end of the outer tube; the far end of the inner tube assembly is provided with a plane structure, so that a plane end is formed at the far end of the ablation catheter after the inner tube assembly is connected with the far end of the mesh basket electrode assembly. According to the ablation catheter provided by the invention, the far end of the inner tube assembly is provided with the plane structure, so that the plane end head is formed at the far end of the ablation catheter after the inner tube assembly is connected with the far end of the mesh basket electrode assembly. The risk that the head end of the ablation catheter punctures the inner wall of the heart cavity can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ablation catheter. Background Art

[0002] Ablation catheters play a very important role in the field of cardiac electrophysiology and are mainly used to treat cardiac diseases such as arrhythmias. In recent years, annular multipolar ablation catheters have been widely promoted in the industry due to their advantages over monopolar ablation catheters, such as shorter ablation time, shorter radiation exposure time, and lower technical requirements for operators. However, due to the special structure of the pulmonary veins and individual differences, the catheter cannot be effectively attached to the target site, and the poor attachment of the electrodes leads to insufficient electric field and failure to achieve the corresponding effect. The basket catheter with a petal-shaped structure can adjust the size of the basket shape through the elastic bending of the basket skeleton distributed along the circumference to adapt to the different sizes of pulmonary vein cavities in patients.

[0003] The ablation catheter in the prior art includes: a first catheter, whose proximal end is connected to the control handle of the ablation device; an ablation assembly, which is arranged at the distal end of the first catheter, including multiple splines, and at least one electrode is arranged on the splines; the electrode is arranged on the surface of the spline on the side away from the longitudinal axis of the first catheter; and the electrode covers 1 / 3 to 1 / 2 of the transverse surface of the spline. In this ablation catheter, the electrode is arranged on the surface of the spline on the side away from the longitudinal axis of the first catheter; and the electrode covers 1 / 3 to 1 / 2 of the transverse surface of the spline, which can avoid discharge into the air (discharge in other directions other than toward the tissue), reduce the generation of bubbles, make ablation safer, and discharge only toward one side, which can reduce the current of pulse ablation. However, the distal ends of the multiple splines in the ablation catheter are fixedly connected to the distal cap, that is, the multiple splines are gathered together by the distal cap. When the catheter enters the heart cavity, the protruding distal cap will cause the risk of puncturing the inner wall of the heart cavity during surgery. Summary of the invention

[0004] Therefore, the present invention aims to solve the problem that when the existing ablation catheter enters the heart cavity, the protruding distal cap may cause the risk of puncturing the inner wall of the heart cavity during surgery, thereby providing an ablation catheter.

[0005] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0006] The present invention provides an ablation catheter, comprising: an outer tube; an inner tube assembly, the proximal end of the inner tube assembly being insertable in the outer tube in a movably axial direction of the outer tube; a basket electrode assembly, comprising a plurality of electrode arms, the plurality of electrode arms extending from the distal end of the inner tube assembly and converging at the distal end of the outer tube; the distal end of the inner tube assembly having a planar structure, so that a planar end is formed at the distal end of the ablation catheter after the inner tube assembly is connected to the distal end of the basket electrode assembly.

[0007] Further, the multiple electrode arms are an integrated structure formed by cutting a whole flexible electrode, and in a natural state, the multiple electrode arms as a whole have a structure that diverges outward from the center.

[0008] Further, the inner tube assembly includes an inner tube connector and an inner tube; an assembly hole is provided at the central position of the distal end of the basket electrode assembly; the inner tube connector as a whole has a T-shaped structure, and the inner tube connector is inserted into the assembly hole along the direction from the distal end to the proximal end of the basket electrode assembly; the inner tube is inserted into the inner tube connector along the direction from the proximal end to the distal end of the inner tube connector and is fixedly connected to the inner tube connector; the proximal end of the inner tube is inserted into the outer tube in a manner that can move along the axial direction of the outer tube.

[0009] Further, the inner tube connector includes a planar portion and a tubular portion, the planar portion is attached to and bonded with the outer edge of the assembly hole, and the tubular portion is inserted into the assembly hole along the direction from the distal end to the proximal end of the basket electrode assembly; the inner tube is inserted into the tubular portion along the direction from the proximal end to the distal end of the tubular portion and is fixedly connected to the tubular portion, and the proximal end of the inner tube is inserted into the outer tube in a manner that can move along the axial direction of the outer tube.

[0010] Further, the inner tube connector includes a planar portion and a tubular portion, a loading tube is provided on one side of the planar portion facing the tubular portion, the loading tube is inserted into the assembly hole along the direction from the distal end to the proximal end of the basket electrode assembly, and the planar portion is attached to the outer edge at the assembly hole; an external thread is provided on the outer circumference of the loading tube, and an internal thread is provided on the inner side wall of the lumen of the tubular portion, the loading tube is inserted into the lumen of the tubular portion and the two are connected by threads, and the distal end face of the tubular portion is attached to the inner edge at the assembly hole to cooperate with the planar portion to clamp the basket electrode assembly; the inner tube is inserted into the tubular portion along the direction from the proximal end to the distal end of the tubular portion and is fixedly connected to the tubular portion, and the proximal end of the inner tube is inserted into the outer tube in a manner that can move along the axial direction of the outer tube.

[0011] Further, the ablation catheter further includes an electrode ring and a magnetic positioning sensor, the electrode ring is provided on the outer peripheral surface of the tubular portion; the magnetic positioning sensor is located in the lumen of the inner tube or the tubular portion; or the magnetic positioning sensor is located in the lumen formed by the cooperation of the tubular portion and the loading tube.

[0012] Further, the electrode arm includes an electrode layer, a first insulating layer, a metal skeleton layer, and a second insulating layer that are stacked from top to bottom; the first insulating layer is used to insulate and isolate the electrode layer from the metal skeleton layer; the second insulating layer is used to insulate and isolate the side of the metal skeleton layer away from the first insulating layer.

[0013] Furthermore, the edges of the first insulating layer are in contact with those of the second insulating layer to completely wrap the metal framework layer therein.

[0014] Furthermore, the electrode layer, the first insulating layer, and the metal framework layer are all disposed centrally with respect to the second insulating layer.

[0015] Furthermore, the widths of both the electrode layer and the metal framework layer are smaller than that of the first insulating layer.

[0016] Furthermore, along the length direction of the electrode arm, the length of the metal framework layer is smaller than that of the first insulating layer.

[0017] Furthermore, a groove is provided on the surface of the second insulating layer facing the metal framework layer, and at least a part of the metal framework layer is embedded in the groove along the thickness direction of the electrode arm.

[0018] Furthermore, the entire metal framework layer is embedded in the groove so that the surface of the metal framework layer facing the first insulating layer is flush with the surface of the second insulating layer facing the first insulating layer.

[0019] Furthermore, along the width direction of the electrode arm, the thicknesses of the two edges of the second insulating layer are smaller than that of the middle part.

[0020] Furthermore, skirt edges are provided on both sides of the second insulating layer, and the outer edges of the skirt edges extend beyond the edges of the first insulating layer along the width direction of the first insulating layer.

[0021] Furthermore, the skirt edges are rectangular skirt edges or arc-shaped skirt edges.

[0022] Furthermore, the maximum width of the skirt edges is smaller than the width difference between the edge of the electrode layer and the edge of the first insulating layer.

[0023] Furthermore, a plurality of the electrode layers are provided along the length direction of the first insulating layer, and the plurality of electrode layers are arranged in an equidistant and equal-length split arrangement.

[0024] Furthermore, a plurality of the electrode layers are provided along the length direction of the first insulating layer, and at least one long electrode and at least one short electrode are included in the plurality of electrode layers; the long electrodes and the short electrodes are arranged in a split arrangement.

[0025] Furthermore, at least one of the short electrodes is embedded in the long electrode.

[0026] Furthermore, the ablation catheter also includes a control handle; the control handle includes a shell, a push-pull switch and a transmission guide mechanism arranged in the shell; the proximal end of the outer tube is connected to the distal end of the shell; the proximal end of the inner tube assembly extends into the shell and is connected to the transmission guide mechanism; the operating end of the push-pull switch is located outside the shell, and the execution end of the push-pull switch is connected to the transmission guide mechanism; the basket electrode assembly is controlled to be retracted or opened by toggling the push-pull switch.

[0027] Furthermore, the transmission guide mechanism includes a slide rail, a slider, a rack and a gear; the slider can be slidably arranged on the slide rail along the length direction of the control handle; the proximal end of the inner tube assembly extends into the shell and is connected to the slider; the gear can be rotatably arranged in the shell around its own axis, the rack is meshed with the gear, and the rack is connected to the slider; the execution end of the push-pull switch is connected to the rack.

[0028] Furthermore, a slot is provided on the slider, and the proximal end of the inner tube assembly is inserted into the slot, so that the proximal end of the inner tube assembly is connected to the slider.

[0029] Furthermore, a slide groove is provided on the slide rail, and the sliding block can be linearly slidably disposed in the slide groove along the axial direction of the inner tube assembly.

[0030] Furthermore, a first square boss is provided on the push-pull switch, and a square countersunk hole is provided on the rack, and the first square boss is embedded in the square countersunk hole so that the push-pull switch and the rack are interconnected.

[0031] Furthermore, a second square boss is provided on the slider, and the second square boss is embedded in the square countersunk hole so that the slider and the rack are interconnected.

[0032] Furthermore, the gear is a gear with a rotation damping function.

[0033] The technical solution of the present invention has the following advantages:

[0034] The ablation catheter provided by the present invention has a basket electrode assembly composed of multiple electrode arms extending from the distal end of the inner tube assembly and gathered at the distal end of the outer tube. The distal end of the inner tube assembly has a planar structure, so that after the inner tube assembly is connected to the distal end of the basket electrode assembly, a planar end is formed at the distal end of the ablation catheter. Compared with the ablation catheter in the prior art, since the distal end of the ablation catheter is a planar end, during the treatment process, when the ablation catheter enters the heart cavity, the risk of the tip of the ablation catheter puncturing the inner wall of the heart cavity can be reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0036] Figure 1 Schematic diagram of an ablation catheter in an embodiment of the present invention;

[0037] Figure 2 Schematic diagram of the basket electrode assembly in the ablation catheter in an embodiment of the present invention;

[0038] Figure 3 Schematic diagram of the inner tube assembly in the ablation catheter in an embodiment of the present invention;

[0039] Figure 4 Schematic diagram of the inner tube assembly in the ablation catheter in another embodiment of the present invention;

[0040] Figure 5 For Figure 2 Cross-sectional view taken along line A-A in

[0041] Figure 6 For Figure 2 Schematic enlarged view of the partial structure of

[0042] Figure 7 Top view of the ablation catheter in yet another embodiment of the present invention;

[0043] Figure 8 Schematic diagram of the control handle in the ablation catheter in an embodiment of the present invention.

[0044] Explanation of reference numerals:

[0045] 1. Outer tube; 2. Basket electrode assembly; 3. Electrode arm; 4. Inner tube assembly; 5. Flat end; 6. Inner tube connector; 7. Inner tube; 8. Flat part; 9. Tubular part; 10. Loading tube; 11. Electrode ring; 12. Magnetic positioning sensor; 13. Electrode layer; 14. First insulating layer; 15. Metal skeleton layer; 16. Second insulating layer; 17. Skirt; 18. Short electrode; 19. Long electrode; 20. Control handle; 21. Push-pull switch; 22. Slide block; 23. Slide rail; 24. Rack; 25. Gear; 26. Housing; 27. Assembly hole. Detailed embodiments

[0046] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0047] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0048] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0049] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0050] As Figure 1 、 Figure 2 shown, this embodiment provides an ablation catheter, including: an outer tube 1; an inner tube assembly 4, the proximal end of the inner tube assembly 4 is inserted into the outer tube 1 movably along the axial direction of the outer tube 1; a basket electrode assembly 2, including a plurality of electrode arms 3, the plurality of electrode arms 3 extend from the distal end of the inner tube assembly 4 and converge at the distal end of the outer tube 1. The distal end of the inner tube assembly 4 has a planar structure, so that after the distal end of the inner tube assembly 4 is connected to the distal end of the basket electrode assembly 2, a planar end 5 is formed at the distal end of the basket electrode assembly 2.

[0051] The ablation catheter provided in this embodiment has a basket electrode assembly 2, where multiple electrode arms 3 extend from the distal end of the inner tube assembly 4 and converge at the distal end of the outer tube 1. The distal end of the inner tube assembly 4 has a planar structure, so that after the distal end of the inner tube assembly 4 is connected to the distal end of the basket electrode assembly 2, a planar end 5 is formed at the distal end of the basket electrode assembly 2. Compared with the ablation catheters in the prior art, since the distal end of the ablation catheter is the planar end 5, during the treatment process, when the ablation catheter enters the heart cavity, the risk of the distal end of the ablation catheter puncturing the inner wall of the heart cavity can be reduced.

[0052] Among them, the multiple electrode arms 3 are of an integral structure formed by cutting a whole flexible electrode, and in the natural state, the multiple electrode arms 3 as a whole are in a structure that diverges from the center outwards. For example, the multiple electrode arms 3 as a whole can be in a petal shape. For example, the distal ends of the multiple electrode arms 3 are connected, and the connected area has a certain size, while the proximal ends diverge towards the surroundings. During use, an assembly hole 27 can be provided at the center of the connected area at the distal ends of the multiple electrode arms 3 to facilitate connection with the inner tube assembly 4. The proximal ends of the multiple electrode arms 3 can be fixedly connected to the outer tube 1. With such a setting, compared with a basket electrode assembly formed by using a single electrode arm and performing a similar coupling method at the distal end as at the proximal end, the overall strength of this basket electrode assembly is higher, and moreover, the deformations generated by each electrode arm 3 after being stressed are consistent, which can make the coordination among the electrode arms 3 of the entire basket electrode assembly 2 better.

[0053] As Figure 3 shown, specifically, the inner tube assembly 4 includes an inner tube connector 6 and an inner tube 7; an assembly hole 27 is provided at the central position of the distal end of the basket electrode assembly 2; the inner tube connector 6 is in an overall T-shaped structure, and the inner tube connector 6 is inserted into the assembly hole 27 along the direction from the distal end to the proximal end of the basket electrode assembly 2; the inner tube 7 is inserted into the inner tube connector 6 along the direction from the proximal end to the distal end of the inner tube connector 6 and is fixedly connected to the inner tube connector 6; the proximal end of the inner tube 7 is inserted into the outer tube 1 in a manner that can move along the axial direction of the outer tube 1.

[0054] As Figure 3As shown, in one embodiment, the inner tube connector 6 includes a planar portion 8 and a tubular portion 9. For example, the planar portion 8 can be a circular flat plate. The planar portion 8 and the tubular portion 9 can be made by an integral molding process, or the planar portion 8 and the tubular portion 9 can be bonded together. The planar portion 8 is located on the distal side of the assembly hole 27. The outer diameter of the planar portion 8 can be greater than the inner diameter of the assembly hole 27, and the outer diameter of the tubular portion 9 can be less than the inner diameter of the assembly hole 27. The planar portion 8 is in contact with and bonded to the outer edge of the assembly hole 27 so that when the entire inner tube connector 6 moves, it can drive the distal end of the basket electrode assembly 2 to move synchronously. The tubular portion 9 is inserted into the assembly hole 27 along the direction from the distal end to the proximal end of the basket electrode assembly 2; the inner tube 7 is inserted into the tubular portion 9 along the direction from the proximal end to the distal end of the tubular portion 9 and is fixedly connected to the tubular portion 9. The proximal end of the inner tube 7 is inserted into the outer tube 1 in a manner that can move along the axial direction of the outer tube 1. For example, the distal end of the inner tube 7 can be fixedly connected to the tubular portion 9 by brazing or an adhesive. For example, a coagulant can be added within the interval from the distal end of the inner tube 7 to the distal end of the planar portion 8 to bond the inner tube 7 and the inner tube connector 6 into one body, so that when the inner tube 7 is pulled, it can drive the inner tube connector 6 to move synchronously.

[0055] As Figure 4 As shown, in another embodiment, the inner tube connector 6 includes a planar portion 8 and a tubular portion 9. For example, the planar portion 8 can be a circular flat plate. A loading tube 10 is provided on the surface of the planar portion 8 facing the tubular portion 9. The outer diameter of the loading tube 10 can be less than the inner diameter of the assembly hole 27. The loading tube 10 is inserted into the assembly hole 27 along the direction from the distal end to the proximal end of the basket electrode assembly 2. The outer diameter of the planar portion 8 can be greater than the inner diameter of the assembly hole 27, and the planar portion 8 is in contact with the outer edge at the assembly hole 27. External threads are provided on the outer circumference of the loading tube 10, and internal threads are provided on the inner side wall of the lumen of the tubular portion 9. The loading tube 10 is inserted into the lumen of the tubular portion 9 and the two are connected by threads. The outer diameter of the tubular portion 9 can be greater than the inner diameter of the assembly hole 27. The distal end surface of the tubular portion 9 is in contact with the inner edge at the assembly hole 27 to cooperate with the planar portion 8 to clamp the basket electrode assembly 2 so that when the entire inner tube connector 6 moves, it can drive the distal end of the basket electrode assembly 2 to move synchronously. The inner tube 7 is inserted into the tubular portion 9 along the direction from the proximal end to the distal end of the tubular portion 9 and is fixedly connected to the tubular portion 9. The proximal end of the inner tube 7 is inserted into the outer tube 1 in a manner that can move along the axial direction of the outer tube 1.

[0056] For example, the planar portion 8 and the tubular portion 9 can be coaxially arranged to ensure that the coaxiality of the inner tube connector 6 and the assembly hole meets the requirements during assembly. The distal end of the inner tube 7 does not exceed the planar portion 8, and the coaxiality of the inner tube 7 and the tubular portion 9 meets the requirements during assembly. In this arrangement, the planar portion 8 is located at the distal end of the basket electrode assembly 2, so that the distal end of the entire ablation catheter is a planar end 5, which can reduce the risk of puncturing the inner wall of the heart compared to the distal cap in the prior art. Moreover, since the distal end of the inner tube 7 does not exceed the planar portion 8, when adjusting the degree of contraction of the basket electrode assembly 2 through the inner tube 7, it can also prevent the inner tube 7 from puncturing the inner wall of the heart due to outward bulging.

[0057] The ablation catheter further includes an electrode ring 11 and a magnetic positioning sensor 12, wherein the electrode ring 11 is arranged on the outer peripheral surface of the tubular portion 9; the magnetic positioning sensor 12 is located in the lumen of the inner tube 7 or the tubular portion 9; or the magnetic positioning sensor 12 is located in the lumen formed by the tubular portion 9 and the loading tube 10. Compared with arranging the magnetic positioning sensor 12 on the outside of the tubular portion 9, such an arrangement can make the outer diameter of the entire tubular portion 9 smaller, which is conducive to miniaturization and convenient for use in the body.

[0058] like Figure 5 , Figure 6 As shown, the electrode arm 3 includes an electrode layer 13, a first insulating layer 14, a metal skeleton layer 15 and a second insulating layer 16 stacked from top to bottom; the first insulating layer 14 insulates the electrode layer 13 from the metal skeleton layer 15; the second insulating layer 16 is used to insulate the side of the metal skeleton layer 15 away from the first insulating layer 14.

[0059] Among them, the edges of the first insulating layer 14 and the second insulating layer 16 can contact each other to completely cover the metal skeleton layer 15. Among them, the direction from top to bottom of the planar flexible electrode corresponds to the direction from outside to inside of the planar flexible electrode, the direction close to the inner tube 7 is the inner side, and the direction away from the inner tube 7 is the outer side. For example, along the width direction of the metal skeleton layer 15, the edges of the first insulating layer 14 and the second insulating layer 16 can be bonded and connected to wrap the metal skeleton layer 15 inside. For example, the first insulating layer 14 and the second insulating layer 16 are both made of materials with insulating properties. For example, the second insulating layer 16 can be an insulating film. With such a configuration, the risk of discharge short circuit between electrodes can be significantly reduced.

[0060] The electrode layer 13, the first insulating layer 14 and the metal skeleton layer 15 are all centrally distributed relative to the second insulating layer 16; the widths of the electrode layer 13 and the metal skeleton layer 15 are both smaller than the width of the first insulating layer 14. This arrangement can avoid arcing.

[0061] Wherein, along the length direction of the electrode arm 3, the length of the metal framework layer 15 can be less than the length of the first insulating layer.

[0062] Wherein, a groove is provided on the surface of the second insulating layer 16 facing the metal framework layer 15, and at least a part of the metal framework layer 15 is embedded in the groove along the thickness direction of the electrode arm 3. For example, the metal framework layer 15 can be entirely embedded in the groove, so that the surface of the metal framework layer 15 facing the first insulating layer 14 is flush with the surface of the second insulating layer 16 facing the first insulating layer 14. With such a setting, the metal framework layer 15 is entirely embedded in the second insulating layer 16, which can achieve the best effect of completely insulating the metal framework layer 15, and can also make the structure of the entire electrode arm 3 more compact and the thickness smaller.

[0063] Wherein, along the width direction of the electrode arm 3, the thicknesses of the two edges of the second insulating layer 16 can be less than the thickness in the middle. There are skirt edges 17 provided on both sides of the second insulating layer 16, and the outer edges of the skirt edges 17 extend beyond the edges of the first insulating layer 14 along the width direction of the first insulating layer 14. For example, the width of the second insulating layer 16 can be greater than the width of the first insulating layer 14, and the extra width of the second insulating layer 16 compared to the first insulating layer 14 can form the skirt edges 17. For example, the skirt edges 17 can be rectangular skirt edges 17 or arc-shaped skirt edges 17. With such a setting, while realizing the insulating function of the entire electrode arm, the skirt edges 17 are formed by the second insulating layer, so that the electrode arm 3 has soft boundary parts, and the risk of the electrode arm 3 scratching the endocardium and vascular intima during the ablation catheter discharge treatment and the access process can be reduced, and the tissue apposition is safer and friendlier.

[0064] Wherein, the maximum width of the skirt edge 17 is less than the width difference between the edge of the electrode layer 13 and the edge of the first insulating layer 14. As Figure 5 shown, the minimum width of the skirt edge 17 is denoted as a, and the width difference between the edge of the electrode layer 13 and the edge of the first insulating layer 14 is denoted as b, then a is less than b. With such a setting, during the process of entering the delivery channel, it is prevented that the skirt edge 17 folds due to being too wide, resulting in the skirt edge 17 not being in place after being delivered, and covering the electrode layer 13 and affecting the ablation effect.

[0065] Among them, at least a part of the metal skeleton layer 15 is embedded in the second insulating layer 16. For example, a groove adapted to the size and shape of the metal skeleton layer 15 can be provided on the second insulating layer 16, so that the metal skeleton layer 15 is completely embedded in the groove, and the upper surface of the metal skeleton layer 15 can be flush with the upper surface of the second insulating layer 16. For example, the thickness of the two edges of the second insulating layer 16 can be smaller than the middle thickness, and the thicker middle area can be used to embed the metal skeleton layer 15, and the thinner areas on both sides can be used as skirt edges 17.

[0066] Among them, a plurality of the electrode layers 13 are arranged along the length direction of the first insulating layer 14, and the plurality of electrode layers 13 are arranged in an equidistant and equal-length split arrangement. For example, each electrode layer 13 can be independently connected to a connector through its internal circuit.

[0067] As Figure 7 shown, among them, a plurality of the electrode layers 13 are arranged along the length direction of the first insulating layer 14, and at least one long electrode 19 and at least one short electrode 18 are included in the plurality of electrode layers 13; the long electrodes 19 and the short electrodes 18 are arranged in a split arrangement. For example, the distance between the long electrode 19 and the short electrode 18 can be equal or unequal.

[0068] Among them, at least one of the short electrodes 18 is embedded in the long electrode 19. For example, one or more short electrodes 18 can be embedded in a certain long electrode 19. With such a setting, since the short electrode 18 and the long electrode 19 are isolated from each other and not connected, within the limited area of the electrode arm 3, the short electrode 18 is embedded inside the long electrode 19, which can make the area of the long electrode 19 the largest and the ablation effect better.

[0069] Among them, the surface of the metal skeleton layer 15 is gold-plated, and the thickness range of the gold plating is 0.2 μmm - 1 μmm. For example, the thickness of the gold plating can be 0.2 μmm, or 0.5 μmm, or 1 μmm, and the gold plating thickness can be designed according to actual needs. With such a setting, the imaging effect of the metal skeleton layer 15 under X-rays can be enhanced.

[0070] For example, the metal skeleton layer 15 can be cut from a shape memory metal sheet. For example, the metal skeleton layer 15 can also be integrally formed by spinning a planar high-toughness metal, so that the coordination of the electrode arm during expansion and contraction deformation is higher.

[0071] As Figure 8As shown in the figure, the ablation catheter further includes a control handle 20; the control handle 20 includes a housing 26, a push-pull switch 21, and a transmission and guiding mechanism disposed in the housing 26. The transmission and guiding mechanism includes a slide rail 23, a slider 22, a rack 24, and a gear 25; the slider 22 is slidably disposed on the slide rail 23 along the length direction of the control handle 20; the proximal end of the outer tube 1 is connected to the distal end of the housing 26; the proximal end of the inner tube 7 extends into the housing 26 and is connected to the slider 22; the rack 24 is meshed with the gear 25, and the rack 24 is connected to the slider 22; the operating end of the push-pull switch 21 is located outside the housing 26, and the actuating end of the push-pull switch 21 is connected to the rack 24; by toggling the push-pull switch 21, the basket electrode assembly 2 is controlled to close or open. For example, a card slot can be provided on the slider 22, and the inner tube 7 is snapped into the card slot to connect the two together. For example, a chute can be provided in the slide rail 23, and the chute can be a T-shaped groove, and the slider 22 can linearly slide along the axial direction of the inner tube in the chute. For example, the push-pull switch 21 can include a first square boss, and a square counterbore can be provided at the corresponding position on the rack 24. The first square boss is embedded in the square counterbore to interconnect the rack 24 and the push-pull switch 21. For example, the slider 22 can include a second square boss, and the second square boss can be embedded in the square counterbore on the rack 24 to interconnect the slider 22 and the rack 24. For example, the gear 25 can be a gear with a rotational damping function. During use, when the push-pull switch 21 is pushed forward, the push switch drives the slider 22 to slide forward, and the slider 22 then drives the inner tube 7 to move forward, so that the basket electrode assembly 2 closes. On the contrary, when the push-pull switch 21 is pushed backward, the push switch drives the slider 22 to slide backward, and the slider 22 then drives the inner tube 7 to move backward, so that the basket electrode assembly 2 opens. Since the gear 25 is a gear with a rotational damping function, there will be a certain resistance when the gear 25 rotates. When the rack 24 makes a linear motion, it drives the gear 25 to rotate. Therefore, the linear motion of the rack 24 also has a certain resistance. During use, the gear 25 and the rack 24 can stay at any position, and the corresponding basket electrode assembly 2 can be stably in its corresponding opened state without being deformed by other acting forces, which can enhance the stability of any opened state of the basket electrode assembly 2 and enable the gear to infinitely adjust the shape of the opened basket electrode assembly 2.

[0072] In summary, the ablation catheter in the present application has a planar end 5. In addition, the metal skeleton layer 15 is integrally formed by spinning a planar high-toughness metal, and the coordination of the expansion and contraction deformation between the electrode arms 3 is higher.

[0073] In the ablation catheter of the present application, the high-toughness metal skeleton layer 15 is entirely surrounded by upper and lower layers of polymer insulating materials with edge pressing, and the metal skeleton layer 15 has good insulation.

[0074] The ablation catheter in this application, with the second insulating layer 16 having a skirt 17, is safer and more user-friendly for tissue contact.

[0075] In the ablation catheter of this application, the inner tube 7, the push-pull switch 21, the rack 24, and the positioning torque gear 25 can enhance the stability of any open form of the basket electrode assembly 2.

[0076] Obviously, the above embodiments are only examples for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all implementation manners here. And the obvious changes or modifications derived therefrom are still within the protection scope of the present invention.

Claims

1. An ablation catheter, characterized in that, Comprising: An outer tube (1); An inner tube assembly (4), the proximal end of the inner tube assembly (4) being inserted movably along the axial direction of the outer tube (1) within the outer tube (1); A basket electrode assembly (2), including a plurality of electrode arms (3), the plurality of electrode arms (3) extending from the distal end of the inner tube assembly (4) and converging at the distal end of the outer tube (1); The distal end of the inner tube assembly (4) has a planar structure, such that after the distal end of the inner tube assembly (4) is connected to the basket electrode assembly (2), a planar tip (5) is formed at the distal end of the ablation catheter.

2. The ablation catheter according to claim 1, wherein The plurality of electrode arms (3) are of an integral structure formed by cutting a whole flexible electrode, and in a natural state, the plurality of electrode arms (3) as a whole have a structure that diverges outward from the center.

3. The ablation catheter according to claim 1, wherein The inner tube assembly (4) includes an inner tube connector (6) and an inner tube (7); An assembly hole (27) is provided at the central position of the distal end of the basket electrode assembly (2); The inner tube connector (6) is integrally in a T-shaped structure, and the inner tube connector (6) is inserted in the assembly hole (27) along the direction from the distal end to the proximal end of the basket electrode assembly (2); The inner tube (7) is inserted in the inner tube connector (6) along the direction from the proximal end to the distal end of the inner tube connector (6) and is fixedly connected to the inner tube connector (6); the proximal end of the inner tube (7) is inserted movably along the axial direction of the outer tube (1) within the outer tube (1).

4. The ablation catheter according to claim 3, wherein The inner tube connector (6) includes a planar portion (8) and a tubular portion (9), the planar portion (8) is in contact with and bonded to the outer edge of the assembly hole (27), and the tubular portion (9) is inserted in the assembly hole (27) along the direction from the distal end to the proximal end of the basket electrode assembly (2); The inner tube (7) is inserted in the tubular portion (9) along the direction from the proximal end to the distal end of the tubular portion (9) and is fixedly connected to the tubular portion (9), the proximal end of the inner tube (7) is inserted movably along the axial direction of the outer tube (1) within the outer tube (1).

5. The ablation catheter according to claim 3, wherein The inner tube connector (6) includes a planar portion (8) and a tubular portion (9). A loading tube (10) is disposed on a surface of the planar portion (8) facing the tubular portion (9). The loading tube (10) is inserted into the assembly hole (27) along a direction from the distal end to the proximal end of the basket electrode assembly (2). The planar portion (8) is in contact with an outer edge at the assembly hole (27). An external thread is provided on an outer circumference of the loading tube (10), and an internal thread is provided on an inner side wall of a lumen of the tubular portion (9). The loading tube (10) is inserted into the lumen of the tubular portion (9) and the two are connected by threads. A distal end surface of the tubular portion (9) is in contact with an inner edge at the assembly hole (27) to cooperate with the planar portion (8) to clamp the basket electrode assembly (2). The inner tube (7) is inserted into the tubular portion (9) along a direction from the proximal end to the distal end of the tubular portion (9) and is fixedly connected to the tubular portion (9). A proximal end of the inner tube (7) is inserted into the outer tube (1) movably along an axial direction of the outer tube (1).

6. The ablation catheter according to claim 4 or 5, wherein it further includes an electrode ring (11) and a magnetic positioning sensor (12). The electrode ring (11) is disposed on an outer circumferential surface of the tubular portion (9). The magnetic positioning sensor (12) is located in a lumen of the inner tube (7) or the tubular portion (9). Or the magnetic positioning sensor (12) is located in a lumen formed by the cooperation of the tubular portion (9) and the loading tube (10).

7. The ablation catheter according to claim 1, wherein the electrode arm (3) includes an electrode layer (13), a first insulating layer (14), a metal skeleton layer (15), and a second insulating layer (16) which are stacked from top to bottom; the first insulating layer (14) is used for insulating and isolating the electrode layer (13) from the metal skeleton layer (15); the second insulating layer (16) is used for insulating and isolating a surface of the metal skeleton layer (15) away from the first insulating layer (14).

8. The ablation catheter according to claim 7, wherein edges of the first insulating layer (14) and the second insulating layer (16) are in contact to completely wrap the metal skeleton layer (15) therein.

9. The ablation catheter according to claim 7, wherein the electrode layer (13), the first insulating layer (14), and the metal skeleton layer (15) are all centered relative to the second insulating layer (16).

10. The ablation catheter according to claim 7, wherein widths of the electrode layer (13) and the metal skeleton layer (15) are both smaller than a width of the first insulating layer (14).

11. The ablation catheter according to claim 7, wherein along a length direction of the electrode arm (3), a length of the metal skeleton layer (15) is smaller than a length of the first insulating layer (14).

12. The ablation catheter according to claim 7, wherein A groove is provided on one side of the second insulating layer (16) facing the metal skeleton layer (15), and the metal skeleton layer (15) is at least partially embedded in the groove along the thickness direction of the electrode arm (3).

13. The ablation catheter according to claim 12, characterized in that: The metal skeleton layer (15) is completely embedded in the groove so that a side of the metal skeleton layer (15) facing the first insulating layer (14) is flush with a side of the second insulating layer (16) facing the first insulating layer (14).

14. The ablation catheter according to claim 12, characterized in that: Along the width direction of the electrode arm (3), the thickness of the second insulating layer (16) at two edges is smaller than the thickness in the middle.

15. The ablation catheter according to claim 7, characterized in that: The second insulating layer (16) is provided with skirts (17) on both side edges, and the outer edges of the skirts (17) extend beyond the edges of the first insulating layer (14) along the width direction of the first insulating layer (14).

16. The ablation catheter according to claim 15, characterized in that: The skirt (17) is a rectangular skirt (17) or an arc-shaped skirt (17).

17. The ablation catheter according to claim 15, characterized in that: The maximum width of the skirt (17) is smaller than the width difference between the edge of the electrode layer (13) and the edge of the first insulating layer (14).

18. The ablation catheter according to claim 7, characterized in that: A plurality of the electrode layers (13) are arranged along the length direction of the first insulating layer (14), and the plurality of the electrode layers (13) are arranged in columns with equal distances and lengths.

19. The ablation catheter according to claim 7, characterized in that: A plurality of electrode layers (13) are arranged along the length direction of the first insulating layer (14), and the plurality of electrode layers (13) include at least one long electrode (19) and at least one short electrode (18); The long electrodes (19) and the short electrodes (18) are arranged in a column-like manner.

20. The ablation catheter according to claim 19, characterized in that: At least one of the short electrodes (18) is embedded in the long electrode (19).

21. The ablation catheter according to claim 1, characterized in that: Also includes a control handle (20); The control handle (20) comprises a housing (26), a push-pull switch (21), and a transmission guide mechanism arranged in the housing (26); The proximal end of the outer tube (1) is connected to the distal end of the housing (26); The proximal end of the inner tube assembly (4) extends into the housing (26) and is connected to the transmission guide mechanism; The operating end of the push-pull switch (21) is located outside the housing (26), and the execution end of the push-pull switch (21) is connected to the transmission guide mechanism; the basket electrode assembly (2) is controlled to be retracted or opened by toggling the push-pull switch (21).

22. The ablation catheter according to claim 21, characterized in that: The transmission and guiding mechanism includes a slide rail (23), a slider (22), a rack (24), and a gear (25); The slider (22) is slidably arranged on the slide rail (23) along the length direction of the control handle (20); The proximal end of the inner tube assembly (4) extends into the housing (26) and is connected to the slider (22); The gear (25) is rotatably arranged about its own axis in the housing (26), the rack (24) is meshed with the gear (25), and the rack (24) is connected to the slider (22); The execution end of the push-pull switch (21) is connected to the rack (24).

23. The ablation catheter according to claim 22, wherein A clamping groove is provided on the slider (22), and the proximal end of the inner tube assembly is clamped into the clamping groove so that the proximal end of the inner tube assembly is connected to the slider (22).

24. The ablation catheter according to claim 22, wherein A sliding groove is provided on the slide rail (23), and the slider (22) is slidably arranged linearly in the sliding groove along the axial direction of the inner tube assembly.

25. The ablation catheter according to claim 22, wherein A first square boss is provided on the push-pull switch (21), a square counterbore is provided on the rack (24), and the first square boss is embedded in the square counterbore so that the push-pull switch (21) and the rack (24) are interconnected.

26. The ablation catheter according to claim 25, wherein A second square boss is provided on the slider (22), and the second square boss is embedded in the square counterbore so that the slider (22) and the rack (24) are interconnected.

27. The ablation catheter according to claim 23, wherein The gear (25) is a gear with a rotational damping function.

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