Reticular head end with variable form and electrode catheter thereof

Abstract

The invention relates to the field of medical electrophysiology mapping and ablation catheters, in particular to a net-shaped head end with a variable shape and an electrode catheter of the net-shaped head end. The net-shaped head end is formed by combining adjacent electrode arms at a far-end combining section or a near-end combining section, arranging a near-end electrode and a far-end electrode at the combining position of the adjacent electrode arms, and conducting electrode connection on the near-end electrode and the far-end electrode. The near-end electrode and the far-end electrode are distributed in a staggered mode in space, the net-shaped head end generates overall deformation in a stress state, the net-shaped head end can be used in different positions in a shape-adaptive mode by changing the shape of the net-shaped head end structure, and when a flower-shaped structure is formed at the net-shaped head end, the near-end electrode and the far-end electrode can complement each other to form a complete and uniform ablation band. When the net-shaped head end shrinks, the sheath entering size is controlled to the maximum extent; according to the electrode catheter, the net-shaped head end is adopted, the electrode catheter can be adapted to electrophysiological signal collection or ablation at different positions, the integrity of an ablation band can be ensured, the recurrence probability of atrial fibrillation can be reduced, and the hemolysis risk can be reduced.

Description

Technical Field

[0001] The invention relates to the field of medical electrophysiological mapping and ablation catheters, and in particular to a mesh head end with a variable shape and an electrode catheter thereof. Background Art

[0002] Pulmonary vein isolation is a common surgical treatment for atrial fibrillation. In recent years, high-voltage pulsed field ablation (PFA) has been widely used in catheter ablation for pulmonary vein isolation because its high-voltage pulsed electric field energy can selectively damage myocardial cells with a lower voltage threshold without harming vascular smooth muscle cells and nerve cells with a higher voltage threshold. It is safer to perform ablation near blood vessels and nerves, and has the characteristics of fast ablation time and high efficiency.

[0003] During high-voltage pulse electric field ablation, the electric field around the electrode decays exponentially with distance. Good contact between the electrode and tissue is conducive to improving the ablation effect and increasing the ablation depth. However, the isolation of the pulmonary veins may involve ablation inside the pulmonary veins (tubular), at the pulmonary vein orifices (trumpet-shaped), and at the pulmonary vein vestibule (large ring). The ablation areas vary in size and shape. It is difficult for existing catheters to conform to all these areas at the same time and achieve stable contact, resulting in uneven ablation effects. At the same time, most of the existing catheters can only achieve partially continuous ablation zones or form intermittent ablation areas around the tubes, and cannot ensure the ablation range at the same time. The circumference is adjustable and the ablation zone is completely closed. If the catheter is rotated for supplementary ablation, because the heart is beating, it is difficult to observe the model with the naked eye and accurately control the rotation of the catheter electrode within a few millimeters, resulting in the inability to perfectly fit the electrode with the gap. Currently, the operator generally needs to manually adjust the catheter position with the assistance of a three-dimensional mapping system to perform multiple inaccurate superimposed ablations. The ablation zone formed before and after such adjustment may be of varying depths, and an ablation gap may also appear. Once there is incomplete ablation, the risk of postoperative recurrence of atrial fibrillation may increase, and multiple inaccurate ablations may also increase the risk of hemolysis. Summary of the invention

[0004] The purpose of the present invention is to overcome the shortcomings of the prior art that the existing catheters cannot conform to different positions at the same time and form a continuous ablation zone, and to provide a mesh head end with a variable shape and an electrode catheter thereof.

[0005] In a first aspect, the present invention provides a mesh headend with a variable shape, comprising: An even number of electrode arms, all of which form a distal joint portion and a proximal joint portion in space, all of which are distributed around a line connecting the distal joint portion and the proximal joint portion, each of which is provided with a distal joint section and a proximal joint section, and adjacent electrode arms are joined at the distal joint section or the proximal joint section; A plurality of proximal electrodes and a plurality of distal electrodes, wherein the proximal electrodes are arranged at the joints of the adjacent electrode arms at the proximal joint section, and the distal electrodes are arranged at the joints of the adjacent electrode arms at the distal joint section; The distal joint portion can be close to the proximal joint portion along the connection line, so that all the electrode arms form a flower-shaped structure in space, and all the distal electrodes and all the proximal electrodes can be staggered around the connection line on the same conical surface or plane.

[0006] The present invention provides a mesh head end with a variable shape. By combining adjacent electrode arms at a distal joint section or a proximal joint section, a mesh head end structure that can produce an overall deformation under stress is formed. The spacing between the electrodes is relatively stable, the stress is more balanced, and the mesh head end can better fit the tissue, so that the ablation effect is stable and uniform. By adjusting the distal joint part and the proximal joint part to be relatively close or far apart, the shape of the mesh head end structure can be changed, so that the mesh head end can be adapted to electrophysiological signal collection or ablation at different positions. By arranging the proximal electrode and the distal electrode at the junction of adjacent electrode arms and distributing the proximal electrode and the distal electrode in a staggered manner in the direction of the connection, the proximal electrode and the distal electrode can complement each other when forming a flower-shaped structure to form a complete and uniform ablation zone, and when the mesh head end contracts, the sheath size can be controlled to the greatest extent.

[0007] Preferably, the flower-shaped structure can form an annular ablation zone or a circular ablation zone.

[0008] Preferably, when the distal joint portion approaches or moves away from the proximal joint portion, all the electrode arms form a spindle-shaped basket structure in space, all the proximal electrodes form a proximal electrode ring, and all the distal electrodes form a distal electrode ring. All the proximal electrodes are located on the same conical surface or plane to form a proximal electrode ring, and all the distal electrodes are located on the same conical surface or plane to form a distal electrode ring.

[0009] Preferably, the proximal electrode sleeve is arranged at the joint of the adjacent electrode arms at the proximal joint section, and the distal electrode sleeve is arranged at the joint of the adjacent electrode arms at the distal joint section, so that the proximal electrode and the distal electrode are stably arranged at the joint of the adjacent electrode arms.

[0010] Preferably, the electrode arm includes a support arm and an outer tube, the support arm is inserted into the outer tube, the support arm is an alloy metal or elastic material structural part, and the outer tube is a polymer material structural part; when the support arm is made of metal material, an insulating layer is provided between the support arm and the outer tube.

[0011] Preferably, a lumen channel is provided in the electrode arm, the proximal electrode is connected to a first wire, the distal electrode is connected to a second wire, and the first wire and the second wire are respectively extended along different lumen channels, so that short circuit or breakdown is not likely to occur between the electrodes or electrode wires.

[0012] Preferably, the first wire and the second wire are respectively extended along the lumen channels of different electrode arms, so as to minimize the probability of short circuit or breakdown between electrodes.

[0013] Preferably, the proximal electrode and the distal electrode have different polarities. When the flower-shaped structure is formed, the proximal electrode and the distal electrode can discharge each other, thereby increasing the area of ​​the continuous annular ablation zone or circular ablation.

[0014] Preferably, the proximal electrode and the distal electrode can be respectively set as discharge electrodes. When the mesh head is made into a spindle basket shape, the distal electrode and the proximal electrode can be independently set to form different ablation rings.

[0015] In a second aspect, the present invention provides an electrode catheter, comprising a handle, a distal tube body, a proximal tube body and a mesh head end with a variable shape as described above, which are arranged in sequence, the distal tube body is an adjustable bending section, the handle is provided with a first control mechanism and a second control mechanism, the first control mechanism is connected to the distal joint via a first traction member, the first control mechanism is used to control the distal joint to be close to or away from the proximal joint, and the second control mechanism is used to control the bending of the distal tube body.

[0016] An electrode catheter of the present invention, by adopting the above-mentioned variable-shape mesh head end, is easy and stable to operate, and can be adapted to electrophysiological signal collection or ablation at different positions. It can be adapted to the openings of blood vessels with smaller diameters or deeper areas in blood vessels when it is in a spindle-shaped basket-mesh shape, and can be adapted to the openings of blood vessels with larger diameters or areas that are approximately flat when it is in a flower-shaped shape. It can also ensure the integrity of the ablation zone, which is beneficial to reducing the probability of recurrence of atrial fibrillation and reducing the risk of hemolysis.

[0017] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention provides a mesh head end with a variable shape, which forms a mesh head end structure capable of producing overall deformation under stress by combining adjacent electrode arms at the distal joint section or the proximal joint section, so as to make the spacing between electrodes relatively stable, the stress more balanced, and the head end better fitted with tissues, so as to make the ablation effect stable and uniform; 2. The present invention provides a mesh head end with a variable shape. By adjusting the distal joint part and the proximal joint part to be relatively close or far away, the shape of the mesh head end structure can be changed, so that the mesh head end can be used in different positions; 3. The present invention provides a mesh head with a variable shape, by arranging the proximal electrode and the distal electrode at the junction of adjacent electrode arms, and distributing the proximal electrode and the distal electrode in a staggered manner in the direction of the connection line, so that when forming a flower-shaped structure, the proximal electrode and the distal electrode complement each other to form a complete and uniform ablation zone; 4. The present invention provides a mesh head end with a variable shape, which can control the sheath size to the greatest extent when the mesh head end is contracted by arranging the proximal electrode and the distal electrode at the junction of adjacent electrode arms; 5. The present invention provides an electrode catheter, which adopts the above-mentioned variable-shape mesh head end, is easy and stable to operate, and can be adapted to electrophysiological signal collection or ablation at different positions. It can be adapted to the openings of blood vessels with smaller diameters or deeper areas in blood vessels when it is in a spindle-shaped basket-mesh shape, and can be adapted to the openings of larger blood vessels or nearly flat areas when it is in a flower-shaped shape. It can also ensure the integrity of the ablation zone, which is beneficial to reducing the probability of recurrence of atrial fibrillation and reducing the risk of hemolysis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic structural diagram of a mesh head end (spindle-shaped) with a variable shape according to Example 1; Figure 2 It is a schematic diagram of a mesh head end (spindle-shaped) with a variable shape matching with a blood vessel in Example 1; Figure 3 is a front view of the electrode arm described in Example 1; Figure 4 is a side view of the electrode arm described in Example 1; Figure 5 is a cross-sectional view of the electrode arm described in Example 1; Figure 6 This is a schematic structural diagram of a mesh head end (flower shape) with a variable shape according to Example 1; Figure 7 It is a schematic diagram of a mesh head end (flower shape) with a variable shape abutting against a blood vessel opening in Example 1; Figure 8 A schematic diagram of a mesh head with a variable shape forming an annular ablation zone in Example 1; Fig. 9 A schematic diagram of a mesh head with a variable shape forming a circular ablation zone in Example 1; Fig.10 This is a schematic diagram of the structure of an electrode catheter in Example 2.

[0019] Markings in the figure: 1-electrode arm, 11-distal joint section, 12-proximal joint section, 13-support arm, 14-outer tube, 15-lumen channel, 1a-first ridge, 1b-second ridge, 1c-third ridge, 1d-fourth ridge, 1e-fifth ridge, 1f-sixth ridge, 1g-seventh ridge, 1h-eighth ridge, 2-distal joint part, 3-proximal joint part, 4-proximal electrode, 5-distal electrode, 6-annular ablation band, 7-circular ablation band, 8-handle, 81-distal tube body, 82-proximal tube body, 83-first control mechanism, 84-second control mechanism, 85-first traction member. DETAILED DESCRIPTION

[0020] The present invention is further described in detail below in conjunction with specific embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following embodiments, and all technologies realized based on the content of the present invention belong to the scope of the present invention.

[0021] Unless otherwise specified, in the description of the specific embodiments of the present invention, the terms indicating the orientation or position relationship such as "up", "down", "left", "right", "center", "inside", "outside", etc. are all expressions based on the orientation or position relationship shown in the drawings, or are the orientation or position relationship when the invented product / equipment / device is usually used. These terms of orientation or position relationship are only for the convenience of describing the scheme of the present invention or simplifying the description in the specific embodiments, so as to facilitate the technicians to quickly understand the scheme, and do not indicate or imply that a specific device / component / element must have a specific orientation, or be constructed and operated in a specific position relationship, and therefore cannot be understood as a limitation on the present invention.

[0022] In addition, if the terms "horizontal", "vertical", "overhanging", "parallel" and the like appear, it does not mean that the corresponding devices / components / elements are required to be absolutely horizontal or vertical or overhanging or parallel, but may be slightly tilted or have deviations. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but may be slightly tilted. Alternatively, it can be simplified to mean that the corresponding devices / components / elements are set in directions such as "horizontal", "vertical", "overhanging", "parallel", etc., and can have an error / deviation of ±10% relative to the corresponding direction setting, more preferably an error / deviation within ±8%, more preferably an error / deviation within ±6%, more preferably an error / deviation within ±5%, and more preferably an error / deviation within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its role in the scheme of the present invention.

[0023] In addition, the expressions “first”, “second”, “third”, etc., which appear in the terms, are merely used to distinguish the description of the same or similar components and should not be understood as emphasizing or implying the relative importance of specific components.

[0024] In addition, in the description of the embodiments of the present invention, "several", "plurality" and "a number" represent at least 2. It can be any number such as 2, 3, 4, 5, 6, 7, 8, 9, and even more than 9.

[0025] In addition, in the description of the technical solution of the present invention, unless otherwise clearly specified / defined / restricted, the terms "set", "install", "connect", "connected", "provided with", "laid", and "arranged" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection, and can be welding, riveting, bolting, threading, and other commonly used connection means in the field. This connection can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements.

[0026] Example 1 like Figure 1-Figure 10 As shown, a mesh head end with a variable shape includes an even number of electrode arms 1, a plurality of proximal electrodes 4 and a plurality of distal electrodes 5. Each electrode arm 1 is bent in space, one end close to the catheter body is called the proximal end, and the other end opposite is called the distal end. All electrode arms 1 are combined at both ends of their own axial direction to form a distal joint portion 2 and a proximal joint portion 3, respectively. All electrode arms 1 are distributed around the line connecting the distal joint portion 2 and the proximal joint portion 3. Each of the electrode arms 1 is provided with a distal joint section 11 and a proximal joint section 3. The connecting section 12, adjacent electrode arms 1 are connected at the distal connecting section 11 or the proximal connecting section 12, and electrodes are arranged at the connecting position, so that the proximal electrode 4 and the distal electrode 5 are staggered in the direction of the connection line. When in use, the distal connecting part 2 can approach the proximal connecting part 3 along the connection line, so that all electrode arms 1 are bent synchronously to form a flower-shaped structure in space. After the distal connecting part 2 is close to the proximal connecting part 3, all the distal electrodes 5 and all the proximal electrodes 4 can be staggered around the connection line on the same conical surface or plane.

[0027] In one or more embodiments, Figure 3-Figure 5 As shown, the electrode arm 1 includes a support arm 13 and an outer tube 14 , and the support arm 13 is inserted into the outer tube 14 .

[0028] In an optional embodiment, the support arm 13 may be an alloy metal or elastic material structural member, and may be a soft, highly elastic material structural member, and specifically may be made of nickel-titanium alloy or other elastic materials.

[0029] In an optional embodiment, the outer tube 14 may be a polymer material structural member, specifically, may be made of polyurethane, PEBAX or other insulating materials.

[0030] In an optional implementation, when the support arm 13 is made of metal material, an insulating layer is provided between the support arm 13 and the outer tube 14 .

[0031] Specifically, the insulating layer may be an insulating coating applied on the surface of the support arm 13 , or an insulating tube additionally sleeved on the support arm 13 , so as to isolate any exposed parts that may be in conduction with the electrode or the electrode wire.

[0032] In one or more embodiments, the proximal electrode 4 is sleeved at the joint of the adjacent electrode arms 1 at the proximal joint section 12, and the distal electrode 5 is sleeved at the joint of the adjacent electrode arms 1 at the distal joint section 11. By sleeved, the proximal electrode 4 and the distal electrode 5 are stably arranged at the joint of the adjacent electrode arms 1, so that each electrode arm 1 is combined with each other to form a mesh head end structure. During the deformation process of the mesh head end, the position of each electrode can be stably controlled, so as to collect electrophysiological signals or send ablation energy to the tissue through each proximal electrode 4 and distal electrode 5.

[0033] Specifically, a mesh head end composed of eight electrode arms 1 is used as an example for explanation. Figure 1 As shown, the electrode arms 1 may be defined as the first ridge 1a, the second ridge 1b, the third ridge 1c, the fourth ridge 1d, the fifth ridge 1e, the sixth ridge 1f, the seventh ridge 1g and the eighth ridge 1h in sequence, and the proximal electrodes 4 are arranged at the proximal joint sections 12 of the adjacent electrode arms 1, so that the first ridge 1a and the second ridge 1b are combined with each other, the third ridge 1c and the fourth ridge 1d are combined with each other, the fifth ridge 1e and the sixth ridge 1f are combined with each other, and the seventh ridge 1g and the eighth ridge 1h are combined with each other. At the same time, the distal electrodes 5 are arranged at the distal joint section 11, so that the second ridge 1b The third ridge 1c is combined with each other, the fourth ridge 1d and the fifth ridge 1e are combined with each other, the sixth ridge 1f and the seventh ridge 1g are combined with each other, and the eighth ridge 1h and the first ridge 1a are combined with each other. In this way, a mesh head end structure is formed in which the proximal electrode 4 and the distal electrode 5 are staggered in the direction of the connection. This combination of electrode arms 1 can make the force on each electrode arm 1 relatively uniform, so that each electrode can be stably attached to the tissue. At the same time, the soft mesh structure can also enable the tissue to maintain its original shape to the greatest extent, and maintain the authenticity of the electrode acquisition model signal.

[0034] like Figure 1-Figure 2 As shown, in the initial state, the mesh head end has a spindle-shaped basket-shaped head end structure that is bulged in the middle and tightened at both ends. In the process of the distal joint 2 approaching or moving away from the proximal joint 3, it is deformed on the basis of the spindle-shaped basket-shaped shape; all proximal electrodes 4 are distributed on a surface at the same height relative to the extension direction of the connecting line to form a proximal electrode ring, and all distal electrodes 5 are distributed on a surface at the same height relative to the extension direction of the connecting line to form a distal electrode ring, so that the proximal electrode ring and the distal electrode ring are both conical in shape, expanding toward the middle.

[0035] like Figure 2 As shown, the distal electrode 5 in the initial state can be used to collect electrophysiological signals or ablate blood vessel openings with smaller diameters or deeper areas within blood vessels. The distal electrode ring can better adapt to the shape of the blood vessel opening, and the middle bulge part and the proximal part of the spindle-shaped basket-shaped mesh head can provide better support for the distal electrode 5, so that the distal electrode 5 is tightly attached to the tissue.

[0036] like Figure 6-Figure 7 As shown, the distance between the distal electrode 5 and the distal joint 2 is equal to the distance between the proximal electrode 4 and the proximal joint 3. When the distal joint 2 is as close to the proximal joint 3 as possible, the mesh head end becomes a flower shape, and the distal electrode 5 and the proximal electrode 4 are close to each other and appear at the same height of the same conical surface in an interlaced manner. At this time, the distal electrode 5 and the proximal electrode 4 are at the same distance relative to the overlapping position of the distal joint 2 and the proximal joint 3, and are located on the same circle with the overlapping position of the distal joint 2 and the proximal joint 3 as the center. The distal electrode 5 and the proximal electrode 4 complement each other, the electrode density is increased, the electrode coverage area is increased, and an electrode ring with a relatively small electrode spacing is formed. A continuous ablation zone can be formed between the electrodes to form a complete electrode surface, and the electrode arm 1 of the original basket-shaped middle bulge becomes the outer edge of the flower shape.

[0037] In one or several embodiments, the flower-shaped structure of the deformed mesh tip can form an annular ablation zone 6 or a circular ablation zone 7 .

[0038] In one or several embodiments, the proximal electrode 4 and the distal electrode 5 have different polarities and can form an electrode pair to discharge each other during the ablation process to form a ring-shaped high-voltage pulse electric field. The proximal and distal positive and negative electrodes are arranged separately, which can greatly reduce the risk of short circuit.

[0039] In an optional embodiment, the positive and negative definitions of the proximal electrode 4 and the distal electrode 5 may be non-fixed and may be set in a supporting device. In the case of a flower-shaped structure, the proximal electrode 4 and the distal electrode 5 may be set to different polarities so that the proximal electrode 4 and the distal electrode 5 can discharge each other to increase the diameter of the continuous annular ablation zone 6 or the area of ​​the circular ablation zone 7 formed; and in the case of a spindle-shaped basket shape, the distal electrode 5 may be selected as the discharge electrode so that the distal electrodes 5 discharge each other to form a small ablation ring, while the proximal electrode 4 does not discharge, so that by controlling the polarity of each electrode, an ablation ring adapted to different tissue parts is formed.

[0040] like Figure 7As shown, the flower-shaped mesh head can conform to the deformation of the tissue, and the cross-arranged electrode arms 1 cooperate with each other to provide support for the electrodes. When in use, the mesh head of the flower-shaped structure is placed close to the trumpet-shaped blood vessel opening, and each electrode arm 1 is deformed accordingly, so that each electrode is closely attached to the tissue, and a larger annular isolation zone can be formed at the outer blood vessel opening or vestibule position.

[0041] In an optional embodiment, if Figure 8 As shown, the closer the proximal electrode 4 and the distal electrode 5 are to the middle bulged portion of the spindle-shaped basket mesh, the larger the outer diameter of the electrode ring formed by the distal electrode 5 and the proximal electrode 4 becomes after the electrode ring is deformed into a flower shape, and an annular ablation zone 6 is formed.

[0042] In an optional embodiment, if Fig. 9 As shown, when the distal electrode 5 and the proximal electrode 4 are closer to the two-stage setting of the spindle-shaped basket, after being deformed into a flower shape, the distal electrode 5 and the proximal electrode 4 are closer to the center of the flower shape. When the distal electrode 5 and the proximal electrode 4 are concentrated to a certain extent, the field strength in the center of the flower shape is compensated, and the ablation area formed will no longer be a ring, but a circular surface ablation zone.

[0043] In an optional embodiment, the length of the proximal electrode 4 and the distal electrode 5 can be extended within a certain range according to actual conditions, so that the size of the ablation ring formed by the proximal electrode 4 and the distal electrode 5 can be adjusted within a larger range, thereby increasing the ablation range to a certain extent and further ensuring the complete conduction block of the electrophysiological signal after ablation.

[0044] In an optional embodiment, if Figure 8 As shown, between the distal electrode 5 and the distal joint 2, adjacent electrode arms 1 are arranged in close contact.

[0045] In an optional embodiment, if Fig. 9 As shown, between the distal electrode 5 and the distal joint 2, adjacent electrode arms 1 are arranged at intervals, and hollowing is formed between the distal electrode 5 and the distal joint 2 to form mesh head ends of different shapes.

[0046] In one or several embodiments, a lumen channel 15 is provided in the electrode arm 1, the proximal electrode 4 is connected to a first wire, and the distal electrode 5 is connected to a second wire. The first wire and the second wire can extend through the lumen channel 15 of any electrode arm 1 and pass through a catheter to be electrically connected to supporting equipment, so that short circuit or breakdown is not likely to occur between the electrodes or electrode wires.

[0047] In an optional embodiment, the first wire and the second wire are respectively extended along the tubular channel 15 of different electrode arms 1, and the positive and negative electrodes are distributed at both ends of the spindle-shaped basket mesh, so that the positive and negative electrodes are structurally isolated from each other. Even when the mesh head end is retracted into the sheath, the positive and negative electrodes cannot contact each other, which largely eliminates the safety risks caused by conduction or breakdown of the positive and negative electrodes during high-voltage discharge, and can minimize the probability of short circuit or breakdown between the electrodes.

[0048] Specifically, if the first wire connected to the proximal electrode 4 mounted on the first ridge 1a and the second ridge 1b passes through the tubular channel 15 of the second ridge 1b, the second wire connected to the distal electrode 5 mounted on the second ridge 1b and the third ridge 1c can pass through the tubular channel 15 of the third ridge 1c.

[0049] A mesh head end with a variable shape in the present embodiment is achieved by combining adjacent electrode arms 1 at the distal combining section 11 or the proximal combining section 12, and arranging the proximal electrode 4 and the distal electrode 5 at the combining point of the adjacent electrode arms 1. While realizing the mapping and ablation functions, each electrode arm 1 is connected into a mesh structure. When any part is displaced by force, other parts will be pulled and deformed at the same time, that is, the deformation of the mesh head end is an overall deformation. Each electrode can be attached to the tissue in a relatively balanced force manner, so that the distance between each electrode is relatively stable, which is beneficial for the operator to grasp the ablation effect. Compared with the independently distributed electrode arms 1, it can ensure the overall support and flexibility of the mesh head end, improve the sticking effect of each electrode, and make the ablation effect stable and uniform.

[0050] The mesh head end of the present embodiment has a variable shape. By adjusting the distal joint 2 and the proximal joint 3 to be relatively close or far apart, the shape of the mesh head end can be switched between a spindle basket shape, a flower shape and any intermediate shape, so that the mesh head end can conform to tissues of different sizes and shapes, and achieve ablation of tubular, trumpet-shaped and approximately planar areas. The distal electrode 5 can be extended into the pulmonary vein for mapping and ablation, and the conduction block verification after the ablation surgery can be completed without switching other catheters.

[0051] Compared with the traditional variable-shape head end structure, the electrode arm 1 of the traditional variable-shape head end structure is generally straight in the initial state, and the distal and proximal ends are combined to form a lantern shape. The electrode arms 1 are independent of each other except the two ends, and there is no connection point. The electrode is installed on a single electrode arm 1. When forming a flower shape, the electrode spacing is large and a complete ablation zone cannot be formed. Multiple rotations and superpositions are required. If a closed ablation zone is to be formed, it is necessary to arrange the electrode arms 1 densely enough around the lumen and increase the number of electrodes. This will increase the overall size of the head end structure, making it difficult to enter and exit the sheath, and the positive and negative electrodes between the two electrode arms 1 may contact, causing safety risks.

[0052] A mesh head end with a variable shape in the present embodiment is arranged at the junction of the two electrode arms 1 by distributing the proximal electrode 4 and the distal electrode 5 in a staggered manner in the direction of the connection. When a flower-shaped structure is formed, the distal electrode 5 and the proximal electrode 4 are staggered and overlapped on an electrode surface. The proximal electrode 4 and the distal electrode 5 complement each other, which can make up for the defect of the traditional mesh head end that the electrode spacing increases with the increase of the electrode coverage when the deformation occurs, and can form a complete and uniform ablation zone. A complete and uniform annular ablation zone can be achieved in situ without rotating the catheter, which can effectively avoid the recurrence of atrial fibrillation caused by the inability to close the ablation zone to form a conduction gap.

[0053] The mesh head end of the present embodiment has a variable shape. The proximal electrode 4 and the distal electrode 5 are staggered in the direction of the connection. When the mesh head end is contracted, only half of the total number of electrodes are still passed through the sheath tube at the maximum lateral dimension of the mesh head end, so that the sheath size can be controlled to the greatest extent.

[0054] Example 2 like Figure 1-Figure 10 As shown, an electrode catheter comprises a handle 8, a distal tube 81, a proximal tube 82 and a mesh head end with a variable shape as described above, which are arranged in sequence. The distal tube 81 is an adjustable bending section. The handle 8 is provided with a first control mechanism 83 and a second control mechanism 84. The first control mechanism 83 is connected to the distal joint 2 through a first traction member 85. The first control mechanism 83 is used to control the distal joint 2 to approach or move away from the proximal joint 3. The second control mechanism 84 is used to control the bending of the distal tube 81.

[0055] like Fig.10As shown, the distal tube body 81 is a soft and bendable part, which is connected to the mesh head end of Example 1, and the proximal tube body 82 can manipulate the distal tube body 81 and the mesh head end to reach a specified position; the distal tube body 81 and the proximal tube body 82 are both multi-layer structures with metal braided meshes, containing one or more lumens, and the lumens contain the relevant first wire, second wire, positioning sensor tail line, traction assembly, perfusion channel, etc.; the handle 8 is connected to the proximal tube body 82, which is the operator's hand-held part, including a first control mechanism 83, a second control mechanism 84 and an internal transmission device, which are used to control the movement, rotation, deformation and other actions of the entire mesh head end and the distal tube body 81; the traction assembly includes a first traction member 8 5 and a second traction member, the distal end of the first traction member 85 is connected to the distal joint 2 of the mesh head end, passes through the distal tube body 81 and the proximal tube body 82 and is connected to the first control mechanism 83. By controlling the first traction member 85, the distal joint 2 can be moved closer to or away from the proximal joint 3, so that the mesh head end can be converted between the spindle-shaped basket shape and the flower shape, or stay in any intermediate shape to meet the needs of ablation or mapping of different parts. The distal end of the second traction member is fixed in the distal tube body 81 and extends along the tube cavity. The proximal end is fixed to the second control mechanism 84 of the handle 8. The distal tube body 81 can be bent or straightened by the second traction member to adjust the position of the mesh head end.

[0056] In an optional embodiment, a perfusion channel may be further provided in the electrode catheter, the perfusion channel opening at the proximal joint 3, for perfusing physiological saline or anticoagulant solution to avoid thrombus formation at the mesh tip during use.

[0057] In an optional embodiment, the electrode catheter may also include one or more positioning sensors, which may be distributed in one or more electrode arms 1, the distal joint 2, the proximal joint 3 or the distal tube body 81. When used in conjunction with a matching electrophysiological three-dimensional mapping system, the positioning sensor can transmit the location information to the host, and then use a series of algorithms to identify and display information such as the position, shape, and rotation direction of the distal end and mesh head end of the catheter.

[0058] An electrode catheter of the present embodiment, by adopting the above-mentioned variable-shape mesh head end, is easy and stable to operate, and can be adapted to electrophysiological signal collection or ablation at different positions. It can be adapted to the openings of blood vessels with smaller diameters or deeper areas in blood vessels when in a spindle-shaped basket mesh shape, and can be adapted to the openings of blood vessels with larger diameters or nearly flat areas when in a flower-shaped shape. It can also ensure the integrity of the ablation zone, which is beneficial to reducing the probability of recurrence of atrial fibrillation and reducing the risk of hemolysis.

[0059] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A mesh head end with a variable shape, characterized in that: include: An even number of electrode arms (1), all of the electrode arms (1) forming a distal joint portion (2) and a proximal joint portion (3) in space, all of the electrode arms (1) being distributed around a line connecting the distal joint portion (2) and the proximal joint portion (3), each of the electrode arms (1) being provided with a distal joint section (11) and a proximal joint section (12), and adjacent electrode arms (1) being joined at the distal joint section (11) or the proximal joint section (12); a plurality of proximal electrodes (4) and a plurality of distal electrodes (5), wherein the proximal electrodes (4) are arranged at the junction of the adjacent electrode arms (1) at the proximal junction section (12), and the distal electrodes (5) are arranged at the junction of the adjacent electrode arms (1) at the distal junction section (11); The distal joint portion (2) can approach the proximal joint portion (3) along the connecting line, so that all the electrode arms (1) form a flower-shaped structure in space, and all the distal electrodes (5) and all the proximal electrodes (4) can be staggered around the connecting line on the same conical surface or plane.

2. A mesh head end with a variable shape according to claim 1, characterized in that: The flower-shaped structure can form an annular ablation zone (6) or a circular ablation zone (7).

3. The mesh head end with a variable shape according to claim 1, characterized in that: When the distal joint (2) approaches or moves away from the proximal joint (3), all the electrode arms (1) form a spindle-shaped basket structure in space, all the proximal electrodes (4) form a proximal electrode ring, and all the distal electrodes (5) form a distal electrode ring.

4. The mesh head end with a variable shape according to claim 1, characterized in that: The proximal electrode (4) is sleeved at the joint of the adjacent electrode arms (1) at the proximal joint section (12), and the distal electrode (5) is sleeved at the joint of the adjacent electrode arms (1) at the distal joint section (11).

5. A mesh head end with a variable shape according to any one of claims 1 to 4, characterized in that: The electrode arm (1) comprises a support arm (13) and an outer tube (14); the support arm (13) is inserted into the outer tube (14); the support arm (13) is a structural component made of alloy metal or elastic material, and the outer tube (14) is a structural component made of polymer material; when the support arm (13) is made of metal material, an insulating layer is provided between the support arm (13) and the outer tube (14).

6. A mesh head end with a changeable shape according to claim 5, characterized in that: A tubular cavity channel (15) is provided in the electrode arm (1), the proximal electrode (4) is connected to a first wire, and the distal electrode (5) is connected to a second wire, and the first wire and the second wire are respectively extended along different tubular cavity channels (15).

7. A mesh head end with a changeable shape according to claim 6, characterized in that: The first conductive wire and the second conductive wire are respectively extended along the lumen channels (15) of different electrode arms (1).

8. A mesh head end with a changeable shape according to claim 7, characterized in that: The proximal electrode (4) and the distal electrode (5) have different polarities.

9. The mesh head end with a changeable shape according to claim 7, characterized in that: The proximal electrode (4) and the distal electrode (5) can be respectively configured as discharge electrodes.

10. An electrode catheter, characterized in that: It comprises a handle (8), a distal tube body (81), a proximal tube body (82) and a mesh head end with a variable shape as described in any one of claims 1 to 9, which are arranged in sequence, the distal tube body (81) is an adjustable bending section, the handle (8) is provided with a first control mechanism (83) and a second control mechanism (84), the first control mechanism (83) is connected to the distal joint (2) through a first traction member (85), the first control mechanism (83) is used to control the distal joint (2) to approach or move away from the proximal joint (3), and the second control mechanism (84) is used to control the bending of the distal tube body (81).

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