A shape-adjustable pulse ablation catheter with liquid perfusion function

Abstract

The present invention discloses a shape-adjustable pulse ablation catheter with a liquid perfusion function, which relates to the field of interventional treatment, and includes an annular flexible adjustable ring, a tube body, and a control device, wherein the annular flexible adjustable ring includes a flexible multi-lumen tube, a ring electrode, and a push tube, and the ring electrode is distributed on the surface of the flexible multi-lumen tube, and the control device includes a sliding straightening button, a perfusion joint, and a bending control unit, and the sliding straightening button is used to control the change in shape and size of the annular flexible adjustable ring. The present invention has the functions of annular pulse electric field ablation and electrocardiogram signal mapping, avoids the risk of surgical instrument replacement, and shortens the operation time. The present invention also has the function of temperature monitoring during the ablation process, so that the operator can more intuitively observe the temperature change information of the ablation area, ensuring that the operation is safer and more efficient.

Description

Technical Field

[0001] The invention relates to the field of interventional therapy, and in particular to a shape-adjustable pulse ablation catheter with a liquid perfusion function. Background Art

[0002] Cardiac radiofrequency ablation and cardiac cryoablation are two common interventional surgical methods currently used in the clinic to treat arrhythmias such as atrial fibrillation. The mechanism of action of cardiac radiofrequency ablation is to generate a thermal effect through high-frequency current through cardiac tissue to ablate abnormal cardiac targets; cardiac cryoablation is to apply low temperature to cardiac tissue to burn local abnormal target sites. The success of both surgical methods depends on the size and adequacy of the injury. In order to achieve the thoroughness of ablation, the surgeon often needs to release more energy than expected at the target site of the heart to fully achieve the ablation effect, but excessive ablation will affect the surrounding healthy tissues and nerves. Common complications include esophageal injury, phrenic nerve injury, pulmonary vein stenosis, etc. The disadvantages of traditional radiofrequency ablation and cryoablation are that the operation time is long, the surgeon's operating level is high, the learning curve is long, and due to the thermal and cold injury principles of ablation, the patient will feel pain during ablation, and a variety of complications are likely to occur after the operation, and the success rate and treatment rate of the operation are low.

[0003] Electric field pulse ablation technology generates a high-voltage pulse with a pulse width of microseconds or even nanoseconds, and applies a local high electric field of hundreds of volts per centimeter to the ablation area, releasing extremely high energy in a short period of time, causing a large number of micropores to form in the myocardial cell membrane. Since the applied electric field is greater than the threshold of the myocardial cell membrane, the pores do not close. The irreversible micropores on the cell membrane allow biological molecules to pass through the membrane for exchange, thereby causing cell necrosis or apoptosis, achieving the desired therapeutic purpose.

[0004] As a non-thermal ablation technology, electric field pulse technology has gradually gained attention in clinical applications. However, current studies have shown that electric field pulse ablation, as an emerging technology, still has many uncontrollable risks in the treatment of atrial fibrillation, such as the difficulty of the catheter to stably and tightly adhere to the target position, poor accuracy of the electrode mapping itself, bubbles generated during electric field pulse ablation, and the risk of thrombosis and scab formation. How to safely and effectively use electric field pulses for atrial fibrillation ablation has become an urgent problem to be solved today.

[0005] Therefore, those skilled in the art are committed to developing a shape-adjustable pulse ablation catheter with a liquid perfusion function for mapping and ablation treatment of arrhythmias. Summary of the invention

[0006] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is that the existing catheter is difficult to stably adhere to the ablation site, and blood clots and scabs are easily generated during the ablation process.

[0007] To achieve the above-mentioned purpose, the present invention provides a shape-adjustable pulse ablation catheter with liquid perfusion function, characterized in that it includes an annular flexible adjustable ring, a tube body and a control device, wherein the annular flexible adjustable ring is connected to the control device through the tube body, the annular flexible adjustable ring includes a flexible multi-lumen tube, a ring electrode and a push tube, the push tube is connected to the flexible multi-lumen tube, the ring electrodes are distributed on the surface of the flexible multi-lumen tube, the flexible multi-lumen tube includes a first inner cavity and a second inner cavity, the tube body includes a third inner cavity, a fourth inner cavity and a fifth inner cavity, the control device includes a sliding straightening button, a perfusion connector and a bending control unit, the first inner cavity is connected to the perfusion connector through the fourth inner cavity, a bending adjustment component is provided in the third inner cavity, the bending adjustment component is connected to the bending adjustment control unit, the push tube passes through the fifth inner cavity and is connected to the sliding straightening button, and the sliding straightening button is used to control the change of the shape and size of the annular flexible adjustable ring.

[0008] Furthermore, the number of the ring electrodes is an odd number, and the distribution is equidistant, the ring electrodes are arranged in a positive and negative interval manner, and the polarities of the two ring electrodes at the farthest end and the closest end are the same.

[0009] Furthermore, a temperature sensor is disposed on the inner surface of at least one of the ring electrodes.

[0010] Furthermore, the annular flexible adjustable ring also includes a ring shaping wire, a shaping wire sleeve, a conductive wire and an extension wire. The ring shaping wire and the shaping wire sleeve are arranged inside the second inner cavity, the shaping wire sleeve is sleeved on the surface of the ring shaping wire, the conductive wire is connected to the ring electrode, the extension wire is connected to the temperature sensor, and the conductive wire and the extension wire pass through the tube body and are connected to the control device.

[0011] Furthermore, a plurality of micropores for fluid perfusion are provided on the surface of the first inner cavity, and the fluid perfused through the micropores forms a film on the surface of the annular flexible adjustable ring.

[0012] Furthermore, a plurality of micropores are provided on the surface of the ring electrode, and the fluid passing through the first inner cavity can be simultaneously infused from the micropores on the surface of the ring electrode.

[0013] Furthermore, the tube body is a three-layer composite braided tube, the inner layer of which is a multi-lumen tube made of polymer material, the middle layer is a metal braided mesh or a metal coil, and the outer layer is a single-lumen tube made of polymer material.

[0014] Furthermore, the outer layer of the three-layer composite braided tube is designed with multiple hardness sections, and the tube section of the outer layer of the three-layer composite braided tube close to the control device has a higher hardness than the tube section far from the control device.

[0015] Furthermore, there are at least two third cavities in the tube body, and the bending adjustment component includes an anchor head, a bending adjustment wire and a spring, the spring is sleeved on the surface of the bending adjustment wire, the bending adjustment wire is connected to the bending adjustment control unit, the anchor head is arranged at a position inside the tube body close to the annular flexible adjustable ring, the bending adjustment wire is fixedly connected to the anchor head, and the bending adjustment control unit is a two-way knob mechanism, and the bending adjustment control unit is used to control the bending shape change of the distal end of the tube body.

[0016] Furthermore, the control device also includes a Luer connector, and the annular flexible adjustable ring also includes a terminal head end, which is connected to the push tube, and a through hole is provided in the terminal head end, and a cavity for inserting a guide wire is provided in the push tube, and the guide wire passes through the through hole and the cavity until it extends out of the Luer connector.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] First, the present invention provides a shape-adjustable pulse ablation catheter with liquid perfusion function. Through the equal spacing layout design of an odd number of ring electrodes, all ring electrodes are arranged in a positive and negative interval manner, and the positive and negative polarities of the farthest and nearest ring electrodes are the same, it can realize the functions of ring pulse ablation and ECG mapping on one catheter at the same time, without the need to replace or increase equipment, reducing the risk of equipment replacement and shortening the operation time. In addition, due to the design of the same polarity of the ring electrodes at both ends, the risk of sparking after the two ring electrodes at both ends come into contact is avoided, making the operation safer.

[0019] Second, the present invention provides a shape-adjustable pulse ablation catheter with a liquid perfusion function. By pushing and pulling the sliding straightening button of the proximal control device, the shape and size of the annular flexible adjustable ring at the distal end of the catheter can be changed. When the annular flexible adjustable ring is converted into a spiral shape, the catheter can enter the pulmonary vein for ablation treatment. When the annular flexible adjustable ring is converted into a ring shape, the catheter can perform ablation treatment at the pulmonary vein orifice and the outer wall of the atrium. At the same time, through the deflection of the bending control unit of the proximal control device, the deflection change of the distal bend of the catheter can be achieved to adapt to more complex surgical environments and enable the annular flexible adjustable ring to better fit the ablation tissue.

[0020] Third, the present invention provides a shape-adjustable pulse ablation catheter with liquid perfusion function. The structure and assembly design of the tube body, especially the combined design of the inner layer super-smooth multi-lumen tube, the bending wire and the spring, simplifies the structural design and greatly simplifies the process complexity compared with the bending technology of existing interventional catheters.

[0021] Fourth, the present invention provides a shape-adjustable pulse ablation catheter with liquid perfusion function, which can perfuse fluid through the micropores on the surface of the ring electrode or the fluid cavity. The fluid perfused by the micropores forms a thin film on the surface of the annular flexible adjustable ring, which can effectively prevent the formation of thrombus scab, thereby reducing the risk of complications such as vascular embolism when using the catheter of the present invention for pulse ablation treatment.

[0022] Fifth, the present invention provides a shape-adjustable pulse ablation catheter with a liquid perfusion function. By setting a temperature sensor on the inner side of the ring electrode, intuitive temperature monitoring of the treatment area during pulse ablation treatment can be achieved to prevent the occurrence of thrombosis and scab formation due to excessively high temperature in the ablation area, thereby ensuring a safer operation.

[0023] The concept, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings to fully understand the purpose, characteristics and effects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a structural schematic diagram of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0025] Figure 2 It is a structural schematic diagram of an annular flexible adjustable ring of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0026] Figure 3 It is a schematic diagram of the internal structure of a flexible multi-lumen tube of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0027] Figure 4 It is a structural schematic diagram of a flexible multi-lumen tube of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0028] Figure 5 It is a structural schematic diagram of a coiled steel wire of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0029] Figure 6 It is a structural schematic diagram of a tube body of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0030] Figure 7 It is a structural schematic diagram of a bending adjustment component of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0031] Figure 8 It is a structural schematic diagram of a control device of a shape-adjustable pulse ablation catheter with a liquid perfusion function according to a preferred embodiment of the present invention;

[0032] Among them, 100-annular flexible adjustable ring, 200-tube body, 300-control device, 101-terminal head end, 102-ring electrode, 103-flexible multi-lumen tube, 104-push tube, 1031-first inner cavity, 1032-second inner cavity, 10321-ring shaping wire, 10322-shaping wire sleeve, 10323-temperature sensor, 10324-conducting wire, 201-outer layer, 202-middle layer, 203-inner layer, 204-third inner cavity, 205-fourth inner cavity, 206-fifth inner cavity, 2041-anchor head, 2042-bending wire, 2043-spring, 301-bending control unit, 302-sliding straightening button, 303-Luer connector, 304-connector, 305-infusion connector. DETAILED DESCRIPTION

[0033] The following describes several preferred embodiments of the present invention with reference to the drawings in the specification, so that the technical content is clearer and easier to understand. The present invention can be embodied in many different forms of embodiments, and the protection scope of the present invention is not limited to the embodiments mentioned in the text.

[0034] In the drawings, components with the same structure are indicated by the same numerical reference numerals, and components with similar structures or functions are indicated by similar numerical reference numerals. The size and thickness of each component shown in the drawings are arbitrarily shown, and the present invention does not limit the size and thickness of each component. In order to make the illustration clearer, the thickness of the components is appropriately exaggerated in some places in the drawings.

[0035] The present invention provides an adjustable ring and adjustable bend annular pulse ablation catheter (hereinafter referred to as "ablation catheter") with liquid perfusion function. The use of the ablation catheter of the present invention can solve the problems that traditional cardiac ablation catheters are difficult to reach the target ablation position, the size and shape of the distal end of the catheter cannot be adjusted, and blood clots and scabs are easily generated during the ablation process. At the same time, the ablation catheter of the present invention has both annular pulse electric field ablation and electrocardiogram signal mapping functions, avoiding the risk of surgical instrument replacement and shortening the operation time. In addition, the present invention also has a temperature monitoring function during the ablation process, allowing the operator to more intuitively observe the temperature change information of the ablation area, ensuring that the operation is safer and more efficient.

[0036] The invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the invention and are not intended to limit the invention.

[0037] like Figure 1 As shown, the embodiment of the present invention provides an adjustable ring and an adjustable curved annular pulse ablation catheter with high-precision mapping function. The device in the embodiment includes: an annular flexible adjustable ring 100, a tube body 200 and a control device 300. The annular flexible adjustable ring 100 is located at the farthest end of the ablation catheter (with Figure 1 The paper direction is used as a reference, with the left side being the distal end and the right side being the proximal end). Its function is to make the distal end of the ablation catheter closely attached to the inner wall of the pulmonary vein or vestibule without damaging the blood vessel. The annular flexible adjustable ring 100 is soft as a whole and has high resilience and contractility. The overall outer diameter of the annular flexible adjustable ring 100 is 10mm-30mm.

[0038] like Figure 2 and Figure 3 As shown, the annular flexible adjustable ring 100 is composed of a terminal head end 101, a ring electrode 102, a flexible multi-lumen tube 103 and a push tube 104. The annular flexible adjustable ring 100 includes the terminal head end 101 located at the tip of the annular flexible adjustable ring 100, a ring shaping wire 10321 bonded to the terminal head end 101 and playing a shaping and supporting role in the flexible multi-lumen tube 103, a shaping wire sleeve 10322 sleeved on the surface of the ring shaping wire 10321, the flexible multi-lumen tube 103, the ring electrode 102 fixed on the surface of the flexible multi-lumen tube, a temperature sensor 10323 fixed in the inner cavity of the flexible multi-lumen tube, and a wire 10324 welded on the inner side of the ring electrode 102, and the proximal end of the terminal head end 101 is connected to the distal ends of the flexible multi-lumen tube 103 and the push tube 104.

[0039] The shape of the terminal head 101 is approximately cylindrical, the distal end surface is spherical, and there are two cavities inside, one is a through hole and the other is a blind hole. The distal end of the push tube 104 is connected to the through hole cavity by glue bonding or hot melting, and the distal ends of the flexible multi-lumen tube 103 and the coiled steel wire 10321 are connected to the blind hole cavity by glue bonding. The material of the terminal head 101 is one of stainless steel, nylon 12, silicone rubber or Pebax, preferably Pebax.

[0040] like Figure 4 As shown, the flexible multi-lumen tube 103 is a multi-lumen tube with a cavity inside, and in this embodiment is a double-lumen tube, and the tube body material is made of polyurethane, block polyether amide or nylon. The second inner cavity 1032 is used to pass the ring shaping wire 10321 and the shaping wire sleeve 10322, as well as the wire 10324 welded on the inner surface of the ring electrode 102 and the extension wire of the temperature sensor 10323. The first inner cavity 1031 is a cavity, which is used as a circulation channel during liquid perfusion.

[0041] In this embodiment, a plurality of ring electrodes 102 need to be fixed on the surface of the flexible multi-lumen tube 103, and the preferred number of ring electrodes is 7 or 9. Seven or nine small holes can be made in advance at predetermined positions on the surface of the flexible multi-lumen tube 103 using a perforating needle, and then the wire 10324 welded on the inner side of the ring electrode 102 is introduced into the second inner cavity 1032 of the flexible multi-lumen tube 103 through the small holes. The ring electrode 102 is inserted into the surface of the flexible multi-lumen tube 103 through one end of the flexible multi-lumen tube 103 until it reaches the required position and is fixed by glue. The temperature sensor 10323 is also built into the second inner cavity 1032 of the flexible multi-lumen tube 103. A plurality of dense micropores are opened on the surface of the first inner cavity 1031 of the flexible multi-lumen tube 103. When liquid flows through the inner cavity 1031, a thin water film can be formed on the surface of the flexible multi-lumen tube 103 to effectively prevent the formation of thrombus scabs.

[0042] like Figure 5 As shown, the material of the coiled steel wire 10321 is an alloy wire with shape memory function, preferably a nitinol alloy wire, with a diameter of 0.2mm-0.5mm, and has high resilience and shape memory characteristics. The coiled steel wire 10321 is heat-treated and shaped into an annular ring, and the outer diameter of the annular ring is 9mm-29mm. The distal end of the coiled steel wire 10321 is fixed in the blind hole lumen of the terminal head end 101, and the proximal end is fixed to the distal end of the tube body 200.

[0043] The shaping wire sleeve 10322 is a single-lumen tubular, and the material is a smooth polymer extrusion tube, which can be one of polyurethane, nylon, PTFE, PET or FEP, preferably PTFE material, with an inner diameter of 0.3mm-0.6mm and an outer diameter of 0.4mm-0.7mm. The shaping wire sleeve 10322 is glued or hot-melted to the outer surface of the circle shaping wire 10321. The ring electrode 102 is a metal ring, and the material is one of gold, platinum or platinum-iridium alloy, and the width is 1mm-3.5mm. There can be multiple numbers of ring electrodes 102, and the distribution method on the surface of the flexible multi-lumen tube 103 is equidistant. In this embodiment, the number of ring electrodes 102 is an odd number, preferably 7 or 9, the spacing between the ring electrodes 102 is 3.75mm, and the preferred width of the ring electrode 102 is 1.2mm. The push tube 104 is a single-lumen tube made of polymer material. The push tube 104 is composed of a multi-layer tube. The outermost layer is made of one of polyimide, Pebax or PTFE, the middle layer is a metal wire braided layer, the metal wire is made of stainless steel wire or nickel-titanium wire, and the innermost layer is made of one of polyimide, Pebax or PTFE. In this embodiment, the innermost layer is made of PTFE, the middle braided layer is made of stainless steel wire, and the outermost layer is made of polyimide.

[0044] like Figure 6As shown, the tube body 200 is a three-layer composite braided tube with multiple inner cavities and multiple hardness levels. In this embodiment, the tube body 200 is a three-layer composite braided tube with four inner cavities, and the tube body 200 has three different hardness level designs. The inner layer 203 is a multi-cavity tube made of a polymer material, the middle layer 202 is a metal braided mesh or a metal coil, and the outer layer 201 is a single-cavity tube made of a polymer material with multiple hardness levels. The three layers are thermally fused to form the tube body 200.

[0045] The polymer material of the inner layer 203 multi-lumen tube is one of PTFE, Pebax or polyurethane. In this embodiment, it is preferably PTFE material, which is made by extrusion process; the material of the middle layer 202 is stainless steel or nickel-titanium alloy. In this embodiment, it is preferably woven from stainless steel wire; the material of the outer layer 201 single-lumen tube is one of nylon 12, Pebax or polyurethane. In this embodiment, it is preferably Pebax material. The outer layer 201 is formed by splicing and fusing three single-lumen tubes of different hardness. The hardness design from the proximal end to the distal end is Shaw 72D, 63D and 35D. The three layers of materials of the inner layer 203, the middle layer 202 and the outer layer 201 are finally put together and heat-sealed to form the tube body 200 by heat fusion.

[0046] like Figure 6 , Figure 7 and Figure 8As shown, the tube body 200 has four inner cavities, wherein two third inner cavities 204 symmetrically along the central axis of the tube body 200 are respectively provided with bending adjustment components. The bending adjustment components are composed of an anchor head 2041, a bending adjustment wire 2042 and a spring 2043. The distal end of the bending adjustment wire 2042 is fixedly connected to the anchor head 2041, and the anchor head 2041 is fixed to the distal end of the tube body 200 by riveting or gluing. A spring 2043 is sleeved on the surface of the bending adjustment wire 2042. The distal end of the spring 2043 abuts against the anchor head 2041, and the proximal end is fixed to the proximal end of the tube body 200. The proximal end of the bending adjustment wire 2042 is fixed to the bending adjustment control unit 301 inside the manipulation device 300, and the proximal end of the tube body 200 is fixed to the distal end of the manipulation device 300. When the bending adjustment control unit 301 in the manipulation device 300 rotates, the rotation of the bending adjustment control unit 301 will pull the bending adjustment wire 2042. Since the distal anchor point 2041 of the bending adjustment wire 2042 is fixed to the distal end of the tube body 200, and the proximal end of the tube body 200 is fixed to the distal end of the manipulation device 300, the traction force generated by the rotation of the bending adjustment control unit 301 will be transmitted to the distal end of the tube body 200 through the bending adjustment wire 2042. In this embodiment, due to the unique multi-hardness segmented design of the tube body 200, the proximal end is a high-hardness Shore 72D, the distal end is a low-hardness Shore 35D, and the third inner cavity 204 of the tube body 200 is supported by a spring 2043. Therefore, when the traction force is transmitted to the tube body 200, the proximal end of the tube body 200 remains unchanged, and the distal end deflects, thereby realizing the adjustable bending function. In the other two inner cavities of the tube body 200, the inner cavity 206 serves as an extension channel of the push tube 104, and the inner cavity 205 serves as an extension line channel of the wire 10324 and the temperature sensor 10323.

[0047] It should be noted that the body design of a conventional bending-adjusting catheter is generally a single-lumen tube, and the interior of the single-lumen tube needs to be independently assembled with components such as a bending-adjusting wire, a spring, and a spring sleeve, which not only has many parts but also has a complicated assembly process. In this embodiment, the inner layer of the tube body 200 is a PTFE multi-lumen tube design, in which the third inner cavity 204 can be directly used to assemble the bending-adjusting components without the need for an additional spring sleeve and its complicated assembly process, which greatly reduces the process complexity and makes the assembled tube body more stable.

[0048] like Figure 2 and Figure 8As shown, in this embodiment, the proximal end of the push tube 104 passes through the fifth inner cavity 206 of the tube body 200 and extends to the interior of the control device 300. A sliding straightening button 302 is provided inside the control device 300. There is a through hole inside the sliding straightening button 302. The proximal extension of the push tube 104 passes through the through hole of the sliding straightening button 302 and is bonded and fixed to the sliding straightening button 302. The proximal end of the push tube 104 is bonded and connected to the Luer connector 303. By pushing or withdrawing the sliding straightening button 302, the push tube 104 can be driven to move forward and backward in the fifth inner cavity 206 of the tube body 200, and then the distal traction end head 101 of the push tube 104 and the distal end of the flexible multi-lumen tube 103 move forward and backward, thereby realizing the morphological change (morphological change between circular shape and spiral shape) of the distal annular flexible adjustable ring 100 of the ablation catheter. When the shape of the annular flexible adjustable ring 100 is converted into a spiral shape, the ablation catheter of the present invention can enter the interior of the pulmonary vein for ablation treatment. When converted into an annular shape, the ablation catheter of the present invention can perform ablation treatment at the pulmonary vein orifice and the outer wall of the atrium. When the ablation catheter is to be inserted into the patient's body through a blood vessel, a guide wire can be placed in the inner cavity of the push tube 104, and the guide wire enters from the through hole of the end head 101, penetrates into the inner cavity of the push tube 104, until the proximal end of the guide wire extends out of the Luer connector 303, pushes the sliding straightening button 302 to make the annular flexible adjustable ring 100 become a spiral shape, and continues to push the sliding straightening button 302 until the annular flexible adjustable ring 100 becomes a straight shape, and then the catheter is sent into the blood vessel access.

[0049] like Figure 8 As shown, the proximal end of the manipulator 300 is also provided with a connector 304, and the wire 10324 welded inside the ring electrode 102 and the extension wire of the temperature sensor 10323 pass through the fourth inner cavity 205 of the tube body 200 and the manipulator 300, until the connector 304, and are welded to the connector 304. The connector 304 can be connected to the pulse generator through an external cable, and the pulse energy output by the pulse generator can be transmitted to the ring electrode 102 on the surface of the annular flexible adjustable ring 100 through the wire 10324, thereby achieving pulse ablation treatment of arrhythmia.

[0050] like Figure 2 , Figure 4 , Figure 6 and Figure 8As shown, the proximal end of the flexible multi-lumen tube 103 is connected to the fourth inner cavity 205 at the distal end of the tube body 200, and the connection method is that the flexible multi-lumen tube 103 is embedded in the fourth inner cavity 205 and sealed and bonded with glue. A liquid perfusion tube is connected to the proximal end of the first inner cavity 1031 of the flexible multi-lumen tube 103, and the liquid perfusion tube extends through the fourth inner cavity 205 of the tube body 200 to the perfusion connector 305 of the control device 300. The liquid perfusion tube and the perfusion connector 305 are sealed and bonded with glue. When the ablation catheter of the present invention performs pulse discharge treatment, cooling liquid perfusion (such as saline) can be performed through the perfusion connector 305, and the micropores on the surface of the flexible multi-lumen tube 103 discharge the cooling liquid and form a thin layer of water film, thereby reducing the temperature of the ablation treatment area to prevent the formation of thrombus scab.

[0051] In summary, the present invention can adjust the shape and size of the annular flexible adjustable ring 100 by advancing or withdrawing the sliding straightening button 302 set in the control device 300, so as to better adapt to the size and shape of the pulmonary vein, so that the ring electrode 102 forms a stable and effective contact with the ablation tissue, thereby making the pulse ablation treatment more accurate and efficient. In addition, during the pulse ablation process, the present invention can perform liquid perfusion through the perfusion interface 305 to form a thin layer of water film on the entire surface of the annular flexible adjustable ring 100 to prevent the formation of thrombus scab during the ablation process. At the same time, the present invention can realize the bending change of the distal end of the ablation catheter of the present invention by rotating the bending control unit 301 of the control device 300, so as to adapt to more complex surgical environments, better ensure the stable contact between the annular flexible adjustable ring 100 and the ablation site, and greatly improve the success rate of the operation. The present invention also has a temperature monitoring function during the ablation process, so that the operator can observe the temperature information of the ablation area more intuitively, ensuring that the operation is safer and more efficient.

[0052] The preferred specific embodiments of the present invention are described in detail above. It should be understood that ordinary technicians in the field can make many modifications and changes based on the concept of the present invention without creative work. Therefore, all technical solutions that can be obtained by technicians in the technical field based on the concept of the present invention through logical analysis, reasoning or limited experiments on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A shape-adjustable pulse ablation catheter with liquid perfusion function, characterized in that: The invention comprises an annular flexible adjustable ring, a tube body and a control device, wherein the annular flexible adjustable ring is connected to the control device through the tube body, the annular flexible adjustable ring comprises a flexible multi-lumen tube, a ring electrode and a push tube, the push tube is connected to the flexible multi-lumen tube, the ring electrode is distributed on the surface of the flexible multi-lumen tube, the flexible multi-lumen tube comprises a first inner cavity and a second inner cavity, the tube body comprises a third inner cavity, a fourth inner cavity and a fifth inner cavity, the control device comprises a sliding straightening button, a perfusion joint and a bending control unit, the first inner cavity is connected to the perfusion joint through the fourth inner cavity, a bending adjustment component is arranged in the third inner cavity, the bending adjustment component is connected to the bending adjustment control unit, the push tube passes through the fifth inner cavity and is connected to the sliding straightening button, and the sliding straightening button is used to control the change of the shape and size of the annular flexible adjustable ring.

2. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 1, characterized in that: The number of the ring electrodes is an odd number, and the distribution is equidistant. The ring electrodes are arranged in a positive and negative interval manner, and the polarities of the two ring electrodes at the farthest end and the closest end are the same.

3. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 2, characterized in that: A temperature sensor is disposed on the inner surface of at least one of the ring electrodes.

4. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 3, characterized in that: The annular flexible adjustable ring also includes a ring shaping wire, a shaping wire sleeve, a conductive wire and an extension wire. The ring shaping wire and the shaping wire sleeve are arranged inside the second inner cavity, the shaping wire sleeve is sleeved on the surface of the ring shaping wire, the conductive wire is connected to the ring electrode, the extension wire is connected to the temperature sensor, and the conductive wire and the extension wire pass through the tube body and are connected to the control device.

5. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 1, characterized in that: The surface of the first inner cavity is provided with a plurality of micropores for fluid perfusion, and the fluid perfused through the micropores forms a film on the surface of the annular flexible adjustable ring.

6. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 5, characterized in that: The surface of the ring electrode is provided with a plurality of micropores, and the fluid passing through the first inner cavity can be simultaneously infused from the micropores on the surface of the ring electrode.

7. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 1, characterized in that: The tube body is a three-layer composite braided tube, the inner layer of which is a multi-lumen tube made of a polymer material, the middle layer is a metal braided mesh or a metal coil, and the outer layer is a single-lumen tube made of a polymer material.

8. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 7, characterized in that: The outer layer of the three-layer composite braided tube is designed with multiple hardness sections, and the tube section of the outer layer of the three-layer composite braided tube close to the control device has a higher hardness than the tube section far from the control device.

9. The shape-adjustable pulse ablation catheter with liquid perfusion function as claimed in claim 1, characterized in that: There are at least two third cavities in the tube body, and the bending adjustment component includes an anchor head, a bending adjustment wire and a spring, the spring is sleeved on the surface of the bending adjustment wire, the bending adjustment wire is connected to the bending adjustment control unit, the anchor head is arranged at a position inside the tube body close to the annular flexible adjustable ring, the bending adjustment wire is fixedly connected to the anchor head, and the bending adjustment control unit is a two-way knob mechanism, and the bending adjustment control unit is used to control the bending shape change of the distal end of the tube body.

10. The shape-adjustable pulse ablation catheter with liquid perfusion function according to claim 1, characterized in that: The control device also includes a Luer connector, and the annular flexible adjustable ring also includes a terminal head end, which is connected to the push tube. A through hole is provided in the terminal head end, and a cavity is provided in the push tube for inserting a guide wire. The guide wire passes through the through hole and the cavity until it extends out of the Luer connector.

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