WO2014166436A1

WO2014166436A1 - Multi-electrode ablation catheter

Info

Publication number: WO2014166436A1
Application number: PCT/CN2014/075318
Authority: WO
Inventors: 胡昌; 陈诚; 谭家宏; 孙毅勇; 陈艳; 奚云珠; 孙飞飞; 罗七一
Original assignee: 上海微创电生理医疗科技有限公司
Priority date: 2013-04-12
Filing date: 2014-04-14
Publication date: 2014-10-16
Also published as: CN104095679A

Abstract

A multi-electrode ablation catheter which includes, connected in sequence, a distal portion (1), a main body portion (4) and a control handle (6); the distal portion (1) can, at least partially, reversibly change into a circumferential configuration having a lower contour configuration, the upper portion of which is provided with a plurality of electrodes (2) used for ablation. Perfusion fluid channels are provided in the main body portion (4) and in the control handle (6); the distal portion (1) includes a perfusion fluid lumen (102), a lateral wall of which perfusion fluid lumen (102) is provided with an opening. Each electrode (2) is provided with at least one perfusion aperture (203), each electrode (2) at least partially surrounds the circumferentially affixed arrangement of the distal portion (1) and forms a perfusion fluid chamber (202) between itself and a perfusion fluid lumen (102). Each perfusion aperture (203) is fluidly connected to a perfusion fluid source by means of a cavity, a corresponding opening, a perfusion fluid lumen (102), and a perfusion fluid channel. The distal portions (1) of the plurality of ablation catheters can be helical in form, thus being able to use a plurality of electrodes (2) to engage in the ablation of a plurality of targets, forming a desired shape of ablation; in addition, the electrode (2) and catheter inner cavity can be effectively used to form a coolant liquid perfusion flow path, efficiently removing heat from the electrode (2).

Description

Multi-electrode ablation catheter

The present invention relates to a multi-electrode ablation catheter for multi-electrode discharge ablation of a target site within a human vessel, and more particularly to a multi-electrode ablation catheter for use in renal artery denervation therapy and pulmonary artery radiofrequency ablation. Background technique

Refractory hypertension, also known as refractory hypertension, refers to the use of three or more antihypertensive drugs (including a diuretic) to treat hypertension that is still uncontrollable. The latest animal and clinical trial data demonstrate that radiofrequency ablation of the renal sympathetic nerve using a percutaneous catheter can permanently and effectively reduce hypertension. The method has a catheter intervention method, and the sympathetic nerve of the renal artery can be heated by the RF energy, which can weaken its activity and even lose its conduction function. The method can not only effectively treat refractory hypertension, but also has the advantages of minimally invasive and no obvious complications. The industry sees this approach as a breakthrough and is considered a new way to treat refractory hypertension. In order to achieve a deeper ablation depth, the traditional electrode uses a higher ablation power in the clinic, which is easy to form a local high temperature on the surface of the target, which is easy to cause thrombosis and eschar, which affects safety and effectiveness, and prolongs the operation time. Increase the suffering of the patient. In order to achieve deeper ablation depth, the perfusion solution can be evenly sprayed around the RF electrode at the same time as the RF ablation, so that the electrode can reach higher power without increasing the temperature rapidly, while ensuring the therapeutic effect. It can also prevent local high temperature from forming on the target surface, reduce the probability of scarring and thrombosis, and improve the safety and effectiveness of the operation. The current distal segment is a spiral electrode ablation catheter that is valued in view of its ability to smoothly deliver aspiration into the vessel to the target site and to form a desired shape around the vessel's inner wall. Those skilled in the art have developed a variety of electrode ablation catheters having a distal segment that is helical. The Chinese Patent Application Publication No. CN102198015A discloses a retractable spiral stacking-type electrode catheter which is used in conjunction with a matching sheath. The distal end of the catheter is a spiral stack ring type, which can be controlled by the expansion and contraction of the core core rod. The shrinkage and unfolding of the spiral stack, the core of the method requires a certain hardness to control the shrinkage and unfolding of the spiral stack. There is a gap between the core mandrel and the sheath, which easily forms a thrombus there. The catheter in this application does not have a perfusion fluid perfusion function, does not effectively cool the electrode and reduces the risk of scarring on the electrode surface, and does not guarantee sufficient ablation depth. The Chinese Utility Model Patent Application Publication No. CN201469401U discloses a spiral-loop renal artery renal sympathetic nerve RF electrode catheter in which the electrode is a continuous spiral type, and the electrode is too large to effectively ensure the ablation depth. There is no special protective measure at the distal end of the electrode. When the catheter enters the renal artery, it is easy to cause perforation of the renal artery, and the risk is high. And no perfusion fluid perfusion function, the risk of scarring is high. The Chinese Patent Application Publication No. CN102488552A discloses a steerable spiral electrode catheter similar to the Chinese invention patent application disclosed in CN102198015A, which also controls the contraction of the catheter through the core mandrel, and also has no perfusate. Perfusion, can not effectively cool the electrode. There is a gap between the core rod and the main body of the catheter, and the core rod and the catheter body move with each other, which is liable to cause thrombus. Chinese Patent Application Publication No. CN 1549694 A discloses a spiral electrophysiological catheter having a helically shaped distal section on which a plurality of electrodes can be disposed, the distal section extending therethrough The core member is configured to have its helical configuration and can be reversibly deformed into a lower profile configuration for smooth delivery in the vessel, but: it only mentions that coolant can be used based on feedback of temperature data, without specific disclosure The perfusion fluid infusion mechanism, and the electrode on the distal segment is preferably a spiral coil, obviously, the electrode itself cannot be The part of the flow path for the coolant is incapable of removing heat from the electrodes; in addition, the electrophysiological catheter can only be used in conjunction with the guiding catheter to deform the distal section into a lower profile and thus smoothly in the vessel Medium delivery, but when used in conjunction with a guiding catheter, it increases the total peripheral diameter, which increases the difficulty of delivery and increases patient discomfort in the thin vessel. The Chinese Patent Application Publication No. CN101309651A discloses a multi-electrode ablation catheter suitable for discharge ablation at the position of a vascular orifice, which can control the adhesion of the electrode to the target position, but has a central core in a part of the structure. There is a gap between the rod and the catheter body, which is easy to cause a thrombus; the catheter also does not have the function of perfusion fluid perfusion. U.S. Patent Application Publication No. US 2013/0304062 A1 discloses a spiral-type catheter for ablation, the change in the helical shape of the catheter is controlled by the contraction wire, and the ablation electrode can be effectively cooled by saline infusion. There are 6 chambers inside the tube, making the overall size of the tube too large, reaching 2.8mm. The renal artery radiofrequency ablation catheter is the most critical and indispensable tool for the treatment of refractory hypertension by Catheter-based renal sympathetic denervation (RDN). Clinical studies have shown that in order to obtain the best ablation end point for the effectiveness and safety of RDN, renal artery radiofrequency ablation catheters require a small outer diameter, can perform multiple ablation, and have the function of cold saline perfusion, but also need to be able to guide The silk, the guiding sheath and the like cooperate to adjust the bending function and the safety inside the blood vessel. Most of the existing patents only have a single function and a small part of the functions. Accordingly, it is desirable to provide a multi-electrode ablation catheter having a distal section that is reversibly changeable between a helical configuration and a lower profile configuration for smooth delivery in the vessel, and utilizing placement on the distal section a plurality of electrodes ablate at a plurality of target points of the inner wall of the vessel to form a desired shape of ablation; and the catheter further has a perfusate perfusion mechanism capable of effectively utilizing the inner cavity of the electrode and the catheter to form a coolant perfusion flow path Thereby, the heat is efficiently removed from all parts of the electrode; in addition, the catheter can be flexibly selected for use in conjunction with the guiding catheter, the guide wire, and the guiding sheath for smooth delivery in the vessel depending on the application; in addition, the catheter can be utilized Control The handle adjusts the size of the loop of the spiral configuration via a pull wire, so that the diameter of the spiral configuration can be adjusted when it is required to enter the vessel, and the diameter of the spiral configuration can be adjusted when the vicinity of the target is reached, so that the electrodes are closely attached. Rely on each target. In addition, the catheter can also adjust the bending deflection of the distal section of the catheter via a pull wire using a control handle such that the distal vessel bend deflection can be adjusted to enter the vessel position by the distal segment bending deflection. In addition, the catheter can also be guided into the guide wire by means of the Luer interface of the control handle so that the distal section of the catheter can be changed to a ground state (circumferential configuration, such as a helical configuration or a ring configuration) and an expanded state by a guide wire when needed. The low profile configuration) allows the vessel to reach the target when needed. In addition, it is sometimes necessary to strictly limit the target of ablation within the longitudinal narrow band, which requires a multi-electrode ablation catheter with a diameter-adjustable annular ring attached to the distal end of the distal segment, which can also be smoothly in the vessel. Delivery, a plurality of electrodes disposed on the annular ring can be used to ablate at a plurality of targets on the inner wall of the vessel that are approximately one turn, forming a desired shape of ablation. Summary of the invention

The present invention provides a multi-electrode ablation catheter comprising a distal section, a body section and a control handle that are sequentially connected, at least a portion of the distal section being a circumferential configuration that can be reversibly changed to a lower profile configuration And a plurality of electrodes for ablation disposed thereon, wherein: the body segment and the control handle are provided with a perfusate channel; the distal segment comprises a perfusion fluid lumen, and the perfusion fluid lumen is on the side wall An opening; and each of the electrodes is provided with at least one perfusion hole, disposed circumferentially around the distal segment, and forming a cavity with the perfusate lumen, each perfusion hole via the cavity, a corresponding opening, The perfusate lumen, the perfusate channel is fluidly coupled to a source of perfusion fluid external to the catheter. With the multi-electrode ablation catheter, the helical configuration of the distal segment can be adjusted as desired, for example, when the multi-electrode catheter is to enter the vessel, it can be changed to a lower profile configuration for smooth access to the vessel and delivery therein. And when it has been delivered to the target site, the helical configuration of the distal segment can be restored to ablate against the target location on the sidewall, ensuring ablation depth and avoiding damage to surrounding tissue; and, the distal side can be utilized a plurality of electrodes disposed on the segment ablate at a plurality of target points of the inner wall of the vessel to form a desired shape of ablation; and the catheter further has a perfusate perfusion mechanism capable of effectively utilizing the lumen of the electrode and the catheter to form a cooling The liquid is perfused into the flow path, thereby efficiently removing heat from all parts of the electrode, including the inner and outer walls. The circumferential configuration can take a variety of forms. Two preferred forms are: the distal segment is in a helical configuration, or the distal segment is in an annular configuration. Preferably, the respective electrodes are evenly distributed over a week of the distal segment portion that presents a circumferential configuration. Thereby, each of the smaller-sized electrodes can be used to form a desired ablation shape. Preferably, the perfusion holes on the respective electrodes are arranged in one or more rows, the perfusion holes in the single row are evenly arranged in the circumferential direction, and the perfusion holes in the adjacent rows are staggered. Thereby, the perfusate can be effectively infused into the respective regions of the electrode surface via the respective perfusion holes thus distributed, thereby effectively achieving the cooling and cooling effect of the electrodes. Preferably, the distal segment is a multi-lumen tube, which can be heat-treated according to the NITI shaped wire or the polymer material of the multi-lumen tube to maintain the spiral configuration or the annular configuration of the distal segment. . The heat treatment temperature is from 100 ° C to 140 ° C, and the heat treatment time is from 30 minutes to 60 minutes. Preferably, the heat treatment parameters are: 110 ° C, 30 minutes. The configuration of the multi-lumen tube facilitates the use of the respective chambers to accommodate the desired components, respectively, to avoid mutual interference between the members. To save space, it is also possible to accommodate some components together in the same cavity, while ensuring that some components do not interfere with each other, such as wires and temperature sensing wires. Preferably, a proximal side of the control handle is provided with a connector conduit, the connector conduit is provided with a first luer connector, and the perfusate channel is connected to the first luer connector via the connector conduit and the first luer connector Prime fluid source. Preferably, the perfusion hole is prepared by one of mechanical hole formation, electric spark hole formation, and laser hole formation. Preferably, the perfusion hole has a diameter of 0.02 mm to 0.5 mm, and the number of perfusion holes is 2 to 40. The invention also provides a multi-electrode ablation catheter comprising a distal section, a main connection a body segment and a control handle, the distal segment is provided with a plurality of electrodes for ablation, wherein the distal segment is in an annular configuration, and the electrode is disposed on the annular ring of the annular configuration . The design of the distal segment with the annular ring is adapted to the strict limitation of the longitudinal extension of the target, and the diameter of the annular ring can be reduced when it is delivered in the vessel, and can be closely attached to the inner wall of the vessel. Increase the diameter of the annular ring. Preferably, the distal section of the two multi-electrode ablation catheters is a multi-lumen tube, wherein one cavity has a nanowire, the control handle is coupled to the cable, under the adjustment of the control handle, the spiral configuration or The diameter of the annular ring changes or the bending deflection angle of the distal segment changes. Thereby, the diameter of the spiral configuration or the annular ring can be adjusted accurately and conveniently using the control handle as needed. For example, when the multi-electrode catheter is to enter the vessel, the diameter can be adjusted to facilitate smooth access to the vessel and delivery therein; When delivered to the target site and the diameter of the helical configuration or annular ring is smaller than the inner diameter of the vessel, so that the side wall of the vessel is not in close contact, the diameter can be adjusted to closely abut the target position on the sidewall to ensure the depth of ablation. And to avoid damage to the surrounding tissue. Preferably, the distal section of the two types of multi-electrode ablation catheters is a multi-lumen tube, wherein one lumen contains a guide wire, the access of the guide wire causes the distal section to straighten, and the withdrawal of the guidewire causes the distal section Restore configuration, such as returning a spiral configuration or returning a circular configuration. Thus, the multi-electrode ablation catheter can be used in conjunction with a commercially available guidewire to facilitate convenient delivery. Preferably, the control handle is provided with a second luer connector on the proximal side, and the guide wire is guided into the catheter via the second luer, whereby the guide wire can be flexibly manipulated. The present invention also provides a multi-electrode ablation catheter comprising a distal section, a body section and a control handle that are sequentially connected, the distal section being of a helical configuration, capable of reversibly changing to a lower profile configuration, and being disposed thereon There are multiple electrodes for ablation, characterized in that: the distal segment is a multi-lumen tube, wherein one cavity contains a guide wire, the access of the guide wire makes the distal segment straight, and the withdrawal of the guide wire makes the distal side The segment returns to the helical configuration. Thus, the multi-electrode ablation catheter in which the distal section is in a helical configuration can be used in conjunction with a commercially available guidewire to facilitate convenient delivery. The present invention further provides a multi-electrode ablation catheter comprising a distal section, a body section and a control handle that are sequentially connected, the distal section being in a helical configuration, capable of reversibly changing to a lower profile configuration, and on which Arranging a plurality of electrodes for ablation, wherein: the distal segment is a multi-lumen tube, wherein a cavity has a nanowire, the control handle is coupled to the wire, and under the adjustment of the control handle, the spiral structure The size of the diameter of the type changes or the angle of deflection of the distal section changes. The novel multi-polar ablation catheter can be coupled to the guidewire to deliver the ablation catheter to the target site, or can be coupled to the guidewire and the introducer sheath to deliver the ablation catheter to the target site. In addition, the multi-polar ablation catheter has a saline perfusion function, and a certain number of perfusion holes are distributed on each ablation electrode, which can effectively perfuse the electrode, reduce the electrode problem and reduce the risk of scarring on the electrode surface. DRAWINGS

In order to more clearly describe the technical solution of the present invention, a brief description will be made below with reference to the accompanying drawings. It is obvious that these drawings are only some of the specific embodiments described herein. In accordance with the present invention, including but not limited to the following figures. Hereinafter, the side far from the operator close to the target is the far side, and the side close to the operator is the near side. A lower profile configuration or an unfolded state indicates a configuration that is closer to a straight line, such as a small diameter spiral configuration or an adjustable annular ring phase with a larger diameter spiral configuration or an adjustable annular ring, respectively, a low profile configuration. The configuration of the helical configuration in the stretched (including straightened) state is a lower profile configuration than the original helical configuration. The circumferential configuration or ground state represents a configuration that extends in the circumferential direction and has a variety of forms, such as a distal configuration of a helical configuration or a toroidal configuration. The annular configuration represents a configuration in which the straight portion is connected to the annular ring, and the number and position of the annular ring can be determined as needed. Where the distal segment is of a helical configuration, a week of the distal segment portion exhibiting a circumferential configuration represents a helical portion of the helical configuration of one pitch, and wherein the distal segment is of a circular configuration, A week of the distal segment portion that presents a circumferential configuration represents one of the annular rings. The ring electrode means that the electrode is a hollow rotating body which is open at both ends in the axial direction, and the rotating body may be a straight cylinder, or may have an undulating circumference, and may be chamfered on both sides as far as necessary. Furthermore, the term "fluid connection" means connected in such a way as to transfer fluid, for example two "fluidly connected" components, indicating that fluid can be transported between two components. 1 illustrates a multi-electrode ablation catheter that can be passed through a guidewire and also has a perfusion fluid perfusion function, in accordance with an embodiment of the present invention;

Figure 2 shows an illustration of Figure 1 taken to the left along the a-a line;

Figure 3 shows a schematic view of a ring electrode having a boss;

Figure 4 is a view showing the manner of fixing between the ring electrode shown in Figure 3 and the distal section of the catheter and the flow path of the perfusate;

Figure 5A is a schematic view showing the distribution of a perforated hole of a straight ring electrode and its surface; Figure 5B is a schematic view showing the distribution of a perforation hole of another straight ring electrode and its surface;

Figure 5C shows a schematic view of a further straight ring electrode and a perfusion hole distribution on its surface;

Figure 6 is a view showing the manner of fixing the straight ring electrode and the distal section of the catheter and the flow path of the infusion solution;

Figure 7 is a schematic view of the multi-electrode ablation catheter of Figure 1 before and after the introduction of the guide wire; Figure 8 is a cross-sectional view of Figure 7 taken along line b-b;

9 shows a schematic view of a multi-electrode ablation catheter that can be used in conjunction with a guiding catheter, in accordance with an embodiment of the present invention;

Figure 10 shows a schematic view of a multi-electrode ablation catheter that can be used in conjunction with a guidewire in accordance with an embodiment of the present invention;

Figure 1 1 shows a schematic view of a multi-electrode ablation catheter having a perfusion fluid perfusion function, in accordance with an embodiment of the present invention;

Figure 12 shows the addition of a multi-electrode ablation for the adjustment of the helical configuration of the distal section of the multi-electrode ablation catheter based on the multi-electrode ablation catheter shown in Figure 11. Schematic diagram of the catheter and before and after adjustment;

Figure 13 is a view showing the left side of the line c-c in Figure 12;

Figure 14 is a view showing a multi-electrode ablation catheter provided with the helical configuration adjustment mechanism shown in Figure 12 and before and after adjustment according to an embodiment of the present invention, the multi-electrode ablation catheter being used in conjunction with a guiding catheter;

15 is a schematic view of a multi-electrode ablation catheter provided with the helical configuration adjustment mechanism shown in FIG. 12 and before and after adjustment according to an embodiment of the present invention. The multi-electrode ablation catheter can be used in conjunction with a guiding catheter or a guide wire as needed. , and has perfusion liquid perfusion function;

Figure 16 is a schematic view showing a multi-pole ablation catheter of an annular ring configuration adjusting mechanism according to an embodiment of the present invention;

Figure 17 is a view showing the left side of the line e-e in Figure 16;

Figure 18 is a schematic view showing the unfolded state of the intraoperative multistage catheter;

Figure 19 shows a schematic diagram of the ground state of an intraoperative multistage catheter. Description of the reference numerals

1 distal segment of a multi-electrode ablation catheter

2 ablation electrode

3 filling hole

4 main body segment of multi-electrode ablation catheter

5 handle function

6 function handle

7 tail cable socket

8 luer connector

9 connector conduit

10 luer connector

1 1 perfusate

12 pull line

13 wire

14 temperature sensing line

16 circumference 17 circumference

21 guide wire elastic section

22 guide wire

23 guide wire proximal end

101 multi-lumen tube

102 perfusate lumen

103 guide wire lumen

104 pull tube lumen

105 wire lumen

106 electrode bottom with boss and multi-lumen tube connection

107 electrode bottom with boss and smoothing of multi-lumen tube

108 ring electrode and multi-lumen tube smoothing

201 ring electrode with boss

202 perfusate cavity

203 filling hole

204 bottom of ring electrode with boss

205 over-extension of the ring electrode with a boss

206 filling hole

207 boss portion of a ring electrode having a boss

208 perfusate cavity

209 straight ring electrode

210 filling hole

21 1 Multi-lumen tube side opening under the ring electrode with boss

212 ring electrode under the multi-lumen tube side opening

213 a straight ring electrode

214 a straight ring electrode embodiment

In order to further understand the present invention, the preferred embodiments of the present invention will be described below in conjunction with the embodiments. These descriptions are merely illustrative of the features and advantages of the present invention and are not intended to be limiting The scope of protection of the invention. 1 illustrates a multi-electrode ablation catheter with a perfusion fluid perfusion function and a perfusion fluid perfusion function, including a distal section 1, a body section 4, and at least a portion of a circumferential configuration that are sequentially connected, in accordance with an embodiment of the present invention. Controlling the handle 6, wherein the circumferential configuration of the distal section 1 can be reversibly changed to a lower profile configuration, such as being straightened, under the action of an external force, such as insertion into the lumen of the guiding catheter or via the access guidewire 22. , to get into the vessel more smoothly and deliver it to the target location. The circumferential configuration can take a variety of forms, for example, the distal segment 1 can be in a helical configuration or an annular configuration, with the one or more annular rings in the helical configuration or annular configuration to form the circumferential configuration. . As an example of an annular configuration, the distal end of the distal section 1 is provided with (e.g., attached) an annular ring, which is preferably of adjustable diameter. Hereinafter, the distal section 1 is first taken as an example of a spiral configuration, but those skilled in the art know that other forms of circumferentially extending circumferential configuration that can be changed to a lower profile configuration by an external force are also available. The various configurations that are applicable in the case where the distal section 1 is of the helical configuration can also be applied correspondingly to the case where at least part of the distal section 1 is of other forms of circumferential configuration. At least one electrode 2 for ablation of the target point is arranged on the distal section, each electrode 2 being at least partially arranged circumferentially around the distal section. The respective electrodes 2 may be fixedly arranged around the circumference of the distal section, whereby various loops may be employed, for example, a ring electrode 201 provided with a boss in the middle section as shown in Fig. 3 and as shown in Figs. 5A-5C Straight ring electrode 209 and the like. Depending on the application, the individual electrodes 2 can also be partially annular. Wherein, the electrode 2 may be provided with at least one perfusion hole 3, and during ablation in the body, for example, radiofrequency ablation of the renal artery denervation, perfusion fluid perfusion may be performed via a perfusion mechanism, the perfusion mechanism being configured as follows: body segment and control handle a perfusate channel is provided therein; the distal segment includes a perfusate lumen 102 (shown in FIG. 8) having an opening in a sidewall of the perfusate lumen 102; and each electrode 2 and perfusate lumen 102 Cavities are formed therebetween (such as perfusate cavities 202 and 208 as shown in Figures 4 and 6), each perfusion hole 3 via the perfusate chamber 202, corresponding opening (opening 21 as shown in Figures 4 and 6) 1 and 221), the perfusate lumen 102, the perfusate channel is fluidly connected to a source of perfusion fluid external to the catheter. Pass With the perfusion mechanism, the perfusate can be delivered from the perfusate source via the perfusate channel, the perfusate lumen 102 and the opening to the perfusate chamber 202, where it accumulates, and the electrode 2 is absorbed from the inner wall during accumulation. The heat, when filled, ejects the perfusate from the perfusion hole 3, scouring and cooling the outer wall of the electrode, thereby more effectively cooling the electrode 2 and efficiently removing heat from the entire portion thereof, thereby being able to be on the electrode 2 Enter more energy to ensure the depth of electrode ablation. The distal section 1 of the helical configuration may be a multi-lumen tube, and the perfusion fluid lumen 102 is one of the chambers, and each of the other chambers may respectively contain a desired component, such as a guide wire, a wire pull wire, and a temperature sensing wire. One or more of the various components, such as wires and temperature sensing wires, can also be housed in the same cavity without affecting the respective operations. The multi-lumen tube can be made of a block copolymer of polyurethane, polyether and polyamide, nylon or the like, and the number of cavities of the multi-lumen tube is 1-6, preferably the number of cavities is 2-5. The multi-lumen tube can be shaped by the heat treatment of the NITI shaped wire or the polymeric material of the multi-lumen tube to maintain the helical shape of the distal section 1. The heat treatment temperature is 100 ° C - 140 ° C, and the heat treatment time is 30 minutes.

60 minutes. Preferably, the heat treatment parameters are: 110 ° C, 30 minutes. The distal section 1 of the helical configuration of the multi-polar ablation catheter according to the present invention is prepared from a multi-lumen tube. One of the lumens of the multilumen tube is a guidewire lumen. The guidewire lumen is adapted to pass through the guidewire, i.e., the distal segment 1 of the helical configuration of the catheter can be changed by the guidewire to be in a grounded or expanded state, and the distal section of the helical configuration can be passed through the guidewire. Delivery to the specified target position can effectively avoid damage to the vessel by the spiral catheter and improve the safety of the operation. The distal section 1 of the helical configuration of the multi-polar ablation catheter according to the present invention is prepared from a multi-lumen tube. One of the multi-lumen tubes is a wire lumen. One end of the pull wire is fixed on the distal section 1 of the catheter, passes through the wire lumen of the distal section 1 of the spiral configuration, enters the wire tube cavity in the main body section of the catheter, and is then fixedly connected to the control handle, and the pull wire is controlled by the handle. The movement in the lumen to achieve a change in the helical diameter and bending deflection of the distal section 1 of the helical configuration of the catheter, the bending deflection angle being 0-180°, preferably the bending deflection angle being 0-90°, the wire can be But not limited to nickel-titanium alloy wire, stainless steel wire, polyurethane wire, polyether wire, Preparation of materials such as block copolymer yarns of polyamide. The multipolar ablation catheter according to the present invention may be helical multipolar ablation. The multi-polar ablation catheter can increase saline perfusion function; the multi-polar ablation catheter can be used to change the spiral shape of the spiral catheter to a ground state or a deployed state by a guide wire; the multi-pole ablation catheter can simultaneously increase saline perfusion and can be used for a saline infusion The spiral shape of the spiral catheter is changed to a ground state or an expanded state; the multi-pole ablation catheter can also increase the function of the adjustable circle. The invention introduces the application in a multi-electrode ablation catheter by taking a four-lumen tube as an example. The diameter of the multi-lumen tube is 0.9-3.0 mm, and the four chambers are the guide wire lumen 103, the wire lumen 104, and the perfusion fluid lumen 102. And the wire lumen 105. A pull wire 12 is fixed in the cable lumen 104, and the pull wire 12 can control the change in the diameter of the spiral of the distal section 1 of the catheter through the handle function 5. Moreover, the pull wire 12 can also control the bending deflection of the catheter distal section 1 by the handle function 5 by the different coupling positions of the distal end of the wire 12 on the distal section 1 of the catheter. That is, by the distal end of the pull wire 12 at a coupling position of the distal section 1 of the catheter, the change in the diameter of the distal section 1 of the catheter can be controlled, while the other end of the distal section 1 of the catheter is coupled via the distal end of the cable 12 The position can control the bending deflection of the distal section 1 of the catheter; both of these controls can be achieved by operation of the handle function 5. The pull wire may be prepared from materials such as, but not limited to, nitinol wire, stainless steel wire, polyurethane wire, polyether wire, block copolymer yarn of polyamide. A guide wire 22 can be introduced into the guide lumen 103 in the catheter. The multi-pole ablation catheter described in the patent can be used in conjunction with the guide wire 22, and can be used to change the spiral shape of the spiral catheter to the ground state through the guide wire 22 ( See Figure 19) or the expanded state (see Figure 18). Deliver the multipolar ablation catheter to the target site within the human vessel. For example, the guidewire 22 is first routinely advanced into the renal artery via the femoral artery and the multi-polar ablation catheter is then delivered along the guidewire 22 to the target site of the renal artery vessel. A schematic view of the front and rear of the multi-electrode ablation catheter leading into the guide wire 22 is shown in FIG. The number of electrodes 2 disposed on the distal section of the helical configuration may be from 1 to 15, preferably from 4 to 10. The electrode 2 can be made of a material such as platinum-rhodium alloy, gold, silver, platinum, copper, stainless steel, etc. The perfusion hole 3 on the electrode 2, as shown in the perfusion hole D in FIGS. 4 and 6, can be mechanically required as needed. One way to make holes, spark holes, and laser holes To prepare. A wire 13 is connected to each of the electrodes 2, and a heat sensor for sensing the temperature of the electrode at the time of discharge ablation is provided in the vicinity of the electrode 2. The heat sensor is connected to the temperature sensing wire 14 in the wire lumen 105, and the wire 13 and the temperature sensing wire 14 pass through The distal section 1 and the body section 4 of the helical configuration are then connected to the tail line socket 7 at the proximal end of the control handle 6, for respectively transmitting electrical signals and/or pulsed RF energy and temperature feedback signals, thereby greatly enhancing the ablation Safety of use of the catheter. The main body section 4 of the multi-electrode ablation catheter is composed of a braided wire and a polymer material prepared from a polymer material, and the braided wire comprises a nickel-titanium wire, a stainless steel wire, a polyurethane wire, a polyether wire, and a block copolymer wire of a polyamide. One or more, and the braided filaments may be a single layer of braided silk or a multi-layer braided filament; the polymeric material is selected from the group consisting of polyurethane, polyether and polyamide block copolymers, nylon, and the like. Control handle 6 for the operator to hold, can be polypropylene (PP), polyethylene (PE), silicone, rubber, polyoxymethylene (POM), polyvinyl chloride (PVC), copolyester (PETG), polystyrene ( HIPS), acrylonitrile-butadiene-styrene plastic (ABS) and other materials are prepared, connected to the main body section 1, for various control of the catheter. The proximal end of the control handle 6 can have a tail cable socket 7 for connecting the radio frequency meter through a matching tail wire. The proximal end of the control handle 6 can be provided with a connector conduit 9 that connects the Luer connector 8 and the Luer connector 10, respectively. The Luer connector 8 is used for fluid connection to the perfusion solution 11, and the perfusate 11 enters the multi-electrode ablation catheter from the Luer connector 8, and sequentially passes through the connector catheter 9, and the perfusion fluid channel in the control handle 6 (not shown) Entering the body segment 4, and then, as shown in Fig. 4, enters the perfusate lumen 102 in the distal section 1 of the helical configuration, and then the perfusate 11 passes through the multilumen tube sidewall opening 211 and enters the perfusate lumen 202, finally The perfusion liquid cavity 202 in the annular electrode 201 having the boss in the middle section is filled with the perfusate 11 and continuously ejected, taking away a large amount of heat, which can effectively remove the energy of the electrode and lower the temperature of the electrode. , also reduces the risk of scarring on the electrode surface. The perfusate can be selected as a safe coolant for the human body, such as cold saline. As seen in Figure 2, looking axially to the left in Figure 1, the helical configuration of the distal section 1 is superimposed on a circle having a diameter of 3-30 mm. All of the electrodes 2 are evenly distributed over one week of the spiral configuration. When the number of the electrodes 2 is four, it appears in Fig. 2 that the electrodes 2 are evenly divided. The cloth is placed on the circumference of the circle with an adjacent angle of 90 °. Preferably, the perfusion holes 3 are evenly distributed on the surface of each of the electrodes 2 in the circumferential direction. When the number of the electrodes 2 exceeds 4, the electrodes 2 are evenly distributed on the circumference of the circle. As seen in Fig. 2, the angle between the electrodes 2 can be various, and the number of 360° / electrode 2 is obtained. Its degrees, typical angles include 72°, 60°, 45 °, and 40 °. The angles described above are typical angles, but the present invention is not limited to the above-described cases, and is still applicable to similar other angles. Figure 3 shows a schematic view of a ring electrode 201 having a boss. The ring-shaped electrode 201 having a boss includes a bottom portion 204, a boss portion 207, and an excessive portion 205 connecting the two, and a filling hole 203 distributed on the boss portion 207, and the filling hole 203 can penetrate the boss portion

The side wall of the 207, the side wall of the boss portion 207 and the perfusate tube lumen 102 form a perfusate chamber 202 as shown in FIG. 4, whereby each of the perfusion holes 203 passes through the perfusate chamber 202, the corresponding opening ( The opening 21 1 ) shown in Fig. 4, the perfusate lumen 102, the perfusate channel are fluidly connected to a perfusion fluid source external to the catheter for perfusion using the delivered perfusate. The number of the filling holes 203 on the ring electrode 201 having the boss is at least one, and the number of the filling holes 203 on the ring electrode 201 having the boss shown in FIG. 3 is six, and is divided into two rows, each of which is distributed. The rows are evenly distributed with three infusion holes 203 in the circumferential direction, and the two rows of perfusion holes 203 are staggered, as shown in FIG. The perfusate can be effectively infused into each region of the electrode surface via the respective perfusion holes, thereby effectively achieving the cooling and cooling effect of the electrodes. The number and number of rows of the filling holes 203 of the ring-shaped electrode 201 having the boss shown in FIG. 3 are only examples, and the number of the filling holes 203 may be any one of 2-40, and the number of rows may be 2- Any number in the 6 rows. The diameter of the perfusion hole 203 is 0.02-0.5 mm, and preferably, the diameter of the perfusion hole is 0.08-0.2 mm. Fig. 5A shows a schematic view of a distribution of a perforated hole of a straight cylindrical electrode and its surface. The ring electrode 209 is provided with two rows of filling holes 210, and each row is uniformly distributed with three filling holes 210 in the circumferential direction, and the two rows of filling holes 210 are staggered. Fig. 5B shows a schematic view of another straight cylindrical electrode and a perfusion hole distribution on its surface. The annular electrode 214 is provided with two rows of filling holes 210, and each row is uniformly distributed with four filling holes 210 in the circumferential direction, and the two rows of filling holes 210 are staggered. Figure 5C shows still another straight ring electrode and its surface perfusion Schematic diagram of pore distribution. The ring electrode 213 is provided with three rows of filling holes 210, and each row is uniformly distributed with three filling holes 210 in the circumferential direction. The filling holes 210 of any two adjacent rows of the three rows of filling holes 210 are staggered. . As shown in Fig. 5C, the adjacent rows of perfusion holes 210 are circumferentially offset by 60 degrees such that the first and third rows of perfusion holes 210 are circumferentially aligned. The perfusion holes on the ring electrodes shown in Figures 5A-5C are arranged as an example of the invention, and an arrangement of other numbers of perfusion holes in 2-40 may be taken as needed. Preferably, the perfusion holes on the respective electrodes are arranged in one or more rows, the perfusion holes in the single row are evenly arranged in the circumferential direction, and the perfusion holes in the adjacent rows are staggered so that the electrodes can be separated from the plurality of longitudinal positions. The perfusate is evenly sprayed at a plurality of angular positions in the circumferential direction to evenly remove heat from the electrodes. As the number of perfusion holes increases on the ring electrode, the diameter of the perfusion hole is correspondingly reduced. Conversely, as the diameter of the perfusion hole increases on the ring electrode, the number of perfusion holes is correspondingly reduced. Preferably, the number of the perfusion holes on the ring electrode is 4-20, and is arranged in one or more rows. The perfusion hole on the ring electrode can be prepared by mechanical hole formation, electric spark hole formation, laser hole formation, etc., the perfusion hole has a diameter of 0.02 mm to 0.5 mm, and preferably, the perfusion hole has a diameter of 0.08-0.2. Mm. Figure 4 shows a schematic representation of the manner of attachment between the ring electrode shown in Figure 3 and the distal section of the catheter and the flow path of the perfusate. The ring electrode 201 having the boss is fixed to the multi-lumen tube 101, and the bottom portion 204 of the ring electrode having the boss is in contact with the multi-lumen tube 101, and the contact portions thereof are sealed and fixed by heat welding, glue or mechanical means. The boss portion 207, specifically the inner wall thereof, forms a perfusate chamber 202 with the multi-lumen tube 101. The perfusion fluid lumen 102 in the multi-lumen tube 101 has an opening 21 on the side wall thereof, and the perfusate 1 1 enters the multi-electrode ablation catheter from the Luer connector 8 (shown in FIG. 1) through the multi-electrode ablation catheter. The perfusate channel (not shown in Figure 1) enters the perfusate lumen 102 in the distal section 1 (multi-lumen tube 101) of the helical configuration, and the perfusate 1 1 enters the multilumen tube along the direction indicated by arrow "A" 101, after the opening 21 1 on the side wall of the perfusion fluid lumen 102, the perfusate 1 1 is divided into two directions, a portion continues to flow distally along the perfusion fluid lumen 102, as indicated by the arrow "C"; A portion enters the cavity 202 via the sidewall opening 21 1 along the direction of the arrow "B". Perfusion The liquid 1 1 is filled with the perfusate chamber 202, and flows out from the six perfusion holes 203 on the ring electrode 201 having the bosses, as indicated by an arrow "D" in FIG. The perfusate 1 1 continuously enters the perfusate chamber 202 and flows out or ejects from the perfusion hole 203 after filling the perfusate chamber 202, and the perfusate 1 1 continuously flows from the inner wall of the ring electrode 201 during accumulation in the perfusate chamber 202. The heat is absorbed, and the outer wall of the ring electrode 201 can be flushed and cooled after flowing out or ejected from the filling hole 203, whereby heat can be sufficiently absorbed from the inside and the outside of the ring electrode 201 having the boss, and the convexity can be effectively reduced. The temperature of the ring electrode 201 of the stage can increase the discharge ablation power, increase the ablation depth, and reduce the risk of scarring on the electrode surface. Figure 6 shows a schematic representation of the manner in which the straight ring electrode is secured to the distal section of the catheter and the perfusate flow path. The straight ring electrode 209 has a substantially straight cylindrical shape except for the edges (shown by oblique lines) on both sides, and is fixedly coupled to the multi-lumen tube 101. The both side edges of the ring electrode 209 are sealed and fixed to the multi-lumen tube 101 by glue or thermal connection, so that the middle portion (the inner wall) of the ring electrode 209 and the perfusate tube lumen 102 in the multi-lumen tube 101 (the outer wall) A perfusate chamber 208 is formed between them. Similar to the situation shown in Figure 4, after the perfusate 1 1 enters the perfusate lumen 102, it flows in the direction indicated by arrow "A" and is split into two directions at the opening 212 in the side wall of the perfusate lumen 102: A portion continues to flow distally along the perfusate lumen 102, as indicated by arrow "C" in Figure 6, and another portion flows into the perfusate chamber 208 via the sidewall opening 212 in the direction indicated by arrow "B", the perfusate After filling the perfusate chamber 208, it flows out of the perfusion hole 206 on the ring electrode 209, as indicated by the arrow "D" in FIG. The perfusate 1 1 continuously absorbs heat from the inner wall of the ring electrode 209 during the accumulation of the perfusate chamber 208, and can flush and cool the outer wall of the ring electrode 209 after flowing out or ejecting from the perfusion hole 206, thereby enabling The inside and the outside of the ring electrode 209 having a straight cylinder sufficiently absorb heat, which can effectively lower the temperature of the ring electrode 209 having a straight cylinder, can increase the discharge ablation power, increase the ablation depth, and reduce the risk of scarring on the electrode surface. Figure 7 is a schematic illustration of the multi-electrode ablation catheter of Figure 1 before and after accessing the guidewire. The multi-electrode ablation catheter has a perfusion fluid perfusion function, can be used with a guide catheter of a suitable size on the market, or can be used with a guide wire of a suitable size on the market to deliver the multi-electrode ablation catheter to the human body. Target site. Multi-electrode ablation catheter access guide After the wire 22, the body of the guide wire 22 provides a supporting force to stretch the distal section 1 of the helical configuration of the multi-electrode ablation catheter in an expanded state (see Figure 18). As shown in the dotted line in Figure 7. The guide wire 22 enters the multi-electrode ablation catheter from the Luer connector 10 and then enters a guidewire channel (not shown) in the multi-electrode ablation catheter. The distal end of the guidewire channel is provided with an opening for the distal end of the guide wire. Out. The surface of the guidewire 22 has an ultra-slip coating that allows the guidewire 22 to pass smoothly within the guidewire channel within the multi-electrode ablation catheter. In this way, the multi-electrode ablation catheter can be used to change the helical configuration of the distal section 1 of the catheter into a ground state or a deployed state through the guide wire 22, and the multi-electrode ablation catheter can be successfully passed through the femoral artery through the blood to the human body through the guide wire. The target position of the vessel can effectively avoid the damage of the vessel to the vessel in the distal section 1 of the spiral configuration, and improve the safety of the operation. These target locations include, but are not limited to, renal artery blood vessels, pulmonary artery blood vessels, and the like. When the guide wire 22 enters the vessel, the distal end of the guide wire 22 is provided with a flexible sheath 21 which is very compliant, and can smoothly enter the human vessel without damaging the vascular tissue. The proximal end 23 of the guidewire can be secured so that the guidewire 22 can be positioned after it enters the body's vasculature. After the distal segment 1 of the helical configuration is positioned at the target of the vessel in the human body, the guide wire proximal end 23 is pulled back to withdraw the guide wire 22, causing the distal segment 1 of the helical configuration to return to a helical or ground state ( See Figure 19) so that the electrode 2 effectively abuts the target position within the vessel. Figure 8 shows a cross-sectional view of Figure 7 taken along line bb. As shown in Fig. 8, the multi-lumen tube 101 comprises four chambers, a perfusate tube chamber 102, a guide tube lumen 103, a pull tube lumen 104 and a lead lumen 105. Wherein, the perfusate lumen 102 is used as a part of the perfusate flow path for transmitting the perfusate; the guidewire lumen 103 is for guiding the guide wire to guide the multi-electrode ablation catheter to the target position of the human vessel A pull wire 12 is fixed in the pull tube lumen 104 for controlling a change in the diameter of the spiral of the distal section of the catheter and a change in the bending deflection angle of the distal end of the catheter. The pull wire 12 may be selected from, but not limited to, a nickel-titanium alloy wire, a stainless steel wire, a polyurethane. Wire, polyether wire, polyamide block copolymer wire and the like; the wire lumen 105 contains the wire 13 and the temperature sensing wire 14, the wire 13 and the temperature sensing wire 14 are sequentially connected through the main body segment 4 and the control handle 6 Connect to the corresponding pin on the tail socket 7 to transfer electrical signals and deliver RF pulse energy. Figure 9 illustrates a multi-electrode that can be used in conjunction with a guiding catheter in accordance with an embodiment of the present invention. Schematic diagram of an ablation catheter. The illustrated multi-polar ablation catheter comprises a distal section of the catheter in a helical configuration

1. Ablation electrode 2, catheter body section 4, handle function member 5, function handle 6 and tail line socket 7. The multi-polar ablation catheter can be used in conjunction with a guiding catheter that first reaches a target point of the human vessel, and the multi-polar ablation catheter fixes the multi-polar ablation catheter after the guiding catheter reaches the target position. Withdrawing the guiding catheter, the distal segment 1 of the multipolar ablation catheter is restored to the helical configuration, ie, the ground state (see Figure 19), and the ablation electrode 2 on the distal segment 1 of the helical configuration abuts the target on the vessel Point location. The target position can then be extracted and the pulsed RF energy delivered to achieve the discharge ablation function. As shown in FIG. 14, an adjustable loop common handle multi-pole ablation catheter has a pull-tab 12 (see FIG. 8) in the handle function member 5, and the pull-wire 12 controls the distal section of the catheter in a spiral configuration by the handle function 5. The diameter of the spiral ring is the same as the bending deflection angle. 10 is a schematic view showing a multi-pole ablation catheter that can be passed through a guidewire in accordance with an embodiment of the present invention. The illustrated multi-polar ablation catheter comprises a catheter distal section 1, ablation electrode 2, catheter body section 4, handle function 5, functional handle 6, tailline socket 7, and luer connector 10. The multi-polar ablation catheter contains a guidewire channel (not shown). After the guidewire 22 is introduced into the multi-polar ablation catheter, the guidewire 22 can extend the distal section 1 of the helical configuration into a deployed state (see Figure 18). The guide wire 22 reaches the target position in the vessel, and then after the multi-electrode ablation catheter reaches the target position along the guide wire 22, the guide wire 22 is withdrawn, and the distal segment 1 returns to a helical configuration, so that the electrode abuts the target point. position. The target position can then be extracted and the pulsed RF energy delivered to achieve the discharge ablation function. Figure 1 1 shows a schematic view of a multi-electrode ablation catheter having a saline perfusion function comprising a distal section 1 in a helical configuration, a plurality of electrodes 2 arranged around a distal segment 1, 2 electrodes 2, in accordance with an embodiment of the present invention. The upper perfusion hole 3, the main body section 4, the handle function 5, the control handle 6, the tail cable socket 7, the luer connector 8, and the connector conduit 9. The body section 4 and the control handle 6 are provided with a perfusate channel (not shown), and the perfusate from the perfusate source passes through the luer connector 8 and enters the distal section 1 of the spiral configuration through the perfusate channel. Then, it enters the inner wall of the electrode 2 and the perfusate chamber 202 of the perfusate lumen 102 (see FIG. 4), and finally flows out of the electrode 2 through the perfusion hole 203, and the perfusate 1 can be efficiently taken from the inside and the outside. The heat on the electrode 2 is moved, so that the power on the electrode 2 can be increased, and the ablation depth of the target position can be increased. Figure 12 is a schematic illustration of a multi-electrode ablation catheter obtained before and after conditioning with the addition of a mechanism for adjusting the helical configuration of the distal section of the multi-electrode ablation catheter based on the multi-electrode ablation catheter of Figure 11. The multi-electrode ablation catheter comprises a distal section 1 of a helical configuration, an electrode 2, a perfusion orifice 3, a body section 4, a handle function 5, a control handle 6, a tail socket 7, a luer 8 and a connector conduit 9. Wherein the handle function member 5 is used for controlling the diameter of the spiral configuration of the distal segment 1, facilitating the multi-electrode ablation catheter to adjust the size of the spiral ring, so that the multi-electrode ablation catheter can easily enter the vessel in the human body, and the electrode can be Effectively abuts the vessel wall. As shown in FIG. 15, a handle function member 5 on a multi-pole ablation catheter of a bendable type guideable ribbon saline infusion function has a pull wire 12 (see FIG. 8), and the pull wire 12 is realized by the handle function member 5. The helical diameter of the distal section 1 of the helical configuration and the change in the bending deflection angle. As shown in Fig. 13, in Fig. 12, as seen to the left along the cc line, the distal section 1 of the helical configuration is projected on the same circumference 16 in the axial direction, and the projection of the electrode 2 is evenly distributed on the circumference 16, the perfusion hole 3 is arranged on the electrode 2 according to a certain regularity. After adjusting the diameter of the helical configuration of the distal section 1 by means of the handle function 5, the distal section 1 of the helical configuration is also projected in the axial direction on a circumference 17 (see dotted line). The diameter of the helical configuration of the distal section 1 can be reduced or increased by the handle function 5 as desired. The diameter of the spiral configuration is small to facilitate the multi-electrode ablation catheter to enter the human vessel, and when adjusted, the distal segment 1 of the helical configuration is facilitated to abut the vessel wall in the vessel, ie, the multi-lumen tube The electrode 2 on 101 can effectively abut the target on the vessel wall. When performing discharge ablation, the multi-electrode ablation catheter shown in Fig. 12 can be filled with perfusate from the perfusion fluid source from the Luer connector 8 and the connector catheter 9, and the perfusate finally flows out from the perfusion hole 3 on the electrode 2, effectively reducing the electrode. 2 and the temperature of the target tissue can increase the ablation power and increase the ablation depth to the tissue. 14 and FIG. 15 respectively show a multi-electrode ablation catheter provided with the helical configuration adjustment mechanism shown in FIG. 12 according to two embodiments of the present invention, and a schematic view before and after adjustment, wherein The multi-electrode ablation catheter shown in Figure 14 can be used in conjunction with a guiding catheter, while the multi-electrode ablation catheter shown in Figure 15 can be used not only in conjunction with a guiding catheter, but also in conjunction with a guidewire, and has a perfusion fluid perfusion function. . In the above, only a multi-electrode ablation catheter that can be used in conjunction with a guiding catheter is illustrated by using FIG. 9, but it is to be understood that the above-mentioned multi-electrode ablation catheters that can be used in conjunction with the guidewire can be combined with appropriate specifications. Guide catheters are used in conjunction. The operator can select one to assist the multi-electrode ablation catheter for delivery positioning based on the surgical needs and the suitability and cost of the guidewire and guide catheter of a suitable size. The various structures that are applicable in the case where the distal segment 1 is in the helical configuration, in particular the wire-related structure and the wire-related structure, can also be applied separately or in combination to at least part of the distal segment 1 in other forms of circumferential configuration. In the case of the type, for example, the case where the distal section 1 is of the annular configuration, in this case, a plurality of electrodes 2 for ablation are arranged on the annular ring of the annular configuration. Hereinafter, an annular configuration in which an adjustable annular ring is connected at the distal end of the distal section 1 will be described as an example. Figure 16 shows a schematic view of a multi-electrode ablation catheter with an adjustable annular ring attached to the distal end of the distal segment 1 and a plurality of ablation electrodes 2 distributed over the annular ring, in accordance with an embodiment of the present invention, A schematic diagram in which the annular ring is reduced is shown by a broken line. In this embodiment, the connection between the annular ring and the distal end of the catheter may be disposed at the edge of the annular ring. In addition, the connection between the annular ring and the distal end of the catheter may also be disposed at the center of the annular ring. Within the scope of the invention. The shape of the annular ring of the illustrated embodiment is shown in the broken lines in Figs. 16 and 17. The number of electrodes in this embodiment is 10, which is more suitable for ablation of a human lumen with a larger vessel diameter. The annular ring of this embodiment can adjust the size of the ring, and can cooperate with the guiding catheter to enter the human vessel, especially the pulmonary vein mouth, the pulmonary artery mouth, the renal artery mouth, and the pulmonary vein, the pulmonary artery, the renal artery blood vessel and the like, and the ablation is not only improved. Ablation efficiency, this adjustable size of the annular ring can more effectively abut the ablation electrode to the target site, ensuring ablation. In addition, the design of the multi-electrode ablation catheter to which the adjustable annular ring is connected at the distal end can be combined with various aspects in addition to the scheme given in this embodiment. Any one or two of the guide wire pulling mechanism and the infusion mechanism in the embodiment shown in the embodiment are used in combination. In the case of a guidewire traction mechanism, the distal section is a multi-lumen tube, wherein one lumen houses a guidewire, the access of the guidewire causes the distal section to include an annular loop, and the withdrawal of the guidewire causes the distal section The return configuration is also the original configuration with the annular ring attached to the distal end. The diameter and bending deflection adjustment mechanism of the annular ring is similar to the adjustment mechanism for the helical configuration associated with Figures 12-15 above, and is also achieved as follows: the pull wire 12 is received in the pull tube lumen 104 of the multi-lumen tube 101, and Coupled to the handle function 5 on the control handle 6, the pull wire 12 controls the diameter and bending deflection angle of the adjustable annular ring of the distal section 1 by the handle function 5. The invention is not limited to the specific details described in the detailed description. The invention provides a catheter for in vivo treatment, in addition to intracardiac ablation for arrhythmia and renal artery ablation to sympathetic treatment of hypertension, and is also suitable for discharge ablation of other intracardiac and/or intravascular vessels. surgery. The above description of the embodiments is merely for helping to understand the core idea of the present invention. It should be noted that those skilled in the art can make several improvements and modifications to the present invention without departing from the principles of the present invention, but such modifications and modifications are also within the scope of the claims of the present invention. .

Claims

Rights request

1. A multi-electrode ablation catheter comprising a distal segment, a main body segment and a control handle connected in sequence, at least part of the distal segment being in a circumferential configuration, the circumferential configuration being reversibly changeable to a lower profile configuration, and A plurality of ablation electrodes are arranged on it, which is characterized by: the main body section and the control handle are provided with perfusion fluid channels;

The distal section includes a perfusate lumen with an opening on a side wall; and

Each electrode has at least one perfusion hole. Each electrode is at least partially fixedly arranged around the circumference of the distal section, and forms a cavity with the perfusion fluid lumen. Each perfusion hole passes through the cavity and the corresponding opening. , the perfusate lumen, and the perfusate channel are fluidly connected to a perfusate source outside the catheter.

2. The multi-electrode ablation catheter according to claim 1, wherein the distal section is in a spiral configuration, or the distal section is in a ring configuration.

3. The multi-electrode ablation catheter according to claim 1, wherein each of the electrodes is evenly distributed around the distal section in a circumferential configuration.

4. The multi-electrode ablation catheter according to claim 1, wherein the perfusion holes on each electrode are arranged in one or more rows, the perfusion holes in a single row are evenly arranged circumferentially, and the perfusion holes in adjacent rows are arranged evenly in the circumferential direction. The holes are arranged in a staggered pattern.

5. The multi-electrode ablation catheter according to claim 2, wherein the distal section is a multi-lumen tube, and the multi-lumen tube relies on NITI shaping wire or the polymer material of the multi-lumen tube itself for heat treatment and shaping. to maintain the helical or annular configuration of the distal segment.

6. The multi-electrode ablation catheter according to claim 5, characterized in that the temperature of the heat treatment is 100°C-140°C, and the time is 30 minutes-60 minutes.

7. The multi-electrode ablation catheter according to claim 6, wherein the heat treatment temperature is 110°C and the time is 30 minutes.

8. The multi-electrode ablation catheter according to claim 1, wherein a connector conduit is provided on the proximal side of the control handle, a first Luer connector is provided on the connector conduit, and the perfusion fluid The channel is connected to a source of perfusate via the connector conduit and the first luer connector.

9. The multi-electrode ablation catheter according to claim 1, wherein the perfusion hole is prepared by one of mechanical hole forming, electric spark hole forming, and laser hole forming.

10. The multi-electrode ablation catheter according to claim 1, characterized in that the diameter of the perfusion holes is 0.02mm-0.5mm, and the number of perfusion holes is 2-40.

1 1. A multi-electrode ablation catheter, including a distal section, a main body section and a control handle connected in sequence, with a plurality of ablation electrodes arranged on the distal section, characterized in that the distal section is annular. configuration, and the electrodes are arranged on the annular ring of the annular configuration.

12. The multi-electrode ablation catheter according to claim 1 or 11, wherein the distal section is a multi-lumen tube, one of the lumens contains a pull wire, and the control handle is coupled to the pull wire. Under the adjustment of the control handle, the diameter of the spiral configuration or annular ring changes or the bending deflection angle of the distal segment changes.

13. The multi-electrode ablation catheter according to claim 1 or 11, characterized in that the distal section is a multi-lumen tube, one of which contains a guide wire, and the introduction of the guide wire straightens the distal section. , the retraction of the guidewire causes the distal segment to return to its configuration.

14. The multi-electrode ablation catheter according to claim 12, wherein the distal section is a multi-lumen tube, one of which contains a guide wire, and the introduction of the guide wire straightens the distal section. Retraction of the guidewire allows the distal segment to return to configuration.

15. A multi-electrode ablation catheter, including a distal segment, a main body segment, and a control handle connected in sequence. The distal segment is in a spiral configuration and can be reversibly changed to a lower profile configuration, and multiple devices are arranged on it. An electrode for ablation, characterized in that: the distal segment is a multi-lumen tube, one of which contains a guide wire, the introduction of the guide wire causes the distal segment to straighten, and the withdrawal of the guide wire causes the distal segment to recover Spiral configuration.

16. The multi-electrode ablation catheter according to claim 15, wherein a second Luer connector is provided on the proximal side of the control handle, and the guide wire passes into the catheter through the second Luer connector.

17. A multi-electrode ablation catheter, including a distal segment, a main body segment, and a control handle connected in sequence. The distal segment is in a spiral configuration and can be reversibly changed to a lower profile configuration, and multiple devices are arranged on it. An electrode for ablation, characterized in that: the distal section is a multi-lumen tube, one of which contains a pull wire, the control handle is coupled to the pull wire, and under the adjustment of the control handle, the diameter of the spiral configuration The size changes or the bending deflection angle of the distal segment changes.

18. The multi-electrode ablation catheter according to claim 17, wherein the electrodes are evenly distributed around the spiral configuration.