Radio frequency ablation catheter and radio frequency ablation device

Abstract

The invention relates to a radiofrequency ablation catheter and a radiofrequency ablation device. The radiofrequency ablation catheter comprises a main body tube; a control handle; the mesh basket structure has an expansion configuration and a contraction configuration and can be switched between the expansion configuration and the contraction configuration, the mesh basket structure comprises a reference electrode, a supporting tube, a plurality of flexible branches and a plurality of ablation electrodes, the reference electrode is arranged in the mesh basket structure, the supporting tube is arranged in the main body tube, and the flexible branches are arranged in the main body tube. Each flexible branch is provided with a plurality of ablation electrodes which are arranged at intervals in the length direction of the flexible branch; the mesh basket structure is in the contraction configuration, a first impedance value exists between the ablation electrode and the reference electrode, the mesh basket structure is in the expansion configuration, a second impedance value exists between the ablation electrode and the reference electrode, and the attaching property of the ablation electrode to the inner wall of the blood vessel is determined according to the ratio of the second impedance value to the first impedance value. The target tissue is efficiently treated, and the ablation depth of the radiofrequency ablation catheter is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to a radiofrequency ablation catheter and a radiofrequency ablation device. Background Art

[0002] In recent years, radiofrequency ablation has been found to be effective in treating hypertension, and it also has certain effects in improving insulin resistance and treating heart failure. The mechanism of radiofrequency ablation is to use radiofrequency electrodes to be close to or close to the human tissue being treated and release radiofrequency energy. For tissues that require deep ablation, the radiofrequency electrodes need to be precisely attached so that the radiofrequency energy can be more effectively exerted. The radiofrequency current flows between the distal radiofrequency electrode at the tissue electrode interface and the neutral ground electrode on the skin. When the radiofrequency current encounters tissue resistance, it generates joules, and conduction heating subsequently occurs due to the temperature gradient between the heated tissue in direct contact with the radiofrequency electrode and the relatively cold surrounding tissue. The formation of radiofrequency damage is determined by direct resistance heating and conduction heating of the tissue in contact with the radiofrequency electrode, and the human tissue is treated through thermal effects.

[0003] Therefore, during the operation, whether the radiofrequency electrode is close to the target plays a decisive role in the treatment effect of radiofrequency ablation. Inaccurate position will cause inaccurate operation process, temperature monitoring and impedance monitoring, and fail to provide real and effective guidance for the operation. Not only may it cause irreversible damage to other healthy tissues, but it will also be difficult to achieve the real treatment purpose. Therefore, the lesion needs to be accurately located before ablation.

[0004] At present, the commonly used technology is to place an additional mapping catheter for mapping before ablation treatment while the ablation electrode is ablated. However, adding an additional mapping catheter for ablation treatment will increase the difficulty and time of the operation, and also increase pain and cost for the patient. Therefore, the current technology for judging whether the RF electrode is in close contact is to judge the degree of contact between the electrode belt and the lesion tissue by the impedance between the RF transmitting electrode and the RF receiving electrode on the electrode belt. However, this method is difficult to sensitively monitor the impedance of slight changes, which in turn affects the judgment of the contact between the electrode belt and the lesion tissue. Summary of the invention

[0005] Based on this, it is necessary to provide a radiofrequency ablation catheter and radiofrequency ablation device that can improve the monitoring of the adhesion sensitivity, ensure the adhesion effect, and thus ensure the safety of the operation, in order to address the problem that the current sensitivity of judging the adhesion degree of the electrode belt by the impedance between the electrodes on the electrode belt is low, which affects the adhesion judgment.

[0006] A radiofrequency ablation catheter, comprising:

[0007] Main pipe;

[0008] a control handle located at the proximal end of the body tube; and

[0009] A basket structure is located at the distal end of the main tube, the basket structure has an expanded configuration and a contracted configuration, and can be switched between the expanded configuration and the contracted configuration, wherein the basket structure includes a reference electrode, a support tube, a plurality of flexible branches, and a plurality of ablation electrodes, the reference electrode is arranged in the basket structure, the support tube is arranged in the main tube, the distal ends of the plurality of flexible branches are mutually connected to the distal end of the support tube, the proximal ends of the plurality of flexible branches are mutually connected to the distal end of the main tube, each of the flexible branches has a plurality of ablation electrodes, and the plurality of ablation electrodes are arranged at intervals along the length direction of the flexible branch;

[0010] When the basket structure is in a contracted configuration, there is a first impedance value between the ablation electrode and the reference electrode. When the basket structure is in an expanded configuration, there is a second impedance value between the ablation electrode and the reference electrode. The adhesion of the ablation electrode to the inner wall of the blood vessel is determined by the ratio between the second impedance value and the first impedance value.

[0011] In one embodiment of the present application, the basket structure further includes a magnetic positioning sensor, and the magnetic positioning sensor is arranged corresponding to the reference electrode.

[0012] In one embodiment of the present application, the basket structure further comprises a proximal fixing member and a distal fixing member, wherein the distal fixing member is disposed at the distal end of the support tube and connected to the distal ends of the plurality of flexible branches, and the proximal fixing member is sleeved on the support tube and connected to the proximal end of the main body tube;

[0013] The reference electrode and the magnetic positioning sensor are arranged on the distal fixing piece, and the control handle drives the proximal fixing piece to move relative to the support tube through the main tube, or the reference electrode and the magnetic positioning sensor are arranged on the proximal fixing piece, and the control handle drives the distal fixing piece to move relative to the main tube through the support tube.

[0014] In one embodiment of the present application, when the reference electrode is disposed on the distal fixture, a wiring channel is provided in the support tube;

[0015] When the reference electrode is arranged on the proximal fixing member, a wiring channel is arranged between the support tube and the main body tube.

[0016] In one embodiment of the present application, the outer wall of the proximal fixing member or the distal fixing member has a mounting groove, and the reference electrode is fixed to the mounting groove by gluing or snapping.

[0017] In one embodiment of the present application, the basket structure further includes a first thermocouple and a plurality of second thermocouples, wherein the first thermocouple is disposed on the inner side of the reference electrode, each of the flexible branches is provided with at least one second thermocouple, and the second thermocouple is located on the surface of the flexible branch away from the ablation electrode;

[0018] When the basket structure is in the expanded configuration, the blood temperature monitored by the first thermocouple is the first temperature value, and the blood temperature monitored by the second thermocouple is recorded as the second temperature value. The adhesion of the ablation electrode to the inner wall of the blood vessel and the ablation temperature are determined based on the ratio of the second temperature value to the first temperature value.

[0019] In one embodiment of the present application, the proximal end of the control handle is electrically connected to a radio frequency device, the ablation electrode and the reference electrode are electrically connected to the radio frequency device, and a processing data collection unit of the radio frequency device receives the first impedance value and the second impedance value, and feeds back the ratio of the second impedance value to the first impedance value to the processing unit of the radio frequency device;

[0020] The first thermocouple and the second thermocouple are electrically connected to the radio frequency device, the processing data collection unit receives the first temperature value and the second temperature value, and the processing unit feeds back a ratio of the second temperature value to the first temperature value.

[0021] In one embodiment of the present application, the proximal end of the control handle is connected to a magnetic positioning device, the ablation electrode and the reference electrode are electrically connected to the magnetic positioning device, and the magnetic positioning device cooperates with the basket structure to generate a three-dimensional model of the basket structure.

[0022] In one embodiment of the present application, the control handle has a pusher, and the pusher is connected to the proximal fixing member or the support tube of the basket structure;

[0023] The control handle has an indicator scale, and the pusher can adjust the maximum diameter of the basket structure when it is in the expanded configuration when moving along the indicator scale.

[0024] In one embodiment of the present application, the basket structure also includes a magnetic positioning sensor, and the magnetic positioning sensor is arranged corresponding to the reference electrode. The magnetic positioning sensor accurately positions the basket structure. The ablation electrode obtains the current exchange coefficient and feeds it back to the magnetic positioning device. The magnetic positioning device determines the three-dimensional model of the basket structure after expansion through the magnetic positioning device and the ablation electrode.

[0025] In one embodiment of the present application, the basket structure also includes a plurality of magnetic positioning sensors, and at least part of the flexible branches is provided with at least one magnetic positioning sensor. Each of the magnetic positioning sensors monitors the morphological data of the flexible branches and feeds back the data to a magnetic positioning device. The magnetic positioning device determines the three-dimensional model of the basket structure after expansion through the magnetic positioning sensor.

[0026] In one embodiment of the present application, the distal end of the control handle has a tail wire interface, and the control handle is electrically connected to the magnetic positioning device and the radio frequency device of the radio frequency ablation device through the tail wire interface;

[0027] The tail line interface is arranged in a Y shape or has a multi-interface structure.

[0028] In one embodiment of the present application, the outer wall of the support tube is coated with a lubricating coating.

[0029] A radiofrequency ablation device, comprising a magnetic positioning device, a radiofrequency device and a radiofrequency ablation catheter as described in any one of the above technical features, wherein the magnetic positioning device is electrically connected to the radiofrequency device and the radiofrequency ablation catheter;

[0030] The magnetic positioning device includes a three-dimensional display and a three-dimensional system. The three-dimensional system has a positioning unit and a volume collection unit. The positioning unit is used to monitor the position of the basket structure in the radiofrequency ablation catheter on the inner wall of the blood vessel. The volume collection unit determines the three-dimensional shape of the basket structure according to the position of the basket structure and the three-dimensional model of the basket structure, and displays it through the three-dimensional display.

[0031] The radio frequency device includes a radio frequency display and a radio frequency system. The radio frequency system has a processing unit and a data collection unit. The data collection unit collects the impedance value and temperature value of the blood and feeds back the ratio through the processing unit.

[0032] In one embodiment of the present application, the volume collection unit constructs a three-dimensional model of the basket structure by adjusting the maximum diameter of the basket structure through the pusher of the radiofrequency ablation catheter;

[0033] Alternatively, the volume collection unit collects the positioning information of the basket structure by the magnetic positioning sensor and the ablation electrode, and constructs a three-dimensional model of the basket structure;

[0034] Alternatively, the volume collection unit collects multiple sets of morphological data acquired by magnetic positioning sensors on each flexible branch of the basket structure to construct a three-dimensional model of the basket structure.

[0035] After adopting the above technical solution, this application has at least the following technical effects:

[0036] The radiofrequency ablation catheter and radiofrequency ablation device of the present application, in which the control handle is arranged at the proximal end of the main body tube, the support tube is arranged in the main body tube, the proximal ends of the multiple flexible branches in the basket structure are connected to the distal end of the main body tube, the distal ends of the multiple flexible branches are connected to the distal end of the support tube, and each flexible branch has multiple ablation electrodes. When the control handle is operated, the control handle can drive the main body tube to move relative to the support tube, and when the main body tube moves, the proximal end of the basket structure can be driven to move, so that the basket structure switches between an expanded configuration and a contracted configuration.

[0037] When the basket structure is in a contracted configuration, the radio frequency device in the radio frequency ablation device can detect that there is a first impedance value between the reference electrode and the ablation electrode. When the basket structure is in an expanded configuration, the radio frequency device can detect that there is a second impedance value between the reference electrode and the ablation electrode. The radio frequency device feeds back the ratio of the second impedance value to the first impedance value, and uses this to determine whether the ablation electrode is in contact with the inner wall of the blood vessel. In this way, by obtaining the ratio of the impedance values ​​of the reference electrode and the ablation electrode when the basket structure is in different forms, the contact between the ablation electrode and the inner wall of the blood vessel is determined, and the influence of the year-on-year amplification or reduction of the value when the external physiological environment changes is eliminated, more accurate impedance monitoring can be obtained, thereby obtaining a more accurate basis for judging the contact of the ablation electrode, so as to ensure the effective contact between the ablation electrode and the inner wall of the blood vessel during the operation, thereby ensuring that the target tissue is efficiently treated, greatly reducing the treatment risk, and at the same time, it also helps to efficiently utilize radio frequency energy and increase the ablation depth of the radio frequency ablation catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic structural diagram of a radiofrequency ablation device according to an embodiment of the present application, wherein the radiofrequency ablation catheter of the first embodiment is in a contracted configuration.

[0039] Figure 2 for Figure 1 The schematic structural diagram of the radiofrequency ablation device is shown, in which the radiofrequency ablation catheter of the first embodiment is in an expanded configuration.

[0040] Figure 3 for Figure 1 The radiofrequency ablation catheter of the first embodiment is shown in a schematic diagram in a collapsed configuration.

[0041] Figure 4 for Figure 3 A partial schematic diagram of a radiofrequency ablation catheter is shown in an expanded configuration.

[0042] Figure 5 It is a schematic diagram of a radiofrequency ablation catheter according to the second embodiment of the present application.

[0043] Figure 6 for Figure 4 A cross-sectional view of the radiofrequency ablation catheter at the distal end fixing member is shown.

[0044] Figure 7 for Figure 3 The structure schematic diagram of the radiofrequency ablation catheter delivering the basket structure to the target area.

[0045] Figure 8 for Figure 7 The basket structure is shown in a schematic structural diagram in a position in which it is in an expanded configuration.

[0046] Fig. 9 for Figure 8 The basket structure shown is a schematic structural diagram in another position.

[0047] Wherein: 10, radiofrequency ablation catheter; 100, main tube; 200, control handle; 210, pusher; 220, tail line interface; 300, basket structure; 310, flexible branch; 320, ablation electrode; 330, reference electrode; 340, support tube; 350, magnetic positioning sensor; 360, first thermocouple; 370, second thermocouple; 380, proximal fixture; 390, distal fixture; 60, magnetic positioning device; 61, three-dimensional display; 62, three-dimensional system; 621, positioning unit; 622, volume collection unit; 70, radiofrequency device; 71, radiofrequency display; 72, radiofrequency system; 721, processing unit; 722, data collection unit; 80, inner wall of blood vessel. DETAILED DESCRIPTION

[0048] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0049] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0050] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0051] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0052] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0053] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0054] See also Figure 1 and Figure 2 The present application provides a radiofrequency ablation catheter 10, which is applied to a radiofrequency ablation device to perform radiofrequency ablation on a target tissue to achieve treatment of the target tissue. Figure 1 FIG. 1 is a schematic structural diagram of a radiofrequency ablation device according to an embodiment of the present application, wherein the radiofrequency ablation catheter 10 of the first embodiment is in a contracted configuration. Figure 2 for Figure 1 The schematic diagram of the structure of the radiofrequency ablation device shown in the figure, wherein the radiofrequency ablation catheter 10 of the first embodiment is in an expanded configuration. In this embodiment, the target tissue is the inner wall 80 of the blood vessel, and the radiofrequency ablation catheter 10 can extend into the inner wall 80 of the blood vessel and treat the inner wall 80 of the blood vessel. Of course, in other embodiments of the present application, the radiofrequency ablation catheter 10 can also treat other target tissues. The present application only takes the target tissue as the inner wall 80 of the blood vessel as an example for explanation, and the radiofrequency ablation catheter 10 can move in the blood vessel and be transported to the target area to abut the inner wall 80 of the blood vessel in the target area.

[0055] It is understandable that among the current technologies for judging whether the RF electrode is in close contact, there is a method of judging the degree of contact between the electrode belt and the lesion tissue by the impedance between the RF transmitting electrode and the RF receiving electrode on the electrode belt. However, this method is difficult to sensitively monitor the impedance of slight changes, which in turn affects the judgment of the contact between the electrode belt and the lesion tissue. To this end, the present application provides a new type of RF ablation catheter 10, which can realize sensitive monitoring of impedance to ensure the effective contact between the ablation electrode 320 and the blood vessel during the operation. The specific structure of the RF ablation catheter 10 of an embodiment is introduced below.

[0056] See also Figures 1 to 4 In one embodiment, the radiofrequency ablation catheter 10 includes a main body tube 100, a control handle 200, and a basket structure 300. The control handle 200 is located at the proximal end of the main body tube 100. The basket structure 300 is located at the distal end of the main body tube 100. The basket structure 300 has an expanded configuration and a contracted configuration, and can be switched between the expanded configuration and the contracted configuration. The basket structure 300 includes a reference electrode 330, a support tube 340, a plurality of flexible branches 310, and a plurality of ablation electrodes 320. The reference electrode 330 is used to provide a position reference, and the ablation electrode 320 is used to perform ablation treatment on the target tissue in the target area. The reference electrode 330 is arranged in the basket structure 300, the support tube 340 is arranged in the main tube 100, the distal ends of the multiple flexible branches 310 are interconnected to the distal end of the support tube 340, the proximal ends of the multiple flexible branches 310 are interconnected to the distal end of the main tube 100, and each flexible branch 310 has multiple ablation electrodes 320, and the multiple ablation electrodes 320 are arranged at intervals along the length direction of the flexible branch 310.

[0057] When the basket structure 300 is in a contracted configuration, there is a first impedance value between the ablation electrode 320 and the reference electrode 330. When the basket structure 300 is in an expanded configuration, there is a second impedance value between the ablation electrode 320 and the reference electrode 330. The adhesion of the ablation electrode 320 to the inner wall 80 of the blood vessel is determined by the ratio between the second impedance value and the first impedance value. Figure 3 for Figure 1The schematic diagram of the radiofrequency ablation catheter 10 of the first embodiment is in a collapsed configuration. Figure 4 for Figure 3 The radiofrequency ablation catheter 10 is shown as a partial schematic diagram in an expanded configuration.

[0058] The main tube 100 is a carrier tube of the radiofrequency ablation catheter 10. The main tube 100 is arranged in a slender tubular shape, and has a proximal end and a distal end arranged oppositely along the length direction. The proximal end of the main tube 100 refers to the end of the main tube 100 close to the operator, and the distal end of the main tube 100 refers to the end of the main tube 100 away from the operator. It should be noted that the explanation of the proximal end and the distal end here is also applicable to other components of the radiofrequency ablation catheter 10 introduced later, and will not be repeated later.

[0059] The proximal end of the main tube 100 is connected to the control handle 200, and the distal end of the main tube 100 is connected to the proximal end of the basket structure 300, and the distal end of the basket structure 300 extends in a direction away from the main tube 100. The basket structure 300 has an expansion configuration and a contraction configuration, and can switch between the expansion configuration and the contraction configuration. When the basket structure 300 is in the contraction configuration, the diameter size of the basket structure 300 is significantly reduced relative to the expansion configuration. Preferably, the basket structure 300 is in a linear state, and the diameter size of the basket structure 300 is the minimum value, so that the basket structure 300 can be easily transported to the target area along the blood vessel. When the basket structure 300 is in the expansion configuration, the diameter size of the basket structure 300 increases compared to the contraction configuration, so that the basket structure 300 expands and abuts against the inner wall 80 of the blood vessel in the target area.

[0060] It is worth noting that the shape / diameter size of the basket structure 300 is not fixed when it is in the expanded configuration, but is adjusted according to the size of the target area, as long as the basket structure 300 can be close to the inner wall 80 of the blood vessel after expansion. Moreover, the switching of the basket structure 300 between the contracted configuration and the expanded configuration is achieved by operating the control handle 200. Figure 3 Before the operation, the operator operates the control handle 200 to adjust the basket structure 300 to the contracted configuration, so that the diameter of the basket structure 300 is in the smallest state. Subsequently, the RF ablation catheter 10 moves along the blood vessel to deliver the basket structure 300 to the target area. The operator operates the control handle 200 to switch the basket structure 300 from the contracted configuration to the expanded configuration, and abuts against the inner wall 80 of the blood vessel in the target area. After the RF ablation operation is completed, the operator operates the control handle 200 to switch the basket structure 300 from the expanded configuration to the contracted configuration, so as to facilitate the recovery of the basket structure 300.

[0061] See also Figures 1 to 4The basket structure 300 has a support tube 340 in the middle, and the support tube 340 is arranged in the main tube 100. The distal ends of the flexible branches 310 of the basket structure 300 are connected to the distal ends of the support tube 340, and the proximal ends of the flexible branches 310 are connected to the distal ends of the main tube 100. The control handle 200 can control the proximal ends of the flexible branches 310 to move relative to the support tube 340, or the control handle 200 can control the distal ends of the support tube 340 to drive the distal ends of the flexible branches 310 to move relative to the support tube 340 to adjust the shape of the basket structure 300. It can be understood that when the basket structure 300 is in the expanded configuration, the space outside the basket structure 300 is the outside, and correspondingly, the space inside the basket structure 300 is the inside. In addition, the inside of each flexible branch 310 is hollow, and there is a certain distance between two adjacent flexible branches 310, allowing blood to flow between the flexible branches 310.

[0062] Each flexible branch 310 has a plurality of ablation electrodes 320, and the plurality of ablation electrodes 320 are arranged on the flexible branch 310 at intervals along the length direction of the flexible branch 310. The purpose of radiofrequency ablation treatment is achieved by the ablation electrodes 320. After the basket structure 300 is in the expanded configuration, the ablation electrodes 320 on the flexible branch 310 can be attached to the inner wall 80 of the blood vessel. After the ablation electrodes 320 are powered on, the ablation electrodes 320 release radiofrequency energy to treat the inner wall 80 of the blood vessel. In principle, the position of the reference electrode 330 on the basket structure 300 is not limited, as long as the reference electrode 330 is in a fixed position and can provide a reference for the positioning of the basket structure 300 in the blood vessel. The position of the reference electrode 330 will be described in detail later.

[0063] The radiofrequency ablation catheter 10 can be connected to the radiofrequency device 70. Specifically, the control handle 200 is electrically connected to the radiofrequency device 70 through the catheter tail line. After the basket structure 300 is delivered to the target area, the radiofrequency device 70 can monitor the resistance value of the basket structure 300 in the expansion process in real time, so as to judge the adhesion between the ablation electrode 320 and the inner wall of the blood vessel 80. In other words, when the basket structure 300 switches from the contracted configuration to the expanded configuration, the resistance value between the reference electrode 330 and the ablation electrode 320 is monitored to judge whether the ablation electrode 320 is in contact with the inner wall of the blood vessel 80.

[0064] When the basket structure 300 is in the contracted configuration, there is a linear blood impedance between the reference electrode 330 and the ablation electrode 320, which is the first impedance value. When the control handle 200 applies a force to the basket structure 300 so that the basket structure 300 switches to the expanded configuration, the ablation electrode 320 moves in a direction gradually away from the support tube 340, and the ablation electrode 320 also gradually moves away from the reference electrode 330. At this time, a real-time changing blood impedance is formed between the reference electrode 330 and the ablation electrode 320, which is the second impedance value.

[0065] The adhesion of the ablation electrode 320 to the inner wall 80 of the blood vessel is determined by the ratio of the second impedance value to the first impedance value. When the basket structure 300 is switched to the expansion configuration, the ratio of the second impedance value to the first impedance value will increase. When the ratio of the second impedance value to the first impedance value increases to a maximum value, at this time, the ratio of the second impedance value to the first impedance value will not change even if the control handle 200 is adjusted or the radiofrequency ablation catheter 10 is rotated, indicating that the ablation electrode 320 on the basket structure 300 is in contact with the inner wall 80 of the blood vessel.

[0066] The radiofrequency ablation catheter 10 of the above-mentioned embodiment determines the adhesion of the ablation electrode 320 to the inner wall 80 of the blood vessel by obtaining the ratio of the impedance values ​​of the reference electrode 330 and the ablation electrode 320 when the basket structure 300 is in different forms, eliminating the influence of the numerical value being magnified or reduced year-on-year when the external physiological environment changes, and can obtain more accurate impedance monitoring, thereby obtaining a more accurate basis for judging the adhesion of the ablation electrode 320, so as to ensure the effective adhesion of the ablation electrode 320 to the inner wall 80 of the blood vessel during the operation, thereby ensuring that the target tissue is efficiently treated, greatly reducing the treatment risk, and at the same time, it also helps to efficiently utilize radiofrequency energy and increase the ablation depth of the radiofrequency ablation catheter 10.

[0067] See also Figure 1 and Figure 2 In one embodiment, the radio frequency device 70 includes a radio frequency display 71 and a radio frequency system 72, and the radio frequency system 72 includes a processing unit 721 and a data collection unit 722. The processing unit 721 is electrically connected to the data collection unit 722 and the radio frequency display 71. The radio frequency display 71 can display relevant parameters during radio frequency ablation for the operator to view, thereby ensuring the safety of the operation. The data collection unit 722 can collect various parameters of each component in the basket structure 300, especially the ablation electrode 320, when it is working, and feed them back to the processing unit 721, which are processed by the processing unit 721 and displayed on the radio frequency display 71. Moreover, operating the radio frequency display 71 can control the ablation electrode 320 to generate radio frequency energy, thereby achieving radio frequency ablation treatment of the inner wall 80 of the blood vessel.

[0068] In the present application, after the data collection unit 722 is electrically connected to the control handle 200 through the catheter tail wire, the ablation electrode 320 and the reference electrode 330 can be electrically connected to the data collection unit 722. The data collection unit 722 can collect the first impedance value and the second impedance value between the reference electrode 330 and the ablation electrode 320, and feed them back to the processing unit 721. The processing unit 721 calculates the ratio of the first impedance value to the second impedance value, and displays it through the radio frequency display 71 for the operator to view conveniently.

[0069] Optionally, the ratio of the second impedance value to the first impedance value is greater than or equal to 1. That is, the ratio of the second impedance value of dynamic blood impedance to the first impedance value of linear blood impedance is greater than or equal to 1, so as to reflect the contact between the ablation electrode 320 and the inner wall 80 of the blood vessel.

[0070] See also Figure 1 and Figure 2 In one embodiment, the proximal end of the control handle 200 is electrically connected to the radio frequency device 70, the ablation electrode 320 and the reference electrode 330 are electrically connected to the radio frequency device 70, and the processing data collection unit 722 of the radio frequency device 70 receives the first impedance value and the second impedance value, and feeds back the ratio of the second impedance value to the first impedance value to the processing unit 721 of the radio frequency device 70. After the data processing unit 721 collects the first impedance value and the second impedance value, it transmits the data to the processing unit 721, and the ratio of the second impedance value to the first impedance value is fed back by the processing unit 721, and is displayed by the radio frequency display 71, so that the operator can check the ratio to judge the abutment of the ablation electrode 320.

[0071] See also Figure 3 and Figure 4 In one embodiment, the basket structure 300 further includes a magnetic positioning sensor 350, and the magnetic positioning sensor 350 is arranged corresponding to the reference electrode 330. It can be understood that the position of the magnetic positioning sensor 350 is not limited in principle, as long as the relative position of the magnetic positioning sensor 350 and the reference electrode 330 is fixed to achieve the positioning of the basket structure 300 in the blood vessel. The control handle 200 is electrically connected to the magnetic positioning device 60. Specifically, the control handle 200 is electrically connected to the magnetic positioning device 60 through the catheter tail line, so that the reference electrode 330 and the magnetic positioning sensor 350 are electrically connected to the magnetic positioning device 60.

[0072] See also Figure 1 and Figure 2In one embodiment, the magnetic positioning device 60 includes a three-dimensional display 61 and a three-dimensional system 62. The three-dimensional system 62 includes a positioning unit 621 and a volume collection unit 622. The positioning unit 621 and the volume collection unit 622 are electrically connected to the three-dimensional display 61. The position of the radiofrequency catheter in the blood vessel and the three-dimensional model of the basket structure 300 are displayed through the three-dimensional display 61, so that the operator can observe the position and posture of the radiofrequency ablation catheter 10 in the blood vessel. The volume collection unit 622 can collect the relevant parameters of various forms of the basket structure 300 in the process of switching from the contraction configuration to the expansion configuration, and feed them back to the three-dimensional display 61, and the three-dimensional model of the basket structure 300 is displayed through the three-dimensional display 61. The positioning unit 621 is electrically connected to the magnetic positioning sensor 350 and the reference electrode 330. The magnetic positioning sensor 350 and the reference electrode 330 send the position of the basket structure 300 in the blood vessel to the positioning unit 621, so that the three-dimensional display 61 displays the movement trajectory of the basket structure 300 in the blood vessel.

[0073] See also Figures 1 to 4 In one embodiment, the basket structure 300 also includes a proximal fixing member 380 and a distal fixing member 390. The distal fixing member 390 is disposed at the distal end of the support tube 340 and connected to the distal ends of the plurality of flexible branches 310. The proximal fixing member 380 is sleeved on the support tube 340 and connected to the proximal end of the main body tube 100.

[0074] The distal fixing member 390 and the proximal fixing member 380 are used to fix the ends of the flexible branches 310 to form a basket structure. The distal ends of each flexible branch 310 are fixed by the distal fixing member 390 and fixed to the distal end of the support tube 340, and the proximal ends of each flexible branch 310 are fixed to the proximal fixing member 380, and the proximal fixing member 380 is located at the distal end of the main tube 100 and can be slidably sleeved on the outside of the support tube 340. Optionally, the proximal fixing member 380 and the distal fixing member 390 are annular structures. Of course, in other embodiments of the present application, the proximal fixing member 380 and the distal fixing member 390 can also be other structures that can fix the flexible branches 310.

[0075] See also Figures 1 to 4 In the first embodiment of the present application, the reference electrode 330 and the magnetic positioning sensor 350 are arranged on the distal fixing member 390, and the control handle 200 drives the proximal fixing member 380 to move relative to the support tube 340. In other words, the reference electrode 330 is fixed on the fixed distal fixing member 390, so that the positions of the reference electrode 330 and the magnetic positioning sensor 350 are fixed. At this time, the reference electrode 330 and the magnetic positioning sensor 350 can locate the position of the distal end of the basket structure 300 in the blood vessel, so that the magnetic positioning device 60 can display the position of the basket structure 300 in real time, which is convenient for transporting the basket structure 300 to the target area.

[0076] When the operator operates the control handle 200, the control handle 200 can drive the proximal fixing member 380 to move relative to the support tube 340, that is, the control handle 200 can drive the proximal fixing member 380 to move closer to or away from the distal fixing member 390 to adjust the shape of the basket structure 300, so that the basket structure 300 switches between the contracted configuration and the expanded configuration. Specifically, when the control handle 200 operates the proximal fixing member 380 to drive the proximal ends of each flexible branch 310 to move relative to the support tube 340 toward the distal end of the support tube 340, the middle area of ​​the flexible branch 310 expands toward the outside of the basket structure 300 to form a basket structure, and the basket structure 300 is in an expanded configuration. When the control handle 200 operates the proximal fixing member 380 to drive the proximal end of each flexible branch 310 to move relative to the support tube 340 toward the distal end away from the support tube 340, the middle area of ​​the flexible branch 310 contracts toward the inner side of the basket structure 300, so that the basket structure 300 switches from an expanded configuration to a contracted configuration.

[0077] See also Figure 5 In the second embodiment of the present application, the reference electrode 330 and the magnetic positioning sensor 350 are arranged on the proximal fixing member 380, and the control handle 200 drives the distal fixing member 390 to move relative to the main body tube 100 through the support tube 340. Figure 5 Schematic diagram of the radiofrequency ablation catheter 10 of the second embodiment of the present application. The reference electrode 330 and the magnetic positioning sensor 350 are arranged on the proximal fixing member 380. Since the reference electrode 330 needs to be fixed when it plays a reference positioning role, in this embodiment, the proximal fixing member 380 is fixed, and in order to enable the basket structure 300 to switch between the expansion configuration and the contraction configuration, the distal fixing member 390 is arranged to be movable relative to the proximal fixing member 380.

[0078] When the operator operates the control handle 200, the control handle 200 can drive the support tube 340 and the distal fixing member 390 to move in the main tube 100, that is, the control handle 200 can drive the distal fixing member 390 to move closer to or away from the proximal fixing member 380 through the support tube 340 to adjust the shape of the basket structure 300, so that the basket structure 300 switches between the contracted configuration and the expanded configuration. Specifically, when the control handle 200 operates the support tube 340 to drive the distal ends of each flexible branch 310 to move toward the distal end of the main tube 100 relative to the main tube 100, the middle area of ​​the flexible branch 310 expands toward the outside of the basket structure 300 to form a basket structure, and the basket structure 300 is in an expanded configuration. When the control handle 200 operates the support tube 340 to drive the distal end of each flexible branch 310 to move relative to the main tube 100 toward the distal end away from the main tube 100, the middle area of ​​the flexible branch 310 contracts toward the inner side of the basket structure 300, so that the basket structure 300 switches from an expanded configuration to a contracted configuration.

[0079] See also Figures 1 to 5 In one embodiment, the control handle 200 has a pusher 210, and the pusher 210 is connected to the proximal fixing member 380 or the support tube 340. The pusher 210 is slidably disposed on the control handle 200, and the portion of the pusher in the control handle 200 can be connected to the proximal end of the proximal fixing member 380 or the support tube 340. In this way, when the operator operates the pusher 210, the pusher 210 can drive the proximal fixing member 380 or the support tube 340 to move. Optionally, the pusher 210 is a push button. Of course, in other embodiments of the present application, the pusher 210 can also be other structural forms that can achieve movement, such as a toggle member, etc.

[0080] In the first embodiment of the present application, the pusher 210 is connected to the proximal fixing member 380. When the operator pushes or pulls the pusher 210, the pusher 210 can drive the proximal fixing member 380 to slide on the support tube 340, thereby adjusting the shape of the basket structure 300. In the second embodiment of the present application, the pusher 210 is connected to the proximal end of the support tube 340. When the operator pushes or pulls the pusher 210, the pusher 210 can drive the support tube 340 and the distal fixing member 390 to slide in the main body tube 100, thereby adjusting the shape of the basket structure 300. Optionally, the basket structure 300 further includes a push-pull rod, and the pusher 210 is connected to the proximal fixing member 380 through the push-pull rod. In this way, the pusher 210 drives the proximal fixing member 380 to move through the push-pull rod to achieve the adjustment of the shape of the basket structure 300.

[0081] See also Figures 4 to 6 In one embodiment, the outer wall of the proximal fixing member 380 or the distal fixing member 390 has a mounting groove, and the reference electrode 330 is fixed to the mounting groove by gluing or snapping. Figure 6 for Figure 4 The RF ablation catheter 10 is shown in a cross-sectional view at the distal fixture 390. It is worth noting that the reference electrode 330 is substantially disposed in the proximal fixture 380 and the distal fixture 390 in the same manner, and only the reference electrode 330 disposed in the distal fixture 390 is used as an example for description.

[0082] The reference electrode 330 is sleeved on the outside of the distal fixing member 390, and the reference electrode 330 is fixed to the distal fixing member 390 by size matching and gluing process to ensure reliable fixation. Of course, the reference electrode 330 can also be fixed to the reference electrode 330 by snap-fitting or other structural matching. In other embodiments of the present application, the distal fixing member 390 or the proximal fixing member 380 itself can also be used as the reference electrode 330.

[0083] It is worth noting that the position and structural form of the magnetic positioning sensor 350 fixed to the distal fixing member 390 are not limited in principle, as long as the fixation can be achieved. Optionally, the magnetic positioning sensor 350 is located on the inner side of the reference electrode 330. Of course, in other embodiments of the present application, the magnetic positioning sensor 350 may also be located at the proximal end, distal end or other position of the reference electrode 330.

[0084] In one embodiment, the basket structure 300 further includes a first thermocouple 360, which is disposed on the inner side of the reference electrode 330. The first thermocouple 360 ​​can conveniently measure the temperature on the inner side of the reference electrode 330, so as to provide real-time feedback on the temperature of the reference electrode 330 and ensure safety during the radiofrequency ablation procedure. In the first embodiment of the present application, the first thermocouple 360 ​​is disposed on the distal fixing member 390, and in the second embodiment of the present application, the first thermocouple 360 ​​is disposed on the proximal fixing member 380.

[0085] Optionally, the basket structure 300 further includes a first connecting wire, a second connecting wire and a third connecting wire, wherein the first connecting wire electrically connects the reference electrode 330 and the control handle 200. The second connecting wire electrically connects the magnetic positioning sensor 350 and the control handle 200, and the third connecting wire electrically connects the first thermocouple 360 ​​and the control handle 200. In this way, power supply and signal transmission of the reference electrode 330, the magnetic positioning sensor 350 and the first thermocouple 360 ​​are realized.

[0086] In the first embodiment of the present application, a wiring channel is provided in the support tube 340. That is, the support tube 340 is a hollow tube, and the first connecting wire, the second connecting wire, and the third connecting wire are routed through the wiring channel inside the support tube 340. The interior of the support tube 340 can be used as an arrangement channel for the first connecting wire, the second connecting wire, and the third connecting wire.

[0087] In the second embodiment of the present application, a wiring channel is set between the support tube 340 and the main tube 100. That is to say, the first connecting wire, the second connecting wire and the third connecting wire can run through a cavity with the fourth connecting wire of the ablation electrode 320 of the flexible branch 310, and run through the wiring channel between the main tube 100 and the support tube 340. Optionally, each wire can be protected by an insulating layer such as paint to ensure the wire and prevent wear from affecting performance. Optionally, the number of wiring channels is multiple, and the first connecting wire, the second connecting wire and the third connecting wire are routed separately. Optionally, the cross-section of the wiring channel is set to be circular or polygonal. Optionally, the support tube 340 is a solid tube.

[0088] Optionally, the support tube 340 is made of metal material. Optionally, the outer wall of the support tube 340 is coated with a lubricating coating. In this way, the resistance to the relative movement between the proximal fixing member 380 and the support tube 340 is reduced.

[0089] In one embodiment, the basket structure 300 further includes a first thermocouple 360 ​​and a plurality of second thermocouples 370, wherein the first thermocouple 360 ​​is disposed on the inner side of the reference electrode 330, and each flexible branch 310 is provided with at least one second thermocouple 370, and the second thermocouple 370 is located on the surface of the flexible branch 310 away from the ablation electrode 320. When the basket structure 300 is in the expanded configuration, the blood temperature monitored by the first thermocouple 360 ​​is the first temperature value, and the blood temperature monitored by the second thermocouple 370 is recorded as the second temperature value, and the adhesion of the ablation electrode 320 to the inner wall 80 of the blood vessel is determined according to the ratio of the second temperature value to the first temperature value, and the ablation temperature is monitored.

[0090] The first thermocouple 360 ​​is arranged on the inner side of the reference electrode 330, and the second thermocouple 370 is arranged on the inner surface of the flexible branch 310 and is arranged corresponding to the second thermocouple 370. The first thermocouple 360 ​​measures the temperature of the reference electrode 330 on the inner side of the reference electrode 330, and the second thermocouple 370 measures the temperature of the ablation electrode 320 on the inner side of the flexible branch 310. After the basket structure 300 is in the expanded configuration, the data collection unit 722 of the radio frequency system 72 can collect the blood temperature monitored by the reference electrode 330 and the ablation electrode 320, and judge the adhesion of the ablation electrode 320 according to the temperature and ensure the safety of the operation.

[0091] The data collection unit 722 inside the radio frequency system 72 can collect that when the basket structure 300 expands, the reference electrode 330 is always in the blood, and a real-time blood temperature is provided, which is recorded as a first temperature value. When the ablation electrode 320 is in different states, a blood temperature is formed, which is recorded as a second temperature value. The ratio between the second temperature value of the dynamic blood temperature and the first temperature value of the blood temperature of the reference electrode 330 is fed back through the processing unit 721 inside the radio frequency system 72.

[0092] By obtaining the ratio of the temperature values ​​of the reference electrode 330 and the ablation electrode 320 when the basket structure 300 is in the expanded configuration, the adhesion between the ablation electrode 320 and the inner wall 80 of the blood vessel is judged and the safety of the operation is ensured. That is, the change in blood temperature is presented in the form of a ratio, eliminating the influence of the year-on-year increase or decrease of the value when the external physiological environment changes, which can improve the accuracy of temperature monitoring, increase the ablation depth, reduce the damage to the surface of the inner wall 80 of the blood vessel, and also provide a certain basis for judging the adhesion of the ablation electrode 320.

[0093] In one embodiment, the second thermocouple 370 and the ablation electrode 320 are disposed correspondingly on both sides of the flexible branch 310. That is, the second thermocouple 370 and the ablation electrode 320 are disposed at the same position of the flexible branch 310 and are disposed back to back. In this way, the accuracy of the temperature monitored by the second thermocouple 370 can be ensured.

[0094] In one embodiment, the ratio of the second temperature value to the first temperature value is greater than or equal to 1. That is, the ratio of the second temperature value of the feedback dynamic blood temperature to the first temperature value of the blood temperature of the reference electrode 330 is greater than or equal to 1, so as to reflect the contact between the ablation electrode 320 and the inner wall 80 of the blood vessel, monitor the ablation temperature, and ensure the safety of the radiofrequency ablation operation.

[0095] In one embodiment, the first thermocouple 360 ​​and the second thermocouple 370 are electrically connected to the radio frequency device 70, the processing data collection unit 722 receives the first temperature value and the second temperature value, and the processing unit 721 feeds back the ratio of the second temperature value to the first temperature value. After the data processing unit 721 collects the first temperature value and the second temperature value, the data is transmitted to the processing unit 721, and the ratio of the second temperature value to the first temperature value is fed back by the processing unit 721, and is displayed through the radio frequency display 71, so that the operator can check the ratio to judge the contact of the ablation electrode 320. At the same time, the temperature of the ablation electrode 320 to the blood vessel wall can be monitored in real time to ensure the safety of the radio frequency ablation operation.

[0096] In one embodiment, the distal end of the control handle 200 has a tail line interface 220, and the control handle 200 is electrically connected to the magnetic positioning device 60 and the radio frequency device 70 of the radio frequency ablation device through the tail line interface 220. The tail line conductor is installed in the tail line interface 220, and then electrically connected to the magnetic positioning device 60 and the radio frequency device 70 to achieve energy and signal transmission. Optionally, the tail line interface 220 is set in a Y shape or has a multi-interface structure. In this way, the tail line interface 220 can meet the wiring requirements of different devices.

[0097] See also Figure 1 and Figure 2In one embodiment, the proximal end of the control handle 200 is connected to the magnetic positioning device 60, the ablation electrode 320 and the reference electrode 330 are electrically connected to the magnetic positioning device 60, and the magnetic positioning device 60 cooperates with the basket structure 300 to generate a three-dimensional model of the basket structure 300. After the radiofrequency ablation catheter 10 is inserted into the blood vessel, the radiofrequency ablation catheter 10 can cooperate with the magnetic positioning device 60 through the reference electrode 330 and the magnetic positioning sensor 350 to locate the position and shape of the basket structure 300 in the blood vessel in real time, thereby presenting the three-dimensional model of the basket structure 300 on the three-dimensional display 61, so that the operator can view the position and shape of the basket structure 300 in the blood vessel.

[0098] During the process of the radiofrequency ablation catheter 10 entering the blood vessel, the real-time position of the magnetic positioning sensor 350 is realized by the receiving and analyzing function of the magnetic signal of the positioning unit 621. Specifically, the three-dimensional system 62 of the magnetic positioning device 60 can provide the magnetic field required for three-dimensional positioning through the three-dimensional magnetic field transmitter placed on the patient bed. The magnetic positioning sensor 350 can sense its frequency and amplitude changes in the magnetic field signal, and further obtain its three-dimensional spatial position in the magnetic field. The volume collection unit 622 can model the basket structure 300 in real time based on the actual size model of the basket structure 300 input in advance and the real-time position of the basket structure 300. Since the volume collection is performed at a rate of 60 times per second or even higher, the three-dimensional system 62 can obtain the data of the radiofrequency ablation catheter 10 in real time, so that the real-time motion trajectory of the radiofrequency ablation catheter 10 can be presented on the three-dimensional display 61. This trajectory image can be presented to the operator on the three-dimensional display 61 from three or more angles. Figure 1 The basket structure 300 of the radio frequency ablation catheter 10 is in a contracted configuration. At this time, the basket structure 300 in the contracted configuration is displayed on the three-dimensional display 61 .

[0099] After the basket structure 300 is delivered to the target position of the blood vessel, the operator operates the pusher 210 of the control handle 200 to adjust the shape of the basket structure 300, so that the basket structure 300 gradually switches from the contracted configuration to the expanded configuration. It is understandable that the three-dimensional data information of the basket structure 300 during the switching process between the contracted configuration and the expanded configuration can be stored in the three-dimensional system 62 of the magnetic positioning device 60 in advance, and the movement of the pusher 210 is input into the three-dimensional system 62 to generate the three-dimensional data information of the basket structure 300; of course, the shape of the basket structure 300 can also be located in real time by the magnetic positioning sensor 350 to generate the three-dimensional data information of the basket structure 300 in the blood vessel. The magnetic positioning device 60 can use the three-dimensional data information to accurately model the expanded configuration of the basket structure 300, which helps to display the three-dimensional model of the basket structure 300 in the expanded configuration in real time, such as Figure 2 shown.

[0100] Several methods for generating three-dimensional data information of the basket structure 300 to generate a three-dimensional model of the basket structure 300 are introduced below:

[0101] In one embodiment of the present application, the control handle 200 has an indicator scale, and the pusher 210 can adjust the maximum diameter of the basket structure 300 in the expanded configuration when it moves along the indicator scale. It can be understood that each movement of the pusher 210 forms a corresponding maximum diameter of the basket structure 300 after expansion, and the data of the two have a one-to-one correspondence.

[0102] That is, every time the pusher 210 moves one scale, the basket structure 300 has a maximum diameter. Before the radiofrequency ablation catheter 10 is used, the volume collection unit 622 of the magnetic positioning device 60 collects the morphological data of the basket structure 300 in any form between the expanded configuration and the contracted configuration, and stores it in the three-dimensional system 62. During the radiofrequency ablation procedure, the morphological data of the basket structure 300 pre-stored in the three-dimensional system 62 can be accurately mobilized according to the travel data of the pusher 210. At this time, the morphology of the basket structure 300 in the expanded configuration can be accurately drawn to display the three-dimensional model of the basket structure 300 in real time.

[0103] In another embodiment of the present application, the basket structure 300 also includes a magnetic positioning sensor 350, which is arranged corresponding to the reference electrode 330. The magnetic positioning sensor 350 accurately positions the basket structure 300. The ablation electrode 320 obtains the current exchange coefficient and feeds it back to the magnetic positioning device 60. The magnetic positioning device 60 determines the three-dimensional model of the basket structure 300 after expansion through the magnetic positioning device 60 and the ablation electrode 320.

[0104] Each flexible branch 310 has a plurality of ablation electrodes 320, which cooperate with the magnetic positioning sensor 350 on the proximal fixing member 380 or the distal fixing member 390 to monitor the shape of the basket structure 300 in real time, so as to generate three-dimensional data information of the basket structure 300, and feed it back to the volume collection unit 622, which constructs the current three-dimensional model of the basket structure 300 according to the three-dimensional information. In other words, the three-dimensional model of the basket structure 300 is displayed on the three-dimensional display 61 by cooperating with the magnetic positioning sensor 350 on the distal fixing member 390 or the proximal fixing member 380 and the ablation electrode 320.

[0105] Specifically, the magnetic positioning sensor 350 can obtain precise positioning, and under the action of the electric field, the ablation electrode 320 on the basket structure 300 is used to obtain the current exchange coefficient. Since a set of spatial coordinates and the current exchange coefficient are unique, the three-dimensional system 62 can compare the displacement matching of the two sets of magnetic field and electric field data, and update the data in real time without manual intervention, thereby maintaining the high-precision display of the basket structure 300 in real time, so as to achieve the purpose of displaying the three-dimensional model of the basket structure 300 on the three-dimensional display 61.

[0106] In another embodiment of the present application, the basket structure 300 also includes a plurality of magnetic positioning sensors 350, and at least part of the flexible branches 310 are provided with at least one magnetic positioning sensor 350. Each magnetic positioning sensor 350 monitors the morphological data of the flexible branches 310 and feeds back the data to the magnetic positioning device 60. The magnetic positioning device 60 determines the three-dimensional model of the basket structure 300 after expansion through the magnetic positioning sensor 350.

[0107] A magnetic positioning sensor 350 is provided on the flexible branch 310 of the basket structure 300, and the magnetic positioning sensor 350 can cooperate with the magnetic positioning sensor 350 on the distal fixing member 390 or the proximal fixing member 380 to monitor the shape of the basket structure 300 in real time, generate three-dimensional data information of the basket structure 300, and feed it back to the volume collection unit 622. The volume collection unit 622 constructs the current three-dimensional model of the basket structure 300 according to the three-dimensional information. In other words, the three-dimensional model of the basket structure 300 is displayed on the three-dimensional display 61 through the magnetic positioning sensor 350 on the distal fixing member 390 or the proximal fixing member 380 and the magnetic positioning sensor 350 of the flexible branch 310.

[0108] Optionally, at least one magnetic positioning sensor 350 is provided for each flexible branch 310. That is, the magnetic positioning sensor 350 can be installed on each flexible branch 310. Of course, the magnetic positioning sensor 350 can also be provided on some of the flexible branches 310. That is, the magnetic positioning sensor 350 can also be installed on any flexible branch 310. The magnetic positioning sensor 350 can be implemented to obtain three-dimensional data information of the basket structure 300 in different forms, and can construct the form of the basket structure 300 in real time without manual intervention, and update the data in real time, thereby maintaining the form of the basket structure 300 with high precision in real time, so as to achieve the purpose of displaying the three-dimensional model of the basket structure 300 on the three-dimensional display 61.

[0109] This application introduces three ways to construct a three-dimensional model of the basket structure 300. The first way is to use the one-to-one correspondence between the stroke of the pusher 210 and the maximum diameter of the basket structure 300, combined with the magnetic positioning sensor 350 on the distal fixing member 390 or the proximal fixing member 380 to provide precise positioning, so as to construct a three-dimensional model of the basket structure 300; the second way is to use magneto-electric dual positioning, that is, the magnetic positioning sensor 350 cooperates with the ablation electrode 320 to directly construct precise visual positioning, thereby constructing a three-dimensional model of the basket structure 300; the third way is to use the method of setting multiple magnetic positioning sensors 350 at different parts to obtain multiple groups of three-dimensional data information and construct a real-time three-dimensional model of the basket structure 300. Combined with the influence, the path of the radiofrequency ablation catheter 10 is changed or the shape of the basket structure 300 is adjusted to guide the ablation electrode 320 to conduct the target area or the ablation electrode 320 to stick to the inner wall 80 of the blood vessel, while reducing the use of radiation.

[0110] See also Figure 1 , Figure 2 , Figures 7 to 9 The surgical operation process is described by taking the radiofrequency ablation catheter 10 of the first embodiment as an example, and a three-dimensional model is constructed in combination with the stroke of the pusher 210 and the pre-stored three-dimensional data information of the basket structure 300 for explanation. Figure 7 for Figure 3 The structure diagram of the radiofrequency ablation catheter 10 delivering the basket structure 300 to the target area is shown. Figure 8 for Figure 7 The basket structure 300 is shown as a schematic diagram of a structure in which the basket structure 300 is in an expanded configuration at one position. Fig. 9 for Figure 8 The basket structure 300 shown is a schematic structural diagram in another position.

[0111] During the actual operation, when the radiofrequency ablation catheter 10 begins to enter the human blood vessel, the magnetic positioning device 60 and the radiofrequency device 70 are started. After obtaining its own accurate positioning, the magnetic positioning sensor 350 on the distal fixture 390 can call the actual volume data of the basket structure 300 from the three-dimensional system 62, such as the volume data of the distal fixture 390 (the volume data can be input according to the actual size of the basket structure 300). The actual volume data of the basket structure 300 is used as a volume unit and modeled and displayed on the three-dimensional display 61. The modeled radiofrequency ablation catheter 10 can roughly limit the basic shape of the basket structure 300 in the contracted configuration, which helps the operator determine the shape and direction of the radiofrequency ablation catheter 10 in the blood vessel, so that the basket structure 300 reaches the target area such as Figure 7 shown.

[0112] When the basket structure 300 is in the target area, the pusher 210 of the control handle 200 is adjusted, and the shape of the basket structure 300 gradually expands from the initial contracted configuration. With the adjustment of the pusher 210, the shape of the basket structure 300 will undergo a change process from olive-shaped, spherical, and then petal-shaped. In each step of the shape change process, a stroke of the pusher 210 and the maximum diameter of the basket structure 300 corresponding to the stroke can be obtained. The data of the two have a one-to-one correspondence and are pre-stored in the three-dimensional system 62. During the operation, the three-dimensional data information stored in the three-dimensional system 62 can be accurately called according to the stroke of the pusher 210. At this time, the shape of the basket structure 300 in the expanded configuration can be accurately drawn, and the three-dimensional model of the basket structure 300 can be displayed in real time, such as Figure 8 and Fig. 9 shown.

[0113] During the operation, if it is necessary to rotate the angle of the basket structure 300 of the radiofrequency ablation catheter 10 so that the ablation electrode 320 is in good contact with the inner wall 80 of the blood vessel in the target area, the shape of the basket structure 300 can be viewed in conjunction with the three-dimensional display 61 to observe whether the position of the basket structure 300 is adjusted, so that the ablation electrode 320 is in close contact with the inner wall 80 of the blood vessel in the target area. Figure 8 and Fig. 9 At the end of the surgical treatment, the pusher 210 can be adjusted to switch the basket structure 300 from the expanded configuration to the contracted configuration. At the same time, the shape of the basket structure 300 displayed on the three-dimensional display 61 can be combined to make the basket structure 300 in the contracted configuration, so that the basket structure 300 can be easily withdrawn from the blood vessel, thereby avoiding the surgical safety hazards caused by not adjusting the pusher 210 to put the basket structure 300 in the contracted configuration or forgetting to adjust the pusher 210 to put the basket structure 300 in the expanded configuration. At the same time, the use of X-ray examination can be reduced to avoid the harm of radiation to the surgeon and the patient.

[0114] After the basket structure 300 is in the expanded configuration, the relative position of the reference electrode 330 and the ablation electrode 320 will change. Therefore, the first impedance value and the second impedance value between the reference electrode 330 and the ablation electrode 320 in the expanded configuration of the basket structure 300, as well as the first temperature value of the reference electrode 330 in the blood and the second temperature value of the ablation electrode 320 in the blood can be seen on the radio frequency display 71 of the radio frequency device 70. Since the ratio of the second impedance value to the first impedance value (greater than or equal to 1) and the ratio of the second temperature value to the first temperature value (greater than or equal to 1) at different positions are different, it can reflect whether the ablation element is in close contact with the inner wall 80 of the blood vessel. At the same time, impedance monitoring and temperature monitoring are set in the form of ratios rather than absolute values, eliminating the influence of the numerical value being enlarged or reduced year-on-year when the external physiological environment changes, improving the monitoring accuracy of temperature and impedance, and obtaining a more accurate basis for judging whether the ablation electrode 320 is in close contact.

[0115] Basket structure 300 from Figure 8 to Figure 9 The position change requires the RF ablation catheter 10 to adjust the angle. Specifically, as the basket structure 300 gradually expands, the ratio of the second impedance value to the first impedance value gradually increases, which indicates that the ablation electrode 320 gradually moves toward the inner wall 80 of the blood vessel. When the ratio of the second impedance value to the first impedance value increases to a maximum value, the ratio of the second impedance value to the first impedance value will not change by adjusting the pusher 210 or rotating the RF ablation catheter 10, indicating that the ablation electrode 320 is in a good abutment position. Since there are multiple ablation electrodes 320 on the basket structure 300, the present application can monitor the ratio of the second impedance value to the first impedance value between the reference electrode 330 and one or more ablation electrodes 320, so as to better judge the abutment effect of the basket structure 300 with the inner wall 80 of the blood vessel.

[0116] When the radiofrequency ablation catheter 10 is in working state, if the basket structure 300 is also in good contact at this time, since the temperature of the inner wall 80 of the blood vessel is higher than the temperature of the blood, then the ratio of the second temperature value to the first temperature value will also have a significant change, so that the temperature of the inner wall 80 of the blood vessel can be judged to avoid the temperature of the inner wall 80 of the blood vessel being too high, so as to increase the ablation temperature and provide guarantee for the safety of the operation. At the same time, it can also reflect the contact between the ablation electrode 320 and the inner wall 80 of the blood vessel. At this time, combined with the shape and position of the basket structure 300 on the three-dimensional display 61, the radiofrequency ablation catheter 10 is slightly rotated. If the ratio of the second temperature value to the first temperature value increases, it indicates that the contact before the rotation is not very good. Therefore, the radiofrequency ablation catheter 10 is fine-tuned according to the angle of increase of the ratio of the second temperature value to the first temperature value, so that the ratio of the second temperature value to the first temperature value reaches the maximum. At this time, it can be judged that the contact between the ablation electrode 320 and the inner wall 80 of the blood vessel is good. On the contrary, if the ratio of the second temperature value to the first temperature value decreases, it indicates that the previous abutment is in a good position and there is no need to rotate the radiofrequency ablation catheter 10. By displaying the shape of the basket structure 300 on the three-dimensional display 61, a good image viewing angle can be provided when adjusting and rotating the radiofrequency ablation catheter 10, avoiding damage to the blood vessel due to blind adjustment and rotation of the radiofrequency ablation catheter 10.

[0117] See also Figures 1 to 9 The radiofrequency ablation catheter 10 of the present application can reduce the use time of radiation during the operation, and at the same time increase the visibility of the radiofrequency ablation catheter 10 at any time, and provide a certain image basis for the adjustment of the shape and rotation of the angle of the basket structure 300 during the operation, which is conducive to the operator to quickly adjust the basket structure 300 to an appropriate shape and size and reach the accurate target area for treatment. At the same time, the present application provides impedance change ratio and blood temperature change ratio monitoring, which is conducive to improving the accuracy of impedance and temperature monitoring, ensuring the good contact between the ablation electrode 320 and the inner wall 80 of the blood vessel, and ensuring the temperature of the inner wall 80 of the blood vessel during the operation, so that the ablation depth is increased and the damage to the inner wall 80 of the blood vessel is reduced.

[0118] See also Figure 1 and Figure 2The present application also provides a radiofrequency ablation device, characterized in that it includes a magnetic positioning device 60, a radiofrequency device 70 and a radiofrequency ablation catheter 10 as any of the above embodiments, the magnetic positioning device 60 is electrically connected to the radiofrequency device 70 and the radiofrequency ablation catheter 10; the magnetic positioning device 60 includes a three-dimensional display 61 and a three-dimensional system 62, the three-dimensional system 62 has a positioning unit 621 and a volume collection unit 622, the positioning unit 621 is used to monitor the position of the basket structure 300 in the radiofrequency ablation catheter 10 on the inner wall 80 of the blood vessel, the volume collection unit 622 determines the three-dimensional shape of the basket structure 300 according to the position of the basket structure 300 and the three-dimensional model of the basket structure 300, and displays it through the three-dimensional display 61; the radiofrequency device 70 includes a radiofrequency display 71 and a radiofrequency system 72, the radiofrequency system 72 has a processing unit 721 and a data collection unit 722, the data collection unit 722 collects the impedance value and temperature value of the blood, and feeds back the ratio through the processing unit 721.

[0119] The specific structure and working principle of the magnetic positioning device 60 and the radio frequency device 70 have been mentioned above and will not be repeated here. After the radio frequency ablation device of the present application adopts the radio frequency ablation catheter 10 of the above embodiment, it can realize the visibility of the basket structure 300 at any time, and realize the monitoring of the impedance change ratio and the blood temperature change ratio, which is conducive to improving the accuracy of impedance and temperature monitoring and ensuring the adhesion between the ablation electrode 320 and the inner wall 80 of the blood vessel.

[0120] In one embodiment, the volume collection unit 622 constructs a three-dimensional model of the basket structure 300 by adjusting the maximum diameter of the basket structure 300 through the pusher 210 of the radio frequency ablation catheter 10; or, the volume collection unit 622 collects the positioning information of the basket structure 300 by the magnetic positioning sensor 350 and the ablation electrode 320 to construct a three-dimensional model of the basket structure 300; or, the volume collection unit 622 collects multiple groups of morphological data obtained by the magnetic positioning sensor 350 on each flexible branch 310 of the basket structure 300 to construct a three-dimensional model of the basket structure 300.

[0121] The radiofrequency ablation device of the present application constructs a three-dimensional model of the basket structure 300 in three ways: the first is to use a one-to-one correspondence between the stroke of the pusher 210 and the maximum diameter of the basket structure 300, combined with the magnetic positioning sensor 350 on the distal fixing member 390 or the proximal fixing member 380 to provide precise positioning, so as to construct a three-dimensional model of the basket structure 300; the second is to use magneto-electric dual positioning, that is, the magnetic positioning sensor 350 cooperates with the ablation electrode 320 to directly construct precise visual positioning, thereby constructing a three-dimensional model of the basket structure 300; the third is to use a method of setting multiple magnetic positioning sensors 350 at different parts to obtain multiple groups of three-dimensional data information and construct a real-time three-dimensional model of the basket structure 300.

[0122] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0123] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A radiofrequency ablation catheter, characterized in that: include: Main pipe; A control handle located at the proximal end of the main body tube; as well as A basket structure is located at the distal end of the main tube, the basket structure has an expanded configuration and a contracted configuration, and can be switched between the expanded configuration and the contracted configuration, wherein the basket structure includes a reference electrode, a support tube, a plurality of flexible branches, and a plurality of ablation electrodes, the reference electrode is arranged in the basket structure, the support tube is arranged in the main tube, the distal ends of the plurality of flexible branches are mutually connected to the distal end of the support tube, the proximal ends of the plurality of flexible branches are mutually connected to the distal end of the main tube, each of the flexible branches has a plurality of ablation electrodes, and the plurality of ablation electrodes are arranged at intervals along the length direction of the flexible branch; When the basket structure is in a contracted configuration, there is a first impedance value between the ablation electrode and the reference electrode. When the basket structure is in an expanded configuration, there is a second impedance value between the ablation electrode and the reference electrode. The adhesion of the ablation electrode to the inner wall of the blood vessel is determined by the ratio between the second impedance value and the first impedance value.

2. The radiofrequency ablation catheter according to claim 1, characterized in that: The basket structure also includes a magnetic positioning sensor, which is arranged corresponding to the reference electrode.

3. The radiofrequency ablation catheter according to claim 2, characterized in that: The basket structure further comprises a proximal fixing member and a distal fixing member, wherein the distal fixing member is arranged at the distal end of the support tube and connected to the distal ends of the plurality of flexible branches, and the proximal fixing member is sleeved on the support tube and connected to the proximal end of the main body tube; The reference electrode and the magnetic positioning sensor are arranged on the distal fixing piece, and the control handle drives the proximal fixing piece to move relative to the support tube through the main tube, or the reference electrode and the magnetic positioning sensor are arranged on the proximal fixing piece, and the control handle drives the distal fixing piece to move relative to the main tube through the support tube.

4. The radiofrequency ablation catheter according to claim 3, characterized in that: When the reference electrode is arranged on the distal fixing member, a wiring channel is provided in the support tube; When the reference electrode is arranged on the proximal fixing member, a wiring channel is arranged between the support tube and the main body tube.

5. The radiofrequency ablation catheter according to claim 3, characterized in that: The outer wall of the proximal fixing member or the distal fixing member has a mounting groove, and the reference electrode is fixed to the mounting groove by gluing or snapping.

6. The radiofrequency ablation catheter according to claim 1, characterized in that: The basket structure further includes a first thermocouple and a plurality of second thermocouples, wherein the first thermocouple is disposed on the inner side of the reference electrode, each of the flexible branches is provided with at least one second thermocouple, and the second thermocouple is located on the surface of the flexible branch away from the ablation electrode; When the basket structure is in the expanded configuration, the blood temperature monitored by the first thermocouple is the first temperature value, and the blood temperature monitored by the second thermocouple is recorded as the second temperature value. The adhesion of the ablation electrode to the inner wall of the blood vessel and the ablation temperature are determined based on the ratio of the second temperature value to the first temperature value.

7. The radiofrequency ablation catheter according to claim 6, characterized in that: The proximal end of the control handle is electrically connected to a radio frequency device, the ablation electrode and the reference electrode are electrically connected to the radio frequency device, a processing data collection unit of the radio frequency device receives the first impedance value and the second impedance value, and feeds back the ratio of the second impedance value to the first impedance value to the processing unit of the radio frequency device; The first thermocouple and the second thermocouple are electrically connected to the radio frequency device, the processing data collection unit receives the first temperature value and the second temperature value, and the processing unit feeds back a ratio of the second temperature value to the first temperature value.

8. The radiofrequency ablation catheter according to any one of claims 1 to 7, characterized in that: The proximal end of the control handle is connected to a magnetic positioning device, the ablation electrode and the reference electrode are electrically connected to the magnetic positioning device, and the magnetic positioning device cooperates with the basket structure to generate a three-dimensional model of the basket structure.

9. The radiofrequency ablation catheter according to claim 8, characterized in that: The control handle has a pusher, and the pusher is connected to the proximal fixing member or the support tube of the basket structure; The control handle has an indicator scale, and the pusher can adjust the maximum diameter of the basket structure when it is in the expanded configuration when moving along the indicator scale.

10. The radiofrequency ablation catheter according to claim 8, characterized in that: The basket structure also includes a magnetic positioning sensor, which is arranged corresponding to the reference electrode. The magnetic positioning sensor accurately positions the basket structure. The ablation electrode obtains the current exchange coefficient and feeds it back to the magnetic positioning device. The magnetic positioning device determines the three-dimensional model of the expanded basket structure through the magnetic positioning device and the ablation electrode.

11. The radiofrequency ablation catheter according to claim 8, characterized in that: The basket structure also includes multiple magnetic positioning sensors, and at least one magnetic positioning sensor is set on at least part of the flexible branches. Each magnetic positioning sensor monitors the morphological data of the flexible branches and feeds back to the magnetic positioning device. The magnetic positioning device determines the three-dimensional model of the basket structure after expansion through the magnetic positioning sensor.

12. The radiofrequency ablation catheter according to any one of claims 1 to 7, characterized in that: The distal end of the control handle has a tail wire interface, and the control handle is electrically connected to the magnetic positioning device and the radio frequency device of the radio frequency ablation device through the tail wire interface; The tail line interface is arranged in a Y shape or has a multi-interface structure.

13. The radiofrequency ablation catheter according to any one of claims 1 to 7, characterized in that: The outer wall of the support tube is coated with a lubricating coating.

14. A radiofrequency ablation device, characterized in that: It comprises a magnetic positioning device, a radio frequency device and a radio frequency ablation catheter according to any one of claims 1 to 13, wherein the magnetic positioning device is electrically connected to the radio frequency device and the radio frequency ablation catheter; The magnetic positioning device includes a three-dimensional display and a three-dimensional system. The three-dimensional system has a positioning unit and a volume collection unit. The positioning unit is used to monitor the position of the basket structure in the radiofrequency ablation catheter on the inner wall of the blood vessel. The volume collection unit determines the three-dimensional shape of the basket structure according to the position of the basket structure and the three-dimensional model of the basket structure, and displays it through the three-dimensional display. The radio frequency device includes a radio frequency display and a radio frequency system. The radio frequency system has a processing unit and a data collection unit. The data collection unit collects the impedance value and temperature value of the blood and feeds back the ratio through the processing unit.

15. The radiofrequency ablation device according to claim 14, characterized in that: The volume collection unit constructs a three-dimensional model of the basket structure by adjusting the maximum diameter of the basket structure through the pusher of the radiofrequency ablation catheter; Alternatively, the volume collection unit collects the positioning information of the basket structure by the magnetic positioning sensor and the ablation electrode, and constructs a three-dimensional model of the basket structure; Alternatively, the volume collection unit collects multiple sets of morphological data acquired by magnetic positioning sensors on each flexible branch of the basket structure to construct a three-dimensional model of the basket structure.

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