Detailed Description
The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art. The term "and/or" is an association relationship describing an associated object, meaning that there may be three relationships, e.g., a and/or B, which may represent: a exists alone, A and B exist together, and B exists alone.
In the description of the present specification, reference to an embodiment of the terms "embodiment," "specific embodiment," "example," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The embodiment of the application provides an ablation catheter and an ablation system, wherein a conductive framework of the ablation catheter is provided with a polyhedral grid structure, the discharge area is larger, a large-area damage area can be formed, a plurality of electrodes are uniformly distributed on the conductive framework, each electrode supports separate mapping, the cardiac electrical signal mapping of the ablation catheter under different leaning conditions can be adapted, each electrode can be independently discharged and also can be subjected to grouping discharge, the damage mode is more flexible, and the ablation system using the ablation catheter has higher ablation efficiency.
Referring to fig. 1, fig. 1 is a schematic diagram of an ablation system 100 for performing an ablation treatment according to the present application.
In some embodiments, ablation system 100 may include ablation catheter 10, negative plate 20, handle 30, three-dimensional mapping system 50, pulse ablator 60, and multi-guide recorder 70. Ablation catheter 10 is connected to handle 30 by wire 40a, negative plate 20 is connected to handle 30 by wire 40b, handle 30 is connected to three-dimensional mapping system 50 by wire 40c, pulse ablator 60 by wire 40d, and multi-conductor recorder 70 by wire 40 e. Ablation catheter 10 may be discharged to generate an electrical current that passes through patient 80 tissue to negative plate 20, which is attached to the back of patient 80, and finally passed back through the lead wire into ablation system 100 to form a circuit. In this embodiment, ablation system 100 is provided with negative plate 20 such that ablation system 100 can achieve both pulsed and radiofrequency ablation.
In some embodiments, the three-dimensional mapping system 50 is used for three-dimensional mapping image generation of the ablation catheter 10 during the treatment to form a positional image of the ablation catheter 10 itself, and the three-dimensional mapping system 50 is also used to map the cardiac electrical signals of the patient 80 prior to and/or during the ablation treatment of the patient 80. The multi-guide recorder 70 may include a storage unit, a processing unit, and a display interface (not shown), wherein the storage unit is configured to receive cardiac electrical signals from the patient 80, the processing unit is configured to analyze the cardiac electrical signals to generate images such as corresponding excitation patterns, voltage patterns, and the like, and the display interface is configured to display the images such as the excitation patterns, the voltage patterns, and the like, so as to direct the operator to the location of the focal area and the low voltage area of the heart of the patient 80.
In some embodiments, the pulse ablator 60 may include a fluid source, a radio frequency energy source, a control unit, and a software interface (not shown). The control unit and software interface of the pulse ablator 60 may be centralized in a computer, which stores executable instructions for causing the control unit to perform the operations described in this embodiment. Under the three-dimensional mapping image, the operator can operate the pulse ablator 60 to control the ablation catheter 10 to reach the low voltage region or focus of the heart of the patient 80, and precisely ablate the focus, thereby blocking the conduction of abnormal electrical signals.
Referring to fig. 1-3 in combination, fig. 2 is a schematic view of a portion of an ablation catheter 10 according to some embodiments of the present application, and fig. 3 is a schematic view of a portion of the ablation catheter 10 shown in fig. 2 in an exploded view.
In some embodiments, the ablation catheter 10 may include a catheter 1, a conductive backbone 2, a plurality of electrodes 3, one or more ring electrodes 4, and an irrigation catheter 5. The proximal end of the conductive framework 2 of the ablation catheter 10 is secured to the distal end of the catheter 1 and the plurality of electrodes 3 are secured to the distal end of the conductive framework 2. The ring electrode 4 is fixed to the distal end of the catheter 1 and is located outside the catheter 1. The infusion catheter 5 is located inside the catheter 1, and the distal end of the infusion catheter 5 is located inside the conductive backbone 2. In an embodiment of the present application, the "proximal" and "distal" orientations of the various structures of ablation catheter 10 are descriptions of the relative orientations of the various components from the perspective of the operator using ablation catheter 10, with "proximal" and "distal" being non-limiting orientations descriptions, wherein the direction of conductive framework 2 by catheter 1 is the "proximal" to "distal" direction. For example, the conductive backbone 2 is located at the distal end of the catheter 1, and the catheter 1 is located at the proximal end of the conductive backbone 2.
In this embodiment, pulse ablator 60 delivers current to conductive skeleton 2, which can be discharged as a whole, and the current is delivered through the patient 80 tissue to negative plate 20 attached to the back of patient 80 and then back into pulse ablator 100 via a wire, forming a loop.
In some embodiments, the distal end of the conductive framework 2 is in a polyhedral lattice structure, and the conductive framework 2 may include a plurality of first struts 21, where the first struts 21 are connected end-to-end with each other to form the polyhedral lattice structure of the conductive framework 2.
In some embodiments, the conductive backbone 2 has a centerline, the centerline of the conductive backbone 2 being parallel to the proximal-to-distal direction of the conductive backbone 2. The polyhedral grid structure at the distal end of the conductive skeleton 2 may be composed of a plurality of five-sided grids and a plurality of six-sided grids, and the polyhedral grid structure is substantially spherical. Wherein the conductive backbone 2 is generally circular in shape at a maximum cross-sectional dimension in a direction perpendicular to a centerline of the conductive backbone 2, and the maximum cross-sectional dimension of the conductive backbone 2 is greater than the diameter of the catheter 1.
In this embodiment, by expanding the treatment site, for example, the maximum cross-sectional dimension of the conductive skeleton 2 is larger than the diameter of the catheter 1, so that the conductive skeleton 2 can provide a larger damaged area, thereby shortening the overall operation time, and also improving the treatment effect. In other embodiments, the conductive skeleton 2 may have other shapes, such as spindle, truncated cone-like, etc., which are not strictly limited by the present application.
Referring to fig. 2 and fig. 4 in combination, fig. 4 is a schematic structural diagram of the conductive framework 2 shown in fig. 3.
In some embodiments, the conductive framework 2 may include a central grid 22 and a plurality of edge grid sets 23, i.e., the first struts 21 are connected end-to-end to form the central grid 22 and the plurality of edge grid sets 23 of the conductive framework 2. A central grid 22 is located at the distal end of the conductive skeleton 2, the center of the central grid 22 being located on the central line of the conductive skeleton 2. The central grid 22 may be polygonal, and a plurality of edge grid sets 23 are arranged around the central grid 22 and rotationally symmetrically arranged around the center line of the conductive skeleton 2, i.e. each edge of the central grid 22 may extend out of one edge grid set 23. Wherein the central grid 22 may be a regular pentagon, the number of side grid sets 23 is five. Each side grid set 23 includes at least one side grid, for example, each side grid set 23 includes a first side grid 231 and a second side grid 232. Wherein the first edge grid 231 is located between the center grid 22 and the second edge grid 232, and the first edge grid 231 and the center grid 22 are multiplexed on one side. The second side grid 232 is located on the side of the first side grid 231 remote from the center grid 22, and the second side grid 232 multiplexes one side with the first side grid 231.
In this embodiment, different forms of grids on the conductive skeleton 2 can form different discharge areas. Compared with a solid ablation large head, the conductive framework 2 with a plurality of grids has larger discharge area, larger area of the formed ablation damage and deeper ablation depth.
In addition, the conductive skeleton 2 with multiple grids and the negative plate 20 (refer to fig. 1) form a loop, and compared with an annular discharge skeleton, the conductive skeleton has larger discharge area, stronger parameter tolerance degree, less possibility of generating electric spark during discharge and uniform damage. And, the grid of the far end different forms of conductive skeleton 2 has the discharge area of equidimension, and total discharge area increases, and the ablation damage area that forms increases.
Second, the central grid 22 and the plurality of edge grid sets 23 of the conductive framework 2 are configured such that when the conductive framework 2 is positioned against tissue at a treatment site, a portion of the tissue enters the central grid 22 and the plurality of edge grid sets 23 to prevent movement of the ablation catheter 10 relative to the treatment site during treatment. The conductive framework 2 has better positioning support, so that the position of the damaged area generated by the ablation catheter 10 is more accurate.
In some embodiments, each side grid set 23 may further include a third side grid 233, and the third side grid 233 may be a pentagon, where the third side grid 233 is located on a side of the second side grid 232 away from the first side grid 231, and the third side grid 233 multiplexes one side with the second side grid 232.
In some embodiments, the conductive framework 2 further comprises at least one connection grid. For example, a first connection mesh 241 is disposed between two adjacent side mesh groups 23, and the first connection mesh 241 may be pentagonal, and the first connection mesh 241 multiplexes one side with each of the first side mesh 231 and the second side mesh 232 of the two adjacent side mesh groups 23. A second connection grid 242 may be further disposed between two adjacent side grids 23, where the second connection grid 242 may be hexagonal, and the second connection grid 242 is located on a side of the first connection grid 241 away from the central grid 22, and is multiplexed with the first connection grid 241 and the second side grid 232 and the third side grid 233 of two adjacent side grids 23. A third connection grid 243 may be further disposed between two adjacent side grid groups 23, where the third connection grid 243 may be an open hexagon, and the third connection grid 243 is located on a side of the second connection grid 242 away from the first connection grid 241, and is multiplexed with the second connection grid 242 and the third side grid 233 of two adjacent side grid groups 23. The conductive skeleton 2 may include 11 regular pentagonal meshes and 20 regular hexagonal meshes in this embodiment.
In some embodiments, the conductive framework 2 may further include a plurality of second struts 25, the second struts 25 connecting the first struts 21 closest to the proximal end, such as connecting the first struts 21 closest to the proximal end of the third connecting grid 243. Wherein the second struts 25 extend proximally from the distal end of the conductive backbone 2, e.g., the second struts 25 may be parallel to the centerline of the conductive backbone 2. The plurality of second struts 25 may fixedly connect the catheter 1 such that the conductive backbone 2 and the catheter 1 are fixed to each other.
Wherein the second support posts 25 may be electrically conductive and electrically connected to the first support posts 21. The second support 25 may be made of a conductive material, and the second support 25 is configured to receive an electric current and transmit the electric current to the first support 21 to discharge the electric current through the first support 21.
Wherein the width of the second struts 25 may be different from the width of the first struts 21. Illustratively, the width of the second struts 25 is greater than the width of the first struts 21, thereby making the connection of the second struts 25 to the catheter 1 more stable.
In some embodiments, the center grid 22 and the sides of each side grid allow for some curvature such that the perimeter of the grid structure formed by the center grid 22 and the side grids is smoother. In other embodiments, the sides of the center grid 22 and side grids may not be curved, as the application is not limited in this regard.
In some embodiments, the conductive skeleton 2 may be made of nickel-titanium. The nickel-titanium conductive framework 2 is elastically flexible in the direction of a central line, is of a deformable structure and can be switched between a contracted state and an expanded state. The conductive skeleton 2 has a polyhedral mesh structure, that is, a generally hollow mesh structure. The plurality of first struts 21 may contract inwardly when the conductive framework 2 is in a contracted state. When the conductive framework 2 is in the expanded state, the plurality of first struts 21 expand outwardly so that the conductive framework 2 can be well abutted against the tissue of the treatment site. In the embodiment of the present application, the "inside" and "outside" orientations of the respective structures of the conductive frame 2 are descriptions of relative orientations, in which the direction from the geometric center of the conductive frame 2 to the first support column 21 is the "inside" to "outside" direction. For example, the geometric center of the conductive frame 2 is located inside the first support column 21, and the first support column 21 is located outside the geometric center of the conductive frame 2.
In this embodiment, when the conductive framework 2 is in the contracted state, the total volume of the conductive framework 2 is small, so that the ablation catheter 10 can be delivered to the treatment site through a minimally invasive delivery catheter of small diameter to facilitate movement of the ablation catheter 10 in the blood vessel of the patient 80 (see fig. 1). When the conductive framework 2 is in an expanded state, the conductive framework 2 has a larger outer surface area, the total discharge area is larger, and the area of ablation damage caused to the treatment part is increased. And the conductive framework 2 with larger volume can shunt current so as to avoid the current electric field concentration effect in a smaller discharge space. In addition, the conductive framework 2 can bear larger current, and electric sparks are not easy to generate, so that the parameter tolerance degree of the ablation catheter 10 is stronger, the damage of the ablation catheter 10 to a treatment part is more uniform, and the conductive framework can be applied to a high-voltage pulse electric field. Therefore, the deformable conductive framework 2 can be suitable for various tissue forms, can be well attached to the tissue of a treatment part, and has better ablation effect.
Illustratively, the conductive skeleton 2 may be formed by three-dimensionally cutting a regular polyhedral lattice to form a lattice structure of the skeleton, such as may be formed by laser cutting. Illustratively, the conductive skeleton 2 may be a continuous, integrally formed structure. In this embodiment, the conductive framework 2 is a continuous nickel-titanium grid structure, so that the uniform stress of the catheter 1 during sheath retraction can be ensured.
Illustratively, the first pillars 21 and/or the second pillars 25 may be plate-like structures, the number of the first pillars 21 being determined according to the shape and size of the mesh of the conductive frame 2, and the specific shape and number of the first pillars 21 are not strictly limited in this embodiment.
Referring to fig. 4 to 6 in combination, fig. 5 is a schematic view showing the structure of the electrode 3 shown in fig. 3 at different angles, and fig. 6 is a schematic view showing the cross-sectional structure of the conductive frame 2 and the electrode 3 shown in fig. 3 taken along A-A in the mounted state.
In some embodiments, the electrode 3 of the ablation catheter 10 may include a first portion 31 and a second portion 32, the first portion 31 being connected to the second portion 32. The outer surface of the first portion 31 facing away from the second portion 32 may be a spherical crown surface, the first portion 31 may be integrally spherical crown-shaped, the second portion 32 may be integrally cylindrical, and the diameter of the largest section of the first portion 31 is larger than the diameter of the second portion 32. The second portion 32 is provided with at least one protrusion 33 at an end facing away from the first portion 31, and the protrusion 33 may be protruded on a circumferential side surface of the second portion 32. For example, the number of the projections 33 may be plural, and the plurality of projections 33 are provided around the second portion 32.
Wherein the first struts 21 of the conductive framework 2 form mesh nodes 26 where they are connected to each other. The mesh nodes 26 of the conductive skeleton 2 are provided with mounting holes 261. The ablation catheter 10 further includes a plurality of wires (not shown) positioned inside the conductive framework 2 and along the interior of the catheter 1 (see fig. 2) to access the handle 30 (see fig. 1).
In some embodiments, the second portion 32 of the electrode 3 is attached to the mounting hole 261 after being connected with a wire, and the second portion 32 of the electrode 3 is adapted to the shape of the mounting hole 261. After the electrode 3 is mounted in the mounting hole 261, the bump 33 is located inside the conductive frame 2, and the first portion 31 of the electrode 3 is located outside the conductive frame 2, that is, the conductive frame 2 is engaged between the bump 33 and the first portion 31 of the electrode 3.
In this embodiment, the electrodes 3 may be used alone to measure the local impedance of the site to be treated and to perform discharge ablation. The bump 33 of the electrode 3 and the mounting hole 261 of the conductive framework 2 can form a buckle structure with a limiting function and a connecting function, so that the connection stability of the electrode 3 and the conductive framework 2 after assembly is higher. Secondly, form the buckle and connect between lug 33 and first portion 31 and the conductive skeleton 2 of electrode 3 for electrode 3 can freely select mounting hole 261 on the conductive skeleton 2 to install, and electrode 3 is more nimble convenient on conductive skeleton 2.
In other embodiments, the electrode 3 may be fixed to the conductive skeleton 2 in other manners, and the conductive skeleton 2 may not be provided with a mounting hole. For example, the electrode 3 may be fixed to the conductive frame 2 by sewing, pasting, attaching, embedding, hot pressing, or the like, which is not strictly limited in the present application.
Referring to fig. 4 and 7 in combination, fig. 7 is a schematic view of the ablation catheter 10 of fig. 2 at another angle.
In some embodiments, the plurality of electrodes 3 of the ablation catheter 10 may be divided into a plurality of electrode sets 34. The plurality of electrode groups 34 are arranged rotationally symmetrically around the center line of the conductive skeleton 2, each electrode group 34 including at least two electrodes 3. And the projection directions of all electrodes 3 in the same electrode group 34 on a first plane are the same, and the first plane is perpendicular to the central line of the conductive framework 2. The plane in which fig. 7 is located may be regarded as a first plane.
In the present embodiment, the plurality of electrodes 3 of the ablation catheter 10 are divided into a plurality of electrode groups 34, and the conductive skeleton 2 is also divided into a plurality of regions, one region corresponding to each electrode group 34. Each electrode set 34 can be ablated by an individual discharge so that the conductive skeleton 2 can achieve zoned ablation. The electrode group 34 which is well attached is selected for discharge ablation according to the impedance of the electrode 3 in the treatment process of an operator, so that the generation of a thermal effect of a treatment part is reduced, and the ablation area and the ablation depth can be controlled.
In some embodiments, the number N of electrode sets 34 satisfies: n is more than or equal to 4 and less than or equal to 6.
In some embodiments, the number of electrode sets 34 is five, and five central electrodes 35 are fixed on the grid nodes 26 of the central grid 22, and each central electrode 35 is multiplexed by two adjacent electrode sets 34. The center electrodes 35 are arranged at 72 intervals with respect to the geometric center of the center grid 22.
In some embodiments, each electrode set 34 includes two first sub-electrodes 341, two second sub-electrodes 342, and two third sub-electrodes 343. The two first sub-electrodes 341 are respectively fixed on the two end grid nodes 26 of the multiplexing side of the center grid 22 and the first side grid 231, the two second sub-electrodes 342 are respectively fixed on the two end grid nodes 26 of the multiplexing side of the first side grid 231 and the second side grid 232, and the two third sub-electrodes 343 are respectively fixed on the two end grid nodes 26 of the side of the second side grid 232 away from the first side grid 231. The two first sub-electrodes 341 of each electrode group 34 are two adjacent center electrodes 35.
In some embodiments, in the same electrode group 34, the arc of the line connecting the first sub-electrode 341 and the third sub-electrode 343 is greater than or equal to 30 °. In the present embodiment, the radian of the connection line between the first sub-electrode 341 and the third sub-electrode 343 is greater than or equal to 30 °, so that the distance between the first sub-electrode 341 and the third sub-electrode 343 is not too small, and adverse effects on the discharge of the conductive frame 2 sub-electrode group 34 are prevented.
In some embodiments, each of the two first sub-electrodes 341, the two second sub-electrodes 342, and the two third sub-electrodes 343 of each electrode group 34 may be used as an ablation electrode for simultaneous discharge ablation. The electrode 3 on the conductive skeleton 2 is divided into five regions, one region corresponds to one electrode group 34, and each electrode group 34 can be discharged independently, that is, two first sub-electrodes 341, two second sub-electrodes 342 and two third sub-electrodes 343 in each region can be discharged simultaneously, and the conductive skeleton 2 can form five discharge regions.
In this embodiment, when the ablation catheter 10 is placed in the heart of the patient 80 (see fig. 1) for treatment, only a portion of the electrodes 3 of the conductive frame 2 may be well adhered to the atrial wall due to the continuous beating of the heart, and a portion of the electrodes 3 in the opposite direction may be suspended in the blood and not adhered to the atrial wall. Therefore, when the electrode set 34 located in a certain area is well attached to the atrial wall, the electrode set 34 in the certain area can be selected to discharge so as to form linear or band-shaped lesions at the treatment site, thereby facilitating the ablation of the connecting point in a linear manner and further improving the ablation efficiency. The conductive framework 2 is discharged in a partitioned mode, partial energy loss of the electrode 3 in a non-contact area can be avoided, the ablation effect is reduced, selective irreversible electroporation can be formed, the generation of the ablation thermal effect is reduced, and the ablation safety is guaranteed. In addition, under the condition of reasonable ablation parameters, the ablation area and the ablation depth can be controlled, so that a better ablation treatment effect is realized.
In some embodiments, all electrodes 3 on the conductive skeleton 2 may also be discharged individually. When all the electrodes 3 are well attached to the treatment site, all the electrodes 3 can be subjected to discharge ablation together, and punctiform lesions can be formed, which is not strictly limited by the present application.
In the present application, all the electrodes 3 on the conductive skeleton 2 are discharged simultaneously, that is, all the electrode groups 34 in five regions of the conductive skeleton 2 are discharged, and the current generated by the conductive skeleton 2 is different from the current generated by the discharge of the electrode groups 34 in only one region, so that all the ablation parameters including the number of the pulses, the pulse time, the pulse width, the pulse frequency, etc. can be integrated to obtain one integrated parameter. And adjusting the voltage plus PI value according to the comprehensive parameters so as to adjust the ablation voltage. In addition, during the ablation process, the tissue of the treatment site is subjected to irreversible electroporation, so that the impedance is reduced, and the voltage and current of the conductive skeleton 2 also change along with the change of the impedance of the treatment site, so that a proper discharge area and discharge voltage are required to be selected according to the three-dimensional mapping result.
In some embodiments, the number of electrodes 3 and the distribution position of the electrodes 3 on the conductive skeleton 2 may affect the distribution of the current of the conductive skeleton 2. Illustratively, the number of electrodes 3 at the distal and proximal ends of the conductive skeleton 2 is less than the number of electrodes 3 arranged at the maximum radial dimension of the conductive skeleton 2. In this embodiment, the maximum radial dimension of the conductive skeleton 2, that is, the portion between the distal end and the proximal end of the conductive skeleton 2, is more likely to form good abutment with the treatment site during the treatment process, and more electrodes 3 can be arranged at the maximum radial dimension of the conductive skeleton 2, so that most of the electrodes 3 can form good abutment with the treatment site, thereby being more beneficial to discharge ablation of the electrodes 3 and improving the ablation efficiency.
In some embodiments, the electrode 3 may also be used as a mapping electrode to perform three-dimensional mapping on the electrocardiographic signals, and generate a voltage map and an excitation map for finding foci and foci in a low-voltage region. The electrodes 3 on the conductive skeleton 2 may be divided into five electrode groups 34, and each electrode group 34 may form one dual-electrode mapping channel by using two first sub-electrodes 341, two second sub-electrodes 342, and two third sub-electrodes 343, that is, each electrode group 34 may form three dual-electrode mapping channels.
In this embodiment, the electrodes 3 on the conductive skeleton 2 may form fifteen dual-electrode mapping channels, which is beneficial to improving the mapping efficiency of the conductive skeleton 2. Secondly, the three double-electrode mapping channels of each electrode group 34 can be attached to a local area of a treatment part, so that the attachment property of the conductive framework 2 is enhanced, the electrocardiograph signal mapping under different attachment conditions can be adapted, and the omnibearing mapping of the treatment part can be realized. Meanwhile, the two first sub-electrodes 341, the two second sub-electrodes 342 and the two third sub-electrodes 343 of each electrode group 34 are closer in interval distance, and the three double-electrode mapping channels can be selected for mapping, so that the far-field potential for mapping is relatively less, and the mapping accuracy of the conductive framework 2 is improved. In addition, the conductive framework 2 can collect mapping signals in five directions, so that multidirectional mapping is realized.
In other embodiments, all of the electrodes 3 on the conductive skeleton 2 may also be used to map the electrocardiographic signals of the patient 80 (see fig. 1) alone, which is not strictly limited by the present application. In this embodiment, each electrode 3 may be used as a separate mapping channel, and mapping may be performed on the electrocardiographic signals in the 360 ° direction. An operator can select mapping channels in multiple directions according to the three-dimensional mapping result or the actual ablation requirement so as to map electrocardiosignals in a certain direction of a treatment part.
Referring again to fig. 2, in some embodiments, the ring electrode 4 of the ablation catheter 10 is fixed to the distal end of the catheter 1 and disposed around the outside of the catheter 1, the ring electrode 4 being used to map the electrocardiographic signals of the patient 80 (see fig. 1). In this embodiment, the plurality of electrodes 3 located at the distal end of the conductive skeleton 2 can be well abutted against the atrial wall of the patient 80, and can be used as mapping electrodes for mapping the electrocardiographic signals of the patient 80. The ring electrode 4 of the catheter 1 shaft does not rest against the atrial wall, but can also be used as a reference electrode 3 for mapping the electrocardiographic signals of the patient 80. The ablation system 100 can obtain a more accurate electric signal according to the difference between the electric signal detected by the ring electrode 4 and the electric signal of the electrode 3 when the conductive framework 2 is wholly discharged, so as to realize accurate detection of the electrocardiosignal of the patient 80. Furthermore, the ring electrode 4 may also serve as a reference for the three-dimensional map image of the ablation catheter 10, such that the position of the ablation catheter 10 is visible in the three-dimensional map image.
Referring again to fig. 2 and 8, fig. 8 is a schematic view of the perfusion catheter 5 of fig. 3.
In some embodiments, the irrigation catheter 5 may comprise a plurality of irrigation ports 51 and a plurality of spiral channels (not shown in the figures), the irrigation ports 51 being connected to the spiral channels and being exposed with respect to the distal end of the catheter 1, the spiral channels being located inside the irrigation catheter 5. The catheter 1 may be a hollow tube and the perfusion catheter 5 is mounted inside the catheter 1. The irrigation port 51 of the irrigation catheter 5 is located inside the conductive skeleton 2. The perfusion catheter 5 can be made of insulating materials such as polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic elastomer rubber, polyamide material and the like.
In this embodiment, the irrigation catheter 5 is connected to a fluid source of a pulse ablator 60 (see fig. 1) for irrigating an irrigation liquid, which may be saline, for example, into the conductive framework 2 during an ablation treatment. The channel of the perfusion catheter 5 is spiral, and the section flow of the flushing liquid at the flushing port 51 can be increased by spiral, so that the flushing liquid is dispersed towards multiple directions inside the conductive framework 2 to fully flush the conductive framework 2, thereby reducing blood stasis, avoiding thrombosis and preventing cumulative thermal effect after repeated pulse ablation.
In some embodiments, a space is left between the irrigation port 51 of the irrigation catheter 5 and the conductive skeleton 2. In this embodiment, the space between the flushing port 51 and the conductive skeleton 2 allows the flushing liquid emitted from the flushing port 51 to generate turbulence characteristics inside the conductive skeleton 2, which promotes heat transfer between the flushing liquid and the conductive skeleton 2. Thereby preventing the pulse ablator 60 from producing cumulative thermal effects after multiple ablations to reduce accidental tissue damage during ablation and reduce the incidence and severity of surgical events.
In other embodiments, when the ablation catheter 10 is used for pulsed ablation, only a slight thermal effect is produced during pulsed ablation, and the ablation catheter 10 may be provided without the irrigation catheter 5. When the ablation catheter 10 is used for radiofrequency ablation, the ablation catheter 10 needs to be provided with the irrigation catheter 5, which is not strictly limited by the present application.
Complex atrial fibrillation refers to atrial fibrillation that is curable without isolation of the pulmonary veins. The nature of it is persistent atrial fibrillation, with the exception that its trigger factor is a complex factor in addition to pulmonary veins. Therefore, the complicated pathogenesis adds difficulty and complexity to the treatment, and recurrent atrial fibrillation is easy to recur after operation. Patients with atrial fibrillation duration exceeding 6 months may have an increased risk of postoperative recurrence of 64%, while patients over 2 years have a postoperative recurrence rate exceeding 50% even after multiple ablations. This is because, as the atrial fibrillation time increases, the normal tissues of the atrium become progressively fibrotic, and these fibrosed tissues affect the normal electrical conduction function, and the longer the time of illness, the less likely such fibrosed tissues will be flattened. Obesity, hypertension, diabetes, gender, age, obstructive sleep apnea, smoking, relapse time, left Fang Rongji, left atrial low voltage region size, epicardial fat pad thickness, left Fang Zongxiang tension, pulmonary vein volume, left atrial scar tissue, different ablative procedures, etc. all have varying degrees of impact on atrial fibrillation relapse.
The occurrence of persistent atrial fibrillation has so far remained a very complex procedure, the main mechanism of which can be divided into a trigger mechanism and a maintenance mechanism. Trigger factors include ganglion plexus, marshall (Marshall) ligament, coronary sinus intramuscular cuff, non-pulmonary venous trigger, pulmonary venous intramuscular cuff, and the like. The maintenance matrix includes a fragmentation potential zone, atrial fibrillation, a low potential zone at sinus rate, etc. Different treatment strategies are available for the trigger and maintenance mechanisms, respectively. The key to the success rate of continuous atrial fibrillation ablation is to improve the integrity and transmurality of the ablation line. For persistent atrial fibrillation, the primary sites of current ablation therapy are the ablation isolation of the mitral isthmus, tricuspid isthmus, and left atrial roof line. Wherein the mitral isthmus line refers to a radial line from the lower left pulmonary vein to the mitral annulus, and the tricuspid isthmus line refers to a radial line from the inferior vena cava to the tricuspid annulus. The embodiment provides an ablation catheter 10 for dotting and scribing, the distal end of the ablation catheter 10 is generally spherical, and can perform dotting and scribing ablation on a two-isthmus line, a three-isthmus line and a left atrial top line, so that the whole operation time required for finishing the damage of the whole line is shortened, and the ablation efficiency can be improved. Furthermore, due to the selective killing characteristics of irreversible electroporation of the ablation catheter 10, safety of ablation may be ensured.
Referring to fig. 1, 2 and 7 again, the method of the partial discharge treatment of the ablation catheter 10 in this embodiment may be, for example: the ablation catheter 10 is pierced into the atrium with the distal end of the ablation catheter 10 abutting against a point on the atrial wall. The electrodes 3 on the conductive skeleton 2 map the electrocardiographic signals of the atrial wall, obtain the local impedance between the two electrodes 3, and display the local impedance at the software interface of the pulse ablation instrument 60. It is judged whether or not the electrode 3 is well-adhered to the atrial wall based on whether or not the local impedance measured between the two electrodes 3 is within a predetermined range. When the electrode 3 is well-held against the atrial wall, the electrode 3 can perform discharge ablation. When there are a plurality of electrodes 3 in good abutment with the atrial wall, the plurality of electrodes 3 can be discharged at the same time.
Illustratively, when a certain electrode set 34 of the conductive skeleton 2 is abutted against the atrial wall, the electrodes 3 of the electrode set 34 map the atrial wall, measure the local impedance between the two first sub-electrodes 341, the local impedance between the two second sub-electrodes 342, and the local impedance between the two third sub-electrodes 343, respectively, and generate corresponding three electrocardiographs. When the values of the three measured local impedances are all within the predetermined range, it is determined that the three sub-electrodes of the electrode group 34 are all well-attached to the atrial wall. When all the sub-electrodes of the electrode set 34 are well-held, three sets of sub-electrodes may default to discharge simultaneously. Judging that the two electrodes are short-circuited when the local impedance measured between the two electrodes is lower than a preset range; when the local impedance between the two electrodes is higher than the predetermined range, it is judged that the two electrodes are not good in reliability, and the electrodes cannot discharge in both cases.
In addition, when the point-supplementing operation is performed on the treatment site, in combination with the three-dimensional mapping system 50, the operator may select one set of sub-electrodes among the two first sub-electrodes 341, the two second sub-electrodes 342, and the two third sub-electrodes 343 that are well-attached to perform the discharge. For example, by combining the local impedances of the two first sub-electrodes 341, the two second sub-electrodes 342, and the two third sub-electrodes 343 with their respective electrocardiograms, it is determined that there is an abnormal potential at the two first sub-electrodes 341 and that there is an abnormal potential at the two second sub-electrodes 342 and the two third sub-electrodes 343, the two first sub-electrodes 341 are selected first for discharging, the electrocardiograms of the two first sub-electrodes 341 are observed, and if the potentials of the two first sub-electrodes 341 drop, the abnormal potential at the two first sub-electrodes 341 is eliminated; if there is any abnormal potential at the two first sub-electrodes 341, then continue to find whether there is any abnormal potential at other positions, and perform discharge treatment until ablation treatment is completed.
Referring to fig. 9 and 10 in combination, fig. 9 is a schematic view of a portion of an ablation catheter 10 according to another embodiment of the present application, and fig. 10 is a schematic view of a portion of the conductive framework 2 shown in fig. 9.
In some embodiments, the ablation catheter 10 may include a catheter 1, a conductive backbone 2, a plurality of electrodes 3, one or more ring electrodes 4, and an irrigation catheter 5. The proximal end of the conductive framework 2 of the ablation catheter 10 is secured to the distal end of the catheter 1 and the plurality of electrodes 3 are secured to the distal end of the conductive framework 2. The ring electrode 4 is fixed to the distal end of the catheter 1 and is located outside the catheter 1. The infusion catheter 5 is located inside the catheter 1, and the distal end of the infusion catheter 5 is located inside the conductive backbone 2.
In some embodiments, the conductive framework 2 of the ablation catheter 10 may include a plurality of struts 27, the plurality of struts 27 being connected to one another to form a grid structure of the conductive framework 2. The conductive skeleton 2 of the ablation catheter 10 may include a central grid 22 and a plurality of edge grid sets 23. Wherein the number of side cell groups 23 is five. Each side grid set 23 includes at least one side grid, for example, each side grid set 23 may include a first side grid 231 and a second side grid 232. Two adjacent first side grids 231 and the central grid 22 form a first grid structure 28, and the center of the first grid structure 28 forms a first grid node 281. The first side mesh 231 of the side mesh set 23, the second side mesh 232 and the first side mesh 231 of the adjacent side mesh set 23 form a second mesh structure 29, the center of the second mesh structure 29 forming a second mesh node 291.
In some embodiments, the central grid 22, the first side grid 231, and the second side grid 232 of the conductive skeleton 2 are pentagons, that is, the conductive skeleton 2 in this embodiment may include 11 pentagon grids. Wherein each side of the center grid 22 and side grids allows for a certain arc.
In this embodiment, both the conductive frame 2 and the electrode 3 can be discharged independently. The mesh quantity of the conductive framework 2 is reduced, so that the area of the mesh structure formed by the support plates 27 of the conductive framework 2 is increased, the area of the conductive framework 2, which is attached to a treatment part, is increased, the discharge area of the conductive framework 2 is increased, the current density of the conductive framework 2 is affected, the electric field generated by the conductive framework 2 is weakened, the discharge is more uniform, and the ablation depth is controlled.
Referring to fig. 9-11, fig. 11 is a schematic view of the ablation catheter 10 of fig. 9 at another angle.
In some embodiments, the plurality of electrodes 3 of the ablation catheter 10 may be divided into a plurality of electrode sets 34. The plurality of electrode groups 34 are arranged rotationally symmetrically around the center line of the conductive skeleton 2, each electrode group 34 including at least two electrodes 3. And the projection directions of all electrodes 3 in the same electrode group 34 on a first plane are the same, and the first plane is perpendicular to the central line of the conductive framework 2. The plane in fig. 11 may be regarded as a first plane. Each electrode set 34 may include a first electrode 344 and a second electrode 345, the first electrode 344 being spaced apart from the second electrode 345. The first electrode 344 is fixed to the first mesh node 281, and the second electrode 345 is fixed to the second mesh node 291. The first grid node 281 and the second grid node 291 of the conductive framework 2 are provided with mounting holes 261, and the first electrode 344 and the second electrode 345 are uniformly and correspondingly mounted in the mounting holes 261. The shape and installation of the first electrode 344 and the second electrode 345 are referred to the shape and installation of the electrode 3, and the present application is not described herein.
In some embodiments, the arc of the line connecting the first electrode 344 and the second electrode 345 is greater than or equal to 30 ° in the same electrode set 34. In the present embodiment, the radian of the connection line between the first electrode 344 and the second electrode 345 is greater than or equal to 30 °, so that the distance between the first electrode 344 and the second electrode 345 is not too small, so as to avoid adverse effects on the discharge of the electrode sub-group 34 of the conductive frame 2.
In some embodiments, both the first electrode 344 and the second electrode 345 of the electrode set 34 may act as ablation electrodes, with discharge ablation occurring. The electrodes 3 on the conductive skeleton 2 are divided into five regions, one region corresponding to each electrode group 34, and each electrode group 34 can be individually discharged. That is, the first electrode 344 and the second electrode 345 of each region may be simultaneously discharged, and the conductive skeleton 2 may form five discharge regions.
In this embodiment, when the ablation catheter 10 is placed in the heart of a patient 80 (see fig. 1) for treatment, since the heart is continuously beating, only a portion of the electrodes 3 of the conductive skeleton 2 may be in good contact with the atrial wall, while a portion of the electrodes 3 in the opposite direction may be suspended in the blood and not in contact with the atrial wall. Therefore, when the electrode set 34 located in a certain area is well adhered to the atrial wall, the first electrode 344 and the second electrode 345 of the electrode set 34 can be selected to discharge, so as to form linear or band-shaped lesions at the treatment site, and the ablation of the connecting points in a linear manner is facilitated. The conductive framework 2 discharges in a partitioned way, so that partial energy loss of the electrode 3 in a non-contact area can be avoided, and the ablation effect is reduced. And can form selective irreversible electroporation, reduce the generation of the thermal effect of ablation, so as to ensure the safety of ablation. In addition, under the condition of reasonable ablation parameters, the ablation area and the ablation depth can be controlled, so that a better ablation treatment effect is realized.
In some embodiments, all electrodes 3 on the conductive skeleton 2 may also be discharged individually. When all electrodes 3 are well attached to the treatment site, all electrodes 3 can be discharge ablated together to form a punctiform lesion, which is not strictly limited by the present application.
In some embodiments, all of the electrodes 3 on the conductive skeleton 2 may be used to map the cardiac signal of the patient 80 (see fig. 1) alone. In this embodiment, each electrode 3 may be used as a separate mapping channel, and mapping may be performed on the electrocardiographic signals in the 360 ° direction. An operator can select mapping channels in multiple directions according to the three-dimensional mapping result or the actual ablation requirement so as to map electrocardiosignals in a certain direction of a treatment part.
It should be noted that, in the present embodiment, the connection manner between the conductive framework 2 and the catheter 1 may refer to the connection manner between the conductive framework 2 and the catheter 1, the material and the processing technology of the conductive framework 2 may refer to the material and the processing technology of the conductive framework 2, and the arrangement of the catheter 1, the ring electrode 4 and the perfusion catheter 5 may refer to the arrangement of the catheter 1, the ring electrode 4 and the perfusion catheter 5, which are not described in detail in the present embodiment.
Referring to fig. 12 and 13 in combination, fig. 12 is a schematic view of a portion of an ablation catheter 10 according to another embodiment of the present application, and fig. 13 is a schematic view of a portion of the conductive framework 2 shown in fig. 12.
In some embodiments, the ablation catheter 10 may include a catheter 1, a conductive backbone 2, a plurality of electrodes 3, one or more ring electrodes 4, and an irrigation catheter 5. The proximal end of the conductive framework 2 of the ablation catheter 10 is secured to the distal end of the catheter 1 and the plurality of electrodes 3 are secured to the distal end of the conductive framework 2. The ring electrode 4 is fixed to the distal end of the catheter 1 and is located outside the catheter 1. The infusion catheter 5 is located inside the catheter 1, and the distal end of the infusion catheter 5 is located inside the conductive backbone 2.
In some embodiments, the conductive framework 2 of the ablation catheter 10 may include a plurality of struts 27, the plurality of struts 27 being connected to one another to form a grid structure of the conductive framework 2. The conductive skeleton 2 may include a central grid 22 and a plurality of edge grid sets 23. The number of edge mesh groups 23 is five. Each side grid set 23 includes at least one side grid, for example, each side grid set 23 may include a first side grid 231 and a second side grid 232. Two adjacent first side grids 231 and the central grid 22 form a first grid structure 28, and the center of the first grid structure 28 forms a first grid node 281. The first side mesh 231 of the side mesh set 23, the second side mesh 232 and the first side mesh 231 of the adjacent side mesh set 23 form a second mesh structure 29, the center of the second mesh structure 29 forming a second mesh node 291.
In some embodiments, the central grid 22, the first side grid 231, and the second side grid 232 of the conductive skeleton 2 are generally decagonal, i.e., the conductive skeleton 2 in this embodiment may include 11 decagonal grids. Wherein each side of the center grid 22 and side grids allows for a certain arc. In other embodiments, the shapes of the central grid 22, the first side grid 231, and the second side grid 232 may be other shapes, such as a circle, etc., which is not strictly limited in the present application.
In this embodiment, both the conductive skeleton 2 and the electrode 3 can be discharged separately. The areas of the central grid 22, the first side grid 231 and the second side grid 232 of the conductive framework 2 are increased, so that the areas of the central grid 22 and the side grids of the conductive framework 2, which are close to the treatment part, are increased, the discharge areas of the conductive framework 2 and the electrode 3 are increased, the current density of the whole conductive framework 2 is affected, the electric field generated by the conductive framework 2 is weakened, more uniform discharge can be formed, and the ablation depth is controlled more favorably.
Referring to fig. 12-14, fig. 14 is a schematic view of the ablation catheter 10 of fig. 12 at another angle.
In some embodiments, the plurality of electrodes 3 of the ablation catheter 10 may be divided into a plurality of electrode sets 34. The plurality of electrode groups 34 are arranged rotationally symmetrically around the center line of the conductive skeleton 2, each electrode group 34 including at least two electrodes 3. And the projection directions of all electrodes 3 in the same electrode group 34 on a first plane are the same, and the first plane is perpendicular to the central line of the conductive framework 2. The plane in which fig. 14 is located may be regarded as a first plane. Each electrode set 34 may include a first electrode 344 and a second electrode 345, the first electrode 344 being spaced apart from the second electrode 345. The first electrode 344 is fixed to the first mesh node 281, and the second electrode 345 is fixed to the second mesh node 291. The first grid node 281 and the second grid node 291 of the conductive framework 2 are provided with mounting holes 261, and the first electrode 344 and the second electrode 345 are uniformly and correspondingly mounted in the mounting holes 261. The shape and installation of the first electrode 344 and the second electrode 345 are referred to the shape and installation of the electrode 3, and the present application is not described herein.
In some embodiments, the arc of the line connecting the first electrode 344 and the second electrode 345 is greater than or equal to 30 ° in the same electrode set 34. In the present embodiment, the radian of the connection line between the first electrode 344 and the second electrode 345 is greater than or equal to 30 °, so that the distance between the first electrode 344 and the second electrode 345 is not too small, so as to avoid adverse effects on the discharge of the electrode sub-group 34 of the conductive frame 2.
In some embodiments, both the first electrode 344 and the second electrode 345 of the electrode set 34 may act as ablation electrodes, with discharge ablation occurring. The electrodes 3 on the conductive skeleton 2 are divided into five regions, one region corresponding to each electrode group 34, and each electrode group 34 can be individually discharged. That is, the first electrode 344 and the second electrode 345 of each region may be simultaneously discharged, and the conductive skeleton 2 may form five discharge regions.
In this embodiment, when the ablation catheter 10 is placed in the heart of a patient 80 (see fig. 1) for treatment, since the heart is continuously beating, only a portion of the electrodes 3 of the conductive skeleton 2 may be in good contact with the atrial wall, while a portion of the electrodes 3 in the opposite direction may be suspended in the blood and not in contact with the atrial wall. Therefore, when the electrode set 34 located in a certain area is well adhered to the atrial wall, the first electrode 344 and the second electrode 345 of the electrode set 34 can be selected to discharge, so as to form linear or band-shaped lesions at the treatment site, and the ablation of the connecting points in a linear manner is facilitated. The conductive framework 2 discharges in a partitioned way, so that partial energy loss of the electrode 3 in a non-contact area can be avoided, and the ablation effect is reduced. And can form selective irreversible electroporation, reduce the generation of the thermal effect of ablation, so as to ensure the safety of ablation. In addition, under the condition of reasonable ablation parameters, the ablation area and the ablation depth can be controlled, so that a better ablation treatment effect is realized.
In some embodiments, all electrodes 3 on the conductive skeleton 2 may also be discharged individually. When all electrodes 3 are well attached to the treatment site, all electrodes 3 can be discharge ablated together to form a punctiform lesion, which is not strictly limited by the present application.
In some embodiments, all of the electrodes 3 on the conductive skeleton 2 may be used to map the cardiac signal of the patient 80 (see fig. 1) alone. In this embodiment, each electrode 3 may be used as a separate mapping channel, and mapping may be performed on the electrocardiographic signals in the 360 ° direction. An operator can select mapping channels in multiple directions according to the three-dimensional mapping result or the actual ablation requirement so as to map electrocardiosignals in a certain direction of a treatment part.
It should be noted that, in the present embodiment, the connection manner between the conductive framework 2 and the catheter 1 may refer to the connection manner between the conductive framework 2 and the catheter 1, the material and the processing technology of the conductive framework 2 may refer to the material and the processing technology of the conductive framework 2, and the arrangement of the catheter 1, the ring electrode 4 and the perfusion catheter 5 may refer to the arrangement of the catheter 1, the ring electrode 4 and the perfusion catheter 5, which are not described in detail in the present embodiment.
The foregoing has outlined and described in detail the basic principles and features of the present application and their advantages. Those skilled in the art will appreciate that the application is not limited to the above-described structural examples and embodiments described herein, but rather, the application is capable of other modifications and improvements without departing from the spirit and scope of the application as claimed.