Mapping pulse ablation multifunctional catheter

Abstract

The invention discloses a mapping pulse ablation multifunctional catheter which comprises a flexible frame, a plurality of electrode sets, a plurality of electrode connecting wires and a plurality of connecting pieces. The flexible frame can deform under pressure and is adapted to tissues; the plurality of electrode groups are sequentially distributed on the flexible frame, and any electrode group comprises a plurality of microelectrodes which are distributed along the flexible tubular part at intervals; the plurality of electrode connecting wires are respectively connected with the plurality of microelectrodes; the plurality of connecting pieces are divided into a plurality of groups, each group of connecting pieces is connected with each microelectrode on the corresponding electrode group, and any connecting piece is in one-way conduction; the conducting directions of the connecting pieces on the same electrode group are the same, the conducting directions of the connecting pieces on any two adjacent electrode groups are arranged in opposite directions, and a pulse electric field can be formed between any two adjacent electrode groups. Based on the technical scheme disclosed by the invention, the mapping pulse ablation multifunctional catheter has mapping, ablation and perfusion functions at the same time, so that the complexity of related surgical operations can be reduced, and the safety of related operations is indirectly improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multifunctional catheter for mapping pulse ablation. Background Technology

[0002] Mapping catheters are medical devices used for cardiac electrophysiological examinations and treatments. They can accurately detect and record electrical activity within the heart, helping doctors determine the type and origin of arrhythmias, providing accurate target information for treatments such as radiofrequency ablation, thereby improving the success rate and safety of the procedure. They also help assess the overall function of the heart and the state of the conduction system.

[0003] In related technologies, mapping catheters typically include at least a catheter sheath, an electrode system, an operating end, and a tail interface. The catheter sheath serves as the catheter's framework, supporting the entire catheter structure. The electrode system comprises multiple electrodes used to sense myocardial electrical activity signals and transmit them to external devices. The operating end can be a handle, allowing physicians to control the bending, rotation, and advancement of the catheter. The tail interface connects to external electrophysiological recorders, 3D mapping systems, perfusion systems, and other equipment, enabling signal transmission, power supply, and high-pressure infusion, providing a practical basis for seamless compatibility with electrochemical ablation and gene therapy.

[0004] However, existing mapping catheters usually only have mapping functions. When ablation surgery is required, a separate radiofrequency ablation catheter is needed. This not only increases the complexity of the surgical procedure but also indirectly increases the risk of the surgery, which urgently needs to be improved. Summary of the Invention

[0005] The purpose of this invention is to overcome the above-mentioned technical deficiencies and propose a multifunctional catheter for mapping pulse ablation, which solves the technical problem that the existing catheters only have mapping or ablation functions, resulting in complicated surgical procedures and additional surgical risks.

[0006] To achieve the above-mentioned technical objectives, the present invention adopts the following technical solution: This invention provides a multifunctional catheter for mapping pulse ablation, comprising: A flexible frame that can deform under pressure and conform to the tissue; Multiple electrode groups are sequentially distributed on the flexible frame, and each electrode group includes multiple microelectrodes spaced apart along the flexible tubular member; Multiple electrode connecting wires are respectively connected to the multiple microelectrodes for transmitting electrical signals; and Multiple connectors are provided, which are divided into multiple groups according to the multiple electrode groups. Each group of connectors is sequentially connected to each microelectrode on the corresponding electrode group, and each of the connectors is unidirectionally conductive. In this configuration, the conduction directions of each connector on the same electrode group are the same, the conduction directions of the connectors on any two adjacent electrode groups are reversed, and positive and negative pulse voltage signals can be applied to any two adjacent electrode groups respectively, so that a pulse electric field can be formed between any two adjacent electrode groups.

[0007] In some embodiments, the flexible frame includes four longitudinal extension arms that extend longitudinally; four electrode groups are correspondingly provided, and the four electrode groups are respectively disposed on the four longitudinal extension arms.

[0008] In some embodiments, the longitudinal extension arm has a hollow tubular structure; the multiple electrode connecting wires are all disposed inside the longitudinal extension arm.

[0009] In some embodiments, the longitudinal extension arm includes a first insulating member and a second insulating member arranged at intervals along the longitudinal direction, and each microelectrode on the corresponding electrode group is sequentially arranged between the first insulating member and the second insulating member, and any two adjacent microelectrodes on the electrode group are connected through the connector.

[0010] In some embodiments, at least one of the plurality of electrode groups has an even number of microelectrodes, and the microelectrodes on the electrode group are grouped in pairs along the longitudinal direction to form a plurality of electrode pairs, which are used to acquire bipolar electrical signals in the tissue.

[0011] In some embodiments, the mapping pulse ablation multifunctional catheter further includes a telescopic cannula, which includes a hollow cannula and a telescopic rod telescopically disposed within the hollow cannula; the flexible frame is a flexible tubular component, which is spirally wound around the telescopic rod, with one end connected to the hollow cannula and the other end connected to the telescopic end of the telescopic rod; the plurality of microelectrodes are sequentially and spaced apart on the flexible tubular component, forming a plurality of electrode groups spaced apart along the flexible tubular component.

[0012] In some embodiments, the flexible tubular component includes a plurality of insulating tubular components, which are respectively used to connect the microelectrode to the hollow sleeve, the microelectrode to the telescopic rod, and any two adjacent electrode groups; and any two adjacent microelectrodes on the same electrode group are connected by the connector.

[0013] In some embodiments, the connector is a diode assembly, the diode assembly comprising at least: Outer shell layer; A functional layer, disposed inside the outer shell layer, is used to connect two adjacent microelectrodes; A wiring layer, disposed inside the outer shell layer, is used for routing the multiple electrode connection lines; and An insulating layer is disposed inside the outer shell layer and located between the functional layer and the wiring layer for insulation protection.

[0014] In some embodiments, the microelectrode is a tubular structure and is made of platinum or a platinum-iridium alloy.

[0015] In some embodiments, the mapping pulse ablation multifunctional catheter further includes: Multiple pressure sensors are respectively disposed on the multiple microelectrodes, or respectively disposed on the flexible frame near each microelectrode, for detecting the pressure of the catheter on the tissue; and Multiple sensing connection lines are connected to the multiple pressure sensors respectively, for transmitting electrical signals containing pressure information.

[0016] Compared with existing technologies, the present invention provides a multifunctional catheter for mapping pulse ablation. By placing multiple electrode groups on a flexible frame, during mapping, all connectors are in a cut-off state, while multiple microelectrodes can adhere to the surface of myocardial tissue, receiving electrical activity signals from a large area of ​​myocardial tissue at once. These electrical signals can be transmitted to a matching magnetic navigation system via electrode connecting lines, and after software processing, a three-dimensional model of the atrium can be quickly constructed. During ablation, all connectors can be in a conductive state, allowing each electrode group to be coupled into a single conductor. By applying positive and negative pulse voltages to adjacent conductors, an electric field can be formed between them. This electric field can act on the biological tissue surrounding the catheter, achieving a pulse ablation effect.

[0017] In this way, the mapping pulse ablation multifunctional catheter has both mapping and ablation functions, which not only reduces the complexity of related surgical procedures, but also indirectly improves the safety of related surgeries. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the multifunctional catheter for pulse ablation in Embodiment 1 of the present invention; Figure 2 This is a cross-sectional schematic diagram of a diode assembly in one embodiment of the present invention; Figure 3 This is a cross-sectional schematic diagram of a diode assembly in another embodiment of the present invention; Figure 4 This is a schematic diagram of the connection between the microelectrode and the diode assembly in one embodiment of the present invention; Figure 5 This is a schematic diagram of the connection between the electrode connection line and the micro motor in one embodiment of the present invention; Figure 6 This is a schematic diagram of the connection between the sensing connection line and the pressure sensor in one embodiment of the present invention; Figure 7This is a schematic diagram of the overall structure of the multifunctional catheter for pulse ablation in Embodiment 2 of the present invention; Figure 8 This is a schematic diagram showing the distribution of multiple microelectrodes on a flexible tubular component in the fully retracted state of the telescopic rod in Embodiment 2 of the present invention.

[0019] Explanation of reference numerals in the attached drawings: 100, flexible frame; 110, first outer arm; 120, second outer arm; 130, first inner arm; 140, second inner arm; 150, first end; 160, second end; 170, center axis; 180, first insulating component; 190, second insulating component; 200, electrode group; 210, first electrode group; 220, second electrode group; 230, third electrode group; 240, fourth electrode group; 300, microelectrode; 310, first microelectrode; 320, second microelectrode; 330, third microelectrode; 340, fourth microelectrode. 350, Sixth microelectrode; 360, Seventh microelectrode; 370, Sixteenth microelectrode; 380, Connector; 400, Diode assembly; 410, Outer shell layer; 420, Functional layer; 430, Insulating layer; 440, Wiring layer; 500, Fixing component; 600, Electrode connection wire; 700, Pressure sensor; 800, Sensing connection wire; 900, Telescopic sleeve; 910, Hollow sleeve; 920, Telescopic rod; 921, Telescopic end; 100', Flexible tubular component; 110', Insulating tubular component; 120', Movable end; 130', Fixed end. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0021] To address the aforementioned technical problems, this invention provides a multifunctional mapping pulse ablation catheter that simultaneously performs mapping and ablation functions. This not only reduces the complexity of related surgical procedures but also indirectly improves the safety of related surgeries.

[0022] Example 1: Please see Figure 1 Embodiment 1 of the present invention provides a multifunctional mapping pulse ablation catheter, which includes a flexible frame 100, on which multiple electrode groups 200 are disposed, and each electrode group 200 includes multiple microelectrodes 300.

[0023] Each microelectrode 300 can be connected to a matching surgical device (such as a magnetic navigation device, a pulse generator, etc.) via a line, and can be used in conjunction with the relevant equipment to perform mapping and / or ablation operations on myocardial tissue.

[0024] Please see Figure 1 The overall structure of the aforementioned flexible frame 100 can be set according to the surface structure of myocardial tissue and can be set into an elastically deformable structural form.

[0025] In this embodiment, the flexible frame 100 can be configured as follows: Figure 1 The mesh structure shown may include four longitudinally extending arms. In this case, the aforementioned electrode group 200 may be configured as four, and the four electrode groups 200 may be respectively disposed on the four longitudinally extending arms, such that each microelectrode 300 on each electrode group 200 is distributed at intervals along the corresponding longitudinally extending arm.

[0026] Specifically, for ease of description, the four longitudinally extending arms can be referred to as the first outer arm 110, the second outer arm 120, the first inner arm 130, and the second inner arm 140, respectively. The first outer arm 110 and the second outer arm 120 are located on opposite sides of the flexible frame 100 in the transverse direction, while the first inner arm 130 and the second inner arm 140 are located between the first outer arm 110 and the second outer arm 120.

[0027] Based on this, four longitudinal extension arms extend along the longitudinal direction of the flexible frame 100, and the two ends of the four longitudinal extension arms can respectively merge to form the first end 150 and the second end 160 of the flexible frame 100; wherein the first end 150 and the second end 160 are respectively located on opposite sides of the flexible frame 100 along the longitudinal direction.

[0028] In one embodiment, the line connecting the first end 150 and the second end 160 can form a dividing axis 170. Based on this dividing axis 170, the first outer arm 110 and the first inner arm 130 are located on one side of the dividing axis 170, while the second outer arm 120 and the second inner arm 140 are located on the other side of the dividing axis 170. In this case, the flexible frame 100 can be arranged in a symmetrical structure along the dividing axis 170, that is, the first outer arm 110 and the first inner arm 130 can be symmetrical with the second outer arm 120 and the second inner arm 140, respectively.

[0029] Based on this, the four electrode groups 200 mentioned above may each include four microelectrodes 300 distributed at intervals along the corresponding longitudinal extension arms, that is, a total of 16 microelectrodes 300 can be set on the flexible frame 100.

[0030] For ease of description, the electrode groups 200 on the first outer arm 110, the second outer arm 120, the first inner arm 130, and the second inner arm 140 can be referred to as the first electrode group 210, the second electrode group 220, the third electrode group 230, and the fourth electrode group 240, respectively.

[0031] Taking the first electrode group 210 as an example, each microelectrode 300 in the first electrode group 210 can be sequentially named as the first microelectrode 310, the second microelectrode 320, the third microelectrode 330, and the fourth microelectrode 340 along the direction from the second end 160 to the first end 150; similarly, each microelectrode 300 on the second electrode group 220, the third electrode group 230, and the fourth electrode group 240 can be named as the fifth microelectrode, the sixth microelectrode 350, ..., the fifteenth microelectrode, and the sixteenth microelectrode 370, respectively.

[0032] It should be noted that the flexible frame 100 includes four longitudinal extension arms, and these four longitudinal extension arms can be symmetrically arranged on both sides of the central axis 170. However, in some embodiments, the flexible frame 100 may also have more longitudinal extension arms, such as two, three, five, or more. Furthermore, the arrangement of each longitudinal extension arm may not be symmetrical about the central axis 170; this is not specifically limited.

[0033] In addition, each of the above-mentioned electrode groups 200 includes four microelectrodes 300. In other embodiments, the number of microelectrodes 300 included in each electrode group 200 can be flexibly set as needed. For example, each electrode group 200 may include fewer (e.g., two or three) or more microelectrodes 300 (e.g., five, six or more). Alternatively, the number of microelectrodes 300 included in each electrode group 200 may also be different. No specific limitation is made in this regard.

[0034] Please see Figure 1 Taking the first outer arm 110 as an example, the first outer arm 110 may include a first insulating member 180 and a second insulating member 190, and the first insulating member 180 and the second insulating member 190 are arranged at intervals along the longitudinal direction.

[0035] Specifically, the first insulating member 180 is located on the side of the first outer arm 110 near the first end 150, while the second insulating member 190 is located on the side of the first outer arm 110 near the second end 160. The first insulating member 180 and the second insulating member 190 can be respectively connected to two microelectrodes 300 located at the beginning and end positions on the first electrode group 210 (i.e., the fourth microelectrode 340 and the first microelectrode 310 in this embodiment).

[0036] Meanwhile, the first outer arm 110 also includes multiple connectors, which are sequentially connected to each microelectrode 300 on the first electrode group 210 along the longitudinal direction. In this embodiment, the number of connectors on the first outer arm 110 can be set to 3, and the 3 connectors are sequentially connected to the first microelectrode 310, the second microelectrode 320, the third microelectrode 330 and the fourth microelectrode 340.

[0037] Based on this, the structures of the second outer arm 120, the first inner arm 130 and the second inner arm 140 can be set with reference to the first outer arm 110 described above, and will not be repeated here.

[0038] It should be noted that the first insulating component 180 and the second insulating component 190 on each longitudinal extension arm can be plastic components that are insulating, compatible with electrodes, biocompatible, and do not interfere with signal transmission. For example, they can be made of any of the following materials: polyimide, polytetrafluoroethylene, or polyetheretherketone; there is no specific limitation in this regard. Furthermore, the first insulating component 180 and the second insulating component 190 can be configured as hollow tubular components to facilitate the connection of wires inside.

[0039] Based on this, in order to enable the formation of this multifunctional pulse ablation catheter as... Figure 1 The shape of the first insulating member 180 on each longitudinally extending arm of the mesh structure shown can be bent and adjusted as needed so that each first insulating member 180 gradually bends toward the first end 150 in the direction close to the first end 150, and finally achieves the effect of converging and gathering at the first end 150, which facilitates its overall connection to other parts of the conduit system (not the focus of this invention).

[0040] Meanwhile, the second insulating elements 190 on each longitudinal extension arm can be connected to each other to form an integral structure, and the structure and number of the second insulating elements 190 can be adjusted as needed to further improve the structural stability of the multifunctional catheter for mapping pulse ablation.

[0041] For example, in one embodiment, two second insulating members 190 can be provided. One second insulating member 190 is connected at one end to the first microelectrode 310, and the other end can be bent toward the side where the second outer arm 120 is located, and connected to the thirteenth microelectrode on the second outer arm 120. Similarly, the other second insulating member 190 is also provided with a bent structure, and its two ends can be connected to the fifth microelectrode on the first inner arm 130 and the ninth microelectrode on the second inner arm 140, respectively.

[0042] At this time, the flexible frame 100 may also include a fixing member 500, which is preferably a plastic ring of the same material as the second insulating member 190. The plastic ring can be sleeved on the outside of the two second insulating members 190 and fix the two second insulating members 190.

[0043] In other embodiments, the second insulating element 190 may be a single unit; in this case, the second insulating element 190 may include a main tube and four branch tubes connected to the main tube, with the ends of the four branch tubes furthest from the main tube respectively connected to the first microelectrode 310, the fifth microelectrode, the ninth microelectrode, and the thirteenth microelectrode. Of course, in other cases where the number of longitudinal extension arms is less or more, the number of branch tubes can be flexibly adjusted as needed, and no specific limitation is made thereto.

[0044] It is understood that the various electrode groups 200 can share the same second insulating element 190, or two or three electrode groups 200 can share one second insulating element 190. The specific configuration can be flexibly adjusted as needed, and no specific limitation is imposed. However, when the number of second insulating elements 190 is greater than or equal to two, the aforementioned fixing element 500 can be provided on the flexible frame 100 to fix each second insulating element 190, thereby ensuring the stability of the flexible frame 100 structure.

[0045] Based on this, regardless of the number of second insulating members 190, the second end 160 on the flexible frame 100 is always formed by the second insulating member 190; at this time, the bending shape of the second insulating member 190 can be adjusted so that it forms a shape at the second end 160 as follows: Figure 1 The clearly defined end structure is shown to facilitate catheter movement within the tissue.

[0046] In this embodiment, taking the first outer arm 110 and the first electrode group 210 thereon as an example, in order to facilitate the connection of the microelectrode 300 to the first / second insulating member and to ensure the contactability of the microelectrode 300 with the myocardial tissue, the microelectrode 300 on the first electrode group 210 (i.e., the first microelectrode 310, the second microelectrode 320, the third microelectrode 330 and the fourth microelectrode 340 in this embodiment) can be set as a ring structure, and its material is preferably platinum or platinum-iridium alloy.

[0047] At this time, one end of the first microelectrode 310 can be sleeved and fixed on the adjacent end of the corresponding second insulating member 190, while its other end can be connected to the second microelectrode 320 through the aforementioned connector. Similarly, one end of the fourth microelectrode 340 can be sleeved and fixed on the adjacent end of the corresponding first insulating member 180, while its other end can be connected to the third microelectrode 330 through the connector.

[0048] Based on this, the three connectors on the first outer arm 110 are sequentially connected to the first microelectrode 310, the second microelectrode 320, the third microelectrode 330 and the fourth microelectrode 340. These three connectors are also preferably configured as hollow tubular structures, so that the ends of each microelectrode 300 can be sleeved and fixed on the corresponding connectors to form a complete first outer arm 110.

[0049] Similarly, the connectors on the second outer arm 120, the first inner arm 130, and the second inner arm 140 can be configured with reference to the connectors on the first outer arm 110, and will not be described in detail here.

[0050] In the above manner, since the microelectrode 300, the first / second insulating member and the connector are all hollow structures, each longitudinal extension arm (corresponding to the first outer arm 110, the second outer arm 120, the first inner arm 130 and the second inner arm 140 in this embodiment) is a hollow tubular structure, so that the interior of each longitudinal extension arm can be used for wiring.

[0051] The aforementioned connector can be a diode assembly 400, which is based on a PN junction and can be packaged into a tubular structure to connect the various microelectrodes 300 and enable unidirectional conduction between the interconnected microelectrodes 300.

[0052] like Figure 2 As shown, in one embodiment, the diode assembly 400 can adopt a coaxial composite tube structure, which includes a shell layer 410. The shell layer 410 can be configured as a hollow tubular structure, which can serve as a mechanical support and connect the microelectrode 300, and can be formed by metal or ceramic encapsulation.

[0053] A functional layer 420 (or semiconductor layer) is coaxially disposed on the inner side of the outer shell layer 410. The functional layer 420 is a semiconductor PN junction unit (such as a diode array), which can be formed by silicon wafer etching and thin film deposition. It is actually equivalent to a diode device formed by longitudinal packaging.

[0054] An insulating layer 430 may be provided on the inner side of the functional layer 420. The insulating layer 430 may be made of polyimide or aluminum oxide, and there is no specific limitation on the material. A wiring layer 440 may also be coaxially provided on the inner side of the functional layer 420. The wiring layer 440 may be set as an empty layer (i.e., set as a through hole) for subsequent wiring.

[0055] In another embodiment, such as Figure 3 As shown, the diode assembly 400 can also adopt a multi-channel parallel structure. In this case, it differs from the coaxial composite tube structure described above in that the functional layer 420, the insulating layer 430, and the wiring layer 440 are located inside the outer shell layer 410, and the functional layer 420, the insulating layer 430, and the wiring layer 440 can be distributed radially along the outer shell layer 410.

[0056] like Figure 4 As shown, taking the diode assembly 400 with a coaxial composite tube structure as an example, the diode assembly 400 is arranged on the first outer arm 110 in the following manner: Taking the first microelectrode 310 and the second microelectrode 320 as examples, the corresponding diode assembly 400 is located between the first microelectrode 310 and the second microelectrode 320, and is coaxially arranged with the first microelectrode 310 and the second microelectrode 320. The adjacent ends of the first microelectrode 310 and the second microelectrode 320 are respectively sleeved and fixed to the two ends of the outer shell layer 410, and a gap is reserved between the adjacent ends of the outer shell layer 410 and the second insulating member 190.

[0057] Based on this, the semiconductor PN junction unit on the functional layer 420 can be connected to the first microelectrode 310 and the second microelectrode 320 respectively via metal contacts or metal leads. Specifically, the P-type semiconductor region on the semiconductor PN junction unit can be connected to the first microelectrode 310, and the N-type semiconductor region can be connected to the second microelectrode 320; or, the N-type semiconductor region on the semiconductor PN junction unit can be connected to the first microelectrode 310, and the P-type semiconductor region can be connected to the second microelectrode 320.

[0058] It is understandable that when the semiconductor PN junction unit uses metal contacts to connect the microelectrode 300, a connecting portion 380 can be formed radially inward on the inner wall of the microelectrode 300. The connecting portion 380 can be disposed in the gap between the second insulating member 190 and the connecting member (such as the first microelectrode 310), or in the gap between the ends of two adjacent connecting members (such as the second microelectrode 320), so that the metal contacts can be electrically connected to the micromotor through the connecting portion 380.

[0059] Meanwhile, the specific microelectrode 300 connected to the P-type semiconductor region and N-type semiconductor region on the semiconductor PN junction unit can be flexibly set as needed, and their correspondence can determine the conduction direction of the diode assembly 400.

[0060] Taking a P-type semiconductor region connected to the first microelectrode 310 and an N-type semiconductor region connected to the second microelectrode 320 as an example, since the P-type semiconductor region is rich in holes, when the P-type semiconductor region is connected to the positive terminal of an external power supply, it can form a forward bias, and the holes can diffuse into the N-type semiconductor region to achieve conduction. Meanwhile, the N-type semiconductor region is rich in free ions, and when it is connected to the negative terminal of an external power supply, it can attract electrons to form a current loop. In this case, the direction from the first microelectrode 310 to the second microelectrode 320 is the conduction direction, while the direction from the second microelectrode 320 to the first microelectrode 310 is the cutoff direction. When the connection relationship between the semiconductor PN junction unit and the first microelectrode 310 and the second microelectrode 320 is reversed, the conduction direction between the first microelectrode 310 and the second microelectrode 320 will also be reversed, which will not be elaborated further here.

[0061] It should be noted that the semiconductor PN junction unit described above adopts a vertically packaged diode structure. Its specific structure belongs to the prior art in this field and is not the focus of this invention, so it will not be described in detail here.

[0062] Based on this semiconductor PN junction unit, the functional layer 420 actually integrates a diode device within the connector; on this basis, the functional layer 420 can also adopt other diode structures, but as long as the diode principle is still used to achieve unidirectional conduction between the microelectrodes 300, it does not exceed the scope of this invention.

[0063] Meanwhile, based on the above configuration, the diode assemblies 400 between other microelectrodes 300 on the first outer arm 110 (such as between the second microelectrode 320 and the third microelectrode 330, and between the third microelectrode 330 and the fourth microelectrode 340) can also be configured in the above manner. However, it must be ensured that the conduction direction of the diode assemblies 400 between each microelectrode 300 on the first outer arm 110 is consistent.

[0064] Similarly, the microelectrodes 300 on the second outer arm 120 are also connected via this connector, and the connection method can be set in the same way as described above. However, it should be ensured that the conduction direction of each connector on the same longitudinal extension arm is consistent, and the conduction direction of the connectors on any two adjacent longitudinal extension arms is reversed.

[0065] For example, in one embodiment, the conduction direction of each connector on the first outer arm 110 is from the fourth microelectrode 340 toward the first microelectrode 310, the conduction direction of each connector on the first inner arm 130 is from the fifth microelectrode toward the eighth microelectrode, the conduction direction of each connector on the second inner arm 140 is from the twelfth microelectrode toward the ninth microelectrode, and the conduction direction of each connector on the second outer arm 120 is from the thirteenth microelectrode toward the sixteenth microelectrode 370.

[0066] In another embodiment, the conduction directions of the connectors on each of the aforementioned longitudinal extension arms can also be reversed simultaneously. That is, the conduction direction of each connector on the first outer arm 110 is from the first microelectrode 310 toward the fourth microelectrode 340, and so on. This will not be elaborated further here.

[0067] Please see Figure 5 The multifunctional catheter for mapping pulse ablation also includes multiple electrode connection lines 600. Each electrode connection line 600 is arranged in a one-to-one correspondence with the microelectrodes 300 on the flexible frame 100. Each connection line can be connected to the corresponding microelectrode 300, and the end of each electrode connection line 600 away from the corresponding microelectrode 300 can be extended and connected to other supporting equipment (such as a magnetic navigation system and a pulse generator).

[0068] Specifically, taking the first outer arm 110 as an example, four electrode connection lines 600 can be provided on the first outer arm 110. The four electrode connection lines 600 can pass through the first insulating member 180 and extend to the corresponding microelectrode 300 respectively.

[0069] Among them, the electrode connection line 600 corresponding to the first microelectrode 310 can extend through the first insulating member 180 to the fourth microelectrode 340, and then pass through the wiring layer 440 on the three connectors in sequence, and finally extend to the first microelectrode 310 and connect with the first microelectrode 310.

[0070] The electrode connection line 600 corresponding to the second microelectrode 320 can extend through the first insulating member 180 to the fourth microelectrode 340, and then pass through the wiring layer 440 on the two connectors in sequence, and finally extend to the second microelectrode 320 and connect with the second microelectrode 320.

[0071] Similarly, the other two electrode connection lines 600 can be connected to the third microelectrode 330 and the fourth microelectrode 340 in the same way.

[0072] Based on this, a corresponding number of electrode connecting lines 600 can be provided on the first inner arm 130, the second inner arm 140 and the second outer arm 120 respectively. Each electrode connecting line 600 can be set with reference to the form of the electrode connecting line 600 on the first outer arm 110, which will not be described in detail here.

[0073] In other embodiments, such as Figure 6 As shown, to avoid the catheter puncturing the atrium, the mapping pulse ablation multifunctional catheter can also be equipped with multiple pressure sensors 700 and multiple sensor connection lines 800. The multiple pressure sensors 700 are connected to the matching control system through multiple sensor connection lines 800 to facilitate real-time monitoring of contact pressure.

[0074] The pressure sensors 700 and microelectrodes 300 can be configured in a one-to-one correspondence. Each pressure sensor 700 can be mounted on the corresponding microelectrode 300 or on the flexible frame 100 near the corresponding microelectrode 300. Similarly, the sensing connection lines 800 and pressure sensors 700 are also configured in a one-to-one correspondence. Each sensing connection line 800 can be configured inside the corresponding longitudinal extension arm in the same manner as the electrode connection lines 600 described above, and connected to the corresponding pressure sensor 700. The end of each sensing connection line 800 furthest from the corresponding pressure sensor 700 can extend and connect to the control system.

[0075] By setting up a pressure sensor 700, the pressure sensor 700 can transmit pressure information in the form of an electrical signal to the matching control system through the sensing connection line 800, thereby enabling real-time monitoring of the contact pressure at the contact point between the catheter and myocardial tissue, and preventing excessive pressure from puncturing the atrium.

[0076] It should be noted that this mapping pulse ablation multifunctional catheter can simultaneously perform mapping and ablation functions, as detailed below: During mapping, the flexible frame 100 deforms under pressure and conforms to the surface of the myocardial tissue, allowing each microelectrode 300 to contact the myocardial tissue surface. Because the flexible frame 100 has a large area, the catheter can receive electrical activity signals from a large area of ​​myocardial tissue at once through each microelectrode 300.

[0077] During mapping, when the electrical activity signal of the myocardial tissue passes through one of the microelectrodes 300, the microelectrode 300 senses the signal and transmits it to the supporting equipment (such as a magnetic navigation system) via the electrode connection line 600. When the same electrical activity signal passes through another microelectrode 300, that microelectrode 300 can also transmit the corresponding electrical signal to the supporting equipment. The supporting equipment can process the signal difference sensed by the two microelectrodes 300 through software to determine the direction of the electrical signal, thereby determining the location of the electrical signal and realizing mapping.

[0078] In this process, to improve the accuracy of mapping and positioning, bipolar electrical signal recording is usually used for mapping. Specifically, in this embodiment, taking the first electrode group 210 as an example, the first electrode group 210 includes four microelectrodes 300; wherein, the first microelectrode 310 and the second microelectrode 320 can form an electrode pair during mapping, and the connector between the first microelectrode 310 and the second microelectrode 320 is always in a cut-off state during the mapping process, so that the electrode pair formed by the first microelectrode 310 and the second microelectrode 320 can acquire and record the bipolar electrical signal of myocardial tissue.

[0079] Similarly, the third microelectrode 330 and the fourth microelectrode 340 can also form an electrode pair. The second electrode group 220, the third electrode group 230 and the fourth electrode group 240 can all be set and understood with reference to the form of the first electrode group 210, and will not be described in detail here.

[0080] During the ablation procedure, all connectors are in a conductive state, coupling the corresponding microelectrodes 300 and thus forming a complete conductor with each electrode group 200. By applying positive and negative pulse voltages to each conductor, a potential difference is generated between them. Charges form an electric field in the region between the conductors, which acts on the biological tissue surrounding the catheter, achieving the effect of pulse ablation (such as destroying abnormal myocardial cells).

[0081] Specifically, in one embodiment, when the conduction direction of the connector on the first outer arm 110 is from the fourth microelectrode 340 toward the first microelectrode 310, and the connectors on the other longitudinal extension arms are respectively set according to the conduction principle mentioned above (i.e., the conduction direction of each connector on the same longitudinal extension arm should be consistent, and the conduction directions of the connectors on any two adjacent longitudinal extension arms should be reversed), a positive pulse voltage can be applied to the first electrode group 210 and the third electrode group 230 through the electrode connection line 600, and a negative pulse voltage can be applied to the second electrode group 220 and the fourth electrode group 240 through the electrode connection line 600.

[0082] At this time, the first electrode group 210, the second electrode group 220, the third electrode group 230 and the fourth electrode group 240 each constitute a conductor, and a pulsed electric field for ablation can be formed between any two adjacent electrode groups 200.

[0083] Taking the first electrode group 210 and the second electrode group 220 as an example, since positive pulse voltage and negative pulse voltage are applied to the first electrode group 210 and the second electrode group 220 respectively, a pulse electric field will be formed between the first electrode group 210 and the second electrode group 220. The electric field lines of this electric field point from the first electrode group 210 to the second electrode group 220, and can be precisely applied to the tissue (such as myocardial tissue) between the first electrode group 210 and the second electrode group 220, thereby achieving local ablation through the electroporation effect of the pulse electric field.

[0084] Based on this, the principle of pulsed electric field formation between other electrode groups 200 is the same, the only difference being the direction of the electric field lines, but the ablation principle remains unchanged, and will not be elaborated here.

[0085] Example 2: Please see Figure 7 Embodiment 2 of the present invention also provides a multifunctional catheter for mapping pulse ablation, which is similar in structure to the catheter in Embodiment 1, except that the structure of the flexible frame 100 and the distribution of each microelectrode 300 on the flexible frame 100 are different.

[0086] Specifically, the mapping pulse ablation multifunctional catheter includes a telescopic cannula 900, a flexible frame 100, and multiple microelectrodes 300. The telescopic cannula 900 includes a hollow cannula 910 and a telescopic rod 920 telescopically disposed within the hollow cannula 910. The flexible frame 100 is disposed at one end of the hollow cannula 910 and connected to the adjacent end of the telescopic rod 920. The end of the telescopic rod 920 furthest from the flexible frame 100 can extend from the other end of the hollow cannula 910, facilitating the telescopic movement of the telescopic rod 920 within the hollow cannula 910.

[0087] For ease of description, the end of the telescopic rod 920 used to connect to the flexible frame 100 can be referred to as the telescopic end 921, while the end away from the flexible frame 100 can be referred to as the operating end.

[0088] In this embodiment, the flexible frame 100 can be configured as a flexible tubular member 100' with a spiral structure. One end of the tube can be fixed to the adjacent end of the hollow sleeve 910 to form a fixed end 130'. The other end of the tube can be connected to the telescopic end 921 of the telescopic rod 920 to form a movable end 120'.

[0089] When the telescopic rod 920 extends along the hollow sleeve 910 toward the side where the flexible tubular member 100' is located, the telescopic end 921 of the telescopic rod 920 can drive the movable end 120' of the flexible tubular member 100' to gradually move away from its fixed end 130'; and when the telescopic rod 920 retracts along the hollow sleeve 910, the telescopic end 921 of the telescopic rod 920 can drive the movable end 120' of the flexible tubular member 100' to move closer to its fixed end 130'.

[0090] When the telescopic rod 920 extends along the hollow sleeve 910 toward the side where the flexible tubular member 100' is located to its maximum extension length, that is, when the telescopic end 921 of the telescopic rod 920 is furthest from the fixed end 130' of the flexible tubular member 100', the flexible tubular member 100' can be spirally wound around the outside of the telescopic rod 920 to form a thread-like structure. The pitch of the "thread" formed on the telescopic rod 920 can be progressively increased from the telescopic end 921 of the telescopic rod 920 to the fixed end 130' of the flexible tubular member 100'.

[0091] When the telescopic rod 920 is retracted to its maximum retraction range, the telescopic end 921 of the telescopic rod 920 can be retracted to the adjacent end of the hollow sleeve 910, that is, the position of the fixed end 130' of the flexible tubular member 100', so that the movable end 120' of the flexible tubular member 100' and its fixed end 130' can be located at the same length position of the telescopic sleeve 900.

[0092] At this time, under the action of the telescopic rod 920, each part of the flexible tubular member 100' can be retracted to the same plane, which is perpendicular to the telescopic rod 920, and the flexible tubular member 100' can form a spiral-like shape on this plane.

[0093] In this embodiment, the aforementioned multiple microelectrodes 300 can be sequentially arranged on the flexible tubular member 100'. For example, when there are 16 microelectrodes, the 16 microelectrodes 300 are distributed at square intervals along the extension of the flexible tubular member 100' on the flexible tubular member 100'.

[0094] The first microelectrode 310 can be disposed on the flexible tubular member 100' for connecting one end of the telescopic end 921. Other microelectrodes 300 can be disposed sequentially and spaced apart between the first microelectrode 310 and the movable end 120' of the flexible tubular member 100', such that the sixteenth microelectrode 370 is located on the tube body of the flexible tubular member 100' near the fixed end 130'.

[0095] In one embodiment, the flexible tubular member 100' may be composed of a plurality of insulating tubular members 110' and a plurality of the aforementioned diode assemblies 400.

[0096] Taking the flexible tubular component 100' with the above-mentioned 16 microelectrodes 300 as an example, the first microelectrode 310 is disposed at one end of the flexible tubular component 100' for connecting the above-mentioned telescopic end 921. The tubular section on the flexible tubular component 100' located between the first microelectrode 310 and the second microelectrode 320 can be an insulating tubular component 110'. Any two adjacent microelectrodes 300 between the second microelectrode 320 and the sixth microelectrode 350 are connected through a diode assembly 400. The sixth microelectrode 350 and the seventh microelectrode 360 ​​can be an insulating tubular component 110'. Any two adjacent microelectrodes 300 between the seventh microelectrode 360 ​​and the sixteenth microelectrode 370 are connected through a diode assembly 400.

[0097] Based on this, multiple electrode connection lines 600 can be provided inside the aforementioned flexible tubular component 100', and each electrode connection line 600 is connected to a microelectrode 300 respectively.

[0098] For example, in one embodiment, each electrode connection line 600 can be connected to an external power supply device. One electrode connection line 600 can be connected to the first microelectrode 310 and apply a positive pulse voltage to the first microelectrode 310, and another electrode connection line 600 can be connected to the second microelectrode 320 and apply a negative pulse voltage to it. Similarly, by connecting each microelectrode 300 with multiple connection lines, negative pulse voltages can be applied to the third microelectrode 330 to the sixth microelectrode 350, and negative pulse voltages can be applied to the seventh microelectrode 360 ​​to the sixteenth microelectrode 370.

[0099] like Figure 8 As shown, when the telescopic rod 920 is fully retracted from the hollow sleeve 910, the flexible tubular member 100' can form a spiral shape as a whole. With the aid of an external power supply, an electrode pair can be formed between the first microelectrode 310 and the second microelectrode 320, and a potential difference can be formed on the electrode pair, so that an electric field can be formed in the region between the first microelectrode 310 and the second microelectrode 320. This electric field can act on the surrounding biological tissue, achieving the effect of pulsed ablation.

[0100] Similarly, negative pulse voltages can be applied to the third microelectrode 330 to the sixth microelectrode 350, and positive pulse voltages can be applied to the seventh microelectrode 360 ​​to the sixteenth microelectrode 370. In this way, the seventh microelectrode 360 ​​to the sixteenth microelectrode 370 can also form an electric field with each microelectrode 300 (second microelectrode 320 to sixth microelectrode 350) on their inner spiral tube segment, thereby realizing the function of pulse ablation.

[0101] It is understandable that, with the help of the diode assembly 400 disposed between the second microelectrode 320 and the sixth microelectrode 350, when the power supply is turned on, the direction of the current between the second microelectrode 320 and the sixth microelectrode 350 is the direction from the second microelectrode 320 along the flexible tubular member 100' to the sixth microelectrode 350 (i.e., Figure 8 (In the counterclockwise direction shown), the current direction between the seventh microelectrode 360 ​​and the sixteenth microelectrode 370 is the direction from the sixteenth microelectrode 370 along the flexible tubular member 100' towards the seventh microelectrode 360 ​​(i.e., the direction of the current from the seventh microelectrode 360 ​​to the sixteenth microelectrode 370). Figure 8 (As shown in the clockwise direction). This current direction also represents the conduction direction of the diode assembly 400 between the individual microelectrodes 300.

[0102] Of course, since current flows from a position with high potential to a position with low potential, by changing the positive and negative pulse signals of each microelectrode 300, the conduction direction of each diode assembly 400 can be adjusted synchronously, so that the current flows in the opposite direction to the current direction mentioned above. This will not be elaborated further here.

[0103] Furthermore, this embodiment only uses the setting of 16 microelectrodes 300 as an example for illustration, but it does not mean that only 16 microelectrodes 300 can be set on the flexible tubular member 100'. The specific number of microelectrodes 300 can be determined according to needs, combined with the overall length of the flexible tubular member 100' and the number of turns of the spiral formed. On the basis of ensuring that an electric field can be formed between the microelectrodes 300 on any two adjacent spiral tube segments, the specific number is not limited.

[0104] In the above manner, with the help of the telescopic sleeve 900, the multifunctional catheter for mapping pulse ablation can achieve telescopic function; when the telescopic rod 920 is completely retracted from the hollow sleeve 910, the flexible tubular member 100' can form a spiral shape on the plane, and the microelectrodes 300 mentioned above can be distributed sequentially and spaced along the spiral line, forming a pulse electric field between any two adjacent spiral tube segments to achieve the function of pulse ablation.

[0105] It should be noted that in Embodiment 2, each microelectrode 300 can be divided into multiple electrode groups along the flexible tubular member 100' according to the voltage applied to each microelectrode 300. Taking the above 16 microelectrodes 300 as an example, the first microelectrode 310 can constitute the first electrode group, the second microelectrode 320 to the sixth microelectrode 350 can constitute the second electrode group, and the seventh microelectrode 360 ​​to the sixteenth microelectrode 370 can constitute the third electrode group, and so on.

[0106] In practical applications, the extension length of the telescopic rod 920 can be adjusted as needed, so that the flexible tubular component 100' can be gradually unfolded from the telescopic end 921 to cope with the limitation of the available space for movement in different parts of the biological tissue. For example, when the telescopic rod 920 is retracted a short distance, the flexible tubular component 100' between the first microelectrode 310 and the second microelectrode 320 can be partially unfolded, so that a small ablation area can be formed between the first microelectrode 310 and the second microelectrode 320. This can facilitate the supplementary ablation of small areas of unablated areas within the biological tissue, realizing single-point and supplementary ablation functions.

[0107] Meanwhile, the specific structure of each microelectrode 300 in Embodiment 2 can be set with reference to Embodiment 1, and pressure sensors can also be set on each microelectrode 300 with reference to Embodiment 1, which will not be described in detail here.

[0108] Understandably, differences in death thresholds exist universally between cells, providing a theoretical basis for large-area targeted ablation of certain harmful cells. Clinical studies have shown that pacemaker cells such as the sinoatrial node, atrioventricular node, and conduction system are more susceptible to impulses, suggesting that their death thresholds may be lower than those of cardiomyocytes. Since atrial or ventricular premature beats are caused by increased automaticity of cardiomyocytes, large-area exploratory targeted ablation of these cells could significantly reduce surgical difficulty and shorten operation time.

[0109] Furthermore, in existing catheter designs, the electric field strength of point electrodes decays too rapidly, and excessively high field strengths exceeding the death threshold can easily lead to necrosis, preventing targeted ablation from penetrating deep into the tissue. In contrast, the plate-shaped electrodes provided in this invention have a more constant electric field strength distribution; therefore, establishing a constant electric field between the catheter electrodes is particularly important for targeted ablation.

[0110] Meanwhile, current catheters typically lack single-point ablation capabilities. To better address clinical application issues, this invention provides an alternative catheter design based on the aforementioned plate-shaped electrode. By altering the structure with a telescopic sleeve 900, a multi-electrode catheter can be converted into a single-point ablation catheter, enabling fragmented potential ablation and linear ablation. A constant electric field ensures uniform ablation of the pulmonary veins, avoiding the formation of single-electrode ablation gaps, achieving good isolation, reducing operation time and atrial fibrillation recurrence. Furthermore, this catheter's advantage lies in its ability to reduce the intensity of the pulsed ablation electric field, thus minimizing hemolysis.

[0111] In the description of this application, it should be noted that the terms "upper" and "lower," etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication between two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0112] It should be noted that in this application, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0113] The specific embodiments of the present invention described above do not constitute a limitation on the scope of protection of the present invention. Any other corresponding changes and modifications made in accordance with the technical concept of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A mapping and pulsed ablation multi-function catheter, comprising: The application relates to a flexible electrode catheter, which comprises the following parts: a flexible frame, which is deformable under pressure and is adapted to the tissue; a plurality of electrode groups, which are sequentially arranged on the flexible frame, any electrode group comprising a plurality of microelectrodes arranged at intervals along the flexible tube; a plurality of electrode connecting lines, which are respectively connected to the microelectrodes, for transmitting electric signals; and a plurality of connectors, which are divided into groups according to the electrode groups, any group of connectors sequentially connecting the microelectrodes on the corresponding electrode group, and any connector being arranged in one-way conduction mode; wherein the conduction directions of the connectors on the same electrode group are the same, the conduction directions of the connectors on any two adjacent electrode groups are reversely arranged, and positive and negative pulse voltage signals can be respectively applied to any two adjacent electrode groups, so that a pulse electric field can be formed between any two adjacent electrode groups.

2. The mapping and ablation multi-functional catheter of claim 1, wherein, The flexible frame comprises four longitudinally extending arms arranged in a longitudinal direction; the electrode groups are correspondingly arranged in four groups, and the four electrode groups are arranged on the four longitudinally extending arms respectively.

3. The mapping and ablation multi-functional catheter of claim 2, wherein, The longitudinally extending arms are in a hollow tubular structure; the electrode connecting lines are arranged inside the longitudinally extending arms.

4. The mapping and ablation multi-functional catheter of claim 2, wherein, The longitudinally extending arms comprise a first insulating member and a second insulating member arranged at intervals in the longitudinal direction, the microelectrodes on the corresponding electrode group being sequentially arranged between the first insulating member and the second insulating member, and any two adjacent microelectrodes on the electrode group being connected through the connectors.

5. The mapping and ablation multi-functional catheter of claim 2, wherein, The number of microelectrodes on at least one electrode group in the plurality of electrode groups is even, the microelectrodes on the electrode group are sequentially grouped into a plurality of electrode pairs in the longitudinal direction, and the electrode pairs are used for acquiring bipolar electric signals in the tissue.

6. The mapping and ablation multi-functional catheter of claim 1, wherein, The application further comprises a telescopic sleeve, which comprises a hollow sleeve and a telescopic rod arranged in the hollow sleeve in a telescopic mode; the flexible frame is a flexible tube, which is spirally wound on the telescopic rod, one end of the flexible tube being connected to the hollow sleeve and the other end being connected to a telescopic end of the telescopic rod; the microelectrodes are sequentially and at intervals arranged on the flexible tube, and form a plurality of electrode groups arranged at intervals along the flexible tube.

7. The mapping and ablation multi-functional catheter of claim 6, wherein, The flexible tube comprises a plurality of insulating tubes, which are respectively used for connecting the microelectrodes, the hollow sleeve and the telescopic rod, and any two adjacent electrode groups; and any two adjacent microelectrodes on the same electrode group are connected through the connectors.

8. The mapping and ablation multi-functional catheter of claim 1, wherein, The connector is a diode assembly, which at least comprises: an outer shell layer; a functional layer arranged on the inner side of the outer shell layer, for connecting adjacent two microelectrodes; a wiring layer arranged on the inner side of the outer shell layer, for wiring of the electrode connecting lines; and an insulating layer arranged on the inner side of the outer shell layer and located between the functional layer and the wiring layer, for insulation protection.

9. The mapping and ablation multi-functional catheter of claim 1, wherein, The microelectrode is in a tubular structure, and is made of platinum or platinum-iridium alloy.

10. The mapping and ablation multi-functional catheter of any of claims 1-9, wherein, The application further comprises: a plurality of pressure sensors, which are respectively arranged on the microelectrodes or respectively arranged on the flexible frame close to the microelectrodes, for detecting the pressure of the catheter on the tissue; and ​ A plurality of sensing connection lines are respectively connected to the plurality of pressure sensors for transmitting electrical signals containing pressure information.

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