Ablation catheter and multi-modal ablation device

Abstract

This application relates to the field of medical device technology, providing an ablation catheter and a multimodal ablation device. The ablation catheter includes a tube body, an inner sheath, and an ablation assembly. The tube body has an inlet channel for introducing coolant. The inner sheath is inserted into the tube body and is movable relative to the tube body. The ablation assembly includes multiple elastic tubes and multiple ablation electrodes. One end of each elastic tube is connected to the inner sheath, and the other end is connected to the tube body. Each elastic tube is equipped with an ablation electrode, which can switch between pulse ablation mode and radiofrequency ablation mode under the control of the ablation device's main unit. An outlet is provided on the side wall of each elastic tube, and the outlet is connected to the inlet channel. The ablation catheter enables dual-modal tissue ablation using both pulsed electric field and radiofrequency energy. When facing deep tissues that are difficult to ablate with pulsed electric field energy, it switches to radiofrequency ablation mode, thereby reducing the recurrence of atrial fibrillation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to an ablation catheter and a multimodal ablation device. Background Technology

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia, and its incidence increases with age. AF typically increases the risk of many complications, including thromboembolic stroke, dilated cardiomyopathy, chest pain, and dyspnea. Treatment methods for AF have also undergone innovation and rapid development. Percutaneous catheter ablation, as an effective method for treating arrhythmias, has gained widespread acceptance. The purpose of ablation is to destroy the underlying arrhythmic tissue, block the propagation of abnormal electrical signals, or disrupt the conduction of abnormal electrical signals in cardiac tissue.

[0003] Pulsed electric field ablation is a rapidly developing ablation technique. It is a novel ablation method that uses a high-voltage pulsed electric field as energy. It does not rely on temperature effects but instead creates irreversible perforations in the cell membrane by releasing high-voltage pulses, disrupting the balance between the inside and outside of the cell and causing rapid cell apoptosis. In the treatment of atrial fibrillation, pulsed electric field ablation has the advantages of short ablation time and the ability to protect the treated area or blood vessels and other tissues.

[0004] While pulsed electric field ablation has the above advantages, due to the characteristics of the catheter, it can only adhere to the surface of the myocardial wall. When ablating lesions of myocardial hypertrophy, it cannot ablate deeper myocardial cells, which may lead to the recurrence of atrial fibrillation. Summary of the Invention

[0005] The purpose of this application is to provide an ablation catheter and a multimodal ablation device, which aims to solve the technical problem that the existing ablation catheter cannot ablate myocardial cells at a deeper depth, leading to a high possibility of atrial fibrillation recurrence.

[0006] To achieve the above objectives, the technical solution adopted in this application is: to provide an ablation catheter, comprising:

[0007] The pipe body is provided with a liquid inlet pipe for introducing coolant.

[0008] An inner sheath tube is inserted through the tube body, and the inner sheath tube is movable relative to the tube body along the axial direction of the tube body;

[0009] The ablation assembly includes multiple elastic tubes and multiple ablation electrodes. One end of each elastic tube is connected to the inner sheath tube, and the other end is connected to the tube body. Each elastic tube is provided with an ablation electrode, which is used to connect to the host of the ablation device. The host is used to control the multiple ablation electrodes to perform pulse ablation mode, radio frequency ablation mode, or to control the multiple ablation electrodes to switch between pulse ablation mode and radio frequency ablation mode. The side wall of each elastic tube is provided with a liquid outlet, and the inner cavity of each elastic tube is connected to the liquid outlet and the liquid inlet pipe, respectively.

[0010] In one possible design, the ablation catheter further includes a temperature measuring mechanism, which includes a temperature measuring mother plate, multiple temperature measuring daughter plates, and multiple temperature sensors. Each temperature sensor is installed on the elastic tube in the region located inside the ablation electrode. Each temperature measuring daughter plate is connected to the temperature measuring mother plate to transmit signals, and the temperature measuring daughter plates are electrically isolated from each other. Each temperature measuring daughter plate is provided with a sub-temperature measuring circuit. Each temperature sensor is connected to each sub-temperature measuring circuit in a one-to-one correspondence. The temperature measuring mother plate is used to connect to the host of the ablation device.

[0011] In one possible design, the temperature sensor includes a sensor and a temperature sensing wire connected to the sensor, and both the temperature sensing wire and the sensor are wrapped with an insulating protective layer.

[0012] In one possible design, each of the elastic tubes is provided with at least two ablation electrodes, and a pressure sensor is provided between the two ablation electrodes, the pressure sensor being connected to an alarm structure.

[0013] In one possible design, the pressure sensor is a resistive bridge sensor, which includes a thin-film strain resistor.

[0014] In one possible design, the ablation catheter further includes a handle assembly comprising a handle body and a sliding portion, the handle body being connected to one end of the tube body, the sliding portion being slidably mounted on the handle body, and the inner sheath being connected to the sliding portion.

[0015] In one possible design, the tube body is also provided with a conduit, and each of the ablation electrodes is connected to a high-voltage resistant wire. Each of the high-voltage resistant wires extends into the conduit, and the high-voltage resistant wires are used to transmit high-voltage pulse energy or radio frequency energy.

[0016] In one possible design, the outlet is a circular hole with a diameter ranging from 0.1 mm to 0.4 mm.

[0017] In one possible design, the ablation catheter further includes a mapping tube with mapping electrodes for detecting electrophysiological signals. The mapping tube is inserted through the inner sheath and is movable relative to the inner sheath.

[0018] A multimodal ablation device includes a host and an ablation catheter as described in any of the above technical solutions. The host is electrically connected to the ablation component of the ablation catheter. The host is used to output pulse energy or radio frequency energy to the ablation component. The host is also used to detect electrophysiological signals through the ablation electrode.

[0019] The beneficial effects of the ablation catheter and ablation device provided in this application are as follows: Compared with the prior art, the ablation catheter of this application can be applied to ablation devices, specifically in single-modal ablation devices (such as pulsed ablation devices or radiofrequency ablation devices), or in multimodal ablation devices. When the ablation catheter provided in this application is applied to a multimodal ablation device, the host in the multimodal ablation device controls the type of energy input to the ablation component, so that each ablation electrode in the ablation component switches between pulsed ablation mode and radiofrequency ablation mode, thereby performing radiofrequency ablation or pulsed ablation on the tissue through each ablation electrode in the ablation component. When ablating relatively deep cardiomyocytes, the pulsed ablation mode can be used; when ablating relatively deep cardiomyocytes, the radiofrequency ablation mode can be used. By moving the inner sheath relative to the tube body, the distance between the two ends of the elastic tube can be changed, thereby causing the elastic tube to deform and better fit the tissue. During radiofrequency ablation, cooling liquid can be introduced through the inlet pipe. The cooling liquid flows through the inlet pipe to the outlet and then out, thereby cooling the ablation electrode and the surrounding tissue to improve the safety of the radiofrequency ablation process and reduce or even avoid the formation of thrombi to a certain extent.

[0020] In summary, the ablation catheter provided in this application can flexibly switch between radiofrequency ablation mode and pulse ablation mode when applied to multimodal ablation devices. When ablating relatively deep myocardial cells, the pulse ablation mode can be used, which has a short ablation time and can protect the treatment area or blood vessels and other tissues. When ablating relatively deep myocardial cells, the radiofrequency ablation mode can be used to achieve better ablation results, reduce the possibility of atrial fibrillation recurrence, and even avoid atrial fibrillation recurrence. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the ablation catheter provided in the first embodiment of this application;

[0023] Figure 2 This is a schematic diagram of the structure of the ablation component in the ablation catheter provided in the first embodiment of this application;

[0024] Figure 3 This is a schematic diagram of the handle assembly in the ablation catheter provided in the first embodiment of this application;

[0025] Figure 4 This is a schematic diagram of the ablation catheter provided in the second embodiment of this application;

[0026] Figure 5 yes Figure 4 A partial schematic diagram of the ablation catheter;

[0027] Figure 6 This is a schematic diagram of the temperature measuring mechanism in the ablation catheter provided in the first embodiment of this application;

[0028] Figure 7 This is a schematic diagram of the circuit principle of the temperature measuring front-end module of the temperature measuring mechanism;

[0029] Figure 8 This is a schematic diagram of the circuit principle of the isolation communication module of the temperature measuring mechanism;

[0030] Figure 9 This is a schematic diagram of the circuit principle of the isolation power supply module of the temperature measuring mechanism.

[0031] The details of the reference numerals used in the above figures are as follows:

[0032] 10. Tube body; 20. Inner sheath; 21. End; 30. Ablation assembly; 31. Elastic tube; 32. Ablation electrode; 33. Outlet; 40. Inlet pipe; 50. Handle assembly; 51. Handle body; 52. Sliding part; 60. Lead wire pipe; 70. Calibration tube; 71. Calibration electrode; 80. Temperature measuring motherboard; 81. Power interface; 82. Fiber optic interface; 83. Daughter board interface; 90. Temperature measuring daughter board; 91. Microcontroller module; 92. Temperature measuring chip; 93. Temperature measuring interface; 94. Isolation power supply module; 95. Protection filter circuit; 96. Isolation communication module. Detailed Implementation

[0033] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0034] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0035] It should be understood that the terms "length", "width", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the structure or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0036] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0037] To illustrate the technical solutions described in this application, the following detailed description is provided in conjunction with specific drawings and embodiments.

[0038] First Embodiment

[0039] like Figures 1 to 3 As shown, one embodiment of this application provides an ablation catheter for use in ablation devices, specifically in single-modal ablation devices or multi-modal ablation devices. The ablation catheter includes a tube body 10, an inner sheath 20, and an ablation assembly 30. The tube body 10 has a hollow inner cavity, and the inner sheath 20 passes through the hollow inner cavity of the tube body 10 and can extend out of one end of the tube body 10.

[0040] For ease of description, the end of the ablation catheter closer to the operator is referred to as the proximal end, and the other end as the distal end. The inner sheath 20 can extend from the distal end of the tube body 10 and can move relative to the axis of the tube body 10.

[0041] The ablation assembly 30 includes multiple elastic tubes 31 and multiple ablation electrodes 32. The multiple elastic tubes 31 are spaced apart circumferentially. Alternatively, one end of each elastic tube 31 is spaced apart along a ring-shaped region, and the other end is spaced apart along another ring-shaped region. When the diameters of the ring-shaped regions formed by the two ends of the multiple elastic tubes 31 are the same, the multiple elastic tubes 31 can form a cylindrical region. In this case, the maximum outer diameter of the overall structure formed by the multiple elastic tubes 31 is minimized, facilitating the movement of the ablation catheter. When the distance between the two ends of the multiple elastic tubes 31 decreases, each elastic tube 31 protrudes in a direction away from its overall axis, forming an arc-shaped tube. This increases the maximum outer diameter of the overall structure formed by the multiple elastic tubes 31, allowing the ablation electrodes 32 on the elastic tubes 31 to adhere to the tissue.

[0042] like Figure 1 As shown, in one optional embodiment, the distal end of the inner sheath 20 is provided with an end 21, which is connected to the distal end of the inner sheath 20. The ends of each elastic tube 31 are respectively connected to the end 21. The outer diameter of the end 21 is larger than the outer diameter of the inner sheath 20 and smaller than the inner diameter of the tube body 10. The provision of the end 21 increases the area of ​​the inner sheath 20 for connecting the elastic tubes 31, making it easier to connect multiple elastic tubes 31 to the distal end of the inner sheath 20.

[0043] The number of ablation electrodes 32 is greater than or equal to the number of elastic tubes 31, and each elastic tube 31 is provided with at least one ablation electrode 32. Each ablation electrode 32 is used to connect to the host of the ablation device, and the host is used to control multiple ablation electrodes 32 to perform pulse ablation mode, radio frequency ablation mode, or control multiple ablation electrodes 32 to switch between pulse ablation mode and video ablation mode.

[0044] Specifically, the single-mode ablation device can be a pulse ablation device or a radiofrequency ablation device. When the ablation catheter is applied to the pulse ablation device, each ablation electrode 32 is connected to the main unit of the pulse ablation device. The main unit controls the multiple ablation electrodes 32 to execute the pulse ablation mode, that is, by outputting pulse electric fields to the multiple ablation electrodes 32, pulse ablation is performed through the multiple ablation electrodes 32. When the ablation catheter is applied to the radiofrequency ablation device, each ablation electrode 32 is connected to the main unit of the radiofrequency ablation device. The main unit controls the multiple ablation electrodes 32 to execute the radiofrequency ablation mode, that is, by outputting radiofrequency energy to the multiple ablation electrodes 32, radiofrequency ablation is performed through the multiple ablation electrodes 32.

[0045] When an ablation catheter is used in a multimodal ablation device, each ablation electrode 32 is connected to the main unit of the multimodal ablation device. The main unit controls the multiple ablation electrodes 32 to switch between pulse ablation mode and video ablation mode. Specifically, under the control of the main unit of the multimodal ablation device, a pulsed electric field is output to the ablation electrode 32, which switches the ablation electrode 32 to pulse ablation mode for pulse ablation operation. Under the control of the main unit, radio frequency energy is output to the ablation electrode 32 for radio frequency ablation operation.

[0046] As can be seen from the above, when the ablation catheter provided in this application is applied to a multimodal ablation device, it can achieve dual-mode tissue ablation using pulsed electric field and radiofrequency energy under the control of the host. This allows for switching to radiofrequency energy ablation when dealing with deep tissues that are difficult to ablate using pulsed electric field energy, thereby reducing the recurrence of atrial fibrillation and facilitating the procedure, thus reducing its difficulty. Furthermore, the host can control the output of a pulsed electric field only to the ablation electrode 32, switching the ablation electrode 32 to pulsed ablation mode for pulsed ablation. In other words, the ablation catheter provided in this embodiment can also achieve single-mode pulsed ablation.

[0047] In one alternative embodiment, a high-voltage resistant wire may be provided inside the tube body 10. The high-voltage resistant wire is connected to each ablation electrode 32 to transmit high-voltage pulse energy or radio frequency energy to the ablation electrode 32 through the high-voltage resistant wire.

[0048] In one alternative implementation, the ablation electrode 32 can be used to monitor the electrophysiological signals of the heart during the ablation operation, and these signals can be transmitted to the host device, controlled by a host computer. Disease assessment can be performed by monitoring the electrophysiological signals of the heart before and after ablation. Before the ablation operation, disease assessment is performed by monitoring the electrophysiological signals of the heart. After the assessment, pulsed or radiofrequency energy is applied to the target tissue via the ablation component 30 to ablate the target tissue, reducing surgical trauma to tissue cells.

[0049] Furthermore, the pipe body 10 is provided with an inlet pipe 40, which is used to introduce coolant; each elastic tube 31 has an outlet 33 on its side wall, and the inner cavity of the elastic tube 31 is connected to the outlet 33 and the inlet pipe 40 respectively.

[0050] During radiofrequency ablation, the temperature of the ablation electrode 32 will rise. At this time, liquid can be introduced into the inlet pipe 40. The liquid flows through the inlet pipe 40 to the outlet 33 and flows out from the outlet 33. The liquid can cool the ablation electrode 32, the elastic tube 31 and the surrounding tissues and blood, reduce the possibility of thrombosis, and even prevent thrombosis.

[0051] Optionally, in actual operation, the inlet line 40 can be connected to an external syringe or other injection structure to inject liquid into the inlet line 40 through the external syringe or other injection structure. The liquid is preferably saline, such as physiological saline.

[0052] exist Figure 1 In the process, there are 5 elastic tubes 31, and each elastic tube 31 is provided with two ablation electrodes 32. The two ablation electrodes 32 on the same elastic tube 31 are arranged at intervals on the corresponding elastic tube 31.

[0053] Although Figure 1 The diagram shows five elastic tubes 31, but the number is not limited to five; preferably, it can be 3-10. Within this range, the elastic tubes 31 allow more ablation electrodes 32 to be ablated simultaneously, resulting in a larger contact area with the tissue and better ablation effects. During ablation, the host computer can control all ablation electrodes 32 to ablate, or only a portion of the electrodes 32 can be used to ablate a specific area. By selecting different ablation electrodes 32 for discharge ablation, local, circumferential, and linear irreversible damage can be achieved, thus treating diseases such as atrial fibrillation, atrial flutter, and arrhythmias.

[0054] Since the inner sheath 20 can move relative to the tube body 10, and the two ends of the elastic tube 31 are connected to the inner sheath 20 and the tube body 10 respectively, during the movement of the inner sheath 20 relative to the tube body 10, one end of the elastic tube 31 is fixed to the tube body 10 and its position remains unchanged, while the other end of the elastic tube 31 moves with the inner sheath 20, that is, the distance between the two ends of the elastic tube 31 changes, thereby causing the area between the two ends of the elastic tube 31 to deform, thereby changing the outer diameter of the structure formed by multiple elastic tubes 31. Thus, the degree of deformation of the elastic tube 31 can be adjusted according to the needs, thereby adjusting the fit between the elastic tube 31 and the tissue to achieve a better ablation effect.

[0055] The ablation electrode 32 is connected to the main power supply via wires. The wires connected to each ablation electrode 32 extend from the tube body 10 via corresponding elastic tubes 31. In one optional embodiment, each wire extends into the liquid inlet pipe 40 within the tube body 10 and extends out of the liquid inlet pipe 40 to connect with the main power supply. Alternatively, in another optional embodiment, a wire conduit 60 is provided within the tube body 10. The wires connected to each ablation electrode 32 extend out of the tube body 10 via their corresponding elastic tubes 31 and converge in the wire conduit 60. The wire conduit 60 extends out of the tube body 10 to connect multiple wires to the main power supply. Specifically, the aforementioned wires are preferably high-voltage resistant wires.

[0056] Optionally, the conduit 60 can be arranged side by side with the inlet conduit 40 inside the pipe body 10, or the conduit 60 can also be inserted through the inlet conduit 40. When the conduit 60 is inserted through the inlet conduit 40, there is a channel between the inner wall of the inlet conduit 40 and the outer wall of the conduit 60 for liquid to pass through.

[0057] Preferably, the surface of the conductor is insulated, and the connection between the ablation electrode 32 and the corresponding conductor can be welding or mechanical crimping.

[0058] Preferably, the ablation electrode 32 is fixed on the surface of the elastic tube 31, and the outer side of the ablation electrode 32 can be flush with the outer side of the elastic tube 31, or the outer side of the ablation electrode 32 can protrude from the outer side of the elastic tube 31.

[0059] The ablation electrode 32 can be made of platinum, stainless steel, platinum-iridium, tantalum, gold, or silver, etc.

[0060] At least one liquid outlet 33 is provided on an elastic tube 31, and the liquid outlet 33 is adjacent to and spaced apart from the ablation electrodes 32 on the elastic tube 31. For example, when two ablation electrodes 32 are provided on the elastic tube 31, the liquid outlet 33 may be located between the two ablation electrodes 32. Preferably, the liquid outlet 33 is located between two other ablation electrodes 32, and is closer to the ablation electrode 32 located at the distal end of the elastic tube 31.

[0061] Optionally, the number of outlets 33 on an elastic tube 31 may be the same as the number of ablation electrodes 32 on the elastic tube 31, such as... Figure 2 As shown, the elastic tube 31 is provided with two ablation electrodes 32, and each ablation electrode 32 is provided with a liquid outlet 33 next to it.

[0062] Optionally, the outlet 33 is a circular hole with a diameter ranging from 0.1 mm to 0.4 mm. For example, the diameter of the outlet 33 can be 0.1 mm, 0.15 mm, 0.18 mm, 0.26 mm, 0.35 mm, 0.4 mm, etc.

[0063] Optionally, the material of the inner sheath 20 can be PA (Polyamide, nylon), Pebax (polyether block polyamide), Peek (Poly ether ether ketone), or PI (Polyimide), etc. The diameter of the inner sheath 20 can range from 0.4mm to 1.5mm, for example, the diameter of the inner sheath 20 can be 0.4mm, 0.5mm, 0.6mm, 0.8mm, 0.9mm, 1.1mm, 1.3mm, 1.5mm, etc.

[0064] The material of the inlet pipe 40 is similar to that of the inner sheath 20, and PA, Pebax, Peek or PI can also be selected.

[0065] To facilitate temperature control, in one possible design, the ablation catheter also includes a temperature measuring mechanism, which includes temperature sensors. Temperature sensors are installed on the inner side of each elastic tube 31, specifically on the area inside the ablation electrode 32. Alternatively, the temperature sensors can be mounted on the ablation electrode 32. Each temperature sensor is electrically connected to the main unit. An electrically controlled valve is installed in the inlet line 40, and this valve is electrically connected to the main unit. The main unit determines whether to open the electrically controlled valve based on the temperature information fed back from the temperature sensors.

[0066] Alternatively, a separate display device can be set up, with the temperature sensor electrically connected to the display device. The temperature measured by the temperature sensor is displayed on the display device. With this setup, the operator can manually operate the device based on the temperature displayed on the display device to determine whether to introduce liquid into the liquid inlet pipe 40.

[0067] In one possible design, the temperature sensor is a thermocouple-type sensor, such as a type T thermocouple or a type K thermocouple. Optionally, the diameter of the thermocouple (specifically a type T thermocouple or a type K thermocouple) ranges from 0.2 mm to 0.4 mm. For example, the diameter of the thermocouple is 0.2 mm, 0.25 mm, 0.3 mm, or 0.4 mm, etc.

[0068] Since the ablation catheter provided in this embodiment can be used not only for pulsed ablation but also for radiofrequency ablation to achieve dual-modal ablation, and during radiofrequency ablation, a temperature sensor can be used to easily detect temperature, which serves as an important treatment feedback. When the temperature sensor is installed below the ablation electrode 32, measures must be taken to provide high-voltage insulation to the temperature sensor and temperature measurement circuit to prevent the high voltage pulse during pulsed electric field ablation mode from damaging the temperature sensor and temperature measurement circuit. The diameter of the ablation electrode 32 is generally no more than 2 mm, and its internal space is very limited, which poses a challenge to the high-voltage insulation of the temperature sensor.

[0069] In one feasible embodiment, the temperature sensor includes a sensor and a temperature sensing wire connected to the sensor. Both the temperature sensing wire and the sensor are wrapped with an insulating protective layer. The insulating protective layer improves the insulation of the temperature sensing wire and the sensor, thereby providing better protection for the temperature sensor.

[0070] In one specific embodiment, the temperature measuring wire is reinforced with multilayer polyimide (PI) insulation, and the sensor connected to one end of the temperature measuring wire is encapsulated with a high-voltage resistant polymer (polyimide, epoxy resin, etc.) to form a high-voltage resistant insulating protective layer on the outer surface of the sensor.

[0071] In one implementation, the ablation electrode 32 is provided with a mounting hole, and the temperature sensor is installed in the corresponding mounting hole of the ablation electrode 32. The temperature sensor, wrapped with an insulating protective layer, is inserted into the mounting hole of the ablation electrode 32, and the temperature sensor and the inner wall of the mounting hole of the ablation electrode 32 are bonded and fixed. Specifically, the adhesive used needs to have good thermal conductivity so that the temperature of the ablation electrode 32 can be better transferred to the temperature sensor.

[0072] In a preferred embodiment, such as Figure 6 As shown, the temperature measuring mechanism also includes a temperature measuring mother plate 80 and multiple temperature measuring daughter plates 90. Each temperature sensor is installed on the inner side of the ablation electrode on each elastic tube. Each temperature measuring daughter plate 90 is connected to the temperature measuring mother plate 80 to transmit signals. Each temperature measuring daughter plate 90 is provided with a sub-temperature measuring circuit. The temperature measuring daughter plates 90 are electrically isolated from each other. Specifically, the multiple temperature measuring daughter plates 90 are electrically isolated from each other under high voltage and can withstand high voltage of more than 3kV. Each temperature sensor is connected to each sub-temperature measuring circuit in a one-to-one correspondence. The temperature measuring mother plate 80 is used to connect to the host of the multimodal ablation device.

[0073] During application, each temperature sensor is used to detect the temperature of its corresponding ablation electrode 32, allowing for real-time monitoring of the temperature of multiple ablation electrodes 32 using multiple temperature sensors. Specifically, each sub-temperature sensing circuit is connected to a corresponding temperature sensor to detect the temperature of the ablation electrode 32 corresponding to that sensor in real time and output temperature data. These sub-temperature sensing circuits are connected to a temperature sensing motherboard 80, which receives the temperature data from each sub-temperature sensing circuit and sends it to the host unit of the multimodal ablation device connected to the ablation conduit, enabling real-time monitoring of the temperature of each ablation electrode 32. In one possible implementation, the host unit is connected to a display, showing the temperature of each ablation electrode 32, allowing the operator to determine whether to introduce liquid into the inlet pipe 40 based on the temperature data. Alternatively, the inlet pipe 40 is equipped with an electrically controlled valve, electrically connected to the host unit, which determines whether to open the valve based on the temperature information from the temperature sensing motherboard 80.

[0074] In one alternative implementation, such as Figure 6 As shown, the temperature sensing motherboard 80 and the temperature sensing daughterboard 90 are connected by a plug-in connection. For example, the temperature sensing motherboard 80 is provided with multiple daughterboard interfaces 83, and each temperature sensing daughterboard 90 is provided with a plug-in connector. Each temperature sensing daughterboard 90 is connected to its corresponding daughterboard interface 83 via a plug-in connector, allowing for pluggable connection with the temperature sensing motherboard 80 and thus signal transmission. This pluggable connection method facilitates control over the number of temperature sensing daughterboards 90 connected to the temperature sensing motherboard 80 and facilitates the assembly and disassembly of the temperature sensing motherboard 80 and the temperature sensing daughterboard 90.

[0075] In one optional embodiment, the temperature sensing motherboard 80 is provided with a power interface 81 for connecting to a power source, thereby supplying power to each temperature sensing daughterboard 90 through the temperature sensing motherboard 80. Furthermore, the temperature sensing motherboard 80 is also provided with a power circuit connected to the power interface 81, through which the temperature sensing motherboard 80 supplies power to each temperature sensing daughterboard 90.

[0076] Please see Figure 6 In one embodiment, the temperature sensing motherboard 80 further includes a fiber optic transceiver and a fiber optic interface 82. The fiber optic transceiver is connected to multiple sub-temperature sensing circuits to convert temperature data from electrical signals to optical signals and transmit the temperature data to the host computer via the fiber optic interface 82.

[0077] In one alternative implementation, such as Figure 6 As shown, the sub-temperature measurement circuit includes a temperature measurement front-end module, a microcontroller module 91, an isolated communication module 96, and an isolated power supply module 94. The temperature measurement front-end module is connected to the temperature sensor, and the microcontroller module 91 is connected to the temperature measurement front-end module to receive temperature data. The microcontroller module 91 is also used to provide a cold junction compensation value to the temperature measurement front-end module to improve its measurement accuracy. Cold junction compensation is achieved by measuring the ambient temperature of the multimodal ablation device, transmitting this ambient temperature to the temperature measurement motherboard 80 via the host computer, and finally transmitting it to each temperature measurement daughterboard 90. Each temperature measurement daughterboard 90 sets the cold junction compensation value to the temperature measurement front-end module through its respective microcontroller module 91, thereby improving the accuracy of the temperature measurement by the temperature measurement front-end module. The isolation communication module 96 is connected to both the microcontroller module 91 and the temperature sensing motherboard 80. The isolation communication module 96 is used for isolated communication between the sub-temperature sensing circuit and the temperature sensing motherboard 80. This means that the sub-temperature sensing circuit and the temperature sensing motherboard 80 transmit communication data, including temperature data and cold junction compensation value settings, through the isolation communication module 96. This isolated communication method prevents high-voltage conduction between the sub-temperature sensing circuit and the temperature sensing motherboard 80 due to the communication connection, which could damage the circuit. The isolation power supply module 94 is connected to the temperature sensing motherboard 80. The isolation power supply module 94 provides the necessary operating voltage for the temperature sensing front-end module, the microcontroller module 91, and the isolation communication module 96. The isolation power supply module 94 uses an isolated method to achieve the power supply connection between the temperature sensing motherboard 80 and the sub-temperature sensing circuit, preventing high-voltage conduction between the sub-temperature sensing circuit and the temperature sensing motherboard 80 due to the power supply connection, which could damage the circuit.

[0078] In one alternative implementation, such as Figure 6As shown, the temperature measurement front-end module includes a temperature measurement chip 92, a protection filter circuit 95, and a temperature measurement interface 93. The temperature measurement chip 92 is connected to a corresponding temperature sensor through the temperature measurement interface 93. The temperature measurement chip 92 can be a digital temperature measurement chip. The protection filter circuit 95 may include a resistor and a filter capacitor. In one specific embodiment, see [reference needed]. Figure 7 The temperature measurement front-end module includes a digital temperature measurement chip U4, a first transient voltage suppression diode D3, a second transient voltage suppression diode D4, a first filter capacitor C11, a second filter capacitor C18, resistors R13 and R17. The first input pin T- (pin 3 of U4) and the second input pin T+ (pin 4 of U4) of the digital temperature measurement chip are used to connect to the temperature sensor. The digital temperature measurement chip U4 uses a Serial Peripheral Interface (SPI) communication method to connect to the microcontroller module, converting the signal output from the temperature sensor into temperature data and sending it to the microcontroller module. The SPI communication pins include pins 9, 10, 11, and 12 of the digital temperature measurement chip U4, used for connection to the microcontroller module. The first transient voltage suppression diode D3 and the first filter capacitor C11 are connected in series between the first input pin T- and ground SSGND, respectively. The second transient voltage suppression diode D4 and the second filter capacitor C18 are connected in series between the second input pin T+ and ground SSGND, respectively. The input terminals TC_N and TC_P are derived from the first input pin T- and the second input pin T+. TC_N and TC_P serve as the input terminals of the temperature sensing front-end unit 211, receiving signals from the temperature sensor. Resistors R13 and R17 are used for current limiting protection.

[0079] See Figure 8In one specific embodiment, the isolation communication module includes a first high-voltage isolation optocoupler U2 and a second high-voltage isolation optocoupler U3. The output terminal USART1_RX of the first high-voltage isolation optocoupler U2, i.e., pin 4 of U2, is used to connect to the microcontroller module. The input terminal RX of the first high-voltage isolation optocoupler U2, i.e., pin 1 of U2, is connected to the temperature sensing motherboard through the temperature sensing daughterboard interface 110, or further connected to the host through the temperature sensing motherboard. The first high-voltage isolation optocoupler U2 is used for isolated communication between the temperature sensing motherboard and the microcontroller module. Pin 2 of the first high-voltage isolation optocoupler U2 is connected to the voltage source VCC_5V through resistor R2. Pin 4 of the first high-voltage isolation optocoupler U2 is also connected to the voltage source SVCC_3.3V through pull-up resistor R1. Pin 3 of the first high-voltage isolation optocoupler U2 is connected to the voltage source SVCC_5V. Pin 5 of the first high-voltage isolation optocoupler U2 is grounded at SGND. A capacitor C9 is connected in series between pins 3 and 5 of the first high-voltage isolation optocoupler U2. The input terminal USART1_TX of the second high-voltage isolation optocoupler U3 is connected to the microcontroller module. The output terminal TX of the second high-voltage isolation optocoupler U3 is connected to the temperature measuring motherboard through the temperature measuring daughterboard interface 110, or further connected to the main control unit of the pulse electric field ablation main device through the temperature measuring motherboard. The second high-voltage isolation optocoupler U3 is used for isolated communication between the temperature measuring motherboard and the microcontroller module. Pin 2 of the second high-voltage isolation optocoupler U3 is connected to the voltage source VCC_5V through resistor R6 and switch Q1. Pin 4 of the second high-voltage isolation optocoupler U3 is also connected to the voltage source VCC_5V through pull-up resistor R5. Pin 3 of the second high-voltage isolation optocoupler U3 is connected to the voltage source VCC_5V. Pin 5 of the second high-voltage isolation optocoupler U3 is grounded to GND. A capacitor C10 is also connected in series between pins 3 and 5 of the second high-voltage isolation optocoupler U3.

[0080] See Figure 9In one feasible embodiment, the isolated power supply module includes an isolated power supply chip IC1 and a first linear voltage regulator chip V2. The isolated power supply chip IC1 is connected to the power supply circuit of the temperature sensing motherboard, and is used to receive and output the input voltage (voltage source VCC_5V) from the temperature sensing motherboard. The first linear voltage regulator chip V2 is used to regulate the output voltage of the isolated power supply chip IC1 before outputting it to provide the first voltage source SVCC_5V to the sub-temperature sensing circuit. The isolated power supply chip IC1 and the first linear voltage regulator chip V2 are magnetically coupled through a magnetic isolation coupling coil T1. Input pins 1, 2, and 3 of the magnetic isolation coupling coil T1 are connected to pins 6, 5, and 4 of the isolated power supply chip IC1, respectively. Output pin 5 of the magnetic isolation coupling coil T1 is grounded to SGND. Output pins 4 and 6 of the magnetic isolation coupling coil T1 are connected to the input pin VIN of the first linear voltage regulator chip V2 through diodes D2 and D1, respectively. Diodes D2 and D1 serve as anti-reverse protection. The output voltage of the isolation power supply chip IC1 is output as voltage source VCC_SIN through the magnetically isolated coupling coil T1. Filter capacitors C1 and C2 are located between the input terminal VIN of the first linear regulator chip V2 and ground SGND, and filter capacitor C6 is located between the output terminal VOUT of the first linear regulator chip V2 and ground SGND. The isolation power supply chip IC1 and the first linear regulator chip V2 are coupled using a magnetically isolated chip. The isolation power supply module 94 also includes a second linear regulator chip V1. The second linear regulator chip V1 is used to regulate the output voltage of the isolation power supply chip IC1, i.e., the voltage source VCC_SIN output through the magnetically coupled coil T1, and then output it to provide a second voltage source SVCC_3.3V to the sub-temperature sensing circuit.

[0081] In one possible design, each elastic tube 31 is equipped with a pressure sensor, which is connected to an alarm structure. The pressure sensor is used to detect the tissue adhesion of the elastic tube 31. It can detect the adhesion strength between the elastic tube 31 and the tissue (e.g., human tissue) located outside the elastic tube 31. By observing the range and variation of the pressure values ​​detected by the pressure sensor, it can be determined whether the corresponding elastic tube 31 is in contact with the tissue, and the adhesion strength between the elastic tube 31 and the tissue. The pressure sensor is used in radiofrequency ablation mode. When the pressure value detected by the pressure sensor exceeds a preset range, the alarm structure issues an alarm. The alarm structure includes a buzzer, a warning light, or a display device. The alarm structure can be installed on the host, or it can be independent of the host and only connected to the pressure sensor. When the alarm structure is a display device, both the temperature sensor and the pressure sensor can be connected to the same display device to display the temperature and pressure values ​​respectively. When the pressure value detected by the pressure sensor exceeds the preset range, an alarm pop-up window, text, or icon can be displayed on the display device to provide a warning.

[0082] In one specific embodiment, each elastic tube 31 is provided with at least two ablation electrodes 32, and a pressure sensor is provided between the two ablation electrodes 32. The pressure sensor is connected to the alarm structure.

[0083] Optionally, the pressure sensor is a resistance bridge sensor, which includes a thin-film strain gauge. The width of the resistance bridge sensor is smaller than the width of the elastic tube 31, and the width of the resistance bridge sensor ranges from 0.2 mm to 0.4 mm. For example, the width of the resistance bridge sensor is 0.2 mm, 0.3 mm, 0.35 mm, or 0.4 mm.

[0084] like Figures 1-3 As shown, in one possible design, the ablation catheter further includes a handle assembly 50, which includes a handle 51 and a sliding portion 52. The handle 51 is connected to one end of the tube body 10, and the sliding portion 52 is slidably mounted on the handle 51. The inner sheath 20 is connected to the sliding portion 52. Because the handle 51 is connected to the tube body 10, the tube body 10 can be moved via the handle 51 for easy operation. By pushing the sliding portion 52 in the handle assembly 50, the inner sheath 20 can be moved relative to the tube body 10 to control the deformation of each elastic tube 31.

[0085] Furthermore, a tail wire processor is provided at the tail of the handle 51, and the wires of each ablation electrode 32 are respectively connected to the tail wire processor, and connected to the main unit in the ablation device through the tail wire processor. When a wire conduit 60 is provided, the wire conduit 60 is connected to the tail wire processor.

[0086] In this embodiment, the elastic tube 31 can be a round tube or a flat tube. When the elastic tube 31 is a round tube, its cross-section is circular, and when the elastic tube 31 is a flat tube, its cross-section is oval. When the elastic tube 31 is a flat tube, it is easier to control the deformation direction of the elastic tube 31. When the elastic tube 31 deforms, it tends to bend outward along its thickness direction.

[0087] The ablation catheter provided in this embodiment is used in a multimodal ablation device. It can achieve pulse ablation mode and radiofrequency ablation mode through the ablation electrode 32 in the ablation assembly 30, so as to realize single-mode pulse ablation, single-mode radiofrequency ablation, or multimodal ablation operation with alternating pulse ablation and radiofrequency ablation. When a temperature measuring mechanism is set on or around the ablation electrode 32, the temperature measuring mechanism is not activated in the single-mode pulse ablation mode, and no temperature measuring operation is required. When radiofrequency ablation is used in the single-mode radiofrequency ablation mode or in the multimodal ablation mode, the temperature measuring mechanism is activated.

[0088] Second Embodiment

[0089] like Figure 4 and Figure 5As shown, the ablation catheter provided in this embodiment is a modified structure based on the ablation catheter provided in the first embodiment. The content described in the first embodiment will not be repeated in this embodiment. The following describes the differences between the ablation catheter provided in this embodiment and the ablation catheter provided in the first embodiment. The ablation catheter provided in this embodiment also includes a mapping tube 70, on which a mapping electrode 71 is disposed. The mapping electrode 71 is used for electrophysiological signal detection. The mapping tube 70 passes through the inner sheath 20 and is movable relative to the inner sheath 20. The mapping electrode 71 is connected to the host via a wire, which extends through the inner lumen of the mapping tube 70 and out of the mapping tube 70. The host monitors the electrophysiological signals before and after cardiac ablation through the mapping electrode 71.

[0090] Optionally, in its initial state, the distal end of the mapping tube 70 is annular or spiral. Since the mapping tube 70 is movable relative to the inner sheath 20, it deforms when pulled into the inner sheath 20, extending into its interior. After being pushed out of the inner sheath 20, the mapping tube 70 returns to its original annular or spiral shape. The proximal end of the mapping tube 70 extends out of the inner sheath 20, and can be directly pulled to allow the distal end of the mapping tube 70 to extend into or out of the inner sheath 20.

[0091] Third Embodiment

[0092] A multimodal ablation device includes a host and an ablation catheter provided in the first embodiment above. The host is electrically connected to the ablation component 30 of the ablation catheter. The host is used to output pulse energy or radio frequency energy to the ablation component 30. The host is also used to detect electrophysiological signals through the ablation electrode 32.

[0093] Specifically, before the ablation procedure, the host computer monitors the electrophysiological signals of the heart using the ablation electrode 32 to assess the disease. After the assessment, the host computer uses the ablation electrode 32 to perform dual-mode tissue ablation using pulsed electric field and radiofrequency energy. This allows for switching to radiofrequency energy ablation when dealing with deep tissues that are difficult to ablate using pulsed electric field energy, thereby reducing the recurrence rate of atrial fibrillation and facilitating the procedure, thus reducing its complexity. After the ablation is completed, the host computer can monitor the electrophysiological signals of the heart using the ablation electrode 32 to assess the disease and determine the ablation effect.

[0094] The multimodal ablation device provided in this embodiment can map electrophysiological signals before and after ablation. It integrates mapping, pulsed electric field ablation, and radiofrequency ablation without removing the ablation catheter, simplifying the surgical procedure and reducing the difficulty of the surgery.

[0095] The multimodal ablation device provided in this embodiment uses the ablation catheter provided in the first embodiment. When a temperature measuring mechanism is provided in the ablation catheter, the temperature measuring mechanism is electrically connected to the main unit. The main unit is used to control the start and stop status of the temperature measuring mechanism. It is worth noting that the main unit only activates the temperature measuring mechanism during dual-mode ablation or single-mode radiofrequency ablation. Pulsed electric field ablation releases high-voltage pulse energy through the ablation electrode 32 to perform tissue ablation treatment. In single-mode pulsed electric field ablation, since it relies on the non-thermal irreversible electroporation effect, it is not necessary to measure the temperature of the ablation electrode 32. Therefore, it is not necessary to activate the temperature measuring mechanism during single-mode pulsed electric field ablation.

[0096] The above description is merely an optional embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An ablation catheter, comprising: include: The tube body has an inlet pipe for introducing coolant; the inner sheath is inserted through the tube body and is movable relative to the tube body along the axial direction of the tube body. An ablation assembly includes multiple elastic tubes and multiple ablation electrodes. One end of each elastic tube is connected to the inner sheath, and the other end is connected to the tube body. Each elastic tube is provided with an ablation electrode, which is used to connect to the host unit of the ablation device. The host unit is at least used to control the multiple ablation electrodes to perform pulse ablation mode, radiofrequency ablation mode, or to control the multiple ablation electrodes to switch between pulse ablation mode and radiofrequency ablation mode. The sidewall of each elastic tube has a liquid outlet, and the inner cavity of each elastic tube is connected to both the liquid outlet and the liquid inlet pipe. The ablation catheter further includes a temperature measuring mechanism, which comprises a temperature measuring mother plate, multiple temperature measuring daughter plates, and multiple temperature sensors. Each temperature sensor is installed on the elastic tube in the region inside the ablation electrode. Each temperature measuring daughter plate is connected to the temperature measuring mother plate to transmit signals, and the daughter plates are electrically isolated from each other. Each daughter plate is provided with a sub-temperature measuring circuit. Each temperature sensor is connected to each sub-temperature measuring circuit in a one-to-one correspondence. The temperature measuring mother plate is used to connect to the host of the ablation device. Each sub-temperature measuring circuit includes an isolated communication module and an isolated power supply module. The sub-temperature measuring circuit and the temperature measuring mother plate communicate in isolation through the isolated communication module, and the sub-temperature measuring circuit and the temperature measuring mother plate are connected in isolation through the isolated power supply module.

2. The ablation catheter of claim 1, wherein, The temperature sensor includes a sensor and a temperature measuring wire, the temperature measuring wire is connected to the sensor, and the temperature measuring wire and the sensor are respectively wrapped with an insulating protective layer.

3. The ablation catheter of claim 1, wherein, Each of the elastic tubes is provided with at least two ablation electrodes, and a pressure sensor is provided between the two ablation electrodes. The pressure sensor is connected to the alarm structure.

4. The ablation catheter of claim 3, wherein, The pressure sensor is a resistance bridge sensor, which includes a thin-film strain gauge.

5. The ablation catheter of any of claims 1-4, wherein, The ablation catheter also includes a handle assembly, which includes a handle body and a sliding part. The handle body is connected to one end of the tube body, the sliding part is slidably mounted on the handle body, and the inner sheath is connected to the sliding part.

6. The ablation catheter of any of claims 1-4, wherein, The tube body is also provided with a wire conduit, and each of the ablation electrodes is connected to a high-voltage resistant wire. Each of the high-voltage resistant wires extends into the wire conduit, and the high-voltage resistant wires are used to transmit high-voltage pulse energy or radio frequency energy.

7. The ablation catheter of any of claims 1-4, wherein, The liquid outlet is a circular hole with a diameter ranging from 0.1 mm to 0.4 mm.

8. The ablation catheter according to any one of claims 1-4, characterized in that, The ablation catheter also includes a mapping tube with mapping electrodes for detecting electrophysiological signals. The mapping tube is inserted into the inner sheath and is movable relative to the inner sheath.

9. A multimodal ablation device, characterized in that, The device includes a host and an ablation catheter as described in any one of claims 1-8, wherein the host is electrically connected to the ablation component of the ablation catheter, the host is used to output pulse energy or radio frequency energy to the ablation component, and the host is also used to detect electrophysiological signals through the ablation electrode.

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