Ablation catheters and ablation devices

Abstract

The present application relates to the medical device technical field and provides an ablation catheter (100) and an ablation device. The ablation catheter (100) includes a catheter assembly (10) and an ultrasonic generator (20) disposed within the catheter assembly. The ultrasonic generator includes a drive assembly (21) and a generator assembly (22) connected to the drive assembly. The drive assembly is used to drive the generator assembly to vibrate, and the generator assembly is used to emit ultrasonic waves and focus the ultrasonic waves at a focal point located outside the catheter assembly. The ablation device includes an ablation catheter. According to the ablation catheter provided herein, ultrasonic waves emitted from the generator assembly can be focused and formed at a focal point outside the blood vessel wall, so that the ultrasonic waves have more energy at the focal point and can ablate sympathetic nerves at the corresponding location. Furthermore, at the location where the ultrasonic waves penetrate the blood vessel wall, the ultrasonic waves are more dispersed and carry less energy, resulting in less heating of the blood vessel wall and therefore less damage to the blood vessel wall caused by the ultrasonic waves.

Description

[Technical Field]

[0001] TECHNICAL FIELD This application relates to the field of medical devices, and more particularly to ablation catheters and ablation devices. [Background technology]

[0002] Renal sympathetic denervation (RDN) is a method of destroying the afferent and efferent renal sympathetic nerves through interventional therapy (e.g., through the femoral or radial artery), thereby reducing sympathetic nervous activity in the kidneys and throughout the body and lowering blood pressure.

[0003] RDN techniques can be based on radiofrequency ablation, ultrasonic ablation, cryoablation, chemical ablation, etc., but currently, radiofrequency ablation (rRDN) and ultrasonic ablation (uRDN) are the mainstream. Among them, ultrasonic ablation has the advantages of good penetration and high energy controllability, and has certain technical advantages in the field of RDN.

[0004] Currently, ultrasonic ablation mainly uses two solutions: annular transducers with 360-degree energy emission and planar transducers with directional energy emission. However, whether annular or planar transducers are used, the ultrasonic energy distribution cannot protect the renal artery vessel wall, and other cooling methods must be used to protect the renal artery vessels, increasing the risk of renal artery damage or stenosis. Summary of the Invention [Problem to be solved by the invention]

[0005] The present application aims to provide an ablation catheter and an ablation device that aim to reduce the adverse effects of ultrasound on the renal artery vascular wall during the process of ablation of the renal artery sympathetic nerve. [Means for solving the problem]

[0006] In a first aspect, some embodiments of the present application provide an ablation catheter, the device comprising: a catheter assembly; and an ultrasonic generator disposed within the catheter assembly, the ultrasonic generator comprising a drive assembly and a generating assembly connected to the drive assembly, the drive assembly being used to drive the generating assembly to vibrate, the generating assembly being used to emit ultrasonic waves and focus the ultrasonic waves at a focal point, the focal point being configured to be located outside the catheter assembly.

[0007] In some embodiments, the generator assembly comprises an arc-shaped piezoelectric sheet configured such that the center and focal point of the piezoelectric sheet are on the same side of the catheter assembly.

[0008] In some embodiments, the radius of the piezoelectric sheet ranges from 6 mm to 15 mm.

[0009] In some embodiments, the piezoelectric sheet has at least one partition groove formed therein, the partition groove being capable of dividing the piezoelectric sheet into at least two piezoelectric sub-sheets, and the piezoelectric sub-sheets being capable of rotating relative to the drive assembly.

[0010] In some embodiments, the generating assembly has a first state and a second state, and the acoustic power of the ultrasound emitted by the generating assembly in the second state is 10% or less of the acoustic power of the ultrasound emitted by the generating assembly in the first state.

[0011] In some embodiments, the ablation catheter further comprises an imaging device disposed within the catheter assembly and lateral to the ultrasound generator.

[0012] In some embodiments, the catheter assembly includes an outer tube and a rotating component disposed within the outer tube, the outer tube having a storage cavity, and the ultrasonic generator is housed within the storage cavity; One end of the rotating component extends into the receiving cavity and is connected to the ultrasonic generator, and the rotating component can be curved together with the outer tube, and the rotating component can rotate relative to the outer tube to rotate the ultrasonic generator.

[0013] In some embodiments, the catheter assembly further comprises a fluid inlet channel and a fluid outlet channel disposed in the outer tube, one end of the fluid inlet channel and one end of the fluid outlet channel both communicating with the storage cavity.

[0014] In some embodiments, the catheter assembly further comprises a covering membrane disposed around the outer tube, the covering membrane forming a covering cavity around the outer periphery of the outer tube, the covering cavity communicating with the storage cavity, and the covering membrane being movable toward or away from the storage cavity.

[0015] In some embodiments, the catheter assembly further comprises a support piece and a movable piece disposed outside the outer tube, one end of the support piece connected to the outer tube and the other end of the support piece connected to the movable piece; The movable part is movably connected to the outer tube and is movable relative to the outer tube along the axial direction of the outer tube, and can drive the support part to deform in a direction away from the outer tube or in a direction toward the outer tube.

[0016] In some embodiments, the outer tube has an opening in communication with the storage cavity, the opening facing the ultrasonic generator.

[0017] A sound-permeable membrane is provided at the opening, and the sound-permeable membrane is used to seal the opening and allow ultrasonic waves to pass through.

[0018] In some embodiments, the ablation catheter further comprises a temperature sensor positioned laterally of the ultrasound generator.

[0019] In a second aspect, some embodiments of the present application further provide an ablation device including an ablation catheter provided by some embodiments of the first aspect. [Effects of the Invention]

[0020] Compared with the prior art, the embodiments of the present application have the following beneficial effects: the ultrasonic generator includes a driving assembly and a generating assembly, and the ultrasonic waves emitted from the generating assembly can be converged to form a focus outside the vascular wall, so that the ultrasonic waves have more energy at the focus and can cauterize the sympathetic nerves at the corresponding location; and at the location where the ultrasonic waves penetrate the vascular wall, the ultrasonic waves are more dispersed and carry less energy, so that the vascular wall generates less heat, thereby reducing the damage caused by the ultrasonic waves to the vascular wall. [Brief explanation of the drawings]

[0021] In order to more clearly describe the technical solutions of the embodiments of the present application, the following briefly introduces the accompanying drawings used in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. Those skilled in the art can obtain other drawings based on these drawings without any creative effort. [Figure 1] 1 is a partial three-dimensional view of an ablation catheter provided in accordance with some embodiments of the present application. FIG. [Figure 2] 1 is a partial three-dimensional view of an ablation catheter provided in accordance with some embodiments of the present application. FIG. [Figure 3] FIG. 2 is a cross-sectional schematic view of the ablation catheter shown in FIG. 1. [Figure 4] FIG. 4 is a partially enlarged schematic view of A in FIG. [Figure 5] FIG. 4 is a schematic cross-sectional view taken along line BB in FIG. 3. [Figure 6] FIG. 3 is a cross-sectional schematic view of the ablation catheter shown in FIG. 2. [Figure 7] FIG. 7 is a partially enlarged schematic view of C in FIG. 6. [Figure 8] FIG. 7 is a schematic cross-sectional view taken along the line DD in FIG. 6. [Figure 9] 1 is a three-dimensional view of an ultrasonic generator of an ablation catheter provided in accordance with some embodiments of the present application. FIG. [Figure 10] 1 is a schematic diagram of the structure of a piezoelectric sheet of an ablation catheter provided in accordance with some embodiments of the present application. FIG. [Figure 11] 1 is a three-dimensional view of an ablation device provided in accordance with some embodiments of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0022] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be described in more detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to interpret the present application and are not intended to limit the present application.

[0023] It should be noted that when a component is described as being "fixed" to or "disposed" on another component, that component may be directly or indirectly disposed on the other component. When a component is described as being "connected" to another component, that component may be directly or indirectly connected to the other component. Any directional or positional relationships indicated by terms such as "upper," "lower," "left," and "right" are based on the drawings and are used solely for the purpose of simplifying the description. No particular orientation or requirement for the depicted devices or elements to be constructed or operated in a particular direction is implied or implied, and should not be construed as a limitation of the present application. The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or as implicitly designating the number of technical features. Unless otherwise specified, "plurality" refers to two or more.

[0024] It should also be noted that the same symbols are used in the embodiments of the present application to represent the same components or parts, and although the drawings may only refer to one part or component as an example, it should be understood that the symbols also apply to other parts or components that are the same.

[0025] Hypertension is the most common chronic disease and a major risk factor for cardiovascular and cerebrovascular diseases, and is known as an "invisible killer" that affects human health, potentially leading to stroke, myocardial infarction, heart failure, and chronic kidney disease. Overexcitation of the renal sympathetic nerves increases blood pressure, increasing the risk of death and the burden of treatment associated with hypertension. RDN technology involves interventional therapy (through the femoral or radial artery) to destroy the afferent and efferent renal sympathetic nerves, thereby reducing sympathetic nervous activity in the kidneys and throughout the body, thereby lowering blood pressure.

[0026] RDN techniques can be based on methods such as radiofrequency ablation, ultrasound ablation, cryoablation, and chemical ablation, but currently radiofrequency ablation (rRDN) and ultrasound ablation (uRDN) are the most common. Radiofrequency ablation involves passing an electrode-equipped catheter into the renal artery and outputting radiofrequency energy through the electrode, which heats the tissue around the electrode and gradually transmits radiofrequency current or heat beneath the adventitia of the renal artery. Although radiofrequency ablation can reduce the temperature of the electrode and the renal artery intima by irrigating with cold saline, the risk of intimal damage and renal artery stenosis remains.

[0027] Ultrasonic energy has advantages such as good penetration and high energy controllability, giving it certain technical advantages in the field of RDN. Currently, prior art solutions mainly include annular transducers with 360-degree energy emission and planar transducers with directional energy emission. However, neither annular nor planar transducer solutions can achieve spatial control of the sound field and ultrasonic energy distribution, which can easily lead to damage to the renal artery vascular wall and renal artery stenosis, and requires cooling of the renal artery intima with cooling water.

[0028] Based on the above considerations, in order to reduce the damage that ultrasonic energy may cause to the vascular wall, the present application provides an ablation catheter including an ultrasonic generator, which includes a driving assembly and a generating assembly, and ultrasonic waves emitted from the generating assembly can be converged outside the vascular wall to form a focus, so that the ultrasonic waves have greater energy at the focus and can ablate the sympathetic nerves at the corresponding location.

[0029] Furthermore, at the point where the ultrasound penetrates the blood vessel wall, the ultrasound is not yet focused and carries less energy, which results in less heating of the blood vessel wall and therefore less damage to the blood vessel wall caused by the ultrasound.

[0030] Such an ablation catheter can not only ablate the target sympathetic nerve outside the blood vessel, but also reduce damage to the blood vessel wall caused by ultrasound. It also has a simple structure, is less difficult to operate, and reduces the cost of the ablation catheter.

[0031] The ablation catheters provided in the embodiments of the present application can be used not only to ablate renal sympathetic nerves but also to ablate tissue in other locations, such as prostatic hyperplasia tissue. For ease of explanation, the following embodiments will describe the use of the ablation catheters provided in the embodiments of the present application for ablation of renal sympathetic nerves.

[0032] In a first aspect, some embodiments of the present application provide an ablation catheter 100. Please refer to FIGS. 1 to 4. FIG. 1 is a partial three-dimensional view of the ablation catheter 100 provided by some embodiments of the present application, FIG. 2 is a partial three-dimensional view of the ablation catheter 100 provided by some other embodiments of the present application, FIG. 3 is a cross-sectional schematic view of the ablation catheter 100 shown in FIG. 1, and FIG. 4 is a partially enlarged schematic view of A in FIG. 3. Because the ablation catheter 100 is typically long, FIGS. 1 and 2 only show a partial structure of the end portion of the ablation catheter 100.

[0033] The ablation catheter 100 includes a catheter assembly 10 and an ultrasonic generator 20. The ultrasonic generator 20 is disposed within the catheter assembly 10 and includes a drive assembly 21 and a generator assembly 22 connected to the drive assembly 21. The drive assembly 21 is used to drive the generator assembly 22 to vibrate. The generator assembly 22 is used to emit ultrasonic waves and focus the ultrasonic waves at a focal point. The focal point is configured to be located outside the catheter assembly 10.

[0034] The catheter assembly 10 refers to a structure or structural assembly for mounting the ultrasound generator 20 and other devices. The catheter assembly 10 can be inserted into a patient's blood vessel and moved along the blood vessel. The ultrasound generator 20 and other devices are housed within the catheter assembly 10 and can be moved to a target location together with one end of the catheter assembly 10. The catheter assembly 10 may include one or more tubular structures. The material of the catheter assembly 10 may be polytetrafluoroethylene, silicone rubber, polyurethane, or other materials. The shape of the catheter assembly 10 may be cylindrical, prismatic, or other shapes.

[0035] The ultrasound generator 20 refers to a structure or combination of structures capable of emitting ultrasound. The ultrasound emitted from the ultrasound generator 20 can penetrate blood vessel walls and ablate target sympathetic nerves. The ultrasound generator 20 may include a transducer, various circuit boards, and other structures and devices.

[0036] The drive assembly 21 refers to a structure or combination of structures in the ultrasonic generator 20 for driving the generating assembly 22 to vibrate. The drive assembly 21 may include various circuit boards, such as an amplifier circuit board. The drive assembly 21 also includes structures such as a matching layer and a backing layer. The drive assembly 21 is used to drive the vibration of the generating assembly 22. For example, the drive assembly 21 can receive and process electrical signals and send the processed electrical signals to the generating assembly 22.

[0037] The generator assembly 22 refers to a structure or combination of structures capable of generating ultrasonic waves in the ultrasonic generator 20. The generator assembly 22 may include only one device capable of vibrating to generate ultrasonic waves, or may include multiple devices capable of vibrating to generate ultrasonic waves. The generator assembly 22 may be made of barium titanate ceramic, lead titanate ceramic, or other materials. The generator assembly 22 receives an electrical signal transmitted from the drive assembly 21 and generates mechanical vibrations in response to the received electrical signal to generate ultrasonic waves.

[0038] The ultrasound waves generated by the generating assembly 22 can be focused at a focal point, where the ultrasound waves generate greater energy and can be used to cauterize the sympathetic nerves at the corresponding location. Specifically, the generating assembly 22 can be configured with a device or multiple devices of a specific shape to focus the ultrasound waves generated by the generating assembly 22 at the focal point. In some embodiments, the generating assembly 22 can include one device of a specific shape, where the specific shape of the piezoelectric sheet 221 can be arc-shaped, U-shaped, or other shape, so that the ultrasound waves generated by the generating assembly 22 can be focused at the focal point. In other embodiments, the generating assembly 22 can include multiple devices, and the multiple devices can be arranged along an arc-shaped, U-shaped, L-shaped, or other shaped track, so that the ultrasound waves generated by the generating assembly 22 can be focused at the focal point. It should be understood that the generating assembly 22 can employ other structures for focusing the ultrasound waves at the focal point and is not limited to the above-described method.

[0039] The ultrasound waves generated by the generator assembly 22 are relatively dispersed before converging to a focal point, and therefore carry little energy. Specifically, the closer the distance to the ultrasound generator 20, the less energy is carried by the ultrasound waves. Because the inner diameter of a blood vessel is typically small, the closer the ultrasound waves are to the ultrasound generator 20 as they pass through the vessel wall, the less energy they carry and the less damage they cause to the vessel wall.

[0040] According to this embodiment, the ultrasonic generator 20 includes a drive assembly 21 and a generator assembly 22. The ultrasonic waves emitted from the generator assembly 22 can converge and form a focus outside the vascular wall, so that the ultrasonic waves have more energy at the focus and can cauterize the sympathetic nerves at the corresponding location. In addition, at the location where the ultrasonic waves penetrate the vascular wall, the ultrasonic waves are more dispersed and carry less energy, so that the vascular wall generates less heat, thereby reducing damage caused by the ultrasonic waves to the vascular wall.

[0041] In some embodiments, the ultrasonic generator 20 is an ultrasonic transducer, in which case the drive assembly 21 may include structures such as a flexible circuit board, a matching layer, and a backing layer, and the generator assembly 22 may include a structure formed from a piezoelectric material.

[0042] In some embodiments, the ultrasonic generator 20 is connected to an external device via a cable 23. One end of the cable 23 is connected to the drive assembly 21 or the generator assembly 22, and the other end of the cable 23 extends through the catheter assembly 10 to the outside world, allowing the external device to send electrical signals to the ultrasonic generator 20 via the cable 23.

[0043] In some embodiments of the present application, reference is made to Figures 3, 4, 6, 7, and 9. Figure 3 is a cross-sectional schematic view of an ablation catheter 100 provided in some embodiments of the present application, Figure 4 is a partially enlarged schematic view of A in Figure 3, Figure 6 is a cross-sectional schematic view of an ablation catheter 100 provided in other embodiments of the present application, Figure 7 is a partially enlarged schematic view of point C in Figure 6, and Figure 9 is a three-dimensional view of the ultrasonic generator 20 in the ablation catheter 100 provided in some embodiments of the present application.

[0044] The generator assembly 22 includes an arc-shaped piezoelectric sheet 221 configured so that the center and focal point of the piezoelectric sheet 221 are located on the same side of the catheter assembly 10 .

[0045] The piezoelectric sheet 221 refers to a structure that can receive an electrical signal and generate mechanical vibrations. For example, the piezoelectric sheet 221 can receive an electrical signal transmitted from the drive assembly 21 and generate internal stress within the material, causing the material to vibrate and generate ultrasonic waves. The piezoelectric sheet 221 can be made of barium titanate ceramic, lead titanate ceramic, or other materials.

[0046] The arc-shaped piezoelectric sheet 221 means that the shape of the piezoelectric sheet 221 is arc-shaped. Specifically, the shape of the piezoelectric sheet 221 may be a part of the side wall of a thin-walled cylindrical structure, a part of the wall surface of a thin-walled spherical structure, or any other arc-shaped structure.

[0047] The center and focal point of the piezoelectric sheet 221 are configured to be located on the same side of the catheter assembly 10, that is, the piezoelectric sheet 221 protrudes in a direction away from the focal point.

[0048] When the arc-shaped piezoelectric sheet 221 receives an electrical signal and vibrates, the generated ultrasonic waves can be focused near the center of a circle or sphere of the arc-shaped piezoelectric sheet 221, thereby achieving the effect of converging the ultrasonic waves at a focal point.

[0049] In this embodiment, the generating assembly 22 includes an arc-shaped piezoelectric sheet 221, which emits ultrasound waves that can be focused, so that the ultrasound waves have higher energy at the focus, resulting in the effect of cauterizing the sympathetic nerves at the corresponding locations.

[0050] In some embodiments, the radius of the piezoelectric sheet 221 ranges from 6 mm to 15 mm, where the radius of the piezoelectric sheet 221 can be 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, or other values.

[0051] Since the ultrasonic waves generated by the piezoelectric sheet 221 can be converged near the center of a circle or sphere of the arc-shaped piezoelectric sheet 221, the position of the focus of the ultrasonic waves can be adjusted by adjusting the radius of the piezoelectric sheet 221.

[0052] Furthermore, since the sympathetic nerves are mainly located in the fatty tissue outside the renal artery adventitia and the depth range of the sympathetic nerves is 2 to 7 millimeters (mm) from the renal artery intima, the radius range of the piezoelectric sheet 221 is set to 6 mm to 15 mm so that the focal point is within a range of 2 to 7 mm from the renal artery intima, making it easier for the ultrasound to cauterize the sympathetic nerves at the focal point.

[0053] In this embodiment, the radius range of the piezoelectric sheet 221 is further limited, and by limiting the radius range of the piezoelectric sheet 221, the position range of the focal point is limited, so that the ultrasound can cauterize the sympathetic nerve at the focal point and reduce damage to the vascular wall in the process of penetrating the vascular wall.

[0054] In some embodiments, refer to Figure 10. Figure 10 shows a specific structure of the piezoelectric sheet 221 provided in some embodiments of the present application.

[0055] At least one partition groove is formed in the piezoelectric sheet 221 , and the partition groove 2211 can divide the piezoelectric sheet 221 into at least two piezoelectric sub-sheets 2212 , and the piezoelectric sub-sheets 2212 can rotate relative to the drive assembly 21 .

[0056] The partition groove 2211 refers to a through groove formed in the piezoelectric sheet 221. The partition groove 2211 can cut the piezoelectric sheet 221 to form two piezoelectric sub-sheets 2212. As the number of partition grooves 2211 increases, the number of piezoelectric sub-sheets 2212 also increases. The partition groove 2211 may extend along the length direction of the piezoelectric sheet 221 or along the width direction of the piezoelectric sheet 221. The partition groove 2211 may extend along another direction, or multiple partition grooves 2211 may extend along different directions.

[0057] The number of piezoelectric subsheets 2212 may be two or more. In some embodiments, the number of piezoelectric subsheets 2212 is odd. Furthermore, in the radial direction of the catheter assembly 10, the piezoelectric subsheets 2212 are arranged in odd-numbered rows, and the piezoelectric subsheets 2212 in each row are arranged along the length of the catheter assembly 10.

[0058] It will be understood that the multiple piezoelectric sub-sheets 2212 formed by the partition grooves 2211 are all located on the same arc-shaped surface, and that the arc-shaped surface may be a part of a cylindrical side wall, a part of a spherical wall, or any other arc-shaped surface. With this configuration, ultrasonic waves generated by the multiple piezoelectric sub-sheets 2212 can be focused on the circular or spherical center of the arc-shaped surface.

[0059] The piezoelectric sub-sheet 2212 can rotate relative to the drive assembly 21. As the piezoelectric sub-sheet 2212 rotates, the shape of the arcuate surface changes, and the position of the circular or spherical center of the arcuate surface also changes. That is, the position of the focal point can be adjusted by rotating the piezoelectric sub-sheet 2212, facilitating ablation of sympathetic nerves at different positions and meeting various ablation needs.

[0060] The rotation of the piezoelectric sub-sheet 2212 relative to the drive assembly 21 may be in one direction only, or in two or more directions. The rotation of the piezoelectric sub-sheet 2212 may be driven by a microdrive or other structure.

[0061] In this embodiment, the piezoelectric sheet 221 is divided into multiple piezoelectric sub-sheets 2212 by partition grooves 2211, and each piezoelectric sub-sheet 2212 is movable relative to the drive assembly 21, allowing the direction and angle of each piezoelectric sub-sheet 2212 to be adjusted.The multiple piezoelectric sub-sheets 2212 can form a phased array structure, allowing staff to adjust the focal position as needed and improving the compatibility of the ablation catheter 100.

[0062] In some embodiments, the partition grooves 2211 can be filled with insulating and absorbing materials to reduce mutual influence between the piezoelectric sub-sheets 2212. The insulating and absorbing materials can be epoxy resin, silicone, or other materials.

[0063] According to some embodiments of the present application, the generating assembly 22 has a first state and a second state, and the acoustic power of the ultrasound waves emitted by the generating assembly 22 in the first state is greater than the acoustic power of the ultrasound waves emitted by the generating assembly 22 in the second state, and the acoustic power of the ultrasound waves emitted by the generating assembly 22 in the second state is 10% or less, for example, the acoustic power of the ultrasound waves emitted by the generating assembly 22 in the second state can be 10%, 7%, 5%, 4%, 3%, 2%, 1%, or other values.

[0064] Acoustic power refers to the energy emitted from a sound source per unit time. The greater the acoustic power, the more energy transmitted by ultrasound per unit time.

[0065] The second state of the generator assembly 22 is used to map the sympathetic nerves. The second state is set to distinguish between the sympathetic and parasympathetic nerves, since the parasympathetic nerves are typically located close to the sympathetic nerves and ablation of the parasympathetic nerves can have a negative effect on blood pressure regulation.

[0066] Because the first state of the generating assembly 22 is used to ablate the sympathetic nerve at the focal point, the acoustic power of the ultrasound emitted by the generating assembly 22 in the first state is greater than the acoustic power of the ultrasound emitted by the generating assembly 22 in the second state, and as a result, the ultrasound emitted by the generating assembly 22 in the first state can carry sufficient energy to ablate the sympathetic nerve.

[0067] Specifically, the acoustic power of the ultrasound emitted from the generating assembly 22 in the second state is referred to as low power. Although the energy carried by low-power ultrasound is small and does not cause tissue damage, low-power ultrasound can cause changes in the permeability and ion channels of nerve cells, resulting in nerve stimulation responses and changes in blood pressure. Because stimulation responses caused by the sympathetic nervous system and those caused by the parasympathetic nervous system have different effects on blood pressure, staff can distinguish between the sympathetic and parasympathetic nervous systems based on changes in blood pressure to achieve a mapping effect.

[0068] Low-power ultrasound does not damage sympathetic nerves, but it does cause changes in pericardial permeability, ion channels, etc., creating a nerve stimulation response that allows staff to identify and determine the target nerves that need to be ablated. Therefore, in this embodiment, the ultrasound has two acoustic power ranges, allowing the ablation catheter 100 to have both the ability to ablate nerves and the ability to identify nerves.

[0069] According to some embodiments of the present application, please refer to Fig. 10. Fig. 10 shows a specific structure of the piezoelectric sheet 221 provided in some embodiments of the present application.

[0070] The ablation catheter 100 further comprises an imaging device 30 disposed within the catheter assembly 10 and to one side of the ultrasound generator 20 .

[0071] The imaging device 30 refers to a device that can enter a blood vessel together with the catheter assembly 10 and collect images of the vicinity of the blood vessel. The imaging device 30 may be an ultrasound imaging transducer, an optical coherence tomography (OCT) optical device, or other imaging device.

[0072] The imaging device 30 can be connected to an external device for communication, and by transmitting the collected images to the external device, staff can determine the position of the catheter assembly 10, the position of the site to be ablated, and other information based on the images, thereby helping staff to more appropriately perform the ablation procedure.

[0073] In some embodiments, the imaging device 30 is positioned on one side of the generating assembly 22 away from the drive assembly 21, and the imaging device 30 is positioned in the direction in which the ultrasound waves are emitted, allowing the ultrasound waves to reach a position where the imaging device 30 can acquire image information.

[0074] In this embodiment, an imaging device 30 is placed near the ultrasound generator 20, allowing staff to obtain tissue images at the corresponding locations, making it easier for staff to perform the cauterization operation.

[0075] According to some embodiments of the present application, reference is made to Figures 3, 5, 6, and 8. Figure 3 is a cross-sectional schematic view of an ablation catheter 100 provided in some embodiments of the present application, and Figure 5 is a cross-sectional schematic view taken along line BB in Figure 3, showing the internal structure of the catheter assembly 10. Figure 6 is a cross-sectional schematic view of an ablation catheter 100 provided in other embodiments of the present application, and Figure 8 is a cross-sectional schematic view taken along line DD in Figure 6, showing the internal structure of the catheter assembly 10.

[0076] The catheter assembly 10 includes an outer tube 11 and a rotating component 12 disposed within the outer tube 11. A storage cavity 111 is provided within the outer tube 11, and an ultrasonic generator 20 is housed within the storage cavity 111. One end of the rotating component 12 extends into the storage cavity 111 and is connected to the ultrasonic generator 20. The rotating component 12 can bend together with the outer tube 11, and can rotate relative to the outer tube 11 to rotationally drive the ultrasonic generator 20.

[0077] The outer tube 11 refers to a structure or a combination of structures for mounting the rotating part 12, the ultrasonic generator 20, etc. The material of the outer tube 11 may be polytetrafluoroethylene, silicone rubber, polyurethane, etc. The shape of the outer tube 11 may be cylindrical, prismatic, or other shapes.

[0078] The storage cavity 111 refers to a space formed inside the outer tube 11. The storage cavity 111 may refer to only the space provided inside the outer tube 11, or may refer to a space surrounded by a structure inside the outer tube 11. The storage cavity 111 is mainly used to store the ultrasonic generator 20, but can also store the imaging device 30 or other structures or devices.

[0079] The rotating part 12 refers to a structure that can be bent and can still rotate after being bent, and has good torque transmission performance and good flexibility. The rotating part 12 may be a Torx® spring tube or another structure that can be bent and can still rotate after being bent.

[0080] The ultrasonic generator 20 is housed in the housing cavity 111, and as the outer tube 11 moves within the blood vessel, the ultrasonic generator 20 is driven to move synchronously, and can be moved to the target position.

[0081] The rotating element 12 is housed within the outer tube 11 and may be arranged coaxially with the outer tube 11, or may be arranged eccentrically rather than coaxially. The outer tube 11 moves within the blood vessel, driving the rotating element 12 to move synchronously. One end of the rotating element 12 extends into the housing cavity 111 and is connected to the ultrasonic generator 20, so that the rotating element 12 can rotate the ultrasonic generator 20 within the housing cavity 111. It is understood that the other end of the rotating element 12, remote from the ultrasonic generator 20, extends outside, allowing staff to rotate the rotating element 12 using equipment or manually.

[0082] The rotating part 12 can bend synchronously with the outer tube 11, and even after the outer tube 11 is bent, the rotating part 12 can still rotate the ultrasonic generator 20 within the storage cavity 111. Because the blood vessels of patients with vascular diseases are usually more tortuous, the ultrasonic generator 20 usually undergoes multiple bends before reaching the target position. Therefore, by using the rotating part 12 to drive the ultrasonic generator 20, the ultrasonic generator 20 can be better rotated within the storage cavity 111.

[0083] The rotating element 12 drives and rotates the ultrasonic generator 20, allowing the ablation catheter 100 to more appropriately adjust the ablation position according to the actual condition of the patient and improving the applicability of the ablation catheter 100. Furthermore, because the renal artery sympathetic nerves are mainly wound around the renal artery in a reticular structure, when the rotating element 12 drives and rotates the ultrasonic generator 20, the focus of the ultrasound also rotates roughly around the blood vessel as an axis, forming a ring-shaped ablation region surrounding the blood vessel. This facilitates ablation of the sympathetic nerves around the blood vessel, improves ablation efficiency, and reduces the movement of the ablation catheter 100 back and forth in and out of the blood vessel.

[0084] In this embodiment, the catheter assembly 10 includes a rotating component 12 that rotates the ultrasonic generator 20. The rotating component 12 can bend together with the outer tube 11 when the outer tube 11 is bent, and the rotating component 12 can also rotate the ultrasonic generator 20 when the outer tube 11 is bent, so that the focus of the ultrasound generated by the ultrasonic generator 20 can move around the blood vessel, expanding the ablation area and better adapting to the distribution of the renal artery sympathetic nerves.

[0085] In some embodiments, an end piece 113 is provided at one end of the outer tube 11, and the end piece 113 can seal the end of the outer tube 11, thereby reducing the amount of liquid or other substances in the outer tube 11 or the storage cavity 111 entering the blood vessel, and reducing the amount of blood vessel or external substances entering the outer tube 11.

[0086] The end piece 113 also has the function of guiding the movement of the ablation catheter 100 within the blood vessel, so by forming the end of the end piece 113 away from the outer tube 11 into a pointed shape, it is possible to reduce resistance when the ablation catheter 100 moves within the blood vessel. The end of the end piece 113 away from the outer tube 11 can also be formed into a rounded head, which can reduce resistance when the ablation catheter 100 moves within the blood vessel and reduce damage to the blood vessel wall caused by the end piece 113.

[0087] In some embodiments, the catheter assembly 10 further comprises a liquid inlet channel 13 and a liquid outlet channel 14 disposed on the outer tube 11, with one end of the liquid inlet channel 13 and one end of the liquid outlet channel 14 both communicating with the storage cavity.

[0088] The liquid inlet channel 13 and the liquid outlet channel 14 each refer to a channel structure or a combination of structures for transporting a liquid. One end of the liquid inlet channel 13 and one end of the liquid outlet channel 14 are both connected to the storage cavity 111. The liquid inlet channel 13 is a channel that transports liquid to the storage cavity 111, and the liquid outlet channel 14 is a channel that discharges the liquid within the storage cavity 111, thereby forming a circulating liquid flow and reducing the temperature within the storage cavity 111.

[0089] The liquid flowing through the liquid entry channel 13 and the liquid exit channel 14 is used to reduce the temperature within the storage cavity 111, and may include water, ethylene glycol, or other materials.

[0090] Since the ultrasonic generator 20 generates heat during operation and the ultrasonic waves themselves also carry heat, in order to reduce damage to the blood vessel wall due to excessive heat, a liquid inlet channel 13 and a liquid outlet channel 14 are provided to form a circulating liquid flow passing through the storage cavity 111, thereby reducing the temperature within the storage cavity 111 and reducing damage to the blood vessel wall due to high temperatures that may be generated.

[0091] It can be understood that the ends of the liquid inlet channel 13 and the liquid outlet channel 14 remote from the storage cavity 111 can be connected to the outside, and an external device can transport liquid to the storage cavity 111 via the liquid inlet channel 13 and discharge the liquid in the storage cavity 111 to the outside via the liquid outlet channel 14.

[0092] The liquid entry channel 13 and the liquid exit channel 14 may be disposed inside or outside the outer tube 11. In some embodiments, the water inlet and water outlet pipes are disposed outside the outer tube 11, and the liquid entry channel 13 and the liquid exit channel 14 are formed inside the water inlet and water exit pipes, respectively. In other embodiments, the water inlet and water exit pipes are disposed inside the outer tube 11, and the liquid entry channel 13 and the liquid exit channel 14 are formed inside the water inlet and water exit pipes, respectively. In still other embodiments, a partition structure is disposed inside the outer tube 11, and this partition structure forms the liquid entry channel 13 and the liquid exit channel 14 together with the wall of the outer tube 11.

[0093] In some embodiments, a water tube 141 is disposed within the outer tube 11, and a liquid entry channel 13 is formed between the outer wall of the water tube 141 and the inner wall of the outer tube 11, and a liquid discharge channel 14 is formed inside the inner wall of the water tube 141.

[0094] The cable 23 may be inserted through the water pipe 141, or may be inserted between the outer wall of the water pipe 141 and the inner wall of the outer pipe 11. The rotating part 12 may be arranged coaxially with the water pipe 141 and sleeved outside the water pipe 141, or the rotating part 12 may be arranged coaxially with the water pipe 141 and inserted through the water pipe 141, or the rotating part 12 does not have to be arranged coaxially with the water pipe 141.

[0095] In this embodiment, the catheter assembly 10 is provided with a liquid inlet channel 13 and a liquid outlet channel 14, and the liquid inlet channel 13 and the liquid outlet channel 14 are connected to the storage cavity 111, thereby forming a circulating water circuit within the catheter assembly 10, and the ultrasonic generator 20 is cooled by the circulating water, thereby reducing damage to the blood vessel wall caused by overheating of the ultrasonic generator 20.

[0096] In some embodiments, the ablation catheter 100 further comprises a temperature sensor 40 positioned laterally of the ultrasound generator 20 .

[0097] The temperature sensor 40 is a device that detects the temperature near the ultrasonic generator 20. The temperature sensor 40 is connected to an external device for communication and can transmit monitored real-time temperature information to the outside. Depending on the real-time temperature information, staff can perform operations such as shutting down the device when the real-time temperature is high, increasing the flow rate of the liquid, or increasing the flow velocity of the liquid.

[0098] The temperature sensor 40 can be connected to an external device via a signal line passing through the outer tube 11, or wirelessly, or can be communicatively connected by other means. In some embodiments, the temperature sensor 40 is a cable-like thermocouple temperature sensor that passes through the outer tube 11 and has one end extending to the side of the ultrasonic generator 20.

[0099] In this embodiment, a temperature sensor 40 is located on one side of the ultrasound generator 20 to make it easier for staff to monitor the temperature of the ultrasound generator 20, thereby reducing damage to blood vessel walls that may be caused by excessive temperature.

[0100] In some embodiments, the ultrasonic generator 20 may also include a base or housing to provide a mounting base for the drive assembly 21, the generator assembly 22, and the cable 23. In this case, the temperature sensor 40 may be housed at one end within the base or housing and positioned near the piezoelectric sheet 221 to better obtain real-time temperature information near the piezoelectric sheet 221.

[0101] According to some embodiments of the present application, reference is made to Figures 3 and 4. Figure 3 is a cross-sectional schematic view of an ablation catheter 100 provided in some embodiments of the present application, and Figure 4 is an enlarged partial view of A in Figure 3, showing the specific structure within the coated cavity 151.

[0102] The catheter assembly 10 further includes a covering membrane 15 disposed around the outer tube 11, and the covering membrane 15 forms a covering cavity 151 on the outer periphery of the outer tube 11. The covering cavity 151 communicates with the storage cavity 111, and the covering membrane 15 can move toward or away from the storage cavity 111.

[0103] The coating film 15 refers to a thin film structure or a combination of structures that is disposed around the outer tube 11 on the outside of the outer tube 11. The coating film 15 can form a coated cavity 151 on the outside of the outer tube 11. The coated cavity 151 is a sealed structure and cannot communicate with the outside.

[0104] The covering cavity 151 communicates with the storage cavity 111; that is, the covering cavity 151 covers the storage cavity 111 on the outside of the outer tube 11. In some embodiments, the outer tube 11 is divided into two stages by the storage cavity 111, called the front stage and the rear stage, and the space between the front stage and the rear stage is the storage cavity 111. In this case, the storage cavity 111 is an open space provided between the front stage and the rear stage. The covering cavity 151 covers the storage cavity 111 and communicates with it; that is, the storage cavity 111 is located within the storage cavity 151 and is part of the space of the storage cavity 151. In other embodiments, a through hole or channel is drilled in the outer tube 11, and the storage cavity 111 and the storage cavity 151 communicate with each other through the through hole or channel.

[0105] Because the covering cavity 151 covers the storage cavity 111 and the ultrasonic generator 20 is stored in the storage cavity 111, the function of the thin film structure of the covering film 15 is to reduce adverse effects that the covering film 15 has on ultrasonic waves, such as reducing energy attenuation as the ultrasonic waves pass through the covering film 15. Examples of materials for the covering film 15 include silicone rubber, polyurethane (PU), polytetrafluoroethylene (PIFE), polyamide (PA), and polyethylene terephthalate (PET). The thickness of the covering film 15 needs to be thin to reduce adverse effects on the ultrasonic waves, but it also needs to have a certain degree of strength. For example, the thickness of the covering film 15 can be 0.01 mm, 0.02 mm, 0.03 mm, etc.

[0106] When the outer tube 11 drives the ultrasonic generator 20 into the patient's blood vessel and reaches the target location, liquid enters the storage cavity 111 through the liquid entry channel 13 and can also enter the covering cavity 151. At this time, the liquid discharge channel 14 can be closed first. The liquid entry allows the covering cavity 151 to gradually expand. At this time, the covering membrane 15 moves away from the storage cavity 111 until it abuts against the blood vessel wall, thereby fixing the outer tube 11. This fixes the position of the ultrasonic generator 20 and reduces shaking that occurs during use of the ultrasonic generator 20. When cauterization is complete, liquid is no longer transported to the storage cavity 111 through the liquid entry channel 13, and the liquid in the covering cavity 151 is discharged through the liquid discharge channel 14. As the liquid decreases, the covering membrane 15 gradually moves toward the storage cavity 111 and away from the blood vessel wall, facilitating removal of the outer tube 11 and reducing adverse effects that may occur during removal of the outer tube 11. In some embodiments, when there is no liquid in the coating cavity 151, the coating film 15 can come into contact with the outer tube 11, which can better reduce the adverse effects that may occur when the outer tube 11 is removed.

[0107] In this embodiment, a coating film 15 is provided on the outside of the catheter, and the coating film 15 forms a coating cavity 151. At the same time, the coating cavity 151 communicates with the storage cavity 111, allowing water to flow into the storage cavity 111 and then into the coating cavity 151. As the water flows in, the coating cavity 151 gradually expands, and the coating film 15 moves away from the storage cavity 111 and abuts against the blood vessel wall, thereby fixing the catheter assembly 10.

[0108] According to some embodiments of the present application, reference is made to Figures 2, 6, and 7. Figure 2 is a partial three-dimensional view of an ablation catheter provided in some embodiments of the present application, Figure 6 is a cross-sectional schematic view of the ablation catheter of Figure 2, and Figure 7 is an enlarged view of C in Figure 6, showing a specific structure within the coated cavity 151.

[0109] The catheter assembly 10 further includes a support part 16 and a movable part 17 disposed outside the outer tube 11, one end of the support part 16 being connected to the outer tube 11 and the other end of the support part 16 being connected to the movable part 17; The movable part 17 is movably connected to the outer tube 11 and is movable relative to the outer tube 11 along the axial direction of the outer tube 11, and can drive the support part 16 to deform in a direction away from the outer tube 11 or in a direction toward the outer tube.

[0110] The support member 16 refers to a support structure or a combination of structures provided outside the outer tube 11. The support member 16 may have a strip-like, sheet-like, or other shape. The support member 16 may be made of metal, plastic, a composite material, or other materials.

[0111] The movable part 17 refers to a structure or a combination of structures that can move along the axial direction of the outer tube 11. The shape of the movable part 17 may be cylindrical, sheet-like, strip-like, or other shapes. The material of the movable part 17 may be metal, plastic, composite material, or other materials. In some embodiments, the movable part 17 is a sleeve that is coaxially fitted to the outer tube 11, and the movable part 17 is bendable.

[0112] The support part 16 can be attached to the outer tube 11 and can be deformed in a direction away from the outer tube 11. When the support part 16 is deformed in a direction away from the outer tube 11, it comes into contact with the blood vessel wall and fixes the position of the outer tube 11, thereby fixing the ultrasonic generator 20.

[0113] One end of the support part 16 is connected to the outer wall of the outer tube 11, and the other end of the support part 16 is connected to the movable part 17. When the movable part 17 moves toward the support part 16 along the axial direction of the outer tube 11, the middle part of the support part 16 undergoes compressive deformation and deforms in a direction away from the outer tube 11. When the movable part 17 moves away from the support part 16 along the axial direction of the outer tube 11, the middle part of the support part 16 undergoes tensile deformation and deforms in a direction toward the outer tube 11 and comes into contact with the outer wall of the outer tube 11.

[0114] In this embodiment, the catheter is provided with a support part 16 and a movable part 17. As the movable part 17 moves, the support part 16 deforms in a direction away from the outer tube 11 and abuts against the blood vessel wall, thereby fixing the position of the outer tube 11. The support part 16 can also deform in a direction closer to the outer tube 11, making it easier for the catheter assembly 10 to enter and move within the blood vessel.

[0115] In some embodiments, the shape of the support part 16 can be set to a convex arc shape in a direction away from the outer tube 11 , and the support part 16 can be deformed in a direction away from the outer tube 11 .

[0116] In some embodiments, the support element 16 is a sheet-like structure, and there are multiple support elements 16. The multiple support elements 16 are equally spaced around the outer tube 11. When the movable element 17 moves in a direction approaching the support elements 16 and deforms the support elements 16, the multiple support elements 16 deform to form a ball-cage-like structure.

[0117] In some embodiments, the support part 16 and the ultrasonic generator 20 are arranged intertwined along the axial direction of the outer tube 11 to reduce the adverse effect of the support part 16 on the ultrasonic waves generated by the ultrasonic generator 20.

[0118] According to some embodiments of the present application, reference is made to Figures 6 and 7. Figure 6 is a cross-sectional schematic view of an ablation catheter 100 provided in some embodiments of the present application, and Figure 7 is an enlarged partial view of C in Figure 6, showing a specific structure within the coated cavity 151.

[0119] The outer tube 11 has an opening 112 that communicates with the storage cavity 111, and the opening 112 faces the ultrasonic generator 20. A sound-permeable thin film 18 is provided at the opening 112, and the sound-permeable thin film 18 is used to seal the opening 112 and allow ultrasonic waves to pass through.

[0120] An opening 112 is provided in the outer tube 11, and the storage cavity 111 can communicate with the outside via the opening 112. A sound-permeable thin film 18 is provided in the outer tube 11, and by sealing the opening 112, the liquid in the storage cavity 111 is prevented from flowing out of the outer tube 11 via the opening 112. On the other hand, ultrasound can pass through the sound-permeable thin film 18, and substances inside or outside the blood vessels do not enter the storage cavity 111 via the sound-permeable thin film 18.

[0121] The sound-permeable thin film 18 can reduce adverse effects on the ultrasound waves compared to ultrasound waves that pass through the wall of the outer tube 11 and converge toward the target position, for example, it can reduce attenuation of ultrasound energy during transmission. The sound-permeable thin film 18 needs to be thin to reduce adverse effects on the ultrasound waves, and also needs to have a certain degree of strength. For example, the material of the sound-permeable thin film 18 may be silicone rubber, PU, ​​PIFE, PA, PET, etc., and the thickness of the sound-permeable thin film 18 may be 0.01 mm, 0.02 mm, 0.03 mm, etc.

[0122] Based on the function of the sonic membrane 18, the opening 112 faces the ultrasonic generator 20, and ultrasonic waves can be transmitted to the target location through the sonic membrane 18.

[0123] In this embodiment, the outer tube 11 has an opening 112 facing the ultrasonic generator 20, and the opening 112 is provided with a sound-permeable membrane 18, thereby reducing the influence of the wall of the outer tube 11 on the propagation of ultrasonic waves. At the same time, the sound-permeable membrane 18 keeps the storage cavity 111 sealed, preventing water and other impurities from entering the blood vessel.

[0124] According to some embodiments of the present invention, ablation catheter 100 can be used to ablate prostatic hyperplasia tissue in addition to ablation of sympathetic nerves near the renal arteries. This embodiment is further described using the ablation of prostatic hyperplasia tissue as an example, and ablation catheter 100 can not only ablate the prostatic hyperplasia tissue at the target site, but also reduce damage to the urethral wall.

[0125] When cauterizing prostatic hyperplasia tissue, the ablation catheter 100 can be inserted through the urethra, so the length of the ablation catheter 100, i.e., the length of the outer tube 11, the rotating part 12, the liquid inlet channel 13, and the liquid outlet channel 14, can be shortened.

[0126] Furthermore, when cauterizing the prostatic hyperplasia tissue, the target position to be cauterized may be far away from the urethra, with the farthest position being 1 centimeter (cm) from the urethra. In this case, the radius of the piezoelectric sheet 221 can be made larger, for example, 13 mm, 14 mm, 15 mm, etc., so that the focal point is at the farthest position, approximately 1 cm from the urethra, and the prostatic hyperplasia tissue can be cauterized at the focal point by ultrasound.

[0127] Due to the structural characteristics of the urethra, specifically because the urethra is substantially straight and not curved, the ablation catheter 100 does not have the ability to bend, i.e., the outer tube 11 does not have the ability to bend, and the rotating element 12 does not have the ability to bend and can only rotate within the outer tube.

[0128] Furthermore, due to the structural characteristics of the urethra, specifically, the width of the external urethral orifice is close to the inner diameter of the urethra, the ablation catheter 100 does not need to be provided with a positioning structure such as a covering membrane 15 or a support component 16, and the ablation catheter 100 can be positioned directly by controlling the outer diameter of the catheter assembly 10.

[0129] In a second aspect, some embodiments of the present application further provide an ablation device including the ablation catheter 100 provided by some embodiments of the first aspect, whereby the ablation device can ablate sympathetic nerves at a target location and reduce damage to a blood vessel wall during the ablation process.

[0130] The cauterization device may also include a structure or combination of structures such as a handle and a body. For example, the body can provide an electrical signal to the ultrasonic generator 20 and can also receive signals transmitted from the temperature sensor 40 and the imaging device 30. The body can also supply liquid to the liquid entry channel 13 and receive liquid discharged from the liquid discharge channel 14. As another example, the handle can be gripped by a staff member to control conduction between the liquid entry channel 13 and the liquid discharge channel 14, or to control the displacement of the movable part 17.

[0131] It should be noted that the above embodiments are not limiting and are only used to explain the technical solutions of the present application. Although the present application has been described in detail with reference to the above embodiments, those skilled in the art can still modify the technical solutions described in the above embodiments or perform equivalent substitutions for some of the technical features, and these modifications or substitutions do not deviate from the essence of the corresponding technical solutions from the concept and scope of each embodiment of the present application, and are within the scope of the claims of the present application. [Explanation of symbols]

[0132] 100 Catheterization 10 Catheter Assembly 11 Outer tube 111 Storage cavity 112 Opening 113 End Piece 12 Rotating parts 13 Liquid entry channel 14 Liquid outlet channel 141 Water pipe 15 Coating membrane 151 Coated Cavity 16 Support parts 17 Moving parts 18 Sound-permeable membrane 20 Ultrasonic generator 21 Drive Assembly 22. Generating Assembly 221 Piezoelectric Sheet 2211 Partition groove 2212 Piezoelectric Sub-Sheet 23 Cable 30 Imaging device 40 Temperature Sensor

Claims

1. 1. An ablation catheter comprising: a catheter assembly; an ultrasonic generator disposed within the catheter assembly, the ultrasonic generator comprising a drive assembly and a generating assembly connected to the drive assembly, the drive assembly being used to drive the generating assembly to vibrate, the generating assembly being used to radiate ultrasonic waves and focus the ultrasonic waves at a focal point, the focal point being configured to be located outside the catheter assembly.

2. The ablation catheter of claim 1 , wherein the generator assembly comprises an arc-shaped piezoelectric sheet configured such that the center of the piezoelectric sheet and the focal point are located on the same side of the catheter assembly.

3. The ablation catheter of claim 2 , wherein the radius of the piezoelectric sheet ranges from 6 mm to 15 mm.

4. 3. The ablation catheter of claim 2, wherein the piezoelectric sheet has at least one partition groove formed therein, the partition groove being capable of dividing the piezoelectric sheet into at least two piezoelectric sub-sheets, and the piezoelectric sub-sheets being capable of rotating relative to the drive assembly.

5. 5. The ablation catheter according to claim 1, wherein the generating assembly has a first state and a second state, and an acoustic power of the ultrasound waves emitted by the generating assembly in the second state is 10% or less of an acoustic power of the ultrasound waves emitted by the generating assembly in the first state.

6. The ablation catheter according to any one of claims 1 to 4, further comprising an imaging device disposed within the catheter assembly and laterally of the ultrasound generator.

7. The catheter assembly includes an outer tube and a rotating part disposed within the outer tube, a storage cavity is provided within the outer tube, and the ultrasonic generator is stored within the storage cavity; 5. The ablation catheter according to claim 1, wherein one end of the rotating component extends into the housing cavity and is connected to the ultrasonic generator, the rotating component can bend together with the outer tube, and the rotating component can rotate relative to the outer tube to rotationally drive the ultrasonic generator.

8. 8. The ablation catheter according to claim 7, wherein the catheter assembly further comprises a liquid inlet channel and a liquid outlet channel disposed in the outer tube, one end of the liquid inlet channel and one end of the liquid outlet channel both communicating with the storage cavity.

9. 9. The ablation catheter according to claim 8, wherein the catheter assembly further comprises a covering film disposed around the outer tube, the covering film forming a covering cavity on the outer periphery of the outer tube, the covering cavity communicating with the storage cavity, and the covering film being movable in a direction toward or away from the storage cavity.

10. the catheter assembly further comprises a support part and a movable part disposed outside the outer tube, one end of the support part being connected to the outer tube and the other end of the support part being connected to the movable part; 8. The ablation catheter according to claim 7, wherein the movable part is movably connected to the outer tube, is movable relative to the outer tube along the axial direction of the outer tube, and can drive the support part to deform in a direction away from the outer tube or in a direction toward the outer tube.

11. an opening communicating with the receiving cavity is formed in the outer tube, the opening facing the ultrasonic generator; 8. The ablation catheter according to claim 7, wherein a sound-permeable membrane is provided at the opening, the sound-permeable membrane being used to seal the opening and allow the ultrasonic waves to pass through.

12. The ablation catheter according to any one of claims 1 to 4, further comprising a temperature sensor disposed on the side of the ultrasonic generator.

13. An ablation device, comprising an ablation catheter according to any one of claims 1 to 12.

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