Ablation catheter and ablation apparatus

Abstract

The application is suitable for the technical field of medical equipment, and provides an ablation catheter and an ablation device. The ablation catheter comprises: a catheter assembly; and an ultrasonic generating device arranged in the catheter assembly, wherein the ultrasonic generating device comprises a driving assembly and a generating assembly connected with the driving assembly, the driving assembly is used for driving the generating assembly to vibrate, and the generating assembly is used for emitting ultrasonic waves and converging the ultrasonic waves at a focal point, and the focal point is arranged outside the catheter assembly. The ablation device comprises the ablation catheter. The ablation catheter provided by the application is characterized in that the ultrasonic generating device comprises the driving assembly and the generating assembly, and the ultrasonic waves emitted by the generating assembly can be converged to form the focal point outside the blood vessel wall, so that the ultrasonic waves can have relatively large energy at the focal point, thereby ablation of the sympathetic nerves at the corresponding position is realized. At the position where the ultrasonic waves penetrate the blood vessel wall, the ultrasonic waves are relatively dispersed and carry relatively low energy, so that the blood vessel wall is heated relatively little, thereby the damage of the ultrasonic waves to the blood vessel wall can be relieved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an ablation catheter and ablation device. Background Technology

[0002] Renal artery denervation (RDN) is a procedure that uses interventional methods (such as via the femoral or radial artery) to disrupt the renal sympathetic afferent and efferent nerves, thereby weakening the activity of the renal and systemic sympathetic nerves and lowering blood pressure.

[0003] RDN technology can be based on radiofrequency ablation, ultrasonic ablation, cryoablation, and chemical ablation, but currently radiofrequency ablation (rRDN) and ultrasonic ablation (uRDN) are the dominant methods. Among them, ultrasonic ablation has advantages such as good penetration and high energy controllability, giving it a certain technological advantage in the RDN field.

[0004] Currently, ultrasound ablation mainly employs two approaches: a ring transducer with 360° energy emission and a planar transducer with directional energy emission. However, neither ring nor planar transducers can effectively protect the renal artery wall with their ultrasound energy distribution. Instead, other cooling methods must be used to protect the renal artery, which increases the risk of renal artery injury and stenosis. Summary of the Invention

[0005] To address the aforementioned issues, this application provides an ablation catheter and ablation device that can mitigate the negative impact of ultrasound on the renal artery wall during the ablation of the renal artery sympathetic nerves.

[0006] In a first aspect, some embodiments of this application provide an ablation catheter, comprising:

[0007] Catheter assembly;

[0008] An ultrasound generator is located within the catheter assembly. The ultrasound generator includes a drive assembly and a generating assembly connected to the drive assembly. The drive assembly drives the generating assembly to vibrate, and the generating assembly emits ultrasound waves and focuses the ultrasound waves at a focal point located outside the catheter assembly.

[0009] In this embodiment, the ultrasound generating device includes a driving component and a generating component. The ultrasound emitted by the generating component can converge outside the blood vessel wall to form a focal point, thereby enabling the ultrasound to have greater energy at the focal point to ablate the sympathetic nerve at the corresponding location. At the location where the ultrasound passes through the blood vessel wall, the ultrasound is more dispersed and carries less energy, resulting in less heating of the blood vessel wall, thereby alleviating the damage of the ultrasound to the blood vessel wall.

[0010] In some embodiments, the generating component includes an arc-shaped piezoelectric sheet, and the center and focal point of the piezoelectric sheet are located on the same side of the conduit assembly.

[0011] In the technical solution of this embodiment, the generating component includes an arc-shaped piezoelectric sheet, which emits focused ultrasonic waves, so that the ultrasonic waves can have high energy at the focal point, thereby achieving the effect of ablating the sympathetic nerves at the corresponding location.

[0012] In some embodiments, the radius of the piezoelectric element ranges from 6 mm to 15 mm.

[0013] In the technical solution of this embodiment, the radius range of the piezoelectric patch is further defined so as to limit the position range of the focal point, thereby enabling the ultrasound to ablate the sympathetic nerve at the focal point and reduce damage to the blood vessel wall during the process of passing through the blood vessel wall.

[0014] In some embodiments, at least one partition groove is formed on the piezoelectric sheet, which can divide the piezoelectric sheet into at least two piezoelectric sheets, which can rotate relative to the driving component.

[0015] In the technical solution of this embodiment, the piezoelectric sheet is divided into multiple piezoelectric sheets by a partition groove, and each piezoelectric sheet can rotate relative to the driving component, thereby allowing each piezoelectric sheet to adjust its orientation and angle, and enabling multiple piezoelectric sheets to form a phased array structure, so that the staff can adjust the position of the focal spot as needed, and improve the compatibility of the ablation catheter.

[0016] In some embodiments, the generating component includes a first state and a second state, and the acoustic power of the ultrasonic wave emitted by the generating component in the second state is less than or equal to 10% of the acoustic power of the ultrasonic wave emitted by the generating component in the first state.

[0017] Because low-power ultrasound does not damage the sympathetic nervous system, it can alter cell permeability and ion channels, triggering a nerve stimulation response. Workers can identify and determine the target nerve to be ablated based on this response. Therefore, the technical solution of this embodiment provides the generating component with two states and the ultrasound with two power ranges, enabling the ablation catheter to both ablate and identify nerves.

[0018] In some embodiments, the ablation catheter further includes an imaging device disposed within the catheter assembly and adjacent to the ultrasound generator.

[0019] In this embodiment, an imaging device is installed next to the ultrasound generator so that staff can obtain tissue images of the corresponding location to facilitate ablation procedures.

[0020] In some embodiments, the catheter assembly includes an outer tube and a rotating member disposed within the outer tube, the outer tube having a receiving cavity in which an ultrasound generator is housed;

[0021] One end of the rotating component extends into the receiving cavity and is connected to the ultrasonic generator. The rotating component can bend with the outer tube and can rotate relative to the outer tube, thereby driving the ultrasonic generator to rotate.

[0022] In this embodiment, the catheter assembly includes a rotating component, which drives the ultrasound generator to rotate. The rotating component can bend with the outer tube when the outer tube bends, and it can also drive the ultrasound generator to rotate when the outer tube bends, so that the focal point of the ultrasound generated by the ultrasound generator can move around the blood vessel, thereby increasing the ablation area.

[0023] In some embodiments, the catheter assembly further includes an inlet channel and a outlet channel disposed on the outer tube, one end of which is connected to the receiving cavity.

[0024] In this embodiment, an inlet channel and an outlet channel are provided in the catheter assembly, and the inlet channel and outlet channel are connected to the receiving cavity, thereby forming a circulating water path in the catheter assembly. The circulating water cools down the ultrasound generator, thereby reducing the damage to the blood vessel wall that may be caused by the ultrasound generator being too hot.

[0025] In some embodiments, the catheter assembly further includes a covering membrane disposed around the outer tube, the covering membrane forming a covering cavity around the outer tube, the covering cavity communicating with the receiving cavity, and the covering membrane being movable toward or away from the receiving cavity.

[0026] The technical solution of this embodiment sets a covering membrane outside the catheter and forms a covering cavity with the covering membrane. At the same time, the covering cavity is connected to the receiving cavity, so that water can enter the covering cavity after entering the receiving cavity. The covering cavity can gradually expand as water flows in, so that the covering membrane can move away from the receiving cavity and abut against the blood vessel wall, thereby playing the role of fixing the catheter assembly.

[0027] In some embodiments, the conduit assembly further includes a support member and a movable member disposed outside the outer tube, one end of the support member being connected to the outer tube and the other end of the support member being connected to the movable member;

[0028] The movable component is movably connected to the outer tube. The movable component can move relative to the outer tube along the axial direction of the outer tube and can drive the support component to deform in a direction away from or close to the outer tube.

[0029] In the technical solution of this embodiment, a support and a movable part are provided on the catheter. The support can deform away from the outer tube as the movable part moves and abut against the blood vessel wall, thereby fixing the position of the outer tube. The support can also deform towards the outer tube to facilitate the catheter assembly to enter the blood vessel and move within the blood vessel.

[0030] In some embodiments, the outer tube has an opening communicating with the receiving cavity, and the opening is opposite to the ultrasonic generator.

[0031] An acoustic membrane is provided on the opening, which is used to seal the opening and to allow ultrasonic waves to pass through.

[0032] In this embodiment, an opening opposite to the ultrasound generator is provided on the outer tube, and an acoustic membrane is provided on the opening so that the ultrasound can be transmitted to the outside of the outer tube through the acoustic membrane, thereby reducing the influence of the outer tube wall on the transmission of ultrasound. At the same time, the acoustic membrane can also maintain the seal of the receiving cavity, preventing water or other impurities from entering the blood vessel.

[0033] In some embodiments, the ablation catheter further includes a temperature sensor located next to the ultrasound generator.

[0034] In this embodiment, a temperature sensor is installed next to the ultrasound generator to allow staff to monitor the temperature of the ultrasound generator, thereby reducing the potential damage to the blood vessel wall caused by excessively high temperatures.

[0035] Secondly, some embodiments of this application also provide an ablation device, including the ablation catheter provided in some embodiments of the first aspect.

[0036] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description

[0037] 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.

[0038] Figure 1 This is a partial three-dimensional schematic diagram of an ablation catheter provided in some embodiments of this application.

[0039] Figure 2This is a partial three-dimensional schematic diagram of an ablation catheter provided in some embodiments of this application.

[0040] Figure 3 for Figure 1 The diagram shows a cross-sectional view of the ablation catheter.

[0041] Figure 4 for Figure 3 A magnified view of a portion of point A in the middle.

[0042] Figure 5 for Figure 3 Schematic diagram of cross-section at point BB.

[0043] Figure 6 for Figure 2 The diagram shows a cross-sectional view of the ablation catheter.

[0044] Figure 7 for Figure 6 A magnified view of a portion of point C.

[0045] Figure 8 for Figure 6 Schematic diagram of cross-section at point DD.

[0046] Figure 9 This is a three-dimensional schematic diagram of an ultrasound generator in an ablation catheter provided in some embodiments of this application.

[0047] Figure 10 This is a schematic diagram of the piezoelectric element in an ablation catheter provided in some embodiments of this application.

[0048] Figure 11 This is a three-dimensional schematic diagram of an ablation device provided in some embodiments of this application.

[0049] The markings in the diagram mean:

[0050] 100. Ablation catheter;

[0051] 10. Conduit assembly; 11. Outer tube; 111. Receiving cavity; 112. Opening; 113. End piece; 12. Rotating component; 13. Inlet channel; 14. Drain channel; 141. Water pipe; 15. Covering membrane; 151. Covering cavity; 16. Support component; 17. Movable component; 18. Sound-permeable membrane;

[0052] 20. Ultrasonic generating device; 21. Drive assembly; 22. Generating assembly; 221. Piezoelectric element; 2211. Partition groove; 2212. Piezoelectric element; 23. Cable;

[0053] 30. Imaging device;

[0054] 40. Temperature sensor. Detailed Implementation

[0055] To make the objectives, technical solutions, and advantages of 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 not intended to limit the scope of this application.

[0056] It should be noted that when a component is referred to as "fixed to" or "set on" another component, it can be directly or indirectly attached to that other component. When a component is referred to as "connected to" another component, it can be directly or indirectly connected to that other component. The terms "upper," "lower," "left," "right," etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are for descriptive convenience only, not indicating or implying that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the patent. 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. "A plurality" means two or more, unless otherwise explicitly defined.

[0057] It should also be noted that in the embodiments of this application, the same reference numerals are used to represent the same component or part. For the same part in the embodiments of this application, the reference numerals may only be used to mark one part or component as an example. It should be understood that the reference numerals are also applicable to other identical parts or components.

[0058] Hypertension is the most common chronic disease and a major risk factor for cardiovascular and cerebrovascular diseases. It easily leads to stroke, myocardial infarction, heart failure, and chronic kidney disease, and is known as the "silent killer" affecting human health. Excessive excitation of the renal sympathetic nervous system can raise blood pressure. Hypertension carries a high risk of death and a heavy treatment burden. RDN (Renal Disorder Density) technology refers to an interventional treatment method (via the femoral or radial artery) that disrupts the renal sympathetic afferent and efferent nerves. This weakens the activity of the renal and systemic sympathetic nervous systems, thereby lowering blood pressure.

[0059] Renal renal artery (RDN) technology can be based on radiofrequency ablation, ultrasound ablation, cryoablation, and chemical ablation, but currently, radiofrequency ablation (rRDN) and ultrasound ablation (uRDN) are the most dominant. Radiofrequency ablation involves inserting a catheter with electrodes into the renal artery and delivering radiofrequency energy through the electrodes, heating the surrounding tissue and gradually conducting the radiofrequency current or heat to below the adventitia of the renal artery. Although radiofrequency ablation can lower the temperature of the electrodes and the renal artery intima through cold saline perfusion, there is still a risk of intimal damage and renal artery stenosis.

[0060] Ultrasonic energy possesses advantages such as good penetration and high energy controllability, giving it a certain technological advantage in the field of renal renal networks (RDN). Current technologies mainly include ring transducers with 360° energy emission and planar transducers with directional energy emission. However, neither ring nor planar transducer solutions can achieve spatial control of the sound field and ultrasonic energy distribution, easily leading to risks of renal artery wall damage and renal artery stenosis, necessitating cooling the renal artery intima with cooling water.

[0061] Based on the above considerations, in order to mitigate the potential damage of ultrasound energy to the blood vessel wall, this application provides an ablation catheter including an ultrasound generating device, wherein the ultrasound generating device includes a driving component and a generating component, and the ultrasound waves emitted by the generating component can converge outside the blood vessel wall to form a focal point, thereby enabling the ultrasound waves to have greater energy at the focal point to ablate the sympathetic nerve at the corresponding location.

[0062] At the point where ultrasound waves pass through the blood vessel wall, the waves have not yet converged to a focal point. Therefore, the waves are more dispersed and carry less energy, resulting in less heating of the blood vessel wall and thus mitigating the damage caused by ultrasound waves to the blood vessel wall.

[0063] This type of ablation catheter can ablate target sympathetic nerves outside the blood vessel and also alleviate the damage of ultrasound to the blood vessel wall. Its simple structure reduces the difficulty of operation and also reduces the cost of the ablation catheter.

[0064] The ablation catheter provided in this application can be used not only for ablation of the renal sympathetic nerve, but also for ablation of tissues in other parts of the body, such as prostatic hyperplasia tissue. For ease of explanation, the following embodiments use the ablation catheter provided in some embodiments of this application for ablation of the renal sympathetic nerve as an example.

[0065] Firstly, some embodiments of this application provide an ablation catheter 100, as referenced Figures 1 to 4 ,in, Figure 1 This is a partial three-dimensional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 2 This is a partial three-dimensional schematic diagram of the ablation catheter 100 provided in other embodiments of this application. Figure 3 for Figure 1 The diagram shows a cross-sectional view of the ablation catheter 100. Figure 4 for Figure 3 A magnified view of a portion of point A; because the ablation catheter 100 is typically quite long. Figure 1 and Figure 2 Only a portion of the structure at the end of the ablation catheter 100 is shown.

[0066] The ablation catheter 100 includes a catheter assembly 10 and an ultrasound generator 20. The ultrasound generator 20 is located inside the catheter assembly 10. The ultrasound generator 20 includes a drive assembly 21 and a generating assembly 22 connected to the drive assembly 21. The drive assembly 21 is used to drive the generating assembly 22 to vibrate. The generating assembly 22 is used to emit ultrasound waves and focus the ultrasound waves at a focal point located outside the catheter assembly 10.

[0067] The catheter assembly 10 refers to a structure or structural component used to carry the ultrasound generator 20 and other devices. The catheter assembly 10 is capable of entering and moving along the patient's blood vessels. The ultrasound generator 20 and other devices are housed within the catheter assembly 10 and can move to a target location 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.

[0068] Ultrasonic generating device 20 refers to a structure or combination of structures capable of emitting ultrasonic waves. The ultrasonic waves emitted by ultrasonic generating device 20 can penetrate the blood vessel wall and ablate the target sympathetic nerve. Ultrasonic generating device 20 may include transducers, various circuit boards or other structures and devices.

[0069] The driving component 21 refers to the structure or combination of structures in the ultrasonic generator 20 used to drive the vibration of the generating component 22. The driving component 21 may include various circuit boards such as amplification circuit boards, and may also include structures such as matching layers and backings. The driving component 21 is used to drive the vibration of the generating component 22. For example, the driving component 21 can receive and process electrical signals and send the processed electrical signals to the generating component 22.

[0070] The generating component 22 refers to the structure or combination of structures in the ultrasonic generating device 20 that can generate ultrasonic waves; the generating component 22 may include only one device that can vibrate and generate ultrasonic waves, or it may include multiple devices that can vibrate and generate ultrasonic waves; the material of the generating component 22 may be barium titanate ceramic, lead titanate ceramic or other materials; the generating component 22 can receive the electrical signal sent by the driving component 21 and generate mechanical vibration according to the received electrical signal, thereby generating ultrasonic waves.

[0071] The ultrasonic waves generated by the generating component 22 can be focused at a focal point, so that the ultrasonic waves generate greater energy at the focal point and use this energy to ablate the sympathetic nerves at the corresponding location. Specifically, the generating component 22 can focus the ultrasonic waves generated by the generating component 22 at a focal point by setting a device of a specific shape or setting multiple devices. In some embodiments, the generating component 22 may include a device of a specific shape, in which case the specific shape of the piezoelectric sheet 221 may be arc-shaped, U-shaped, or other shapes, so that the ultrasonic waves generated by the generating component 22 can be focused at a focal point; in other embodiments, the generating component 22 may also include multiple devices, and the multiple devices may also be arranged along an arc-shaped, U-shaped, L-shaped, or other shaped trajectory, so that the ultrasonic waves generated by the generating component 22 can be focused at a focal point; it is understood that the generating component 22 may also adopt other structures to focus ultrasonic waves at a focal point, and is not limited to the aforementioned methods.

[0072] Before the ultrasound generated by the generating component 22 converges to the focal point, the ultrasound waves are relatively dispersed and carry less energy. Specifically, the closer the ultrasound waves are to the ultrasound generating device 20, the less energy they carry. Since the inner diameter of blood vessels is usually small, the ultrasound waves are closer to the ultrasound generating device 20 when passing through the blood vessel wall, and the ultrasound waves carry less energy, resulting in less damage to the blood vessel wall.

[0073] In this embodiment, the ultrasound generating device 20 includes a driving component 21 and a generating component 22, and the ultrasound emitted by the generating component 22 can converge outside the blood vessel wall to form a focal point, so that the ultrasound can have greater energy at the focal point to ablate the sympathetic nerve at the corresponding location; while at the location where the ultrasound passes through the blood vessel wall, the ultrasound is more dispersed and carries less energy, so that the blood vessel wall heats up less, thereby alleviating the damage of ultrasound to the blood vessel wall.

[0074] In some embodiments, the ultrasonic generator 20 is an ultrasonic transducer, in which case the driving component 21 may include a flexible circuit board, a matching layer, a backing, and other structures, and the generating component 22 may include a structure formed of piezoelectric material.

[0075] 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 can pass through the conduit assembly 10 and extend to the outside, so that the external device can send an electrical signal to the ultrasonic generator 20 via the cable 23.

[0076] According to some embodiments of this application, reference is made to Figure 3 , Figure 4 , Figure 6 , Figure 7 , Figure 9 ,in, Figure 3This is a cross-sectional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 4 for Figure 3 A magnified view of a portion of point A in the diagram. Figure 6 This is a cross-sectional schematic diagram of the ablation catheter 100 provided in other embodiments of this application. Figure 7 for Figure 6 A magnified view of a portion of point C in the middle. Figure 9 This is a three-dimensional schematic diagram of the ultrasonic generator 20 in the ablation catheter 100 provided in some embodiments of this application.

[0077] The generating component 22 includes an arc-shaped piezoelectric sheet 221, and the center and focal point of the piezoelectric sheet 221 are located on the same side of the conduit assembly 10.

[0078] The piezoelectric element 221 refers to a structure that can receive electrical signals and generate mechanical vibrations. For example, the piezoelectric element 221 can receive electrical signals sent by the drive component 21 and generate internal stress in the material, thereby causing the material to vibrate and generate ultrasonic waves. The material of the piezoelectric element 221 can be barium titanate ceramic, lead titanate ceramic or other materials.

[0079] The arc-shaped piezoelectric element 221 refers to the piezoelectric element 221 having an arc shape. Specifically, the shape of the piezoelectric element 221 can be part of the side wall of a thin-walled cylindrical structure, part of the wall of a thin-walled spherical structure, or other arc-shaped structures.

[0080] The center of the piezoelectric element 221 and the focal point are located on the same side of the conduit assembly 10, that is, the piezoelectric element 221 protrudes in a direction away from the focal point.

[0081] When the arc-shaped piezoelectric element 221 receives an electrical signal and vibrates, the generated ultrasonic waves can be focused near the center of the arc-shaped piezoelectric element 221, thereby enabling the ultrasonic waves to achieve the effect of focusing at a focal point.

[0082] In this embodiment, the generating component 22 includes an arc-shaped piezoelectric sheet 221, which emits focused ultrasonic waves, so that the ultrasonic waves can have high energy at the focal point, thereby achieving the effect of ablating the sympathetic nerves at the corresponding location.

[0083] In some embodiments, the radius of the piezoelectric sheet 221 ranges from 6 mm to 15 mm, wherein 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.

[0084] Since the ultrasonic waves generated by the piezoelectric element 221 can be focused near the center of the arc-shaped piezoelectric element 221, the position of the ultrasonic focus can be adjusted by adjusting the radius of the piezoelectric element 221.

[0085] Since the sympathetic nerves are mainly located in the adipose tissue outside the adventitia of the renal artery, and the depth range of the sympathetic nerves is 2 to 7 millimeters (mm) from the intima of the renal artery, the radius range of the piezoelectric patch 221 is set to 6 mm to 15 mm so that the focal point can be located within the range of 2 to 7 mm from the intima of the renal artery, so that the ultrasound can ablate the sympathetic nerves at the focal point.

[0086] This embodiment further defines the radius range of the piezoelectric patch 221, thereby defining the focal point location range by defining the radius range of the piezoelectric patch 221, so that the ultrasound can ablate the sympathetic nerve at the focal point and reduce damage to the blood vessel wall during the process of passing through the blood vessel wall.

[0087] In some embodiments, reference Figure 10 , Figure 10 The specific structure of the piezoelectric element 221 provided in some embodiments of this application is shown.

[0088] At least one partition groove 2211 is provided on the piezoelectric sheet 221, which can divide the piezoelectric sheet 221 into at least two piezoelectric sheets 2212, and the piezoelectric sheets 2212 can rotate relative to the drive assembly 21.

[0089] The partition groove 2211 refers to the through groove formed on the piezoelectric sheet 221. The partition groove 2211 can cut the piezoelectric sheet 221 and form two piezoelectric sheets 2212. As the number of partition grooves 2211 increases, the number of piezoelectric sheets 2212 will also increase. The partition groove 2211 can extend along the length direction of the piezoelectric sheet 221, or along the width direction of the piezoelectric sheet 221, or along other directions. Multiple partition grooves 2211 can also extend in different directions.

[0090] The number of piezoelectric pads 2212 can be two or more. In some embodiments, the number of piezoelectric pads 2212 is an odd number; further, in the radial direction of the conduit assembly 10, the piezoelectric pads 2212 have an odd number of columns, and the piezoelectric pads 2212 in each column are arranged along the length direction of the conduit assembly 10.

[0091] Understandably, the multiple piezoelectric sheets 2212 formed by the partition groove 2211 are all located on the same arc surface. This arc surface can be part of a cylindrical sidewall, part of a spherical wall, or other arc surface. This arrangement enables the ultrasonic waves generated by the multiple piezoelectric sheets 2212 to converge at the center of the arc surface or the center of the sphere.

[0092] The piezoelectric patch 2212 can rotate relative to the drive component 21. As the piezoelectric patch 2212 rotates, the shape of the arc surface will also change, and the position of the center or center of the sphere of the arc surface will also change. That is, the rotation of the piezoelectric patch 2212 can adjust the position of the focal point so as to ablate sympathetic nerves at different locations and meet different ablation needs.

[0093] The rotation of the piezoelectric chip 2212 relative to the drive assembly 21 can have only one rotation direction or two or more rotation directions; the rotation of the piezoelectric chip 2212 can be driven by a micro-drive device or by other structures.

[0094] In this embodiment, the piezoelectric sheet 221 is divided into multiple piezoelectric sheets 2212 by the partition groove 2211, and each piezoelectric sheet 2212 can move relative to the driving component 21, thereby allowing each piezoelectric sheet 2212 to adjust its orientation and angle, and enabling multiple piezoelectric sheets 2212 to form a phased array structure, so that the staff can adjust the position of the focal spot as needed, and improve the compatibility of the ablation catheter 100.

[0095] In some embodiments, the partition groove 2211 may be filled with insulating and absorbing material to reduce the mutual influence between the individual piezoelectric sheets 2212. The insulating and absorbing material may be epoxy resin, silicone or other materials.

[0096] According to some embodiments of this application, the generating component 22 includes a first state and a second state. The acoustic power of the ultrasonic wave emitted by the generating component 22 in the first state is greater than the acoustic power of the ultrasonic wave emitted by the generating component 22 in the second state, and the acoustic power of the ultrasonic wave emitted by the generating component 22 in the second state is less than or equal to 10%. For example, the acoustic power of the ultrasonic wave emitted by the generating component 22 in the second state can be 10%, 7%, 5%, 4%, 3%, 2%, 1% or other values.

[0097] Sound power refers to the energy radiated outward by a sound source per unit time. The greater the sound power, the stronger the energy transmitted by the ultrasound per unit time.

[0098] The second state of the generating component 22 is used to map the sympathetic nerves. Since there are usually parasympathetic nerves near the sympathetic nerves, and the ablation of parasympathetic nerves will have a negative impact on blood pressure control, the second state is set to distinguish between the sympathetic nerves and the parasympathetic nerves.

[0099] The first state of the generating component 22 is used to ablate the sympathetic nerve at the focal point. Therefore, the acoustic power of the ultrasonic waves emitted by the generating component 22 in the first state is greater than that of the ultrasonic waves emitted by the generating component 22 in the second state, so that the ultrasonic waves emitted by the generating component 22 in the first state can carry enough energy to ablate the sympathetic nerve.

[0100] Specifically, the acoustic power of the ultrasound emitted by the generating component 22 in the second state is called low power. Low power ultrasound carries less energy and does not cause tissue damage. However, low power ultrasound can cause changes in nerve cell permeability and ion channels, thereby forming a nerve stimulation response and causing changes in blood pressure. The stimulation responses produced by the sympathetic nerve and the parasympathetic nerve have different effects on blood pressure. Therefore, staff can distinguish between the sympathetic nerve and the parasympathetic nerve by changes in blood pressure to achieve the mapping effect.

[0101] Because low-power ultrasound does not damage the sympathetic nervous system, but it can alter pericardial permeability, ion channels, and other functions, and trigger a nerve stimulation response. Workers can identify and determine the target nerve to be ablated based on this response. Therefore, this embodiment provides two acoustic power ranges for the ultrasound, enabling the ablation catheter 100 to both ablate and identify nerves.

[0102] According to some embodiments of this application, reference is made to Figure 10 , Figure 10 The specific structure of the piezoelectric element 221 provided in some embodiments of this application is shown.

[0103] The ablation catheter 100 also includes an imaging device 30, which is disposed within the catheter assembly 10 and on one side of the ultrasound generator 20.

[0104] The imaging device 30 refers to a device that can enter the blood vessel with the catheter assembly 10 and acquire the influence of the vicinity of the blood vessel. The imaging device 30 can be an imaging ultrasound transducer, an optical coherence tomography (OCT) optical device, or other imaging devices.

[0105] The imaging device 30 can communicate with external devices to send the acquired images to the external devices, so that staff can determine the location of the catheter assembly 10, the location of the ablation site, and other information based on the images, thereby facilitating the ablation operation.

[0106] In some embodiments, the imaging device 30 is located on the side of the generating component 22 away from the driving component 21, and the imaging device 30 is located in the direction in which the ultrasonic wave is emitted, so that the ultrasonic wave can reach the position where the imaging device 30 acquires image information.

[0107] In this embodiment, an imaging device 30 is set up next to the ultrasound generator 20 so that the staff can obtain tissue images of the corresponding location to facilitate the ablation operation.

[0108] According to some embodiments of this application, reference is made to Figure 3 , Figure 5 , Figure 6 , Figure 8 ,in, Figure 3 This is a cross-sectional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 5 for Figure 3 A cross-sectional view at the middle BB section shows the internal structure of the catheter assembly 10. Figure 6 for Figure 2 The application provides cross-sectional schematic diagrams of the ablation catheter 100 according to other embodiments. Figure 8 for Figure 6 A cross-sectional view at the DD position shows the internal structure of the catheter assembly 10.

[0109] The catheter assembly 10 includes an outer tube 11 and a rotating member 12 disposed inside the outer tube 11. The outer tube 11 has a receiving cavity 111, and the ultrasonic generator 20 is housed in the receiving cavity 111. One end of the rotating member 12 extends into the receiving cavity 111 and is connected to the ultrasonic generator 20. The rotating member 12 can bend with the outer tube 11 and can rotate relative to the outer tube 11, thereby driving the ultrasonic generator 20 to rotate.

[0110] The outer tube 11 refers to the structure or combination of structures used to support the rotating part 12, the ultrasonic generator 20, etc. The material of the outer tube 11 can be polytetrafluoroethylene, silicone rubber, polyurethane or other materials. The shape of the outer tube 11 can be cylindrical, prismatic or other shapes.

[0111] The cavity 111 refers to the space formed inside the outer tube 11; the cavity 111 may refer only to the space set inside the outer tube 11, or it may be a space enclosed by the structure inside the outer tube 11; the cavity 111 is mainly used to accommodate the ultrasound generator 20, and the cavity 111 may also accommodate the imaging device 30 or other structures or devices.

[0112] Rotating component 12 refers to a structure that can be bent and still rotate after bending. Rotating component 12 has good torque transmission performance and good flexibility. Rotating component 12 can be a torque spring tube or other structures that can be bent and still rotate after bending.

[0113] The ultrasound generator 20 is housed in the receiving cavity 111. The outer tube 11 moves within the blood vessel, which can drive the ultrasound generator 20 to move synchronously and to the target position.

[0114] The rotating component 12 is housed within the outer tube 11. The rotating component 12 can be coaxially arranged with the outer tube 11 or eccentrically arranged. The movement of the outer tube 11 within the blood vessel can drive the rotating component 12 to move synchronously. One end of the rotating component 12 can extend into the receiving cavity 111 and be connected to the ultrasound generator 20, so that the rotating component 12 can drive the ultrasound generator 20 to rotate within the receiving cavity 111. Understandably, the other end of the rotating component 12 away from the ultrasound generator 20 can extend to the outside, so that the operator can drive the rotating component 12 to rotate via equipment or manually.

[0115] The rotating component 12 can bend synchronously with the outer tube 11. After the outer tube 11 bends, the rotating component 12 can still drive the ultrasound generator 20 to rotate within the receiving cavity 111. Since the blood vessels of vascular patients are usually tortuous, the ultrasound generator 20 usually bends multiple times before reaching the target position. Therefore, using the rotating component 12 to drive the ultrasound generator 20 can better drive the ultrasound generator 20 to rotate within the receiving cavity 111.

[0116] The rotating component 12 drives the ultrasound generator 20 to rotate, allowing the ablation catheter 100 to better adjust the ablation position according to the patient's actual situation, thus increasing the applicability of the ablation catheter 100. Furthermore, since the renal artery sympathetic nerves are mainly surrounded by a reticular structure around the renal artery, the rotating component 12 drives the ultrasound generator 20 to rotate, so that the focus of the ultrasound waves can also rotate roughly around the blood vessel axis, forming a ring-shaped ablation area around the blood vessel. This facilitates the ablation of the sympathetic nerves around the blood vessel, thereby improving the ablation efficiency and reducing the need for the ablation catheter 100 to repeatedly enter and exit the blood vessel.

[0117] In this embodiment, the catheter assembly 10 includes a rotating member 12, which drives the ultrasound generator 20 to rotate. When the outer tube 11 bends, the rotating member 12 can bend with the outer tube 11, and the rotating member 12 can also drive the ultrasound generator 20 to rotate when the outer tube 11 bends, so that the focus of the ultrasound generated by the ultrasound generator 20 can move around the blood vessel, increasing the ablation area and better adapting to the distribution of the renal artery sympathetic nerves.

[0118] In some embodiments, one end of the outer tube 11 is provided with an end piece 113, which can seal the end of the outer tube 11, thereby reducing the occurrence of liquid or other substances in the outer tube 11 or the receiving cavity 111 entering the blood vessel, and also reducing the occurrence of substances from the blood vessel or the outside entering the outer tube 11.

[0119] The end piece 113 also serves to guide the movement of the ablation catheter 100 within the blood vessel. Therefore, the end of the end piece 113 opposite to the outer tube 11 can be set as a pointed tip to reduce the resistance to the movement of the ablation catheter 100 within the blood vessel. Alternatively, the end of the end piece 113 opposite to the outer tube 11 can be set as a rounded tip, which reduces the resistance to the movement of the ablation catheter 100 within the blood vessel while also reducing damage to the blood vessel wall caused by the end piece 113.

[0120] In some embodiments, the conduit assembly 10 further includes an inlet channel 13 and an outlet channel 14 disposed on the outer tube 11, one end of which is connected to the receiving cavity 111.

[0121] Both the inlet channel 13 and the outlet channel 14 refer to channel structures or combinations of structures used for conveying liquids. One end of both the inlet channel 13 and the outlet channel 14 is connected to the receiving cavity 111. That is, the inlet channel 13 is used to convey liquids into the receiving cavity 111, and the outlet channel 14 is used to discharge the liquids from the receiving cavity 111, thereby forming a circulating liquid flow to reduce the temperature inside the receiving cavity 111.

[0122] The liquid flowing in the inlet channel 13 and the outlet channel 14 is used to reduce the temperature inside the containment cavity 111. The liquid may include water, ethylene glycol or other materials.

[0123] Because the ultrasound generator 20 generates heat during operation, and the ultrasound waves themselves also carry heat, in order to reduce the damage to the blood vessel wall caused by excessive heat, an inlet channel 13 and an outlet channel 14 are set up to form a circulating fluid flow through the receiving cavity 111, so as to reduce the temperature inside the receiving cavity 111 and thus reduce the possible damage to the blood vessel wall caused by high temperature.

[0124] Understandably, the ends of the liquid inlet channel 13 and the liquid outlet channel 14 that are away from the receiving cavity 111 can be connected to the outside, so that external equipment can deliver liquid to the receiving cavity 111 through the liquid inlet channel 13, and the liquid in the receiving cavity 111 can be discharged to the outside through the liquid outlet channel 14.

[0125] The inlet channel 13 and the outlet channel 14 can be located inside or outside the outer tube 11. In some embodiments, an inlet pipe and an outlet pipe are respectively provided outside the outer tube 11, in which case the inlet channel 13 and the outlet channel 14 are respectively formed inside the inlet pipe and the outlet pipe. In other embodiments, an inlet pipe and an outlet pipe are respectively provided inside the outer tube 11, in which case the inlet channel 13 and the outlet channel 14 are respectively formed inside the inlet pipe and the outlet pipe. In still other embodiments, a partition structure is provided inside the outer tube 11, so that the partition structure cooperates with the tube wall of the outer tube 11 to form the inlet channel 13 and the outlet channel 14.

[0126] In some embodiments, a water pipe 141 is provided inside the outer pipe 11, and an inlet channel 13 is formed between the outer wall of the water pipe 141 and the inner wall of the outer pipe 11, while a drain channel 14 is formed inside the inner wall of the water pipe 141.

[0127] Cable 23 can be run inside water pipe 141 or between the outer wall of water pipe 141 and the inner wall of outer pipe 11; rotating part 12 can be coaxially arranged with water pipe 141 and sleeved on the outside of water pipe 141, rotating part 12 can also be coaxially arranged with water pipe 141 and run inside water pipe 141, or rotating part 12 can be not coaxially arranged with water pipe 141.

[0128] In this embodiment, an inlet channel 13 and an outlet channel 14 are provided in the catheter assembly 10, and the inlet channel 13 and the outlet channel 14 are connected to the receiving cavity 111, thereby forming a circulating water path in the catheter assembly 10. The circulating water cools down the ultrasound generator 20, thereby reducing the damage to the blood vessel wall that may be caused by the ultrasound generator 20 being too hot.

[0129] In some embodiments, the ablation catheter 100 further includes a temperature sensor 40, which is disposed on one side of the ultrasound generator 20.

[0130] Temperature sensor 40 is a device used to detect the temperature near ultrasonic generator 20. Temperature sensor 40 can communicate with external devices to send the monitored real-time temperature information to the outside world. Operators can operate according to the real-time temperature information, such as stopping the machine, increasing the liquid flow rate, and increasing the liquid flow velocity when the real-time temperature is high.

[0131] The temperature sensor 40 can communicate with external devices through a signal line passing through the outer tube 11, or it can communicate wirelessly with external devices, or communicate in other ways. In some embodiments, the temperature sensor 40 is a cable-shaped thermocouple temperature sensor that passes through the outer tube 11 and extends one end to the side of the ultrasonic generator 20.

[0132] In this embodiment, a temperature sensor 40 is provided on one side of the ultrasound generator 20 so that staff can monitor the temperature of the ultrasound generator 20, thereby reducing the damage to the blood vessel wall that may be caused by excessive temperature.

[0133] In some embodiments, the ultrasonic generator 20 may further include a base or housing for providing a fixed foundation for the drive assembly 21, the generator assembly 22 and the cable 23. In this case, one end of the temperature sensor 40 may be housed in the base or housing and positioned close to the piezoelectric element 221 to better obtain real-time temperature information near the piezoelectric element 221.

[0134] According to some embodiments of this application, reference is made to Figure 3 , Figure 4 ,in, Figure 3 This is a cross-sectional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 4 for Figure 3 The enlarged view at point A shows the specific structure inside the encapsulated cavity 151.

[0135] The catheter assembly 10 also includes a covering membrane 15 surrounding the outer tube 11. The covering membrane 15 forms a covering cavity 151 around the outer tube 11. The covering cavity 151 is connected to the receiving cavity 111. The covering membrane 15 can move towards or away from the receiving cavity 111.

[0136] The coating membrane 15 refers to a thin film structure or structural component that surrounds the outer tube 11. The coating membrane 15 can form a coating cavity 151 around the outer tube 11. The coating cavity 151 is a sealed structure and cannot be connected to the outside.

[0137] The covering cavity 151 is connected to the receiving cavity 111, that is, the covering cavity 151 covers the receiving cavity 111 outside the outer tube 11; in some embodiments, the outer tube 11 is divided into two ends of the receiving cavity 111, which are respectively called the front section and the rear section, and the space between the front section and the rear section is the receiving cavity 111. In this case, the receiving cavity 111 is an open space set between the front section and the rear section, and the covering cavity 151 covers and is connected to the receiving cavity 111, that is, the receiving cavity 111 is inside the covering cavity 151 and is part of the space of the covering cavity 151; in other embodiments, the outer tube 11 is provided with a through hole or channel to connect the receiving cavity 111 and the covering cavity 151 through the through hole or channel.

[0138] Since the covering cavity 151 covers the receiving cavity 111, and the ultrasonic generator 20 is housed within the receiving cavity 111, the purpose of the covering membrane 15 being a thin film structure is to reduce the negative impact of the covering membrane 15 on the ultrasonic waves, such as reducing the energy attenuation of the ultrasonic waves during the transmission of the covering membrane 15. The material of the covering membrane 15 can be silicone rubber, polyurethane (PU), polytetrafluoroethylene (PIFE), polyamide (PA), polyethylene terephthalate (PET), etc. The thickness of the covering membrane 15 should be relatively thin to reduce the negative impact on the ultrasonic waves, while also having a certain strength. For example, the thickness of the covering membrane 15 can be 0.01 mm, 0.02 mm, 0.03 mm, or other thicknesses.

[0139] When the outer tube 11 drives the ultrasound generator 20 into the patient's blood vessel and reaches the target position, the liquid can enter the receiving cavity 111 through the inlet channel 13 and then enter the covering cavity 151. At this time, the drain channel 14 can be closed first. As the liquid enters, the covering cavity 151 can gradually expand. At this time, the covering membrane 15 moves away from the receiving cavity 111 until it abuts against the blood vessel wall, thereby fixing the outer tube 11 and fixing the position of the ultrasound generator 20, reducing the possible shaking of the ultrasound generator 20 during use; when ablation... After completion, liquid can no longer be supplied to the receiving cavity 111 through the inlet channel 13, and the liquid in the covering cavity 151 can be discharged through the drain channel 14. At this time, as the liquid decreases, the covering membrane 15 gradually moves towards the receiving cavity 111 and detaches from the blood vessel wall, so as to facilitate the removal of the outer tube 11 and reduce the negative impact that may be caused when the outer tube 11 is removed. In some embodiments, when there is no liquid in the covering cavity 151, the covering membrane 15 can be in contact with the outer tube 11 to better reduce the negative impact that may be caused when the outer tube 11 is removed.

[0140] In this embodiment, a covering membrane 15 is provided outside the catheter, and the covering membrane 15 forms a covering cavity 151. At the same time, the covering cavity 151 is connected to the receiving cavity 111, so that water can enter the covering cavity 151 after entering the receiving cavity 111. The covering cavity 151 can gradually expand as water flows in, and the covering membrane 15 can move away from the receiving cavity 111 and abut against the blood vessel wall, thereby fixing the catheter assembly 10.

[0141] According to some embodiments of this application, reference is made to Figure 2 , Figure 6 , Figure 7 ,in, Figure 2 This is a partial three-dimensional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 6 for Figure 2 Cross-sectional schematic diagram of ablation catheter 100. Figure 7 for Figure 6 The enlarged view at point C shows the specific structure inside the encapsulated cavity 151.

[0142] The conduit assembly 10 also includes a support member 16 and a movable member 17 disposed outside the outer tube 11. One end of the support member 16 is connected to the outer tube 11, and the other end of the support member 16 is connected to the movable member 17.

[0143] The movable part 17 is movably connected to the outer tube 11. The movable part 17 can move 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 the direction away from or close to the outer tube 11.

[0144] Support member 16 refers to a support structure or structural combination located outside the outer tube 11; the shape of support member 16 can be strip-shaped, sheet-shaped or other shapes; the material of support member 16 can be metal, plastic, composite material or other materials.

[0145] The movable component 17 refers to a structure or combination of structures that can move along the axial direction of the outer tube 11. The shape of the movable component 17 can be cylindrical, sheet-like, strip-like, or other shapes. The material of the movable component 17 can be metal, plastic, composite material, or other materials. In some embodiments, the movable component 17 is a sleeve coaxially sleeved on the outer tube 11, and the movable component 17 can be bent and deformed.

[0146] The support 16 can fit against the outer tube 11 and can also deform away from the outer tube 11. When the support 16 deforms away from the outer tube 11, it can abut against the blood vessel wall to fix the position of the outer tube 11, thereby fixing the ultrasound generator 20.

[0147] One end of the support member 16 is connected to the outer wall of the outer tube 11, and the other end of the support member 16 is connected to the movable member 17. When the movable member 17 moves along the axial direction of the outer tube 11 toward the support member 16, the middle part of the support member 16 is deformed by pressure and deforms away from the outer tube 11. When the movable member 17 moves along the axial direction of the outer tube 11 toward the direction away from the support member 16, the middle part of the support member 16 is deformed by tension and deforms toward the outer tube 11 to contact the outer wall of the outer tube 11.

[0148] In this embodiment, a support member 16 and a movable member 17 are provided on the catheter. The support member 16 can deform away from the outer tube 11 and abut against the blood vessel wall as the movable member 17 moves, thereby fixing the position of the outer tube 11. The support member 16 can also deform towards the outer tube 11 so that the catheter assembly 10 can enter the blood vessel and move in the blood vessel.

[0149] In some embodiments, the support member 16 may be shaped as an arc protruding away from the outer tube 11, so that the support member 16 can deform in the direction away from the outer tube 11.

[0150] In some embodiments, the support member 16 is a sheet-like structure, and there are multiple support members 16. The multiple support members 16 are evenly spaced on the periphery of the outer tube 11. When the movable member 17 moves toward the support member 16 and deforms the support member 16, the multiple support members 16 deform and form a ball cage-like structure.

[0151] In some embodiments, to reduce the negative impact of the support member 16 on the ultrasonic waves generated by the ultrasonic generator 20, the support member 16 and the ultrasonic generator 20 are staggered along the axial direction of the outer tube 11.

[0152] According to some embodiments of the application, reference Figure 6 , Figure 7 ,in, Figure 6 This is a cross-sectional schematic diagram of the ablation catheter 100 provided in some embodiments of this application. Figure 7 for Figure 6 The enlarged view at point C shows the specific structure inside the encapsulated cavity 151.

[0153] The outer tube 11 has an opening 112 that communicates with the receiving cavity 111 and is opposite to the ultrasonic generator 20. The opening 112 is provided with a sound-transmitting membrane 18, which is used to seal the opening 112 and to allow ultrasonic waves to pass through.

[0154] An opening 112 is formed on the outer tube 11, and the receiving cavity 111 can be connected to the outside through the opening 112. An acoustic membrane 18 is provided on the outer tube 11 and seals the opening 112, so that the liquid in the receiving cavity 111 cannot flow out of the outer tube 11 through the opening 112. At the same time, ultrasound can pass through the acoustic membrane 18, and substances in blood vessels or the outside cannot enter the receiving cavity 111 through the acoustic membrane 18.

[0155] Compared to the ultrasonic waves converging towards the target location through the wall of the outer tube 11, the acoustic membrane 18 can reduce the negative impact on the ultrasonic waves, such as reducing the energy attenuation of the ultrasonic waves during transmission. The acoustic membrane 18 should be thin to reduce the negative impact on the ultrasonic waves, while also having a certain strength. For example, the material of the acoustic membrane 18 can be silicone rubber, PU, ​​PIFE, PA, PET, etc., and the thickness of the acoustic membrane 18 can be 0.01mm, 0.02mm, 0.03mm, or other thicknesses.

[0156] Due to the function of the acoustic membrane 18, the opening 112 is opposite to the ultrasonic generator 20, which allows ultrasonic waves to be transmitted to the target location through the acoustic membrane 18.

[0157] In this embodiment, an opening 112 is provided on the outer tube 11 opposite to the ultrasound generator 20, and an acoustic membrane 18 is provided on the opening 112 to reduce the influence of the outer tube 11 wall on the transmission of ultrasound waves. At the same time, the acoustic membrane 18 can also maintain the seal of the receiving cavity 111 to prevent water or other impurities from entering the blood vessel.

[0158] According to some embodiments of this application, the ablation catheter 100 can be used not only to ablate the sympathetic nerves near the renal artery, but also to ablate prostatic hyperplasia tissue. This embodiment takes the ablation of prostatic hyperplasia tissue as an example for further explanation, so that the ablation catheter 100 can ablate the prostatic hyperplasia tissue at the target location, and also reduce damage to the urethral wall.

[0159] Because the ablation catheter 100 can enter through the urethra during the ablation of prostatic hyperplasia tissue, the length of the ablation catheter 100 can be relatively short, that is, the lengths of the outer tube 11, the rotating component 12, the inlet channel 13, and the outlet channel 14 can all be relatively short.

[0160] Furthermore, during the ablation of prostatic hyperplasia tissue, the target location to be ablated may be far from the urethra, reaching as far as 1 cm from the urethra. In this case, the radius of the piezoelectric pad 221 should be relatively large, such as 13 mm, 14 mm, 15 mm or other values, so that the focal point can reach as far as 1 cm from the urethra, thereby enabling the ultrasound to ablate the prostatic hyperplasia tissue at the focal point.

[0161] Furthermore, due to the structural characteristics of the urethra, specifically since the urethra is mostly straight and not curved, the ablation catheter 100 may not have the ability to bend, that is, the outer tube 11 may not have the ability to bend. At this time, the rotating component 12 may also not have the ability to bend and can only rotate inside the outer tube.

[0162] Furthermore, due to the structural characteristics of the urethra, specifically, the external urethral orifice and the internal urethra have similar widths, the ablation catheter 100 does not need to be equipped with a covering membrane 15 or a support 16 or other positioning structures. Instead, the positioning of the ablation catheter 100 can be achieved directly by controlling the outer diameter of the catheter assembly 10.

[0163] Secondly, some embodiments of this application also provide an ablation device, which includes the ablation catheter 100 provided in some embodiments of the first aspect, so that the ablation device can ablate the sympathetic nerve at the target location and reduce damage to the blood vessel wall during the ablation process.

[0164] The ablation device may also include a handle, a main unit, or a combination thereof; for example, the main unit can provide electrical signals to the ultrasonic generator 20, and can also receive signals sent by the temperature sensor 40 and the imaging device 30. The main unit can also provide liquid to the inlet channel 13 and receive liquid discharged from the outlet channel 14; for another example, the handle can be held by the operator and can also control the conduction of the inlet channel 13 and the outlet channel 14, and can also control the displacement of the moving part 17.

[0165] The above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. An ablation catheter, comprising: The application relates to an ablation catheter. The ablation catheter comprises a catheter assembly, an ultrasonic generating device arranged in the catheter assembly, the ultrasonic generating device comprising a driving assembly and a generating assembly connected with the driving assembly, the driving assembly being used for driving the generating assembly to vibrate, the generating assembly being used for generating ultrasonic waves and converging the ultrasonic waves to a focus point, the focus point being arranged outside the catheter assembly. The generating assembly comprises a piezoelectric sheet, at least one partition groove is arranged on the piezoelectric sheet, the piezoelectric sheet can be divided into at least two piezoelectric sub-sheets by the partition groove, the piezoelectric sub-sheets can rotate in at least one direction relative to the driving assembly, so that each piezoelectric sub-sheet can adjust the direction and angle and adjust the position of the focus point. The piezoelectric sheet is in an arc structure, and the center of the piezoelectric sheet is arranged on the same side of the focus point arranged outside the catheter assembly.

2. The ablation catheter of claim 1, wherein, The radius of the piezoelectric sheet ranges from 6mm to 15mm.

3. The ablation catheter of claim 2, wherein, The generating assembly comprises a first state and a second state, the sound power of the ultrasonic waves generated by the generating assembly in the second state is less than or equal to 10% of the sound power of the ultrasonic waves generated by the generating assembly in the first state.

4. The ablation catheter of any of claims 1-3, wherein, The ablation catheter further comprises an imaging device arranged in the catheter assembly, and the imaging device is arranged beside the ultrasonic generating device.

5. The ablation catheter of any of claims 1-3, wherein, The catheter assembly comprises an outer tube and a rotating member arranged in the outer tube, the outer tube is provided with a containing cavity, and the ultrasonic generating device is arranged in the containing cavity.

6. The ablation catheter of any of claims 1-3, wherein, One end of the rotating member extends into the containing cavity and is connected with the ultrasonic generating device, the rotating member can bend with the outer tube, and the rotating member can rotate relative to the outer tube and drive the ultrasonic generating device to rotate. The catheter assembly further comprises a liquid inlet channel and a liquid outlet channel arranged on the outer tube, one end of the liquid inlet channel and the liquid outlet channel is connected with the containing cavity.

7. The ablation catheter of claim 6, wherein, The catheter assembly further comprises a covering film arranged around the outer tube, the covering film forms a covering cavity around the outer tube, the covering cavity is connected with the containing cavity, and the covering film can move towards or away from the containing cavity.

8. The ablation catheter of claim 7, wherein, The catheter assembly further comprises a support member and a movable member arranged outside the outer tube, one end of the support member is connected with the outer tube, and the other end of the support member is connected with the movable member.

9. The ablation catheter of claim 6, wherein, The movable member is movably connected with the outer tube, the movable member can move relative to the outer tube along the axial direction of the outer tube, and can drive the support member to deform away from or close to the outer tube. An opening is arranged on the outer tube and connected with the containing cavity, and the opening is opposite to the ultrasonic generating device.

10. The ablation catheter of claim 6, wherein, A sound transmission film is arranged on the opening, the sound transmission film is used for sealing the opening and making the ultrasonic waves transmit through. The ablation catheter further comprises a temperature sensor arranged beside the ultrasonic generating device.

11. The ablation catheter of any of claims 1-3, wherein, The application further relates to an ablation catheter comprising any one of the ablation catheters in claims 1-11.

12. An ablation device, characterized by ​

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