CN117204913A - Ablation catheter and ablation device - Google Patents

Abstract

The application is applicable to the technical field of medical equipment, and provides an ablation catheter and ablation equipment, wherein the ablation catheter comprises: a catheter assembly; the ultrasonic generating device is arranged in the catheter assembly and 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, the generating assembly is used for emitting ultrasonic waves and converging the ultrasonic waves at a focus, and the focus is arranged outside the catheter assembly; the ablation device includes an ablation catheter; the ablation catheter provided by the application has the advantages that the ultrasonic generating device comprises the driving component and the generating component, and ultrasonic waves emitted by the generating component can be converged outside the blood vessel wall to form a focus, so that the ultrasonic waves can have larger energy at the focus to ablate sympathetic nerves at corresponding positions; and at the position that the ultrasonic wave permeates the vascular wall, the ultrasonic wave is more dispersed and carries the energy lower for the vascular wall generates heat less, thereby can alleviate the damage of ultrasonic wave to the vascular wall.

Description

Ablation catheter and ablation device

Technical Field

The application relates to the technical field of medical equipment, in particular to an ablation catheter and ablation equipment.

Background

Renal artery denervation (RDN) refers to the manner in which blood pressure is reduced by disrupting renal sympathetic afferent and efferent nerves, attenuating renal and systemic sympathetic nerve activity, by interventional procedures (e.g., via the femoral artery, radial artery).

RDN technology can be based on radiofrequency ablation, ultrasound ablation, cryoablation, chemical ablation, etc., but currently is mainly dominated by radiofrequency ablation (rRDN) and ultrasound ablation (uddn). The ultrasonic ablation has the advantages of good penetrability, high energy controllability and the like, and has certain technical advantages in the RDN field.

At present, two schemes of an annular transducer for 360-degree energy emission and a planar transducer for directional energy emission are mainly adopted for ultrasonic ablation. However, the ultrasonic energy distribution of the annular transducer or the planar transducer cannot realize the protection of the wall of the renal artery blood vessel, and other cooling means are required to realize the protection of the renal artery blood vessel, so that the risk of damage and stenosis of the renal artery is increased.

Disclosure of Invention

In view of the above problems, the present application provides an ablation catheter and an ablation apparatus, which can alleviate the negative influence of ultrasonic waves on the wall of a renal artery blood vessel in the process of ablating renal artery sympathetic nerves.

In a first aspect, some embodiments of the present application provide an ablation catheter comprising:

a catheter assembly;

the ultrasonic generating device is arranged in the catheter assembly and 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, the generating assembly is used for emitting ultrasonic waves and converging the ultrasonic waves at a focus, and the focus is arranged outside the catheter assembly.

In the technical scheme of the embodiment, the ultrasonic generating device comprises a driving component and a generating component, and ultrasonic waves emitted by the generating component can be converged outside the blood vessel wall to form a focus, so that the ultrasonic waves can have larger energy at the focus to ablate sympathetic nerves at corresponding positions; and at the position that the ultrasonic wave permeates the vascular wall, the ultrasonic wave is more dispersed and carries the energy lower for the vascular wall generates heat less, thereby can alleviate the damage of ultrasonic wave to the vascular wall.

In some embodiments, the generating assembly includes an arcuate piezoelectric patch, and the center of the piezoelectric patch and the focal point are located on the same side of the catheter assembly.

In the technical scheme of the embodiment, the generating component comprises an arc-shaped piezoelectric sheet, and ultrasonic waves capable of being focused are emitted through the arc-shaped piezoelectric sheet, so that the ultrasonic waves can have higher energy at a focus point, and the effect of ablating sympathetic nerves at corresponding positions is achieved.

In some embodiments, the radius of the piezoelectric patch ranges from 6mm to 15mm.

In the technical solution of this embodiment, the radius range of the piezoelectric sheet is further defined, so that the focal position range is defined by defining the radius range of the piezoelectric sheet, so that the ultrasonic energy ablates the sympathetic nerve at the focal point, and the damage to the vessel wall is reduced in the process of penetrating the vessel wall.

In some embodiments, the piezoelectric sheet is provided with at least one partition slot, the partition slot can partition the piezoelectric sheet into at least two piezoelectric electronic sheets, and the piezoelectric sheets can rotate relative to the driving assembly.

In the technical scheme of this embodiment, separate the piezoelectric plate into a plurality of piezoelectric plates through the separating groove to make every piezoelectric plate homoenergetic rotate relative drive assembly, thereby make every piezoelectric plate can adjust orientation and angle, and make a plurality of piezoelectric plates can form phased array structure, so that the staff adjusts the position of focus as required, improves the compatibility of ablation pipe.

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

Because low power ultrasound does not damage the sympathetic nerve, low power ultrasound causes changes in cell permeability, ion channels, etc., and creates a neural stimulation response by which a worker can identify and determine the target nerve to be ablated. Accordingly, the technical solution of this embodiment enables the generating assembly to have two states and the ultrasound to have two ranges of acoustic power, so that the ablation catheter has the ability to ablate the nerve as well as the ability to identify the nerve.

In some embodiments, the ablation catheter further comprises an imaging device disposed within the catheter assembly, and the imaging device is disposed beside the ultrasound generating device.

In the technical scheme of the embodiment, the imaging device is arranged beside the ultrasonic generating device, so that a worker can obtain tissue images at corresponding positions, and the worker can conveniently conduct ablation operation.

In some embodiments, the catheter assembly comprises an outer tube and a rotating member arranged in the outer tube, wherein a containing cavity is arranged in the outer tube, and the ultrasonic generating device is contained in the containing cavity;

one end of the rotating piece extends into the accommodating cavity and is connected with the ultrasonic generating device, the rotating piece can be bent along with the outer tube, and the rotating piece can rotate relative to the outer tube and drive the ultrasonic generating device to rotate.

In the technical scheme of this embodiment, make the pipe subassembly include the rotating member to drive ultrasonic generating device through the rotating member and rotate, the rotating member can be crooked along with the outer tube when outer tube takes place to bend, and the rotating member can also drive ultrasonic generating device and rotate when outer tube takes place to bend, so that ultrasonic generating device's ultrasonic wave's focus can be around the vascular removal, has increased the ablation area.

In some embodiments, the catheter assembly further comprises a liquid inlet channel and a liquid outlet channel arranged on the outer tube, wherein one ends of the liquid inlet channel and the liquid outlet channel are communicated with the accommodating cavity.

In the technical scheme of this embodiment, set up feed liquor passageway and flowing back passageway in the pipe subassembly to make feed liquor passageway, flowing back passageway be linked together with holding the chamber, thereby form the circulation water route in the pipe subassembly, carry out cooling to ultrasonic generating device through circulating water, thereby reduce the damage that ultrasonic generating device high temperature probably can the vascular wall cause.

In some embodiments, the catheter assembly further comprises a coating disposed around the outer tube, the coating forming a coating cavity around the outer tube, the coating cavity in communication with the receiving cavity, the coating being capable of moving in a direction toward or away from the receiving cavity.

According to the technical scheme, the coating film is arranged outside the catheter and surrounds the catheter to form the coating cavity through the coating film, meanwhile, the coating cavity is communicated with the accommodating cavity, so that water flow can enter the coating cavity after entering the accommodating cavity, the coating cavity can be gradually expanded along with the filling of the water flow, the coating film can move in a direction away from the accommodating cavity and is abutted to the wall of the blood vessel, and the catheter assembly is fixed.

In some embodiments, the catheter assembly further comprises a support member and a movable member disposed outside the outer tube, one end of the support member is connected to the outer tube, and the other end of the support member is connected to the movable member;

the movable piece is movably connected to the outer tube, can move relative to the outer tube along the axial direction of the outer tube, and can drive the support piece to deform along the direction deviating from or approaching to the outer tube.

In the technical scheme of the embodiment, the supporting piece and the movable piece are arranged on the catheter, and the supporting piece can deform along with the movement of the movable piece in a direction away from the outer tube and is abutted against the wall of the blood vessel, so that the effect of fixing the position of the outer tube is achieved; the support member is also deformable in a direction proximal to the outer tube to facilitate movement of the catheter assembly into and within the blood vessel.

In some embodiments, the outer tube is provided with an opening communicated with the accommodating cavity, and the opening is opposite to the ultrasonic generating device;

the opening is provided with an acoustic film which is used for sealing the opening and transmitting ultrasonic waves.

In the technical scheme of this embodiment, set up the opening relative with ultrasonic generator on the outer tube to set up the sound-transmitting film on the opening, make the ultrasonic energy transmit outside the outer tube through the sound-transmitting film, with the influence of reduction outer tube pipe wall to ultrasonic transmission, can also keep holding the seal of holding the chamber through the sound-transmitting film simultaneously, avoid rivers or other impurity to get into in the blood vessel.

In some embodiments, the ablation catheter further comprises a temperature sensor disposed beside the ultrasound generating device.

In the technical scheme of the embodiment, the temperature sensor is arranged beside the ultrasonic generating device so as to facilitate the monitoring of the temperature of the ultrasonic generating device by staff, thereby reducing the damage to the vessel wall caused by overhigh temperature.

In a second aspect, some embodiments of the present application also provide an ablation device comprising an ablation catheter provided by some embodiments of the first aspect.

The foregoing description is only an overview of the present application, and is intended to be implemented in accordance with the teachings of the present application in order that the same may be more clearly understood and to make the same and other objects, features and advantages of the present application more readily apparent.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a partial schematic perspective view of an ablation catheter provided in some embodiments of the application.

Fig. 2 is a partial schematic perspective view of an ablation catheter provided in accordance with some embodiments of the application.

Fig. 3 is a schematic cross-sectional view of the ablation catheter shown in fig. 1.

Fig. 4 is an enlarged partial schematic view at a in fig. 3.

Fig. 5 is a schematic cross-sectional view at B-B in fig. 3.

Fig. 6 is a schematic cross-sectional view of the ablation catheter shown in fig. 2.

Fig. 7 is an enlarged partial schematic view at C in fig. 6.

Fig. 8 is a schematic cross-sectional view at D-D in fig. 6.

Fig. 9 is a schematic perspective view of an ultrasound generating device in an ablation catheter according to some embodiments of the present application.

Fig. 10 is a schematic structural view of a piezoelectric sheet in an ablation catheter according to some embodiments of the application.

Fig. 11 is a schematic perspective view of an ablation device provided in some embodiments of the application.

The meaning of the labels in the figures is:

100. an ablation catheter;

10. a catheter assembly; 11. an outer tube; 111. a receiving chamber; 112. an opening; 113. an end piece; 12. a rotating member; 13. a liquid inlet channel; 14. a liquid discharge channel; 141. a water pipe; 15. a coating film; 151. a cladding cavity; 16. a support; 17. a movable member; 18. an acoustically transparent film;

20. an ultrasonic generating device; 21. a drive assembly; 22. a generating component; 221. a piezoelectric sheet; 2211. a partition groove; 2212. a piezoelectric sheet; 23. a cable;

30. an imaging device;

40. a temperature sensor.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be further described in detail below with reference to the accompanying drawings, i.e., embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "upper," "lower," "left," "right," and the like are used for convenience of description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements in question must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be construed as limiting of the patent. The terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "a plurality of" is two or more, unless specifically defined otherwise.

It should be further noted that, in the embodiments of the present application, the same reference numerals denote the same components or the same parts, and for the same parts in the embodiments of the present application, reference numerals may be given to only one of the parts or the parts in the drawings, and it should be understood that, for other same parts or parts, the reference numerals are equally applicable.

Hypertension is the most common chronic disease, also the main risk factor for cardiovascular and cerebrovascular diseases, and is easy to cause stroke, myocardial infarction, heart failure, chronic kidney diseases and the like, and is called as an 'intangible killer' affecting human health. Excessive excitation of renal sympathetic nerve can raise blood pressure, and has high risk of hypertension death and heavy treatment burden. RDN technology refers to the technology of destroying renal sympathetic afferent and efferent nerves by interventional procedures (via the femoral artery, radial artery) that can attenuate renal and systemic sympathetic nerve activity, thereby lowering blood pressure.

RDN technology can be based on radiofrequency ablation, ultrasound ablation, cryoablation, chemical ablation, etc., but currently is mainly dominated by radiofrequency ablation (rRDN) and ultrasound ablation (uddn). The radiofrequency ablation is to convey the catheter with the electrode to the renal artery, and output radiofrequency energy through the electrode, so that tissues around the electrode generate heat, and the radiofrequency current or heat is gradually conducted below the adventitia of the renal artery blood vessel. Although radiofrequency ablation can reduce the temperature of the electrodes and the renal artery intima by means of cold saline infusion, there is still the risk of intima injury and renal artery stenosis.

The ultrasonic energy has the advantages of good penetrability, high energy controllability and the like, and has certain technical advantages in the RDN field. The prior art currently mainly includes solutions of annular transducers for 360 ° energy emission and planar transducers for directional energy emission. However, the scheme of the annular transducer or the scheme of the planar transducer cannot realize the spatial distribution regulation and control of the sound field and ultrasonic energy, so that the risk of damage to the vessel wall of the renal artery and the risk of renal artery stenosis are easily caused, and the renal artery intima needs to be cooled by cooling water.

Based on the above considerations, in order to mitigate the damage that ultrasonic energy may cause to the vessel wall, the present application provides an ablation catheter that includes an ultrasound generating device that includes a drive assembly and a generating assembly, and that causes ultrasonic energy emitted by the generating assembly to converge outside the vessel wall to form a focal point, thereby enabling the ultrasonic energy to have a greater energy at the focal point to ablate sympathetic nerves at a corresponding location.

And at the position that the ultrasonic wave permeates the vascular wall, the ultrasonic wave is not converged at the focus yet, so the ultrasonic wave is more dispersed and carries lower energy for the vascular wall generates less heat, thereby can alleviate the damage of ultrasonic wave to the vascular wall.

The ablation catheter can ablate target sympathetic nerves outside the blood vessel, can relieve the damage of ultrasonic waves to the wall of the blood vessel, has a simple structure, reduces the operation difficulty and also reduces the cost of the ablation catheter.

The ablation catheter provided by the embodiment of the application can be used for ablating tissues of other parts, such as prostatic hyperplasia tissues and the like, besides being used for ablating renal sympathetic nerves, and the following embodiments are taken as examples for facilitating the explanation.

In a first aspect, some embodiments of the present application provide an ablation catheter 100, referring to fig. 1 to 4, wherein fig. 1 is a partial schematic perspective view of the ablation catheter 100 provided in some embodiments of the present application, fig. 2 is a partial schematic perspective view of the ablation catheter 100 provided in other embodiments of the present application, fig. 3 is a schematic cross-sectional view of the ablation catheter 100 shown in fig. 1, and fig. 4 is a schematic enlarged partial view at a in fig. 3; since the length of the ablation catheter 100 is generally longer, fig. 1 and 2 only show a partial structure of the end of the ablation catheter 100.

The ablation catheter 100 comprises a catheter assembly 10 and an ultrasonic generating device 20, wherein the ultrasonic generating device 20 is arranged in the catheter assembly 10, the ultrasonic generating device 20 comprises a driving assembly 21 and a generating assembly 22 connected with the driving assembly 21, the driving assembly 21 is used for driving the generating assembly 22 to vibrate, the generating assembly 22 is used for emitting ultrasonic waves and converging the ultrasonic waves into a focus, and the focus is arranged outside the catheter assembly 10.

Catheter assembly 10 refers to a structure or structural assembly for carrying an ultrasound generating device 20 and other components, the catheter assembly 10 being capable of entering and moving along a patient's blood vessel, the ultrasound generating device 20 and other components being housed within the catheter assembly 10 and being capable of moving with one end of the catheter assembly 10 to a target location; catheter assembly 10 may include one or more tubular structures; the catheter assembly 10 may be made of polytetrafluoroethylene, silicone rubber, polyurethane or other materials; the catheter assembly 10 may be cylindrical in shape, prismatic or otherwise.

The ultrasonic generating device 20 refers to a structure or a combination of structures capable of emitting ultrasonic waves, and the ultrasonic waves emitted by the ultrasonic generating device 20 can penetrate through the vascular wall and ablate target sympathetic nerves; the ultrasound generating apparatus 20 may include a transducer, various circuit boards, or other structures, devices.

The driving component 21 refers to a structure or a combination of structures in the ultrasonic generating device 20 for driving the generating component 22 to vibrate, the driving component 21 can comprise various circuit boards such as an amplifying circuit board, and the driving component 21 can also comprise a matching layer, a backing and the like; the driving assembly 21 is used to drive the vibration of the generating assembly 22, for example, the driving assembly 21 may receive and process the electrical signal and transmit the processed electrical signal to the generating assembly 22.

The generating component 22 refers to a structure or a combination of structures in the ultrasound generating device 20 that are capable of generating ultrasound waves; the generating assembly 22 may include only one device capable of vibrating and generating ultrasonic waves, and the generating assembly 22 may include a plurality of devices capable of vibrating and generating ultrasonic waves; the material of the generating component 22 can be barium titanate ceramics, lead titanate ceramic or other materials; the generating assembly 22 is capable of receiving the electrical signal transmitted from the driving assembly 21 and generating mechanical vibration based on the received electrical signal, thereby generating ultrasonic waves.

The ultrasonic waves generated by the generating assembly 22 can be focused at the focal point so that the ultrasonic waves generate a greater amount of energy at the focal point and ablate the sympathetic nerves at the corresponding location using that energy, and in particular, the generating assembly 22 can be configured with a device of a particular shape or with a plurality of devices to focus the ultrasonic waves generated by the generating assembly 22 at the focal point. In some embodiments, the generating assembly 22 may include a device of a particular shape, in which case the particular shape of the piezoelectric sheet 221 may be arcuate, U-shaped, or otherwise shaped so that the ultrasonic energy generated by the generating assembly 22 is focused at a focal point; in other embodiments, the generating assembly 22 may also include a plurality of devices that may also be positioned along an arcuate, U-shaped, L-shaped or other shaped trajectory such that the ultrasonic energy generated by the generating assembly 22 is focused at a focal point; it will be appreciated that other arrangements of the generating assembly 22 may be used to focus ultrasonic waves, and are not limited to the foregoing.

Before the ultrasonic waves generated by the generating assembly 22 are focused, the ultrasonic waves are more dispersed and carry less energy, in particular, the ultrasonic waves closer to the ultrasonic generating device 20 carry less energy, and the inner diameter of the blood vessel is generally smaller, so that the ultrasonic waves pass through the blood vessel wall closer to the ultrasonic generating device 20, the energy carried by the ultrasonic waves is smaller, and the damage of the ultrasonic waves to the blood vessel wall is also smaller.

The present embodiment provides that the ultrasound generating apparatus 20 comprises a driving assembly 21 and a generating assembly 22, and that the ultrasound emitted by the generating assembly 22 can be focused outside the vessel wall, such that the ultrasound can have a greater energy at the focus to ablate the sympathetic nerves at the corresponding location; and at the position that the ultrasonic wave permeates the vascular wall, the ultrasonic wave is more dispersed and carries the energy lower for the vascular wall generates heat less, thereby can alleviate the damage of ultrasonic wave to the vascular wall.

In some embodiments, the ultrasound generating device 20 is an ultrasound transducer, where the drive assembly 21 may include a flexible circuit board, a matching layer, a backing, etc., and the generating assembly 22 may include a structure formed of piezoelectric material.

In some embodiments, the ultrasound generating apparatus 20 communicates with an external device via a cable 23, one end of the cable 23 is connected to the drive assembly 21 or the generating assembly 22, and the other end of the cable 23 can pass through the catheter assembly 10 and extend to the outside so that the external device sends an electrical signal to the ultrasound generating apparatus 20 via the cable 23.

Referring to fig. 3, fig. 4, fig. 6, fig. 7, and fig. 9, in which fig. 3 is a schematic cross-sectional view of an ablation catheter 100 according to some embodiments of the present application, fig. 4 is a schematic enlarged partial view at a in fig. 3, fig. 6 is a schematic cross-sectional view of an ablation catheter 100 according to other embodiments of the present application, fig. 7 is a schematic enlarged partial view at C in fig. 6, and fig. 9 is a schematic perspective view of an ultrasound generating device 20 in an ablation catheter 100 according to some embodiments of the present application.

The generating assembly 22 includes an arcuate piezoelectric sheet 221 with the center of the piezoelectric sheet 221 and the focal point being located on the same side of the catheter assembly 10.

The piezoelectric sheet 221 refers to a structure capable of receiving an electric signal and generating mechanical vibration, for example, the piezoelectric sheet 221 is capable of receiving an electric signal transmitted from the driving assembly 21 and generating internal stress inside a material, thereby vibrating the material and forming ultrasonic waves; the piezoelectric plate 221 may be made of barium titanate ceramic, milled lead titanate ceramic or other materials.

The curved piezoelectric sheet 221 means that the shape of the piezoelectric sheet 221 is curved, and specifically, the shape of the piezoelectric sheet 221 may be a part of a sidewall of a thin-walled cylindrical structure, a part of a wall of a thin-walled spherical structure, or other curved structures.

The center of the piezoelectric sheet 221 is located on the same side of the catheter assembly 10 as the focal point, i.e., the piezoelectric sheet 221 projects away from the focal point.

When the arc-shaped piezoelectric sheet 221 receives the electric signal and vibrates, the generated ultrasonic waves can be converged near the center of the circle or the center of the sphere of the arc-shaped piezoelectric sheet 221, so that the ultrasonic waves can reach the effect of converging at the focus.

The present embodiment makes the generating assembly 22 include an arc-shaped piezoelectric sheet 221, and the arc-shaped piezoelectric sheet 221 emits ultrasonic waves capable of focusing, so that the ultrasonic waves can have higher energy at the focal point to achieve the effect of ablating the sympathetic nerves at the corresponding positions.

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

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

The sympathetic nerve is mainly positioned in the adipose tissue outside the adventitia of the renal artery, and the depth range of the sympathetic nerve is 2-7 millimeters (mm) from the intima of the renal artery blood vessel; the radius of the piezoelectric sheet 221 is set to be 6mm to 15mm so that the focal point can be in the range of 2 to 7mm from the intima of the renal artery vessel, so that the ultrasonic waves ablate the sympathetic nerve at the focal point.

The present embodiment further defines the radius of the piezoelectric patch 221 to define the location of the focal point by defining the radius of the piezoelectric patch 221 so that ultrasound can ablate sympathetic nerves at the focal point and reduce damage to the vessel wall during penetration through the vessel wall.

In some embodiments, referring to fig. 10, fig. 10 is a specific structure of a piezoelectric sheet 221 according to some embodiments of the present application.

At least one partition groove 2211 is formed in the piezoelectric sheet 221, the partition groove 2211 can partition the piezoelectric sheet 221 into at least two piezoelectric sheets 2212, and the piezoelectric sheets 2212 can rotate relative to the driving assembly 21.

The isolation groove 2211 is a through groove formed in the piezoelectric sheet 221, the isolation groove 2211 can cut off the piezoelectric sheet 221 and form two piezoelectric sheets 2212, and as the number of the isolation grooves 2211 increases, the number of the piezoelectric sheets 2212 increases; the partition groove 2211 may extend in the longitudinal direction of the piezoelectric sheet 221, or may extend in the width direction of the piezoelectric sheet 221, or the partition groove 2211 may extend in other directions, or a plurality of partition grooves 2211 may extend in different directions.

The number of the piezoelectric sheets 2212 may be two or more. In some embodiments, the number of piezos 2212 is an odd number; further, in the radial direction of the catheter assembly 10, the piezoelectric sheets 2212 have odd-numbered columns, and the piezoelectric sheets 2212 in each column are arranged along the length direction of the catheter assembly 10.

It can be appreciated that the plurality of piezoelectric sheets 2212 formed by the partition groove 2211 are all located on the same arc surface, and the arc surface can be a part of a cylindrical side wall, a part of a spherical wall surface, or other arc surfaces; this arrangement enables the ultrasound waves formed by the plurality of piezoelectric patches 2212 to converge at the center or sphere of the arcuate surface.

The piezoelectric sheet 2212 can rotate relative to the driving assembly 21, along with the rotation of the piezoelectric sheet 2212, the shape of the arc surface will also change, and the center of a circle or the position of the sphere of the arc surface will also change, i.e. the rotation of the piezoelectric sheet 2212 can adjust the position of the focus, so as to facilitate the ablation of the sympathetic nerves with different positions, and meet different ablation requirements.

The rotation of the piezoelectric sheet 2212 relative to the driving assembly 21 may have only one rotation direction, or may have two or more rotation directions; the rotation of the piezoelectric film 2212 can be driven by a micro-driving device or by other structures.

The piezoelectric sheets 221 are separated into a plurality of piezoelectric sheets 2212 by the separation grooves 2211, and each piezoelectric sheet 2212 can move relative to the driving assembly 21, so that each piezoelectric sheet 2212 can adjust the direction and angle, and the piezoelectric sheets 2212 can form a phased array structure, so that a worker can adjust the position of a focus as required, and the compatibility of the ablation catheter 100 is improved.

In some embodiments, the isolation groove 2211 may be filled with an insulating and absorbing material, which may be epoxy, silicone, or other material, to reduce interactions between the various piezoelectric sheets 2212.

According to some embodiments of the present application, the generating element 22 includes a first state and a second state, the acoustic power of the ultrasonic wave generated by the generating element 22 in the first state is greater than the acoustic power of the ultrasonic wave generated by the generating element 22 in the second state, and the acoustic power of the ultrasonic wave generated by the generating element 22 in the second state is less than or equal to 10%, for example, the acoustic power of the ultrasonic wave generated by the generating element 22 in the second state may be 10%, 7%, 5%, 4%, 3%, 2%, 1%, or other values.

The acoustic power refers to the energy radiated by the sound source outwards in a unit time, and the greater the acoustic power, the stronger the energy transmitted by the ultrasonic wave in a unit time.

The second state of the generating component 22 is used to map the sympathetic nerves, which are set to distinguish between the sympathetic and parasympathetic nerves, since parasympathetic nerves are also typically present in the vicinity of the sympathetic nerves, and ablation of parasympathetic nerves will negatively affect blood pressure control.

The first state of the generating assembly 22 is for ablating sympathetic nerves at the focal point, so that the acoustic power of the ultrasonic waves emitted by the generating assembly 22 in the first state is greater than the acoustic power of the ultrasonic waves emitted by the generating assembly 22 in the second state, such that the ultrasonic waves emitted by the generating assembly 22 in the first state can carry enough energy to ablate sympathetic nerves.

Specifically, the acoustic power of the ultrasonic wave emitted by the generating component 22 in the second state is called low power, the ultrasonic wave with low power carries less energy and does not cause tissue damage, but the ultrasonic wave with low power can cause the change of permeability and ion channel of nerve cells, thereby forming nerve stimulating reaction and causing the change of blood pressure, and the stimulating reaction generated by the sympathetic nerve and the parasympathetic nerve has different influence on the blood pressure, so that staff can distinguish the sympathetic nerve and the parasympathetic nerve through the change of the blood pressure so as to achieve the mapping effect.

Because low power ultrasound does not damage the sympathetic nerve, but low power ultrasound causes changes in pericardial permeability, ion channels, etc., and creates a neural stimulation response by which a worker can identify and determine the target nerve to be ablated. Accordingly, the present embodiment provides ultrasound with two ranges of acoustic power, such that the ablation catheter 100 has the ability to ablate both nerves and identify nerves.

Referring to fig. 10, fig. 10 is a specific structure of a piezoelectric sheet 221 according to some embodiments of the present application.

The ablation catheter 100 further includes an imaging device 30, the imaging device 30 being disposed within the catheter assembly 10, and the imaging device 30 being disposed on one side of the ultrasound generating device 20.

Imaging device 30 refers to a device that is capable of accessing a blood vessel and capturing effects in the vicinity of the blood vessel with catheter assembly 10, and imaging device 30 may be an imaging ultrasound transducer, or may be an Optical coherence tomography (Optical CoherenceTomography, OCT) Optical apparatus or other imaging device.

The imaging device 30 can be in communication connection with external equipment to send the acquired image to the external equipment, so that a worker can conveniently determine the position of the catheter assembly 10, the position of the part to be ablated and other information according to the image, and the worker can conveniently and well conduct ablation operation.

In some embodiments, the imaging device 30 is disposed on a side of the generating assembly 22 facing away from the driving assembly 21, and the imaging device 30 is disposed in a direction in which ultrasound waves are emitted so that the ultrasound waves can reach a location where the imaging device 30 obtains image information.

The imaging device 30 is arranged beside the ultrasonic generating device 20 in the embodiment, so that a worker can obtain tissue images of corresponding positions, and the worker can conveniently conduct ablation operation.

Referring to fig. 3, 5, 6, and 8, wherein fig. 3 is a schematic cross-sectional view of an ablation catheter 100 provided in accordance with some embodiments of the application, fig. 5 is a schematic cross-sectional view at B-B in fig. 3 and illustrates an internal structure of catheter assembly 10, fig. 6 is a schematic cross-sectional view of ablation catheter 100 provided in accordance with other embodiments of fig. 2, and fig. 8 is a schematic cross-sectional view at D-D in fig. 6 and illustrates an internal structure of catheter assembly 10, in accordance with some embodiments of the application.

The catheter assembly 10 comprises an outer tube 11 and a rotating piece 12 arranged in the outer tube 11, wherein a containing cavity 111 is arranged in the outer tube 11, and the ultrasonic generating device 20 is contained in the containing cavity 111; one end of the rotating member 12 extends into the accommodating cavity 111 and is connected with the ultrasonic generating device 20, the rotating member 12 can bend along with the outer tube 11, and the rotating member 12 can rotate relative to the outer tube 11 and drive the ultrasonic generating device 20 to rotate.

The outer tube 11 refers to a structure or a combination of structures for carrying the rotary member 12, the ultrasonic generating device 20, and the like; the material of the outer tube 11 can be polytetrafluoroethylene, silicon rubber, polyurethane or other materials; the outer tube 11 may have a cylindrical shape, a prismatic shape, or other shapes.

The accommodation chamber 111 refers to a space formed inside the outer tube 11; the accommodating chamber 111 may be a space defined only in the outer tube 11, or may be a space surrounded by a structure in the outer tube 11; the accommodating chamber 111 is mainly used for accommodating the ultrasound generating device 20, and the accommodating chamber 111 can also accommodate the imaging device 30 or other structures and devices.

The rotating member 12 is a structure capable of bending and still rotating after bending, and the rotating member 12 has better torque transmission performance and better flexibility; the rotary member 12 may be a torsion spring tube or other structure that is capable of bending and still rotates after bending.

The ultrasonic generating device 20 is accommodated in the accommodating cavity 111, and the outer tube 11 can drive the ultrasonic generating device 20 to synchronously travel in the blood vessel and move to the target position.

The rotating piece 12 is accommodated in the outer tube 11, the rotating piece 12 can be coaxially arranged with the outer tube 11, and can also be eccentrically and non-coaxially arranged, and the outer tube 11 can drive the rotating piece 12 to synchronously move in the blood vessel; one end of the rotary member 12 can extend into the accommodating cavity 111 and be connected with the ultrasonic generating device 20, so that the rotary member 12 can drive the ultrasonic generating device 20 to rotate in the accommodating cavity 111; it will be appreciated that the other end of the rotatable member 12 remote from the ultrasound generating apparatus 20 can extend to the outside world to facilitate the operator's rotation of the rotatable member 12 by means of equipment or manually.

The rotating member 12 can synchronously bend along with the outer tube 11, and after the outer tube 11 bends, the rotating member 12 can still drive the ultrasonic generating device 20 to rotate in the accommodating cavity 111; because the blood vessel of the vascular patient is often bent for a plurality of times before the ultrasonic generating device 20 reaches the target position, the ultrasonic generating device 20 can be driven to rotate in the accommodating cavity 111 better by using the rotating member 12 to drive the ultrasonic generating device 20.

The rotating piece 12 drives the ultrasonic generating device 20 to rotate, so that the ablation catheter 100 can better adjust the ablation position according to the actual condition of a patient, and the applicability of the ablation catheter 100 is improved; because the renal artery sympathetic nerves are mainly wrapped around the renal artery in a reticular structure, the rotating piece 12 drives the ultrasonic generating device 20 to rotate, so that the focus of ultrasonic waves can also rotate approximately by taking a blood vessel as an axis, and an annular ablation area surrounding the blood vessel is formed, so that the sympathetic nerves on the peripheral side of the blood vessel are ablated conveniently, the ablation efficiency is improved, and the conditions that the ablation catheter 100 enters and is pumped into the blood vessel in a reciprocating manner are reduced.

The catheter assembly 10 includes the rotating member 12, and drives the ultrasonic generating device 20 to rotate through the rotating member 12, the rotating member 12 can bend along with the outer tube 11 when the outer tube 11 bends, and the rotating member 12 can also drive the ultrasonic generating device 20 to rotate when the outer tube 11 bends, so that the focus of the ultrasonic wave generated by the ultrasonic generating device 20 can move around the blood vessel, the ablation area is increased, and the distribution situation of renal artery sympathetic nerves can be better adapted.

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, so as to reduce the occurrence of liquid or other substances in the outer tube 11 or the accommodating cavity 111 entering into the blood vessel, and also reduce the occurrence of substances in the blood vessel or the outside entering into the outer tube 11.

The tip member 113 also has the effect of guiding the movement of the ablation catheter 100 within the blood vessel, so that the end of the tip member 113 facing away from the outer tube 11 may be provided as a tip to reduce the resistance of the ablation catheter 100 to movement within the blood vessel; the end of the tip member 113 facing away from the outer tube 11 may also be provided with a rounded tip to reduce the resistance of the ablation catheter 100 to movement within the vessel while also reducing the damage of the tip member 113 to the vessel wall.

In some embodiments, the catheter assembly 10 further includes a liquid inlet channel 13 and a liquid outlet channel 14 provided on the outer tube 11, and one end of each of the liquid inlet channel 13 and the liquid outlet channel 14 is in communication with the receiving cavity 111.

The liquid inlet channel 13 and the liquid outlet channel 14 are channel structures or structure combinations for conveying liquid; one end of each of the liquid inlet channel 13 and the liquid outlet channel 14 is communicated with the accommodating cavity 111, namely, the liquid inlet channel 13 is used for conveying liquid into the accommodating cavity 111, and the liquid outlet channel 14 is used for discharging the liquid in the accommodating cavity 111, so that a circulating liquid flow is formed, and the temperature in the accommodating cavity 111 is reduced.

The liquid, which may include water, glycol or other materials, flowing in the liquid inlet channel 13 and the liquid outlet channel 14 serves to reduce the temperature in the receiving chamber 111.

Because the ultrasonic generating device 20 generates heat during operation, and the ultrasonic waves carry heat, in order to reduce damage to the blood vessel wall caused by excessive heat, the liquid inlet channel 13 and the liquid outlet channel 14 are arranged and form circulating liquid flow flowing through the accommodating cavity 111, so as to reduce the temperature in the accommodating cavity 111, thereby reducing damage to the blood vessel wall caused by possible high temperature.

It will be appreciated that the ends of the liquid inlet channel 13 and the liquid outlet channel 14, which are far away from the accommodating cavity 111, can be communicated with the outside, so that the outside equipment can conveniently convey liquid to the accommodating cavity 111 through the liquid inlet channel 13, and the liquid in the accommodating cavity 111 can conveniently be discharged to the outside through the liquid outlet channel 14.

The liquid inlet channel 13 and the liquid outlet channel 14 can be arranged in the outer tube 11 or outside the outer tube 11; in some embodiments, the outer tube 11 is provided with a water inlet tube and a water outlet tube, respectively, and the liquid inlet channel 13 and the liquid outlet channel 14 are formed in the water inlet tube and the water outlet tube respectively; in other embodiments, the outer tube 11 is provided with a water inlet tube and a water outlet tube, respectively, and the liquid inlet channel 13 and the liquid outlet channel 14 are formed in the water inlet tube and the water outlet tube respectively; in still other embodiments, the outer tube 11 is provided with a partition structure, so that the partition structure encloses the liquid inlet channel 13 and the liquid outlet channel 14 in cooperation with the tube wall of the outer tube 11.

In some embodiments, the outer tube 11 is provided with a water pipe 141, a liquid inlet channel 13 is formed between the outer wall of the water pipe 141 and the inner wall of the outer tube 11, and a liquid outlet channel 14 is formed inside the inner wall of the water pipe 141.

The cable 23 may be disposed in the water pipe 141 or between the outer wall of the water pipe 141 and the inner wall of the outer pipe 11; the rotary member 12 may be disposed coaxially with the water pipe 141 and sleeved outside the water pipe 141, the rotary member 12 may be disposed coaxially with the water pipe 141 and penetrating inside the water pipe 141, or the rotary member 12 may not be disposed coaxially with the water pipe 141.

In this embodiment, the liquid inlet channel 13 and the liquid outlet channel 14 are disposed in the catheter assembly 10, and the liquid inlet channel 13 and the liquid outlet channel 14 are communicated with the accommodating cavity 111, so that a circulating water path is formed in the catheter assembly 10, and the ultrasonic generating device 20 is cooled by the circulating water, so that damage to the blood vessel wall, which may be caused by overhigh temperature of the ultrasonic generating device 20, is reduced.

In some embodiments, the ablation catheter 100 further includes a temperature sensor 40, the temperature sensor 40 being disposed on one side of the ultrasound generating device 20.

The temperature sensor 40 is a device for detecting the temperature near the ultrasonic generating device 20, and the temperature sensor 40 can be in communication connection with an external device so as to send monitored real-time temperature information to the outside, and a worker can operate according to the real-time temperature information, such as stopping the machine, increasing the flow rate of liquid, etc. when the real-time temperature is high.

The temperature sensor 40 can be in communication connection with external equipment through a signal wire penetrating through the outer tube 11, can also be in wireless communication connection with the external equipment, or can be in communication connection in other modes; in some embodiments, the temperature sensor 40 is a cable-like thermocouple temperature sensor that is threaded through the outer tube 11 and extends to the side of the ultrasound generating device 20 at one end.

The temperature sensor 40 is disposed on one side of the ultrasonic generating device 20 in this embodiment, so that a worker can monitor the temperature of the ultrasonic generating device 20, thereby reducing the damage to the vessel wall caused by the excessive temperature.

In some embodiments, the ultrasound generating apparatus 20 may further include a base or housing for providing a fixed base for the drive assembly 21, the generating assembly 22, and the cable 23, where one end of the temperature sensor 40 may be housed within the base or housing and located proximate to the piezoelectric patch 221 to facilitate better acquisition of real-time temperature information proximate to the piezoelectric patch 221.

Referring to fig. 3 and 4, wherein fig. 3 is a schematic cross-sectional view of an ablation catheter 100 provided in accordance with some embodiments of the application, fig. 4 is an enlarged view at a in fig. 3 and illustrates a specific structure within a covering lumen 151.

The catheter assembly 10 further comprises a coating film 15 arranged around the outer tube 11, wherein the coating film 15 forms a coating cavity 151 at the periphery of the outer tube 11, the coating cavity 151 is communicated with the accommodating cavity 111, and the coating film 15 can move towards or away from the accommodating cavity 111.

The coating film 15 is a film-like structure or a structural component that is disposed around the outer tube 11 outside the outer tube 11, and the coating film 15 can form a coating cavity 151 at the outer periphery of the outer tube 11, where the coating cavity 151 is of a sealed structure and cannot communicate with the outside.

The cladding cavity 151 is communicated with the accommodating cavity 111, namely, the cladding cavity 151 covers the accommodating cavity 111 outside the outer tube 11; in some embodiments, the outer tube 11 is divided into two ends of the accommodating cavity 111 and is respectively referred to as a front section and a rear section, the space between the front section and the rear section is the accommodating cavity 111, at this time, the accommodating cavity 111 is an open space set between the front section and the rear section, the coating cavity 151 covers and is in communication with the accommodating cavity 111, that is, the accommodating cavity 111 is located in the coating cavity 151 and is a part of the space of the coating cavity 151; in other embodiments, the outer tube 11 is provided with a through hole or a passage to communicate the accommodating chamber 111 and the covering chamber 151 therethrough.

Because the coating cavity 151 coats the accommodating cavity 111, and the ultrasonic generating device 20 is accommodated in the accommodating cavity 111, the coating film 15 has a film-like structure to reduce the negative influence of the coating film 15 on the ultrasonic wave, for example, reduce the energy attenuation of the ultrasonic wave in the process of transmitting through the coating film 15; the material of the coating film 15 may be silicone rubber, polyurethane (PU), polytetrafluoroethylene (pifa), polyamide (PA), polyethylene terephthalate (PET), or the like; the thickness of the coating 15 should be thin to reduce negative effects on the ultrasonic waves and should have a certain strength, for example, the thickness of the coating 15 may be 0.01mm, 0.02mm, 0.03mm or other thickness.

When the outer tube 11 drives the ultrasonic generating device 20 to enter a blood vessel of a patient and reach a target position, liquid can enter the accommodating cavity 111 through the liquid inlet channel 13 and enter the coating cavity 151, at the moment, the liquid outlet channel 14 can be closed firstly, the coating cavity 151 can be gradually expanded along with the liquid entering, and at the moment, the coating film 15 moves in the direction away from the accommodating cavity 111 until being abutted against the wall of the blood vessel, so that the effect of fixing the outer tube 11 is achieved, the position of the ultrasonic generating device 20 is fixed, and shaking possibly occurring in the using process of the ultrasonic generating device 20 is reduced; when the ablation is finished, the liquid can not be conveyed into the accommodating cavity 111 through the liquid inlet channel 13, and the liquid in the coating cavity 151 can be discharged through the liquid discharge channel 14, at the moment, the coating film 15 gradually moves towards the direction close to the accommodating cavity 111 along with the reduction of the liquid and is separated from the vessel wall, so that the outer tube 11 is conveniently taken out, and the possible negative influence caused when the outer tube 11 is taken out is reduced; in some embodiments, the coating 15 can be applied to the outer tube 11 in the absence of liquid within the coating cavity 151 to better reduce the negative effects that may be caused when the outer tube 11 is removed.

The embodiment sets up the coating film 15 outside the catheter and encloses into the coating cavity 151 through the coating film 15, still makes the coating cavity 151 be linked together with holding the chamber 111 simultaneously to in making rivers can also get into the coating cavity 151 after getting into holding the intracavity 111, the coating cavity 151 can be along with filling of rivers and expanding gradually, the coating film 15 can move and the butt is in the vascular wall to the direction of keeping away from holding the chamber 111, thereby plays the effect of fixed catheter assembly 10.

Referring to fig. 2, 6, and 7, wherein fig. 2 is a schematic partial perspective view of an ablation catheter 100 provided in accordance with some embodiments of the application, fig. 6 is a schematic cross-sectional view of the ablation catheter 100 of fig. 2, and fig. 7 is an enlarged view of fig. 6 at C and illustrates a specific structure within the covering cavity 151.

The catheter assembly 10 further comprises a support member 16 and a movable member 17 which are arranged outside the outer tube 11, wherein one end of the support member 16 is connected with the outer tube 11, and the other end of the support member 16 is connected with the movable member 17;

the movable member 17 is movably connected to the outer tube 11, and the movable member 17 can move relative to the outer tube 11 along the axial direction of the outer tube 11 and can drive the support member 16 to deform in a direction away from or close to the outer tube 11.

The support 16 refers to a support structure or combination of structures provided outside the outer tube 11; the shape of the support 16 may be a bar, sheet or other shape; the material of the support 16 may be metal, plastic, composite material or other materials.

The movable member 17 is a structure or a combination of structures capable of moving along the axial direction of the outer tube 11, and the shape of the movable member 17 may be a cylinder, a sheet, a strip or other shapes; the movable member 17 may be made of metal, plastic, composite material or other materials. In some embodiments, the movable member 17 is a sleeve coaxially sleeved on the outer tube 11, and the movable member 17 can be bent and deformed.

The support piece 16 can be attached to the outer tube 11 and also can deform in a direction away from the outer tube 11, and the support piece 16 can abut against the wall of a blood vessel when deformed in a direction away from the outer tube 11, so as to play a role in fixing the position of the outer tube 11 and further play a role in fixing the ultrasonic generator 20.

One end of the supporting piece 16 is connected to the outer wall of the outer tube 11, and the other end of the supporting piece 16 is connected to the movable piece 17, when the movable piece 17 moves along the axial direction of the outer tube 11 towards the direction approaching the supporting piece 16, the middle part of the supporting piece 16 is pressed and deformed, and deforms towards the direction far away from the outer tube 11; when the movable member 17 moves in the axial direction of the outer tube 11 in a direction away from the support member 16, the middle portion of the support member 16 is deformed in tension and in a direction approaching the outer tube 11 to contact the outer wall of the outer tube 11.

In the embodiment, the supporting piece 16 and the movable piece 17 are arranged on the catheter, and the supporting piece 16 can deform along with the movement of the movable piece 17 in a direction away from the outer tube 11 and is abutted against the wall of the blood vessel, so that the effect of fixing the position of the outer tube 11 is achieved; the support 16 is also capable of deforming in a direction toward the outer tube 11 to facilitate the catheter assembly 10 to enter and move within the blood vessel.

In some embodiments, the support 16 may be shaped as an arc protruding away from the outer tube 11, such that the support 16 is deformable in a direction away from the outer tube 11.

In some embodiments, the support member 16 is a sheet structure, and the plurality of support members 16 are provided, and the plurality of support members 16 are uniformly spaced apart from each other on the peripheral side of the outer tube 11, and when the movable member 17 moves in a direction approaching the support member 16 and deforms the support member 16, the plurality of support members 16 deform and form a spherical cage structure.

In some embodiments, to reduce the negative effects of the support 16 on the ultrasound waves generated by the ultrasound generating device 20, the support 16 and the ultrasound generating device 20 are staggered along the axis of the outer tube 11.

In accordance with some embodiments of the application, reference is made to fig. 6, 7, wherein fig. 6 is a schematic cross-sectional view of an ablation catheter 100 provided in accordance with some embodiments of the application, and fig. 7 is an enlarged view at C of fig. 6 and illustrates a specific structure within the covering lumen 151.

The outer tube 11 is provided with an opening 112 communicated with the accommodating cavity 111, and the opening 112 is opposite to the ultrasonic generating device 20; the opening 112 is provided with an acoustic membrane 18, and the acoustic membrane 18 is used for sealing the opening 112 and transmitting ultrasonic waves.

The opening 112 is formed in the outer tube 11, the accommodating cavity 111 can be communicated with the outside through the opening 112, the sound-transmitting membrane 18 is arranged on the outer tube 11 and seals the opening 112, so that liquid in the accommodating cavity 111 cannot flow out of the outer tube 11 through the opening 112, ultrasonic waves can penetrate through the sound-transmitting membrane 18, and meanwhile, substances in blood vessels or the outside cannot enter the accommodating cavity 111 through the sound-transmitting membrane 18.

The sound-transmitting film 18 can reduce adverse effects on the ultrasonic waves, for example, can reduce attenuation of energy of the ultrasonic waves at the time of transmission, as compared with converging the ultrasonic waves toward the target position through the wall of the outer tube 11; the thickness of the sound-transmitting film 18 should be thinner to reduce the negative influence on the ultrasonic wave and have a certain strength, for example, the material of the sound-transmitting film 18 may be silicone rubber, PU, PIFE, PA, PET, etc., and the thickness of the sound-transmitting film 18 may be 0.01mm, 0.02mm, 0.03mm, or other thicknesses.

The opening 112 is opposite the ultrasound generating device 20 such that ultrasound waves can be transmitted through the acoustically transparent film 18 to the target site, based on the action of the acoustically transparent film 18.

The present embodiment provides an opening 112 on the outer tube 11 opposite to the ultrasound generating device 20, and provides an acoustically transparent film 18 on the opening 112, so as to reduce the influence of the tube wall of the outer tube 11 on the transmission of ultrasound, and simultaneously, can maintain the seal of the accommodating cavity 111 through the acoustically transparent film 18, so as to avoid the water flow or other impurities from entering the blood vessel.

According to some embodiments of the present application, the ablation catheter 100 can be used to ablate benign prostatic hyperplasia tissue in addition to sympathetic nerves in the vicinity of the renal arteries, and this embodiment is further described by taking the ablation of prostatic hyperplasia tissue as an example, so that the ablation catheter 100 can ablate both prostatic hyperplasia tissue at the target site and also reduce damage to the urethral wall.

Because the ablation catheter 100 can enter from the urethra during the ablation of the prostatic hyperplasia tissue, the length of the ablation catheter 100 can be shorter, namely the lengths of the outer tube 11, the rotating member 12, the liquid inlet channel 13 and the liquid outlet channel 14 can be shorter.

Also, in the process of ablation of the prostatic hyperplasia tissue, the target position to be ablated may be far from the urethra, and the position which is farthest from the urethra can be up to 1 centimeter (cm), and at this time, the radius of the piezoelectric sheet 221 should be large, for example, 13mm, 14mm, 15mm or other values, so that the focal point can be furthest up to a position which is near 1cm from the urethra, and thus the ultrasonic wave can ablate the prostatic hyperplasia tissue at the focal point.

Further, since the urethra is generally linear and is not curved due to its structural characteristics, the ablation catheter 100 may not have a bending capability, that is, the outer tube 11 may not have a bending capability, and the rotator 12 may not have a bending capability and may rotate only within the outer tube.

Because of the structural characteristics of the urethra, and in particular, the urethral orifice and the urethral inner diameter are similar in width, the ablation catheter 100 can be positioned by directly controlling the outer diameter of the catheter assembly 10 without arranging a positioning structure such as a coating film 15 or a supporting piece 16.

In a second aspect, some embodiments of the present application also provide an ablation device comprising an ablation catheter 100 provided by some embodiments of the first aspect, such that the ablation device is capable of ablating sympathetic nerves at a target site and reducing damage to a vessel wall during ablation.

The ablation device may also include a handle, a host, or the like, or a combination of structures; for example, the main body can provide an electrical signal to the ultrasonic generating device 20, can also receive signals sent by the temperature sensor 40 and the imaging device 30, and can also provide liquid to the liquid inlet channel 13, receive liquid discharged by the liquid discharge channel 14, and the like; for example, the handle can be held by a worker, and the conduction of the liquid inlet channel 13 and the liquid outlet channel 14 can be controlled, and the displacement of the movable member 17 can be controlled.

The above embodiments are only for illustrating the technical solution of the present application, and are not limiting; although the application has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present application, and are intended to be included in the scope of the present application.

Claims (13)

1. An ablation catheter, comprising:

a catheter assembly;

the ultrasonic generating device is arranged in the catheter assembly and 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, the generating assembly is used for emitting ultrasonic waves and converging the ultrasonic waves to a focus, and the focus is arranged outside the catheter assembly.

2. The ablation catheter of claim 1, wherein the generation assembly comprises an arcuate piezoelectric patch, and the center of the piezoelectric patch and the focal point are disposed on the same side of the catheter assembly.

3. The ablation catheter of claim 2, wherein the radius of the piezoelectric patch is in the range of 6mm to 15mm.

4. The ablation catheter of claim 2, wherein the piezoelectric sheet is provided with at least one isolation slot, the isolation slot being capable of isolating the piezoelectric sheet into at least two piezoelectric electronic sheets, the piezoelectric electronic sheets being capable of rotating relative to the drive assembly.

5. The ablation catheter of any of claims 1-4, wherein the generation assembly comprises a first state and a second state, the generation assembly emitting the ultrasound waves in the second state with an acoustic power less than or equal to 10% of the acoustic power of the ultrasound waves emitted by the generation assembly in the first state.

6. The ablation catheter of any of claims 1-4, further comprising an imaging device disposed within the catheter assembly and beside the ultrasound generating device.

7. The ablation catheter of any of claims 1-4, wherein the catheter assembly comprises an outer tube having a receiving cavity therein, and a rotating member disposed within the outer tube, the ultrasound generating device being received within the receiving cavity;

one end of the rotating piece extends into the accommodating cavity and is connected with the ultrasonic generating device, the rotating piece can bend along with the outer tube, and the rotating piece can rotate relative to the outer tube and drive the ultrasonic generating device to rotate.

8. The ablation catheter of claim 7, wherein the catheter assembly further comprises a fluid inlet channel and a fluid outlet channel disposed on the outer tube, each of the fluid inlet channel and the fluid outlet channel having one end in communication with the receiving cavity.

9. The ablation catheter of claim 8, wherein the catheter assembly further comprises a cover disposed around the outer tube, the cover forming a cover lumen around the outer tube, the cover lumen in communication with the receiving lumen, the cover being movable in a direction toward or away from the receiving lumen.

10. The ablation catheter of claim 7, wherein the catheter assembly further comprises 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;

the movable piece is movably connected with the outer tube, can move along the axial direction of the outer tube relative to the outer tube, and can drive the support piece to deform along the direction deviating from or approaching to the outer tube.

11. The ablation catheter of claim 7, wherein the outer tube is provided with an opening in communication with the receiving cavity, the opening being opposite the ultrasound generating device;

and the opening is provided with an acoustic transmission film which is used for sealing the opening and transmitting the ultrasonic waves.

12. The ablation catheter of any of claims 1-4, further comprising a temperature sensor disposed alongside the ultrasound generating device.

13. An ablation device comprising the ablation catheter of any of claims 1-12.