WO2023092851A1

WO2023092851A1 - Radio frequency ablation catheter device

Info

Publication number: WO2023092851A1
Application number: PCT/CN2022/073458
Authority: WO
Inventors: 刘广志; 江挺益
Original assignee: 苏州润迈德医疗科技有限公司
Priority date: 2021-11-23
Filing date: 2022-01-24
Publication date: 2023-06-01
Also published as: CN113995503A

Abstract

A radio frequency ablation catheter device, comprising: a catheter body (1), a plurality of side holes (12) being arranged on an outer peripheral wall surface (11) of the catheter body (1); an ablation assembly, comprising a plurality of ablation members (2), proximal ends (22) of the ablation members (2) being arranged inside the catheter body (1); and electrodes (3) arranged at distal ends (21), the electrodes (3) on the plurality of ablation members (2) being distributed at intervals in the axial direction of the catheter body (1), and on a section perpendicular to the axial direction of the catheter body (1), the projections of the plurality of electrodes (3) on the section in the axial direction of the catheter body (1) being distributed at intervals in the peripheral direction of the section. The catheter device is configured as follows: when the ablation members (2) and the catheter body (1) move relative to each other in the axial direction of the catheter body (1), the ablation members (2) can slide along the side holes, and the ablation assembly can switch between a working state and an accommodated state. The radio frequency ablation catheter device has a simple structure, and can adapt to blood vessels with different diameters and effectively ensure that a plurality of electrodes (3) are attached to a wall at the same time.

Description

Radiofrequency Ablation Catheter Device

technical field

The present application relates to the technical field of medical devices, in particular to a radiofrequency ablation catheter device.

Background technique

Renal sympathetic and afferent nerves lie within and immediately adjacent to the renal artery wall and are critical for the initiation and maintenance of systemic hypertension. Denervation is a method for the treatment of resistant hypertension. This operation uses an ablation device with electrodes to enter the blood vessel to reach the ablation target site and ablate the overactive renal artery sympathetic nerve to achieve the purpose of blood pressure regulation.

Currently, among methods of renal denervation for treating hypertension, a representative method is the use of a catheter. Denervation using a catheter is achieved by inserting the catheter into a part of the body, allowing the distal end of the catheter to enter the renal artery along the blood vessel, an electrode placed at the distal end of the catheter, and passing radiofrequency (RF, Radio Frequency) energy etc. generate heat, thereby blocking the sympathetic nerves surrounding the renal artery.

As mentioned above, in the process of denervation with a catheter, on the one hand, the catheter needs to be able to move freely along the inner wall of the blood vessel, and on the other hand, the electrode needs to be well adhered to the wall, so as to achieve a good therapeutic effect.

In the prior art, when the distal end of the catheter reaches the surgical site, the head expands, so that the electrode is close to the inner wall of the blood vessel. In this case, the structure of the catheter is designed to be more complicated; The problem that the electrodes cannot be attached to the wall at the same time affects the surgical effect. In addition, the diameter of human blood vessels varies from person to person, and there are differences in the diameter of blood vessels in the human body at different ablation sites. Adaptive adjustment.

Contents of the invention

In order to solve at least one technical problem existing in the prior art, the present application provides a radiofrequency ablation catheter device, which has a simple structure, can adapt to blood vessels of different diameters, and can effectively ensure simultaneous adhesion of multiple electrodes.

In order to achieve the above object, the technical solution provided by the application is as follows:

A radiofrequency ablation catheter device, comprising:

a catheter body, a plurality of side holes are arranged on the peripheral wall of the catheter body;

An ablation assembly, comprising: a plurality of ablation members, the ablation members having opposite proximal ends and distal ends in their longitudinally extending direction, the proximal ends being arranged inside the catheter body; The electrodes on the ablation member are distributed at intervals along the axial direction of the catheter body, and on a section perpendicular to the axial direction of the catheter body, the plurality of electrodes are distributed along the The axial projection of the catheter body falling on the section is distributed along the circumference of the surface at intervals;

The catheter device is configured such that when the ablation member and the catheter body move relative to each other along the axial direction of the catheter body, the ablation member can slide along the side hole, and the ablation assembly can Switching between an operating state in which the electrodes extend out of the catheter body and a containment state in which the electrodes are retracted.

As a preferred embodiment, when the ablation assembly is in a housed state, the electrode on the distal end of the ablation member is in close contact with the outer peripheral wall of the catheter body.

As a preferred embodiment, one of the side hole and the electrode is provided with a stopper for restricting the electrode from entering the interior of the catheter body from the side hole.

As a preferred implementation manner, the outer contour size of the electrode is larger than the outer contour size of the side hole.

As a preferred implementation manner, when the ablation assembly is in a stored state, the electrode on the distal end of the ablation member can be accommodated in the catheter body.

As a preferred embodiment, the catheter body is provided with a guide mechanism for forming a channel. When the ablation assembly is in the storage state, all the ablation components are stored in the channel, and the ablation assembly is in the working state. When , the channel is capable of directing the ablation member inside it toward the side hole.

As a preferred embodiment, the catheter body has a solid structure, the channel is formed by a groove opened toward the interior of the catheter body along the position of the side hole, and the ablation member is arranged in the channel.

As a preferred implementation manner, the outer contour size of the electrode is smaller than the outer contour size of the side hole.

As a preferred embodiment, the ablation member is made of elastic material, the distal end of the ablation member has a supporting force, and the supporting force at the distal end can promote the response of the distal end to the An axial force on the ablation member or the catheter body expands.

As a preferred embodiment, in the accommodated state, the ablation member is configured from the proximal end to the distal end in a curved structure that expands away from the axis of the catheter body toward the side hole.

As a preferred embodiment, the ablation assembly includes: an inner tube disposed inside the catheter body, and the proximal ends of the ablation members are all connected to the inner tube;

When the inner tube moves toward the proximal end of the ablation member relative to the catheter body, the ablation assembly is in a housed state, and the inner tube moves toward the distal end of the ablation member relative to the catheter body , the ablation assembly is in working state.

As a preferred implementation manner, the ablation member is a conductive material, and the electrode is electrically connected to an external radio frequency device through the ablation member.

As a preferred embodiment, the ablation member has a chamber, and the catheter device includes: an ablation wire, the ablation wire is arranged in the chamber, and the electrode is electrically connected to an external radio frequency device through the ablation wire. connect.

As a preferred embodiment, the ablation member is a conductive material, and the electrodes are electrically connected to external radio frequency equipment through the ablation member, and a plurality of ablation members are connected to each other to form a conductive wire bundle, and the conductive wire bundle is opposite to each other. When the catheter body moves toward the proximal end of the ablation member, the ablation assembly is in a housed state, and when the conductive wire bundle moves toward the distal end of the ablation member relative to the catheter body, the ablation assembly Component is in working state.

As a preferred embodiment, the catheter device includes: a handle, the handle is provided with an operating part, and the handle can control the axis of the catheter body between the ablation member and the catheter body through the operating part. Relative movement occurs upwards.

Beneficial effect:

The radiofrequency ablation catheter device provided by the embodiment of the present application can not only realize that the electrode is close to the inner wall of the blood vessel so as to act on the nerve at the corresponding position, but also satisfy the requirement that the electrode can move conveniently in the blood vessel without damaging the blood vessel wall. Multiple electrodes are distributed at intervals along the axial direction of the catheter body, which will not cause excessive ablation on a certain section of the blood vessel. At the same time, on a section perpendicular to the axial direction of the catheter body, multiple electrodes The projections falling on the section are spaced along the circumference of the plane, which can effectively remove the renal nerves in the circumferential direction of the blood vessel.

In addition, the electrode is arranged at the distal end of the ablation member. When the ablation member slides along the side hole and expands outward, the sliding distance of the ablation member relative to the side hole can be adjusted, so the apposition operation can be completed regardless of the diameter of the blood vessel. Therefore, when it is necessary to adapt to large-diameter or small-diameter blood vessels, the purpose of adjustment is achieved by controlling the relative movement distance between the ablation member and the catheter body.

With reference to the following description and accompanying drawings, specific embodiments of the present application are disclosed in detail, indicating the manner in which the principles of the application may be employed. It should be understood that the embodiments of the present application are not limited thereby in scope.

Features described and/or illustrated with respect to one embodiment can be used in the same or similar manner in one or more other embodiments, in combination with, or instead of features in other embodiments .

It should be emphasized that the term "comprising/comprising" when used herein refers to the presence of a feature, integer, step or component, but does not exclude the presence or addition of one or more other features, integers, steps or components.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present application. For those skilled in the art, other drawings can also be obtained according to these drawings without creative labor.

Fig. 1 is a schematic structural diagram of a radiofrequency ablation catheter device provided by an embodiment of this specification;

Fig. 2 is a schematic structural diagram of an ablation assembly provided by an embodiment of this specification;

Fig. 2A is a schematic structural diagram of the ablation assembly provided by an embodiment of the present specification in a contained state;

Fig. 2B is a side view of the target anatomical structure of the ablation assembly provided by an embodiment of the present specification in a contained state;

Fig. 2C is a schematic structural diagram of the ablation assembly provided by an embodiment of the present specification in a working state;

Fig. 2D is a side view of the target anatomical structure of the ablation assembly provided by an embodiment of the present specification in a working state;

Fig. 3 is a structural schematic diagram of a radiofrequency ablation catheter device provided by another embodiment of the present specification (the handle is not shown);

Fig. 4 is a structural schematic diagram of a radiofrequency ablation catheter device provided by another embodiment of the present specification (the handle is not shown);

Figure 4A is a schematic cross-sectional view cut along the A-A direction in Figure 4;

FIG. 4B is a schematic cross-sectional view taken along the B-B direction in FIG. 4 .

Explanation of reference signs:

1. Catheter body; 11. Peripheral wall; 12. Side hole; 2. Ablation member; 21. Distal end; 22. Proximal end; 3. Electrode; 4a, first channel; 4b, second channel; 4c, third Channel; 4d, fourth channel; 5, sheath tube; 6, inner tube; 7, compliance structure; 8, handle; 81, operating part; 9, vessel wall.

Detailed ways

The technical solutions of the present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope. After reading the present invention, those skilled in the art will understand the present invention Modifications of various equivalent forms fall within the scope defined in the present application.

It should be noted that when an element is referred to as being “disposed on” another element, it may be directly on the other element or there may also be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present.

The radiofrequency ablation catheter device according to the embodiment of the present specification will be explained and described below with reference to FIG. 1 to FIG. 4 . It should be noted that, in the embodiments of the present invention, the same reference numerals represent the same components. For the sake of brevity, in different embodiments, detailed descriptions of the same components are omitted, and the descriptions of the same components can be referred to and quoted from each other.

In the description of this specification, it should be noted that the terms "proximal end" and "distal end" are relative to the patient's body. The term "distal" refers to a direction relatively close to the patient's body, and the term "proximal" refers to a direction relatively away from the patient's body. The orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", etc. is based on the orientation or positional relationship shown in Figure 1, which is only for the convenience of describing this specification Implementation limitations.

This specification provides a radiofrequency ablation catheter device, which is mainly used for regulating the renal nerve located on the renal artery, and the regulation refers to removing or reducing the activity of the renal nerve through damage or non-damage. However, if it is necessary to adjust the nerves of other parts (for example, heart parts), those skilled in the art can make adjustments without creative labor according to the embodiments of this specification.

As shown in Figures 1 to 4, the radiofrequency ablation catheter device includes: a catheter body 1; an ablation assembly, including: a plurality of ablation members 2, and the ablation members 2 have opposite proximal ends 22 in their longitudinal extension direction And the distal end 21, the proximal end 22 is arranged inside the catheter body 1; the electrodes 3 arranged on the distal end 21, the electrodes 3 on a plurality of the ablation members 2 are arranged along the catheter body 1 at intervals in the axial direction, on a section perpendicular to the axial direction of the catheter body 1, the projections of a plurality of electrodes 3 falling on the section along the axial direction of the catheter body 1 are along the Circumferential spacing of the face.

When the electrode 3 is close to the target area that needs to be adjusted, the electrode 3 releases a certain amount of energy and acts on the nerves in this area, so as to remove or reduce the activity of renal nerves. The electrodes 3 can do this by transferring heat to this area. Specifically, the electrode 3 needs to be electrically connected to a device that generates the energy (such as a radio frequency device) or enables the electrode 3 itself to generate the energy.

The catheter body 1 is used to drive the ablation assembly to move in the blood vessel. The ablation assembly is provided with a plurality of ablation members 2, wherein each ablation member 2 carries at least one electrode 3 thereon. The ablation member 2 may be in a linear configuration as a whole, and has an opposite proximal end 22 and a distal end 21 along its longitudinal extension direction, the electrode 3 is arranged on the distal end 21, and the proximal end 22 extends into the catheter body 1 interior. Wherein, the plurality of electrodes 3 on the ablation member 2 are discretely spaced apart from each other along the axial direction of the catheter body 1 , but when projected along the axial direction of the catheter body 1 to a direction perpendicular to the axial direction of the catheter body 1 On any section, the projections of all electrodes 3 can be distributed around the circumferential interval of the section. Further, the projection of the ablation area generated by the electrode 3 on the section can form a closed loop. In this way, on the one hand, the renal nerve can be effectively removed in the circumferential direction of the blood vessel, and on the other hand, excessive ablation of a certain section of the blood vessel will not be caused.

In this specification, the ablation assembly has a working state in which the electrode 3 can extend out of the catheter body 1, and a storage state in which the electrode 3 can be retracted. When the ablation assembly moves from the storage state to When the working state is switched, the distal end of the ablation member 2 moves away from the axis of the catheter body 1 . In this way, the electrode 3 can be closely attached to the inner wall of the blood vessel so as to act on the nerve at the corresponding position, and the electrode 3 can be moved conveniently in the blood vessel without damaging the blood vessel wall 9 .

When the ablation assembly is in working state, the distal end of the ablation member 2 moves away from the axis of the catheter body 1, so that the electrode 3 can approach or contact the blood vessel wall 9, thereby approaching the renal nerve. Preferably, the number of electrodes 3 is four, and correspondingly, the number of ablation components 2 is four, and each ablation component 2 is correspondingly provided with one electrode 3 . However, the number of electrodes 3 can also be set to other numbers, such as 6, 8, etc., and the application does not limit the specific number of electrodes. Correspondingly, the number of ablation members 2 should match the number of electrodes 3 .

In this specification, as shown in FIG. 2 to FIG. 2D , when the ablation assembly is in a housed state, the electrode 3 on the distal end of the ablation member 2 can be in close contact with the outer peripheral wall 11 of the catheter body 1 .

Specifically, a plurality of side holes 12 matching the ablation member 2 may be provided on the outer peripheral wall 11 of the catheter body 1 . Wherein, the size of the side hole 12 allows the ablation member 2 to protrude in and out, but prevents the electrode 3 from entering the catheter body 1 from the side hole 12 . Therefore, by adjusting the position and number of side holes 12, the adhering positions of multiple electrodes 3 on the blood vessel can be set.

The outer contour size of the side hole 12 may be smaller than the outer contour size of the electrode 3, so that the electrode 3 is prevented from entering the catheter body 1 from the side hole 12 when the ablation assembly is in a housed state. Or, in some possible embodiments, one of the side hole 12 and the electrode 3 is provided with a stopper for restricting the electrode 3 from entering the interior of the catheter body 1 from the side hole 12 .

In this specification, the catheter device is configured such that when the ablation member 2 and the catheter body 1 move relatively along the axial direction of the catheter body 1, the ablation member 2 can move along the The side hole 12 slides, and the ablation assembly can be switched between the working state and the receiving state.

Specifically, when an axial force is applied to one of the proximal end 22 of the ablation member 2 and the catheter body 1, and the other of the two remains stationary, the ablation member 2 can be driven to slide along the side hole 12, In this way, the distal end 21 of the ablation member 2 expands in a sliding direction toward the side hole 12 . In some possible embodiments, as shown in FIG. 2C and FIG. 2D , when an axial force is applied to one of the proximal end 22 of the ablation member 2 and the catheter body 1 , the ablation assembly is directed distally relative to the catheter body 1 . When the end 21 moves in the direction, the distal end 21 of the ablation member 2 can be extended along the direction of sliding toward the side hole 12, so that the electrode 3 is close to the blood vessel wall 9; as shown in Figure 2A and Figure 2B, when the ablation member 2 One of the proximal end 22 and the catheter body 1 exerts an axial force, so that when the ablation assembly moves toward the proximal end 22 relative to the catheter body 1, the distal end 21 of the ablation member 2 can slide toward the side hole 12 Retract so that the electrode 3 is away from the vessel wall 9 .

In some other possible embodiments, when the ablation assembly moves toward the proximal end 22 relative to the catheter body 1, the distal end 21 of the ablation member 2 can expand along the direction of sliding toward the side hole 12, so that the electrode 3 is close to the Blood vessel wall 9 ; when the ablation assembly moves toward the distal end 21 relative to the catheter body 1 , the distal end 21 of the ablation member 2 can retract along the direction of sliding toward the side hole 12 to keep the electrode 3 away from the blood vessel wall 9 .

In this specification, the ablation member 2 is made of elastic material, the distal end 21 of the ablation member 2 has a supporting force, and the supporting force of the distal end 21 can promote the response of the distal end 21 to the applied The axial force applied to the ablation member 2 or the catheter body 1 expands. The ablation component 2 needs to meet certain bending resistance and support, so that it can respond to the axial force in time and transmit the force to its distal end 21 in the working state, and can support the electrode 3 against the blood vessel wall 9 .

Preferably, the ablation member 2 is made of nickel alloy, and its surface is provided with an insulating coating.

Further, as shown in FIG. 2A and FIG. 2C , in the accommodated state, the ablation member 2 is configured from the proximal end 22 to the distal end 21 to be away from the axis of the catheter body 1 toward the side hole 12 expansion curve structure. When the ablation member 2 or catheter body 1 responds to the axial force, the curved structure can make the distal end 21 of the ablation member 2 expand in a curved form when sliding along the side hole 12. Compared with the straight structure, the electrode 3 is arranged on the curved line. Structurally, it can stick to the wall more stably.

In addition, whether the ablation member 2 is a curved structure or a straight line structure, it is a linear structure, and the electrode 3 is arranged at the distal end 21. When the ablation member 2 slides along the side hole 12 and expands outward, the ablation member 2 is relatively opposite to the side hole. The sliding distance of 12 can be adjusted, so no matter what the diameter of the blood vessel is, the wall-attaching operation can be completed. Therefore, when it is necessary to adapt to large-diameter or small-diameter blood vessels, the purpose of adjustment is achieved by controlling the relative movement distance between the ablation member 2 and the catheter body 1 .

Compared with the common bracket method in which the electrode 3 is fixed on a mesh structure or a basket structure, the catheter device provided by the embodiment of this specification is not only simple in structure, but also easy to adjust, and can be quickly restored to the working state by applying axial force. It can be switched between the storage state and the working state, and can adjust the wall-attached range of the electrode in the working state without recovering deformation and without damaging the blood vessel wall 9 .

In some embodiments, the ablation assembly includes: an inner tube 6 disposed inside the catheter body 1, the proximal end 22 of the ablation member 2 is connected to the inner tube 6; the inner tube 6 is relatively When the catheter body 1 moves toward the proximal end 22 of the ablation member 2, the ablation assembly is in a housed state, and the inner tube 6 faces toward the distal end 21 of the ablation member 2 relative to the catheter body 1 When moving, the ablation assembly is in a working state.

The proximal end 22 of the ablation member 2 may be bonded to the head end of the inner tube 6 . In this way, when the inner tube 6 is pushed toward the distal end of the catheter body 1 or the catheter body 1 is pushed toward the proximal end of the ablation member 2 , the ablation member 2 can slide along the direction of the side hole 12 .

In this embodiment, the catheter body 1 may be a hollow structure, and the ablation member 2 and the inner tube 6 may be disposed in the hollow structure. The ablation member 2 may be a conductive material, and the electrode 3 is electrically connected to an external radio frequency device through the ablation member 2 . When the proximal ends 22 of a plurality of ablation members 2 are connected to the inner tube 6 , the ablation members 2 can be electrically connected to external radio frequency equipment through wires embedded in the inner tube 6 .

Alternatively, the ablation member 2 has a chamber, and the catheter device includes: an ablation wire, the ablation wire is disposed in the chamber, and the electrode 3 is electrically connected to an external radio frequency device through the ablation wire. The ablation wire can extend from the chamber of the ablation member 2 into the inner tube 6 until it is connected with an external radio frequency device.

In some embodiments, the ablation member 2 is a conductive material, the electrode 3 is electrically connected to an external radio frequency device through the ablation member 2, and a plurality of the ablation members 2 are connected to each other to form a conductive wire bundle. When the wire harness moves toward the proximal end 22 of the ablation member 2 relative to the catheter body 1, the ablation assembly is in a housed state, and the conductive wire bundle moves toward the distal end of the ablation member 2 relative to the catheter body 1 When moving in direction 21, the ablation assembly is in working state.

In this embodiment, multiple ablation members 2 are directly connected in parallel to form a conductive wire bundle, the catheter body 1 may be a hollow structure, and the ablation member 2 and the conductive wire bundle may be arranged in the hollow structure. The conductive wire bundle can be directly pushed under the action of the axial force, and the ablation member 2 can directly make the electrode 3 electrically connected with the external radio frequency device.

In some embodiments, as shown in FIG. 3 , the catheter device may include: a sheath 5 sheathed on the catheter body 1 , and the catheter device is configured to: when the sheath 5 runs along the catheter body 1, when sliding and covering the ablation member 2, the ablation assembly is in the accommodated state; when the sheath 5 is slid away from the ablation member 2, the ablation assembly is in the working state.

When the ablation assembly is in the working state, the ablation member 2 is in a natural state without external force. The ablation member 2 can be made of a shape memory material, and the ablation member 2 remains in an expanded state without external force. At this time, the ablation member The electrodes 3 on the 2 all protrude from the outside of the catheter body 1. When an external force is given to the ablation member 2 , the ablation member 2 can be deformed so that the ablation assembly can be returned to the accommodated state in response to the external force, and the electrode 3 can be tightly attached to the peripheral wall 11 of the catheter body 1 .

In this embodiment, the material of the sheath tube 5 is slightly harder than that of the ablation member 2 . The shape of the ablation member 2 when no external force is applied is the working state of the ablation assembly. When the user manipulates the sheath tube 5 to cover the ablation member 2 and separate from the ablation member 2, the ablation member 2 can be transformed between changing its own shape and recovering its own shape.

When the sheath tube 5 is overlaid on the ablation component 2, since the material of the sheath tube 5 is harder than the ablation component 2, the ablation component 2 will change its shape and be accommodated in the sheath tube 5. At this time, the electrode 3 is closely attached to the catheter body 1; when the sheath tube 5 is detached from the ablation member 2, the ablation member 2 can restore its deformation, so that the ablation assembly can return to the working state.

Of course, in some possible solutions, the catheter body is a sheath, and when the ablation component moves toward the proximal end of the catheter body, the ablation member can be completely retracted into the catheter body; when the ablation component moves toward the distal end of the catheter body, the The ablation member extends out of the catheter body. In this embodiment, the relative positions of the catheter body and the ablation assembly need to be readjusted.

In this specification, as shown in FIG. 4 , when the ablation assembly is in the accommodated state, the electrode 3 on the distal end 21 of the ablation member 2 can be accommodated in the catheter body 1 .

Specifically, the catheter body 1 is provided with a guide mechanism for forming a channel; when the ablation assembly is in a housed state, all of the ablation components 2 are housed in the channel; when the ablation assembly is in a working state, the Said channel can guide the ablation member 2 inside it towards said side hole 12.

Different from the above-mentioned embodiments, the outer contour size of the electrode 3 needs to be smaller than the outer contour size of the side hole 12. In the accommodated state, the electrode 3 can be accommodated in the guide mechanism from the side hole 12, thereby facilitating the passage of the catheter device in the blood vessel. . When the electrode 3 needs to stick to the wall, the proximal end 22 of the ablation member 2 or the catheter body 1 is under the action of axial force, and the ablation member 2 can be drawn out from the side hole 12 through the guide mechanism and move away from the axis of the catheter body 1 .

As shown in FIG. 4A , in this embodiment, the catheter body 1 may have a solid structure, the guiding mechanism is a channel opened toward the inside of the catheter body 1 along the position of the side hole 12, and the ablation member 2 is arranged in the channel. Specifically, when there are four electrodes 4, four ablation members 2 are provided, and the guiding mechanism is the first channel 4a, the second channel 4b, the third channel 4c and Fourth channel 4d.

Further, as shown in FIG. 4B , the catheter body 1 is provided with a cavity at its proximal end. When the ablation member 2 is connected to the inner tube 6, the inner tube 6 may be arranged in the cavity. Alternatively, when the ablation member 2 is composed of a conductive wire bundle, the proximal end of the conductive wire bundle may be arranged in the cavity. The cavity communicates with the guiding mechanism to guide part of the ablation member 2 into the cavity.

Alternatively, in some embodiments, when the ablation member 2 slides along the side hole 12 by applying an axial force to the catheter body 1, the proximal end of the catheter body 1 does not need to have a cavity, and can only pass through the first channel 4a , the second channel 4b, the third channel 4c and the fourth channel 4d guide the ablation member 2 to move.

In this specification, the end of the catheter body 1 is provided with a compliance structure 7 for facilitating the delivery of the catheter body 1 in the target vessel anatomy when in the accommodated state. The conforming structure 7 is made of soft material so that the catheter device is not easy to push against the blood vessel when it passes through the bending part.

In this specification, the catheter device includes: a handle 8 matched with the catheter body 1, the handle 8 is provided with an operating part 81, and the handle 8 can control the ablation member 2 through the operating part 81 Relatively moving with the catheter body 1 in the axial direction of the catheter body 1, so as to realize the transition of the ablation member 2 between the working state and the receiving state.

Specifically, the handle 8 can be provided with an operating part 81, which can control the forward and backward movement of the catheter body 1, or can control the forward and backward movement of the inner tube 6 or the conductive wire bundle. When the operating part 81 is used to control the forward and backward movement of the catheter body 1, it is matched with the proximal end of the catheter body 1; match up. The operation part 81 may be in the form of a dial, a paddle, a knob, or a sliding part, which is not particularly limited in this application.

The control of the operation part 81 can be controlled by humans, or a special clamping mechanism can be designed for automatic control, so as to cooperate with surgical robots in possible scenarios. The handle 8 is also connected with a radiofrequency ablation power supply, which can provide the required radiofrequency energy to the electrode 3 .

In order to better understand this application, the following will further elaborate on the use process of the radiofrequency ablation catheter device provided by the embodiment of this specification:

After the catheter device is pushed to the target blood vessel, the relative movement of the catheter body 1 or the inner tube 6 is controlled by the operating part 81 on the handle 8, causing each ablation member 2 to slide relative to the side hole 12, and the ablation member 2 moves the distal end The electrode 3 at 21 protrudes from the catheter body 1 until the electrode 3 abuts against the blood vessel wall 9 to complete the operation of adhering the electrode 3 to the wall. At this time, the ablation member 2 is in a stretched state.

The ablation member 2 is made of materials such as nickel alloy, so it has certain bending resistance and support, and can support the electrode 3 against the blood vessel wall 9 . The position of the side hole 12 on the catheter body 1 is pre-designed, and the adhering positions of the electrodes 3 are distributed at intervals along the axial direction of the blood vessel, and distributed at equal angles along the circumferential direction of the blood vessel at 360°. Since the sliding distance of the ablation member 2 relative to the upper side hole 12 of the catheter body 1 can be adjusted, no matter whether it is a large blood vessel or a small blood vessel, the apposition operation can be completed.

After the electrodes are adhered to the wall, the radiofrequency ablation power supply can be controlled to generate radiofrequency electric energy pulses to ablate the target renal nerve tissue. After the preset ablation time is reached, the release of energy is stopped to complete the ablation of the current point. Then, through the operating part 81 on the handle 8, the relative movement of the catheter body 1 or the inner tube 6 is controlled to cause the reverse sliding of each ablation member 2 relative to the side hole 12 until all the electrodes 3 return to the catheter body 1 at the same time At this time, the ablation member 2 returns to the original contracted state.

Hold the handle 8, and continue to adjust the position of the catheter device until the next target blood vessel or ablation area, and perform the next renal sympathetic nerve ablation. Repeat the above operations, complete the ablation of multiple regions and multiple blood vessels, including the renal aorta and its branch vessels, and complete all ablation operations to complete the renal artery ablation operation.

The above-mentioned embodiments are only to illustrate the technical concept and characteristics of the present application, and the purpose is to enable those familiar with this technology to understand the content of the present application and implement it accordingly, and not to limit the protection scope of the present application. All equivalent changes or modifications made according to the spirit of the present application shall fall within the protection scope of the present application.

Multiple elements, ingredients, parts or steps can be provided by a single integrated element, ingredient, part or step. Alternatively, a single integrated element, ingredient, part or step may be divided into separate plural elements, ingredients, parts or steps. The disclosure of "a" or "an" to describe an element, ingredient, component or step is not meant to exclude other elements, ingredients, parts or steps.

It should be understood that the foregoing description is for purposes of illustration and not limitation. Many implementations and many applications other than the examples provided will be apparent to those of skill in the art from reading the above description. The disclosures of all articles and references, including patent applications and publications, are hereby incorporated by reference for completeness.

Claims

A radiofrequency ablation catheter device, characterized in that it comprises:

a catheter body, a plurality of side holes are arranged on the peripheral wall of the catheter body;

An ablation assembly, comprising: a plurality of ablation members, the ablation members having opposite proximal ends and distal ends in their longitudinally extending direction, the proximal ends being arranged inside the catheter body; The electrodes on the ablation member are distributed at intervals along the axial direction of the catheter body, and on a section perpendicular to the axial direction of the catheter body, the plurality of electrodes are distributed along the The axial projection of the catheter body falling on the section is distributed along the circumference of the surface at intervals;

The catheter device is configured such that when the ablation member and the catheter body move relative to each other along the axial direction of the catheter body, the ablation member can slide along the side hole, and the ablation assembly can Switching between an operating state in which the electrodes extend out of the catheter body and a containment state in which the electrodes are retracted.
The radiofrequency ablation catheter device according to claim 1, wherein when the ablation assembly is in a housed state, the electrode on the distal end of the ablation member is in close contact with the outer peripheral wall of the catheter body.
The radiofrequency ablation catheter device according to claim 2, wherein one of the side hole and the electrode is provided with a stop for limiting the electrode from entering the catheter body from the side hole pieces.
The catheter device for radiofrequency ablation according to claim 2, wherein the outer contour size of the electrode is larger than the outer contour size of the side hole.
The radiofrequency ablation catheter device according to claim 1, wherein, when the ablation assembly is in a housed state, the electrode on the distal end of the ablation member can be housed in the catheter body.
The radiofrequency ablation catheter device according to claim 5, wherein a guide mechanism for forming a channel is provided in the catheter body, and when the ablation assembly is in a housed state, all of the ablation components are accommodated in the channel , when the ablation assembly is in a working state, the channel can guide the ablation member inside it toward the side hole.
The radiofrequency ablation catheter device according to claim 6, wherein the catheter body has a solid structure, the channel is formed by a groove opened toward the interior of the catheter body along the position of the side hole, and the ablation member placed within the channel.
The catheter device for radiofrequency ablation according to claim 5, wherein the outer contour size of the electrode is smaller than the outer contour size of the side hole.
The radiofrequency ablation catheter device according to claim 1, wherein the ablation member is made of elastic material, the distal end of the ablation member has a supporting force, and the supporting force at the distal end can promote the The distal end expands in response to an axial force applied to the ablation member or the catheter body.
The radiofrequency ablation catheter device according to claim 1, characterized in that, in the accommodated state, the ablation member is configured from the proximal end to the distal end away from the axis of the catheter body and toward the side hole Expansive curvilinear structure.
The radiofrequency ablation catheter device according to claim 1, wherein the ablation assembly comprises: an inner tube disposed inside the catheter body, and the proximal ends of the ablation members are all connected to the inner tube;

When the inner tube moves toward the proximal end of the ablation member relative to the catheter body, the ablation assembly is in a housed state, and the inner tube moves toward the distal end of the ablation member relative to the catheter body , the ablation assembly is in working state.
The radiofrequency ablation catheter device according to claim 1, wherein the ablation member is a conductive material, and the electrode is electrically connected to an external radio frequency device through the ablation member.
The radiofrequency ablation catheter device according to claim 1, wherein the ablation member has a chamber, and the catheter device includes: an ablation wire, the ablation wire is arranged in the chamber, and the electrode passes through the The ablation lead is electrically connected to an external radio frequency device.
The radiofrequency ablation catheter device according to claim 1, wherein the ablation member is a conductive material, the electrode is electrically connected to an external radio frequency device through the ablation member, and a plurality of the ablation members are connected to each other and are configured as A conductive wire bundle, when the conductive wire bundle moves toward the proximal end of the ablation member relative to the catheter body, the ablation assembly is in a housed state, and the conductive wire bundle moves toward the distal end of the ablation member relative to the catheter body When moving in the end direction, the ablation assembly is in working state.
The radiofrequency ablation catheter device according to claim 1, wherein the catheter device comprises: a handle, the handle is provided with an operating part, and the handle can control the ablation member and the catheter through the operating part The body relatively moves in the axial direction of the catheter body.