CN115105188A

CN115105188A - Ablation catheter and ablation device

Info

Publication number: CN115105188A
Application number: CN202210728023.9A
Authority: CN
Inventors: 罗中宝; 代聪育; 张朕华
Original assignee: Shanghai Remedicine Co ltd
Current assignee: Shanghai Remedicine Co ltd
Priority date: 2022-06-23
Filing date: 2022-06-23
Publication date: 2022-09-27

Abstract

An ablation catheter and ablation device, the ablation catheter comprising a tube assembly and a basket assembly; the pipe assembly comprises a first pipe body and a second pipe body, the first pipe body is arranged in the second pipe body, and the first pipe body and the second pipe body can move relatively along the axis direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket lateral branches, first ends of the basket lateral branches are connected with the first end of the second tube body, second ends of the basket lateral branches are connected with the first end of the first tube body, so that the basket lateral branches at least partially surround the first tube body, and the electrodes are arranged on the basket lateral branches respectively; the plurality of basket side branches are configured as: the first end of the first tubular body and the first end of the second tubular body are spaced apart by a predetermined distance to assume an initial state, and the plurality of basket sidebranches are first deformable to assume a first predetermined state when the first tubular body is moved in the axial direction relative to the second tubular body. The operation of the ablation catheter is convenient, and the formed first predetermined state is more stable.

Description

Ablation catheter and ablation device

Technical Field

Embodiments of the present disclosure relate to an ablation catheter and an ablation device.

Background

Atrial Fibrillation (AF) is a common arrhythmia affecting over tens of millions of people worldwide. Radiofrequency ablation and cryoablation are two common methods currently used clinically to treat cardiac arrhythmias (e.g., atrial fibrillation). The damage must be sufficient to destroy the arrhythmic tissue or substantially interfere with or isolate abnormal electrical conduction within the myocardial tissue. Excessive ablation in turn can affect surrounding healthy tissue as well as neural tissue.

The radio frequency ablation point-by-point ablation operation time is long, the requirement on the catheter operation level of an operator is high, a patient is uncomfortable in operation, and Pulmonary Vein (PV) stenosis is easy to occur after the operation; radiofrequency ablation can damage the cardiac endothelial surface, activate the extrinsic coagulation cascade, and lead to coke and thrombosis, which in turn can lead to systemic thromboembolism. Application of rf energy to targeted tissue can have an effect on non-targeted tissue, application of rf energy to atrial wall tissue can cause esophageal or nerve damage, and rf ablation can also cause tissue scarring, further causing embolization problems. Cryoablation causes a high rate of phrenic nerve damage, and epicardial freezing near the coronary arteries can lead to thrombosis and progressive coronary stenosis.

A new emerging technology for treating atrial fibrillation is the Pulsed Electric Field (PEF) technology, which applies brief high voltages to tissue cells and can produce local high voltage electric fields of several hundred volts per centimeter. The local high electric field destroys the cell membrane by forming pores in the cell membrane, wherein the applied electric field is above the cell threshold, thereby leaving the pores unclosed, and such electroporation is irreversible, thereby allowing biomolecular material to exchange across the membrane, resulting in cell necrosis or apoptosis. Since different tissue cells have different voltage penetration thresholds, the high voltage pulse technique can selectively treat myocardial cells (the threshold is relatively low) without affecting other non-target cell tissues (such as nerves, esophagus, blood vessels and blood), and since the time for releasing energy is very short, the pulse technique cannot generate heat effect, thereby avoiding the problems of tissue damage, pulmonary vein stenosis and the like.

The pulse electric field ablation is a non-heat-generating technology, and the damage mechanism is that nano-scale micropores are formed on certain cell membranes through high-frequency electric pulses. Potential advantages of pulsed electric fields for atrial fibrillation ablation include: (1) has tissue selectivity, and can protect surrounding tissues from being damaged; (2) PEF can be released rapidly within a few seconds; (3) no coagulative necrosis and reduced risk of pulmonary vein stenosis.

Disclosure of Invention

At least one embodiment of the present disclosure provides an ablation catheter including a tube assembly and a basket assembly; the pipe assembly comprises a first pipe body and a second pipe body, wherein the first pipe body is arranged in the second pipe body, and the first pipe body and the second pipe body can move relatively along the axis direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket lateral branches, first ends of the basket lateral branches are configured to be connected with first ends of the second pipe bodies, second ends of the basket lateral branches, opposite to the first ends, are configured to be connected with first ends of the first pipe bodies, so that the basket lateral branches at least partially surround the first pipe bodies, and the electrodes are respectively arranged on the basket lateral branches; wherein the plurality of basket side branches are configured as: the first end of the first tube and the first end of the second tube are spaced apart by a predetermined distance to assume an initial state, and the plurality of basket sidebranches may be first deformed to assume a first predetermined state when the first tube is moved in the axial direction relative to the second tube.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which, in the first predetermined state, intermediate portions of the plurality of basket side branches project away from the first tubular body; wherein the intermediate portions of the plurality of basket side branches are respectively located between the first and second ends of the plurality of basket side branches.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which the basket is deformed to assume a second predetermined state when the first tube is moved relative to the second tube along the axial direction until the first tube is substantially retracted into the second tube.

For example, at least one embodiment of the present disclosure provides an ablation catheter further comprising: an end cap assembly connected to the first end of the first tube and the second end of the plurality of basket sidebranches.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which, in the second predetermined state, the middle portions of the plurality of basket limbs are located on a side of the first and second ends of the plurality of basket limbs that is distal from the second tubular body to at least partially surround the endcap assembly.

For example, at least one embodiment of the present disclosure provides an ablation catheter, wherein the basket assembly further comprises: a basket base, wherein the first ends of the plurality of basket sidebranches are connected with the basket base, which is connected with the first end of the second tube.

For example, at least one embodiment of the present disclosure provides an ablation catheter wherein, for at least one basket sidebranch of the plurality of basket sidebranches, a line connecting a first connection point of a first end of the basket sidebranch on the basket base and a second connection point of a second end of the basket sidebranch on the endcap assembly is non-parallel to the axial direction.

For example, in the ablation catheter provided by at least one embodiment of the present disclosure, an orthographic projection of the endcap assembly on a first plane perpendicular to the axial direction is a first orthographic projection, a line connecting an orthographic projection of the first connection point on the first plane and a center of the first orthographic projection and a line connecting an orthographic projection of the second connection point on the first plane and a center of the first orthographic projection form a first angle, and the first angle is 50 degrees to 180 degrees.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which the first angle is 90-120 degrees.

For example, in the ablation catheter provided by at least one embodiment of the present disclosure, the plurality of basket limbs are obliquely arranged relative to the basket base, and each of the plurality of basket limbs forms a second included angle with the basket base, where the second included angle is 70 degrees to 90 degrees.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which, in the first predetermined state, there is at least one plane parallel to the axial direction, and an orthographic projection of at least one of the plurality of basket limbs on the at least one plane is linear.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which, in the first predetermined state, for any plane parallel to the axial direction, an orthographic projection of each of the plurality of basket limbs on the any plane is curved.

For example, at least one embodiment of the present disclosure provides an ablation catheter wherein the plurality of basket sidebranches comprises 4-6 basket sidebranches.

For example, in the ablation catheter provided in at least one embodiment of the present disclosure, the basket assembly further includes a plurality of basket insulating tubes, a plurality of basket sleeves, and a plurality of wires, the basket insulating tubes are respectively sleeved on the basket side branches, the basket sleeves are respectively sleeved on the basket insulating tubes, the wires are respectively disposed between the basket insulating tubes and the basket sleeves, wherein the electrodes are respectively disposed on the basket sleeves, the basket sleeves are respectively provided with through holes, and the electrodes are respectively electrically connected to the wires through the through holes on the basket sleeves.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which the plurality of wires extend between the first tube and the second tube.

For example, in an ablation catheter provided in at least one embodiment of the present disclosure, the catheter assembly further includes an intermediate catheter body disposed between the first catheter body and the second catheter body, the intermediate catheter body forming a first channel with the first catheter body and a second channel with the second catheter body; the plurality of wires extend to at least one of the first channel and the second channel.

For example, at least one embodiment of the present disclosure provides an ablation catheter further comprising: the developing assembly comprises a first developing element and a second developing element, wherein the first developing element is arranged at the first end of the first pipe body, and the second developing element is arranged at the first end of the second pipe body.

For example, at least one embodiment of the present disclosure provides an ablation catheter in which the second visualization element is annular, the second tube has a retracted portion at a first end of the second tube, and the second visualization element is sleeved on the retracted portion; the tube body assembly further comprises a connecting tube, and the connecting tube is at least sleeved on the second developing element.

For example, in an ablation catheter provided by at least one embodiment of the present disclosure, the end cap assembly includes an end cap base and an end cap, the end cap base is connected to the second ends of the basket limbs and has a recess at least at one end away from the basket limbs, and the end cap has a protrusion, wherein the first visualization element is ring-shaped, the first visualization element is sleeved on the protrusion, and the recess is sleeved on the first visualization element.

At least one embodiment of the present disclosure further provides an ablation device, including any one of the ablation catheters described above, and an adjustment assembly, where the adjustment assembly includes an adjustment button connected to the first tubular body of the ablation catheter, so as to control the relative state of the first tubular body and the second tubular body.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.

Fig. 1A is an exploded schematic view of an ablation catheter provided in accordance with at least one embodiment of the present disclosure;

fig. 1B is an elevation view of an ablation catheter provided in accordance with at least one embodiment of the present disclosure in an initial state;

fig. 2A and 2B are front and side views, respectively, of an ablation catheter provided in accordance with at least one embodiment of the present disclosure in a first predetermined state;

fig. 3A and 3B are front and side views, respectively, of an ablation catheter provided in accordance with at least one embodiment of the present disclosure in a second predetermined state;

fig. 4 is a schematic view of a basket and basket base in an ablation catheter provided in accordance with at least one embodiment of the present disclosure;

fig. 5A-5C are front and side views, respectively, of a basket in an ablation catheter provided in accordance with at least one embodiment of the present disclosure and a side view of a basket assembly having a basket insulator, a basket sleeve, and a plurality of electrodes disposed thereon;

FIGS. 6A-6C are front and side views, respectively, of a basket in another ablation catheter provided in accordance with at least one embodiment of the present disclosure and a side view of a basket assembly having a basket insulator, a basket sleeve, and a plurality of electrodes disposed thereon;

FIGS. 7A-7C are front and side views, respectively, of a basket in yet another ablation catheter provided in accordance with at least one embodiment of the present disclosure and a side view of a basket assembly having a basket insulator, a basket sleeve, and a plurality of electrodes disposed thereon;

fig. 8A-8B are front and side views, respectively, of a basket in an ablation catheter provided in accordance with at least one embodiment of the present disclosure;

fig. 9A-9B are front and side views, respectively, of a basket in another ablation catheter provided in accordance with at least one embodiment of the present disclosure;

fig. 10A-10B are front and side views, respectively, of a basket in another ablation catheter provided in accordance with at least one embodiment of the present disclosure;

11A-11C are front and side views, respectively, of a basket in yet another ablation catheter provided in accordance with at least one embodiment of the present disclosure and a front view of the ablation catheter in a second predetermined state;

12A-12C are front and side views, respectively, of a basket in yet another ablation catheter provided in accordance with at least one embodiment of the present disclosure and a front view of the ablation catheter in a second predetermined state;

fig. 13A-13B are front and side views, respectively, of an ablation catheter provided in accordance with at least one embodiment of the present disclosure in a first predetermined state;

fig. 14A and 14B are front and side views, respectively, of an ablation catheter provided in accordance with at least one embodiment of the present disclosure in a second predetermined state;

fig. 15 is a schematic structural view of an ablation device provided in accordance with at least one embodiment of the present disclosure; and

fig. 16 is a schematic view of an adjustment assembly of an ablation device according to at least one embodiment of the present disclosure.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.

Unless otherwise defined, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The use of "first," "second," and similar terms in this disclosure is not intended to indicate any order, quantity, or importance, but rather is used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

The inventor of the present disclosure has found that some pulse ablation catheters mainly use one or more flexible electrode arms, mostly in the shape of basket or flower, and have the following disadvantages:

(1) the basket-shaped ablation catheter is complicated in flower-forming shape operation process, the inner structure is complex, the inner tube is pulled down while the outer tube is twisted, so that the twisting of the basket is realized by applying external force to the basket to form a flower shape, the deformation of the basket in the mode is the superposed effect of two forces, namely the superposed effect of the twisting force and the pulling force, the catheter is complex in structure and the formed flower shape is very unstable, only the pipe can adjust the better flower shape under specific conditions, and if the outer tube is bent and deformed, the flower shape cannot be formed or the formed flower shape cannot meet the requirements.

(2) The complex structure is arranged in the outer pipe, so that the outer pipe is twisted to achieve a flower-shaped form, and other functions such as bending adjusting function can not be arranged on the outer pipe, so that the catheter has no bending adjusting function.

At least one embodiment of the present disclosure provides an ablation catheter and an ablation device, the ablation catheter including a tube assembly and a basket assembly; the pipe assembly comprises a first pipe body and a second pipe body, the first pipe body is arranged in the second pipe body, and the first pipe body and the second pipe body can move relatively along the axis direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket lateral branches, first ends of the basket lateral branches are connected with a first end of the second pipe body, second ends, opposite to the first ends, of the basket lateral branches are connected with a first end of the first pipe body, so that the basket lateral branches at least partially surround the first pipe body, and the electrodes are arranged on the basket lateral branches respectively; wherein the plurality of basket side branches are configured as: the first end of the first tubular body and the first end of the second tubular body are spaced apart by a predetermined distance to assume an initial state, and the plurality of basket sidebranches are first deformable to assume a first predetermined state when the first tubular body is moved in the axial direction relative to the second tubular body.

The ablation catheter provided by the embodiment of the disclosure can simply realize the change of the state of the ablation catheter through the relative movement of the first tube body and the second tube body along the axial direction, the ablation catheter has a simple structure, is convenient to operate, and forms a first preset state which is more stable, thereby being beneficial to the ablation operation.

The ablation catheter and ablation device of the present disclosure are described below in terms of several specific embodiments.

At least one embodiment of the present disclosure provides an ablation catheter, with fig. 1A showing an exploded view of the ablation catheter, fig. 1B showing a view of the ablation catheter in an initial state, and fig. 2A and 2B showing front and side views, respectively, of the ablation catheter in a first predetermined state.

As shown in fig. 1A-2B, the ablation catheter includes a tube assembly, a basket assembly, and the like. The pipe assembly includes a first pipe 11 and a second pipe 12, the first pipe 11 and the second pipe 12 are substantially coaxially arranged (for example, in some cases, radial offset may occur so that the axes of the first pipe 11 and the second pipe 12 do not strictly coincide), for example, the first pipe 11 and the second pipe 12 are arranged along an axial direction X as shown in fig. 1A, the first pipe 11 is arranged inside the second pipe 12, and the first pipe 11 and the second pipe 12 are relatively movable along the axial direction X.

The basket assembly includes a basket including a plurality of basket limbs 21, a first end 21A (a right end of the basket limb 21 in fig. 1A) of the plurality of basket limbs 21 configured to be connected to a first end 12A (a left end of the second tube 12 in fig. 1A) of the second tube 12, and a second end 12B (a left end of the basket limb 21 in fig. 1A) of the plurality of basket limbs 21 opposite the first end 12A configured to be connected to a first end 11A (a left end of the first tube 11 in fig. 1A) of the first tube 11 such that the plurality of basket limbs 21 at least partially surround the first tube 11, and a plurality of electrodes 22. A plurality of electrodes 22 are respectively disposed on the plurality of basket limbs 21 for performing an ablation operation.

The plurality of basket side branches 21 are configured as: the initial state is assumed with the first end 11A of the first tubular body 11 and the first end 12A of the second tubular body 12 spaced apart by a predetermined distance substantially equal to the maximum distance by which the first end 11A of the first tubular body 11 and the first end 12A of the second tubular body 12 can be spaced apart and substantially equal to the maximum distance by which each basket sidebranch 21 extends in the axial direction X, at which time the plurality of basket sidebranches 21 are gathered, the entirety of the plurality of basket sidebranches 21 having a small diameter, for example, substantially equal to or slightly smaller than the inner diameter of the second tubular body 12; at this time, the entirety of the plurality of basket side branches 21 may assume a straight state, a nearly straight state, or a curved state along with the bending of the second tube 12, and fig. 1B shows the straight state as an example, and at this time, the diameter of the entirety of the basket is small, so as to facilitate the entry of the object to be ablated; as shown in fig. 2A and 2B, in the case where the first pipe 11 is moved in the axial direction X relative to the second pipe 12, that is, the distance between the first end 11A of the first pipe 11 and the first end 12A of the second pipe 12 is decreased, and the first pipe 11 is retracted into the second pipe 12, the plurality of basket side branches 21 may be deformed, for example, assume the first predetermined state under the first deformation.

For example, the plurality of basket side branches 21 are subjected to a predetermined setting process in advance, for example, a heat setting process using a mold having a shape corresponding to the first predetermined state, so that the first deformation can easily occur in the case where the first pipe 11 is moved in the axial direction X with respect to the second pipe 12, and the first predetermined state is assumed. For example, in some embodiments, in the case where the first tubular body 11 is moved in the axial direction X relative to the second tubular body 12 through the presetting process, the basket may only have a deformation tendency of a first deformation, thereby it is possible to avoid a complicated structure and a complicated operation of adjusting the basket shape by applying various external forces to the basket and problems of the basket shape being difficult to reach a predetermined state, difficult to stably and accurately form the predetermined state, thereby causing an ablation operation failure, and the like.

For example, as shown in fig. 2A and 2B, in the first predetermined state, the intermediate portions 21C of the plurality of basket side branches 21 protrude in a direction away from the first tubular body 11, and the intermediate portions 21C of the plurality of basket side branches 21 are respectively located between the first ends 21A and the second ends 21B of the plurality of basket side branches 21. For example, in the first predetermined condition, the overall diameter of the basket may be 20mm-35mm, such as 25mm, 28mm, 30mm or 32mm, etc. At this point, the basket may perform a supporting function and the electrodes 22 may perform an ablation operation when energized.

For example, as shown in fig. 3A and 3B, in the case where the first tube 11 is moved relative to the second tube 12 in the axial direction X until the first tube 11 is substantially retracted into the second tube 12, the basket undergoes a second deformation to assume a second predetermined state. In the second predetermined condition, the first and second ends 21A, 21B of the plurality of basket side branches 21 are close, e.g., touching or spaced only a small distance apart. In the second predetermined condition, the overall diameter of the basket may be 20mm-35mm, such as 25mm, 28mm, 30mm or 32 mm. The basket may now perform the supporting function in another configuration.

For example, in the process of manufacturing the basket, the basket may be pre-shaped into the first predetermined state (also referred to as a deflected state) and the second predetermined state (also referred to as a flower type state) by a pre-shaping process such as heat-shaping, so as to facilitate the transformation of the different states of the basket by simply relatively moving the first tubular body 11 and the second tubular body 12 along the axial direction X, so as to avoid the formation of other unexpected forms on the basket to affect the ablation operation.

For example, during the use of the ablation catheter, the ablation catheter can be controlled to enter an object to be ablated, such as a pulmonary vein, in an initial state (e.g., a flat state or a nearly flat state), and after reaching a target position, the ablation catheter is controlled to assume a first predetermined state or a second predetermined state to perform an ablation operation. For example, in some embodiments, pulmonary vein isolation may also be determined in conjunction with a mapping guide (e.g., a mapping catheter or a mapping guidewire), so that the target location may be found more accurately and quickly.

For example, in some embodiments, as shown in fig. 1A-3B, the ablation catheter may further include an endcap assembly 30, the endcap assembly 30 coupled to the first end 11A of the first tube 11 and the second ends 21B of the plurality of basket limbs 21 to secure the first end 11A of the first tube 11 and the second ends 21B of the plurality of basket limbs 21.

For example, as shown in fig. 3A and 3B, in the second predetermined state, the middle portion 21C of the plurality of basket limbs 21 is located on a side of the first end 21A and the second end 21B of the plurality of basket limbs 21 away from the second tube 12 to at least partially surround the end cap assembly 30. That is, the central portions 21C of the plurality of basket limbs 21 are inclined away from the second tubular body 12 to cover the end cap assembly 30 to prevent the end cap assembly 30 from abrading an object to be ablated.

For example, in some embodiments, as shown in fig. 1A, the basket assembly may further comprise a basket base 23, the first end 21A of the plurality of basket sidebranches 21 is connected to the basket base 23, and the basket base 23 is connected to the first end 12A of the second tube 12, thereby achieving a stable connection of the first end 21A of the plurality of basket sidebranches 21 to the first end 12A of the second tube 12.

For example, in some embodiments, the plurality of basket limbs 21 are integral with the basket base 23. For example, a metal sheet or an alloy sheet or the like may be used as a raw material in the manufacturing process, and the plurality of basket side branches 21 may be formed by cutting or dicing the metal sheet or the alloy sheet. For example, the basket may be made of nitinol. For example, in some examples, the basket is cut at an angle from a nickel titanium tube. The basket base 23 may be firmly connected to the second tube 12 by gluing, hot melting, welding, and the like, and the second ends 21B of the basket side branches 21 may be firmly connected to the end cap assembly 30 by mechanical, gluing, hot melting, injection molding, and the like.

For example, fig. 4 shows a schematic view of a plurality of basket side branches and a basket base, as shown in fig. 4, the plurality of basket side branches 21 are obliquely arranged relative to the basket base 23, and each of the plurality of basket side branches 21 forms a second included angle a with the basket base 23, and the second included angle a may be 70 degrees to 90 degrees, such as 75 degrees, 80 degrees, or 85 degrees, and the like.

For example, in some embodiments, the plurality of basket limbs 21 may be connected between the end cap assembly 30 and the second tube 12 in a deflecting/rotating manner, i.e., the plurality of basket limbs 21 extend in a direction different from the axial direction X of the first tube 11 and the second tube 12. For example, as shown in fig. 2A, for at least one basket sidebranch 21 of the plurality of basket sidebranches 21, e.g., each basket sidebranch 21, a line C connecting a first connection point C1 of the first end 21A of the basket sidebranch 21 on the basket base 23 and a second connection point C2 of the second end 21B of the basket sidebranch 21 on the end cap assembly 30 is not parallel to, i.e., at an angle relative to, the axial direction X.

Therefore, the basket side branches 21 have longer extension paths between the first connecting point C1 and the second connecting point C2, and the supporting and ablating range of each basket side branch 21 is wider, so that a wider supporting and ablating operation can be realized by arranging fewer basket side branches 21.

For example, in some embodiments, the plurality of basket sidebranches 21 includes 4-6 basket sidebranches, five basket sidebranches being shown as an example. For example, each basket side branch 21 is sheet-shaped, that is, each basket side branch 21 has a rectangular or nearly rectangular cross section.

For example, as shown in fig. 1A, the basket assembly may further include a plurality of basket insulating tubes 24, a plurality of basket sleeves 25, and a plurality of wires 26. A plurality of basket insulating tubes 24 are established respectively on a plurality of basket side branches 21, and a plurality of basket sleeve pipes 25 are established respectively on a plurality of basket insulating tubes 24, and a plurality of wires 26 set up respectively between a plurality of basket insulating tubes 24 and a plurality of basket sleeve pipes 25. For example, the plurality of basket insulating tubes 24 and the plurality of basket bushings 25 are each made of an insulating material, such as an organic insulating material. The basket insulating tube 24 may be a basket heat shrink tube.

For example, as shown in fig. 1A and 1B, the plurality of electrodes 22 are respectively disposed on the plurality of basket sleeves 25, the plurality of basket sleeves 25 are respectively provided with through holes 25A (one through hole 25A is shown in fig. 1A as an example), and the plurality of electrodes 22 are respectively electrically connected to the plurality of wires 26 through the through holes 25A of the plurality of basket sleeves 25, so that the plurality of electrodes 22 can transmit electrical signals through the plurality of wires 26 to perform an ablation operation.

For example, a plurality of electrodes 22, e.g., 2-8 electrodes 22, e.g., 3, 4, 5, 6, or 7, etc., may be provided on each basket sidebranch 21 to achieve sufficient ablation. The number of the electrodes 2 on each basket side branch 21 can be the same or different. In the embodiment of fig. 1A, 4 electrodes 22 are shown as an example disposed on each basket sidebranch 21.

For example, the electrode 22 may be made of a metal material or an alloy material with good electrical conductivity, such as platinum-iridium alloy in some examples. The electrode 22 may be formed as an electrode ring that fits over the basket sleeve 25. For example, the length of each electrode 22 may be 1.0mm-3.0mm, such as 1.5mm, 2mm, or 2.5mm, and the length of each electrode 22 may be the same or different.

For example, referring to fig. 1A, a plurality of wires 26 extend between the first tube 11 and the second tube 12 to facilitate connection to a power source at the other end of the first tube 11 and the second tube 12 opposite the first end. Thus, the plurality of wires 26 are not exposed throughout the ablation catheter to avoid electrical leakage.

For example, in some embodiments, as shown in fig. 1A, the tube assembly may further include an intermediate tube 13 disposed between the first tube 11 and the second tube 12, the intermediate tube 13 forming a first passageway with the first tube 11, and the intermediate tube 13 forming a second passageway with the second tube 12. For example, the plurality of wires 26 extend to at least one of the first and second channels.

For example, in some examples, the plurality of leads 26 extend in one of a first channel and a second channel, and the other of the first channel and the second channel may be used to provide a solution, such as a catheter, for delivering the solution. For example, in one example, a first channel is used to provide a solution as required for heparin/saline, etc., and a second channel is used to extend the lead 26.

For example, in some embodiments, the tubing of the first tube 11, the second tube 12, and the intermediate tube 13 may be made of a polymer material, such as PEBAX, TPU, Nylon, etc., which has a certain flexibility to facilitate bending of the tubing to facilitate reaching the target location of the ablation catheter. For example, the second tube 12 may have a size of 8F-12F, i.e., the second tube 12 may have a diameter of 8mm-12mm, such as 9mm, 10mm, or 11mm, etc. For example, the tubing may be braided with stainless steel to provide support strength.

For example, in some embodiments, as shown in fig. 1A, the ablation catheter further comprises a visualization assembly comprising a first visualization element 41 and a second visualization element 42, the first visualization element 41 being disposed at the first end 11A of the first tube 11 and the second visualization element 42 being disposed at the first end 12A of the second tube 12. The first and second developing

elements

41 and 42 may perform the functions of developing marks, positioning basket positions, and the like.

For example, in some embodiments, as shown in fig. 1A, the second developing element 42 is ring-shaped, the second tube 12 has a recessed portion 12B at the first end 12A of the second tube 12, and the second developing element 42 is disposed on the recessed portion 12B. For example, the pipe assembly further includes a connection pipe 14, and the connection pipe 14 is at least sleeved on the second developing element 42 to cover the second developing element 42, so that the second developing element 42 is not exposed, as shown in fig. 1B.

For example, in some embodiments, as shown in fig. 1A, the end cap assembly 30 includes an end cap base 31 and an end cap 32, the end cap base 31 is connected to the second end 21B of the plurality of basket limbs 21 and has a recess 31A at least at an end remote from the plurality of basket limbs 21, the recess 31A may be in the form of a blind hole or a through hole, for example, as shown in fig. 1A as an example. The end cap 32 has a protrusion 32A, the first developing element 41 is ring-shaped, the first developing element 41 is fitted over the protrusion 32A, and the recess 31A is fitted over the first developing element 41, thereby covering the first developing element 41 without exposing the first developing element 41, as shown in fig. 1B.

For example, in some embodiments, the end cap base 31 and the end cap 32 may also be made of a polymer material, such as PEBAX, TPU, Nylon, and the like.

For example, in some embodiments, the deflection angle of the basket side branches 21 may be designed for better morphology and support.

For example, as shown in fig. 5A-7C, an orthographic projection of the endcap assembly 30 on a first plane perpendicular to the axial direction X (which can refer to any plane perpendicular to the axial direction X) is a first orthographic projection P1, e.g., the first orthographic projection P1 can be circular or other rounded patterns, such as rounded squares, etc. The connection point of the first end 21A of the basket side branch 21 on the basket base 23 is a first connection point C1, the connection point of the second end 21B of the basket side branch 21 on the end cap assembly 30 is a second connection point C2, a connection line between an orthographic projection of the first connection point C1 on the first plane and the center O of the first orthographic projection and a connection line between an orthographic projection of the second connection point C2 on the first plane and the center O of the first orthographic projection form a first angle, that is, the deflection angle of the plurality of basket side branches 21 is the first angle. For example, the first angle is 50 degrees to 180 degrees, such as 70 degrees to 150 degrees. For example, in some embodiments, the first angle may be 90-120 degrees, such as 90, 100, or 120 degrees, etc.

For example, the plurality of basket side branches 21 may be pre-shaped differently, so that the plurality of basket side branches 21 formed in the first predetermined state have different trends (different extending paths), and thus the basket has a better shape and a better supporting effect when the basket is in the first predetermined state.

For example, in the embodiment of fig. 5A to 7C, in the first predetermined state, there is at least one plane parallel to the axis direction X such that an orthographic projection of at least one basket sidebranch 21 of the plurality of basket sidebranches 21 on the at least one plane is linear, for example, in the embodiment of fig. 5A to 7C, the orthographic projection of the basket sidebranch 21 indicated by reference numeral 21 is linear. At this time, the basket side branch 21 has substantially the shortest extension path between the first connection point C1 and the second connection point C2, and the extension paths of the basket side branch 21 between the first connection point C1 and the second connection point C2 may be located on the same plane. The manner of deflection of the baskets shown in fig. 5A-7C is hereinafter referred to as horizontal deflection.

For example, fig. 5A to 5C, 6A to 6C, and 7A to 7C respectively show a front view and a side view of a basket and a basket assembly having a basket insulation tube, a basket bushing, and a plurality of electrodes disposed thereon, wherein the first angle is 70 degrees in the embodiment of fig. 5A to 5C, 100 degrees in the embodiment of fig. 6A to 6C, and 120 degrees in the embodiment of fig. 7A to 7C.

For example, in other embodiments, the baskets may be deflected in other ways. For example, fig. 8A to 10B respectively show a front view and a side view of the basket, and in the embodiment of fig. 8A to 10B, in the first predetermined state, for any plane parallel to the axial direction X, an orthographic projection of each of the plurality of basket side branches 21 on any plane is curved, and the extending paths of the basket side branches 21 between the first connecting point C1 and the second connecting point C2 do not lie on the same plane. At this time, the basket side branch 21 torsionally extends between the first connection point C1 and the second connection point C2, for example, the orthographic projection of each of the plurality of basket side branches 21 on any one of the above planes is S-shaped, C-shaped, or wave-shaped, and the like, and at this time, the basket side branch 21 has a long extending path between the first connection point C1 and the second connection point C2. The manner of deflection of the baskets shown in fig. 8A-10B is hereinafter referred to as helical deflection.

For example, in embodiments of the present disclosure, the helically deflected baskets may provide a very plump pattern relative to horizontally deflected baskets, but relatively poor support, basket sidebranches 21 tend to collapse inward or deflect sideways, which may make it difficult to provide a stable configuration and sufficient support for ablation against a target site. Compared with a net basket deflected spirally, the net basket deflected horizontally can provide good support, but the pattern is not full, but an ideal pattern can be achieved through the design of the deflection angle.

For example, it has been experimentally determined that a horizontally deflecting basket with a deflection angle of 120 °, i.e., the basket shown in fig. 7A-7C, can provide good support while having a plump pattern to achieve sufficient support and ablation effect, and fig. 2A and 2B illustrate the state of the ablation catheter in a first predetermined state in this case, and fig. 3A and 3B illustrate the state of the ablation catheter in a second predetermined state in this case. As can be seen from fig. 2A and 2B and fig. 3A and 3B, in both states, the baskets have a very plump flower type, which provides good support for the ablation operation to be performed adequately.

For example, the form stability and support properties can be improved by changing the deflection of the basket side branches 21 of a spirally deflected basket. For example, fig. 11A-11C show schematic views of another helically deflected lower basket, and fig. 12A-12C show schematic views of yet another helically deflected lower basket. Fig. 11A-11C and 12A-12C show front and side views, respectively, of a basket and a basket assembly with a basket insulating tube, a basket sleeve, and a plurality of electrodes disposed thereon in a second predetermined state.

The deflection paths of fig. 11A-11C and 12A-12C are slightly different compared to the deflection patterns of fig. 8A-10B, with the basket sidebranches 21 of the baskets of fig. 11A-11C and 12A-12C having a greater deflection angle in the middle portion.

For example, as shown in fig. 11A-11C, the deflection angle of the basket is 120 degrees (i.e., the first angle is 120 degrees), the basket has a large deflection angle in the middle portion, and in the second predetermined state, the flower pattern formed by the plurality of basket limbs 21 is substantially perpendicular to the axial direction X, and the plurality of basket limbs 21 do not wrap the end cap assembly 30. For example, as shown in fig. 12A-12C, the deflection angle of the basket is 90 degrees (i.e., the first angle is 90 degrees), the basket has a large deflection angle in the middle portion, and in a second predetermined state, the flower-type clad end cap assembly 30 formed by the plurality of basket limbs 21.

The flower type deflection forms are different mainly in that the shaping trend and the deflection angle of side branches of the net basket are adjusted so as to present different flower type effects, the plump degree of the flower type can be adjusted by adjusting the deflection angle, and the trend of petals can be tilted upwards through material object assembly; to the pre-shaping basket, the trend of the side branch of the flower pattern can be adjusted, the trend of the petal can be upwards tilted to cover the length of the end cover component 30, the purpose of hiding the head is realized, and the ablation operation is beneficial, because the flower pattern is attached to the situation that the end cover component 30 is contacted with the tissue and the basket side branch can not be contacted with the tissue when ablating the house wall, the pulmonary vein can be ablated, and the house wall can be ablated. Thus, the baskets shown in fig. 12A-12C are more widely applicable than the embodiment of fig. 11A-11C.

For example, fig. 13A and 13B illustrate front and side views of the basket-configured ablation catheter of fig. 12A-12C in a first predetermined configuration, and fig. 14A and 14B illustrate front and side views of the basket-configured ablation catheter of fig. 12A-12C in a second predetermined configuration. As shown in fig. 13A and 13B and fig. 14A and 14B, the ablation catheter has a fuller pattern in both the first predetermined state and the second predetermined state, which provides stable support.

In summary, in the ablation catheter provided in the embodiments of the present disclosure, the basket can simply realize the change of the state of the ablation catheter by the relative movement of the first tube and the second tube along the axial direction, the ablation catheter has a simple structure and is convenient to operate, the formed first predetermined state and the second predetermined state are more stable, and the basket can have good support and stable patterns under the above states, thereby facilitating the ablation operation.

At least one embodiment of the present disclosure also provides an ablation device, a structural schematic diagram of which is shown in fig. 15, and which includes an ablation catheter of any of the above and an adjustment assembly 50, as shown in fig. 15. For example, fig. 16 shows a schematic structural view of an adjustment assembly, and as shown in fig. 16, the adjustment assembly 50 includes an adjustment button 51 connected to the first tube 11 of the ablation catheter to control the relative state of the first tube 11 and the second tube 12.

For example, the adjustment button 51 may be in the form of a push rod, such that by pushing and pulling the first tube 11 in the second tube 12, a movement of the first tube 11 relative to the second tube 12 is achieved, thereby enabling a transition to different states of the ablation catheter, such as a straight device (initial state), a first predetermined state and a second predetermined state as shown in fig. 15.

For example, the adjustment button 51 is stably connected to a second end of the first tube 11 opposite to the first end 11A by bonding or welding. For example, a second end of the second tube 12 opposite to the first end 12A is stably connected to the end 50A of the adjusting assembly 50 by bonding, heat fusing, or welding.

For example, in some embodiments, as shown in fig. 16, the adjustment assembly 50 may further include a bend adjustment knob 52, whereby bi-directional bending of the ablation catheter may be achieved to control the ablation catheter to facilitate entry into the object to be ablated. For example, two control wires (not shown) are disposed on the inner wall of the second tube 12, and the two control wires are disposed opposite to each other, and when the bending adjustment knob 52 is rotated, the two control wires are driven to contract, so as to drive the second tube 12 to deflect and bend, and thus drive the ablation catheter to perform deflection adjustment. For example, as shown in fig. 15, the bend adjustment knob 52 may adjust the ablation catheter to bend up and down relative to the phantom line.

For example, as shown in FIG. 16, the adjustment assembly 50 may further include a lead connector 53 and a catheter connector 54, etc., wherein the lead connector 53 may be connected to a power source to provide an electrical signal to the electrode 22 via the lead 26, and the catheter connector 54 may be connected to a source of a desired solution, such as heparin/saline, to provide the desired solution, such as heparin/saline, etc.

For example, the ablation device may also include other structures, which are not limited by the embodiments of the present disclosure, and reference may be made to the related art.

At least one embodiment of the present disclosure also provides a method of operation based on an ablation device, including one or more of the following procedures (or steps):

step S1: the coronary sinus electrode is placed in position via the jugular vein or the femoral vein.

Step S2: atrial septal puncture and left atrial and pulmonary vein angiography were performed through the right femoral vein.

Step S3: the pulse ablation delivery system is replaced.

Step S4: and feeding the ablation catheter. For example, the ablation catheter is delivered to a target site, such as a pulmonary vein, in an initial state (e.g., in a straightened or nearly straightened state).

Step S5: the ablation catheter reaches the target location and the basket configuration is adjusted, such as by adjusting the ablation catheter to assume the first predetermined configuration or the second predetermined configuration using adjustment assembly 50, to perform the ablation procedure.

For example, the ablation device may perform other operations in addition to those described above and will not be described in detail herein.

The following points need to be explained:

(1) the drawings of the embodiments of the disclosure only relate to the structures related to the embodiments of the disclosure, and other structures can refer to the common design.

(2) For purposes of clarity, the thickness of layers or regions in the figures used to describe embodiments of the present disclosure are exaggerated or reduced, i.e., the figures are not drawn on a true scale.

(3) Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.

The above is only a specific embodiment of the present disclosure, but the scope of the present disclosure is not limited thereto, and the scope of the present disclosure should be determined by the scope of the claims.

Claims

1. An ablation catheter comprising:

the pipe assembly comprises a first pipe body and a second pipe body, wherein the first pipe body is arranged in the second pipe body, and the first pipe body and the second pipe body can move relatively along the axis direction;

a basket assembly comprising a basket and a plurality of electrodes, wherein the basket comprises a plurality of basket limbs, first ends of the plurality of basket limbs are configured to be connected to a first end of the second tube, second ends of the plurality of basket limbs opposite the first ends are configured to be connected to a first end of the first tube such that the plurality of basket limbs at least partially surround the first tube, and the plurality of electrodes are disposed on the plurality of basket limbs, respectively;

wherein the plurality of basket side branches are configured as: the first end of the first tube and the first end of the second tube are spaced apart by a predetermined distance to assume an initial state, and the plurality of basket sidebranches may be first deformed to assume a first predetermined state when the first tube is moved in the axial direction relative to the second tube.

2. The ablation catheter of claim 1, wherein in the first predetermined state, intermediate portions of the plurality of basket sidebranches project away from the first tubular body;

wherein the intermediate portions of the plurality of basket side branches are respectively located between the first and second ends of the plurality of basket side branches.

3. The ablation catheter of claim 1 or 2, wherein the basket is second deformed to assume a second predetermined state upon movement of the first tube relative to the second tube in the axial direction to a point where the first tube is substantially retracted within the second tube.

4. The ablation catheter of claim 3, further comprising:

an end cap assembly connected to the first end of the first tubular body and the second end of the plurality of basket sidebranches.

5. The ablation catheter of claim 4, wherein in the second predetermined state, the medial portion of the plurality of basket limbs is located on a side of the first and second ends of the plurality of basket limbs distal from the second tubular body to at least partially surround the endcap assembly.

6. The ablation catheter of claim 5, wherein the basket assembly further comprises:

a basket base, wherein the first ends of the plurality of basket side branches are connected with the basket base, which is connected with the first end of the second tube.

7. The ablation catheter of claim 6, wherein, for at least one basket sidebranch of the plurality of basket sidebranches,

a line connecting a first connecting point of the first end of the basket side branch on the basket base and a second connecting point of the second end of the basket side branch on the end cover assembly is not parallel to the axial direction.

8. The ablation catheter of claim 7, wherein an orthographic projection of the endcap assembly on a first plane perpendicular to the axial direction is a first orthographic projection,

a connecting line of the orthographic projection of the first connecting point on the first plane and the center of the first orthographic projection forms a first angle with a connecting line of the orthographic projection of the second connecting point on the first plane and the center of the first orthographic projection, and the first angle is 50-180 degrees.

9. The ablation catheter of claim 8, wherein the first angle is 90-120 degrees.

10. The ablation catheter of claim 6, wherein the plurality of basket limbs are obliquely disposed relative to the basket base, and each of the plurality of basket limbs is at a second included angle with the basket base, the second included angle being 70-90 degrees.

11. The ablation catheter of claim 1 or 2, wherein in the first predetermined state there is at least one plane parallel to the axial direction on which an orthographic projection of at least one of the plurality of basket limbs is rectilinear.

12. The ablation catheter of claim 1 or 2, wherein, in the first predetermined state, for any plane parallel to the axial direction, an orthographic projection of each of the plurality of basket limbs on said any plane is curvilinear.

13. The ablation catheter of claim 1 or 2, wherein the plurality of basket sidebranches comprises 4-6 basket sidebranches.

14. The ablation catheter of claim 1 or 2, wherein the basket assembly further comprises:

a plurality of basket insulating pipes which are respectively sleeved on the plurality of basket side branches,

a plurality of basket sleeves respectively sleeved on the basket insulating pipes, and

a plurality of wires respectively disposed between the plurality of basket insulating tubes and the plurality of basket bushings,

the electrodes are respectively arranged on the plurality of basket sleeves, through holes are respectively formed in the basket sleeves, and the electrodes are electrically connected with the wires through the through holes in the basket sleeves.

15. The ablation catheter of claim 14, wherein the plurality of wires extend between the first tube and the second tube.

16. The ablation catheter of claim 14, wherein the catheter assembly further comprises an intermediate catheter body disposed between the first catheter body and the second catheter body, the intermediate catheter body forming a first channel with the first catheter body and a second channel with the second catheter body;

the plurality of wires extend to at least one of the first channel and the second channel.

17. The ablation catheter of claim 5, further comprising:

a developing assembly including a first developing member and a second developing member,

the first developing element is arranged at the first end of the first pipe body, and the second developing element is arranged at the first end of the second pipe body.

18. The ablation catheter of claim 17, wherein the second visualization element is ring-shaped, the second tube having a recessed portion at a first end of the second tube, the second visualization element being sleeved over the recessed portion;

the tube body assembly further comprises a connecting tube, and the connecting tube is at least sleeved on the second developing element.

19. The ablation catheter of claim 18, wherein the endcap assembly comprises:

an end cap base connected to the second ends of the basket limbs and having a recess at least at one end remote from the basket limbs, an

An end cap having a protrusion portion, wherein,

the first developing element is annular, the first developing element is sleeved on the protruding portion, and the recessed portion is sleeved on the first developing element.

20. An ablation device, comprising:

the ablation catheter of any of claims 1-19, and

and the adjusting component comprises an adjusting button connected with the first tube body of the ablation catheter so as to control the relative state of the first tube body and the second tube body.