CN115105188B

CN115105188B - Ablation catheters and ablation devices

Info

Publication number: CN115105188B
Application number: CN202210728023.9A
Authority: CN
Inventors: 罗中宝; 代聪育; 张朕华
Original assignee: Shanghai Ruidao Medical Technology Co ltd
Current assignee: Shanghai Ruidao Medical Technology Co ltd
Priority date: 2022-06-23
Filing date: 2022-06-23
Publication date: 2024-11-12
Anticipated expiration: 2042-06-23
Also published as: CN115105188A

Abstract

An ablation catheter and an ablation device, the ablation catheter comprises a tube assembly and a basket assembly; the tube assembly comprises a first tube body and a second tube body, the first tube body is inside the second tube body, and the first tube body and the second tube body can move relatively along the axial direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket side branches, the first ends of the plurality of basket side branches are configured to be connected to the first end of the second tube body, and the second ends are configured to be connected to the first end of the first tube body, so that the plurality of basket side branches at least partially surround the first tube body, and the plurality of electrodes are respectively arranged on the plurality of basket side branches; the plurality of basket side branches are configured to present an initial state when the first end of the first tube body and the first end of the second tube body are spaced a predetermined distance apart, and when the first tube body moves relative to the second tube body along the axial direction, the plurality of basket side branches can undergo a first deformation to present a first predetermined state. The ablation catheter is easy to operate, and the first predetermined state formed 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 more than ten millions of people worldwide. Radio frequency ablation and cryoablation are two common methods currently used clinically to treat cardiac arrhythmias (such as 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 affects surrounding healthy tissue and neural tissue.

The radio frequency ablation point-by-point type ablation operation time is long, the requirement on the catheter operation level of an operator is high, the patient is uncomfortable in operation, and Pulmonary Vein (PV) stenosis is easy to occur after operation; radiofrequency ablation can disrupt the heart endothelial surface, activate an exogenous coagulation cascade, and lead to coke and thrombosis, which in turn can lead to systemic thromboembolism. Application of rf energy to target tissue can have an effect on non-target tissue, application of rf energy to atrial wall tissue can result in esophageal or nerve damage, and rf ablation can also result in tissue scarring, further leading to embolic 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.

The new technology currently emerging for treating atrial fibrillation is the Pulsed Electric Field (PEF) technology, which applies a brief high voltage to tissue cells and can generate a localized high voltage electric field of several hundred volts per centimeter. The local high electric field disrupts the cell membrane by forming pores in the cell membrane, wherein the applied electric field is above the cell threshold so that the pores are not closed, and such electroporation is irreversible so that the biomolecular material is exchanged across the membrane, resulting in cell necrosis or apoptosis. Because 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 meanwhile, the pulse technique can not generate a thermal effect due to very short energy release time, so that the problems of tissue injury, pulmonary vein stenosis and the like are avoided.

Pulsed electric field ablation is a non-heat-generating technique, and the damage mechanism is to make some cell membranes have nano-scale micropores 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 damage; (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 relatively move along the axial direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket side branches, first ends of the basket side branches are configured to be connected with first ends of the second pipe bodies, second ends of the basket side branches, which are opposite to the first ends, are configured to be connected with first ends of the first pipe bodies, so that the basket side branches at least partially surround the first pipe bodies, and the electrodes are respectively arranged on the basket side branches; wherein the plurality of basket side branches are configured to: the first end of the first pipe body and the first end of the second pipe body are separated by a predetermined distance to present an initial state, and the plurality of basket side branches can be first deformed to present a first predetermined state when the first pipe body moves relative to the second pipe body along the axial direction.

For example, in an ablation catheter provided by at least one embodiment of the present disclosure, in the first predetermined state, intermediate portions of the plurality of basket side branches protrude in a direction away from the first tube body; the middle parts of the basket side branches are respectively positioned between the first ends and the second ends of the basket side branches.

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

For example, at least one embodiment of the present disclosure provides an ablation catheter further comprising: and the end cover assembly is connected with the first end of the first pipe body and the second ends of the basket side branches.

For example, at least one embodiment of the present disclosure provides for an ablation catheter wherein, in the second predetermined state, the intermediate portions of the plurality of basket side branches are located on a side of the first and second ends of the plurality of basket side branches remote from the second tube body to at least partially surround the end cap assembly.

For example, in an ablation catheter provided by at least one embodiment of the present disclosure, the basket assembly further comprises: the net basket base, wherein, a plurality of net basket side branch's first end with the net basket base is connected, the net basket base with the first end of second body is connected.

For example, in an ablation catheter provided in at least one embodiment of the present disclosure, for at least one basket side branch of the plurality of basket side branches, a line connecting a first connection point of the first end of the basket side branch on the basket base and a second connection point of the second end of the basket side branch on the end cap assembly is not parallel to the axial direction.

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

For example, in an ablation catheter provided by at least one embodiment of the present disclosure, the first angle is 90 degrees to 120 degrees.

For example, in the ablation catheter provided in at least one embodiment of the present disclosure, the basket side branches are disposed obliquely with respect to the basket base, and each of the basket side branches and the basket base form a second included angle, and the second included angle is 70 degrees to 90 degrees.

For example, in an ablation catheter provided in at least one embodiment of the present disclosure, 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 side branches on the at least one plane is rectilinear.

For example, at least one embodiment of the present disclosure provides for 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 lateral branches on the any plane is curved.

For example, in an ablation catheter provided by at least one embodiment of the present disclosure, the plurality of basket side branches includes 4-6 basket side branches.

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 pipes, a plurality of basket sleeves, and a plurality of wires, the plurality of basket insulating pipes are respectively sleeved on the plurality of basket side branches, the plurality of basket sleeves are respectively sleeved on the plurality of basket insulating pipes, the plurality of wires are respectively disposed between the plurality of basket insulating pipes and the plurality of basket sleeves, wherein the plurality of electrodes are respectively disposed on the plurality of basket sleeves, the plurality of basket sleeves are respectively provided with through holes, and the plurality of electrodes are respectively electrically connected with the plurality of wires through the through holes on the plurality of basket sleeves.

For example, at least one embodiment of the present disclosure provides for an ablation catheter wherein 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 body assembly further includes an intermediate catheter body disposed between the first catheter body and the second catheter body, a first channel is formed between the intermediate catheter body and the first catheter body, and a second channel is formed between the intermediate catheter body and the second catheter body; the plurality of wires extends 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: and 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, in the ablation catheter provided in at least one embodiment of the present disclosure, the second developing element is annular, the second tube body has a retracted portion at a first end of the second tube body, and the second developing 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 in 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 side branches, and has a recess at least at one end far away from the basket side branches, the end cap has a protrusion, wherein the first developing element is annular, the first developing element is sleeved on the protrusion, and the recess is sleeved on the first developing element.

At least one embodiment of the present disclosure further provides an ablation device including any of the above described ablation catheters and an adjustment assembly including an adjustment button coupled to a first tube of the ablation catheter to control the relative state of the first tube and the second tube.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly described below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure, not to limit 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 a front view of an ablation catheter provided in 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 in a first predetermined state provided in at least one embodiment of the present disclosure;

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

FIG. 4 is a schematic illustration of a basket and basket mount in an ablation catheter provided in accordance with at least one embodiment of the present disclosure;

FIGS. 5A-5C are, respectively, a front view and a side view of a basket in an ablation catheter, and a side view of a basket assembly having basket insulation tubes, basket sleeves, and a plurality of electrodes disposed thereon, in accordance with at least one embodiment of the present disclosure;

FIGS. 6A-6C are, respectively, a front view, a side view 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 basket insulation tubing, basket sleeve, and a plurality of electrodes disposed thereon;

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

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;

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;

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, respectively, a front view, a side view 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;

FIGS. 12A-12C are, respectively, a front view, a side view 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 condition;

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

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

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 structural view of an adjustment assembly of an ablation device provided in accordance with at least one embodiment of the present disclosure.

Detailed Description

For the purpose of making 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 clearly and completely described below with reference to the accompanying drawings of the embodiments of the present disclosure. It will be apparent that the described embodiments are some, but not all, of the embodiments of the present disclosure. All other embodiments, which can be made by one of ordinary skill in the art without the need for inventive faculty, are within the scope of the present disclosure, based on the described embodiments of the present disclosure.

Unless defined otherwise, technical or scientific terms used in this disclosure should be given the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The terms "first," "second," and the like, as used in this disclosure, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

The inventors of the present disclosure have found that the tip of some pulse ablation catheters primarily employ one or more flexible electrode arms, most in the form of baskets and flowers, with the following disadvantages:

(1) The basket-shaped ablation catheter has the advantages that the operation process of forming the pattern is complicated, the inner structure is complex, the inner tube is pulled down while the outer tube is twisted, the outer tube is used for applying external force to the basket to realize twisting of the basket so as to form the pattern, the deformation of the basket in the mode is an effect of superposition of two forces, namely, the effect of superposition of twisting force and tension, the structure of the catheter is complex, the formed pattern is unstable, the better pattern can be adjusted only under specific conditions, and if the outer tube is bent and deformed, the pattern cannot be formed or the formed pattern does not meet the requirements.

(2) Because the complex structure is arranged inside the outer tube, the outer tube is twisted to form a flower shape, and other functions such as bending adjusting function cannot be arranged on the outer tube, 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 relatively move along the axial direction; the basket assembly comprises a basket and a plurality of electrodes, the basket comprises a plurality of basket side branches, first ends of the basket side branches are configured to be connected with first ends of the second pipe bodies, second ends, opposite to the first ends, of the basket side branches are configured to be connected with first ends of the first pipe bodies, so that the basket side branches at least partially surround the first pipe bodies, and the electrodes are respectively arranged on the basket side branches; wherein the plurality of basket side branches are configured to: the first end of the first tube body and the first end of the second tube body are separated by a predetermined distance to present an initial state, and the plurality of basket side branches can be first deformed to present a first predetermined state when the first tube body moves in the axial direction relative to the second tube body.

The ablation catheter provided by the embodiment of the disclosure can change the state of the ablation catheter simply by the relative movement of the first tube body and the second tube body along the axial direction, and has the advantages of simple structure, convenience in operation, and more stable formed first preset state, thereby being beneficial to the ablation operation.

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

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

As shown in fig. 1A-2B, the ablation catheter includes a tube assembly, a basket assembly, and the like. The tube assembly comprises a first tube body 11 and a second tube body 12, the first tube body 11 and the second tube body 12 being arranged substantially coaxially (e.g. in some cases radial offset may occur such that the axes of the first tube body 11 and the second tube body 12 are not exactly coincident), such as shown in fig. 1A as the first tube body 11 and the second tube body 12 being arranged along an axial direction X, the first tube body 11 being arranged inside the second tube body 12, and the first tube body 11 and the second tube body 12 being relatively movable along the axial direction X.

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

The plurality of basket side branches 21 are configured to: an initial state is assumed in a case where the first end 11A of the first pipe body 11 and the first end 12A of the second pipe body 12 are spaced apart by a predetermined distance substantially equal to the farthest distance that the first end 11A of the first pipe body 11 and the first end 12A of the second pipe body 12 can be spaced apart and also substantially equal to the farthest distance that each basket side branch 21 extends in the axial direction X, at which time the plurality of basket side branches 21 are gathered, and the entirety of the plurality of basket side branches 21 has a smaller diameter, for example, substantially equal to or slightly smaller than the inner diameter of the second pipe body 12; at this time, the whole of the basket side branches 21 may take a straight state, a nearly straight state, or a curved state along with the bending of the second tube body 12, fig. 1B shows the straight state as an example, where the basket has a smaller overall diameter so as to be convenient for entering the object to be ablated; as shown in fig. 2A and 2B, in the case where the first pipe body 11 moves in the axial direction X with respect to the second pipe body 12, that is, the distance between the first end 11A of the first pipe body 11 and the first end 12A of the second pipe body 12 decreases, the plurality of basket side branches 21 may be deformed, for example, may take a first predetermined state under the first deformation, in the case where the first pipe body 11 is retracted into the second pipe body 12.

For example, the plurality of basket lateral branches 21 are subjected to a predetermined molding 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 and the first predetermined state is exhibited in the case where the first pipe body 11 is moved in the axial direction X with respect to the second pipe body 12. For example, in some embodiments, since the deformation tendency of the basket can occur only in the case where the first tube body 11 is moved in the axial direction X with respect to the second tube body 12 by the pre-forming process, it is possible to avoid a complicated structure and a complicated operation of adjusting the shape of the basket by applying various external forces thereto and to avoid problems that the shape of the basket is difficult to reach a predetermined state, difficult to stably and accurately form a predetermined state, cause failure of the ablation operation, 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 pipe 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 state, the overall diameter of the basket may be 20mm-35mm, such as 25mm, 28mm, 30mm, 32mm, or the like. At this point, the basket may provide support and the electrode 22 may provide ablation while energized.

For example, as shown in fig. 3A and 3B, in the case where the first pipe body 11 is moved in the axial direction X with respect to the second pipe body 12 to the extent that the first pipe body 11 is substantially retracted into the second pipe body 12, the basket is subjected to a second deformation to assume a second predetermined state. In the second predetermined state, first ends 21A and second ends 21B of the plurality of basket side branches 21 are close, e.g., in contact or only separated by a small distance. In the second predetermined state, the overall diameter of the basket may be 20mm-35mm, such as 25mm, 28mm, 30mm, 32mm, or the like. At this time, the basket may be supported in another form.

For example, in the process of manufacturing the basket, the basket may be pre-shaped into the first predetermined state (may be also referred to as a deflection state) and the second predetermined state (may be also referred to as a flower state) by adopting a pre-shaping process such as heat shaping, so that the transition between the different states of the basket can be accurately realized by simply moving the first tube 11 and the second tube 12 along the axis direction X, so as to avoid that the basket forms other unexpected states to influence the ablation operation.

For example, during use of the ablation catheter, the ablation catheter may be controlled to enter an object to be ablated, such as a pulmonary vein, in an initial state (e.g., a straightened state or a near-straightened state), and after reaching a target location, the ablation catheter may be controlled to assume a first predetermined state or a second predetermined state for performing 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 end cap assembly 30, the end cap assembly 30 being coupled to the first end 11A of the first tube 11 and the second ends 21B of the plurality of basket side branches 21 to secure the first end 11A of the first tube 11 and the second ends 21B of the plurality of basket side branches 21.

For example, as shown in fig. 3A and 3B, in the second predetermined state, the intermediate portions 21C of the plurality of basket side branches 21 are located on the side of the first and second ends 21A, 21B of the plurality of basket side branches 21 remote from the second tube body 12 to at least partially surround the end cap assembly 30. That is, the intermediate portions 21C of the plurality of basket side branches 21 are inclined away from the second tube 12 to cover the end cap assembly 30 to avoid the end cap assembly 30 from abrading the object to be ablated.

For example, in some embodiments, as shown in fig. 1A, the basket assembly may further include a basket base 23, the first ends 21A of the plurality of basket side branches 21 being connected to the basket base 23, the basket base 23 being connected to the first ends 12A of the second tubular bodies 12, thereby achieving a stable connection of the first ends 21A of the plurality of basket side branches 21 to the first ends 12A of the second tubular bodies 12.

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

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

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

Therefore, basket side branches 21 have longer extending paths between first connecting point C1 and second connecting point C2, and the supporting and ablating range of each basket side branch 21 is wider, at this time, a larger supporting and ablating range can be realized by arranging fewer basket side branches 21.

For example, in some embodiments, the plurality of basket branches 21 includes 4-6 basket branches, five basket branches being shown as an example. For example, each basket side branch 21 is in the form of a sheet, 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. The plurality of basket insulating pipes 24 are respectively sleeved on the plurality of basket side branches 21, the plurality of basket sleeves 25 are respectively sleeved on the plurality of basket insulating pipes 24, and the plurality of wires 26 are respectively arranged between the plurality of basket insulating pipes 24 and the plurality of basket sleeves 25. For example, the plurality of basket insulating pipes 24 and the plurality of basket sleeves 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, a plurality of electrodes 22 are respectively provided on a plurality of basket sleeves 25, through holes 25A (one through hole 25A is shown in fig. 1A as an example) are respectively provided on the plurality of basket sleeves 25, and the plurality of electrodes 22 are respectively electrically connected to a plurality of wires 26 through the through holes 25A on the plurality of basket sleeves 25, whereby the plurality of electrodes 22 can transmit electric signals through the plurality of wires 26 to realize an ablation operation.

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

For example, the electrode 22 may be made of a material having good electrical conductivity, such as a metal material or an alloy material, for example, platinum iridium alloy in some examples. The electrode 22 may be formed as an electrode ring that fits over the basket sheath 25. For example, the length of each electrode 22 may be 1.0mm-3.0mm, such as 1.5mm, 2mm, or 2.5mm, etc., 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 and second tubes 11 and 12 so as to be connected to a power source at the other ends of the first and second tubes 11 and 12 opposite to 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 channel with the first tube 11, and the intermediate tube 13 forming a second channel 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 wires 26 extend in one of the first and second channels, while the other of the first and second channels may be used to provide a desired solution of heparin/saline or the like, such as a catheter provided with a desired solution for delivering heparin/saline or the like. For example, in one example, a first channel is used to provide the desired solution of heparin/saline, etc., and a second channel is used to extend the lead 26.

For example, in some embodiments, the first tube 11, the second tube 12, the intermediate tube 13, and the like may be made of a polymer material, such as PEBAX, TPU, nylon, which has a certain flexibility, so as to facilitate bending of the tube, and thus facilitate reaching the target position by 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, 11mm, etc. For example, the tubing may be woven from stainless steel to provide support strength.

For example, in some embodiments, as shown in fig. 1A, the ablation catheter further includes a visualization assembly including 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 developing element 41 and the second developing element 42 can perform 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 annular, the second tube 12 has a tapered portion 12B at the first end 12A of the second tube 12, and the second developing element 42 is sleeved on the tapered portion 12B. For example, the tube assembly further includes a connection tube 14, and the connection tube 14 is at least sleeved on the second developing member 42 to cover the second developing member 42, whereby the second developing member 42 is not exposed, as shown in fig. 1B.

For example, in some embodiments, as shown in fig. 1A, end cap assembly 30 includes an end cap base 31 and an end cap 32, end cap base 31 being connected to second ends 21B of the plurality of basket side branches 21 and having a recess 31A at least at an end remote from the plurality of basket side branches 21, recess 31A may be in the form of a blind hole or a through hole, for example, the blind hole form being shown in fig. 1A as an example. The end cap 32 has a protruding portion 32A, the first developing element 41 is annular, the first developing element 41 is fitted over the protruding portion 32A, and the recessed portion 31A is fitted over the first developing element 41, thereby covering the first developing element 41, and the first developing element 41 is not exposed, as shown in fig. 1B.

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

For example, in some embodiments, the deflection angle of the plurality of basket side branches 21 may be designed to have a better morphology and support effect.

For example, as shown in fig. 5A-7C, the front projection of the end cap assembly 30 on a first plane perpendicular to the axis direction X (which may refer to any plane perpendicular to the axis direction X) is a first front projection P1, e.g., the first front projection P1 may be in a circular shape or other rounded pattern, such as a rounded square shape, 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 cover assembly 30 is a second connection point C2, and the connection line of the orthographic projection of the first connection point C1 on the first plane and the center O of the first orthographic projection and the connection line of the 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 angles of the basket side branches 21 are first angles. 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 degrees to 120 degrees, such as 90 degrees, 100 degrees, 120 degrees, or the like.

For example, the basket side branches 21 may be formed to have different shapes (different extending paths) in the first predetermined state by performing different pre-shaping processes on the basket side branches 21, so that the basket may have a better shape and support effect when in the first predetermined state.

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

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

For example, in other embodiments, the basket may deflect in other ways. For example, fig. 8A to 10B show a front view and a side view, respectively, of the basket in the embodiment of fig. 8A to 10B, in a first predetermined state, for any plane parallel to the axial direction X, the orthographic projection of each of the plurality of basket side branches 21 on the any plane is curved, and the extending paths of the basket side branches 21 between the first connection point C1 and the second connection point C2 do not lie on the same plane. At this time, the basket side branches 21 are twisted and extended 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-mentioned planes is S-shaped, C-shaped, wavy, or the like, and at this time, the basket side branches 21 have a long extension path between the first connection point C1 and the second connection point C2. The manner of deflection of the basket shown in fig. 8A-10B is hereinafter referred to as helical deflection.

For example, in embodiments of the present disclosure, the above-described helically deflected basket may provide a very full flower shape relative to a horizontally deflected basket, but may be relatively poorly supported, with basket side branches 21 easily collapsing inward or deflecting sideways, which may be difficult to provide a stable configuration and sufficient support when ablating against a target site. Compared with the spiral deflection basket, the horizontal deflection basket can provide good support, but the flower shape is not full, and the ideal flower shape can be achieved through the design of the deflection angle.

For example, it has been experimentally determined that a horizontal deflection basket having a deflection angle of 120 °, i.e., the basket shown in fig. 7A-7C, can have a full flower shape while providing good support, and can sufficiently achieve support and ablation, as shown in fig. 2A and 2B, i.e., the state of the ablation catheter in a first predetermined state in this case, and as shown in fig. 3A and 3B, i.e., 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 conditions the basket has a very full pattern, providing good support to fully effect the ablation procedure.

For example, by making deflection changes to basket side branches 21 of a spiral deflected basket, the morphological stability and support thereof can be improved. For example, fig. 11A-11C illustrate another exemplary spiral deflected basket, and fig. 12A-12C illustrate yet another exemplary spiral deflected basket. Fig. 11A to 11C and fig. 12A to 12C show a front view, a side view, and a side view of a basket assembly in a second predetermined state, respectively, in which basket insulating tubes, basket bushings, and a plurality of electrodes are provided on the basket.

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

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

The flower shape deflection forms are different, namely, the flower shape deflection forms are mainly characterized in that the flower shape effect is different by adjusting the side branch shaping trend and the deflection angle of the net basket, the plumpness of the flower shape can be adjusted by adjusting the deflection angle, and the trend of petals can be tilted upwards through the assembly of a real object; for the pre-formed basket, the trend of the side branches of the flower type is adjustable, the petal can tilt upwards to cover the length of the end cover assembly 30, the purpose of hiding the head is achieved, and the method is beneficial to ablation operation, because the phenomenon that the end cover assembly 30 contacts with tissues and the basket side branches cannot contact with tissues when the flower type is attached to the wall of an ablation room can be avoided, not only pulmonary veins but also the wall of the ablation room can be ablated. Therefore, the basket shown in fig. 12A-12C has a wider range of applicability than the embodiment of fig. 11A-11C.

For example, fig. 13A and 13B show front and side views of the basket of fig. 12A-12C in a first predetermined state, and fig. 14A and 14B show front and side views of the basket of fig. 12A-12C in a second predetermined state. As shown in fig. 13A and 13B and fig. 14A and 14B, the ablation catheter has a more filled flower shape in both the first predetermined state and the second predetermined state, and can provide stable support.

In summary, in the ablation catheter provided by the embodiment of the disclosure, the basket 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 and convenient operation, the formed first preset state and second preset state are more stable, and the basket can have good supportability and stable flower shape at the same time under the states, thereby being beneficial to the ablation operation.

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

For example, the adjustment button 51 may be in the form of a push rod to effect movement of the first tube 11 relative to the second tube 12 by pushing and pulling the first tube 11 within the second tube 12 to effect transition between different states of the ablation catheter, such as transition between 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 coupled to the second end of the first pipe body 11 opposite to the first end 11A by bonding or welding. For example, a second end of the second tube 12 opposite the first end 12A is stably coupled to the end 50A of the adjustment assembly 50 by bonding, heat staking, welding, or the like.

For example, in some embodiments, as shown in fig. 16, the adjustment assembly 50 may further include a turn knob 52, whereby bi-directional turn adjustment of the ablation catheter may be achieved to control the smooth entry of the ablation catheter 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 rotates, the two control wires are driven to shrink so as to drive the second tube 12 to deflect and bend, thereby driving the ablation catheter to deflect and adjust. For example, as shown in fig. 15, the turn knob 52 may adjust the turn of the ablation catheter up and down relative to the dashed line.

For example, as shown in fig. 16, the conditioning assembly 50 may further include a lead connector 53, which may be connected to a power source to provide electrical signals to the electrodes 22 via the leads 26, and a conduit connector 54, which may be connected to a source of a desired solution of heparin/saline, etc., to provide a desired solution of heparin/saline, etc., as shown in fig. 16.

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

At least one embodiment of the present disclosure also provides a method of operating an ablation device comprising one or more of the following processes (or steps):

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

Step S2: the septum puncture is performed through the right femoral vein, and the left atrium and pulmonary vein are imaged.

Step S3: the pulse ablation delivery system is replaced.

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

Step S5: the ablation catheter reaches the target site and the basket configuration is adjusted, for example, by adjusting the ablation catheter to assume a first predetermined state or a second predetermined state using the adjustment assembly 50, for performing an ablation procedure.

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

The following points need to be described:

(1) The drawings of the embodiments of the present disclosure relate only to the structures related to the embodiments of the present disclosure, and other structures may refer to the general design.

(2) In the drawings for describing embodiments of the present disclosure, the thickness of layers or regions is exaggerated or reduced for clarity, i.e., the drawings are not drawn to actual scale.

(3) The embodiments of the present disclosure and features in the embodiments may be combined with each other to arrive at a new embodiment without conflict.

The above is merely a specific embodiment of the disclosure, but the protection scope of the disclosure should not be limited thereto, and the protection scope of the disclosure should be subject to the claims.

Claims

1. An ablation catheter, comprising:

A pipe assembly, comprising a first pipe body and a second pipe body, wherein the first pipe body is arranged inside the second pipe body, and the first pipe body and the second pipe body can move relatively along an axial direction;

A basket assembly, comprising a basket and a plurality of electrodes, wherein the basket comprises a plurality of basket side branches, a first end of the plurality of basket side branches is configured to be connected to the first end of the second tube body, a second end of the plurality of basket side branches opposite to the first end is configured to be connected to the first end of the first tube body, so that the plurality of basket side branches at least partially surround the first tube body, and the plurality of electrodes are respectively arranged on the plurality of basket side branches;

Wherein, the plurality of basket side branches are configured as follows: when the first end of the first tube body and the first end of the second tube body are spaced apart by a predetermined distance, the initial state is presented, wherein the predetermined distance is the farthest distance that the first end of the first tube body and the first end of the second tube body can be spaced apart; when the first tube body moves relative to the second tube body along the axial direction, the plurality of basket side branches may undergo a first deformation to present a first predetermined state; when the first tube body moves relative to the second tube body along the axial direction until the first tube body is basically retracted into the second tube body, the basket undergoes a second deformation to present a second predetermined state;

Wherein, the basket assembly further comprises:

A basket base, wherein the first ends of the plurality of basket side branches are connected to the basket base, and the basket base is connected to the first end of the second tube body;

Wherein, in the initial state, the plurality of basket side branches are non-vertically arranged relative to the basket base, and each of the plurality of basket side branches forms a second angle with the basket base, and the second angle is 70 degrees to 90 degrees.

2. The ablation catheter according to claim 1, wherein, in the first predetermined state, the middle portions of the plurality of basket side branches protrude in a direction away from the first tube body;

Wherein, the middle parts of the plurality of basket side branches are respectively located between the first ends and the second ends of the plurality of basket side branches.

3. The ablation catheter according to claim 1, further comprising:

An end cap assembly is connected to the first end of the first tube body and the second ends of the plurality of basket side branches.

4. An ablation catheter according to claim 3, wherein, in the second predetermined state, the middle portion of the plurality of basket branches is located on a side of the first end and the second end of the plurality of basket branches away from the second tube body so as to at least partially surround the end cap assembly.

5. The ablation catheter according to claim 3, wherein for at least one basket side branch among the plurality of basket side branches,

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

6. The ablation catheter according to claim 5, wherein the orthographic projection of the end cap assembly on a first plane perpendicular to the axial direction is a first orthographic projection,

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

The ablation catheter according to claim 6 , wherein the first angle is 90 degrees to 120 degrees.

8. The ablation catheter according to claim 1 or 2, wherein, in the first predetermined state, there is at least one plane parallel to the axial direction, and the orthographic projection of at least one of the plurality of basket branches on the at least one plane is in a straight line shape.

9. The ablation catheter according to claim 1 or 2, wherein, in the first predetermined state, for any plane parallel to the axial direction, the orthographic projection of each of the plurality of basket branches on any plane is curved.

10. The ablation catheter according to claim 1 or 2, wherein the plurality of basket side branches include 4-6 basket side branches.

11. The ablation catheter according to claim 1 or 2, wherein the basket assembly further comprises:

A plurality of mesh basket insulating tubes are respectively sleeved on the plurality of mesh basket side branches.

A plurality of basket sleeves are respectively sleeved on the plurality of basket insulating tubes, and

A plurality of wires are respectively arranged between the plurality of mesh basket insulating tubes and the plurality of mesh basket casings,

The plurality of electrodes are respectively arranged on the plurality of mesh basket casings, the plurality of mesh basket casings respectively have through holes, and the plurality of electrodes are respectively electrically connected to the plurality of wires through the through holes on the plurality of mesh basket casings.

12 . The ablation catheter according to claim 11 , wherein the plurality of wires extend between the first tube body and the second tube body.

13. The ablation catheter according to claim 11, wherein the tube assembly further comprises an intermediate tube body disposed between the first tube body and the second tube body, a first channel is formed between the intermediate tube body and the first tube body, and a second channel is formed between the intermediate tube body and the second tube body;

The plurality of conductive lines extend to at least one of the first channel and the second channel.

14. The ablation catheter according to claim 4, further comprising:

A developing assembly, comprising a first developing element and a second developing element,

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

15. The ablation catheter according to claim 14, wherein the second developing element is ring-shaped, the second tube body has an indented portion at the first end of the second tube body, and the second developing element is sleeved on the indented portion;

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

16. The ablation catheter according to claim 15, wherein the end cap assembly comprises:

an end cap base connected to the second ends of the plurality of basket side branches and having a recessed portion at least at one end away from the plurality of basket side branches, and

An end cap having a protrusion,

Wherein, the first developing element is ring-shaped, the first developing element is sleeved on the protruding portion, and the recessed portion is sleeved on the first developing element.

17. An ablation device, comprising:

The ablation catheter according to any one of claims 1 to 16, and

The adjustment component includes an adjustment button connected to the first tube body of the ablation catheter to control the relative state of the first tube body and the second tube body.