CN113317866B

CN113317866B - Ablation assembly, ablation device and method of operation

Info

Publication number: CN113317866B
Application number: CN202110696618.6A
Authority: CN
Inventors: 罗中宝; 王海峰; 代聪育
Original assignee: Shanghai Remedicine Co ltd
Current assignee: Shanghai Ruidao Medical Technology Co ltd
Priority date: 2021-06-23
Filing date: 2021-06-23
Publication date: 2023-01-10
Anticipated expiration: 2041-06-23
Also published as: CN113317866A

Abstract

The present disclosure provides an ablation assembly, an ablation device, and a method of operation, the assembly including a support, a first electrode arm, and a second electrode arm, the first and second electrode arms being arranged generally along a length of the support, a first end of the support being connected to the first electrode arm and the second electrode arm, respectively, the first electrode arm including a first working portion including a first working electrode and deployable at least partially away from the support in a direction perpendicular to the length to form a first annular body, the second electrode arm including a second working portion including a second working electrode and deployable at least partially away from the support in a direction perpendicular to the length to form a second annular body, an outer edge of the first annular body being a distance from an axis of the support that is less than a distance from an outer edge of the second annular body to the axis of the support. The diagnosis and mapping of atrial fibrillation signals or ablation operation can be selectively performed, the operation cost is reduced, the operation steps are reduced, and the operation difficulty is reduced.

Description

Ablation assembly, ablation device and method of operation

Technical Field

Embodiments of the present disclosure relate to an ablation assembly, an ablation device, and a method of operation.

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 therein, 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.

Pulsed electric field ablation is a non-heat-generating technology, and the damage mechanism is that nano-scale micropores appear 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; and (3) coagulation necrosis does not exist, and the risk of pulmonary vein stenosis is reduced.

Disclosure of Invention

At least one embodiment of the present disclosure provides an ablation assembly, an ablation device, and an operation method, which can reduce ablation operation cost, reduce ablation operation steps, and reduce ablation operation difficulty.

At least one embodiment of the present disclosure provides an ablation assembly including a support, a first electrode arm, and a second electrode arm, wherein the first electrode arm and the second electrode arm are disposed generally along a length of the support, a first end of the support along the length is connected to a first end of the first electrode arm along the length and a first end of the second electrode arm along the length, respectively, the first electrode arm includes a first working portion at the first end of the first electrode arm, the first working portion includes at least one first working electrode and is configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a first annular body, the second electrode arm includes a second working portion at the first end of the second electrode arm, the second working portion includes at least one second working electrode and is configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a second annular body, a distance from an outer edge of the first annular body to an outer edge of the support is less than a distance from an axis of the support.

For example, at least one embodiment of the present disclosure provides an ablation assembly further comprising a connector, wherein the first end of the support member is fixedly connected to the first end of the first electrode arm and the first end of the second electrode arm, respectively, via the connector.

For example, in at least one embodiment of the present disclosure, an ablation assembly is provided in which the first working portion of the first electrode arm further includes at least one third working electrode, the first and third working electrodes being spaced apart from each other and configured to apply working voltages of different polarities.

For example, in at least one embodiment of the present disclosure, an ablation assembly is provided in which the second working portion of the second electrode arm further includes at least one fourth working electrode, the second and fourth working electrodes being spaced apart from one another and configured to apply working voltages of different polarities.

For example, in at least one embodiment of the present disclosure, an ablation assembly is provided in which the first working electrode of the first electrode arm and the second working electrode of the second electrode arm are spaced apart from each other and are configured to apply working voltages of different polarities.

For example, in an ablation assembly provided in at least one embodiment of the present disclosure, the first annular body includes a first transition connection section, a first circular arc-shaped body, and a second transition connection section connected in sequence, wherein the first circular arc-shaped body and the second transition connection section are in a first plane, and a first end of the first circular arc-shaped body is connected to an end of the second transition connection section away from the axis of the support member, and a second end of the first circular arc-shaped body is connected to an end of the first transition connection section away from the axis of the support member, and the first transition connection section is located on a side of the first plane close to the connection member, and the second annular body includes a third transition connection section, a second circular arc-shaped body, and a fourth transition connection section connected in sequence, wherein the second circular arc-shaped body and the fourth transition connection section are in a second plane, and a first end of the second circular arc-shaped body is connected to an end of the fourth transition connection section away from the axis of the support member, and a second end of the first circular arc-shaped body and an end of the third transition connection section are located on a side of the connection member close to the connection member, and a distance from the second plane is smaller than a distance from the connection plane to the connection member.

For example, in at least one embodiment of the present disclosure, an ablation assembly is provided wherein the first electrode arm further comprises: a first inner core as a support body; a first wire disposed along a core length direction of the first inner core; the first insulation sleeve is wrapped on the outer sides of the first inner core and the first lead, the at least one first working electrode is sleeved on the outer side of the first insulation sleeve, and the first lead penetrates through a first lead hole formed in the first insulation sleeve and is electrically connected to the at least one first working electrode; the second electrode arm further includes: a second inner core as a support body; a second wire disposed along a core length direction of the second inner core; and the second insulating sleeve is wrapped on the outer sides of the second inner core and the second lead, the at least one second working electrode is sleeved on the outer side of the second insulating sleeve, and the second lead penetrates through a second lead hole formed in the second insulating sleeve and is electrically connected to the at least one second working electrode.

For example, in at least one embodiment of the present disclosure, an ablation assembly is provided in which the at least one first working electrode includes a plurality of first electrode rings and the plurality of first electrode rings are uniformly arranged along a length of the first inner core, the at least one second working electrode includes a plurality of second electrode rings and the plurality of second electrode rings are uniformly arranged along a length of the second inner core.

At least one embodiment of the present disclosure provides an ablation device comprising: an ablation assembly as described in any of the above; a control assembly, at least a portion of which is fixedly connected to the support, wherein the control assembly is configured to control the support to move along the length direction, so that the first working portion and the second working portion are respectively drawn from the first ring body and the second ring body to be arranged along the length direction of the support, or so that the first working portion and the second working portion are driven to be spread to form the first ring body and the second ring body, respectively.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the control assembly includes a pushing member, the pushing member is fixedly connected to the support and drives the support to move along the length direction by pushing the pushing member, so that the first working portion and the second working portion are respectively drawn from the first ring body and the second ring body to be arranged along the length direction of the support, or the first working portion and the second working portion are driven to be unfolded to form the first ring body and the second ring body, respectively.

For example, at least one embodiment of the present disclosure provides an ablation device further including a sleeve, wherein the ablation assembly further includes a connecting member, the first end of the supporting member is fixedly connected to the first end of the first electrode arm and the first end of the second electrode arm, respectively, the sleeve is sleeved on an outer side of at least a portion of the supporting member, and the first annular body and the second annular body are interposed between an end of the sleeve near the connecting member and the connecting member.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the control assembly further includes a telescopic assembly, the telescopic assembly includes a telescopic elastic body, and a first end part and a second end part respectively connected to two ends of the telescopic elastic body along the length direction, the first end part is located on a side of the telescopic elastic body close to the connecting piece, the second end part is located on a side of the telescopic elastic body away from the connecting piece, the first end part is sleeved on an outer side of at least a portion of a side of the sleeve close to the telescopic elastic body, the first end part is fixedly connected to the sleeve, and one end of the second end part away from the telescopic elastic body is fixedly connected to the pushing piece.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the first electrode arm further includes a first extension portion, an end of the first extension portion near the connector is connected to an end of the first working portion far from the connector, the second electrode arm further includes a second extension portion, an end of the second extension portion near the connector is connected to an end of the second working portion far from the connector, and the first extension portion and the second extension portion are disposed on an outer surface of the support along a length direction of the support.

For example, in an ablation device provided in at least one embodiment of the disclosure, the control assembly further includes a first fixed shim and a second fixed shim, an axial direction of the first fixed shim and an axial direction of the second fixed shim are both parallel to a length direction of the support member, the support member passes through the first fixed shim and the second fixed shim along the length direction, the first extending portion of the first electrode arm and the second extending portion of the second electrode arm pass through the first fixed shim and the second fixed shim along the length direction, the second fixed shim is located inside the elastic body, and the second fixed shim is fixedly connected to the first electrode arm, such that the pusher member pushes on the second fixed shim to achieve the first working portion of the first electrode arm is completely stretched to be arranged along the length direction of the support member, the second electrode arm is fixedly connected to the first fixed shim, and the first fixed shim is fixedly connected to an end of the sleeve member far from the connecting member, such that the pusher member pushes on the second fixed shim and carries the second fixed shim and the second fixed shim until the pusher member is completely stretched to achieve the second working portion of the stretched.

For example, in an ablation device provided in at least one embodiment of the present disclosure, an elastic member is disposed between the first fixing pad and the second fixing pad, and the elastic member is sleeved outside the first electrode arm and the second electrode arm.

For example, in at least one embodiment of the present disclosure, an ablation device is provided in which the first and second rings are heat-set rings, wherein the first and second working portions include a memory metal.

For example, at least one embodiment of the present disclosure provides an ablation device further comprising a handle assembly, wherein the control assembly is disposed within the handle assembly.

For example, at least one embodiment of the present disclosure provides an ablation device further comprising a mapping guide, wherein the support is tubular and serves as a passage for the mapping guide, and the mapping guide passes through a second end of the support, which is distal from the connector, along the length of the support until protruding beyond a first end of the support, which is proximal to the connector.

At least one embodiment of the present disclosure provides a method of operating an ablation assembly as described in any of the above, comprising: applying a working voltage to the at least one first working electrode comprised by the first working portion; controlling the first working part to unfold away from the supporting part at least partially in a direction perpendicular to the length direction to form the first annular body; and/or, applying an operating voltage to the at least one second working electrode comprised by the second working portion; and controlling the second working part to be at least partially unfolded away from the supporting part in the direction perpendicular to the length direction to form the second annular body.

For example, at least one embodiment of the present disclosure provides a method of operation further comprising: controlling the support to move along the length direction, so that the first working part and the second working part are respectively drawn from the first ring body and the second ring body to be arranged along the length direction of the support, or the first working part and the second working part are driven to be unfolded to respectively form the first ring body and the second ring body.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1-2 are front views of ablation assemblies provided by some embodiments of the present disclosure;

fig. 3 is a side view of an ablation assembly provided in accordance with some embodiments of the present disclosure;

fig. 4 is a front view of an ablation assembly provided in accordance with further embodiments of the present disclosure;

fig. 5 is a front view of a first working portion of an ablation assembly according to some embodiments of the present disclosure deployed alone;

fig. 6 is a front view of a second working portion of an ablation assembly according to some embodiments of the present disclosure deployed alone;

fig. 7 is a schematic perspective view of an ablation device provided in accordance with some embodiments of the present disclosure;

fig. 8-9 are partial schematic views of an ablation device provided in accordance with some embodiments of the present disclosure;

fig. 10-11 are schematic views of a control assembly of an ablation device provided in accordance with some embodiments of the present disclosure;

fig. 12 is an internal schematic view of a control assembly of an ablation device provided in accordance with some embodiments of the present disclosure;

FIG. 13 is a front view of a handle assembly provided by some embodiments of the present disclosure; and

fig. 14 is a top view of a handle assembly provided by some embodiments of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be described clearly and completely with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the embodiments described are only some embodiments of the present disclosure, rather than all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without inventive step, are intended to be within the scope of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The use of "first," "second," and similar terms in the embodiments of the disclosure is not intended to indicate any order, quantity, or importance, but rather is used to distinguish one element from another. The use of the terms "a" and "an" or "the" and similar referents do not denote a limitation of quantity, but rather denote the presence of at least one. Similarly, the word "comprising" or "comprises", and the like, means that the element or item preceding the word comprises the element or item listed after the word and its equivalent, 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.

The inventor finds that the head end of some pulse ablation catheters mainly adopts one or more flexible electrode arms, most of which are in a single ring shape, a basket shape and a flower shape, and the defects comprise the following:

(1) The single-ring electrode arm is not well positioned, is not easy to be attached, and has single size, thus being not suitable for pulmonary vein orifices with various shapes and sizes. The electrode arms are made of nickel-titanium alloy or stainless steel and the like, each electrode arm is about 1mm, and the electrode arms with only a single expansion size are easy to deform or cannot be well attached when attached to the pulmonary vein opening due to different shapes and sizes of the pulmonary vein opening, and the attachment angle is not easy to control.

(2) At present, some balloon catheters need to be matched with a mapping electrode catheter for use, are used for judging the pulmonary vein isolation condition, and have higher cost.

(3) The effect of the simulation electric field is not ideal; for example, when a single-ring electrode arm model and a flower-type electrode arm model are subjected to simulation by applying corresponding voltages, the effect of a pulse electric field is not ideal, and the axial effect of a generated ablation region in a pulmonary vein is not good.

At least one embodiment of the present disclosure provides an ablation assembly including a support, a first electrode arm, and a second electrode arm, wherein the first electrode arm and the second electrode arm are disposed generally along a length of the support, a first end of the support along the length is connected to a first end of the first electrode arm along the length and a first end of the second electrode arm along the length, respectively, the first electrode arm includes a first working portion at the first end of the first electrode arm, the first working portion includes at least one first working electrode and is configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a first ring, the second electrode arm includes a second working portion at the first end of the second electrode arm, the second working portion includes at least one second working electrode and is configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a second ring, a distance from an outer edge of the support to an axis of the support is less than a distance from an outer edge of the support to the axis of the second ring.

At least one embodiment of the present disclosure also provides an ablation device including the ablation assembly described above. At least one embodiment of the present disclosure further provides a method of operating an ablation assembly as described above.

The ablation assembly or the ablation device or the operation method of the above-mentioned embodiments of the present disclosure can selectively map corresponding signals (for example, atrial fibrillation signals) or release an electric field to perform ablation operation, can perform both conducting and recording of electrophysiological signals, and can also generate an effective annular pulsed electric field to perform operation, so as to selectively ablate a target tissue through operation, and can reduce ablation operation cost, ablation operation steps, and ablation operation difficulty.

Embodiments of the present disclosure and examples thereof are described in detail below with reference to the accompanying drawings.

Fig. 1-2 are front views of an ablation assembly according to some embodiments of the present disclosure, wherein the first and second working portions of the ablation assembly of fig. 1 are in an expanded state and the first and second working portions of the ablation assembly of fig. 2 are in a collapsed state (i.e., an undeployed state).

For example, as shown in fig. 1 and 2, at least one embodiment of the present disclosure provides an ablation assembly 100 including a first electrode arm 110, a second electrode arm 120, and a support 130.

For example, the first electrode arm 110 and the second electrode arm 120 are arranged along a length direction of the support 130 as a whole (e.g., a transverse direction as shown in fig. 1 and 2). A first end of the support 130 in a length direction thereof (e.g., a left end of the support 130) is connected to a first end of the first electrode arm 110 in the length direction (e.g., a left end of the first electrode arm 110) and a first end of the second electrode arm 120 in the length direction (e.g., a left end of the second electrode arm 120), respectively.

For example, the first electrode arm 110 includes a first working portion 111 at a first end of the first electrode arm 110, and the first working portion 111 includes at least one first working electrode 1111 and is configured to be capable of expanding in a direction substantially perpendicular to the length direction at least partially away from the support 130 to form a first loop 111a (e.g., the first working portion 111 is at least partially flexible so as to be capable of expanding in a vertical direction as shown in fig. 1 to form the first loop 111 a).

For example, the second electrode arm 120 includes a second working portion 121 at a first end of the second electrode arm 120, and the second working portion 121 includes at least one second working electrode 1211 and is configured to be capable of being deployed at least partially away from the support 130 in a direction substantially perpendicular to the length direction to form a second ring 121a (e.g., the second working portion 121 is at least partially flexible so as to be capable of being deployed in the vertical direction shown in fig. 1 to form the second ring 121 a).

For example, the distance from the outer edge of the first ring body 111a to the axis of the support 130 is smaller than the distance from the outer edge of the second ring body 121a to the axis of the support 130. This means that the first ring 111a is a small ring of the two rings and the second ring 121a is a large ring of the two rings.

For example, as shown in fig. 1 and 2, the support 130 may be tubular (e.g., in which case the support 130 may be referred to as an inner tube) and act as a support, and the support 130 may also act as a guidewire pathway (see details below).

For example, in some examples, whether the first working portion 111 generates an ablating electric field is controlled by applying or not applying an operating voltage to the first working electrode 111 of the first working portion 111, i.e., the first working electrode 111 of the first working portion 111 is applied with the operating voltage while the first working portion 111 of the first electrode arm 110 is operated. Likewise, whether the second working portion 121 generates an ablation electric field is controlled by applying or not applying an operating voltage to the second working electrode 121 of the second working portion 121, i.e., the second working electrode 121 of the second working portion 121 is applied with the operating voltage while the second working portion 121 of the second electrode arm 120 is operated.

It should be noted that the upper, lower, left, right and other orientations referred to in the present disclosure all represent the orientation in the drawings for the convenience of the reader, but this does not affect the orientation in the practical application, and the present disclosure is not limited thereto.

In contrast to an ablation assembly having a single ring of electrodes, the ablation assembly of at least one embodiment of the present disclosure has two rings of different sizes, each provided with an electrode, whereby the diameter of the small ring (i.e., the first ring body 111 a) can be designed to be smaller than the opening of the target object (e.g., the ostium of the pulmonary vein), the small ring can be advanced into the pulmonary vein, which makes it easier to find and place the ostium of the pulmonary vein in close proximity, and the ablation procedure can be performed with the large ring (i.e., the second ring body 121 a) in close proximity to the ostium of the pulmonary vein. For example, the small ring of the ablation assembly can be inserted into the pulmonary vein to perform a positioning function, and a mapping guide member (such as a mapping catheter or a mapping guide wire) can be combined to determine the pulmonary vein isolation condition, so that the pulmonary vein ostium can be found more accurately and quickly.

The ablation assembly of some embodiments of the present disclosure can also accommodate different sizes of pulmonary vein ostia. For example, the small loop may be placed directly against the relatively thin ostium of the pulmonary vein and the ablation procedure performed directly with the small loop, i.e., the large loop may not be functional.

For example, as shown in fig. 1 and 2, the first end of the support member 130 is fixedly connected to the first end of the first electrode arm 110 and the first end of the second electrode arm 120, respectively, by a connection member 140.

For example, in some examples, the connector 140 may be a flexible head end member. Of course, this is merely exemplary and not a limitation of the present disclosure.

It should be noted that the structural form, the material composition, and the like of the connecting member 140 are not limited in the present disclosure, as long as the connecting member can be used to fixedly connect the supporting member 130, the first electrode arm 110, and the second electrode arm 120, which is not exhaustive and described in detail herein.

It should be further noted that the first end of the supporting member 130 of the present disclosure is not limited to be fixedly connected to the first end of the first electrode arm 110 and the first end of the second electrode arm 120, and may be connected in other manners as long as the first electrode arm 110 and the second electrode arm 120 can be pulled with the supporting member 130 moving relatively, so as to make the first electrode arm 110 and the second electrode arm 120 complete contraction, and the connection manners are not exhaustive and repeated here.

It should be noted that the connecting member 140 according to some embodiments of the present disclosure is not only used to fixedly connect the supporting member 130 to the first electrode arm 110 and the second electrode arm 120, respectively, but also used to combine with the first electrode arm 110 to position the pulmonary vein ostium, which is easier for the operator to find.

As can be seen from the above, an ablation assembly according to at least one embodiment of the present disclosure may not require an additional mapping guide when performing an ablation procedure, for example, one of the two rings (e.g., the first ring) included in the ablation assembly may be used to replace the mapping guide to find, for example, a pulmonary vein ostium, and the other ring (e.g., the second ring) may be used as an ablation component to perform an ablation procedure, so that the operation cost may be reduced, and the operation steps may be reduced.

For example, in some examples, the first working portion 111 of the first electrode arm 110 further includes at least one third working electrode, the first working electrode 1111 and the third working electrode being spaced apart from each other and configured to apply working voltages of different polarities. For example, a first working electrode 1111 and an adjacent third working electrode are spaced apart from each other.

For example, in some examples, the second working portion 121 of the second electrode arm 120 further includes at least one fourth working electrode, the second working electrode 1211 and the fourth working electrode being spaced apart from each other and configured to apply working voltages of different polarities. For example, a second working electrode 1211 and an adjacent fourth working electrode are spaced apart from each other.

Thus, in some examples, the ablation assembly 100 may form two electric fields during an ablation operation:

first electric field: when the first electrode arm 110 and the second electrode arm 120 operate simultaneously, the first working electrode 1111 and the third working electrode configured with different polarity working voltages on the first electrode arm 110 are energized in a positive-negative staggered manner to form an ablation electric field, and the second working electrode 1211 and the fourth working electrode configured with different polarity working voltages on the second electrode arm 120 are energized in a positive-negative staggered manner to form an ablation electric field.

Second electric field: when the first electrode arm 110 and the second electrode arm 120 work independently, the first working electrode 1111 and the third working electrode configured with different polarity working voltages on the first electrode arm 110 are energized in a positive-negative staggered manner to form an ablation electric field, or the second working electrode 1211 and the fourth working electrode configured with different polarity working voltages on the second electrode arm 120 are energized in a positive-negative staggered manner to form an ablation electric field.

For example, in some examples, the at least one first working electrode 1111 includes a plurality of first working electrodes 1111 that are uniformly arranged along a length direction of the first electrode arm 110.

It should be noted that, the first working electrode 1111 and the corresponding third working electrode, and the second working electrode 1211 and the corresponding fourth working electrode of the above embodiment of the present disclosure are all intended to distinguish the working electrodes configured with the working voltages with different polarities, but not limit other aspects of each working electrode, for example, the third working electrode may be the working electrode at the left and right ends of one of the first working electrodes 1111 marked in fig. 2 and the working voltage configured with the one of the first working electrodes 1111 has a different polarity, and the fourth working electrode may be the working electrode at the left and right ends of one of the second working electrodes 1211 marked in fig. 2 and the working voltage configured with the one of the second working electrodes 12011 has a different polarity, which is not limited by the present disclosure.

For example, in other examples, first working electrode 1111 of first electrode arm 110 and second working electrode 1211 of second electrode arm 120 are spaced apart from each other and configured to apply different polarity of working voltages. It should be noted that the first working electrode 1111 of the first electrode arm 110 and the second working electrode 1211 of the second electrode arm 120 described herein are spaced apart from each other, and it is understood that there is a space between the first working electrode 1111 and the second working electrode 1211 to achieve the spaced apart. It should be further noted that, one first working electrode 1111 of the first electrode arm 110 and the corresponding second working electrode 1211 of the second electrode arm 120 may be disposed opposite to each other, or may be disposed partially opposite to each other and partially in a staggered manner.

As such, in some examples, the ablation assembly 100 may form a third electric field during an ablation operation as follows: when the first electrode arm 110 and the second electrode arm 120 are simultaneously operated, the first working electrode 1111 of the first electrode arm 110 and the second working electrode 1211 of the second electrode arm 120 may be respectively used as a positive electrode and a negative electrode to form an ablation electric field.

For example, in some examples, the at least one second working electrode 1211 includes a plurality of second working electrodes 1211, the plurality of second working electrodes 1211 are uniformly arranged along a length direction of the second electrode arm 120.

Compared with an ablation assembly with a single ring electrode, the ablation assembly of some embodiments of the present disclosure has two rings with different sizes, each ring is provided with an electrode, and the electrodes on the two rings can be used as a positive electrode and a negative electrode respectively, so that an ablation electric field with a larger electric field range can be formed, and ablation operation is facilitated. In other examples, the ablation assembly according to the present disclosure may also be used alone with one of the electrode arms for ablation, and may be operated in different electrode distribution modes according to a doctor or preoperative planning, so as to meet different requirements.

Fig. 3 is a side view of an ablation assembly according to some embodiments of the present disclosure. Fig. 4 is a front view of an ablation assembly provided in accordance with further embodiments of the present disclosure.

For example, as shown in fig. 3 and 4, the first annular body 111a includes a first transition connection section L11, a first arc-shaped body S13 and a second transition connection section L12 connected in sequence, wherein the first arc-shaped body S13 and the second transition connection section L12 are in a first plane and a first end of the first arc-shaped body S13 is connected to an end of the second transition connection section L12 away from the axis of the support 130 (e.g., an upper end of the second transition connection section L12 in fig. 3), a second end of the first arc-shaped body S13 is connected to an end of the first transition connection section L11 away from the axis of the support (e.g., an upper end of the first transition connection section L11 in fig. 3), and the first transition connection section L11 is located on a side of the first plane close to the connection member 140 (e.g., the first transition connection section L11 in fig. 4 is located on a left side of the first plane).

For example, as shown in fig. 3 and 4, the second ring-shaped body 121a includes a third transition connection segment L21, a second circular arc-shaped body S23 and a fourth transition connection segment L22 connected in sequence, wherein the second circular arc-shaped body S23 and the fourth transition connection segment L22 are in a second plane and a first end of the second circular arc-shaped body S23 is connected with an end of the fourth transition connection segment L22 away from the axis of the support 130 (e.g., a lower end of the fourth transition connection segment L22 in fig. 3), a second end of the first circular arc-shaped body S23 is connected with an end of the third transition connection segment L21 away from the axis of the support 130 (e.g., a lower end of the third transition connection segment L21 in fig. 3), and the third transition connection segment L21 is located on a side of the second plane close to the connection member 140 (e.g., the third transition connection segment L21 in fig. 4 is located on a left side of the second plane).

For example, as shown in fig. 3 and 4, the first plane is a smaller distance from the connection member 140 than the second plane is from the connection member 140, i.e., the first plane is closer to the connection member 140 than the second plane.

Compared with the first working portion 111 and the second working portion 121 of the ablation assembly shown in fig. 1 and 4 which are both in the unfolded state, one of the first working portion 111 and the second working portion 121 of the ablation assembly according to other embodiments of the present disclosure may also be unfolded independently, which may be determined according to actual needs and will not be described herein again.

Fig. 5 is a front view of a first working portion of an ablation assembly according to some embodiments of the present disclosure deployed alone. Fig. 6 is a front view of a second working portion of an ablation assembly according to some embodiments of the present disclosure deployed alone.

For example, as shown in fig. 5, the first working portion 111 of the first electrode arm 110 may be separately expanded to form a first loop 111a, and the second working portion 121 of the second electrode arm 120 may not be expanded to assume a contracted state. For example, as shown in fig. 6, the second working portion 121 of the second electrode arm 120 may be separately expanded to form a second ring-shaped body 121a, and the first working portion 111 of the first electrode arm 110 may not be expanded to assume a contracted state.

It should be noted that, the specific manner of how to implement the first working portion 111 to be separately expanded and the second working portion 121 to be contracted and how to implement the second working portion 121 to be separately expanded and the first working portion 111 to be contracted in the present disclosure is not limited in the present disclosure, and any implementation manner that can implement the state shown in fig. 5 or fig. 6 is within the protection scope of the present disclosure, and is not a focus point required to be set forth in the present disclosure, and is not described herein again.

For example, as shown in fig. 1 and 2, the first electrode arm 110 further includes a first insulation package 1112, a first wire (not shown) and a first inner core (not shown) because they are encased by the first insulation package 1112. The first inner core serves as a support body for the first electrode arm 110, the first wire is disposed along a core length direction (e.g., a transverse direction as shown in fig. 2) of the first inner core, and the first insulation package 1112 is wrapped outside the first inner core and the first wire. The first working electrode 1111 is disposed outside the first insulation sleeve 1112, and the first wire penetrates through a first wire hole formed in the first insulation sleeve 1112 and is electrically connected to the first working electrode.

For example, in some examples, the first wires are arranged around and along a core length direction of the first inner core. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, the first lead may be soldered to the first working electrode. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, the at least one first working electrode 1111 includes a plurality of first electrode rings that are uniformly arranged along the core length direction of the first inner core.

It should be noted that fig. 2 and 3 are a simple and intuitive illustration for the reader to understand, and not to limit the disclosure, for example, although fig. 2 and 3 illustrate the first working electrode 1111 and the first insulation assembly 1112 separately, in some embodiments of the disclosure, the first insulation assembly 1112 is located at the position where the first working electrode 1111 is located on the first electrode arm 110, because the first working electrode 1111 is located outside the first insulation assembly 1112.

For example, as shown in fig. 1 and 2, the second electrode arm 120 further includes a second insulation sleeve 1212, a second wire (not shown because it is wrapped by the second insulation sleeve 1212), and a second inner core (not shown because it is wrapped by the second insulation sleeve 1212). The second inner core serves as a support body of the second electrode arm, the second wire is disposed along a core length direction (e.g., a transverse direction shown in fig. 2) of the second inner core, and the second insulation assembly 1212 is wrapped around the second inner core and the second wire. The second working electrode 1211 is disposed outside the second insulating sleeve 1212, and a second wire passes through a second wire hole formed in the second insulating sleeve 1212 and is electrically connected to the second working electrode 1211.

For example, in some examples, the second wires are arranged around and along a core length of the second inner core. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, the second lead may be soldered to the second working electrode. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, the at least one second working electrode 1211 includes a plurality of second electrode rings, and the plurality of second electrode rings are uniformly arranged along the core length direction of the second inner core.

It should be noted that fig. 2 and 3 are schematic diagrams for ease of understanding by the reader, and are not intended to limit embodiments of the present disclosure, for example, although fig. 2 and 3 illustrate the second working electrode 1211 and the second insulating sleeve 1212 separately, in some embodiments of the present disclosure, the second insulating sleeve 1212 is located at the second working electrode 1211 on the second electrode arm 120 because the second working electrode 1211 is disposed outside the second insulating sleeve 1212.

For example, in some examples, the first inner core and/or the second inner core may be made of a memory alloy or a medical stainless steel material or other suitable material, which is not limited by the present disclosure.

For example, in some examples, the cross-section of the first and/or second wires may be circular or rectangular, although this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, one or more of the first working electrode (e.g., first electrode ring), the second working electrode (e.g., second electrode ring), the third working electrode (e.g., third electrode ring), and the fourth working electrode (e.g., fourth electrode ring) employ platinum or platinum iridium, and can be 1-10mm in length and 0.01-0.1mm in thickness. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, the number of electrode rings on the first electrode arm 120 and/or the second electrode arm 120 may be 6-12. Of course, this is merely exemplary, not limiting of the present disclosure, and may be freely adjusted according to practical applications.

For example, in some examples, the material of the support 130 may be selected from PEBAX, TPU, nylon, and the like, which are not limited by this disclosure. For example, in some examples, the support 130 may be braided using stainless steel to provide support strength.

For example, in some examples, the maximum outer diameter of the first electrode arm 110 and/or the second electrode arm 120 is 1-2mm. Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, the working diameter of the first annular body 111a formed after the first working portion 111 of the first electrode arm 110 is expanded may be 10-20mm (e.g., the diameter of the first circular arc-shaped body S13 may be 10-20 mm). For example, in some examples, the second ring-shaped body 121a formed after the second working portion 121 of the second electrode arm 120 is unfolded may have a working diameter of 20-30mm (e.g., the second circular arc body S23 may have a diameter of 20-30 mm). Of course, this is merely exemplary and not a limitation of the present disclosure.

Fig. 7 is a perspective view of an ablation device provided in accordance with some embodiments of the present disclosure. Fig. 8-9 are partial schematic views of an ablation device provided in accordance with some embodiments of the present disclosure. Fig. 10-11 are schematic views of a control assembly of an ablation device provided in accordance with some embodiments of the present disclosure. Fig. 12 is an internal schematic view of a control assembly of an ablation device provided in accordance with some embodiments of the present disclosure.

For example, as shown in fig. 7-12, an ablation device 200 according to at least one embodiment of the present disclosure includes an ablation assembly 100 (e.g., an ablation assembly as described in any of the above embodiments, which is not described in detail below) and a control assembly 210. At least a portion of the control assembly 210 is fixedly connected to the supporting member 130, and the control assembly 210 is configured to control the supporting member 130 to move along a length direction (e.g., a transverse direction shown in fig. 8 and 9) thereof, so that the first working portion 111 and the second working portion 121 are respectively drawn from the first ring body 111a and the second ring body 121a to be arranged along the length direction of the supporting member 130, or so that the first working portion 111 and the second working portion 121 are brought to be unfolded to form the first ring body 111a and the second ring body 121a, respectively.

For example, as shown in fig. 10 to 12, the control assembly 210 includes a pushing member 211, and the pushing member 211 is fixedly connected to the support 130 and drives the support 130 to move along the length direction thereof by pushing the pushing member 211, so that the first working portion 111 and the second working portion 121 are respectively drawn from the first ring body 111a and the second ring body 121a to be arranged along the length direction of the support 130, or the first working portion 111 and the second working portion 121 are driven to be unfolded to form the first ring body 111a and the second ring body 121a, respectively.

For example, in some examples, the pusher 211 is a push rod, although this is merely exemplary and not a limitation of the present disclosure.

For example, as shown in fig. 7 to 12, the ablation device 200 further includes a sleeve 220, the sleeve 220 is disposed on an outer side of at least a portion of the supporting member 130 (e.g., the sleeve 220 is disposed on an outer side of a portion of the supporting member 130 located on a right side of the second working portion 121), and the first annular body 111a and the second annular body 121a are interposed between an end of the sleeve 220 close to the connecting member 140 and the connecting member 140. For example, as shown in fig. 9, the first ring 111a and the second ring 121a are interposed between the left end of the sleeve 220 and the right end of the link 140.

For example, in some examples, the sleeve 220 is a sleeve (e.g., in this case, the sleeve 220 may also be referred to as an outer tube 220 relative to the tubular support 130). Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, the kit 220 is at least partially flexible. For example, the material of the sleeve 220 may be selected from PEBAX, TPU, nylon, and the like. For example, the diameter of outer tube 220 may be 8-15F. For example, the outer tube 220 may be braided with stainless steel to provide support strength.

For example, as shown in fig. 10-12, the control assembly 210 further includes a telescoping assembly 212. The telescopic assembly 212 includes a telescopic elastic body 2123 and a first end part 2121 and a second end part 2122 connected to both ends of the telescopic elastic body 2123 in a length direction (e.g., a transverse direction as shown in fig. 11), respectively. The first end part 2121 is located on a side of the resilient elastomer 2123 close to the connector 140 (e.g., the first end part 2121 is located on a left side of the resilient elastomer 2123) and the second end part 2122 is located on a side of the resilient elastomer 2123 away from the connector 140 (e.g., the second end part 2122 is located on a right side of the resilient elastomer 2123). The first end part 2121 is disposed on at least a portion of the outer side of the sleeve 220 close to the elastic body 2123 (e.g., the first end part 2121 is disposed on the right end of the sleeve 220), and the first end part 2121 is fixedly connected to the sleeve 220, and an end of the second end part 2122 away from the elastic body 2123 (e.g., the right end of the second end part 2122) is fixedly connected to the pushing part 211.

For example, in some examples, the pusher member 211 is adhesively secured or welded to the support member 130. For example, when the pushing member 211 is pushed, the pushing member 211 is moved relatively to the first electrode arm 110 and the second electrode arm 120 during the stroke, and the respective head ends (e.g., left end or front end) of the support member 130, the first electrode arm 110, and the second electrode arm 120 are fixedly coupled based on the connection member 140, so that the contraction of the first working part 111 and the second working part 121 can be completed.

For example, in some examples, the resilient elastomer 2123 comprises a stretchable rubber ring. Of course, this is merely exemplary and not a limitation of the present disclosure, as long as it has a stretchable elastic body, and thus will not be described herein again.

For example, as shown in fig. 10 to 12, the first electrode arm 110 further includes a first extension part 112, and one end of the first extension part 112 close to the connection member 140 (e.g., the left end of the first extension part 112) is connected to one end of the first working part 111 far from the connection member 140 (e.g., the right end of the first working part 111). The second electrode arm 120 further includes a second extension part 122, and one end of the second extension part 122, which is close to the connection member 140 (e.g., the left end of the second extension part 122), is connected to one end of the second working part 121, which is away from the connection member 140 (e.g., the right end of the second working part 121). The first and

second extension portions

112 and 122 are disposed on the outer surface of the support 130 along the length direction of the support 130.

For example, as shown in fig. 10 to 12, the control assembly 210 further includes a first fixing pad 213 and a second fixing pad 214, and an axial direction of the first fixing pad 213 (e.g., a transverse direction shown in fig. 11 and 12) and an axial direction of the second fixing pad 214 (e.g., a transverse direction shown in fig. 11 and 12) are both parallel to a length direction of the support 130.

For example, the support 130 passes through the first and

second fixing pads

213 and 214 in the length direction, and the first extension portion 112 of the first electrode arm 110 and the second extension portion 122 of the second electrode arm 120 pass through the first and

second fixing pads

213 and 214 in the length direction. The second fixing pad 214 is located inside the elastic body 2123, and the second fixing pad 214 is fixedly connected to the first electrode arm 110, so that when the pushing member 211 pushes the second fixing pad 214, the first working portion 111 of the first electrode arm 110 is completely drawn to be arranged along the length direction of the support 130, that is, the first working portion 111 is completely contracted.

For example, the second electrode arm 120 is fixedly connected to the first fixing pad 213, and the first fixing pad 213 is fixedly connected to an end of the sleeve 220 away from the connecting member 140 (e.g. a right end of the sleeve 220), so that the pushing member 211 pushes the second fixing pad 214 and drives the second fixing pad 214 and the first electrode arm 110 until the pushing member pushes the first fixing pad 213 to achieve that the second working portion 121 of the second electrode arm 120 is completely drawn to be arranged along the length direction of the supporting member 130, i.e. the second working portion 121 is completely contracted.

For example, in some examples, since the second fixing pad 214 is fixedly connected to the first electrode arm 110, if the second fixing pad 214 is not pushed, the second fixing pad 214 and the first electrode arm 110 are stationary, but if the second fixing pad 214 is pushed, the second fixing pad 214 carries the first electrode arm 110 to move forward (e.g. move leftward) to continue shrinking until the first fixing pad 213 is pushed, so that the second working portion 121 completes shrinking.

For example, in some examples, the first fixing washer 213 is integrally formed with an end of the sleeve 220 away from the connecting member 140, that is, the first fixing washer 213 is an end of the sleeve 220 away from the end of the connecting member 140.

For example, in some examples, the second electrode arm 120 is adhesively or weld-secured to the first securing pad 213, and the first securing pad 213 is adhesively or weld-secured to the right end of the sleeve 220.

For example, in some examples, the second fixing pad 214 is adhesively or weld-fixed to the first electrode arm 110 at a location within the elastic resilient body 2123.

For example, as shown in fig. 10, an elastic member 215 is disposed between the first fixing pad 213 and the second fixing pad 214 and the elastic member 215 is fitted over the outer sides of the first electrode arm 110 and the second electrode arm 120.

For example, in some examples, the first ring 111a and the second ring 121a are heat-set rings, wherein the first working portion 111 and the second working portion 121 comprise a memory metal. For example, the first and second working

portions

111 and 121 are heat-set using nitinol, expanded in a natural unstressed state, and contracted by pushing the support 130 on the first and

second rings

111a and 121a.

It should be noted that the first working part 111 and the second working part 121 are respectively formed by heat setting to expand the first ring 111a and the second ring 121a, if the operator uses the pushing action of the pushing member 211, the first ring 111a and the second ring 121a can be contracted by drawing, and if the operator releases the pushing member 211, the contracted first working part 111 and second working part 121 are rebounded and restored to the first ring 111a and second ring 121a based on the elastic action of the elastic member 215 and the elastic body 2123.

Fig. 13 is a front view of a handle assembly provided by some embodiments of the present disclosure. Fig. 14 is a top view of a handle assembly provided by some embodiments of the present disclosure.

For example, as shown in fig. 7, 13, and 14, the ablation device 200 further includes a handle assembly 230, with the control assembly 210 disposed inside the handle assembly 230. For example, the control assembly 210 is disposed within an opening of the main housing 231 of the handle assembly 230.

For example, as shown in fig. 13 and 14, the control assembly 210 is located at a proximal end portion of the handle assembly 230 (e.g., the right end of the handle assembly 230). Of course, this is merely exemplary and not a limitation of the present disclosure.

For example, in some examples, the ablation device 200 further includes a mapping guide (not shown), the support 130 being tubular and in the path of the mapping guide, the mapping guide passing along the length of the support 130 from a second end of the support 130 distal from the connector 140 (e.g., a right end of the support 130) until protruding beyond a first end of the support 130 proximal to the connector 140 (e.g., a left end of the support 130).

For example, in some examples, the mapping guide is a mapping catheter or a mapping guidewire.

For example, in some examples, handle assembly 230 is an adjustable bend handle assembly.

For example, as shown in fig. 7 and 11-14, the adjustable bending handle assembly further includes a rotating member 232, a connecting mechanism 233, and a support joint 234.

For example, in some examples, the connection mechanism 233 is disposed in the opening of the main housing 231, the pushing member 211 is fixedly connected (e.g., adhesively or by welding) to the connection mechanism 233, the support tab 234 is located on a side of the connection mechanism 233 away from the connection member 140 (e.g., the support tab 234 is located on a right end of the connection mechanism 233), and the support tab 234 is connected to the connection mechanism 233. Thus, the support 130 passes through the connection mechanism 233 and the support joint 234, allowing the mapping guide to pass through.

For example, in some examples, the rotational member 232 can be configured to rotate bi-directionally to control the subsequent deflection of the ablation assembly 100 of the ablation device for smooth access to the ostium of the pulmonary vein.

For example, the rotating member 232 is connected to two control wires disposed on the side wall of the sheath member 220, and when the rotating member 232 rotates, the control wires are retracted to drive the sheath member 220 (e.g., the side of the sheath member 220 close to the connecting member 140) to deflect and bend, thereby driving the ablation assembly 100 to perform deflection adjustment. Of course, this is merely exemplary and not a limitation of the present disclosure.

At least one embodiment of the present disclosure provides a method of operating an ablation assembly, comprising:

applying an operating voltage to at least one first working electrode 1111 comprised by the first working portion 111 of the first electrode arm 110; controlling the first working portion 111 to be unfolded away from the supporting member 130 at least partially in a direction perpendicular to the length direction to form a first ring body 111a; and/or the presence of a gas in the gas,

applying an operating voltage to at least one second working electrode 1211 comprised by the second working portion 121 of the second electrode arm 120; the second working portion 121 is controlled to be spread apart from the supporting member 130 at least partially in a direction perpendicular to the length direction to form a second ring-shaped body 121a.

Therefore, in some embodiments of the present disclosure, the first working portion 111 and the second working portion 121 of the ablation assembly may be deployed at the same time for operation, or one of the first working portion 111 and the second working portion 121 of the ablation assembly may also be deployed separately, and details may refer to the above description, which is not repeated herein.

For example, in some examples, the method of operation of the ablation assembly further comprises: the movement of the supporter 130 in the length direction is controlled such that the first working part 111 and the second working part 121 are drafted from the first ring body 111a and the second ring body 121a, respectively, to be arranged in the length direction of the supporter 130, or the first working part 111 and the second working part 121 are spread with being brought to form the first ring body 111a and the second ring body 121a, respectively.

It should be noted that, in the embodiments of the present disclosure, the specific procedures and technical effects of the operation method of the ablation assembly can refer to the description of the ablation assembly above, and are not repeated herein.

At least one embodiment of the present disclosure provides a method of ablation of an ablation assembly, including one or more of the following procedures:

a first ablation procedure: the support 130 is configured to be tubular such that the mapping guide passes along the length of the support 130 from a second end of the support 130 distal from the connector 140 to a first end of the support 130 proximal to the connector 140, and the first annular body 111a is positioned against an opening of the subject (e.g., the ostium of a pulmonary vein). For example, for a first ablation procedure in which first annular body 111a is placed against the ostium of a pulmonary vein, first annular body 111a is used for the ablation procedure, and second annular body 121a may be deactivated.

A second ablation procedure: the first ring 111a is passed through an opening (e.g., pulmonary vein ostium) of the subject and into the interior (e.g., pulmonary vein) of the subject, and the second ring 121a is placed against the opening (e.g., pulmonary vein ostium) of the subject. For example, for a second ablation procedure in which the first ring 111a is advanced into a pulmonary vein and the second ring 121a is positioned against the ostium, the second ring 121a is used for the ablation procedure, in which case the first ring 111a is used in place of a mapping guide to find the ostium, i.e., in which case no additional mapping guide may be needed.

And (3) a third ablation process: passing the first annular body 111a through an opening (e.g., ostium) of the subject and into the interior of the subject, e.g., interior of a pulmonary vein), disposing the support 140 in a tubular shape such that the mapping guide passes along the length of the support 140 from a second end of the support 130 distal from the connector 140 to a first end of the support 130 proximal to the connector 140, and abutting the second annular body 121a against the opening (e.g., ostium) of the subject. For example, for a third ablation procedure in which the first ring 111a is inserted into a pulmonary vein and the second ring 121a is placed against the ostium of the pulmonary vein, the second ring 121a is used for the ablation procedure, where the first ring 111a is used for positioning and is used with a mapping guide to find the ostium of the pulmonary vein, where the mapping guide is used primarily to find the ostium of the pulmonary vein.

It should be noted that, in the embodiments of the present disclosure, the specific processes and technical effects of the ablation method of the ablation assembly can refer to the description of the ablation assembly above, and are not described herein again.

Some embodiments of the present disclosure also provide a method of operation based on an ablation assembly, including one or more of the following procedures (or steps):

step S1, using femoral vein puncture to place a vascular sheath into the bilateral femoral vein.

S2, feeding the coronary sinus electrode into place through the left sheath;

s3, performing atrial septal puncture and left atrial and pulmonary vein angiography through a right femoral vein;

s4, replacing the pulse ablation delivery system;

s5, feeding an ablation assembly;

step S6, a mapping guide (e.g., a mapping guidewire) enters the target vein of interest, and the first working portion 111 of the first electrode arm 110 is deployed and mapped against the pulmonary vein;

and S7, unfolding a proper second working part 121 of the second electrode arm 120, selecting corresponding electrode distribution, and carrying out ablation operation by attaching to the vestibule of the pulmonary vein.

As mentioned above, steps S1 to S7 of the above operation method correspond to the case of the above third ablation procedure, and the steps S1 to S7 of the operation method corresponding to the case of the first ablation procedure and the case of the second ablation procedure can be referred to, and are not described again here.

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 common designs.

(2) 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 description 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 subject to the scope of the claims.

Claims

1. An ablation device, comprising:

an ablation assembly comprising a support, a first electrode arm, and a second electrode arm, wherein the first electrode arm and the second electrode arm are disposed generally along a length of the support, the first end of the support along the length being connected to the first end of the first electrode arm along the length and the first end of the second electrode arm along the length, respectively, the first electrode arm comprising a first working portion at the first end of the first electrode arm, the first working portion comprising at least one first working electrode and being configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a first annulus, the second electrode arm comprising a second working portion at the first end of the second electrode arm, the second working portion comprising at least one second working electrode and being configured to be deployable at least partially away from the support in a direction perpendicular to the length to form a second annulus, an outer edge of the first annulus being a distance from an axis of the support that is less than an outer edge of the second annulus;

a control assembly, at least a part of which is fixedly connected with the support, wherein the control assembly is configured to control the support to move along the length direction, so that the first working part and the second working part are respectively drawn from the first ring body and the second ring body to be arranged along the length direction of the support, or the first working part and the second working part are driven to be unfolded to form the first ring body and the second ring body respectively;

wherein the control assembly comprises a pushing member fixedly connected with the support member and driving the support member to move along the length direction by pushing the pushing member, so that the first working part and the second working part are respectively drawn from the first ring body and the second ring body to be arranged along the length direction of the support member, or the first working part and the second working part are driven to be unfolded to form the first ring body and the second ring body respectively;

the ablation device further comprises a kit, wherein the ablation assembly further comprises a connector, the first end of the support is fixedly connected with the first end of the first electrode arm and the first end of the second electrode arm through the connector, the kit is sleeved on the outer side of at least one part of the support, and the first annular body and the second annular body are arranged between one end of the kit close to the connector and the connector;

the control assembly further comprises a telescopic assembly, the telescopic assembly comprises a telescopic elastic body, a first end part and a second end part, the first end part and the second end part are respectively connected to two ends of the telescopic elastic body in the length direction, the first end part is located on one side, close to the connecting piece, of the telescopic elastic body, the second end part is located on one side, far away from the connecting piece, of the telescopic elastic body, the first end part is sleeved on at least part of the outer side, close to one side of the telescopic elastic body, of the sleeve, the first end part is fixedly connected with the sleeve, and one end, far away from the telescopic elastic body, of the second end part is fixedly connected with the pushing piece.

2. The ablation apparatus of claim 1,

the first electrode arm further comprises a first extension part, one end of the first extension part close to the connecting piece is connected with one end of the first working part far away from the connecting piece,

the second electrode arm further comprises a second extension part, one end of the second extension part close to the connecting piece is connected with one end of the second working part far away from the connecting piece,

the first extension portion and the second extension portion are disposed on an outer surface of the support along a length direction of the support.

3. The ablation apparatus of claim 2, wherein the control assembly further comprises a first retaining washer and a second retaining washer, an axial direction of the first retaining washer and an axial direction of the second retaining washer both being parallel to a length of the support member,

the support member passes through the first fixing pad and the second fixing pad along the length direction, the first extension portion of the first electrode arm and the second extension portion of the second electrode arm pass through the first fixing pad and the second fixing pad along the length direction,

the second fixed gasket is positioned on the inner side of the telescopic elastic body and is fixedly connected with the first electrode arm, so that when the pushing piece pushes the second fixed gasket, the first working part of the first electrode arm is drawn to be arranged along the length direction of the support piece,

the second electrode arm is fixedly connected with the first fixed gasket, and the first fixed gasket is fixedly connected with one end, far away from the connecting piece, of the sleeve part, so that the pushing piece pushes the second fixed gasket and drives the second fixed gasket and the first electrode arm until the pushing piece pushes the first fixed gasket to achieve that a second working part of the second electrode arm is drawn to be arranged along the length direction of the supporting piece.

4. The ablation apparatus of claim 3, wherein a resilient member is disposed between the first and second retaining pads and is disposed over the first and second electrode arms.

5. The ablation device of any one of claims 1-4, wherein the first and second annular bodies are heat set annular bodies, wherein the first and second working portions comprise a memory metal.

6. The ablation device according to any one of claims 1 to 4, further comprising a handle assembly, wherein the control assembly is arranged inside the handle assembly.

7. The ablation device of any one of claims 1-4, further comprising a mapping guide, wherein the support is tubular and serves as a passage for the mapping guide, and the mapping guide passes through a second end of the support, which is far from the connector, along the length of the support until the mapping guide extends out of a first end of the support, which is close to the connector.

8. The ablation apparatus of claim 1, wherein the first working portion of the first electrode arm further comprises at least one third working electrode,

the first working electrode and the third working electrode are spaced apart from each other and configured to apply working voltages of different polarities.

9. The ablation apparatus of claim 1, wherein the second working portion of the second electrode arm further comprises at least one fourth working electrode,

the second working electrode and the fourth working electrode are spaced apart from each other and configured to apply working voltages of different polarities.

10. The ablation device of claim 1, wherein the first working electrode of the first electrode arm and the second working electrode of the second electrode arm are spaced apart from each other and configured to apply working voltages of different polarities.

11. The ablation apparatus of claim 1,

the first annular body comprises a first transition connecting section, a first circular arc-shaped body and a second transition connecting section which are connected in sequence, wherein the first circular arc-shaped body and the second transition connecting section are positioned in a first plane, the first end of the first circular arc-shaped body is connected with one end, far away from the axis of the supporting piece, of the second transition connecting section, the second end of the first circular arc-shaped body is connected with one end, far away from the axis of the supporting piece, of the first transition connecting section, and the first transition connecting section is positioned on one side, close to the connecting piece, of the first plane,

the second annular body comprises a third transition connecting section, a second circular arc-shaped body and a fourth transition connecting section which are sequentially connected, wherein the second circular arc-shaped body and the fourth transition connecting section are positioned in a second plane, the first end of the second circular arc-shaped body is connected with one end, far away from the axis of the supporting piece, of the fourth transition connecting section, the second end of the first circular arc-shaped body is connected with one end, far away from the axis of the supporting piece, of the third transition connecting section, and the third transition connecting section is positioned on one side, close to the connecting piece, of the second plane,

the distance from the first plane to the connector is smaller than the distance from the second plane to the connector.

12. The ablation apparatus of claim 1,

the first electrode arm further comprises:

a first inner core as a support body;

a first wire disposed along a core length direction of the first inner core;

the first insulation sleeve is wrapped on the outer sides of the first inner core and the first lead, the at least one first working electrode is sleeved on the outer side of the first insulation sleeve, and the first lead penetrates through a first lead hole formed in the first insulation sleeve and is electrically connected to the at least one first working electrode;

the second electrode arm further includes:

a second inner core as a support body;

a second wire disposed along a core length direction of the second inner core;

and the second insulating sleeve is wrapped on the outer sides of the second inner core and the second lead, the at least one second working electrode is sleeved on the outer side of the second insulating sleeve, and the second lead penetrates through a second lead hole formed in the second insulating sleeve and is electrically connected to the at least one second working electrode.

13. The ablation apparatus of claim 12,

the at least one first working electrode comprises a plurality of first electrode rings uniformly arranged along a core length direction of the first inner core,

the at least one second working electrode comprises a plurality of second electrode rings, and the plurality of second electrode rings are uniformly arranged along the core length direction of the second inner core.