CN113317866B - Ablation assembly, ablation device and method of operation - Google Patents

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 technique

Atrial fibrillation (AF) is a common heart rhythm disorder that affects more than tens of millions of people worldwide. Radiofrequency ablation and cryoablation are two commonly used clinical methods for the treatment of arrhythmias (such as atrial fibrillation). The injury 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.

Radiofrequency ablation point-by-point ablation takes a long time, requires high catheter operation level of the surgeon, patients are uncomfortable during operation, and postoperative pulmonary vein (PV) stenosis is easy; radiofrequency ablation can damage the surface of the heart endothelium and activate the extrinsic coagulation cascade , and lead to coking and thrombus formation, which in turn can lead to systemic thromboembolism. Application of radiofrequency energy to target tissue can affect non-target tissue, application of radiofrequency energy to atrial wall tissue may cause esophageal or nerve damage, and radiofrequency ablation may also cause tissue scarring, further causing embolism problems. Cryoablation has a higher rate of phrenic nerve injury, and freezing of the epicardium near the coronary arteries may lead to thrombosis and progressive coronary stenosis.

The new emerging technology for the treatment of atrial fibrillation is pulsed electric field (PEF) technology, which applies a short high voltage to tissue cells and can generate a local high voltage electric field of hundreds of volts per centimeter. Local high electric fields disrupt the cell membrane by creating pores in the cell membrane where the applied electric field is above the cellular threshold so that the pores do not close and this electroporation is irreversible allowing biomolecular material to be exchanged across the membrane leading to cell necrosis or apoptosis. Since different tissue cells have different voltage penetration thresholds, high-voltage pulse technology can selectively treat cardiomyocytes (threshold is relatively low), without affecting other non-target cell tissues (such as nerves, esophagus, blood vessels, and blood) At the same time, because the energy release time is very short, the pulse technology cannot produce thermal effects, thereby avoiding tissue damage, pulmonary vein stenosis and other problems.

Pulsed electric field ablation is a non-heat-generating technique, and the damage mechanism is that nanometer-scale micropores appear in some cell membranes through high-frequency electric pulses. Potential advantages of pulsed electric fields for ablation of AF include: (1) tissue-selective, which can protect surrounding tissues from damage; (2) PEF can be released rapidly within seconds; (3) no coagulative necrosis, pulmonary vein stenosis Risk reduction.

Contents of the 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 integrally along the support The length direction of the support member is arranged along the length direction, and the first end of the support member along the length direction is respectively connected with the first end of the first electrode arm along the length direction and the first end of the second electrode arm along the length direction. end connection, the first electrode arm includes a first working portion at a first end of the first electrode arm, the first working portion includes at least one first working electrode, and is configured to be able to operate perpendicular to the Extending at least partially away from the support in a lengthwise direction to form a first annular body, the second electrode arm includes a second working portion at a first end of the second electrode arm, the second working portion The portion includes at least one second working electrode and is configured to be expandable in a direction perpendicular to the length direction at least partially away from the support to form a second annular body, the outer edge of the first annular body extending to The distance from the axis of the support is smaller than the distance from the outer edge of the second annular body to the axis of the support.

For example, an ablation assembly provided in at least one embodiment of the present disclosure further includes a connecting piece, wherein the first end of the support piece is respectively connected to the first end of the first electrode arm through the connecting piece. It is fixedly connected with the first end of the second electrode arm.

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

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

For example, in an ablation assembly provided in at least one embodiment of the present disclosure, 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 different polarity of the operating voltage.

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

For example, in an ablation assembly provided in at least one embodiment of the present disclosure, the first electrode arm further includes: a first inner core as a supporting body; a first wire along the core length of the first inner core Direction setting; the first insulating sleeve is wrapped on the outside of the first inner core and the first wire, wherein the at least one first working electrode is sleeved on the outside of the first insulating sleeve, and the first A wire passes through the first wire hole provided on the first insulating sleeve and is electrically connected to the at least one first working electrode; the second electrode arm also includes: a second inner core as a supporting body; Two wires, arranged along the core length direction of the second inner core; a second insulating sleeve, wrapped around the second inner core and the outside of the second wire, wherein the at least one second working electrode sleeve Located outside the second insulating sleeve, the second wire passes through a second wire hole opened on the second insulating sleeve and is electrically connected to the at least one second working electrode.

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

At least one embodiment of the present disclosure provides an ablation device, including: the ablation assembly as described above; a control assembly, at least a part of which is fixedly connected to the support, wherein the control assembly is configured to control the support The member moves along the length direction so that the first working part and the second working part are respectively drawn from the first and second rings to move along the support The length direction of the piece is arranged, or, so that the first working part and the second working part are driven to expand to form the first annular body and the second annular body respectively.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the control assembly includes a pusher, and the pusher is fixedly connected to the support and drives the support along the said lengthwise movement such that said first and second working portions are drawn respectively from said first and second annular bodies to extend along the length of said support Oriented so that the first working portion and the second working portion are driven to expand to form the first annular body and the second annular body, respectively.

For example, an ablation device provided in at least one embodiment of the present disclosure further includes a kit, wherein the ablation assembly further includes a connecting piece, and the first end of the support piece is respectively connected to the first end through the connecting piece. The first end of the electrode arm is fixedly connected to the first end of the second electrode arm, the sleeve is sleeved on the outside of at least a part of the support member, the first annular body and the The second annular body is interposed between an end of the sleeve close to the connecting piece and the connecting piece.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the control assembly further includes a telescopic assembly, and the telescopic assembly includes a telescopic elastic body and two The first end part and the second end part of the end, the first end part is located on the side of the elastic elastic body close to the connecting part and the second end part is located on the side of the elastic elastic body away from the connecting part On one side, the first end piece is sleeved on at least part of the outer side of the side of the sleeve close to the stretchable elastic body and the first end piece is fixedly connected to the sleeve, and the second end piece The end far away from the elastic body is fixedly connected with the pusher.

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 part, and an end of the first extension part close to the connecting part is connected to the first working part. The end of the part far away from the connecting piece is connected, the second electrode arm also includes a second extension part, and the end of the second extending part close to the connecting piece is connected to the second working part far away from the connection One end of the support member is connected, and the first extension portion and the second extension portion are arranged on the outer surface of the support member along the length direction of the support member.

For example, in an ablation device provided in at least one embodiment of the present disclosure, the control assembly further includes a first fixed washer and a second fixed washer, and the axial direction of the first fixed washer is the same as that of the second fixed washer. The axial directions of the fixed gaskets are all parallel to the length direction of the support, and the support passes through the first fixed gasket and the second fixed gasket along the length direction, and the first electrode The first extension part of the arm and the second extension part of the second electrode arm pass through the first fixing washer and the second fixing washer along the length direction, and the second fixing washer is located at The inner side of the stretchable elastic body, and the second fixed gasket is fixedly connected with the first electrode arm, so that when the pusher pushes to the second fixed gasket, the first electrode arm The first working part is drafted to be arranged along the length direction of the support, the second electrode arm is fixedly connected to the first fixing spacer, and the first fixing spacer is connected to the casing One end away from the connecting piece is fixedly connected, so that the pusher pushes to the second fixed pad and drives the second fixed pad and the first electrode arm until pushed to the first fixed pad To achieve the second working portion of the second electrode arm is drawn to be arranged along the length direction of the support.

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

For example, in an ablation device provided in at least one embodiment of the present disclosure, the first annular body and the second annular body are heat-set annular bodies, wherein the first working part and the The second working part includes memory metal.

For example, an ablation device provided in at least one embodiment of the present disclosure further includes a handle assembly, wherein the control assembly is disposed inside the handle assembly.

For example, an ablation device provided in at least one embodiment of the present disclosure further includes a mapping guide, wherein the support is tubular and acts as a passage for the mapping guide, and the mapping guide is along the The length direction of the support member passes through from the second end of the support member away from the connecting member until it protrudes from the first end of the support member close to the connecting member.

At least one embodiment of the present disclosure provides an operation method based on any one of the above ablation assemblies, including: applying a working voltage to the at least one first working electrode included in the first working part; controlling the The first working part is at least partly deployed away from the support member in a direction perpendicular to the length direction to form the first annular body; and/or, for the at least one first working part included in the second working part Applying a working voltage to the two working electrodes; controlling the second working part to expand at least partly away from the support in a direction perpendicular to the length direction to form the second annular body.

For example, an operation method provided by at least one embodiment of the present disclosure further includes: controlling the movement of the support member along the length direction, so that the first working part and the second working part respectively move from the first working part to The annular body and the second annular body are drawn to be arranged along the length direction of the support, or the first working part and the second working part are driven to expand to form the the first annular body and the second annular body.

Description of drawings

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

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

Fig. 3 is a side view of an ablation assembly provided by some embodiments of the present disclosure;

Fig. 4 is a front view of an ablation assembly provided by another embodiment of the present disclosure;

Fig. 5 is a front view of the first working part of the ablation assembly provided by some embodiments of the present disclosure;

Fig. 6 is a front view of the second working part in the ablation assembly provided by some embodiments of the present disclosure, which is independently expanded;

Fig. 7 is a schematic perspective view of an ablation device provided by some embodiments of the present disclosure;

8-9 are partial schematic diagrams of ablation devices provided by some embodiments of the present disclosure;

10-11 are schematic diagrams of the control components of the ablation device provided by some embodiments of the present disclosure;

Fig. 12 is an internal schematic diagram of the control assembly of the ablation device provided by some embodiments of the present disclosure;

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

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

detailed description

The following will clearly and completely describe the technical solutions in the embodiments of the present disclosure with reference to the accompanying drawings in the embodiments of the present disclosure. Apparently, the described embodiments are only some of the embodiments of the present disclosure, not all of them. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection 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 should also be understood that terms such as those defined in common dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in idealized or extremely formalized meanings, unless the disclosure Embodiments are expressly defined as such.

"First", "second" and similar words used in the embodiments of the present disclosure do not indicate any sequence, quantity or importance, but are only used to distinguish different components. Words such as "a", "an" or "the" also do not denote a limitation of quantity, but mean that there is at least one. Likewise, "comprising" or "comprises" and similar words mean that the elements or items appearing before the word include the elements or items listed after the word and their equivalents, and do not exclude other elements or items. Words such as "connected" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect.

The inventors found that the head end of some pulse ablation catheters mainly uses one or more soft electrode arms, most of which are in the shape of a single ring, basket, or flower. The disadvantages include the following:

(1) The single ring-shaped electrode arm is not easy to locate and stick to, and its single size cannot be applied to pulmonary vein ostia of various shapes and sizes. The electrode arm is made of nickel-titanium alloy or stainless steel, and each electrode arm is about 1mm. Due to the different shapes and sizes of the pulmonary vein ostium, only a single expanded size electrode arm is easy to deform or cannot be well placed when it is attached to the pulmonary vein ostium. Fit, and the fit angle is not easy to control.

(2) At present, some balloon catheters need to be used with mapping electrode catheters to judge the isolation of pulmonary veins, and the cost is relatively high.

(3) The effect of the simulated electric field is not ideal; for example, when the corresponding voltage is applied to the single-ring electrode arm model and the flower-shaped electrode arm model for simulation, the effect of the pulsed electric field is not ideal, and the effect of the ablation area in the axial direction of the 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 arranged along the length direction of the support as a whole, and the support The first end of the member along the length direction is respectively connected with the first end of the first electrode arm along the length direction and the first end of the second electrode arm along the length direction, and the first electrode arm includes The first working part, the first working part includes at least one first working electrode, and is configured to be at least partially deployed away from the support in a direction perpendicular to the length direction to form a first annular body, and the second electrode arm is included in the second electrode arm. The second working part of the first end of the two electrode arms, the second working part includes at least one second working electrode, and is configured to be able to expand away from the support at least partially in a direction perpendicular to the length direction to form a second annular body , the distance from the outer edge of the first annular body to the axis of the support is smaller than the distance from the outer edge of the second annular body to the axis of the support.

At least one embodiment of the present disclosure further provides an ablation device including the above ablation assembly. At least one embodiment of the present disclosure further provides an operation method of the above ablation assembly.

The ablation components or ablation devices or operating methods in the above embodiments of the present disclosure can selectively map corresponding signals (such as atrial fibrillation signals) or release electric fields for ablation operations, which can not only conduct and record electrophysiological signals, but also generate effective The ring pulse electric field is operated to achieve selective ablation of target tissue, and can reduce the cost of ablation operation, reduce the steps of ablation operation, and reduce the difficulty of ablation operation.

Embodiments and examples of the present disclosure will be described in detail below in conjunction with the accompanying drawings.

1-2 are front views of the ablation assembly provided by some embodiments of the present disclosure, wherein the first working part and the second working part of the ablation assembly in FIG. Both the part and the second working part are in a contracted state (that is, a state when not unfolded).

For example, as shown in FIGS. 1 and 2 , an ablation assembly 100 provided by at least one embodiment of the present disclosure includes 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 generally arranged along the length direction of the support member 130 (eg, the transverse direction shown in FIGS. 1 and 2 ). The first end of the support member 130 along its length direction (for example, the left end of the support member 130) is respectively connected to the first end of the first electrode arm 110 along the length direction (for example, the left end of the first electrode arm 110) and the second electrode arm 120. The first end in the length direction (for example, the left end of the second electrode arm 120 ) is connected.

For example, the first electrode arm 110 includes a first working portion 111 at a first end of the first electrode arm 110, the first working portion 111 includes at least one first working electrode 1111, and is configured to be able to move substantially perpendicular to the length direction. The direction is at least partially expanded away from the support member 130 to form the first annular body 111a (for example, the first working portion 111 is at least partially flexible so as to be able to expand along the vertical direction shown in FIG. 1 to form the first annular body 111a).

For example, the second electrode arm 120 includes a second working portion 121 at a first end of the second electrode arm 120, the second working portion 121 includes at least one second working electrode 1211, and is configured to be able to move substantially perpendicular to the length direction. The direction is at least partially expanded away from the support member 130 to form the second annular body 121a (for example, the second working portion 121 is at least partially flexible so as to be able to expand along the vertical direction shown in FIG. 1 to form the second annular body 121a).

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

For example, as shown in FIGS. 1 and 2, the support 130 can be tubular (for example, in this case, the support 130 can be referred to as an inner tube) and play a supporting role, and the support 130 can also serve as a guide wire passage ( See description below for details).

For example, in some examples, by applying or not applying a working voltage to the first working electrode 111 of the first working part 111, to control whether the first working part 111 generates an ablation electric field, that is, the first working of the first electrode arm 110 When the part 111 is working, the first working electrode 111 of the first working part 111 is applied with a working voltage. Similarly, by applying or not applying a working voltage to the second working electrode 121 of the second working part 121, to control whether the second working part 121 generates an ablation electric field, that is, when the second working part 121 of the second electrode arm 120 is working , the second working electrode 121 of the second working part 121 is applied with a working voltage.

It should be noted that the up, down, left, right and other orientations involved in the present disclosure all represent the orientations in the illustrations for the convenience of readers to understand, but this does not affect the orientations in practical applications, and the disclosure does not limit this.

Compared with the ablation assembly with a single-ring electrode, the ablation assembly in at least one embodiment of the present disclosure has double rings of different sizes and each ring is equipped with an electrode, so that the small ring (ie, the first ring-shaped body 111a) can be The diameter is designed to be smaller than the opening of the target object (such as the pulmonary vein ostium), so that the small ring can penetrate deep into the pulmonary vein, so that it is easier to find the pulmonary vein orifice and stick to it, and use the large ring (ie, the second annular body 121a) to stick to the pulmonary vein mouth for ablation. For example, the small ring of the ablation component can go deep into the pulmonary vein to play a positioning role, and it can also be combined with a mapping guide (such as a mapping catheter or a mapping guide wire) to judge the isolation of the pulmonary vein, so that it can be more accurately and quickly. to the pulmonary veins.

The ablation assemblies of some embodiments of the present disclosure can also accommodate pulmonary vein ostia of different sizes. For example, the small ring can also be directly attached to the relatively thin pulmonary vein ostium, and the ablation operation can be performed directly using the small ring, that is, the large ring may not work at this time.

For example, as shown in FIG. 1 and FIG. 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 through the connecting member 140 .

For example, in some examples, connector 140 may be a flexible tip piece. Of course, this is only exemplary and not a limitation of the present disclosure.

It should be noted that the present disclosure does not limit the structural form and material composition of the connector 140, as long as it can be used to fix and connect the support member 130, the first electrode arm 110, and the second electrode arm 120, it is not exhaustive here. and repeat.

It should also be noted that the first end of the support member 130 in the present disclosure is not limited to fixed connection with the first end of the first electrode arm 110 and the first end of the second electrode arm 120 respectively, and other connection methods are also possible. As long as the first electrode arm 110, the second electrode arm 120 and the supporting member 130 that move relatively can be pulled, any connection method can be used to complete the contraction of the first electrode arm 110 and the second electrode arm 120. And then exhaustive and repeat.

It should be noted that the connecting member 140 in some embodiments of the present disclosure is not only used to fixedly connect the support member 130 to the first electrode arm 110 and the second electrode arm 120 respectively, but also can be used to combine with the first electrode arm 110 to Play a role in positioning the pulmonary vein orifice, making it easier for the operator to find the pulmonary vein orifice.

It can be seen from the above that, based on the ablation assembly of at least one embodiment of the present disclosure, no additional mapping guide is required during the ablation operation, for example, one of the two annular bodies included in the ablation assembly (such as the first ring Shape body) can replace the mapping guide to find, for example, the pulmonary vein ostium, and another ring (such as the second ring body) can be used as an ablation component for ablation operation, thereby reducing operation cost and operation steps.

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 are spaced apart from each other, and are configured to apply different polarities Operating Voltage. For example, there is a gap between a first working electrode 1111 and its adjacent third working electrode to realize the distance from each other.

For example, in some examples, the second working part 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 are spaced apart from each other, and are configured to apply different polarities. Operating Voltage. For example, there is a gap between a second working electrode 1211 and its adjacent fourth working electrode to realize the distance from each other.

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

The first type of electric field: when the first electrode arm 110 and the second electrode arm 120 work at the same time, the first working electrode 1111 and the third working electrode, which are configured with different polarity operating voltages on the first electrode arm 110, are electrified positively and negatively, forming The 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 positively and negatively energized alternately to form an ablation electric field.

The second type of electric field: when the first electrode arm 110 and the second electrode arm 120 work alone, the first working electrode 1111 and the third working electrode configured with different polarity operating voltages on the first electrode arm 110 are electrified positively and negatively, forming The 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 alternately, forming an ablation electric field.

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

It should be noted that the first working electrode 1111 and the corresponding third working electrode, as well as the second working electrode 1211 and the corresponding fourth working electrode in the above-mentioned embodiments of the present disclosure are all intended to distinguish between different working voltages of different polarities. Working electrodes, rather than limiting other aspects of each working electrode, for example, the third working electrode can be the working electrodes at the left and right ends of one of the first working electrodes 1111 marked in FIG. The polarity of the working voltage configured by 1111 is different. The fourth working electrode can be the working electrode at the left and right ends of one of the second working electrodes 1211 marked in FIG. Sex is different, and the present disclosure does not limit it.

For example, in some other examples, the first working electrode 1111 of the first electrode arm 110 and the second working electrode 1211 of the second electrode arm 120 are spaced apart from each other, and are configured to apply working voltages of different polarities. It should be noted that the space between the first working electrode 1111 of the first electrode arm 110 and the second working electrode 1211 of the second electrode arm 120 described here can be understood as the first working electrode 1111 and the second working electrode There is a space between 1211 to achieve spacing from each other. It should also be noted that a first working electrode 1111 of the first electrode arm 110 and a corresponding second working electrode 1211 on the second electrode arm 120 can be arranged facing each other, or they can be partially opposite and partially misaligned. Limitations, as long as the first working electrode 1111 of the first electrode arm 110 and the second working electrode 1211 of the second electrode arm 120 can form an ablation electric field after applying different polarity working voltages, details will not be described here.

It can be seen that, in some examples, the ablation assembly 100 can form the following third electric field during the ablation operation: when the first electrode arm 110 and the second electrode arm 120 work simultaneously, the first working electrode 1111 of the first electrode arm 110 The second working electrode 1211 of the second electrode arm 120 and the second electrode arm 120 can respectively serve as positive and negative electrodes to form an ablation electric field.

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

Compared with the ablation assembly with a single-ring electrode, the ablation assembly in some embodiments of the present disclosure has double rings of different sizes and each ring is equipped with electrodes, and the electrodes on the two rings can be used as positive and negative electrodes respectively, so that An ablation electric field with a larger electric field range is formed, which is beneficial to the ablation operation. In other examples, the ablation assembly based on the present disclosure can also use one of the electrode arms alone for ablation, and can select different electrode distribution modes for operation according to doctors or preoperative planning to meet different needs.

Figure 3 is a side view of an ablation assembly provided by some embodiments of the present disclosure. Fig. 4 is a front view of an ablation assembly provided by some other embodiments of the present disclosure.

For example, as shown in FIG. 3 and FIG. 4, the first annular body 111a includes a first transitional connection segment L11, a first circular arc-shaped body S13 and a second transitional connection segment L12 connected in sequence, wherein the first circular arc-shaped The body S13 and the second transitional connection section L12 are in the first plane, and the first end of the first arc-shaped body S13 is connected to the end of the second transitional connection section L12 away from the axis of the support member 130 (for example, the second transition in FIG. 3 The upper end of the connecting section L12) is connected, and the second end of the first arc-shaped body S13 is connected to the end of the first transitional connecting section L11 away from the axis of the support (such as the upper end of the first transitional connecting section L11 in FIG. 3 ), And the first transition connection section L11 is located on a side of the first plane close to the connecting piece 140 (for example, the first transition connection section L11 in FIG. 4 is located on the left side of the first plane).

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

For example, as shown in FIG. 3 and FIG. 4 , the distance from the first plane to the connector 140 is smaller than the distance from the second plane to the connector 140 , that is, the first plane is closer to the connector 140 than the second plane.

Compared with the first working part 111 and the second working part 121 of the ablation assembly shown in FIG. 1 and FIG. One of 121 can also be expanded independently, which can be determined according to actual needs, and will not be repeated here.

Fig. 5 is a front view of the first working part of the ablation assembly provided by some embodiments of the present disclosure unfolded separately. Fig. 6 is a front view of the second working part of the ablation assembly provided by some embodiments of the present disclosure, which is unfolded separately.

For example, as shown in FIG. 5 , the first working part 111 of the first electrode arm 110 can be expanded independently to form the first annular body 111a, and the second working part 121 of the second electrode arm 120 can be in a contracted state without being expanded. For example, as shown in FIG. 6 , the second working portion 121 of the second electrode arm 120 can be expanded independently to form the second annular body 121a, and the first working portion 111 of the first electrode arm 110 can be in a contracted state without expanding.

It should be noted that the present disclosure does not limit the specific method of how to realize the first working part 111 to be independently deployed and the second working part 121 to be contracted, and how to realize the second working part 121 to be independently deployed and the first working part 111 to be contracted, as long as the Any implementation of the state shown in FIG. 5 or FIG. 6 is within the protection scope of the present disclosure, and since it is not the focus of the present disclosure, details are not described here.

For example, as shown in Figures 1 and 2, the first electrode arm 110 also includes a first insulating sleeve 1112, a first wire (not shown in the figure because it is wrapped by the first insulating sleeve 1112) and a first inner core (due to being wrapped by the first insulating sleeve 1112). An insulating sleeve 1112 is wrapped, not shown in the figure). The first inner core is used as the supporting body of the first electrode arm 110, the first wire is arranged along the core length direction of the first inner core (such as the transverse direction shown in Figure 2), and the first insulating sleeve 1112 is wrapped around the first inner core and the outside of the first lead. The first working electrode 1111 is sheathed on the outside of the first insulating sleeve 1112 , and the first wire passes through the first wire hole opened on the first insulating sleeve 1112 and is electrically connected to the first working electrode.

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

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

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

It should be noted that FIG. 2 and FIG. 3 are simple and intuitive diagrams for the convenience of readers to understand, and are not intended to limit the present disclosure. For example, although the first working electrode 1111 and the first working electrode 1111 in FIG. The first insulating sleeve 1112 is marked separately, but in some embodiments of the present disclosure, there is also a first insulating sleeve 1112 where the first working electrode 1111 is placed on the first electrode arm 110, because the first working electrode 1111 is sleeved on The outside of the first insulating sleeve 1112 .

For example, as shown in Figures 1 and 2, the second electrode arm 120 also includes a second insulating sleeve 1212, a second wire (not shown in the figure because it is wrapped by the second insulating sleeve 1212) and a second inner core (due to being wrapped by the second insulating sleeve 1212). Two insulating sets 1212 are wrapped, not shown in the figure). The second inner core is used as the supporting body of the second electrode arm, the second wire is arranged along the core length direction (such as the transverse direction shown in Figure 2 ) of the second inner core, and the second insulating sleeve 1212 is wrapped around the second inner core and the second inner core. outside of the second lead. The second working electrode 1211 is sheathed on the outside of the second insulating sleeve 1212 , and the second wire passes through the second wire hole opened on the second insulating sleeve 1212 and is electrically connected to the second working electrode 1211 .

For example, in some examples, the second wire surrounds the second inner core and is arranged along the core length direction of the second inner core. Of course, this is only exemplary and not a limitation of the present disclosure.

For example, in some examples, the second wire can be welded to the second working electrode. Of course, this is only exemplary and not a limitation of the present disclosure.

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

It should be noted that Fig. 2 and Fig. 3 are simple and intuitive diagrams for the convenience of readers' understanding, and are not intended to limit the embodiments of the present disclosure. For example, although the second work in Fig. 2 and Fig. The electrode 1211 and the second insulating sleeve 1212 are marked separately, but in some embodiments of the present disclosure, there is also a second insulating sleeve 1212 where the second working electrode 1211 is located on the second electrode arm 120 because the second working electrode 1211 covers It is arranged on the outside of the second insulating sleeve 1212 .

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

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

For example, in some examples, a first working electrode (e.g., first electrode ring), a second working electrode (e.g., second electrode ring), a third working electrode (e.g., third electrode ring), a fourth working electrode (e.g., One or more of the four electrode rings) adopt platinum or platinum-iridium, the length can be 1-10 mm, and the thickness can be 0.01-0.1 mm. Of course, this is only 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 only exemplary, not a limitation of the present disclosure, and can be freely adjusted according to actual applications.

For example, in some examples, suitable materials such as PEBAX, TPU, and Nylon can be selected as the material of the support member 130 , which is not limited in the present disclosure. For example, in some examples, the support member 130 may be braided with 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 1-2 mm. Of course, this is only 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 part 111 of the first electrode arm 110 is expanded may be 10-20 mm (for example, the diameter of the first arc-shaped body S13 may be 10 mm. -20mm). For example, in some examples, the working diameter of the second annular body 121a formed after the second working part 121 of the second electrode arm 120 is expanded can be 20-30 mm (for example, the diameter of the second arc body S23 can be 20-30 mm). 30mm). Of course, this is only exemplary and not a limitation of the present disclosure.

Fig. 7 is a schematic perspective view of an ablation device provided by some embodiments of the present disclosure. 8-9 are partial schematic diagrams of ablation devices provided by some embodiments of the present disclosure. 10-11 are schematic diagrams of the control components of the ablation device provided by some embodiments of the present disclosure. Fig. 12 is an internal schematic diagram of a control assembly of an ablation device provided by some embodiments of the present disclosure.

For example, as shown in FIGS. 7 to 12 , an ablation device 200 provided by at least one embodiment of the present disclosure includes an ablation component 100 (such as the ablation component described in any embodiment above, which will not be described in detail below) and a control component 210 . At least a part of the control assembly 210 is fixedly connected to the support member 130, and the control assembly 210 is configured to control the movement of the support member 130 along its length direction (for example, the transverse direction shown in FIGS. 8 and 9 ), so that the first working part 111 and The second working part 121 is respectively drawn from the first annular body 111a and the second annular body 121a to be arranged along the length direction of the support member 130, or, so that the first working part 111 and the second working part 121 are driven are unfolded to form a first annular body 111a and a second annular body 121a, respectively.

For example, as shown in Figures 10 to 12, the control assembly 210 includes a pusher 211, which is fixedly connected to the support 130 and drives the support 130 to move along its length direction by pushing the pusher 211, so that the first working The part 111 and the second working part 121 are respectively drawn from the first annular body 111a and the second annular body 121a to be arranged along the length direction of the support 130, or such that the first working part 111 and the second working part 121 is driven to expand to form the first annular body 111a and the second annular body 121a respectively.

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

For example, as shown in FIGS. 7 to 12 , the ablation device 200 further includes a sleeve 220 , and the sleeve 220 is sleeved on the outside of at least a part of the support 130 (for example, the sleeve 220 is sleeved in the support 130 and is located on the second working part 121 . part of the right side), the first annular body 111a and the second annular body 121a are interposed between an end of the sleeve 220 close to the connecting piece 140 and the connecting piece 140 . For example, as shown in FIG. 9 , the first annular body 111 a and the second annular body 121 a are interposed between the left end of the sleeve 220 and the right end of the connecting piece 140 .

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

For example, in some examples, sleeve 220 is at least partially flexible. For example, the material of the casing 220 can be PEBAX, TPU, Nylon and other suitable materials. For example, the diameter of the outer tube 220 may be 8-15F. For example, outer tube 220 may be braided with stainless steel to provide support strength.

For example, as shown in FIGS. 10 to 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 piece 2121 and a second end piece 2122 respectively connected to two ends of the elastic body 2123 along the length direction (for example, the transverse direction shown in FIG. 11 ). The first end part 2121 is located on the side of the stretchable elastic body 2123 close to the connector 140 (for example, the first end part 2121 is located on the left side of the stretchable elastic body 2123), and the second end part 2122 is located on the side of the stretchable elastic body 2123 away from the connector 140 side (for example, the second end part 2122 is located on the right side of the stretchable elastic body 2123). The first end piece 2121 is sleeved on at least part of the outer side of the sleeve 220 near the side of the stretchable elastic body 2123 (for example, the first end piece 2121 is sleeved on the right end of the sleeve 220), and the first end piece 2121 is fixedly connected to the sleeve 220 One end of the second end part 2122 away from the stretchable elastic body 2123 (for example, the right end of the second end part 2122 ) is fixedly connected with the pusher 211 .

For example, in some examples, the pushing member 211 is fixed to the support member 130 by bonding or welding. For example, when the pusher 211 is pushed, the pusher 211 moves relative to the first electrode arm 110 and the second electrode arm 120 during the stroke, and the support member 130, the first electrode arm 110, and the second electrode arm are moved based on the connecting piece 140. The respective head ends (for example, the left end or the front end) of 120 are fixedly connected, 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 stretchable elastic body 2123 includes a stretchable rubber ring. Of course, this is only exemplary and not a limitation of the present disclosure, as long as it is a stretchable elastic body, it will not be repeated here.

For example, as shown in FIGS. 10 to 12 , the first electrode arm 110 further includes a first extension portion 112 , and one end of the first extension portion 112 close to the connector 140 (for example, the left end of the first extension portion 112 ) is connected to the first working part. An end of the part 111 away from the connecting piece 140 (for example, the right end of the first working part 111 ) is connected. The second electrode arm 120 also includes a second extension part 122, an end of the second extension part 122 close to the connecting part 140 (for example, the left end of the second extending part 122) and an end of the second working part 121 away from the connecting part 140 (for example, The right end of the second working part 121) is connected. The first extension part 112 and the second extension part 122 are arranged on the outer surface of the supporter 130 along the length direction of the supporter 130 .

For example, as shown in FIGS. 10-12 , the control assembly 210 also includes a first fixed washer 213 and a second fixed washer 214. The axial direction of the first fixed washer 213 (for example, the transverse direction shown in FIGS. 11 and 12 direction) and the axial direction of the second fixing washer 214 (such as the transverse direction shown in FIGS. 11 and 12 ) are both parallel to the lengthwise direction of the support member 130 .

For example, the support member 130 passes through the first fixing spacer 213 and the second fixing spacer 214 along the length direction, and the first extending portion 112 of the first electrode arm 110 and the second extending portion 122 of the second electrode arm 120 along The length direction passes through the first fixing washer 213 and the second fixing washer 214 . The second fixed gasket 214 is located inside the stretchable elastic body 2123, and the second fixed gasket 214 is fixedly connected to the first electrode arm 110, so that when the pusher 211 is pushed to the second fixed gasket 214, the first electrode arm 110 is realized. The first working part 111 is stretched to be arranged along the length direction of the support member 130 , that is, the first working part 111 is completely shrunk.

For example, the second electrode arm 120 is fixedly connected to the first fixed washer 213, and the first fixed washer 213 is fixedly connected to an end (such as the right end of the sleeve 220) of the sleeve 220 away from the connector 140, so that the pusher 211 pushes to The second fixed washer 214 drives the second fixed washer 214 and the first electrode arm 110 until it is pushed to the first fixed washer 213 to realize that the second working part 121 of the second electrode arm 120 is completely drawn to move along the Arranged along the length direction of the support member 130, that is, the second working part 121 completes contraction.

For example, in some examples, since the second fixed gasket 214 is fixedly connected to the first electrode arm 110, if the second fixed gasket 214 is not pushed, the second fixed gasket 214 and the first electrode arm 110 are stationary, However, if the second fixed washer 214 is pushed, the second fixed washer 214 will move forward together with the first electrode arm 110 (for example, move to the left) and continue to shrink until it is pushed to the first fixed washer 213, The shrinking of the second working part 121 is achieved.

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

For example, in some examples, the second electrode arm 120 is glued or welded to the first fixing gasket 213 , and the first fixing gasket 213 is glued or welded to the right end of the sleeve 220 .

For example, in some examples, the second fixing gasket 214 is fixed to the first electrode arm 110 by bonding or welding at a certain position in the stretchable elastic body 2123 .

For example, as shown in FIG. 10 , an elastic member 215 is provided between the first fixing washer 213 and the second fixing washer 214 and the elastic member 215 is sleeved on the outside of the first electrode arm 110 and the second electrode arm 120 .

For example, in some examples, the first annular body 111 a and the second annular body 121 a are heat-set annular bodies, wherein the first working part 111 and the second working part 121 include memory metal. For example, the first working part 111 and the second working part 121 are heat-set by nickel-titanium alloy, and are unfolded in a natural unstressed state, and the first ring-shaped body 111a and the second The annular body 121a shrinks.

It should be noted that the first working part 111 and the second working part 121 are expanded by heat setting to form the first annular body 111a and the second annular body 121a respectively. Stretching can complete the contraction of the first annular body 111a and the second annular body 121a. If the operator releases the pushing member 211, based on the elastic effect of the elastic member 215 and the elastic elastic body 2123, the contracted first working part 111 and The second working part 121 rebounds and returns to the first annular body 111a and the second annular body 121a.

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

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

For example, as shown in FIGS. 13 and 14 , the control assembly 210 is located at the proximal end of the handle assembly 230 (eg, the right end of the handle assembly 230 ). Of course, this is only 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 is tubular and serves as a passage for the mapping guide, and the mapping guide extends from the support 130 along the length direction of the support 130 The second end of 130 away from the connecting piece 140 (for example, the right end of the supporting piece 130 ) passes through until the first end of the supporting piece 130 close to the connecting piece 140 (for example, the left end of the supporting piece 130 ) protrudes.

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

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

For example, as shown in FIG. 7 and FIGS. 11 to 14 , the adjustable curved handle assembly further includes a rotating part 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 pusher 211 is fixedly connected to the connection mechanism 233 (for example, adhesively fixed or welded), and the support member joint 234 is located at the remote connection of the connection mechanism 233. One side of the piece 140 (for example, the support piece joint 234 is located at the right end of the connection mechanism 233 ), the support piece joint 234 is connected with the connection mechanism 233 . Thus, the support 130 passes through the connecting mechanism 233 and the support joint 234 , allowing the mapping guide to pass through.

For example, in some examples, the rotating member 232 can realize two-way rotation, so as to control the ablation assembly 100 of the ablation device to deflect accordingly, so as to smoothly enter the pulmonary vein ostium.

For example, the rotating part 232 is connected with two control wires provided on the side wall of the sleeve 220. When the rotating part 232 rotates, the control wires are driven to shrink to drive the deflection and bending of the sleeve 220 (for example, the side of the sleeve 220 close to the connecting piece 140), thereby driving The ablation assembly 100 performs deflection adjustments. Of course, this is only exemplary and not a limitation of the present disclosure.

At least one embodiment of the present disclosure provides an operation method of an ablation assembly, including:

Apply a working voltage to at least one first working electrode 1111 included in the first working part 111 of the first electrode arm 110; control the first working part 111 to spread away from the support member 130 at least partially in a direction perpendicular to the length direction, forming a first annulus 111a; and/or,

Apply a working voltage to at least one second working electrode 1211 included in the second working part 121 of the second electrode arm 120; control the second working part 121 to expand away from the support 130 at least partially in a direction perpendicular to the length direction, forming a second Ring body 121a.

It can be seen from this that in some embodiments of the present disclosure, the first working part 111 and the second working part 121 of the ablation assembly can be deployed simultaneously to work, or one of the first working part 111 and the second working part 121 of the ablation assembly can also be deployed It can be expanded separately, and the details can be referred to above, so I won’t go into details here.

For example, in some examples, the operation method of the ablation assembly further includes: controlling the movement of the support member 130 along the lengthwise direction, so that the first working part 111 and the second working part 121 are separated from the first annular body 111a and the second annular body 111a respectively. The body 121a is stretched to be arranged along the length direction of the support member 130, or the first working portion 111 and the second working portion 121 are driven to expand to form the first annular body 111a and the second annular body 121a respectively.

It should be noted that, in the embodiments of the present disclosure, for the specific process and technical effect of the operation method of the ablation assembly, reference may be made to the description of the ablation assembly above, and details are not repeated here.

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

The first ablation procedure: the support 130 is set in a tubular shape so that the mapping guide passes along the length direction of the support 130 from the second end of the support 130 away from the connection 140 until it protrudes from the close connection of the support 130 The first end of the member 140, and the first annular body 111a abuts against an opening of the target object (for example, a pulmonary vein ostium). For example, when the first annular body 111a is attached to the ostium of the pulmonary vein during the first ablation process, the first annular body 111a is used for the ablation operation, and at this time the second annular body 121a may not work.

The second ablation process: the first ring-shaped body 111a passes through an opening of the target object (such as the pulmonary vein ostium) and extends into the inside of the target object (such as the inside of the pulmonary vein), and the second ring-shaped body 121a is attached to the target object Openings (such as pulmonary vein ostia). For example, during the second ablation process, when the first ring body 111a is inserted into the pulmonary vein and the second ring body 121a abuts against the pulmonary vein ostium, the second ring body 121a is used for the ablation operation. At this time, the first ring body 121a The shape body 111a is used to replace the mapping guide to find the pulmonary vein ostium, that is, no additional mapping guide is needed at this time.

The third ablation process: the first annular body 111a passes through an opening of the target object (such as the pulmonary vein ostium) and extends into the inside of the target object (such as the inside of the pulmonary vein), and the support member 140 is set in a tubular shape so that the mapping guide along The length direction of the support member 140 passes through from the second end of the support member 130 away from the connecting member 140 until it protrudes from the first end of the support member 130 close to the connecting member 140, and attaches the second annular body 121a to the target object openings (e.g. pulmonary vein ostia). For example, in the third ablation process, when the first annular body 111a is inserted into the pulmonary vein and the second annular body 121a is attached to the pulmonary vein ostium, the second annular body 121a is used for the ablation operation. At this time, the first annular body 111a The shape body 111a plays a positioning role, and cooperates with the mapping guide to find the pulmonary vein ostium. At this time, the main function of the mapping guide is to find the pulmonary vein ostium.

It should be noted that, in the embodiment of the present disclosure, for the specific process and technical effect of the ablation method of the ablation assembly, reference may be made to the above description of the ablation assembly, and details are not repeated here.

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

Step S1, using femoral vein puncture to place the vascular sheath into the bilateral femoral veins.

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

Step S3, perform interatrial septal puncture through the right femoral vein, left atrium and pulmonary venography;

Step S4, replacing the pulse ablation delivery system;

Step S5, sending into the ablation component;

Step S6, the mapping guide (such as a mapping guide wire) enters the target target vein, unfolds the first working part 111 of the first electrode arm 110 and abuts against the pulmonary vein for mapping;

Step S7 , unfolding the second working part 121 of the second electrode arm 120 and selecting the corresponding electrode distribution, adhering to the vestibule of the pulmonary vein and performing the ablation operation.

According to the foregoing, steps S1-S7 of the above-mentioned operation method correspond to the above-mentioned third ablation process, and for the execution steps of the operation method corresponding to the first ablation process and the second ablation process, refer to the above-mentioned steps S1-S7. Step S7, which will not be repeated here.

The following points need to be explained:

(1) Embodiments of the present disclosure The drawings only relate to the structures involved in the embodiments of the present disclosure, and other structures may refer to common designs.

(2) In the case of no conflict, the embodiments of the present disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

The above description is only a specific implementation manner of the present disclosure, but the protection scope of the present disclosure is not limited thereto, and the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims (13)

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.

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