CN115444542A

CN115444542A - Left auricle plugging and ablation device

Info

Publication number: CN115444542A
Application number: CN202110790616.3A
Authority: CN
Inventors: 李建民; 尤岩; 吴能标; 王坤; 王永胜
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2021-06-08
Filing date: 2021-07-13
Publication date: 2022-12-09
Also published as: CN115444543A; WO2022257992A1

Abstract

The invention relates to a left atrial appendage occlusion ablation device. Left atrial appendage shutoff ablation device includes: the anchoring disc is of a radial telescopic support structure; the sealing disc is of a radial telescopic support structure and is arranged at the near end of the anchoring disc; the sealing disc is made of a conductive material, and the whole sealing disc is used as a first conductive part for transmitting ablation energy or collecting tissue physiological signals. The anchoring disc is released in the left auricle, the anchoring disc can anchor the inner wall of the tissue of the left auricle, and the sealing disc is released at the entrance of the left auricle, so that the sealing disc blocks the entrance of the left auricle, blocks thrombus in the left auricle and effectively prevents the thrombus from entering the left atrium. Simultaneously the whole electrically conductive and transmission of sealed dish melts the energy, melts left auricle portion, more is favorable to melting the area at the complete ring-shaped of oral area formation, and then is convenient for thoroughly keep apart left auricle and left atrium electricity at left auricle portion, greatly improves and melts the effect.

Description

Left auricle plugging and ablation device

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a left atrial appendage occlusion ablation device.

Background

Atrial fibrillation (atrial fibrillation for short) is the most common persistent arrhythmia, and the incidence rate of atrial fibrillation is increased continuously with the increase of age, and the population over 75 years old can reach 10 percent. The incidence of atrial fibrillation is also closely related to coronary heart disease, hypertension, heart failure and other diseases. The left atrial appendage is not only the most important part of atrial fibrillation thrombosis formation due to the special shape and structure of the left atrial appendage, but also one of key areas for generation and maintenance of the atrial fibrillation thrombosis, and part of patients with atrial fibrillation can benefit from active left atrial appendage electrical isolation.

A number of successful atrial fibrillation cases have been treated using a one-stop treatment combining catheter radio frequency ablation and left atrial appendage occlusion. Currently, a number of successful atrial fibrillation cases have been treated using a one-stop treatment approach that combines catheter radio frequency ablation and left atrial appendage occlusion. In the one-stop treatment method, through left atrial appendage occlusion, the patient can still obtain good stroke prevention effect without lifelong administration of anticoagulant drugs; and the symptoms of patients with atrial fibrillation are improved by combining with the radio frequency ablation of the catheter to recover and maintain the sinus rhythm, so that the patients can obtain stable long-term treatment effect. However, if the ablation and the occlusion of the left atrial appendage are to be performed in the one-stop treatment process, the ablation catheter and the left atrial appendage occlusion ablation device need to be introduced in an interventional manner, and the key is to successively position the two devices at the oral area of the left atrial appendage, and then respectively perform the ablation and the occlusion.

Disclosure of Invention

The invention aims to provide a left atrial appendage occlusion ablation device which can effectively solve the technical problems of complex and difficult one-stop therapeutic operation procedure of ablation and left atrial appendage occlusion in the prior art.

In order to solve the technical problems, the invention adopts the following technical scheme:

embodiments of the present invention provide a left atrial appendage occlusion ablation device, comprising: the anchoring disc is of a radial telescopic support structure; the sealing disc is of a radial telescopic support structure and is arranged at the near end of the anchoring disc; the sealing disc is made of a conductive material, and the whole sealing disc is used as a first conductive part for transmitting ablation energy or collecting tissue physiological signals.

According to some embodiments of the present application, the left atrial appendage occlusion ablation device further comprises a second conductive portion for transmitting ablation energy or collecting tissue physiological signals, respectively; the second conductive part is arranged on the anchoring disc; the sealing disk is electrically isolated from the second conductive portion.

According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:

the embodiment of the invention provides a left atrial appendage occlusion ablation device, which comprises an anchoring disc and a sealing disc; anchor dish and sealed dish are radial telescopic supporting structure, utilize anchor dish release in the auricle of the left heart, the tissue inner wall of the auricle of the left heart of the anchorable of anchor dish, utilize sealed dish release at auricle of the left heart entrance, usable sealed dish shutoff auricle of the left heart entrance, the inside thrombus of shutoff auricle of the left heart prevents effectively that the thrombus from getting into the left atrium. Simultaneously the whole electrically conductive and as first conductive part of sealed dish and transmission melt the energy, melt left auricle portion, more be favorable to forming complete annular in the oral area and melt the area, and then be convenient for thoroughly with left auricle and left atrium electricity isolation at left auricle portion, greatly improve and melt the effect. The sealing disc as the first conductive part can also be used for collecting tissue physiological signals for mapping. In addition, the left auricle plugging and ablating device combines ablation and plugging, simplifies the procedure of one-stop treatment operation of 'ablation and left auricle plugging', and is beneficial to reducing the operation difficulty.

Drawings

Fig. 1 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in embodiment 1 of the present invention.

Fig. 2 is a schematic cross-sectional structural view of a left atrial appendage occlusion ablation device provided in embodiment 1 of the invention.

Fig. 3 is an enlarged view of a part of the structure at iii in fig. 2.

Fig. 4 is a schematic structural diagram of a conveyor provided in embodiment 1 of the present invention.

Fig. 5 is a schematic structural diagram of the first framework in fig. 2.

Fig. 6 is a schematic structural diagram of an insulating connector in the left atrial appendage occlusion ablation device provided in embodiment 2 of the invention.

Fig. 7 is a schematic structural diagram of an insulating connector in the left atrial appendage occlusion ablation device provided in embodiment 3 of the invention.

Fig. 8 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in embodiment 4 of the invention at the location of the insulated connectors.

Fig. 9 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in example 5 of the present invention at the location of the insulated connectors.

Fig. 10 is a schematic view of the insulated connector of the left atrial appendage occlusion ablation device of fig. 9 in an extended and twisted configuration.

Fig. 11 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 6 of the present invention.

Figure 12 is a cross-sectional schematic view of the left atrial appendage occlusion ablation device of figure 11 with the covering removed.

Fig. 13 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 7 of the present invention.

Fig. 14 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 8 of the present invention.

Fig. 15 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 9 of the present invention.

Figure 16 is a schematic view of the left atrial appendage occlusion ablation device of figure 15 with the covering removed.

Fig. 17 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in embodiment 10 of the invention.

Figure 18 is a schematic view of the left atrial appendage occlusion ablation device of figure 17 with the covering removed.

Fig. 19 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 11 of the present invention.

Figure 20 is a schematic view of the left atrial appendage occlusion ablation device of figure 19 with the covering removed.

Fig. 21 is a schematic structural view of a left atrial appendage occlusion ablation device provided in embodiment 12 of the invention with a covering film removed.

Fig. 22 is a schematic structural diagram of a first framework in the left atrial appendage occlusion ablation device of fig. 21.

Fig. 23 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 13 of the present invention.

Fig. 24 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 14 of the present invention.

Figure 25 is a schematic view of the left atrial appendage occlusion ablation device of figure 24 with the covering removed.

Fig. 26 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 15 of the present invention.

FIG. 27 is a schematic view of the movable member of FIG. 26.

FIG. 28 is a second structural schematic view of the moveable member of FIG. 26.

FIG. 29 is a third structural schematic view of the moveable member of FIG. 26.

FIG. 30 is a fourth structural schematic view of the moveable member of FIG. 26.

FIG. 31 is a fifth structural view of the movable member of FIG. 26.

Fig. 32 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 16 of the present invention.

Fig. 33 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 17 of the present invention.

Fig. 34 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in example 18 of the present invention.

Description of the drawings: 100. an ablation stent; 110. an anchor plate; 111. a first skeleton; 112. a support portion; 1121. a support bar; 1122. a first branch; 1123. a second branch; 1124. a first connection point; 113. an anchoring portion; 1131. a connecting rod; 1132. a third branch; 1133. a fourth branch; 1134. a second connection point; 114. a second conductive portion; 116. a first pole element; 117. a barb; 118. a connecting ring; 119. a distal connector; 120. sealing the disc; 121. a second skeleton; 122. a first conductive portion; 123. a second pole element; 124. a second conductive connection portion; 125. an insulating film; 126. a flow-blocking membrane; 127. a disc surface; 128. a plate bottom; 129. a waist part; 130. an insulating connector; 131. a first connecting member; 1311. a first installation space; 132. a second connecting member; 1321. an inner sleeve; 1322. an outer sleeve; 1323. a second installation space; 133. a third connecting member; 1331. a large pipe section; 1332. a small pipe section; 134. a first conductive connection portion; 135. a fourth connecting member; 140. a conveyor; 141. a second conduit; 142. a first conduit; 143. an outer tube; 144. a handle; 150. a movable member; 1501. a convergence unit; 1511. a first part; 1512. a second section; 1513. a third section; 1521. a first strut; 1522. a second support bar; 1523. a first link; 1524. a second link; 1525. a third connection point; 153. a pipe body; 1531. an axis section; 1532. an extension section; 1533. an annular segment; 154. a tube electrode; 161. a first disk; 162. a second disc; 163. and a third disk.

Detailed Description

Exemplary embodiments that embody features and advantages of the invention are described in detail below in the specification. It is to be understood that the invention is capable of other embodiments and that various changes in form and details may be made therein without departing from the scope of the invention and the description and drawings are to be regarded as illustrative in nature and not as restrictive.

In the description of the present application, it is to be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the present application and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated in a particular manner, and are not to be construed as limiting the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", may explicitly or implicitly include one or more of the described features. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.

Definition of definitions:

entrance of left atrial appendage: from the left atrium into the left atrial appendage.

Proximal and distal: after a part is implanted, one end which is relatively close to the outside of the body is the proximal end of the part; one end of a component that is relatively close to the body after implantation is the distal end of the component. In other words, after the left atrial appendage occlusion ablation device is implanted at the left atrial appendage, the proximal end of a component in the left atrial appendage occlusion ablation device is the end of the component close to the left atrium, and the distal end of the component is the end of the component close to the left atrial appendage.

Insulation treatment: an insulating layer is formed on the surface of a member to insulate the portion of the member. Specifically, the insulation treatment is performed in the following manner: coating an insulating coating material at the position needing insulating treatment, wherein the coating material comprises but is not limited to parylene coating, PTFE coating and PI coating; or, covering an insulating film at the position to be subjected to the insulating treatment, wherein the film material comprises but is not limited to FEP, PU, ETFE, PFA, PTFE, PEEK and silica gel; or, an insulating sleeve is sleeved at the position to be subjected to the insulating treatment, and the material of the insulating sleeve comprises but is not limited to FEP, PU, ETFE, PFA, PTFE, PEEK and silica gel.

The left auricle plugging ablation device provided by the embodiment of the invention is used for being implanted into the mouth part of the left auricle and can perform pulse ablation or radio frequency ablation on left auricle tissues. The pulse ablation uses a high-intensity pulsed electric field to cause Irreversible electrical breakdown of a cell membrane, which is called Irreversible electroporation (IRE) in the medical field, to cause apoptosis so as to achieve non-thermal effect ablation of cells, so that the cells are not affected by a heat sink effect. The high-voltage pulse sequence generates less heat and does not need to be washed by normal saline for cooling, and the occurrence of air explosion, eschar and thrombus can be effectively reduced. The pulse ablation treatment time is short, the treatment time for applying a group of pulse sequences is less than 1 minute, and the whole ablation time is generally not more than 5 minutes. And because different tissues have different reaction thresholds to the pulse electric field, the possibility is provided for ablating the cardiac muscle without interfering other adjacent tissues, thereby avoiding accidentally injuring the tissues adjacent to the left auricle. In addition, compared with other energy, the pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field intensity can be subjected to electroporation, so that the requirement on the catheter attaching pressure during ablation is reduced. Therefore, even if the ablation device does not completely fit the inner wall of the left atrial appendage after entering the left atrial appendage, the IRE ablation effect is not affected. The electrode for applying pulse energy can also collect intracardiac electric signals, and before ablation, the collected intracardiac electric signals are transmitted to an electrocardiograph synchronizer, so that pulse output is synchronized in an absolute refractory period of myocardial contraction, heart rate is not interfered, and sudden arrhythmia is reduced; after an ablation procedure, it can also be judged by the intracardiac signals whether the tissue is completely electrically isolated.

Example 1

Fig. 1 is a schematic structural view of a left atrial appendage occlusion ablation device provided in this embodiment, fig. 2 is a schematic sectional structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and fig. 2 is compared with fig. 1 with a flow blocking film 126 removed, and in fig. 2, a part of the first framework 111 of the anchor disk 110 located in a box forms the second conductive portion 114, and the second framework 121 of the seal disk 120 forms the first conductive portion 122 integrally.

Referring to fig. 1 and fig. 2 in combination, the left atrial appendage occlusion ablation device provided in this embodiment includes an ablation support 100, where the ablation support 100 includes an anchor plate 110, a sealing plate 120, and an insulating connector 130.

The first backbone 111 of the anchor disk 110 and the second backbone 121 of the sealing disk 120 are both radially expandable and contractible support structures. For example, the scaffold structure may be a lattice or mesh-like scaffold. The stent structure can be radially contracted at the axial center under the compression of external force, so that the ablation stent 100 can be integrally stored or delivered conveniently. When the pressure force disappears, the ablation stent 100 can be naturally expanded along the radial direction to restore the grid-shaped or mesh-tube-shaped stent structure, so that the ablation stent 100 can be integrally fixed at the left atrial appendage. It will be appreciated that the support structure may also be a radially retractable support structure of other shapes.

Generally, first and

second bobbins

111 and 121 are each made of a metal material having shape memory and superelasticity, such as nitinol. In particular, it can be made by weaving metal wires or by cutting metal tubes.

In this embodiment, the sealing disk 120 is used as an electrically conductive portion for transmitting ablation energy for ring ablation or for collecting tissue physiological signals for mapping. When the anchoring disc 110 is anchored in the left atrial appendage, the sealing disc 120 can completely block the entrance of the left atrial appendage, so as to block thrombus inside the left atrial appendage, and effectively prevent the thrombus from entering the left atrium. Meanwhile, the sealing disc 120 can well ablate the inner wall tissue of the left atrial appendage entrance, and has good ablation effect. Specifically, left auricle oral area tissue is more regular for left auricle internal tissue, and the surface is smooth, melts left auricle oral area, more is favorable to forming complete ablation area at the oral area, and then is convenient for thoroughly keep apart left auricle and left atrium electricity at left auricle oral area.

In some embodiments, the anchor disk 110 has a second conductive portion 114 disposed thereon, the sealing disk 120 is integrally formed as a first conductive portion 122, and the second conductive portion 114 and the first conductive portion 122 are used to transmit ablation energy to tissue or to map, respectively. The second conductive portion 114 and the first conductive portion 122 may be used to transmit electrical ablation energy of different polarities. The second conductive portion 114 and the first conductive portion 122 can form an ablation electric field to improve the ablation effect.

In some embodiments, such as embodiments where second conductive portion 114 and first conductive portion 122 are used to transmit radiofrequency energy, second conductive portion 114 and first conductive portion 122 may be used to transmit ablation energy of the same polarity, or to transmit the same ablation energy.

In some embodiments, the second and first electrically

conductive portions

114, 122 may also be used for mapping, i.e., for acquiring electrophysiological signals of the target tissue. Or in some embodiments, both ablation and mapping functions, for example, a portion of the second conductive portion 114 and/or the first conductive portion 122 is used for mapping and a portion is used for ablation, or a portion of the second conductive portion 114 and/or the first conductive portion 122 is used for mapping and ablation.

It should be noted that, in some other embodiments, the first skeleton 111 may also be integrally taken as the second conductive portion 114; alternatively, the second conductive portion 114 may be an electrode provided on the outer peripheral wall of the first frame 111, and the second conductive portion 114 may be fixedly connected to the inner wall or the outer peripheral wall of the first frame 111, or may be detachably or movably connected to the first frame 111.

Still referring to fig. 1 and 2, both ends of the insulating connection member 130 are connected to the anchor plate 110 and the sealing plate 120, respectively, specifically, the distal end of the insulating connection member 130 is connected to the anchor plate 110, the proximal end is connected to the sealing plate 120, and the second conductive portion 114 on the first skeleton 111 and the first conductive portion 122 on the second skeleton 121 are electrically isolated by the insulating connection member 130.

It should be noted that, in some other embodiments, the insulating connection 130 may be omitted, and the first frame 111 itself is used for insulating the portions other than the second conductive portion 114, so as to electrically isolate the second conductive portion 114 from the first conductive portion 122.

When the ablation device is used, different electrical ablation energies are transmitted to the second conductive part 114 and the first conductive part 122 respectively, for example, the second conductive part 114 is electrically conducted with the positive electrode of the output end of an external signal source, the first conductive part 122 is electrically conducted with the negative electrode of the output end of the external signal source, and ablation is realized through an electric field formed between the second conductive part 114 and the first conductive part 122, so that the ablation effect is good.

In addition, the insulating property between the second conductive part 114 and the first conductive part 122 is improved through the insulating connecting part 130, the possibility of realizing the electric connection between the second conductive part 114 and the first conductive part 122 is reduced, and the ablation success rate and the reliability of the device are improved.

It is understood that in other embodiments, electrical signals with the same parameters may be transmitted to the second conductive portion 114 and the first conductive portion 122 as desired.

The left atrial appendage occlusion ablation device provided in this embodiment is further described below:

fig. 3 is an enlarged view of a part of the structure at iii in fig. 2, and fig. 4 is a schematic view of the structure of the conveyor 140 according to this embodiment.

Referring to fig. 1 to 4, the left atrial appendage occlusion ablation device provided in this embodiment further includes a delivery unit 140, the ablation stent 100 is configured to be loaded on a distal end of the delivery unit 140, and the delivery unit 140 is configured to deliver and release the ablation stent 100 to a target location, i.e., an entrance of the left atrial appendage. It will be appreciated that in some embodiments, the left atrial appendage occluder ablation device provided herein may also be applied to treat other tissue defects.

The delivery device 140 includes an outer tube 143, a first conduit 142, a second conduit 141, and a handle 144.

The outer tube 143 is tubular, and the distal end of the outer tube 143 is capable of receiving the anchor disk 110 and the sealing disk 120 in a radially contracted state.

The first conduit 142 is tubular and movably disposed through the outer tube 143. The first conduit 142 is axially movable relative to the outer tube 143. The distal end of first conduit 142 is removably coupled to sealing disk 120 and is in electrically conductive communication with sealing disk 120. The proximal end of first conduit 142 is electrically connected to an external source of signal, so that the external source of signal can transmit ablative energy through first conduit 142 to sealing disk 120. Moreover, the first conduit 142 can drive the sealing disc 120 and the anchoring disc 110 to move axially in the outer tube 143, so that the entire ablation stent 100 can be released by extending out of the distal end of the outer tube 143, or retracted and contained in the outer tube 143.

The second conduit 141 is tubular and movably disposed through the first conduit 142. The second guide duct 141 is movable in the axial direction relative to the first guide duct 142. The distal end of the second catheter 141 may be removably coupled to the anchor plate 110 and electrically coupled to the second conductive portion 114 to deliver electrical ablation energy to the second conductive portion 114 through the second catheter 141. It is understood that the second conduit 141 may be electrically connected to the second conductive portion 114 directly and detachably without being connected to the anchor plate 110.

Specifically, the first conduit 142 and the second conduit 141 are used for connecting different output terminals of the external signal source, such as one of the first conduit 142 and the second conduit 141 is used for connecting a positive electrode of the output terminal of the external signal source, and the other is used for connecting a negative electrode of the output terminal of the external signal source.

It should be noted that the first catheter 142 and the second catheter 141 may also be used to transmit the acquired tissue physiological signals for mapping.

A handle 144 is provided at the proximal end of the outer tube 143. When the ablation stent 100 is implanted, the first catheter 142 controls the ablation stent 100 to be received at the distal end of the outer tube 143. When the distal end of the outer tube 143 extends into the left atrial appendage and the distal end of the outer tube 143 rests on the left atrial appendage, the outer tube 143 is retracted by the handle 144, and the ablation stent 100 is released.

Moreover, the second catheter 141 is provided as a tubular structure such that the inner bore of the second catheter 141 is available for guiding a pull wire therethrough, thereby facilitating movement of the outer tube 143, the first catheter 142, the second catheter 141, and the ablation stent 100 as a whole along the pull wire and delivery to a target site.

Referring to fig. 3, the insulating connection member 130 is provided with a first conductive connection portion 134. The first conductive connection 134 is adapted to detachably connect with a second catheter 141 of the delivery device 140, and the second catheter 141 is electrically connected to the second conductive portion 114 via the first conductive connection 134, so that ablation energy is delivered to the second conductive portion 114 via the second catheter 141, and after ablation is completed, the second catheter 141 can be detached from the first conductive connection 134.

In some embodiments, the insulating connection member 130 has a cylindrical shape, and the first conductive connection part 134 is disposed on an inner surface of the insulating connection member 130. Optionally, the first conductive connection 134 is screwed with the second conduit 141 to realize a detachable connection between the first conductive connection 134 and the second conduit 141. It will be appreciated that in other embodiments, the first conductive connection 134 may be detachably connected to the second conduit 141 in other manners, such as magnetic connection or clamping connection.

An insulating connector 130 extends axially with a proximal end connected to the sealing disk 120 and a distal end connected to the anchor disk 110. The insulating connecting member 130 has an insulating axial section provided therein, that is, an insulating connection between the sealing disk 120 and the anchor disk 110 is achieved, thereby improving the insulating property between the two disks. "axial section" means a section extending in the axial direction of the component and surrounding the axial direction by one turn, along which the component extends, and this axial section may be provided inside the insulating connection member 130 or on the surface of the insulating connection member 130. In this embodiment, the ablation stent 100 is symmetrical along the axis, and the axis of the insulating connecting member 130 is the axis of the ablation stent 100.

The insulating connecting member 130 includes a first connecting member 131 and a second connecting member 132 connected in sequence, that is, the first connecting member 131 and the second connecting member 132 are connected in sequence along the axial direction. The first connecting member 131 is connected to the anchor plate 110, i.e., the anchor plate 110 is bound to the first connecting member 131. The second connecting element 132 is connected to the sealing disk 120, and the sealing disk 120 is connected to the second connecting element 132 in a constricted manner.

Further, as shown in fig. 3, in the present embodiment, the insulating connecting member 130 further includes a third connecting member 133, and the third connecting member 133 is disposed between the first connecting member 131 and the second connecting member 132, so that the first connecting member 131 is indirectly connected to the second connecting member 132. The distal end of the third connecting member 133 is connected to the proximal end of the first connecting member 131, and the proximal end of the third connecting member 133 is connected to the distal end of the second connecting member 132.

The third connecting member 133 may be provided in plural and connected in series along the axial direction, wherein the most distal third connecting member 133 is connected to the first connecting member 131, and the most proximal third connecting member 133 is connected to the second connecting member 132. That is, in the ablation support 100 shown in this embodiment, the first connecting member 131 is connected to the second connecting member 132 via one or more third connecting members 133, thereby extending the length of the insulating connecting member 130 to achieve indirect connection of the anchor plate 110 to the sealing plate 120.

In the present embodiment, the anchor plate 110 is connected to the first connecting member 131, the first connecting member 131 includes a first conductive connecting portion 134, and the first conductive connecting portion 134 is connected to the second connecting member 132 in an insulated manner, so as to achieve electrical isolation between the second conductive portion 114 and the first conductive portion 122. The distal end of sealing disk 120 is connected to second connector 132. Meanwhile, the second connecting member 132 is cylindrical and has a passage for the second conduit 141 to pass through, so that the second conduit 141 passes through the passage of the second connecting member 132 and is connected to the first conductive connecting portion 134. In some embodiments, second connector 132 is configured to securely couple to the distal end of gland plate 120, capturing the plurality of nitinol wires in gland plate 120.

In particular, at least part of the axial section insulation in the first connecting element 131 may be provided, so that an insulated connection of the first conductive connecting portion 134 with the first conductive portion 122 is achieved. In some embodiments, the proximal end of the at least partial axial section extends beyond the proximal end of first conductive connection 134, i.e., the proximal end of first conductive connection 134, further from sealing disk 120 than the proximal end of the at least partial axial section.

For example, the first connecting member 131 is provided to be insulated at least at the proximal end, and the first conductive connecting portion 134 is provided to be threaded on the inner wall of the distal end of the first connecting member 131, in which case, the conductive and insulating properties of the second connecting member 132 and the third connecting member 133 are not limited. The proximal end of the insulated axial section is closer to the proximal end of the first connector 131 than to the proximal end of the first conductive connection 134. The insulated axial section may be disposed on the insulating surface of the first connecting member 131, or the first connecting member 131 in the axial section may be made of an insulating material, and the distal end of the insulated axial section is not limited.

In some embodiments, the distal end of the insulated axial section is closer to sealing disk 120 relative to the proximal end of first conductive connection 134, or the distal end of the insulated axial section is closer to anchor disk 110 relative to the proximal end of first conductive connection 134, or the insulated axial section extends over first connection 131 in the axial direction.

In some embodiments, the second connecting element 132 may also be configured to be at least partially insulated along the axial section surface to achieve the insulated connection between the first conductive connecting portion 134 and the first conductive portion 122, for example, the second connecting element 132 is configured to have one end made of an insulating material and the other end made of a conductive material, where the conductive performance of the first connecting element 131 except for the first conductive connecting portion 134 is not limited, and the whole of the first connecting element 131 may be made of a conductive material. The anchor portion 113 is tied to the first connector 131; or at least part of the axial section at the proximal end of the first electrically conductive connection 134 in the first connector 131 is surface insulated, while the second connector 132 is provided at least part of the axial section is surface insulated.

It is understood that in other embodiments, at least a portion of the axial section surface of any one of the third connecting members 133 may be insulated to achieve the insulated connection between the first connecting member 131 and the second connecting member 132, and thus the insulated connection between the first conductive connecting portion 134 and the first conductive portion 122.

Specifically, the insulated connection of the first conductive connecting portion 134 and the third connecting member 133 can be achieved by providing the first connecting member 131 such that at least a part of the axial section thereof located at the proximal end of the first conductive connecting portion 134 is surface insulated; correspondingly, the second connecting element 132 can also be provided with at least partially insulated axial section surfaces, or at least partially insulated axial section surfaces of at least one third connecting element 133; even if two or three of the above-described modes are provided simultaneously, the insulation between the first conductive connection 134 and the seal disk 120 can be achieved, and thus the electrical isolation between the first conductive connection 134 and the first conductive portion 122 can be achieved.

According to the requirement, the structure of the insulating connection member 130 can be a structure in which the first connection member 131, the second connection member 132 and the third connection member 133 are integrally combined as shown in fig. 3, or the insulating connection member 130 can be a one-piece cylindrical structure, the distal end of the sealing disc 120 is converged at the proximal end of the cylindrical structure, the anchoring disc 110 is converged at the distal end of the cylindrical structure, and the first conductive connection portion 134 is an internal thread made of a conductive material and disposed on the inner surface thereof. In this embodiment, the first connecting element 131 is made of a conductive material, so as to electrically connect the second conduit 141 and the second conductive part 114, and the second conduit 141 is electrically connected to the first skeleton 111 of the anchor plate 110 through the first conductive connecting part 134. The third connecting member 133 is made of an insulating material, so that the second connecting member 132 is connected to the first connecting member 131 and the first conductive connecting portion 134 in an insulating manner, and thus the second connecting member 132 can be set to be insulated or conductive as a whole as required.

In this embodiment, the insulating connecting member 130 has a cavity formed therein for the second conduit 141 to pass through, and the cavity extends to the first conductive connecting portion 134, so that the second conduit 141 passing through the cavity can be electrically connected to the first conductive connecting portion 134. Specifically, the insulating connecting member 130 in this embodiment includes a first connecting member 131, a third connecting member 133, and a second connecting member 132, the first connecting member 131, the third connecting member 133, and the second connecting member 132 are all cylindrical, and the first connecting member 131, the second connecting member 132, and the third connecting member 133 are sequentially communicated to form the cavity (the arrow in fig. 3 is the cavity, and the arrow indicates the direction of the second conduit 141 penetrating through the cavity during the product loading process).

The two parts connected to each other in the insulating connector 130 are detachably connected, that is, in the present embodiment, the first connector 131 is detachably connected to the third connector 133, and the second connector 132 is detachably connected to the third connector 133. Alternatively, the first connector 131 is threadedly coupled to the third connector 133, and the second connector 132 is threadedly coupled to the third connector 133. Specifically, the first connecting member 131 is provided with a first threaded portion, and the distal end of the third connecting member 133 is provided with a second threaded portion, and the first threaded portion is in threaded fit with the second threaded portion, so that the detachable connection of the first connecting member 131 and the third connecting member 133 is realized. The second connector 132 is threadedly coupled to the third connector 133. Specifically, the proximal end of the third connecting member 133 is provided with a third threaded portion, and the second connecting member 132 is provided with a fourth threaded portion, and the third threaded portion is threadedly engaged with the fourth threaded portion.

Specifically, the third connector 133 includes a large pipe section 1331 and a small pipe section 1332 arranged in the axial direction, and an outer diameter of the large pipe section 1331 is larger than that of the small pipe section 1332. The first threaded portion is an internal thread provided on an inner wall of the proximal end of the first connector 131, and the second threaded portion is an external thread provided on an outer wall of the small pipe section 1332. The third screw part is an internal screw provided on the inner wall of the large pipe section 1331, and the fourth screw part is an external screw provided on the outer wall of the second connector 132. It is understood that in other embodiments, the third connecting member 133 may be configured as a single-segment tube with two ends having the same diameter.

Further, the first connector 131 is provided with a first installation space 1311, and one end of the anchor tray 110 extends into the first installation space 1311 so as to be caught in the first installation space 1311. Specifically, the first connecting element 131 is provided with two annular protrusions that are sleeved with each other, a receiving groove is formed between the two annular protrusions, a space in the receiving groove is used as a first installation space 1311, and the first installation space 1311 is annular. The receiving slot has a distally facing opening from which one end of the anchor plate 110 protrudes into the first mounting space 1311. It is understood that in other embodiments, the first connecting member 131 may be configured to include an inner sleeve and an outer sleeve, which are sleeved with each other, and an annular region formed between the inner sleeve and the outer sleeve is used as the first installation space 1311, and one of the inner sleeve and the outer sleeve is connected to the second connecting member 132.

Further, a second mounting space 1323 is formed on the second connecting member 132, and the distal end of the sealing disk 120 is caught in the second mounting space 1323. Specifically, the second connecting member 132 includes an inner sleeve 1321 and an outer sleeve 1322 that are sleeved with each other, and a second installation space 1323 is formed between the inner sleeve 1321 and the outer sleeve 1322, and the second installation space 1323 is annular. One of the inner sleeve 1321 and the outer sleeve 1322 is connected to the third connecting member 133. In this embodiment, the fourth screw part is provided on the outer circumferential wall of the outer sleeve 1322, that is, the outer sleeve 1322 in the second connecting member 132 is connected with the third connecting member 133. It is understood that, in some other embodiments, the second connecting element 132 may be provided as an integral structure, and a receiving groove is formed on the integral structure, and a space in the receiving groove is the second mounting space 1323.

Referring to fig. 1 and 2, in the present embodiment, the sealing disc 120 includes a proximal portion of the ablation support 100, the anchor disc 110 includes a distal portion of the ablation support 100, the second conductive portion 114 is a portion of the anchor disc 110, and the first conductive portion 122 is the entire sealing disc 120. That is, second conductive portion 114 is at least a portion of anchor pad 110, and first conductive portion 122 is the entirety of seal pad 120. It is understood that the second conductive portion 114 may also be the entirety of the anchor plate 110.

Further, in the ablation stent 100, the region corresponding to the second conductive part 114 and the first conductive part 122 serves as an active region, and the region other than the active region in the ablation stent 100 serves as an insulating region. It is understood that in some embodiments, at least a portion of the ablation stent 100 in the insulating region may also be formed from an insulating material, such as a degradable material that is insulating.

Specifically, in the present embodiment, the first frame 111 and the second frame 121 are connected by the insulating connector 130, and in the present embodiment, the first connector 131 is used for the end of the first frame 111 in the closing and anchoring disk 110, and the second connector 132 is used for the distal end of the second frame 121 in the closing and sealing disk 120.

In this embodiment, the entire first frame 111 is made of a metal material, and a part of the surface of the first frame is used as the second conductive portion 114, that is, the part of the first frame 111 used as the second conductive portion 114 is not subjected to insulation treatment, and the rest of the surface is subjected to insulation treatment, so that the part of the surface is insulated, and the problem that the conductive area of the second conductive portion 114 is too large to affect the ablation effect is avoided. Since the first frame 111 is made of metal, the first connecting element 131 is entirely conductive, and the second conductive portion 114 and the first conductive connecting portion 134 can be directly electrically connected to the first frame 111.

It is understood that, in some other embodiments, only a portion of the first skeleton 111 may be made of a metal material, and the rest of the first skeleton may be made of an insulating material, so as to insulate the surface of the portion, and thus, an additional electric wire is required to electrically connect the first conductive connecting portion 134 and the second conductive portion 114.

Furthermore, the portion of the first frame 111, which is used to abut against the tissue of the inner wall of the left atrial appendage, serves as the second conductive portion 114, and the second conductive portion 114 is annular, so that the ablation band correspondingly formed by the second conductive portion 114 is annular, which is beneficial to improving the ablation effect of the left atrial appendage. The outer periphery of the second conductive part 114 is covered with a flow blocking film 126, and the flow blocking film 126 has pores, so that the flow blocking film 126 can at least filter thrombus, i.e. prevent the thrombus in the left atrial appendage from entering the left atrium, and ensure that the second conductive part 114 can release ablation energy to the tissue.

It should be noted that, in this embodiment, a part of the first skeleton 111 serves as the second conductive portion 114, and the rest of the surface is insulated, and it is understood that, in some other embodiments, all of the first skeleton 111 may also serve as the second conductive portion 114 at the same time, so as to release ablation energy to the tissue.

Referring to fig. 1 and 2, for the sealing disc 120, the second frame 121 is made of metal material, and the second frame 121 is used as the first conductive part 122. Since the second frame 121 is made of metal, the first conductive part 122 can be directly electrically connected to the second frame 121 without additional wires.

Note that, in this embodiment, the portion of the second skeleton 121 that needs surface insulation is realized by insulation processing. In this embodiment, the sealing disk 120 further includes an insulating film 125, the insulating film 125 covers the outer peripheral wall of the distal end of the second skeleton 121, the insulating film 125 can be isolated between the distal end of the second skeleton 121 and the proximal end of the first skeleton 111, and the insulating film 125 is used to isolate the first skeleton 111 from the second skeleton 121, so as to prevent the expanded first skeleton 111 and second skeleton 121 from directly contacting.

In this embodiment, the second frame 121 is a double-layer mesh disk made by metal wire weaving, and includes a proximal frame and a distal frame, the proximal frame is located on one side of the proximal end of the distal frame, and the proximal frame and the distal frame are connected at the periphery. Optionally, the seal disk 120 has an axial projection of a profile that is trapezoidal to match the anatomy of the left atrial portion site that is closed by the seal disk 120.

It should be noted that, in this embodiment, the second frame 121 is made by weaving metal wires, and it should be understood that, in some other embodiments, the second frame 121 may be made in other manners according to requirements, for example, made by cutting a tube.

Referring to fig. 1 to 4, in the present embodiment, the sealing disk 120 further includes a second conductive connection portion 124, and a proximal end of the second skeleton 121 is connected to the second conductive connection portion 124, specifically, the proximal end of the second skeleton 121 is constrained at the second conductive connection portion 124. The second conductive connecting portion 124 is used for detachably connecting with the first conduit 142, and the external signal source is electrically connected to the first conductive portion 122 sequentially through the first conduit 142 and the second conductive connecting portion 124. The second conductive connection 124 may also be used to transmit tissue physiological signals collected by the sealing disk 120.

Specifically, the second conductive connecting portion 124 is an annular cylindrical structure in which a through hole extending in the axial direction is formed, and the through hole is penetrated by the second conduit 141. The first catheter 142 is detachably connected to the second conductive connection 124 such that when the ablation stent 100 is released from the left atrial appendage by the delivery device 140, the ablation stent 100 is implanted and ablated, the first catheter 142 and the second conductive connection 124 are released, leaving the ablation stent 100 in the left atrial appendage and withdrawing the first catheter 142 and the second catheter 141 from the body.

Optionally, the second conductive connection 124 is threadedly connected to the first conduit 142. Specifically, the inner wall of the second conductive connecting part 124 is provided with a sixth threaded part, so that the detachable connection of the second conductive connecting part 124 and the first conduit 142 is realized through the threaded connection of the sixth threaded part and the first conduit 142. It is understood that in other embodiments, the second conductive connecting portion 124 and the first guide tube 142 may be detachably connected by magnetic connection or clamping connection, etc. according to the requirement.

Referring to fig. 1, in the present embodiment, the sealing disc 120 further includes a flow blocking membrane 126 disposed in the second skeleton 121. Specifically, in the present embodiment, the choke film 126 is disposed radially inside the second bobbin 121. In other embodiments, the flow blocking film 126 may also be coated on the outer side of the second skeleton 121. The flow blocking membrane 126 at least serves to block the outflow of thrombus within the left atrial appendage, and even to block the flow of blood into the left ventricle within the left atrial appendage depending on the porosity of the flow blocking membrane 126. Specifically, since the second skeleton 121 of the sealing disc 120 is a net structure having a plurality of meshes formed thereon, the meshes are closed by disposing the flow blocking membrane 126, so that thrombus at the distal end of the flow blocking membrane 126 is blocked from moving proximally, and thrombus and the like in the left atrial appendage is prevented from entering the left ventricle. It should be noted that when the mesh openings of the second skeleton 121 are small enough and dense enough, the current blocking film 126 may not be provided.

The distal end of the anchor disk 110 is provided with a flow blocking membrane 126 having a flow blocking effect, and the flow blocking membrane 126 is provided at the distal end of the first frame 111, so as to help block thrombus at the distal end of the anchor disk 110 from moving in a direction close to the sealing disk 120. Further, the flow-blocking membrane 126 on the anchor plate 110 is provided in a perforated configuration to enable the second electrically conductive portion 114 to release ablative energy into the inner wall tissue. It should be noted that, in some embodiments, the material of the flow resisting film 126 and the material used for the insulation process may be the same.

Fig. 5 is a schematic structural diagram of the first framework 111 in fig. 2.

Referring to fig. 1 and 5, in the present embodiment, the first frame 111 includes a plurality of supporting portions 112 and a plurality of anchoring portions 113, and the plurality of anchoring portions 113 are disposed around the peripheries of the plurality of supporting portions 112.

Each of the support portions 112 includes a support rod 1121, and a first branch 1122 and a second branch 1123 provided at one end of the support rod 1121, and the first branch 1122 and the second branch 1123 are rod-shaped, so that the support portion 112 is formed to have a substantially Y-shaped outer shape.

Specifically, the supporting rods 1121 includes opposite first and second ends, the first ends of the plurality of supporting rods 1121 are connected to the insulating connection member 130, the second ends of the plurality of supporting rods 1121 are spread outward in the radial direction, gradually get away from the axis of the anchor plate 110, form a trumpet-like shape, and the first branches 1122 and the second branches 1123 are connected at the second ends of the corresponding supporting rods 1121. In this embodiment, the first end is a proximal end of the supporting rod 1121, and the second end is a distal end of the supporting rod 1121. It is understood that, in the modified embodiment, the first end is not limited to be the proximal end of the support rod 1121, and the second end is not limited to be the distal end of the support rod 1121.

One end of each first branch 1122 away from the supporting rod 1121 is connected to one end of the second branch 1123 of the adjacent supporting portion 112 away from the supporting rod 1121, and the connection point forms a first connection point 1124. Each anchor portion 113 is connected to a corresponding first connection point 1124 and extends proximally. The first frame 111 thus formed has a double-layered structure, the plurality of support rods 1121 surrounds an inner layer forming the first frame 111, and the plurality of anchor portions 113 surrounds an outer layer forming the first frame 111. In the first skeleton 111, a portion of the anchor portion 113 for abutting against the inner wall tissue of the left atrial appendage serves as a second conductive portion 114, and the second conductive portion 114 is annular, so that an annular ablation band extending in the circumferential direction of the first skeleton 111 is formed by the second conductive portion 114.

Optionally, the first frame 111 further comprises a connection ring 118, and the proximal ends of the plurality of support rods 1121 are connected to the connection ring 118, so as to connect the proximal ends of the plurality of support rods 1121 together. When the anchor plate 110 is coupled to the insulating connector 130, the connection ring 118 is received in the first installation space 1311, thereby constricting the proximal end of the inner layer of the first bobbin 111 in the first installation space 1311. It is understood that, in other embodiments, the connection ring 118 may not be provided, and the proximal end of the supporting rod 1121 may be directly constrained within the first installation space 1311 to connect the anchoring disc 110 and the insulating connection member 130. Alternatively, the connection ring 118, the plurality of support portions 112 and the plurality of anchor portions 113 are integrally formed by tube cutting.

Further, the plurality of anchoring portions 113 are divided into a plurality of groups, each group of anchoring portions 113 includes two adjacent anchoring portions 113, and the proximal ends of the two anchoring portions 113 in each group of anchoring portions 113 are connected, thereby forming a mesh structure. Furthermore, in each set of anchoring portions 113, the joint of the two anchoring portions 113 is bent and extended in the axial direction of the first frame 111, i.e. bent inward to form a hook shape, thereby reducing the stimulation and damage of the end of the anchoring portion 113 to the tissue.

Further, anchor disc 110 still includes barb 117 that sets up at the radial outside of first skeleton 111, and the distal end of barb 117 is connected in anchoring portion 113, and the proximal end of barb 117 is located the radial outside of first skeleton 111. Specifically, barb 117 is connected on anchor portion 113, and after left atrial appendage shutoff ablation device implanted left atrial appendage department, barb 117 penetrated in the left atrial appendage tissue, avoided anchor dish 110 to break away from the inner wall tissue of left atrial appendage.

According to the left auricle plugging ablation device that this embodiment provided, the theory of operation of left auricle plugging ablation device is:

the first conductive connection 134 of the left atrial appendage occlusion ablation device is electrically connected to the second catheter 141 and the second conductive connection 124 is electrically connected to the first catheter 142. Before use, the ablation stent 100 is accommodated in the conveyor 140 in a compressed manner, when the ablation stent is used, the ablation stent 100 is conveyed and released to the oral area of the left atrial appendage in a body through the conveyor 140, at the moment, the anchoring disc 110 of the ablation stent 100 is anchored in the left atrial appendage in an expanded state, and the barbs 117 of the anchoring disc 110 penetrate into the inner wall tissue of the left atrial appendage; the sealing disc 120 of the ablation support 100 is positioned in an expanded state at the entrance of the left atrial appendage to close the entrance of the left atrial appendage with the sealing disc 120.

After the implantation is completed, the external energy source sequentially transmits electrical ablation energy to the first conductive part 122 through the first catheter 142 and the second conductive connecting part 124, meanwhile, the second catheter 141 transmits electrical ablation energy to the second conductive part 114 through the first conductive connecting part 134, and the electrical ablation energy of the second conductive part 114 is different from that of the first conductive part 122, for example, if the second conductive part 114 is electrically conducted with the positive electrode of the transmission end of the external signal source, the first conductive part 122 is electrically conducted with the negative electrode of the transmission end of the external signal source; if second conductive portion 114 is electrically conductive with the negative electrode, first conductive portion 122 is electrically conductive with the positive electrode. Thus, an electric field is formed between the second conductive part 114 and the first conductive part 122 to realize ablation, and the ablation effect is good. After the ablation is completed, the first conductive connecting part 134 is detached from the second catheter 141, and the second conductive connecting part 124 is detached from the first catheter 142, so that the second catheter 141 and the first catheter 142 are withdrawn from the body, and the left atrial appendage occlusion ablation device is left in the body of the patient.

The left atrial appendage occlusion ablation device provided by the embodiment has at least the following advantages:

the left atrial appendage plugging ablation device provided by the embodiment utilizes the anchoring disc 110 to release in the left atrial appendage, the anchoring disc 110 can anchor the inner wall of the tissue of the left atrial appendage, the sealing disc 120 is used to release at the entrance of the left atrial appendage, the entrance of the left atrial appendage can be plugged by the sealing disc 120, and then the whole left atrial appendage plugging ablation device is fixed at the left atrial appendage. Meanwhile, the whole sealing disc 120 is conductive and used for transmitting ablation energy to ablate tissues at the entrance of the left auricle and in the left auricle, so that the ablation effect can be greatly improved. The sealing disc as the first conductive part can also be used for collecting tissue physiological signals for mapping. In addition, the left auricle plugging and ablating device combines ablation and plugging, simplifies the one-stop therapeutic operation procedure of 'ablation and left auricle plugging', and is beneficial to reducing the operation difficulty.

Example 2

Fig. 6 is a schematic structural diagram of an insulating connecting member 130 in the ablation apparatus for sealing left atrial appendage according to this embodiment.

Referring to fig. 6 in combination with fig. 3, this embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that the structure of the insulating connecting member 130 is different.

In this embodiment, the parts interconnected in the insulating connection member 130 are in interference fit with each other, so that the parts interconnected in the insulating connection member 130 are detachably connected. Namely, the first connector 131 and the third connector 133 are in interference fit, and the third connector 133 and the second connector 132 are in interference fit. It is understood that in other embodiments, the connection manner between the first connection member 131 and the third connection member 133 may be different from the connection manner between the third connection member 133 and the second connection member 132.

Specifically, the inner peripheral wall of the proximal end of the first connector 131 is interference fit with the outer peripheral wall of the small section 1332 of the third connector 133. The inner peripheral wall of the large tube section 1331 of the third connector 133 is interference fitted with the outer peripheral wall of the outer sleeve 1322 of the second connector 132.

Example 3

Fig. 7 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment at the location of the insulating connector 130.

Referring to fig. 7 in combination with fig. 3, this embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structure of the insulating connecting member 130 is different.

In this embodiment, the parts connected to each other in the insulating connector 130 are engaged with each other, so that the parts connected to each other in the insulating connector 130 are detachably connected. That is, the first connector 131 is connected to the third connector 133 in a snap-fit manner, and the third connector 133 is connected to the second connector 132 in a snap-fit manner.

Specifically, a clamping groove is formed in the first connecting piece 131, a clamping wedge is arranged on the outer side of the far end of the third connecting piece 133, and the first connecting piece 131 and the third connecting piece 133 are clamped by the clamping groove and the clamping wedge, so that the first connecting piece 131 and the third connecting piece 133 are stopped in the axial direction. The inner side of the proximal end of the third connecting piece 133 is provided with a clamping groove, the outer side of the second connecting piece 132 is provided with a clamping wedge, the clamping of the third connecting piece 133 and the second connecting piece 132 is realized through the clamping of the clamping groove of the third connecting piece 133 and the clamping wedge of the second connecting piece 132, and thus the second connecting piece 132 and the third connecting piece 133 are stopped in the axial direction.

It should be noted that the specific structure of the clamping is not limited herein, and it is understood that in other embodiments, other structures may be adopted to implement the clamping fit between the parts connected to each other in the insulating connector 130 according to requirements.

Example 4

Fig. 8 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment at the location of the insulating connector 130.

Referring to fig. 8 in combination with fig. 3, this embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structure of the insulating connecting member 130 is different.

In this embodiment, the parts connected to each other in the insulating connecting member 130 are pivotally connected, that is, the first connecting member 131 is pivotally connected to the third connecting member 133, and the third connecting member 133 is pivotally connected to the second connecting member 132, so that the first connecting member 131 can rotate axially relative to the third connecting member 133, and the second connecting member 132 can rotate axially relative to the third connecting member 133.

Specifically, the proximal end and the distal end of the third connecting member 133 are respectively provided with a pivoting groove. The proximal end of the first connecting member 131 is provided with a first pivot joint, and the first pivot joint is pivoted with the pivot groove at the distal end of the third connecting member 133 to realize the pivot joint of the first connecting member 131 and the third connecting member 133. The far end of the second connecting element 132 is provided with a second pivot joint, which is pivotally connected to the pivot groove of the near end of the third connecting element 133, so as to pivotally connect the third connecting element 133 to the second connecting element 132.

It should be noted that the insulating connecting member 130 is still provided with a through hole at the axial center, and the through hole can be penetrated by the second conduit 141.

Example 5

Fig. 9 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment at the location of the insulating connector 130. Fig. 10 is a schematic view of the insulated connector 130 of the left atrial appendage occlusion ablation device of fig. 9 in a stretched and twisted configuration.

Referring to fig. 9 and 10 in combination with fig. 3, this embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structure of the insulating connecting member 130 is different.

In the present embodiment, the flexible connection between the parts connected to each other in the insulating connecting member 130 may be configured such that the first connecting member 131 is flexibly connected to the third connecting member 133, and the third connecting member 133 is flexibly connected to the second connecting member 132.

Specifically, the third connecting member 133 is integrally of a flexible rubber structure, a first connecting head is disposed at a proximal end of the first connecting member 131, a second connecting head is disposed at a distal end of the second connecting member 132, the third connecting member 133 is formed by vulcanization between the first connecting head and the second connecting head, the distal end of the third connecting member 133 covers the first connecting head, and the proximal end of the third connecting member 133 covers the second connecting head, so that the anchor disc 110 connected to the first connecting member 131 and the sealing disc 120 connected to the second connecting member 132 can move in a stretching and twisting manner (as shown in fig. 10).

It should be further noted that, in this embodiment, the third connecting element 133 is directly molded on the first connecting element and the second connecting element through vulcanization, and the connection between the third connecting element 133 and the first connecting element 131 and the second connecting element 132 is not detachable, and it should be understood that, in some other embodiments, the flexible detachable connection between the components may be implemented in other manners according to requirements.

Example 6

Fig. 11 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment, and fig. 12 is a schematic sectional structural diagram of the left atrial appendage occlusion ablation device of fig. 11 with the flow-blocking film 126 and the insulating film 125 removed.

Referring to fig. 11 and 12, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that the second conductive portion 114 is formed in a different manner.

In the present embodiment, the second conductive portion 114 is an electrode disposed on the first frame 111. Specifically, the anchor pad 110 further includes a first pole element 116 provided on the first skeleton 111, thereby employing the first pole element 116 as the second conductive portion 114. The anchor plate 110 may be provided such that only the surface of the first bobbin 111, which is not in contact with the first electrode 116, is insulated, the entire surface of the first bobbin 111 is insulated, or the entire first bobbin 111 is electrically conductive.

In the present embodiment, the anchor disc 110 is provided with the current blocking film 126, and the first electrode 116 is located outside the current blocking film 126, that is, the current blocking film 126 is disposed between the first electrode 116 and the first skeleton 111. The portion of the first framework 111 that contacts the first pole element 116 can be regarded as the projection of the first pole element 116 onto the anchoring portion 113. As shown in fig. 12, in the case that the current blocking film 126 is omitted from the anchor disk 110, the intersecting portion of the first skeleton 111 and the first electrode element 116 is the contacting portion of the first skeleton 111 and the first electrode element 116, and accordingly, the non-intersecting portion of the first skeleton 111 and the first electrode element 116 is the non-contacting portion of the first skeleton 111 and the first electrode element 116.

The second conductive portion 114 extends along the circumferential bend of the left atrial appendage ablation device. In this embodiment, the first electrode element 116 is bent and extended along the circumferential direction of the first frame 111, so that the first electrode element 116 disposed at the outer periphery of the first frame 111 extends in the axial direction of the first frame 111 for a certain range, and the ablation region formed by the first electrode element 116 extends in the axial direction of the first frame 111 to form a belt shape.

Specifically, the first electrode element 116 is a zigzag structure formed by bending a conductive wire. It will be appreciated that in other embodiments, the first pole element 116 may be provided with other shapes extending in a bent manner, such as a wave shape.

Alternatively, the first electrode element 116 is a wire electrode, or a strip-shaped electrode sheet, and it is understood that the type of the first electrode element 116 may be selected according to the requirement, for example, the first electrode element is configured as a rod electrode, an array ring electrode, or a ring ablation catheter. Optionally, the first electrode element 116 extends to the first conductive connection portion 134 and is connected to the first conductive connection portion 134 by welding, so as to electrically connect the first electrode element 116 and the first conductive connection portion 134.

In the present embodiment, the first electrode element 116 is electrically connected to the first skeleton 111 in the active region, and a hole may be provided in the flow blocking film 126 therebetween to ensure electrical conduction therebetween. In one embodiment, the first connecting member 131 is insulated from the surface and/or the first frame 111 is insulated from the surface, and the first electrode element 116 extends to the first conductive connecting portion 134 or is connected to the first conductive connecting portion 134 by a wire to transmit ablation energy.

It should be noted that the insulating connecting member 130 in the left atrial appendage occlusion ablation device provided in this embodiment is the insulating connecting member 130 provided in embodiment 1, and it should be understood that the structures of the insulating connecting member 130 provided in embodiments 2 to 6 may also be adopted.

Example 7

Fig. 13 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

Referring to fig. 13, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structure of the insulating connecting member 130 is different.

In the present embodiment, the first conductive connecting part 134 is detachably disposed on the first connecting part 131. The first conductive connecting portion 134 is cylindrical, and has an axially extending through hole formed therein. The first conductive connecting portion 134 is made of a conductive material, and the first conductive connecting portion 134 is used for electrically connecting with the second conductive portion 114 on the first skeleton 111.

In some embodiments, the first connecting member 131 and the third connecting member 133 are integrally made of an insulating material, and the second connecting member 132 may not be limited, so as to electrically isolate the first conductive connecting portion 134 from the sealing plate 120. Since the first connector 131 is insulated from the third connector 133 as a whole, the insulation distance between the first conductive connection 134 and the seal plate 120 can be increased, and the insulation distance and the insulation performance between the second conductive portion 114 on the anchor plate 110 and the seal plate 120 can be improved.

It should be noted that the second conduit 141 may be connected to the first conductive connection portion 134, and electrically connected to the second conductive portion 114, or electrically connected to the first electrode element 116 through the first conductive connection portion 134.

In other embodiments, the first connecting member 131 and the second connecting member 132 are integrally made of conductive material, and the third connecting member 133 is at least surface-insulated, so as to achieve the insulated connection between the first connecting member 131 and the second connecting member 132, and further achieve the electrical isolation between the first conductive connecting portion 134 and the sealing plate 120. In the present embodiment, the third connecting member 133 is made of an insulating material. It is understood that the insulated connection between the second connection member 132 and the first conductive connection portion 134 may be implemented according to other manners.

Example 8

Fig. 14 shows a schematic structural diagram of the left atrial appendage occlusion ablation device provided in the present embodiment. For clarity, the membrane structures of the left atrial appendage occlusion ablation device, such as the flow blocking membrane 126 and the insulating membrane 125, are omitted from fig. 14.

Referring to fig. 14, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structure of the insulating connecting member 130 is different. The insulated connector 130 according to the present embodiment is applied to the embodiment in which the first electrode 116 is the second conductive portion 114 or the embodiment in which the first electrode 116 is the third conductive portion independent of the second conductive portion 114.

In the present embodiment, the insulating connection member 130 further includes a fourth connection member 135 disposed between the first connection member 131 and the first conductive connection portion 134. The fourth connecting member 135 is detachably provided to the first connecting member 131. The first conductive connecting portion 134 is detachably provided on the fourth connecting member 135. That is, the fourth connection member 135 is sandwiched between the first connection member 131 and the first conductive connection portion 134.

The first connecting piece 131 is used for collecting the first framework 111, the second connecting piece 132 is used for collecting the second framework 121, and the first connecting piece 131 and the second connecting piece 132 are made of conductive metal materials, so that the collecting frameworks are firmer, and the mechanical properties of the sealing disc 120 and the anchoring disc 110 are improved.

The third connection 133 is entirely insulating for electrically isolating the sealing disk 120 from the anchor disk 110.

The first conductive connection portion 134 is entirely conductive and is used for electrically connecting with the first electrode element 116 disposed on the periphery of the anchor plate 110, and the first electrode element 116 directly extends to the first conductive connection portion 134 or is connected to the first conductive connection portion 134 by disposing an additional wire.

The fourth connection member 135 is integrally insulated to electrically isolate the first connection members 131 at both ends from the first conductive connection portion 134, so that the first bobbin 111 in the anchor plate 110 is electrically isolated from the first conductive connection portion 134 and the first electrode member 116.

Referring to fig. 14 in combination with fig. 4, in some embodiments, in the case that only the first electrode element 116 is conductive, the first frame 111 may be insulated. At this time, the first electrode element 116 is ablated as the second conductive portion 114. The second conduit 141 may be directly connected to the first conductive connection 134 and electrically connected to the first pole element 116 via the first conductive connection 134. Since the first electrode 116 is disposed on the outer periphery or the distal end of the first frame 111, the distance between the second conductive portion 114 and the sealing plate 120, i.e., the distance between the conductive portion on the anchor plate 110 and the sealing plate 120, can be increased, thereby improving the insulating performance between the first conductive portion 122 and the second conductive portion 114.

Still referring to fig. 14 in combination with fig. 4, in other embodiments, when both the first electrode element 116 and the first frame 111 are conductive, the whole or part of the first frame 111 serves as the second conductive part 114, and the first electrode element 116 serves as the third conductive part and can be electrically isolated from the second conductive part 114.

At this time, the first connector 131, the second connector 132, and the first conductive connection 134 are entirely conductive, and the third connector 133 and the fourth connector 135 are entirely insulated. The third connection member 133 electrically isolates the first connection member 131 from the second connection member 132, and the fourth connection member 135 electrically isolates the first connection member 131 from the first conductive connection portion 134. Also, the transporter 140 further includes a third conduit passing through the second conduit 141. The third duct is movably inserted into the second duct 141 and is capable of moving relative to the second duct 141 along the axial direction. The first catheter 142 is connected to and conductively coupled to the second conductive connection 124 to provide ablation energy to the first conductive portion 122. The second catheter 141 is connected and electrically connected to the first connector 131 to provide ablation energy to the second electrically conductive portion 114. The third conduit is connected to and in conductive communication with the first conductive connection 134 to provide ablative energy to the first electrode element 116 (i.e., the third conductive portion).

The second conductive part 114, the first conductive part 122 and the third conductive part can be electrically isolated from each other, so that ablation can be realized at the same time, and the ablation effect is good. In some embodiments, in a direction from the proximal end to the distal end, the first conductive portion 122, the second conductive portion 114, and the third conductive portion may be sequentially and alternately connected to the positive signal source output end and the negative signal source output end, so as to form two electric fields between the first conductive portion 122 and the second conductive portion 114, and between the second conductive portion 114 and the third conductive portion to achieve ablation, thereby improving an ablation effect.

In other embodiments, the second conductive portion 114, the first conductive portion 122, and the third conductive portion may transmit electrical ablation signals with the same polarity.

Example 9

Fig. 15 is a schematic structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and fig. 16 is a schematic structural view of the left atrial appendage occlusion ablation device of fig. 15 with a covering film (e.g., a flow blocking film) removed.

Referring to fig. 15 and 16, the present embodiment also provides a left atrial appendage occlusion ablation device, which is mainly different from the left atrial appendage occlusion ablation device provided in embodiment 1 in the structure of the anchor plate 110.

In this embodiment, the first frame 111 of the anchor plate 110 is made of metal wires by weaving, and the distal ends of the first frame 111 are radially inwardly bound and connected together, so that the first frame 111 is in a cage shape. Specifically, the anchor plate 110 further includes a distal connecting member 119, the distal connecting member 119 is disposed at a distal end of the anchor plate 110, a distal end of the wire braided to form the first skeleton 111 is radially inwardly constricted at the distal connecting member 119, and the distal connecting member 119 is located inside a cage shape surrounded by the wires.

Meanwhile, in the left atrial appendage occlusion ablation device shown in this embodiment, the anchor plate 110 is provided with a first electrode element 116, and the first electrode element 116 serves as a second conductive part 114 for transmitting ablation energy. In some other embodiments, part or all of the first skeleton 111 may be used as the second conductive portion 114, and the first electrode element 116 may be used as a third conductive portion electrically isolated from the second conductive portion 114.

Example 10

Fig. 17 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in this embodiment, and fig. 18 is a schematic structural diagram of the left atrial appendage occlusion ablation device of fig. 17 with a covering film (e.g., a flow blocking film) removed.

Referring to fig. 17 and 18, this embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 mainly in that the structures of the anchor disk 110 and the sealing disk 120 are different.

In this embodiment, the first frame 111 of the anchor plate 110 is made of metal wires by weaving, and the first frame 111 is formed by inner and outer layers. Specifically, the wires extend along the proximal end of the anchor plate 110 to extend in a diverging manner to the distal end, forming an inner layer of the first skeleton 111, and then are folded back from the distal end to the proximal end, braided to form an outer layer of the first skeleton 111.

In the present embodiment, the second skeleton 121 of the sealing disk 120 is a metal wire woven structure, and the sealing disk 120 includes a disk surface 127 facing away from the anchor disk 110, a disk bottom 128 facing the anchor disk 110, and a waist portion 129 connected between the disk surface 127 and the disk bottom 128. Wherein, the diameter of the disk surface 127 is larger than that of the disk bottom 128, and the diameter of the disk surface 127 is slightly larger than the inner diameter of the left auricle, the disk surface 127 presses the outlet of the left auricle after being implanted, the disk bottom 128 is plugged into the left auricle, and the diameter of the disk bottom 128 is approximately consistent with the inner diameter of the left auricle.

Meanwhile, in the left atrial appendage occlusion ablation device shown in the present embodiment, the second conductive part 114 on the anchoring disc 110 is part of the first framework 111, and it can be understood that a specific framework or a mode of additionally arranging an electrode element may also be adopted according to requirements. The second skeleton 121 of the seal disk 120 is entirely a first conductive portion 122.

Example 11

Fig. 19 is a schematic structural diagram of a left atrial appendage occlusion ablation device provided in this embodiment, and fig. 20 is a schematic structural diagram of the left atrial appendage occlusion ablation device of fig. 19 with a covering film (e.g., a flow blocking film) removed.

Referring to fig. 19 and 20, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 in the structure of the anchor disk 110.

In this embodiment, the first frame 111 of the anchor plate 110 is made of metal wires by weaving, and the first frame 111 of the anchor plate 110 in the first embodiment is made of tubes by cutting. The first frame 111 and the second frame 121 in the present application do not limit the manufacturing process, the first frame 111 may be woven or cut, and the second frame 121 may also be woven or cut.

As shown in fig. 19-20, the distal end of the first frame 111 is open, that is, the distal end of the first frame 111 has an opening, so that the first frame 111 has a cup shape.

Meanwhile, in the left atrial appendage occlusion ablation device shown in this embodiment, the anchor disc 110 may use part or all of the first framework 111 as the second conductive part 114, or may also use the externally connected first electrode element 116 as the second conductive part 114, as required.

Example 12

Fig. 21 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment after a covering film is removed, and fig. 22 is a schematic structural diagram of a first framework 111 in the left atrial appendage occlusion ablation device of fig. 21.

Referring to fig. 21 and 22, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that the anchoring disc 110 has a different structure.

In the present embodiment, the anchor disk 110 is made by cutting a tube, and unlike the first frame 111 of the embodiment, two adjacent anchor portions 113 of the first frame 111 are independently disposed in the present embodiment, that is, any one of the anchor portions 113 is not directly connected to the other anchor portions 113. The anchoring portion 113 extends in a rod shape toward the proximal end, and one end of the anchoring portion 113 away from the first connection point 1124 is bent inward.

Similarly, the second conductive part 114 in the left atrial appendage occlusion ablation device provided by this embodiment may also adopt a framework or a mode of additionally arranging an electrode element according to requirements.

Example 13

Fig. 23 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

Referring to fig. 23, the present embodiment also provides a left atrial appendage occlusion ablation device, which is mainly different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that the structure of the anchoring disc 110 is different, and specifically, the structure of the anchoring portion 113 is different from that of embodiment 1.

In this embodiment, the anchor plate 110 is cut from tubing, and each anchor portion 113 includes third and

fourth branches

1132, 1133 that are distally connected to one another, with the junction of the third and

fourth branches

1132, 1133 forming a second connection point 1134, and the second connection point 1134 connecting with the first connection point 1124. Meanwhile, the proximal end of each third branch 1132 is connected to the proximal end of the fourth branch 1133 of an adjacent anchor 113, so as to form a lattice structure between two adjacent anchors 113.

Further, the anchor portions 113 further include a connecting bar 1131, two ends of the connecting bar 1131 are respectively connected to the first connecting point 1124 and the second connecting point 1134, so that a grid enclosed between two adjacent anchor portions 113 is a hexagon. Barbs 117 are provided on tie bar 1131.

The wire electrode on the first and

second branches

1122 and 1123 serves as the first pole element 116. Specifically, a portion of the wire electrode is spirally wound along a circumferential direction of the first branch 1122 so as to be wound around the first branch 1122. Another portion of the wire electrode is spirally wound along the circumference of the second branch 1123 so as to be wound around the second branch 1123. The first pole element 116 may serve as the second conductive portion 114. It is understood that in some other embodiments, the second conductive portion 114 may be implemented in other manners, such as the structure of the second conductive portion 114 provided in embodiment 1 or embodiment 7.

Example 14

Fig. 24 is a schematic structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and fig. 25 is a schematic structural view of the left atrial appendage occlusion ablation device of fig. 24 with a covering film removed.

Referring to fig. 24 and 25, the present embodiment also provides a left atrial appendage occlusion ablation device, which is mainly different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that the ablation support 100 has a different structure.

In the present embodiment, the ablation support 100 is a three-disk structure, and the second conductive portion 114 and the first conductive portion 122 are respectively disposed on any two of the three disks. Meanwhile, the second conductive portion 114 may be a framework or an additional electrode element according to the requirement.

Similarly, the left atrial appendage occlusion ablation device provided by the present embodiment may also adopt the relevant structures in other embodiments. Specifically, the three discs of the ablation stent 100 are, from distal to proximal, a first disc 161, a second disc 162, and a third disc 163, respectively, disposed in that order.

In some embodiments, the first plate 161 and the second plate 162 are connected and electrically isolated by the insulating connection member 130, and the insulating connection member 130 may be replaced by an insulating skeleton. At this time, whether the second disk 162 is electrically isolated from the third disk 163 is not limited.

In some embodiments, the second plate 162 is connected to and electrically isolated from the third plate 163 by another insulating connection 130, and the insulating connection 130 may be replaced by an insulating skeleton. At this time, whether the first plate 161 and the second plate 162 are electrically isolated is not limited.

In some embodiments, the first plate 161 and the second plate 162 are connected and electrically isolated by an insulating connector 130, and the second plate 162 and the third plate 163 are connected and electrically isolated by another insulating connector 130, and the insulating connector 130 may be replaced by an insulating skeleton. In some embodiments, third disk 163 may serve as sealing disk 120, and both second disk 162 and first disk 161 may serve as anchor disk 110. The third pad 163 is entirely conductive and serves as the first conductive part 122. The second conductive portion 114 may be provided on either the second plate 162 or the first plate 161.

As shown in fig. 24 and 25, in the present embodiment, the first electrode 116 is provided on the first disk 161 as the second conductive portion 114, and the second electrode 123 is provided on the second disk 162 as the third conductive portion. It will be appreciated that only the first pole element 116 may be provided, without the second pole element 123.

When the first electrode member 116 is disposed on the first disk 161 as the second conductive portion 114, it is possible to connect only the first disk 161 and the second disk 162 in an insulating manner, and whether or not the second disk 162 is electrically isolated from the third disk 163 is not limited. Alternatively, only the second disk 162 and the third disk 163 may be connected in an insulating manner, and whether or not the first disk 161 and the second disk 162 are electrically isolated is not limited. Alternatively, the second plate 162 is made of an insulating material, and whether or not the first plate 161 and the second plate 162 are electrically isolated is not limited, and whether or not the second plate 162 and the third plate 163 are electrically isolated is also not limited.

In this embodiment, the first disk 161 is for anchoring inside the left atrial appendage, the third disk 163 is for sealing the left atrial appendage opening as a sealing disk 120, and the second disk 162 is located near the left atrial appendage opening.

Example 15

Fig. 26 is a schematic structural view of a left atrial appendage occlusion ablation device provided in example 15 of the present invention;

fig. 27 is a structural schematic view of the movable element 150 in fig. 26, and fig. 27 is a first structural schematic view of the movable element 150.

Referring to fig. 26 and 27, the present embodiment also provides a left atrial appendage occlusion ablation device, which is mainly different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that a movable element 150 is added, the movable element 150 is used for transmitting ablation energy or collecting tissue physiological signals, and the movable element 150 can be relatively movably disposed on the sealing disc 120 and the anchoring disc 110. And after tissue ablation is complete, the moveable member 150 can be separated from the sealing disc 120 and the anchor disc 110 and withdrawn from the body leaving only the sealing disc 120 and the anchor disc 110 in the body.

In this embodiment, the left atrial appendage occlusion ablation device includes a sealing disk 120, an anchoring disk 110, and a movable member 150 movably disposed on the anchoring disk 110.

In some embodiments, sealing disk 120 is connected to anchor disk 110 by an insulating connector 130. The proximal end of the movable member 150 movably extends through a lumen in the insulating connector 130. The distal end of the movable member 150 is movably disposed at a distal or peripheral side of the anchor plate 110. It is understood that the insulating connection member 130 may be replaced with an insulating frame.

In some embodiments, the movable member 150 is insulated from the anchor disk 110, and thus whether the sealing disk 120 is insulated from the anchor disk 110 is not limited.

All or part of the moving member 150 is made of a conductive material. In some embodiments, the movable member 150 may be movably disposed at a distal end or an outer circumferential side of the anchor plate 110 as the second conductive portion 114. At this point, the second conduit 141 may be connected to and electrically connected to the movable member 150 to provide ablative energy to the movable member 150.

In other embodiments, the movable element 150 may be disposed at the distal end or the outer periphery of the anchor plate 110 as a third conductive portion independent of the second conductive portion 114. The second conductive portion 114 may be a part or all of the first skeleton 111 of the anchor plate 110, or may be a first electrode member 116 independent of the first skeleton 111. At this time, the second catheter 141 may be electrically connected with the second conductive portion 114 to provide ablation energy to the second conductive portion 114; the third conduit is disposed through the second conduit 141 and electrically connected to the movable member 150 to provide ablation energy to the movable member 150 (i.e., the third conductive portion).

Referring to fig. 27, the movable member 150 of the present embodiment is a mesh plate structure, and the distal end thereof is retractable in the radial direction. When the movable member 150 is released at the distal end of the anchor plate 110, the movable member 150 expands radially.

The movable member 150 may be an ablation disk woven from metal wire or an ablation disk cut from metal tubing. The proximal end of the ablation disk is bunched up forming a bunched up portion 1501. The ablation disc is of a double-layer mesh disc structure, namely the near end and the far end of the ablation disc are provided with latticed mesh disc structures, and the mesh disc structures extend along the radial direction.

FIG. 28 is a second structural schematic view of the moveable member 150 of FIG. 26.

Referring to fig. 28, the movable element 150 in the present embodiment has a different structure from the movable element 150 in fig. 27. In the present embodiment, the movable element 150 includes a first portion 1511, a second portion 1512, and a third portion 1513 sequentially connected in a radial direction. The first portion 1511 is used to connect a wire to electrically connect with an external ablation signal source. Second portion 1512 extends radially outward from first portion 1511. Third portion 1513 is bent from the outer end of second portion 1512 and extends radially inward.

It is understood that the third portion 1513 may be bent upward or downward from the outer end of the second portion 1512.

FIG. 29 is a third structural view of the movable member 150 of FIG. 26.

Referring to fig. 29, the movable element 150 in the present embodiment has a different structure from the movable element 150 in fig. 27. In this embodiment, the movable member 150 has an overall umbrella-shaped structure and can be extended and contracted in the radial direction. The movable member 150 may be cut from a metal tube.

Specifically, the movable member 150 includes a plurality of first struts 1521 and a plurality of second struts 1522. The plurality of first struts 1521 extend radially outward, and in a radially outward direction, a distance between adjacent first struts 1521 becomes gradually larger. The plurality of first struts 1521 form a stent structure that gradually flares radially outward from the proximal end to the distal end. The plurality of second struts 1522 are disposed around the outer circumference of the plurality of first struts 1521 and gradually bend and extend from the distal end to the proximal end. The distal end of the second rod 1522 is connected to the outer end of the first rod 1521. A plurality of second struts 1522 may also be used to anchor the inner wall tissue of the left atrial appendage.

In the embodiment shown in fig. 29, the movable member 150 further includes a plurality of first and

second links

1523 and 1524 connected between the first and second support bars 1521 and 1522. The end of each first rod 1521 away from the axis of the movable member 150 is connected to a first link 1523 and a second link 1524, forming a Y-shaped structure. The end of the first link 1523 remote from the first link 1521 is connected to the end of another second link 1524 adjacent thereto remote from the first link 1521 and forms a third connection point 1525. The distal end of the second strut 1522 is connected to a third connection point 1525. The proximal ends of the second struts 1522 are bent radially inward and gradually hooked back to the distal ends to avoid the second struts 1522 from penetrating into the inner wall tissue of the left atrial appendage and reduce the damage to the tissue.

The movable member 150 has an overall umbrella-like structure, which is easy to release and retract. At the end of the ablation, the moveable member 150 may be pulled proximally through the second conduit 141 in the carrier 140 and retracted back into the first conduit 142. Or by pulling the movable member 150 proximally through the third conduit and retracting into the second conduit 141.

FIG. 30 is a fourth structural schematic view of the movable member 150 of FIG. 26.

Referring to fig. 30, a structure of the movable element 150 in the present embodiment is different from that of the movable element 150 in fig. 27. In the present embodiment, the movable member 150 has a tubular structure as a whole. Specifically, the movable member 150 includes a tube body 153 and a plurality of tube electrodes 154 disposed on the tube body 153 at intervals.

The tube 153 includes a hub portion 1531, an extension portion 1532 and an annular portion 1533 connected in sequence from the proximal end to the distal end.

The hub section 1531 is used to connect to an ablation signal source. When the movable element 150 is used as the second conductive portion 114, the shaft portion 1531 is detachably connected or integrally connected to the second conduit 141. When the movable element 150 is used as a third conductive part independent from the second conductive part 114, the shaft portion 1531 is detachably or integrally connected to the third conduit and movably inserted into the second conduit 141.

The extension segment 1532 extends radially outward from the distal end of the hub segment 1531.

The annular section 1533 extends from the end of the extension section 1532 away from the hub section 1531 in a ring around the circumference of the hub section 1531. A plurality of tube electrodes 154 are arranged in spaced relation on the extension segment 1532 and the ring segment 1533.

In some embodiments, adjacent tube-electrodes 154 of the plurality of tube-electrodes 154 may be connected to the same ablation electrical signal; different ablation electrical signals can also be connected, such as a positive ablation signal source and a negative ablation signal source which are alternately connected in sequence.

In other embodiments, the moveable member 150 may also be used to acquire electrophysiological signals inside the left atrial appendage and, accordingly, the tube electrodes 154 may be used for mapping.

Fig. 31 is a fifth structural schematic view of the movable member 150 in fig. 26.

Referring to fig. 31, the movable element 150 in the present embodiment has substantially the same structure as the movable element 150 in fig. 30, and the main difference is that the annular segment 1533 has a different structure. In the embodiment, the annular portion 1533 surrounds the axial portion 1531 in a spiral shape, and may surround the axial portion 1531 in a spiral structure, or may gradually surround the axial portion 1531 in a spiral shape in a cylindrical or conical shape.

Example 16

Referring to fig. 32 in combination with fig. 19 and 20, the present embodiment also provides a left atrial appendage occlusion ablation device, which is different from the left atrial appendage occlusion ablation device provided in embodiment 1 in that a movable element 150 is added.

In some embodiments, sealing disk 120 is coupled to anchor disk 110 by an insulating coupling 130. The proximal end of the moveable member 150 is movably disposed through a lumen in the insulated connector 130. The distal end of the movable member 150 is movably disposed at a distal or peripheral side of the anchor plate 110. It is understood that the insulating connecting member 130 may be replaced with an insulating skeleton.

In this embodiment, the distal end of the moveable member 150 is movably disposed within or distal of the anchor plate 110.

The distal end of the first backbone 111 of the anchor plate 110 is open. Through which the movable member 150 can move back and forth between the interior of the first frame 111 and the exterior of the distal end.

In some embodiments, the moveable member 150 is made of an electrically conductive material, in whole or in part. The movable member 150 can be movably disposed inside or at a distal end of the anchor plate 110 as the second conductive portion 114. At this point, second conductive portion 114 is ablated in conjunction with first conductive portion 122 (i.e., seal disk 120).

In other embodiments, the second conductive portion 114 can be part or all of the first frame 111, and the moveable element 150 can be a third conductive portion independent of the second conductive portion 114 and electrically isolated from the second conductive portion 114. At this time, the second conductive portion 114, the first conductive portion 122, and the third conductive portion are collectively ablated.

It is understood that the movable member 150 of the present embodiment may adopt the structure of any one of the movable members 150 in fig. 27 to 31.

Example 17

Fig. 33 is a schematic structural view of a left atrial appendage occlusion ablation device provided in example 17 of the present invention.

Referring to fig. 33 in conjunction with fig. 32, this embodiment also provides a left atrial appendage occlusion ablation device, which has substantially the same structure as the left atrial appendage occlusion ablation device provided in embodiment 16, except that a first electrode element 116 is added.

In the present embodiment, the first electrode 116 is electrically isolated from the movable element 150, that is, the first electrode 116 and the movable element 150 are insulated, which can be referred to the insulation treatment method described above. The first electrode element 116 and the movable element 150 can be used as the second conductive portion 114 and the third conductive portion, respectively, and cooperate with the first conductive portion 122 to perform ablation together.

Example 18

Referring to fig. 34 in conjunction with fig. 26, this embodiment also provides a left atrial appendage occlusion ablation device, which has substantially the same structure as the left atrial appendage occlusion ablation device provided in embodiment 15, and the main difference is that an electrode wire is added as the first electrode element 116.

In this embodiment, the wire electrode is wound around the first bobbin 111 to form the first electrode 116. The first electrode element 116 formed by winding the wire electrode may serve as the second conductive part 114.

All or a portion of the moveable member 150 is made of an electrically conductive material. The moving part 150 may serve as a third conductive part and be ablated together with the second conductive part 114.

It should be noted that the specific technical solutions in the above embodiments of the present application can be mutually applied.

While the present invention has been described with reference to several exemplary embodiments, it is understood that the terminology used is intended to be in the nature of words of description and illustration, rather than of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the metes and bounds of the claims, or equivalence of such metes and bounds are therefore intended to be embraced by the appended claims.

Claims

1. A left atrial appendage occlusion ablation device, comprising:

the anchoring disc is of a radial telescopic support structure; and

the sealing disc is of a radial telescopic support structure and is arranged at the near end of the anchoring disc; the sealing disc is made of a conductive material, and the whole sealing disc is used as a first conductive part for transmitting ablation energy or collecting tissue physiological signals.

2. The left atrial appendage occlusion ablation device of claim 1, further comprising a second conductive portion for transmitting ablation energy or collecting tissue physiological signals, respectively; the second conductive part is arranged on the anchoring disc; the sealing disk is electrically isolated from the second electrically conductive portion.

3. The left atrial appendage occlusion ablation device of claim 2, further comprising an insulating connector disposed between the anchor disk and the sealing disk;

the insulating connecting piece extends along the axial direction, the far end of the insulating connecting piece is connected with the anchoring disc, and the near end of the insulating connecting piece is connected with the sealing disc; the insulating connector is configured to electrically isolate the second conductive portion from the seal land.

4. The left atrial appendage occlusion ablation device of claim 3, wherein a distal end of the insulating connector is provided with a first conductive connection that is electrically connected to the second conductive portion;

there is at least partial axial section insulation on the insulating connector between the first conductive connection and the sealing disk to electrically isolate the first conductive connection from the sealing disk.

5. The left atrial appendage occlusion ablation device of claim 4, wherein the insulating connector comprises a first connector and a second connector connected in series along an axial direction; the second connector is located at the proximal end of the first connector;

the anchoring disc is connected to the first connecting piece; the sealing disc is connected with the second connecting piece; the first conductive connecting part is arranged on the first connecting piece;

the insulated axial section is formed on the first connector, or on the second connector, or between the first connector and the second connector.

6. The left atrial appendage occlusion ablation device of claim 5, wherein the insulating connector further comprises a third connector disposed between the first connector and the second connector; the insulated axial section is formed on the third connector.

7. The left atrial appendage occlusion ablation device of claim 5, wherein a plurality of the third connectors are provided, and the plurality of third connectors are axially connected in sequence; wherein the third connector at the most distal end is connected to the first connector, the third connector at the most proximal end is connected to the second connector, and the insulated axial section is formed at least on one of the third connectors.

8. The left atrial appendage occlusion ablation device of claim 5, wherein a first installation space is formed in the first connector, and one end of the anchoring disk is connected in a constrained manner in the first installation space;

and/or a second mounting space is formed on the second connecting piece, and the far end of the sealing disc is converged in the second mounting space.

9. A left atrial appendage occlusion ablation device as in claim 6, wherein the first conductive connection is removably connected to the first connector.

10. The left atrial appendage occlusion ablation device of claim 9, wherein the insulating connector further comprises a fourth connector disposed between the first connector and the first conductive connection;

the fourth connector has the insulated axial section formed thereon to electrically isolate the first conductive connection from the first connector;

the third connector has the insulated axial section formed thereon to electrically isolate the first connector from the third connector.

11. A left atrial appendage occlusion ablation device as in claim 3, wherein the anchoring disk comprises a first backbone; the first framework is a radially telescopic support structure; the first framework is made of metal wires in a weaving mode or metal pipes in a cutting mode;

the far end of the insulating connecting piece is connected with the first framework;

the second conductive part is part or all of the first framework, or the second conductive part is an electrode element arranged on the peripheral wall of the first framework.

12. The left atrial appendage occlusion ablation device of claim 1, wherein the anchor disk comprises a support portion and an anchor portion;

the supporting parts are arranged in plurality and surround the axis of the anchoring disc; one end of the supporting part is connected with the sealing disc, and the other end of the supporting part is bent and extended outwards gradually along the radial direction;

the anchoring parts are arranged in a plurality and surround the periphery of the supporting part; the anchoring part is bent and extended towards the proximal end from the end part of the supporting part far away from the axis of the anchoring disc.

13. A left atrial appendage occlusion ablation device as in claim 12, wherein each support portion comprises a support rod, a first branch and a second branch;

one end of the supporting rod is connected to the sealing disc, and the other end of the supporting rod is bent and extended outwards gradually along the radial direction;

one end of each of the first branch and the second branch is connected to one end, far away from the axis of the anchoring disc, of the corresponding supporting rod; one end of the first branch, which is far away from the supporting rod, is connected with one end of the second branch, which is far away from the supporting rod, of the adjacent supporting part, and a connecting point is formed; the anchoring portion extends from the connection point toward the proximal end.

14. A left atrial appendage closure ablation device as in claim 13, wherein the end of the anchoring portion distal from the connection point is bent toward the axis of the anchoring disk.

15. A left atrial appendage occlusion ablation device as in claim 14, wherein an end of the anchor portion distal from the connection point is crimped to an end of another adjacent anchor portion distal from the connection point.

16. The left atrial appendage occlusion ablation device of claim 4, wherein the insulating connector has an axially extending channel formed therein, the channel extending from a proximal end of the insulating connector to the first conductive connection.

17. The left atrial appendage occlusion ablation device of claim 2, further comprising a movable member that movably passes through the anchor disk and the sealing disk; the movable part is used for transmitting ablation energy or collecting tissue physiological signals, and the movable part serves as the second conductive part or a third conductive part electrically isolated from the second conductive part.

18. The left atrial appendage occlusion ablation device of claim 17, wherein a distal end of the anchor disk is provided with an opening;

the distal end of the moveable member is capable of moving through the opening from the interior of the anchor plate to the distal side of the anchor plate or from the distal side of the anchor plate to the interior of the anchor plate.

19. The left atrial appendage closure ablation device of claim 17, wherein the distal end of the moveable member is a radially retractable structure, the distal end of the moveable member being releasable and in a radially expanded state.

20. The left atrial appendage occlusion ablation device of claim 2, wherein a second conductive connection is formed at a proximal end of the sealing disk and is configured to receive ablation energy or transmit tissue physiological signals; the second conductive connecting portion is cylindrical, and a through hole extending in the axial direction is formed in the second conductive connecting portion.

21. A left atrial appendage occlusion ablation device as in claim 20, wherein the sealing disk comprises a second skeleton, the second skeleton is a radially retractable support structure, and the second skeleton is woven from metal wires or cut from metal tubing; and the near end of the second framework is connected to the second conductive connecting part in a converging manner.

22. A left atrial appendage closure ablation device as in claim 21, wherein the outer peripheral wall of the distal end of the second backbone is provided with an insulating membrane that is blocked between the distal end of the second backbone and the proximal end of the anchor disk.

23. A left atrial appendage occlusion ablation device of any one of claims 2-22; the left atrial appendage occlusion ablation device is characterized by further comprising an outer tube, a first catheter and a second catheter;

the outer pipe is tubular, and the distal end of the outer pipe can accommodate the anchoring disc and the sealing disc in a radial contraction state;

the first guide pipe is movably arranged in the outer pipe in a penetrating way and can move relative to the outer pipe along the axial direction; the distal end of the first conduit is in electrically conductive connection with the sealing disk;

the second guide pipe is movably arranged in the first guide pipe in a penetrating way and can move relative to the first guide pipe along the axial direction; the distal end of the second conduit is movably disposed through the sealing disk and is in electrically conductive communication with the second electrically conductive portion.

24. A left atrial appendage occlusion ablation device of any one of claims 17-19; when the movable piece is used as a third conductive part electrically isolated from the second conductive part, the left atrial appendage occlusion ablation device further comprises an outer tube, a first catheter, a second catheter and a third catheter;

the outer tube is tubular, and the distal end of the outer tube can accommodate the anchoring disc and the sealing disc in a radial contraction state;

the first guide pipe is movably arranged in the outer pipe in a penetrating way and can move relative to the outer pipe along the axial direction; the distal end of the first conduit is in conductive communication with the sealing disk to transmit ablation energy to the sealing disk;

the second guide pipe is movably arranged in the first guide pipe in a penetrating way and can move relative to the first guide pipe along the axial direction; the distal end of the second conduit movably passes through the sealing disc and is electrically connected with the second conductive part;

the third guide pipe is movably arranged in the second guide pipe in a penetrating way and can move relative to the second guide pipe along the axial direction; the distal end of the third catheter is electrically connected to the third conductive portion.