Left atrial appendage occlusion ablation device

Abstract

The application relates to a left auricle occlusion and ablation device. The left auricle occlusion and ablation device comprises an anchoring disc which is a radially telescopic stent structure, and a sealing disc which is a radially telescopic stent structure and is arranged at the proximal end of the anchoring disc; the sealing disc is made of a conductive material, and the sealing disc as a whole serves as a first conductive part for transmitting ablation energy or collecting tissue physiological signals. The anchoring disc is released in the left auricle and can anchor the tissue inner wall of the left auricle, and the sealing disc is released at the entrance of the left auricle so as to occlude the entrance of the left auricle and occlude thrombus in the interior of the left auricle, thereby effectively preventing the thrombus from entering the left atrium. Meanwhile, the sealing disc is conductive as a whole and transmits ablation energy, and ablation is performed on the left auricle mouth, which is more conducive to forming a complete annular ablation zone at the mouth, thereby facilitating complete electrical isolation of the left auricle from the left atrium at the left auricle mouth, and greatly improving the ablation effect.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a left atrial appendage occlusion ablation device. Background Technology

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia. Its incidence increases with age, reaching up to 10% in people over 75. AF prevalence is also closely related to coronary heart disease, hypertension, and heart failure. The left atrial appendage, due to its unique morphology and structure, is not only the primary site of thrombus formation in AF but also a key area for its development and maintenance. Some AF patients can benefit from active left atrial appendage electrical isolation.

[0003] A combined approach of catheter radiofrequency ablation and left atrial appendage occlusion has yielded numerous successful cases in treating atrial fibrillation. In this one-stop treatment, left atrial appendage occlusion allows patients to achieve good stroke prevention without the need for lifelong anticoagulation; combined with catheter radiofrequency ablation to restore and maintain sinus rhythm, thus improving symptoms and providing stable long-term therapeutic effects. However, performing ablation and occlusion of the left atrial appendage during this one-stop treatment requires the interventional introduction of an ablation catheter and a left atrial appendage occlusion ablation device. The key is to position both devices sequentially at the opening of the left atrial appendage before performing ablation and occlusion. The difficulty in locating both the ablation catheter and the left atrial appendage occlusion device at the opening makes the procedure complex and time-consuming, hindering the convenience of the "ablation + left atrial appendage occlusion" one-stop treatment. Summary of the Invention

[0004] The purpose of this invention is to provide a left atrial appendage occlusion ablation device, which can effectively improve the technical problems of the complex and difficult one-stop treatment procedure of "ablation + left atrial appendage occlusion" in the prior art.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0006] An embodiment of the present invention provides a left atrial appendage occlusion ablation device, which includes: an anchoring plate, which is a radially expandable support structure; and a sealing plate, which is a radially expandable support structure and is disposed at the proximal end of the anchoring plate; the sealing plate is made of conductive material, and the sealing plate as a whole serves as a first conductive part for transmitting ablation energy or collecting tissue physiological signals.

[0007] According to some embodiments of this application, the left atrial appendage occlusion ablation device further includes a second conductive part, which is used to transmit ablation energy or collect tissue physiological signals; the second conductive part is disposed on the anchoring plate; the sealing plate is electrically isolated from the second conductive part.

[0008] As can be seen from the above technical solutions, the embodiments of the present invention have at least the following advantages and positive effects:

[0009] The left atrial appendage occlusion ablation device provided in this invention includes an anchoring plate and a sealing plate. Both the anchoring plate and the sealing plate are radially retractable support structures. The anchoring plate is released within the left atrial appendage, anchoring itself to the inner wall of the tissue. The sealing plate is released at the entrance of the left atrial appendage, sealing the entrance and blocking any thrombi inside, effectively preventing thrombi from entering the left atrium. Simultaneously, the sealing plate is electrically conductive and serves as the first conductive part, transmitting ablation energy. Ablation of the left atrial appendage opening facilitates the formation of a complete annular ablation band at the opening, thus enabling complete electrical isolation between the left atrial appendage and the left atrium, significantly improving the ablation effect. The sealing plate, as the first conductive part, can also be used to collect tissue physiological signals for mapping. Furthermore, this left atrial appendage occlusion ablation device combines ablation and occlusion, simplifying the procedure of a one-stop "ablation + left atrial appendage occlusion" treatment and helping to reduce surgical difficulty. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 1 of the present invention.

[0011] Figure 2 A cross-sectional structural schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 1 of the present invention.

[0012] Figure 3 for Figure 2 A magnified schematic diagram of the local structure at point III.

[0013] Figure 4 This is a schematic diagram of the conveyor provided in Embodiment 1 of the present invention.

[0014] Figure 5 for Figure 2 A schematic diagram of the first skeleton in the middle.

[0015] Figure 6 This is a schematic diagram of the insulating connector in the left atrial appendage occlusion ablation device provided in Embodiment 2 of the present invention.

[0016] Figure 7 This is a schematic diagram of the insulating connector in the left atrial appendage occlusion ablation device provided in Embodiment 3 of the present invention.

[0017] Figure 8 This is a schematic diagram of the insulating connector in the left atrial appendage occlusion ablation device provided in Embodiment 4 of the present invention.

[0018] Figure 9 This is a schematic diagram of the insulating connector in the left atrial appendage occlusion ablation device provided in Embodiment 5 of the present invention.

[0019] Figure 10 for Figure 9 A schematic diagram of the structure of the insulating connector of the left atrial appendage occlusion ablation device during tensile and torsional movements.

[0020] Figure 11 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 6 of the present invention.

[0021] Figure 12 for Figure 11 A schematic diagram of the cross-sectional structure of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0022] Figure 13 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 7 of the present invention.

[0023] Figure 14 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 8 of the present invention.

[0024] Figure 15 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 9 of the present invention.

[0025] Figure 16 for Figure 15 A schematic diagram of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0026] Figure 17 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 10 of the present invention.

[0027] Figure 18 for Figure 17 A schematic diagram of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0028] Figure 19 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 11 of the present invention.

[0029] Figure 20 for Figure 19 A schematic diagram of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0030] Figure 21 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 12 of the present invention after the covering membrane has been removed.

[0031] Figure 22 for Figure 21 A schematic diagram of the first skeleton in the left atrial appendage occlusion ablation device.

[0032] Figure 23 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 13 of the present invention.

[0033] Figure 24 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 14 of the present invention.

[0034] Figure 25 for Figure 24 A schematic diagram of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0035] Figure 26 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 15 of the present invention.

[0036] Figure 27 for Figure 26 A schematic diagram of the moving parts in the middle.

[0037] Figure 28 for Figure 26 A schematic diagram of the second structure of the moving part.

[0038] Figure 29 for Figure 26 A schematic diagram of the third type of structure for the moving parts.

[0039] Figure 30 for Figure 26 A schematic diagram of the fourth structure of the moving part.

[0040] Figure 31 for Figure 26 A schematic diagram of the fifth structure of the moving part.

[0041] Figure 32 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 16 of the present invention.

[0042] Figure 33 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 17 of the present invention.

[0043] Figure 34 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 18 of the present invention.

[0044] Figure Descriptions: 100, Ablation stent; 110, Anchoring plate; 111, First frame; 112, Support part; 1121, Support rod; 1122, First branch; 1123, Second branch; 1124, First connection point; 113, Anchoring part; 1131, Connecting rod; 1132, Third branch; 1133, Fourth branch; 1134, Second connection point; 114, Second conductive part; 116, First electrode Components; 117. Barb; 118. Connecting ring; 119. Distal connector; 120. Sealing disc; 121. Second frame; 122. First conductive part; 123. Second electrode; 124. Second conductive connection part; 125. Insulating film; 126. Flow-blocking film; 127. Disc surface; 128. Disc bottom; 129. Waist; 130. Insulating connector; 131. First connector; 1311. First mounting space; 132. Second connector; 1321. Inner sleeve; 1322. Outer sleeve; 1323. Second mounting space; 133. Third connector; 1331. Large pipe section; 1332. Small pipe section; 134. First conductive connection; 135. Fourth connector; 140. Conveyor; 141. Second conduit; 142. First conduit; 143. Outer pipe; 144. Handle; 150. Movable part; 1501. Convergence Part; 1511, First Part; 1512, Second Part; 1513, Third Part; 1521, First Support Rod; 1522, Second Support Rod; 1523, First Connecting Rod; 1524, Second Connecting Rod; 1525, Third Connection Point; 153, Tube Body; 1531, Axial Section; 1532, Extension Section; 1533, Annular Section; 154, Tube Electrode; 161, First Disc; 162, Second Disc; 163, Third Disc. Detailed Implementation

[0045] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.

[0046] In the description of this application, it should 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", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0047] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0048] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0049] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0050] Definition and Explanation:

[0051] Left atrial appendage entrance: The location where the left atrium enters the left atrial appendage.

[0052] Proximal and distal ends: After a component is implanted, the end relatively closer to the outside of the body is the proximal end of the component; after a component is implanted, the end relatively closer to the inside of the body is the distal end of the component. In other words, after the left atrial appendage occlusion ablation device is implanted in the left atrial appendage, the proximal end of a component in the left atrial appendage occlusion ablation device is the end of the component closer to the left atrium, and the distal end of a component is the end of the component closer to the left atrial appendage.

[0053] Insulation treatment: Forming an insulating layer on the surface of a component to insulate that part of the component. Specifically, insulation treatment methods include: applying an insulating coating material to the location requiring insulation treatment, the coating material including but not limited to pyrene coating, PTFE coating, and PI coating; or covering the location requiring insulation treatment with an insulating film, the film material including but not limited to FEP, PU, ​​ETFE, PFA, PTFE, PEEK, and silicone; or wearing an insulating sleeve on the location requiring insulation treatment, the insulating sleeve material including but not limited to FEP, PU, ​​ETFE, PFA, PTFE, PEEK, and silicone.

[0054] The left atrial appendage occlusion ablation device provided in this invention is implanted into the opening of the left atrial appendage and can perform pulsed ablation or radiofrequency ablation on the left atrial appendage tissue. Pulsed ablation utilizes a high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, known in the medical field as irreversible electroporation (IRE), inducing cell apoptosis and thus achieving non-thermal ablation of cells, therefore unaffected by heat sink effects. The high-voltage pulse sequence generates less heat and does not require saline flushing for cooling, effectively reducing the occurrence of gas explosion, eschar, and thrombosis. Pulsed ablation treatment time is short; the treatment time for one pulse sequence is less than 1 minute, and the total ablation time generally does not exceed 5 minutes. Furthermore, because different tissues have different response thresholds to the pulsed electric field, it is possible to ablate myocardium without interfering with other adjacent tissues, thereby avoiding accidental damage to tissues adjacent to the left atrial appendage. Furthermore, compared to other energy sources, pulsed ablation does not require heat conduction to ablate deep tissues. All myocardial cells distributed above a certain electric field strength will undergo electroporation, reducing the pressure requirements for catheter contact during ablation. Therefore, even if the ablation device does not completely adhere to the left atrial appendage wall after entering the left atrial appendage, it does not affect the IRE ablation effect. The electrodes that deliver pulsed energy can also collect intracardiac electrical signals. Before ablation, the intracardiac electrical signals are collected and transmitted to a cardiac synchronizer, ensuring that the pulse output is synchronized during the absolute refractory period of myocardial contraction, thus not interfering with heart rate and reducing the risk of sudden arrhythmias. After the ablation procedure, the intracardiac signals can also be used to determine whether complete electrical isolation of the tissue has been achieved.

[0055] Example 1

[0056] Figure 1 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 2 This is a cross-sectional structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 2 Compared to Figure 1 The flow-blocking membrane 126 was removed, and Figure 2 The portion of the first frame 111 of the anchoring disc 110 located within the frame forms the second conductive part 114, and the second frame 121 of the sealing disc 120 as a whole forms the first conductive part 122.

[0057] Please refer to the reference. Figure 1 and Figure 2 The left atrial appendage occlusion ablation device provided in this embodiment includes an ablation stent 100, which includes an anchoring plate 110, a sealing plate 120, and an insulating connector 130.

[0058] Both the first skeleton 111 of the anchoring disc 110 and the second skeleton 121 of the sealing disc 120 are radially expandable support structures. For example, this support structure can be a mesh-like or tubular support. Under external pressure, this support structure can radially contract at the axis to facilitate the preservation or transport of the ablation stent 100 as a whole. When the pressure is removed, it can naturally expand radially, restoring the mesh-like or tubular support structure, so that the ablation stent 100 as a whole can be fixed at the left atrial appendage. It is understood that this support structure can also be a radially expandable support structure of other shapes.

[0059] Generally, both the first skeleton 111 and the second skeleton 121 are made of metallic materials with shape memory and superelasticity, such as nickel-titanium alloys. Specifically, they can be made by weaving metal wires or cutting metal tubes.

[0060] In this embodiment, the sealing disc 120 serves as a conductive part for transmitting ablation energy for annular ablation or for acquiring tissue physiological signals for mapping. When the anchoring disc 110 is anchored inside the left atrial appendage, the sealing disc 120 can completely block the entrance of the left atrial appendage, sealing the thrombus inside the left atrial appendage and effectively preventing the thrombus from entering the left atrium. At the same time, the sealing disc 120 can also effectively ablate the inner wall tissue of the left atrial appendage entrance, exhibiting excellent ablation effect. Specifically, the tissue at the opening of the left atrial appendage is more regular and has a smoother surface than the internal tissue of the left atrial appendage. Ablation of the opening of the left atrial appendage is more conducive to forming a complete ablation band at the opening, thereby facilitating complete electrical isolation between the left atrial appendage and the left atrium at the opening of the left atrial appendage.

[0061] In some embodiments, the anchoring disc 110 is provided with a second conductive portion 114, and the sealing disc 120 as a whole serves as a first conductive portion 122. The second conductive portion 114 and the first conductive portion 122 are used to transmit ablation energy to the tissue, or for mapping. The second conductive portion 114 and the first conductive portion 122 can be used to transmit electroablation 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.

[0062] In some embodiments, such as those in which the second conductive portion 114 and the first conductive portion 122 are used to transmit radio frequency energy, the second conductive portion 114 and the first conductive portion 122 may be used to transmit ablation energy of the same polarity or transmit the same ablation energy.

[0063] In some embodiments, the second conductive portion 114 and the first conductive portion 122 can also be used for mapping, i.e., for acquiring electrophysiological signals of the target tissue. Alternatively, in some embodiments, they can have both ablation and mapping functions. For example, a portion of the second conductive portion 114 and / or the first conductive portion 122 can be used for mapping and a portion for ablation, or the second conductive portion 114 and / or the first conductive portion 122 can be used for both mapping and ablation in a time-sharing manner.

[0064] It should be noted that in some other embodiments, the first frame 111 may also be used as the second conductive part 114 as a whole; or, the second conductive part 114 may be an electrode provided on the outer peripheral wall of the first frame 111, and the second conductive part 114 may be fixedly connected to the inner wall or outer peripheral wall of the first frame 111, or may be detachably or movably connected to the first frame 111.

[0065] Please refer to Figure 1 and Figure 2 The two ends of the insulating connector 130 are connected to the anchor plate 110 and the sealing plate 120 respectively. Specifically, the far end of the insulating connector 130 is connected to the anchor plate 110 and the near end is connected to the sealing plate 120. The insulating connector 130 electrically isolates the second conductive part 114 on the first frame 111 and the first conductive part 122 on the second frame 121.

[0066] It should be noted that in some other embodiments, the insulating connector 130 may be omitted, and the first frame 111 itself, except for the second conductive part 114, may be used for insulation, thereby electrically isolating the second conductive part 114 and the first conductive part 122.

[0067] In use, 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 connected to the positive terminal of the output of the external signal source, and the first conductive part 122 is electrically connected to the negative terminal of the output of the external signal source. Ablation is achieved through the electric field formed between the second conductive part 114 and the first conductive part 122, resulting in a good ablation effect.

[0068] In addition, the insulating connector 130 improves the insulation performance between the second conductive part 114 and the first conductive part 122, reduces the possibility of electrical connection between the second conductive part 114 and the first conductive part 122, and improves the ablation success rate and the reliability of the device.

[0069] It is understood that in some other embodiments, electrical signals with identical parameters can be transmitted to the second conductive part 114 and the first conductive part 122 as needed.

[0070] The left atrial appendage occlusion ablation device provided in this embodiment will be further described below:

[0071] Figure 3 for Figure 2 Enlarged schematic diagram of the local structure at point III. Figure 4 This is a schematic diagram of the structure of the conveyor 140 provided in this embodiment.

[0072] Please refer to the reference. Figures 1 to 4 The left atrial appendage occlusion ablation device provided in this embodiment also includes a delivery device 140. An ablation stent 100 is mounted on the distal end of the delivery device 140, which delivers and releases the ablation stent 100 to the target location, i.e., the left atrial appendage inlet. It is understood that in some embodiments, the left atrial appendage occlusion ablation device provided in this application can also be used to treat other tissue defects.

[0073] The conveyor 140 includes an outer tube 143, a first conduit 142, a second conduit 141, and a handle 144 that are nested together.

[0074] The outer tube 143 is tubular, and the distal end of the outer tube 143 can accommodate the anchoring disc 110 and the sealing disc 120 in a radially contracted state.

[0075] The first conduit 142 is tubular and movably inserted within the outer tube 143. The first conduit 142 is axially movable relative to the outer tube 143. The distal end of the first conduit 142 is detachably connected to and electrically connected to the sealing disc 120. The proximal end of the first conduit 142 is electrically connected to an external signal source, allowing the external signal source to transmit ablation energy to the sealing disc 120 via the first conduit 142. Furthermore, the first conduit 142 can drive the sealing disc 120 and the anchoring disc 110 to move axially within the outer tube 143, thereby allowing the entire ablation stent 100 to extend beyond the distal end of the outer tube 143 for release, or retract and be housed within the outer tube 143.

[0076] The second conduit 141 is tubular and movably inserted within the first conduit 142. The second conduit 141 is axially movable relative to the first conduit 142. The distal end of the second conduit 141 can be detachably connected to the anchoring plate 110 and electrically connected to the second conductive part 114, thereby delivering electroablation energy to the second conductive part 114 through the second conduit 141. It is understood that the second conduit 141 may also be detachably electrically connected to the second conductive part 114 without being connected to the anchoring plate 110.

[0077] Specifically, the first conduit 142 and the second conduit 141 are used to connect to different output terminals of an external signal source. For example, one of the first conduit 142 and the second conduit 141 is used to connect to the positive terminal of the output terminal of the external signal source, and the other is used to connect to the negative terminal of the output terminal of the external signal source.

[0078] It should be noted that the first catheter 142 and the second catheter 141 can also be used to transmit the collected tissue physiological signals for mapping.

[0079] The handle 144 is positioned at the proximal end of the outer tube 143. During the implantation of the ablation stent 100, the first catheter 142 controls the ablation stent 100 to be housed at the distal end of the outer tube 143. When the distal end of the outer tube 143 is inserted into the left atrial appendage and remains there, the ablation stent 100 can be released by manipulating the outer tube 143 backward through the handle 144.

[0080] Moreover, the second catheter 141 is configured as a tubular structure, so that the inner hole of the second catheter 141 can be used to guide the traction wire to pass through, thereby facilitating the movement of the outer tube 143, the first catheter 142, the second catheter 141 and the ablation stent 100 as a whole along the traction wire and delivered to the target position.

[0081] Please refer to Figure 3 The insulating connector 130 is provided with a first conductive connection portion 134. The first conductive connection portion 134 is used to detachably connect to the second conduit 141 in the delivery device 140, and the second conduit 141 is electrically connected to the second conductive part 114 through the first conductive connection portion 134, thereby delivering ablation energy to the second conductive part 114 through the second conduit 141, and after ablation is completed, the second conduit 141 can be detached from the first conductive connection portion 134.

[0082] In some embodiments, the insulating connector 130 is cylindrical, and the first conductive connection portion 134 is disposed on the inner surface of the insulating connector 130. Optionally, the first conductive connection portion 134 and the second conduit 141 are threaded together to achieve a detachable connection between the first conductive connection portion 134 and the second conduit 141. It is understood that in other embodiments, the detachable connection between the first conductive connection portion 134 and the second conduit 141 can be achieved in other ways as needed, such as magnetic connection or snap-fit.

[0083] The insulating connector 130 extends axially, with its proximal end connected to the sealing disc 120 and its distal end connected to the anchoring disc 110. The insulating connector 130 includes an insulating axial section, achieving an insulating connection between the sealing disc 120 and the anchoring disc 110, thereby improving the insulation performance between the two discs. The "axial section" refers to a section extending along the axial direction of the component and circling it. This axial section can be located inside the insulating connector 130 or on its surface. In this embodiment, the ablation stent 100 is symmetrical along its axis, and the axis of the insulating connector 130 is the axis of the ablation stent 100.

[0084] The insulating connector 130 includes a first connector 131 and a second connector 132 connected in sequence, that is, the first connector 131 and the second connector 132 are connected in sequence along the axial direction. The first connector 131 is connected to the anchoring disc 110, that is, the anchoring disc 110 is converging and connected to the first connector 131. The second connector 132 is connected to the sealing disc 120, and the sealing disc 120 is converging and connected to the second connector 132.

[0085] Furthermore, such as Figure 3 As shown, in this embodiment, the insulating connector 130 further includes a third connector 133, which is disposed between the first connector 131 and the second connector 132, so that the first connector 131 and the second connector 132 are indirectly connected. The distal end of the third connector 133 is connected to the proximal end of the first connector 131, and the proximal end of the third connector 133 is connected to the distal end of the second connector 132.

[0086] Multiple third connectors 133 can be provided and connected sequentially along the axial direction. The farthest third connector 133 is connected to the first connector 131, and the closest third connector 133 is connected to the second connector 132. That is, in the ablation stent 100 shown in this embodiment, the first connector 131 is connected to the second connector 132 through one or more third connectors 133, thereby extending the length of the insulating connector 130 and realizing the indirect connection between the anchoring plate 110 and the sealing plate 120.

[0087] In this embodiment, the anchoring disc 110 is connected to the first connector 131, which includes a first conductive connection portion 134. The first conductive connection portion 134 is insulated from the second connector 132, thereby achieving electrical isolation between the second conductive portion 114 and the first conductive portion 122. The distal end of the sealing disc 120 is connected to the second connector 132. The second connector 132 is cylindrical and has a channel for the second conduit 141 to pass through, thus the second conduit 141 passes through the channel of the second connector 132 and connects to the first conductive connection portion 134. In some embodiments, the second connector 132 is used to fixably connect to the distal end of the sealing disc 120, converging multiple nickel-titanium alloy wires in the sealing disc 120.

[0088] Specifically, at least a portion of the axial section of the first connector 131 can be insulated to achieve an insulated connection between the first conductive connection 134 and the first conductive part 122. In some embodiments, the proximal end of the at least portion of the axial section extends beyond the proximal end of the first conductive connection 134, that is, the proximal end of the first conductive connection 134 is farther from the sealing disc 120 than the proximal end of the at least portion of the axial section.

[0089] For example, if the first connector 131 is configured to be at least proximally insulated, and the first conductive connection portion 134 is configured as a thread on the inner wall of the distal end of the first connector 131, then the conductivity and insulation properties of the second connector 132 and the third connector 133 are not limited. The proximal end of the insulated axial section is closer to the proximal end of the first connector 131 than the proximal end of the first conductive connection portion 134. The insulated axial section may be disposed on the insulating surface of the first connector 131, or the material of the first connector 131 in the axial section may all be insulating, and the distal position of the insulated axial section is not limited.

[0090] In some embodiments, the distal end of the insulating axial section is closer to the sealing disc 120 than the proximal end of the first conductive connection 134, or the distal end of the insulating axial section is closer to the anchoring disc 110 than the proximal end of the first conductive connection 134, or the insulating axial section extends throughout the first connector 131.

[0091] In some embodiments, the second connector 132 may be configured to have at least a portion of its axial section surface insulated to achieve an insulated connection between the first conductive connection portion 134 and the first conductive portion 122. For example, the second connector 132 may be configured such that one end is made of insulating material and the other end is made of conductive material. In this case, the conductivity of the portion of the first connector 131 excluding the first conductive connection portion 134 is not limited, and the entire component may be made of conductive material. The anchor portion 113 is constricted within the first connector 131; or at least a portion of the axial section of the first connector 131 near the first conductive connection portion 134 may be surface insulated, while the second connector 132 may also have at least a portion of its axial section surface insulated.

[0092] It is understood that in some other embodiments, any one of the third connectors 133 may be configured to have at least a portion of its axial section surface insulated, so as to achieve an insulated connection between the first connector 131 and the second connector 132, thereby achieving an insulated connection between the first conductive connection portion 134 and the first conductive portion 122.

[0093] Specifically, the first conductive connection 134 and the third connector 133 can be insulated by setting the first connector 131 to have at least a portion of its axial section surface insulated near the end of the first conductive connection 134. Correspondingly, the second connector 132 can also be set to have at least a portion of its axial section surface insulated, or at least a portion of the axial section surface of at least one third connector 133 can be insulated. Even if two or three of the above methods are set simultaneously, insulation between the first conductive connection 134 and the sealing disc 120 can be achieved, thereby achieving electrical isolation between the first conductive connection 134 and the first conductive part 122.

[0094] Depending on the requirements, the structure of the insulating connector 130 can be set as follows: Figure 3 The first connector 131, the second connector 132, and the third connector 133 are integrally combined, or the insulating connector 130 is set as an integral cylindrical structure, with the distal end of the sealing disc 120 converging at the proximal end of the cylindrical structure, and the anchoring disc 110 converging at the distal end of the cylindrical structure. Simultaneously, the first conductive connection portion 134 has an internal thread made of conductive material on its inner surface. In this embodiment, the first connector 131 is made of conductive material, achieving electrical connection between the second conduit 141 and the second conductive portion 114. The second conduit 141 is electrically connected to the first skeleton 111 of the anchoring disc 110 through the first conductive connection portion 134. The third connector 133 is made of insulating material, thereby achieving an insulating connection between the second connector 132 and the first connector 131 and the first conductive connection portion 134. Thus, the second connector 132 can be set as either entirely insulating or entirely conductive as required.

[0095] In this embodiment, an insulating connector 130 has a cavity for the second conduit 141 to pass through, and the cavity extends to the first conductive connection portion 134, so that the second conduit 141 passing through the cavity can be electrically connected to the first conductive connection portion 134. Specifically, the insulating connector 130 in this embodiment includes a first connector 131, a third connector 133, and a second connector 132. The first connector 131, the third connector 133, and the second connector 132 are all cylindrical, and the first connector 131, the second connector 132, and the third connector 133 are sequentially connected to form the cavity. Figure 3 The middle arrow indicates the location of the cavity, and the arrow direction indicates the direction in which the second conduit 141 passes through the cavity during product loading.

[0096] In the insulating connector 130, the two interconnected parts are detachably connected. Specifically, in this embodiment, the first connector 131 and the third connector 133 are detachably connected, and the second connector 132 and the third connector 133 are detachably connected. Optionally, the first connector 131 and the third connector 133 are screwed together, and the second connector 132 and the third connector 133 are screwed together. Specifically, the first connector 131 has a first threaded portion, and the distal end of the third connector 133 has a second threaded portion. The first threaded portion and the second threaded portion are threadedly engaged, thereby achieving a detachable connection between the first connector 131 and the third connector 133. The second connector 132 and the third connector 133 are screwed together. Specifically, the proximal end of the third connector 133 has a third threaded portion, and the second connector 132 has a fourth threaded portion. The third threaded portion and the fourth threaded portion are threadedly engaged.

[0097] Specifically, the third connector 133 includes a large pipe section 1331 and a small pipe section 1332 arranged axially, with the outer diameter of the large pipe section 1331 being larger than the outer diameter of the small pipe section 1332. The first threaded portion is an internal thread on the inner wall near the proximal end of the first connector 131, and the second threaded portion is an external thread on the outer wall of the small pipe section 1332. The third threaded portion is an internal thread on the inner wall of the large pipe section 1331, and the fourth threaded portion is an external thread on the outer wall of the second connector 132. It is understood that in some other embodiments, the third connector 133 may also be a single-section tubular structure with equal diameters at both ends.

[0098] Furthermore, the first connector 131 is provided with a first mounting space 1311, and one end of the anchoring disc 110 extends into the first mounting space 1311, thereby converging within the first mounting space 1311. Specifically, the first connector 131 is provided with two interlocking annular protrusions, forming a receiving groove between the two annular protrusions. The space within the receiving groove serves as the first mounting space 1311, and the first mounting space 1311 is annular. The receiving groove has an opening facing the distal end, and one end of the anchoring disc 110 extends into the first mounting space 1311 through this opening. It is understood that in some other embodiments, the first connector 131 can also be configured to include interlocking inner and outer sleeves, with the annular area formed between the inner and outer sleeves serving as the first mounting space 1311. In this case, one of the inner and outer sleeves can be connected to the second connector 132.

[0099] Furthermore, a second mounting space 1323 is formed on the second connector 132, and the distal end of the sealing disc 120 converges within this second mounting space 1323. Specifically, the second connector 132 includes an inner sleeve 1321 and an outer sleeve 1322 that are nested together, forming the second mounting space 1323, which is annular. One of the inner sleeve 1321 and the outer sleeve 1322 is connected to the third connector 133. In this embodiment, the fourth threaded portion is provided on the outer peripheral wall of the outer sleeve 1322, that is, the outer sleeve 1322 of the second connector 132 is connected to the third connector 133. It is understood that in some other embodiments, the second connector 132 may also be configured as an integral structure with a receiving groove, the space within which is the second mounting space 1323.

[0100] Please refer to Figure 1 and Figure 2In this embodiment, the sealing disc 120 includes the proximal portion of the ablation stent 100, the anchoring disc 110 includes the distal portion of the ablation stent 100, the second conductive portion 114 is a portion of the anchoring disc 110, and the first conductive portion 122 is the entire sealing disc 120. That is, the second conductive portion 114 is at least a portion of the anchoring disc 110, and the first conductive portion 122 is the entire sealing disc 120. It can be understood that the second conductive portion 114 may also be the entire anchoring disc 110.

[0101] Furthermore, in the ablation stent 100, the regions corresponding to the second conductive portion 114 and the first conductive portion 122 are designated as the active regions, while the regions outside the active regions of the ablation stent 100 are designated as insulating regions. It is understood that in some embodiments, at least a portion of the ablation stent 100 in the insulating regions may be made of an insulating material, for example, an insulating biodegradable material.

[0102] Specifically, in this embodiment, the first skeleton 111 and the second skeleton 121 are connected by an insulating connector 130. In this embodiment, the first connector 131 is used to gather the end of the first skeleton 111 in the anchoring disc 110, and the second connector 132 is used to gather the far end of the second skeleton 121 in the sealing disc 120.

[0103] In this embodiment, the first frame 111 is entirely made of metal, with a portion of its surface serving as the second conductive part 114. Specifically, the portion of the first frame 111 that serves as the second conductive part 114 is not insulated, while the remaining surface is insulated. This ensures the surface of this portion is insulated, preventing the conductive area of ​​the second conductive part 114 from becoming too large and affecting the ablation effect. Because the first frame 111 is made of metal, and the first connector 131 is entirely conductive, the second conductive part 114 and the first conductive connection part 134 can be directly electrically connected through the first frame 111.

[0104] It is understood that in some other embodiments, only a portion of the first skeleton 111 may be made of metal, while the rest may be made of insulating material to make the surface of that portion insulated. In this case, additional wires are required to achieve the electrical connection between the first conductive connection portion 134 and the second conductive portion 114.

[0105] Furthermore, the portion of the first skeleton 111 that adheres to the inner wall of the left atrial appendage serves as the second conductive portion 114. The second conductive portion 114 is annular, thus forming a ring-shaped ablation band, which helps improve the ablation effect on the left atrial appendage. The outer periphery of the second conductive portion 114 is covered with a flow-blocking membrane 126. The flow-blocking membrane 126 has pores, allowing it to at least filter thrombi, preventing thrombi from entering the left atrium, while also ensuring that the second conductive portion 114 can release ablation energy to the tissue.

[0106] It should be noted that in this embodiment, a portion of the first skeleton 111 serves as the second conductive part 114, while the remaining portion is surface-insulated. It is understood that in some other embodiments, the entire first skeleton 111 may also serve as the second conductive part 114 to release ablation energy to the tissue.

[0107] Please refer to Figure 1 and Figure 2 For the sealing disc 120, the second frame 121 is made entirely of metal, and the second frame 121 serves as the first conductive part 122. Since the second frame 121 is made of metal, the first conductive part 122 can be electrically connected directly through the second frame 121 without the need for additional wiring.

[0108] It should be noted that, in this embodiment, the portion of the second frame 121 requiring surface insulation is achieved through insulation treatment. In this embodiment, the sealing disk 120 is configured to also include an insulating film 125, which covers the outer peripheral wall of the distal end of the second frame 121. The insulating film 125 can block the distal end of the second frame 121 from the proximal end of the first frame 111. The insulating film 125 is used to isolate the first frame 111 and the second frame 121, preventing the expanded first frame 111 and the second frame 121 from directly contacting each other.

[0109] In this embodiment, the second skeleton 121 is a double-layer mesh disc woven from metal wires, comprising a proximal skeleton and a distal skeleton. The proximal skeleton is located on one side of the proximal end of the distal skeleton, and the proximal skeleton and the distal skeleton are connected at their periphery. Optionally, the axial projection of the sealing disc 120 is trapezoidal to match the anatomical structure of the left atrial appendage inlet, thereby sealing the left atrial appendage inlet with the sealing disc 120.

[0110] It should be noted that in this embodiment, the second skeleton 121 is made of woven metal wire. It is understood that in some other embodiments, the second skeleton 121 can also be made in other ways as needed, such as by cutting pipes.

[0111] Please refer to the reference. Figures 1 to 4In this embodiment, the sealing disc 120 further includes a second conductive connection portion 124. The 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 converges at the second conductive connection portion 124. The second conductive connection portion 124 is used for detachable connection with the first catheter 142. An external signal source is electrically connected to the first conductive portion 122 sequentially through the first catheter 142 and the second conductive connection portion 124. The second conductive connection portion 124 can also be used to transmit tissue physiological signals collected by the sealing disc 120.

[0112] Specifically, the second conductive connection 124 is an annular cylindrical structure with an axially extending through hole inside, through which the second catheter 141 can pass. The first catheter 142 is detachably connected to the second conductive connection 124. Thus, when the ablation stent 100 is released into the left atrial appendage under the action of the delivery device 140, the implantation of the ablation stent 100 is completed, and after ablation, the first catheter 142 can be detached from the second conductive connection 124, thereby leaving the ablation stent 100 in the left atrial appendage and removing the first catheter 142 and the second catheter 141 from the body.

[0113] Optionally, the second conductive connection portion 124 is threadedly connected to the first conduit 142. Specifically, the inner wall of the second conductive connection portion 124 is provided with a sixth threaded portion, thereby achieving a detachable connection between the second conductive connection portion 124 and the first conduit 142 through the threaded connection of the sixth threaded portion and the first conduit 142. It is understood that in some other embodiments, magnetic connection or snap-fit ​​methods can also be used to achieve a detachable connection between the second conductive connection portion 124 and the first conduit 142 as needed.

[0114] Please refer to Figure 1 In this embodiment, the sealing disk 120 further includes a flow-blocking membrane 126 disposed within the second frame 121. Specifically, in this embodiment, the flow-blocking membrane 126 is radially disposed inside the second frame 121. In other embodiments, the flow-blocking membrane 126 may also cover the outer side of the second frame 121. The flow-blocking membrane 126 can at least block the outflow of thrombi from the left atrial appendage, and depending on the porosity of the flow-blocking membrane 126, it can even block the flow of blood from the left atrial appendage into the left ventricle. Specifically, since the second frame 121 of the sealing disk 120 has a mesh structure with multiple mesh openings, the flow-blocking membrane 126 is used to seal the mesh openings, thereby preventing thrombi at the distal end of the flow-blocking membrane 126 from moving proximally, thus preventing thrombi from the left atrial appendage from entering the left ventricle. It should be noted that when the mesh openings on the second frame 121 are small and dense enough, the flow-blocking membrane 126 may not be necessary.

[0115] An anchoring disc 110 has a flow-blocking membrane 126 at its distal end. The flow-blocking membrane 126 is located at the distal end of the first skeleton 111, thereby helping to prevent thrombi at the distal end of the anchoring disc 110 from moving towards the sealing disc 120. Furthermore, the flow-blocking membrane 126 on the anchoring disc 110 has a perforated structure, allowing the second conductive portion 114 to release ablation energy to the inner wall tissue. It should be noted that in some embodiments, the material of the flow-blocking membrane 126 and the material used for insulation can be the same.

[0116] Figure 5 for Figure 2 A schematic diagram of the structure of the first skeleton 111.

[0117] Please refer to the reference. Figure 1 and Figure 5 In this embodiment, the first frame 111 includes a plurality of support portions 112 and a plurality of anchor portions 113, with the plurality of anchor portions 113 arranged around the outer periphery of the plurality of support portions 112.

[0118] Each support portion 112 includes a support rod 1121 and a first branch 1122 and a second branch 1123 disposed at one end of the support rod 1121. The first branch 1122 and the second branch 1123 are both rod-shaped, and the support portion 112 thus formed is roughly Y-shaped.

[0119] Specifically, the support rod 1121 includes opposing first and second ends. The first ends of multiple support rods 1121 are connected to the insulating connector 130, and the second ends of multiple support rods 1121 extend radially outward, gradually moving away from the axis of the anchoring plate 110, forming a trumpet-like shape. A first branch 1122 and a second branch 1123 are connected to the corresponding second ends of the support rod 1121. In this embodiment, the first end is the proximal end of the support rod 1121, and the second end is the distal end of the support rod 1121. It is understood that in alternative embodiments, the first end is not limited to being the proximal end of the support rod 1121, and the second end is not limited to being the distal end of the support rod 1121.

[0120] Each first branch 1122 has its end away from the support rod 1121 connected to the end of the second branch 1123 of the adjacent support portion 112 that is also away from the support rod 1121, forming a first connection point 1124 at the connection. Each anchor portion 113 is connected to the corresponding first connection point 1124 and extends proximally. The first skeleton 111 thus formed is a double-layer structure, with multiple support rods 1121 surrounding to form the inner layer of the first skeleton 111, and multiple anchor portions 113 surrounding to form the outer layer of the first skeleton 111. In the first skeleton 111, the portion of the anchor portion 113 that abuts against the inner wall tissue of the left atrial appendage serves as a second conductive portion 114. The second conductive portion 114 is annular, thereby forming an annular ablation band extending circumferentially along the first skeleton 111 through the second conductive portion 114.

[0121] Optionally, the first frame 111 further includes a connecting ring 118, to which the proximal ends of the plurality of support rods 1121 are connected, thus connecting the proximal ends of the plurality of support rods 1121 together. When the anchoring plate 110 is connected to the insulating connector 130, the connecting ring 118 is housed within the first mounting space 1311, thereby constricting the proximal end of the inner layer of the first frame 111 within the first mounting space 1311. It is understood that in some other embodiments, the connecting ring 118 may not be provided, and the proximal ends of the support rods 1121 may be directly constricted within the first mounting space 1311 to achieve the connection between the anchoring plate 110 and the insulating connector 130. Optionally, the connecting ring 118, the plurality of support parts 112, and the plurality of anchoring parts 113 are integrally formed by cutting tubing.

[0122] Furthermore, the multiple anchoring portions 113 are divided into multiple 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 are connected to form a grid structure. Furthermore, in each group of anchoring portions 113, the connection point of the two anchoring portions 113 bends and extends inward toward the axis of the first skeleton 111, that is, bends inward in a hook shape, thereby reducing the stimulation and damage to the tissue at the end of the anchoring portion 113.

[0123] Furthermore, the anchoring disc 110 also includes barbs 117 disposed radially outward of the first skeleton 111. The distal end of the barb 117 is connected to the anchoring portion 113, and the proximal end of the barb 117 is located radially outward of the first skeleton 111. Specifically, the barb 117 is connected to the anchoring portion 113. When the left atrial appendage occlusion ablation device is implanted into the left atrial appendage, the barb 117 pierces into the left atrial appendage tissue, preventing the anchoring disc 110 from detaching from the inner wall tissue of the left atrial appendage.

[0124] According to the left atrial appendage occlusion ablation device provided in this embodiment, the working principle of the left atrial appendage occlusion ablation device is as follows:

[0125] 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 compressed and housed in the delivery device 140. During use, the ablation stent 100 is delivered and released into the left atrial appendage opening through the delivery device 140. At this time, the anchoring plate 110 of the ablation stent 100 is in an expanded state and anchored in the left atrial appendage, and the barbs 117 of the anchoring plate 110 are inserted into the inner wall tissue of the left atrial appendage. The sealing plate 120 of the ablation stent 100 is in an expanded state and located at the entrance of the left atrial appendage to seal the entrance of the left atrial appendage.

[0126] After implantation, an external energy source sequentially delivers ablation energy to the first conductive part 122 through the first conduit 142 and the second conductive connection 124. Simultaneously, the second conduit 141 delivers ablation energy to the second conductive part 114 through the first conductive connection 134. The ablation energy of the second conductive part 114 and the first conductive part 122 are different. For example, if the second conductive part 114 is electrically connected to the positive terminal of the external signal source, then the first conductive part 122 is electrically connected to the negative terminal of the external signal source; conversely, if the second conductive part 114 is electrically connected to the negative terminal, then the first conductive part 122 is electrically connected to the positive terminal. This creates an electric field between the second conductive part 114 and the first conductive part 122 to achieve ablation, resulting in a good ablation effect. After ablation is completed, the first conductive connection 134 is disconnected from the second catheter 141, and the second conductive connection 124 is disconnected from the first catheter 142, thereby removing the second catheter 141 and the first catheter 142 from the body, leaving the left atrial appendage occlusion ablation device in the patient's body.

[0127] The left atrial appendage occlusion ablation device provided in this embodiment has at least the following advantages:

[0128] The left atrial appendage occlusion ablation device provided in this embodiment utilizes an anchoring disc 110 released within the left atrial appendage. The anchoring disc 110 anchors to the inner wall of the left atrial appendage tissue. A sealing disc 120 is released at the entrance of the left atrial appendage, sealing the entrance and thus fixing the entire device in place. Simultaneously, the sealing disc 120 is electrically conductive and used to transmit ablation energy, ablating the tissue at the entrance and within the left atrial appendage, significantly improving the ablation effect. The sealing disc, as the first conductive part, can also be used to collect tissue physiological signals for mapping. Furthermore, this left atrial appendage occlusion ablation device combines ablation and occlusion, simplifying the procedure of a one-stop "ablation + left atrial appendage occlusion" treatment and helping to reduce surgical difficulty.

[0129] Example 2

[0130] Figure 6 This is a schematic diagram of the structure of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

[0131] Please refer to Figure 6 and combined Figure 3 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0132] In this embodiment, the interconnected parts in the insulating connector 130 are interference-fitted, thereby allowing the interconnected parts in the insulating connector 130 to be detachably connected. Specifically, the first connector 131 and the third connector 133 are interference-fitted, and the third connector 133 and the second connector 132 are interference-fitted. It is understood that in some other embodiments, the connection method between the first connector 131 and the third connector 133 may be different from the connection method between the third connector 133 and the second connector 132.

[0133] Specifically, the inner peripheral wall of the proximal end of the first connector 131 is press-fitted with the outer peripheral wall of the small pipe section 1332 of the third connector 133. The inner peripheral wall of the large pipe section 1331 of the third connector 133 is press-fitted with the outer peripheral wall of the outer sleeve 1322 of the second connector 132.

[0134] Example 3

[0135] Figure 7 This is a schematic diagram of the structure of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

[0136] Please refer to Figure 7 and combined Figure 3 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0137] In this embodiment, the interconnected parts in the insulating connector 130 are snapped together, thereby allowing the interconnected parts in the insulating connector 130 to be detachably connected. That is, the first connector 131 is snapped together with the third connector 133, and the third connector 133 is snapped together with the second connector 132.

[0138] Specifically, the first connector 131 has a snap-fit ​​groove, and the third connector 133 has a snap-fit ​​wedge on its distal outer side. The snap-fit ​​groove and the snap-fit ​​wedge engage to achieve snap-fit ​​between the first connector 131 and the third connector 133, thus stopping them in the axial direction. The third connector 133 has a snap-fit ​​groove on its proximal inner side, and the second connector 132 has a snap-fit ​​wedge on its outer side. The snap-fit ​​groove of the third connector 133 engages with the snap-fit ​​wedge of the second connector 132, thus stopping them in the axial direction.

[0139] It should be noted that the specific structure of the snap-fit ​​is not limited here. It is understood that in some other embodiments, other structures can also be used to achieve the snap-fit ​​between the interconnected parts in the insulating connector 130 as needed.

[0140] Example 4

[0141] Figure 8 This is a schematic diagram of the structure of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

[0142] Please refer to Figure 8 and combined Figure 3 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0143] In this embodiment, the interconnected parts in the insulating connector 130 are pivotally connected, that is, the first connector 131 is pivotally connected to the third connector 133, and the third connector 133 is pivotally connected to the second connector 132. Thus, the first connector 131 can rotate about the axial direction relative to the third connector 133, and the second connector 132 can rotate about the axial direction relative to the third connector 133.

[0144] Specifically, the third connector 133 has pivot grooves at its proximal and distal ends. The first connector 131 has a first pivot joint at its proximal end, which pivots with the pivot groove at the distal end of the third connector 133, thus achieving pivot connection between the first connector 131 and the third connector 133. The second connector 132 has a second pivot joint at its distal end, which pivots with the pivot groove at the proximal end of the third connector 133, thus achieving pivot connection between the third connector 133 and the second connector 132.

[0145] It should be noted that each of the insulating connectors 130 has a through hole at its axis, through which the second conduit 141 can pass.

[0146] Example 5

[0147] Figure 9 This is a schematic diagram of the structure of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment. Figure 10 for Figure 9 A schematic diagram of the structure of the insulating connector 130 of the left atrial appendage occlusion ablation device during tensile and torsional movements.

[0148] Please refer to Figure 9 and Figure 10 and combined Figure 3 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0149] In this embodiment, the interconnected parts in the insulating connector 130 are flexibly connected, such that the first connector 131 and the third connector 133 are flexibly connected, and the third connector 133 and the second connector 132 are flexibly connected.

[0150] Specifically, the third connector 133 is a flexible rubber structure. A first connector head is located at the proximal end of the first connector 131, and a second connector head is located at the distal end of the second connector 132. The third connector 133 is vulcanized and formed between the first and second connector heads, with the distal end of the third connector 133 covering the first connector head and the proximal end of the third connector 133 covering the second connector head. Thus, the anchoring disc 110 connected to the first connector 131 and the sealing disc 120 connected to the second connector 132 can move in relative tension and torsion (e.g., ...). Figure 10 (As shown).

[0151] It should be noted that each of the insulating connectors 130 has a through hole at its axis, through which the second conduit 141 can pass.

[0152] It should also be noted that in this embodiment, the third connector 133 is directly formed on the first connector and the second connector by vulcanization. The connection between the third connector 133 and the first connector 131 and the second connector 132 is non-detachable. It is understood that in some other embodiments, other methods can be used to achieve flexible and detachable connection between the parts as needed.

[0153] Example 6

[0154] Figure 11 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 12 for Figure 11 A schematic diagram of the cross-sectional structure of the left atrial appendage occlusion ablation device after removing the flow-blocking membrane 126 and the insulating membrane 125.

[0155] Please refer to Figure 11 and Figure 12 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the formation method of the second conductive part 114 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0156] In this embodiment, the second conductive part 114 is an electrode element disposed on the first frame 111. Specifically, the anchoring plate 110 also includes a first electrode element 116 disposed on the first frame 111, thereby using the first electrode element 116 as the second conductive part 114. The anchoring plate 110 can be configured to have only the surface of the portion of the first frame 111 that is not in contact with the first electrode element 116 insulated, or it can be configured to have the entire surface of the first frame 111 insulated, or it can be configured to have the entire first frame 111 conductive.

[0157] In this embodiment, a flow-blocking membrane 126 is provided on the anchoring plate 110, and the first electrode 116 is located outside the flow-blocking membrane 126, that is, the flow-blocking membrane 126 is disposed between the first electrode 116 and the first frame 111. The portion of the first frame 111 that contacts the first electrode 116 can be regarded as the projection portion of the first electrode 116 on the anchoring part 113. Figure 12 As shown, when the flow-blocking membrane 126 is omitted from the anchoring plate 110, the part where the first frame 111 intersects with the first electrode 116 is the part where the first frame 111 contacts the first electrode 116. Correspondingly, the part of the first frame 111 that does not intersect with the first electrode 116 is the part of the first frame 111 that does not contact the first electrode 116.

[0158] The second conductive part 114 extends circumferentially along the left atrial appendage ablation device. In this embodiment, the first electrode 116 extends circumferentially along the first skeleton 111. The first electrode 116, which is disposed on the outer periphery of the first skeleton 111, extends a certain range in the axial direction of the first skeleton 111, thereby forming a strip-shaped ablation area formed by the first electrode 116 extending along the axial direction of the first skeleton 111.

[0159] Specifically, the first electrode 116 is a serrated structure formed by bending a conductive wire. It is understood that in some other embodiments, the first electrode 116 may also be configured with other bent and extended shapes, such as a wavy shape.

[0160] Optionally, the first electrode 116 is an electrode wire or a strip-shaped electrode sheet. It is understood that the type of the first electrode 116 can also be selected according to requirements, such as a rod-shaped electrode, an array of ring electrodes, or a ring-shaped ablation conduit. Optionally, the first electrode 116 extends to the first conductive connection portion 134 and is connected to the first conductive connection portion 134 by welding, thereby achieving an electrical connection between the first electrode 116 and the first conductive connection portion 134.

[0161] In this embodiment, the first electrode 116 is electrically connected to the first skeleton 111 in the action area, and pores may be provided in the flow-blocking membrane 126 between them to ensure electrical conductivity. In one embodiment, if the surface of the first connector 131 is insulated and / or the surface of the first skeleton 111 is insulated, the first electrode 116 extends to the first conductive connection portion 134, or is connected to the first conductive connection portion 134 via a wire to transmit ablation energy.

[0162] It should be noted that the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment is the insulating connector 130 structure provided in Embodiment 1. It can be understood that it can also adopt the insulating connector 130 structure provided in Embodiments 2-6.

[0163] Example 7

[0164] Figure 13 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

[0165] Please refer to Figure 13 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0166] In this embodiment, the first conductive connection portion 134 is detachably disposed on the first connector 131. The first conductive connection portion 134 is cylindrical and has an axially extending through hole inside. The first conductive connection portion 134 is made entirely of conductive material and is used for conductive connection with the second conductive portion 114 on the first frame 111.

[0167] In some embodiments, the first connector 131 and the third connector 133 are made entirely of insulating material, while the second connector 132 is not limited, thereby achieving electrical isolation between the first conductive connection portion 134 and the sealing disk 120. Since the first connector 131 and the third connector 133 are entirely insulated, the insulation distance between the first conductive connection portion 134 and the sealing disk 120 can be increased, thereby improving the insulation distance and insulation performance between the second conductive portion 114 on the anchoring disk 110 and the sealing disk 120.

[0168] It should be noted that the second conduit 141 can be connected to the first conductive connection part 134 and electrically connected, and then electrically connected to the second conductive part 114, or electrically connected to the first electrode 116 through the first conductive connection part 134.

[0169] In some other embodiments, the first connector 131 and the second connector 132 are entirely made of conductive material, and the third connector 133 is at least surface-insulated to achieve an insulated connection between the first connector 131 and the second connector 132, thereby achieving electrical isolation between the first conductive connection portion 134 and the sealing disk 120. In this embodiment, the third connector 133 is entirely made of insulating material. It is understood that an insulated connection between the second connector 132 and the first conductive connection portion 134 can also be achieved in other ways.

[0170] Example 8

[0171] Figure 14 A schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment is shown. For clarity, Figure 14 The membrane structures, such as the flow-blocking membrane 126 and the insulating membrane 125, of the left atrial appendage occlusion ablation device are omitted from the text.

[0172] Please refer to Figure 14 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the insulating connector 130 compared to the left atrial appendage occlusion ablation device provided in Embodiment 1. The insulating connector 130 provided in this embodiment is suitable for embodiments where the first electrode 116 is used as the second conductive part 114, or embodiments where the first electrode 116 is used as a third conductive part independent of the second conductive part 114.

[0173] In this embodiment, the insulating connector 130 further includes a fourth connector 135 disposed between the first connector 131 and the first conductive connection portion 134. The fourth connector 135 is detachably disposed on the first connector 131. The first conductive connection portion 134 is detachably disposed on the fourth connector 135. That is, the fourth connector 135 is sandwiched between the first connector 131 and the first conductive connection portion 134.

[0174] The first connector 131 is used to secure the first skeleton 111, and the second connector 132 is used to secure the second skeleton 121. The first connector 131 and the second connector 132 are made of conductive metal material, which can secure the skeleton more firmly and is beneficial to improving the mechanical properties of the sealing disc 120 and the anchoring disc 110.

[0175] The third connector 133 is insulated as a whole and is used to electrically isolate the sealing disc 120 from the anchoring disc 110.

[0176] The first conductive connection portion 134 is electrically conductive and is used to make an electrical connection with the first electrode 116 disposed around the anchor plate 110. The first electrode 116 extends directly to the first conductive connection portion 134, or is connected to the first conductive connection portion 134 by providing an additional wire.

[0177] The fourth connector 135 is insulated as a whole and is used to electrically isolate the first connector 131 at both ends from the first conductive connection portion 134, so that the first skeleton 111 in the anchoring plate 110 is electrically isolated from the first conductive connection portion 134 and the first electrode 116.

[0178] Please refer to Figure 14 and combined Figure 4 In some embodiments, when only the first electrode 116 is conductive, the first frame 111 can be insulated. In this case, the first electrode 116 acts as the second conductive part 114 for ablation. The second conduit 141 can be directly connected to the first conductive connection part 134 and electrically connected, and then electrically connected to the first electrode 116 through the first conductive connection part 134. Because the first electrode 116 is located on the outer periphery or distal end of the first frame 111, the distance between the second conductive part 114 and the sealing disk 120 can be increased, that is, the distance between the conductive part on the anchoring disk 110 and the sealing disk 120 can be increased, thereby improving the insulation performance between the first conductive part 122 and the second conductive part 114.

[0179] Please refer to Figure 14 and combined Figure 4 In some other embodiments, when both the first electrode 116 and the first frame 111 are conductive, the entirety or part of the first frame 111 serves as the second conductive part 114, the first electrode 116 serves as the third conductive part, and can be electrically isolated from the second conductive part 114.

[0180] At this time, the first connector 131, the second connector 132, and the first conductive connection 134 are electrically conductive, while the third connector 133 and the fourth connector 135 are electrically insulated. The third connector 133 electrically isolates the first connector 131 and the second connector 132, and the fourth connector 135 electrically isolates the first connector 131 and the first conductive connection 134. Simultaneously, the delivery device 140 also includes a third conduit passing through the second conduit 141. The third conduit is movably inserted within the second conduit 141 and is axially movable relative to the second conduit 141. The first conduit 142 is connected to and electrically conductively connected to the second conductive connection 124, thereby providing ablation energy to the first conductive part 122. The second conduit 141 is connected to and electrically conductively connected to the first connector 131, thereby providing ablation energy to the second conductive part 114. The third conduit is connected to and electrically conductively connected to the first conductive connection 134, thereby providing ablation energy to the first electrode 116 (i.e., the third conductive part).

[0181] The second conductive part 114, the first conductive part 122, and the third conductive part can be electrically isolated from each other, thereby achieving ablation simultaneously and resulting in a good ablation effect. In some embodiments, in the direction from the proximal end to the distal end, the first conductive part 122, the second conductive part 114, and the third conductive part can be sequentially and alternately connected to the positive and negative signal source output terminals, thereby forming two electric fields between the first conductive part 122 and the second conductive part 114, and between the second conductive part 114 and the third conductive part to achieve ablation, thereby improving the ablation effect.

[0182] In some other embodiments, the second conductive part 114, the first conductive part 122 and the third conductive part may also transmit electrical ablation signals of the same polarity.

[0183] Example 9

[0184] Figure 15 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 16 for Figure 15 A schematic diagram of the structure of a left atrial appendage occlusion ablation device after removing the covering membrane (such as a flow-blocking membrane).

[0185] Please refer to Figure 15 and Figure 16 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the anchoring plate 110 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0186] In this embodiment, the first skeleton 111 of the anchoring disc 110 is made of woven metal wire, and the distal ends of the first skeleton 111 are radially converged and connected together, thereby making the first skeleton 111 cage-like. Specifically, the anchoring disc 110 also includes a distal connector 119, which is disposed at the distal end of the anchoring disc 110. The distal ends of the metal wires woven to form the first skeleton 111 are radially converged and connected to the distal connector 119, and the distal connector 119 is located inside the cage-like structure formed by the metal wires.

[0187] Meanwhile, in the left atrial appendage occlusion ablation device shown in this embodiment, a first electrode 116 is provided on the anchoring plate 110, which serves as the second conductive part 114 for transmitting ablation energy. In some other embodiments, part or all of the first frame 111 may be used as the second conductive part 114, and the first electrode 116 may serve as a third conductive part electrically isolated from the second conductive part 114.

[0188] Example 10

[0189] Figure 17 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 18 for Figure 17A schematic diagram of the structure of a left atrial appendage occlusion ablation device after removing the covering membrane (such as a flow-blocking membrane).

[0190] Please refer to Figure 17 and Figure 18 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is that the anchoring plate 110 and the sealing plate 120 have different structures compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0191] In this embodiment, the first skeleton 111 of the anchoring disc 110 is made of woven metal wire, and the woven first skeleton 111 has two layers, inner and outer. Specifically, the metal wire extends from the proximal end to the distal end of the anchoring disc 110 to form the inner layer of the first skeleton 111, and then folds back from the distal end to the proximal end to form the outer layer of the first skeleton 111.

[0192] In this embodiment, the second skeleton 121 of the sealing disc 120 is a structure woven from metal wire, and the sealing disc 120 includes a disc surface 127 facing away from the anchoring disc 110, a disc bottom 128 facing the anchoring disc 110, and a waist portion 129 connecting the disc surface 127 and the disc bottom 128. The diameter of the disc surface 127 is larger than the diameter of the disc bottom 128, and the diameter of the disc surface 127 is slightly larger than the inner diameter of the left atrial appendage. After implantation, the disc surface 127 presses against the outlet of the left atrial appendage, and the disc bottom 128 is inserted into the left atrial appendage, with the diameter of the disc bottom 128 being approximately the same as the inner diameter of the left atrial appendage.

[0193] Meanwhile, in the left atrial appendage occlusion ablation device shown in this embodiment, the second conductive part 114 on the anchoring plate 110 is part of the first skeleton 111. It can be understood that, depending on the requirements, a specific skeleton can be selected or additional electrode components can be added. The second skeleton 121 of the sealing plate 120 serves as the first conductive part 122.

[0194] Example 11

[0195] Figure 19 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 20 for Figure 19 A schematic diagram of the structure of a left atrial appendage occlusion ablation device after removing the covering membrane (such as a flow-blocking membrane).

[0196] Please refer to Figure 19 and Figure 20 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the anchoring plate 110 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0197] In this embodiment, the first frame 111 of the anchoring disc 110 is made of woven metal wire. In the first embodiment, the first frame 111 of the anchoring disc 110 is made of cut tubing. The first frame 111 and the second frame 121 in this application are not limited in manufacturing process. The first frame 111 can be woven or cut, and the second frame 121 can also be woven or cut.

[0198] like Figures 19-20 As shown, the distal end of the first skeleton 111 is open, that is, the distal end of the first skeleton 111 has an opening, so that the shape of the first skeleton 111 is cup-shaped.

[0199] Meanwhile, in the left atrial appendage occlusion ablation device shown in this embodiment, the anchoring plate 110 can use part or all of the first skeleton 111 as the second conductive part 114 as required, or it can use the external first electrode 116 as the second conductive part 114.

[0200] Example 12

[0201] Figure 21 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment after the covering membrane has been removed. Figure 22 for Figure 21 A schematic diagram of the structure of the first skeleton 111 in the left atrial appendage occlusion ablation device.

[0202] Please refer to Figure 21 and Figure 22 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the structure of the anchoring plate 110 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0203] In this embodiment, the anchoring disc 110 is made of tubular material. Unlike the first frame 111 in the previous embodiment, in this embodiment, the two adjacent anchoring portions 113 of the first frame 111 are independently provided, that is, neither of its anchoring portions 113 is directly connected to the other anchoring portions 113. The anchoring portion 113 extends proximally in a rod shape, and the end of the anchoring portion 113 away from the first connection point 1124 is bent inward.

[0204] Similarly, the second conductive part 114 in the left atrial appendage occlusion ablation device provided in this embodiment can also be made into a skeleton or additional electrode components as needed.

[0205] Example 13

[0206] Figure 23 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

[0207] Please refer to Figure 23This embodiment also provides a left atrial appendage occlusion ablation device, which differs from the left atrial appendage occlusion ablation device provided in Embodiment 1 in that the structure of the anchoring plate 110 is different. Specifically, the structure of the anchoring part 113 is different from that in Embodiment 1.

[0208] In this embodiment, the anchoring disc 110 is made of tubing, and each anchoring portion 113 includes a third branch 1132 and a fourth branch 1133 connected at their distal ends. The connection between the third branch 1132 and the fourth branch 1133 forms a second connection point 1134, which is connected to the first connection point 1124. Simultaneously, the proximal end of each third branch 1132 is connected to the proximal end of the fourth branch 1133 of the adjacent anchoring portion 113, thus forming a grid structure between adjacent anchoring portions 113.

[0209] Furthermore, the anchoring part 113 also includes a connecting rod 1131, the two ends of which are connected to the first connection point 1124 and the second connection point 1134 respectively, so that the grid formed between two adjacent anchoring parts 113 is hexagonal. Barbs 117 are provided on the connecting rod 1131.

[0210] The electrode wires on the first branch 1122 and the second branch 1123 serve as the first electrode element 116. Specifically, a portion of the electrode wire is spirally wound around the first branch 1122 in a circumferential direction. Another portion of the electrode wire is spirally wound around the second branch 1123 in a circumferential direction. This first electrode element 116 can serve as the second conductive part 114. It is understood that in some other embodiments, other types of second conductive parts 114 may also be used, such as the structure of the second conductive part 114 provided in Embodiment 1 or Embodiment 7.

[0211] Example 14

[0212] Figure 24 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in this embodiment. Figure 25 for Figure 24 A schematic diagram of the left atrial appendage occlusion ablation device after the covering membrane has been removed.

[0213] Please refer to Figure 24 and Figure 25 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is that the structure of the ablation stent 100 is different from that of the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0214] In this embodiment, the ablation stent 100 has a three-disc structure, with the second conductive part 114 and the first conductive part 122 respectively disposed on any two of the three discs. The second conductive part 114 can be selected from a frame or additionally equipped with electrodes, depending on requirements.

[0215] Similarly, the left atrial appendage occlusion ablation device provided in this embodiment can also adopt the relevant structure in other embodiments. Specifically, the three discs of the ablation stent 100 are arranged sequentially from distal to proximal as a first disc 161, a second disc 162, and a third disc 163.

[0216] In some embodiments, the first tray 161 and the second tray 162 are connected and electrically isolated by an insulating connector 130, which may also be replaced by an insulating frame. In this case, whether the second tray 162 and the third tray 163 are electrically isolated is not limited.

[0217] In some embodiments, the second disk 162 and the third disk 163 are connected and electrically isolated by another insulating connector 130, which may also be replaced by an insulating frame. In this case, whether the first disk 161 and the second disk 162 are electrically isolated is not limited.

[0218] In some embodiments, the first disk 161 and the second disk 162 are connected and electrically isolated by an insulating connector 130, while the second disk 162 and the third disk 163 are connected and electrically isolated by another insulating connector 130. The insulating connector 130 can also be replaced by an insulating frame. In some embodiments, the third disk 163 can serve as a sealing disk 120, and both the second disk 162 and the first disk 161 can serve as anchoring disks 110. The third disk 163 is electrically conductive as a first conductive part 122. The second conductive part 114 can be provided on either the second disk 162 or the first disk 161.

[0219] like Figure 24 and Figure 25 As shown, in this embodiment, the first electrode 116 is disposed on the first disk 161 as the second conductive part 114, and the second electrode 123 is disposed on the second disk 162 as the third conductive part. It is understood that only the first electrode 116 may be disposed, without the second electrode 123.

[0220] When the first electrode 116 is disposed on the first disk 161 as the second conductive part 114, it is permissible to only insulate between the first disk 161 and the second disk 162, while it is not limited whether the second disk 162 and the third disk 163 are electrically isolated. Alternatively, it is permissible to only insulate between the second disk 162 and the third disk 163, while it is not limited whether the first disk 161 and the second disk 162 are electrically isolated. Alternatively, the second disk 162 is made of insulating material, and it is not limited whether the first disk 161 and the second disk 162 are electrically isolated, nor is it limited whether the second disk 162 and the third disk 163 are electrically isolated.

[0221] In this embodiment, the first disc 161 is used to anchor inside the left atrial appendage, the third disc 163 serves as a sealing disc 120 to block the opening of the left atrial appendage, and the second disc 162 is located near the opening of the left atrial appendage.

[0222] Example 15

[0223] Figure 26 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 15 of the present invention;

[0224] Figure 27 for Figure 26 Structural diagram of the moving part 150. Figure 27 The middle part is a schematic diagram of the first structure of the movable part 150.

[0225] Please refer to Figure 26 and Figure 27 This embodiment also provides a left atrial appendage occlusion ablation device, which differs from the left atrial appendage occlusion ablation device provided in Embodiment 1 in that it adds a movable component 150. This movable component 150 is used to transmit ablation energy or collect tissue physiological signals, and it can be relatively movably disposed on the sealing plate 120 and the anchoring plate 110. After the tissue ablation is completed, the movable component 150 can be separated from the sealing plate 120 and the anchoring plate 110 and withdrawn from the body, leaving only the sealing plate 120 and the anchoring plate 110 inside the body.

[0226] In this embodiment, the left atrial appendage occlusion ablation device includes a sealing disc 120, an anchoring disc 110, and a movable component 150 movably disposed on the anchoring disc 110.

[0227] In some embodiments, the sealing disc 120 and the anchoring disc 110 are connected by an insulating connector 130. The proximal end of the movable member 150 movably passes through a cavity within the insulating connector 130. The distal end of the movable member 150 is movably disposed at the distal end or outer periphery of the anchoring disc 110. It is understood that the insulating connector 130 may also be replaced by an insulating frame.

[0228] In some embodiments, the movable member 150 and the anchoring plate 110 are insulated, so whether the sealing plate 120 and the anchoring plate 110 are insulated is not limited.

[0229] The movable element 150 may be made wholly or partially of a conductive material. In some embodiments, the movable element 150 may be movably disposed as a second conductive part 114 at the distal end or outer periphery of the anchoring plate 110. In this case, the second conduit 141 may be connected to and electrically connected to the movable element 150 to provide ablation energy to the movable element 150.

[0230] In other embodiments, the movable member 150 may also be movably disposed at the distal end or outer periphery of the anchoring plate 110 as a third conductive member independent of the second conductive member 114. The second conductive member 114 may be part or all of the first frame 111 of the anchoring plate 110, or it may be a first electrode member 116 independent of the first frame 111. In this case, the second conduit 141 may be electrically connected to the second conductive member 114 to provide ablation energy to the second conductive member 114; the third conduit is inserted into 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 member).

[0231] Please refer to Figure 27 In this embodiment, the movable member 150 is a mesh structure, and its distal end is radially expandable. When the movable member 150 is released at the distal end of the anchoring plate 110, the movable member 150 expands radially.

[0232] The movable part 150 can be an ablation disc made of woven metal wire or cut from metal tubing. The ablation disc has a converging portion 1501 at its proximal end. The ablation disc has a double-layer mesh structure, that is, both the proximal and distal ends of the ablation disc are provided with a mesh structure that extends radially.

[0233] Figure 28 for Figure 26 A schematic diagram of the second structure of the moving part 150.

[0234] Please refer to Figure 28 In this embodiment, the movable element 150 and Figure 27 The structure of the movable component 150 differs in this embodiment. In this embodiment, the movable component 150 includes a first part 1511, a second part 1512, and a third part 1513 connected radially in sequence. The first part 1511 is used to connect a wire, thereby electrically connecting it to an external ablation signal source. The second part 1512 extends radially outward from the first part 1511. The third part 1513 is bent from the outer end of the second part 1512 and extends radially inward.

[0235] It is understandable that the third part 1513 can be bent upwards or downwards from the outer end of the second part 1512.

[0236] Figure 29 for Figure 26 A schematic diagram of the third structure of the moving part 150.

[0237] Please refer to Figure 29 In this embodiment, the movable element 150 and Figure 27 The structure of the movable component 150 differs from that in this embodiment. In this embodiment, the movable component 150 has an overall umbrella-shaped structure and can extend and retract radially. The movable component 150 can be made by cutting metal tubing.

[0238] Specifically, the movable component 150 includes a plurality of first support rods 1521 and a plurality of second support rods 1522. The plurality of first support rods 1521 extend radially outward, and the distance between adjacent first support rods 1521 gradually increases in the radially outward direction. The plurality of first support rods 1521 form a support structure that gradually expands radially outward from proximal to distal end. The plurality of second support rods 1522 are disposed around the outer periphery of the plurality of first support rods 1521 and gradually bend and extend from distal to proximal end. The distal end of the second support rod 1522 is connected to the outer end of the first support rod 1521. The plurality of second support rods 1522 can also be used to anchor the inner wall tissue of the left atrial appendage.

[0239] like Figure 29 In the illustrated embodiment, the movable component 150 further includes a plurality of first connecting rods 1523 and second connecting rods 1524 connected between the first support rod 1521 and the second support rod 1522. The end of each first support rod 1521 remote from the axis of the movable component 150 is connected to a first connecting rod 1523 and a second connecting rod 1524, forming a Y-shaped structure. The end of the first connecting rod 1523 remote from the first support rod 1521 is connected to the end of an adjacent second connecting rod 1524 remote from the first support rod 1521, forming a third connection point 1525. The distal end of the second support rod 1522 is connected to the third connection point 1525. The proximal end of the second support rod 1522 is bent radially inward and gradually hooked back towards the distal end to prevent the second support rod 1522 from piercing the inner wall tissue of the left atrial appendage, thus reducing damage to the tissue.

[0240] The movable component 150 has an overall umbrella-shaped structure for easy release and retrieval. At the end of ablation, the movable component 150 can be pulled proximally through the second conduit 141 in the delivery device 140 and retracted into the first conduit 142. Alternatively, the movable component 150 can be pulled proximally through the third conduit and retracted into the second conduit 141.

[0241] Figure 30 for Figure 26 A schematic diagram of the fourth structure of the moving part 150.

[0242] Please refer to Figure 30In this embodiment, the movable element 150 and Figure 27 The structure of the movable component 150 differs from that in this embodiment. In this embodiment, the movable component 150 is generally tubular. Specifically, the movable component 150 includes a tube body 153 and a plurality of tube electrodes 154 spaced apart on the tube body 153.

[0243] The tube body 153 includes, from the proximal end to the distal end, a central segment 1531, an extension segment 1532, and an annular segment 1533 connected in sequence.

[0244] The core segment 1531 is used to connect the ablation signal source. When the movable member 150 is used as the second conductive part 114, the core segment 1531 is detachably connected to the second conduit 141 or integrally connected. When the movable member 150 is used as a third conductive part independent of the second conductive part 114, the core segment 1531 is detachably connected to the third conduit or integrally connected, and is movably inserted into the second conduit 141.

[0245] The extension segment 1532 extends radially outward from the distal end of the axial segment 1531.

[0246] The annular segment 1533 extends in a ring shape around the axial segment 1531 from the end of the epitaxial segment 1532 away from the axial segment 1531. A plurality of tube electrodes 154 are arranged at intervals on the epitaxial segment 1532 and the annular segment 1533.

[0247] In some embodiments, among the plurality of tube electrodes 154, adjacent tube electrodes 154 may be connected to the same ablation signal; or they may be connected to different ablation signals, such as alternating positive and negative ablation signal sources in sequence.

[0248] In other embodiments, the movable element 150 can also be used to acquire electrophysiological signals inside the left atrial appendage, and correspondingly, the tube electrode 154 can be used for mapping.

[0249] Figure 31 for Figure 26 A schematic diagram of the fifth structure of the moving part 150.

[0250] Please refer to Figure 31 In this embodiment, the movable element 150 and Figure 30 The structures of the movable parts 150 are generally the same, with the main difference being the structure of the annular segment 1533. In this embodiment, the annular segment 1533 is spirally wound around the circumference of the central axis segment 1531. It can be a planar spiral structure around the central axis segment 1531, or it can gradually spiral around the central axis segment 1531 in a columnar or conical shape.

[0251] Example 16

[0252] Figure 32This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 16 of the present invention.

[0253] Please see Figure 32 and combined Figure 19 and Figure 20 This embodiment also provides a left atrial appendage occlusion ablation device, the main difference of which is the addition of a movable part 150 compared with the left atrial appendage occlusion ablation device provided in Embodiment 1.

[0254] In some embodiments, the sealing disc 120 and the anchoring disc 110 are connected by an insulating connector 130. The proximal end of the movable member 150 movably passes through a cavity within the insulating connector 130. The distal end of the movable member 150 is movably disposed at the distal end or outer periphery of the anchoring disc 110. It is understood that the insulating connector 130 may also be replaced by an insulating frame.

[0255] In some embodiments, the movable member 150 and the anchoring plate 110 are insulated, so whether the sealing plate 120 and the anchoring plate 110 are insulated is not limited.

[0256] In this embodiment, the distal end of the movable member 150 is movably arranged inside or at the distal end of the anchoring plate 110.

[0257] The anchor plate 110 has a distal opening in the first frame 111. The movable member 150 can move back and forth between the interior and the exterior of the distal end of the first frame 111 through this opening.

[0258] In some embodiments, the movable member 150 is made wholly or partially of a conductive material. The movable member 150 may be movably disposed inside or at the distal end of the anchoring disk 110 as a second conductive part 114. In this case, the second conductive part 114 and the first conductive part 122 (i.e., the sealing disk 120) undergo ablation together.

[0259] In other embodiments, the second conductive portion 114 may be part or all of the first skeleton 111, while the movable member 150 serves as a third conductive portion independent of the second conductive portion 114 and is electrically isolated from it. In this case, the second conductive portion 114, the first conductive portion 122, and the third conductive portion together undergo ablation.

[0260] It is understood that the movable part 150 in this embodiment can be adopted. Figures 27 to 31 The structure of any one of the moving parts 150.

[0261] Example 17

[0262] Figure 33 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 17 of the present invention.

[0263] Please see Figure 33 and combined Figure 32 This embodiment also provides a left atrial appendage occlusion ablation device, which has a structure that is roughly the same as the left atrial appendage occlusion ablation device provided in Embodiment 16, with the main difference being the addition of a first electrode 116.

[0264] In this embodiment, the first electrode 116 is electrically isolated from the movable member 150, that is, the first electrode 116 and the movable member 150 are insulated from each other, specifically referring to the aforementioned insulation treatment method. The first electrode 116 and the movable member 150 can respectively serve as the second conductive part 114 and the third conductive part, and cooperate with the first conductive part 122 to perform ablation.

[0265] Example 18

[0266] Figure 34 This is a schematic diagram of the left atrial appendage occlusion ablation device provided in Embodiment 18 of the present invention.

[0267] Please see Figure 34 and combined Figure 26 This embodiment also provides a left atrial appendage occlusion ablation device, which has a structure that is roughly the same as the left atrial appendage occlusion ablation device provided in Embodiment 15. The main difference is that an electrode wire is added as the first electrode 116.

[0268] In this embodiment, the electrode wire is wound around the first skeleton 111 to form the first electrode 116. The first electrode 116 formed by winding the electrode wire can serve as the second conductive part 114.

[0269] The movable part 150 may be made wholly or partially of a conductive material. The movable part 150 may serve as a third conductive part and be ablated together with the second conductive part 114.

[0270] It should be noted that the specific technical solutions in the above embodiments of this application are applicable to each other.

[0271] Although the invention has been described with reference to several typical embodiments, it should be understood that the terminology used is illustrative and exemplary, and not restrictive. Since the invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims. Therefore, all variations and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. A left atrial appendage occlusion ablation device, characterized in that, include: Anchor plate, which is a radially expandable support structure; as well as A sealing disc, which is a radially expandable support structure, is located near the anchoring disc; the sealing disc is made of conductive material, and the sealing disc as a whole serves as a first conductive part for transmitting ablation energy; The left atrial appendage occlusion ablation device further includes a second conductive part disposed on the anchoring plate; the sealing plate is electrically isolated from the second conductive part; the first conductive part and the second conductive part are used to transmit ablation energy of different polarities. The left atrial appendage occlusion ablation device further includes an insulating connector disposed between the anchoring plate and the sealing plate; the insulating connector extends axially, with its distal end connected to the anchoring plate and its proximal end connected to the sealing plate; the insulating connector is used to electrically isolate the second conductive part from the sealing plate. The distal end of the insulating connector is provided with a first conductive connection portion, which is electrically connected to a second conductive portion; there is at least a partial axial section of insulation between the first conductive connection portion and the sealing disc on the insulating connector, so as to electrically isolate the first conductive connection portion from the sealing disc; The sealing disc has a second conductive connection portion formed at its proximal end, and the second conductive connection portion is used to receive ablation energy or transmit tissue physiological signals; the second conductive connection portion is cylindrical and has a through hole extending axially inside. The insulating connector has an axially extending cavity that extends from the proximal end of the insulating connector to the first conductive connection portion.

2. The left atrial appendage occlusion ablation device according to claim 1, characterized in that, The insulating connector includes a first connector and a second connector connected sequentially along the axial direction; the second connector is located near the end of the first connector; the anchoring disc is connected to the first connector; the sealing disc is connected to the second connector; the first conductive connection portion is disposed on the first connector; the axial section of the insulation is formed on the first connector, or on the second connector, or between the first connector and the second connector.

3. The left atrial appendage occlusion ablation device according to claim 2, characterized in that, The insulating connector further includes a third connector disposed between the first connector and the second connector; the axial section of the insulation is formed on the third connector.

4. The left atrial appendage occlusion ablation device according to claim 3, characterized in that, The third connector is provided in multiple parts, and the multiple third connectors are connected sequentially along the axial direction; wherein, the farthest third connector is connected to the first connector, the closest third connector is connected to the second connector, and the insulating axial section is formed on at least one of the third connectors.

5. The left atrial appendage occlusion ablation device according to claim 2, characterized in that, The first connector has a first mounting space, and one end of the anchoring disc is connected to the first mounting space; and / or, the second connector has a second mounting space, and the distal end of the sealing disc is connected to the second mounting space.

6. The left atrial appendage occlusion ablation device according to claim 3, characterized in that, The first conductive connection portion is detachably connected to the first connector.

7. The left atrial appendage occlusion ablation device according to claim 6, characterized in that, The insulating connector further includes a fourth connector disposed between the first connector and the first conductive connection portion; the fourth connector has an insulating axial section formed thereon to electrically isolate the first conductive connection portion from the first connector; the third connector has an insulating axial section formed thereon to electrically isolate the first connector from the third connector.

8. The left atrial appendage occlusion ablation device according to claim 1, characterized in that, The anchoring plate includes a first frame; the first frame is a radially expandable support structure; the first frame is made of woven metal wire or cut from metal tubing; the distal end of the insulating connector is connected to the first frame; the second conductive part is part or all of the first frame, or the second conductive part is an electrode provided on the outer peripheral wall of the first frame.

9. The left atrial appendage occlusion ablation device according to claim 1, characterized in that, The anchoring disc includes a support portion and an anchoring portion; multiple support portions are provided and arranged around the axis of the anchoring disc; one end of the support portion is connected to the sealing disc, and the other end of the support portion gradually bends outward in a radial direction; multiple anchoring portions are provided, and multiple anchoring portions are arranged around the outer periphery of the support portion; the anchoring portion bends and extends from the end of the support portion away from the axis of the anchoring disc towards the proximal end.

10. The left atrial appendage occlusion ablation device according to claim 9, characterized in that, Each of the aforementioned support portions includes a support rod, a first branch, and a second branch; one end of the support rod is connected to the sealing disc, and the other end of the support rod gradually bends outward in a radial direction; one end of the first branch and the second branch are both connected to the end of the corresponding support rod away from the axis of the anchoring disc; the end of the first branch away from the support rod is connected to the end of the second branch of an adjacent support portion away from the support rod, forming a connection point; the anchoring portion bends and extends proximally from the connection point.

11. The left atrial appendage occlusion ablation device according to claim 10, characterized in that, The end of the anchoring part away from the connection point bends and extends toward the axis of the anchoring plate.

12. The left atrial appendage occlusion ablation device according to claim 11, characterized in that, The end of the anchoring part away from the connection point is bent and connected to the end of the adjacent anchoring part away from the connection point.

13. The left atrial appendage occlusion ablation device according to claim 1, characterized in that, The left atrial appendage occlusion ablation device also includes a movable component that movably passes through the anchoring plate and the sealing plate; the movable component is used to transmit ablation energy or collect tissue physiological signals, and the movable component serves as the second conductive part or as a third conductive part electrically isolated from the second conductive part.

14. The left atrial appendage occlusion ablation device according to claim 13, characterized in that, The anchoring disc has an opening at its distal end; the distal end of the movable member can move through the opening from the interior of the anchoring disc to the distal end of the anchoring disc, or from the distal end of the anchoring disc to the interior of the anchoring disc.

15. The left atrial appendage occlusion ablation device according to claim 13, characterized in that, The distal end of the movable component is a radially expandable structural component, which can be released and is in a radially expanded state.

16. The left atrial appendage occlusion ablation device according to claim 1, characterized in that, The sealing disc includes a second skeleton, which is a radially expandable support structure. The second skeleton is made of woven metal wire or cut from metal tubing. The proximal end of the second skeleton is connected to the second conductive connection portion.

17. The left atrial appendage occlusion ablation device according to claim 16, characterized in that, An insulating film is provided on the outer peripheral wall of the distal end of the second frame, and the insulating film is positioned between the distal end of the second frame and the proximal end of the anchoring plate.

18. The left atrial appendage occlusion ablation device according to any one of claims 1-17; characterized in that, The left atrial appendage occlusion ablation device further includes an outer tube, a first catheter, and a second catheter; the outer tube is tubular, and its distal end can accommodate the anchoring disc and the sealing disc in a radially contracted state; the first catheter is movably inserted into the outer tube and can move axially relative to the outer tube; the distal end of the first catheter is electrically connected to the sealing disc; the second catheter is movably inserted into the first catheter and can move axially relative to the first catheter; the distal end of the second catheter movably passes through the sealing disc and is electrically connected to the second conductive part.

19. The left atrial appendage occlusion ablation device according to any one of claims 13-15; when the movable member serves as a third conductive part electrically isolated from the second conductive part, the left atrial appendage occlusion ablation device further includes an outer tube and a first catheter, a second catheter, and a third catheter; the outer tube is tubular, and the distal end of the outer tube is capable of receiving the anchoring disc and the sealing disc in a radially contracted state; the first catheter is movably inserted within the outer tube and is axially movable relative to the outer tube; the distal end of the first catheter is electrically connected to the sealing disc to transmit ablation energy to the sealing disc; the second catheter is movably inserted within the first catheter and is axially movable relative to the first catheter; the distal end of the second catheter movably passes through the sealing disc and is electrically connected to the second conductive part; the third catheter is movably inserted within the second catheter and is axially movable relative to the second catheter; the distal end of the third catheter is electrically connected to the third conductive part.

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