Left atrial appendage occlusion device and system

Abstract

The application discloses a left atrial appendage occlusion device and system, and relates to the field of medical instruments.The left atrial appendage occlusion device comprises a first framework with a first conductive part used for transmitting first ablation energy to tissues, a second framework with a second conductive part used for transmitting second ablation energy to tissues, and a first insulating connecting piece used for connecting the first framework and the second framework.The left atrial appendage occlusion device and system are beneficial to reducing the operation difficulty of one-stop treatment of left atrial appendage ablation and occlusion and simplifying the operation procedure.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a left atrial appendage occlusion device and system. Background Technology

[0002] Atrial fibrillation is the most common sustained arrhythmia, and its incidence increases with age. Data shows that the incidence of atrial fibrillation can reach 10% in people over 75 years of age. Furthermore, the prevalence of atrial fibrillation is closely related to coronary heart disease, hypertension, and heart failure.

[0003] In cardiac tissue, the left atrial appendage, due to its unique morphology and structure, is not only the main site of atrial fibrillation thrombus formation, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can benefit from active left atrial appendage electrical isolation surgery.

[0004] The "radiofrequency ablation + left atrial appendage occlusion" integrated treatment is currently a hot topic in the treatment of atrial fibrillation. Many successful cases of atrial fibrillation have been achieved using this combined approach. In this integrated treatment, left atrial appendage occlusion allows patients to achieve good stroke prevention without the need for lifelong anticoagulation; combined with radiofrequency ablation to restore and maintain sinus rhythm, thereby improving symptoms, patients can achieve stable long-term treatment outcomes.

[0005] However, current ablation methods primarily involve pulmonary vein isolation (PVI) combined with ablation of atrial fibrillation foci outside the pulmonary veins, without adding left atrial appendage isolation (unless the triggering foci from the left atrial appendage can cause persistent atrial fibrillation, atrial flutter, or atrial tachycardia). This ablation method results in a high recurrence rate of atrial fibrillation one year later. Studies have shown that for patients with long-term persistent atrial fibrillation, left atrial appendage isolation can reduce postoperative atrial fibrillation recurrence without increasing surgical complications. Furthermore, current ablation catheters used to treat atrial fibrillation are designed for pulmonary vein ablation. Due to significant differences in the size, depth, and location of the left atrial appendage opening among different patients, existing pulmonary vein ablation catheters are clearly unsuitable for left atrial appendage ablation.

[0006] If ablation and occlusion of the left atrial appendage are to be performed during the aforementioned one-stop treatment, an ablation catheter and a left atrial appendage occlusion device need to be introduced via interventional means. The key is to position the two devices sequentially at the opening of the left atrial appendage before performing ablation and occlusion, which is not conducive to achieving one-stop treatment that combines ablation and occlusion functions. Summary of the Invention

[0007] This invention addresses the problem that existing medical devices for surgical treatment of the left atrial appendage are not conducive to achieving one-stop treatment with ablation and occlusion functions, and provides a left atrial appendage occlusion device and system.

[0008] The technical solution proposed by this invention to address the above-mentioned technical problems is as follows:

[0009] On one hand, the present invention provides a left atrial appendage occlusion device, comprising:

[0010] A first skeleton having a first conductive portion, the first conductive portion being used to transmit first ablation energy to tissue;

[0011] A second skeleton having a second conductive portion for transmitting a second ablation energy to tissue, wherein the first ablation energy and the second ablation energy have opposite polarities; and

[0012] A first insulating connector for connecting the first frame and the second frame.

[0013] According to the aforementioned left atrial appendage occlusion device, the connection methods between the first insulating connector and the first skeleton and the second skeleton include one or more of the following: fusion connection, plug connection, and snap-fit ​​connection.

[0014] According to the aforementioned left atrial appendage occlusion device, both the first frame and the second frame include multiple support rods. The multiple support rods are interconnected and form a mesh with holes with the first insulating connector. The support rods of the first frame and the support rods of the second frame are fused together, plugged together, or snapped together through the first insulating connector.

[0015] According to the aforementioned left atrial appendage occlusion device, the first insulating connector includes multiple connecting rods, the support rod of the first frame is the first support rod, the support rod of the second frame is the second support rod, and each connecting rod is connected between the corresponding first support rod and the corresponding second support rod.

[0016] According to the aforementioned left atrial appendage occlusion device, the connecting rod is made of an insulating polymer material.

[0017] According to the aforementioned left atrial appendage occlusion device, the first frame and the second frame are axially separated, and the first insulating connector forms an annular insulating region, which is arranged around the axis of the first frame and the axis of the second frame.

[0018] According to the left atrial appendage occlusion device described above, the projection of the insulating region onto the axis is perpendicular to the axis.

[0019] According to the left atrial appendage occlusion device described above, the projection of the insulating region onto the axis forms an acute angle with the axis.

[0020] According to the left atrial appendage occlusion device described above, the first skeleton and the second skeleton are coaxial and circumferentially separated.

[0021] According to the left atrial appendage occlusion device described above, both the first skeleton and the second skeleton include an inner end and a peripheral end that are connected to each other, wherein the peripheral end is disposed adjacent to the periphery of the first skeleton and the second skeleton relative to the inner end;

[0022] The first insulating connector is connected between the peripheral end of the first frame and the peripheral end of the second frame;

[0023] The left atrial appendage occlusion device is further provided with a second insulating connector, which is connected between the inner end of the first skeleton and the inner end of the second skeleton.

[0024] The left atrial appendage occlusion device described above includes a separate sealing disc and an anchoring disc. The sealing disc is located at the proximal end and is used to cover the opening of the left atrial appendage. The anchoring disc is located at the distal end and is used to fix it in the cavity of the left atrial appendage. The first skeleton and the second skeleton are both located on the anchoring disc. The distal end of the sealing disc is connected to the inner end of the first skeleton and the inner end of the second skeleton through the second insulating connector.

[0025] According to the aforementioned left atrial appendage occlusion device, the first conductive part and the first frame are either an integral structure or separate structures; and

[0026] The second conductive part and the second skeleton are either an integral structure or separate structures.

[0027] According to the aforementioned left atrial appendage occlusion device, the first insulating connector is provided with barbs.

[0028] According to the left atrial appendage occlusion device described above, the ablation energy of the first ablation energy and the second ablation energy is any one of the following: high-voltage pulse energy and radio frequency energy.

[0029] The left atrial appendage occlusion device described above includes a flow-blocking membrane disposed on the first skeleton and / or the second skeleton.

[0030] On the other hand, the present invention also provides a left atrial appendage occlusion system, including a delivery device and a left atrial appendage occlusion device as described above, wherein the delivery device is used to deliver the left atrial appendage occlusion device to the opening of the left atrial appendage.

[0031] The beneficial effects of the technical solution provided by the embodiments of the present invention are as follows:

[0032] After being implanted into the left atrial appendage (LAA) of the heart, the left ACA occlusion device covers the opening of the LCA and is fixed within the LCA cavity. The circumferential surfaces of both the first and second skeletons abut against the LCA tissue, thus securely occluding the LCA opening. Simultaneously, pulsed ablation or radiofrequency ablation is performed on the LCA tissue using the first conductive part integrated with the first skeleton and the second conductive part integrated with the second skeleton, thereby achieving a one-stop treatment that combines ablation and occlusion functions.

[0033] The left atrial appendage occlusion device of the present invention integrates both occlusion and ablation functions. On the one hand, it helps to reduce the cost of interventional medical devices. On the other hand, when applied to left atrial appendage ablation and occlusion procedures, only the left atrial appendage occlusion device of this application needs to be released at the opening of the left atrial appendage. There is no need to deliver and position any additional ablation device at the left atrial appendage. This reduces the difficulty of positioning the device at the opening of the left atrial appendage in the one-stop treatment procedure of "ablation + left atrial appendage occlusion", simplifies the surgical procedure, helps to shorten the operation time, and improves the accuracy, convenience and popularity of the one-stop treatment procedure of "ablation + left atrial appendage occlusion". Attached Figure Description

[0034] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0035] Figure 1 This is a schematic diagram illustrating the structural principle of the left atrial appendage occlusion device provided by the present invention.

[0036] Figure 2 A schematic diagram of the left atrial appendage occlusion device provided by the present invention in a first embodiment;

[0037] Figure 3 for Figure 2 A schematic diagram of the connection structure between the sealing disc and the first frame;

[0038] Figure 4 for Figure 2 A schematic diagram of the second skeleton in the diagram;

[0039] Figure 5 This is a schematic diagram of the left atrial appendage occlusion device provided by the present invention in a second embodiment;

[0040] Figure 6 for Figure 5 A schematic diagram of the disassembled structure of the central anchor plate;

[0041] Figure 7 for Figure 6 A top view of the central anchoring plate.

[0042] Figure 8 This is a schematic diagram of the left atrial appendage occlusion device provided by the present invention in a third embodiment.

[0043] Explanation of the markings in the image:

[0044] 1. Left atrial appendage occlusion device; 11. First frame; 111. First conductive part; 12. Second frame; 121. Second conductive part; 13. First insulating connector;

[0045] 2. Left atrial appendage occlusion device; 21. Anchoring plate; 211. First frame; 2111. First conductive part; 2112. First support rod; 2113. Main rod; 212. Second frame; 2121. Second conductive part; 2122. Second support rod; 2123. Fold-back end; 213. First insulating connector; 2131. Barb; 214. Hexagonal mesh; 22. Sealing plate; 221. Flat plate body; 222. Support rod body; 23. Bolt head;

[0046] 3. Left atrial appendage occlusion device; 31. Anchoring plate; 311. First frame; 3111. First conductive part; 3112. First support rod; 312. Second frame; 3121. Second conductive part; 3122. Second support rod; 313. First insulating connector; 314. Second insulating connector; 32. Sealing plate; 33. Bolt head; 315. Inner end; 316. Peripheral end; 34. Another bolt head;

[0047] 4. Left atrial appendage occlusion device; 41. Anchoring part; 411. First frame; 4111. First conductive part; 4112. First support rod; 4113. Barb; 42. Sealing part; 421. Second frame; 4211. Second conductive part; 4212. Second support rod; 43. First insulating connector; 44. First plug head; 45. Second plug head. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of this invention clearer, the embodiments of this invention will be described in further detail below with reference to the accompanying drawings. It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally referred to as the proximal end, and the end that is farther from the operator is referred to as the distal end. Based on this principle, the proximal and distal ends of any component of a medical device are defined. Without departing from the technical principles of this application, the specific technical solutions in the following embodiments can be applied interchangeably.

[0049] See Figure 1This is a schematic diagram illustrating the structural principle of the left atrial appendage occlusion device provided by the present invention. The left atrial appendage occlusion device 1 includes three main components: a first frame 11, a second frame 12, and a first insulating connector 13. The first insulating connector 13 connects the first frame 11 and the second frame 12 to form an integral structure. The first frame 11 has a first conductive part 111 for transmitting a first ablation energy to the tissue, and the second frame 12 has a second conductive part 121 for transmitting a second ablation energy to the tissue. The first ablation energy and the second ablation energy have opposite polarities. Here, the ablation energy of the first ablation energy and the second ablation energy can be high-voltage pulse energy with opposite polarities, or radio frequency energy with opposite polarities.

[0050] In this invention, the connection methods of the first insulating connector 13 with the first skeleton 11 and the second skeleton 12 may include one or more of the following: fusion connection, plug connection and snap connection.

[0051] In the ablation treatment scenario, the first conductive part 111 and the second conductive part 121 are electrically connected to the corresponding energy source to transmit energy for ablation of the corresponding tissue in the left atrial appendage, thereby achieving tissue ablation. At the same time, the first insulating connector 13 separates the first skeleton 11 and the second skeleton 12, so that the first skeleton 11 and the second skeleton 12 have a good electrical isolation effect.

[0052] like Figure 1 As shown, the left atrial appendage occlusion device 1 has a rotating structure. The structure at the proximal end (i.e., the lower end in the figure) is used to cover the opening of the left atrial appendage, while the structure at the distal end (i.e., the upper end in the figure) is used to fix it in the cavity of the left atrial appendage. The conductive area formed by the first conductive part 111 and the conductive area formed by the second conductive part 121 are located between the proximal end and the distal end, and are insulated and separated by the insulating area formed by the first insulating connector 13.

[0053] In a preferred embodiment, both the first conductive part 111 and the second conductive part 121 are annular, which facilitates the formation of a closed annular ablation electric field in the area between the first conductive part 111 and the second conductive part 121 on the peripheral wall of the left atrial appendage, which is beneficial for complete electrical isolation of the left atrial appendage.

[0054] In some specific application examples, both the first frame 11 and the second frame 12 can be conductive frames, such as metal frames. In this case, the first conductive part 111 is an integral structure with the first frame 11, and the second conductive part 121 is an integral structure with the second frame 12. Specifically, insulating treatment can be performed on the corresponding surfaces of the first frame 11 and the second frame 12 to obtain insulating parts that are distinct from the corresponding first conductive parts 111 and second conductive parts 121. Since the surfaces of the first conductive parts 111 and the second conductive parts 121 are not insulated, they can release ablation energy to the tissue. Because the first conductive part 111 is an integral structure with the first frame 11, and the second conductive part 121 is an integral structure with the second frame 12, it is beneficial to reduce the risk of device thrombus formation in the conductive area of ​​the left atrial appendage occlusion device 1, avoid the phenomenon of electrodes detaching from the frame, and improve the reliability of the application.

[0055] In some specific application examples, both the first frame 11 and the second frame 12 are insulating frames. In this case, the first conductive part 111 and the first frame 11 are separate structures, and the second conductive part 121 and the second frame 12 are separate structures. Specifically, ablation electrodes for transmitting ablation energy to tissue can be provided at corresponding positions on the first frame 11 and the second frame 12, with the additionally provided ablation electrodes serving as the first conductive part 111 and the second conductive part 121.

[0056] In one embodiment, both the first skeleton 11 and the second skeleton 12 can be conductive frames, such as metal frames. In this case, the first conductive part 111 and the first skeleton 11 are separate structures, and the second conductive part 121 and the second skeleton 12 are also separate structures. Specifically, ablation electrodes for transmitting ablation energy to tissue can be provided at corresponding positions on the first skeleton 11 and the second skeleton 12, with the additionally provided ablation electrodes serving as the first conductive part 111 and the second conductive part 121. The material of the ablation electrode can differ from the material of the skeleton; for example, the conductivity parameters of the ablation electrode can be superior to those of the skeleton supporting it, thereby improving the ablation effect of the ablation portion.

[0057] In some specific application examples, one of the frames and the conductive parts it carries are integrated into one structure: an insulating part that is different from the corresponding conductive part can be obtained by insulating the corresponding position on the conductive frame; the other frame and the conductive parts it carries are separate structures: an additional ablation electrode can be set on the corresponding frame as the corresponding conductive part.

[0058] In some embodiments of the present invention, a flow-blocking membrane is provided on the left atrial appendage occlusion device 1 to prevent thrombi deep in the left atrial appendage from entering the left atrium, reduce the irritation of the skeleton to the left atrial appendage tissue, maintain good mechanical properties of the left atrial appendage occlusion device 1, and constrain deformation of the left atrial appendage occlusion device 1. In other embodiments, the flow-blocking membrane can further be used to prevent blood flow from forming at the opening of the left atrial appendage. In one embodiment, the flow-blocking membrane is disposed on the first skeleton 11 and / or the second skeleton 12, such as on the inner or outer surface of the corresponding skeleton. It is understood that the flow-blocking membrane can also be disposed on the first insulating connector 13.

[0059] In this invention, after the left atrial appendage occlusion device 1 is implanted into the left atrial appendage of the heart, the proximal structure (which may be a sealing part or a sealing disc) covers the opening of the left atrial appendage, while the distal structure (which may be an anchoring part or an anchoring disc) is fixed in the cavity of the left atrial appendage. The circumferential surfaces of both are used to abut against the left atrial appendage tissue, thereby stably occluding the opening of the left atrial appendage. At the same time, pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue using the first conductive part 111 on the first skeleton 11 and the second conductive part 121 on the second skeleton 12. This achieves a one-stop treatment that combines ablation and occlusion functions, avoiding the cumbersome procedures and surgical costs associated with traditional methods that require two separate devices to achieve ablation and occlusion functions.

[0060] The left atrial appendage occlusion device of the present invention integrates both occlusion and ablation functions. On the one hand, it helps to reduce the cost of interventional medical devices. On the other hand, when applied to left atrial appendage ablation and occlusion procedures, only the left atrial appendage occlusion device of this application needs to be released at the opening of the left atrial appendage. There is no need to deliver and position any additional ablation device at the left atrial appendage. This reduces the difficulty of positioning the device at the opening of the left atrial appendage in the one-stop treatment procedure of "ablation + left atrial appendage occlusion", simplifies the surgical procedure, helps to shorten the operation time, and improves the accuracy, convenience and popularity of the one-stop treatment procedure of "ablation + left atrial appendage occlusion".

[0061] Here, pulsed ablation utilizes a high-intensity pulsed electric field to induce irreversible electrical rupture (IRE) in the cell membrane, leading to apoptosis and achieving non-thermal ablation of cells, thus unaffected by heat sink effects. Furthermore, the high-voltage pulse sequence generates minimal heat, eliminating the need for saline flushing for cooling, effectively reducing the occurrence of gas explosion, eschar, and thrombosis. Pulsed ablation treatment is short, with a single pulse sequence taking less than one minute, and the entire ablation process generally not exceeding five minutes. Moreover, 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 near the left atrial appendage.

[0062] Compared to other ablation energies, 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 inner wall of the left atrial appendage after entering, it does not affect the irreversible electroporation 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 ablation, the intracardiac signals can also be used to determine whether complete electrical isolation of the tissue has been achieved.

[0063] The left atrial appendage occlusion device 1 of the present invention is mainly used in a left atrial appendage occlusion system. The left atrial appendage occlusion system may include a delivery device and the left atrial appendage occlusion device 1, wherein the delivery device is used to deliver the left atrial appendage occlusion device 1 to the opening of the left atrial appendage. After the left atrial appendage occlusion device 1 reaches the opening of the left atrial appendage, it can be adjusted and released to occlude and ablate the left atrial appendage.

[0064] See Figures 2 to 4 ,in, Figure 2 A schematic diagram of the left atrial appendage occlusion device provided by the present invention in a first embodiment; Figure 3 for Figure 2 A schematic diagram of the connection structure between the sealing disc and the first frame; Figure 4 for Figure 2 A schematic diagram of the second skeleton is shown. To facilitate observation and determination of the corresponding parts, the dorsal structure portion of the regular left atrial appendage occlusion device 2 is omitted, but this is not used to limit the overall structure of the left atrial appendage occlusion device 2. It is understood that the following... Figures 3 to 8 All cases were handled in accordance with this method.

[0065] The left atrial appendage occlusion device 2 in this embodiment includes an anchoring plate 21 located at the distal end and a sealing plate 22 located at the proximal end. The anchoring plate 21 is used to fix the device within the cavity of the left atrial appendage, while the sealing plate 22 covers the opening of the left atrial appendage. In this embodiment, the first skeleton 211, the second skeleton 212, and the first insulating connector 213 are all located on the anchoring plate 21. The first skeleton 211 and the second skeleton 212 are axially separated by the first insulating connector 213. A first conductive part 2111 is disposed on the first skeleton 211, and a second conductive part 2121 is disposed on the second skeleton 212. Here, the sealing plate 22 and the first skeleton 211 of the anchoring plate 21 are cut from a metal tube. The metal tube can be a nickel-titanium alloy tube, a cobalt-chromium alloy tube, or stainless steel, or other biocompatible metal tubes. Preferably, the sealing plate 22 is integrally cut from the first skeleton 211. In some modified embodiments, the sealing disc 22, the first skeleton 211, and the second skeleton 212 can all be made of superelastic shape memory alloy wire, such as nickel-titanium alloy shape memory alloy wire or cobalt-chromium alloy wire.

[0066] In this embodiment, both the anchoring plate 21 and the sealing plate 22 are frame structures. The first frame 211 and the second frame 212 of the anchoring plate 21 each include multiple support rods. These support rods are interconnected and form a mesh with openings with the first insulating connector 213. The support rods of the first frame 211 and the second frame 212 are fused together, plugged in, or snapped together via the first insulating connector 213. Here, the support rods of the first frame 211 are designated as the first support rods 2112, and these first support rods 2112 are interconnected. The support rods of the second frame 212 are designated as the second support rods 2122, and these second support rods 2122 are interconnected. It is understood that the interconnected first support rods 2112 form a wave-like shape, and similarly, the interconnected second support rods 2122 also form a wave-like shape. In the wave-like shape formed by the first support rods 2112 and the second support rods 2122, the near-end portion is the crest, and the far-end portion is the trough.

[0067] The first insulating connector 213 includes multiple connecting rods, each connecting rod being connected between a corresponding first support rod 2112 and a corresponding second support rod 2122. Specifically, the connecting rod is a straight rod, one end of which is connected to the trough of the wave formed by the first support rod 2112, and the other end is connected to the crest of the wave formed by the second support rod 2122. In this case, the first support rod 2112, the second support rod 2122, and the connecting rod can form a hexagonal mesh 214, and multiple hexagonal meshes 214 form a hexagonal array on the anchoring plate 21. The outer periphery of the hexagonal array is used to fit tightly against the inner wall of the left atrial appendage. Compared with the mesh structure at the proximal or distal position, the skeleton structure at this position has more support rods and a larger contact area with the inner wall of the left atrial appendage, which helps to improve the uniform force distribution effect of the inner wall tissue of the left atrial appendage and reduce the stimulation of the left atrial appendage tissue by the left atrial appendage occlusion device 2. At the same time, this structure can also facilitate the generation of frictional forces in more directions with the inner wall tissue of the left atrial appendage, thereby improving the anchoring performance of the left atrial appendage occlusion device 2.

[0068] In this embodiment, each connecting rod of the first insulating connector 213 can form an insulating portion, and this insulating portion is arranged around the axis of the first frame 211 and the second frame 212. The first insulating connector 213 is made of insulating material, specifically insulating polymer material.

[0069] In this embodiment, the material of the first insulating connector 213 is more specifically a fusible implantable insulating polymer material. In this case, the first insulating connector 213 is fusedly connected to the first skeleton 211 and the second skeleton 212. More specifically, when the insulating polymer material is heated and softened, an external force can be applied to deform it into a preset shape to connect the first skeleton 211 and the second skeleton 212. Figure 2 The first insulating connector 213 shown is specifically a straight rod. When the polymer material is heated and softened, an external force can be applied to deform it into multiple softened, spaced straight connecting rods. The two ends of each connecting rod contact the corresponding ends of the first skeleton 211 and the second skeleton 212. Subsequently, the softened connecting rods solidify during cooling, thereby achieving a fusion connection between the first insulating connector 213 and the first skeleton 211 and the second skeleton 212.

[0070] like Figure 2 As shown, a barb 2131 with elasticity and capable of embedding into the rod body is further provided on the outer peripheral side of the connecting rod body. The barb 2131 is inclined towards the sealing disc 22. Correspondingly, an opening or slot for the barb 2131 to be embedded is also provided on the rod body. In one embodiment, the material of the barb 2131 is the same as that of the first skeleton 211 or the same as that of the second skeleton 212.

[0071] like Figure 2 , Figure 3 As shown, the sealing disc 22 includes multiple interconnected rods, the proximal ends of which are converged by a plug head 23, meaning the proximal end of the sealing disc 22 is contained within the plug head 23. The plug head 23 may have a perforation for inserting a guide wire or a conductive element for connection to a handle, and its material may be metal. It can be connected to the sealing disc 22 by welding or bonding. In this embodiment, the plug head 23 and the sealing disc 22 are integrally cut, forming a single structure. Specifically, the plug head 23 and the sealing disc 22 are processed using laser-cut tubing. The plug head 23 is one end of the tubing and is not cut axially. The sealing disc 22 is obtained by laser-cutting a section of the tubing adjacent to the end used to make the plug head 23. The plug head 23 may be cup-shaped or cylindrical. In an alternative embodiment, the plug head 23 has two parallel channels axially arranged, each channel capable of accommodating a conductive element.

[0072] The sealing disc 22 has multiple rods that form a flat disc body 221 at its proximal end. The flat disc body 221 is hollow and has a grid. Specifically, as the multiple rods extend from the plug head 23 to the distal end, they radiate outward in the radial direction and then converge in the axial direction to form the aforementioned flat disc body 221. The axial dimension of the flat disc body 221 is smaller than the maximum radial dimension, thus obtaining a disc surface for sealing the left atrial appendage opening. The distal portion of the multiple rods forms a support rod 222. The proximal end of the support rod 222 is connected to the distal end of the flat disc body 221, and the distal end of the support rod 222 is connected to the anchoring disc 21. The multiple support rods 222 are arranged at intervals in the circumferential direction and form a column. In this embodiment, the multiple support rods 222 are evenly spaced around the axis.

[0073] In this embodiment, both the sealing disc 22 and the anchoring disc 21 are made of conductive metal material and are connected together by the support rod 222 of the sealing disc 22. In an alternative embodiment, the distal end of the sealing disc 22 may be insulated from the proximal end of the anchoring disc 21.

[0074] In the anchoring disc 21, the first frame 211 also includes multiple first main rods 2113 connected to corresponding support rods 222. These main rods extend away from the sealing disc 22 and expand radially after extending a predetermined distance. One end of each first main rod 2113 is connected to the support rod 222, while the other end is connected to the wave-shaped crest formed by the first support rods 2112. Here, the multiple interconnected first support rods 2112 form a first annular conductive portion; similarly, the multiple interconnected second support rods 2122 form a second annular conductive portion.

[0075] like Figure 4The second frame 212 shown also includes a folded-back end 2123, which is connected to the trough of the wave-like structure formed by the interconnected second support rods 2122, and adjacent folded-back ends 2123 are interconnected. The folded-back end 2123 also includes a folded-back free end extending in the axial direction of the anchoring part 211.

[0076] In this embodiment, based on the material difference between the first frame 211 and the second frame 212, the arrangement of the first conductive part 2111 and the second conductive part 2121 may include the following situations:

[0077] (1) When both the first frame 211 and the second frame 212 are made of metal:

[0078] ① An insulating coating is applied to the first main rod 2113 of the first frame 211 to obtain an insulating part and a conductive first conductive part 2111. An insulating coating is applied to the folded-back end 2123 of the second frame 212 to obtain an insulating part and a conductive second conductive part 2121. Here, the material of the insulating coating includes, but is not limited to, pyrene coating, polytetrafluoroethylene (PTFE) coating, and polyimide (PI) coating.

[0079] ② An insulating film is attached to the first main rod 2113 of the first frame 211 to obtain an insulating part and a conductive first conductive part 2111. An insulating film is attached to the folded-back end 2123 of the second frame 212 to obtain an insulating part and a conductive second conductive part 2121. Here, the material of the insulating film includes, but is not limited to, fluorinated ethylene propylene copolymer (FEP), polyurethane (PU), ethylene-tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy (PFA), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and silicone.

[0080] ③ An insulating sleeve is fitted onto the first main rod 2113 of the first frame 211 to obtain an insulating part and a conductive first conductive part 2111. An insulating sleeve is fitted onto the folded-back end 2123 of the second frame 212 to obtain an insulating part and a conductive second conductive part 2121. Here, the material of the insulating sleeve includes, but is not limited to, fluorinated ethylene propylene copolymer, polyurethane, ethylene-tetrafluoroethylene copolymer, fusible polytetrafluoroethylene, polytetrafluoroethylene, polyether ether ketone, and silicone.

[0081] It is understandable that when both the first frame 211 and the second frame 212 are made of metal, and after insulating the corresponding parts using the insulation methods described in ① to ③, ablation electrodes can be installed on the frame at the uninsulated locations as corresponding conductive parts. That is, a first ablation electrode is installed on the first frame 211 as a first conductive part 2111, and a second ablation electrode is installed on the second frame 212 as a second conductive part 2121. In this case, the conductivity parameters of the ablation electrodes are superior to those of the frames supporting them.

[0082] Through the insulation treatment described above, the ablation reaction between the insulation area and the tissue or blood can be avoided, and the ablation energy can be concentrated between the first conductive part 2111 and the second conductive part 2121 to ablate the inner wall of the left atrial appendage.

[0083] (2) When both the first frame 211 and the second frame 212 are made of non-metallic materials:

[0084] A metal part is provided on the first support rod 2112 to obtain a first ablation electrode located on the first frame 211, which is the first conductive part 2111. A metal part is provided on the second support rod 2122 to obtain a second ablation electrode located on the second frame 212, which is the second conductive part 2121.

[0085] In this embodiment, it is preferred that both the first frame 211 and the second frame 212 are made of metal, and the first conductive part 2111 is formed on the first support rod 2112 of the first frame 211, and the second conductive part 2121 is formed on the second support rod 2122 of the second frame 212. That is, the first conductive part 2111 and the first frame 211 are an integral structure, and the second conductive part 2121 and the second frame 212 are an integral structure.

[0086] In this embodiment, the first conductive part 2111 is located at the end of the first frame 211, and the second conductive part 2121 is located at the end of the second frame 212. In an alternative embodiment, the first conductive part 2111 and the second conductive part 212 are not limited to being respectively disposed at the ends of the first frame 211 and the second frame 212.

[0087] When the left atrial appendage occlusion device 2 provided in this embodiment is applied to a left atrial appendage system, the left atrial appendage system may include the left atrial appendage occlusion device 2 and a delivery device (not shown in the figure). The delivery device can deliver the left atrial appendage occlusion device to the opening of the left atrial appendage for adjustment and release. Here, the delivery device may include a handle and a sheath, with the proximal end of the sheath connected to the distal end of the handle, and the distal end of the sheath connected to the proximal end of the left atrial appendage occlusion device 2.

[0088] The first skeleton 211 is electrically connected to the handle and the ablation source (external pulse signal source) via the sealing disc 22 and a conductive element in the sheath. The second skeleton 212 is electrically connected to the handle and the ablation source via another conductive element in the sheath, the distal end of which extends through the distal end of the sheath to connect to the second skeleton 212. Here, the conductive element can be a wire or a steel cable, etc. After the first skeleton 211 and the second skeleton 212 have completed the ablation process, the conductive elements connected to the first skeleton 211 and the second skeleton 212 are disengaged from the left atrial appendage occlusion device 2, and the sheath and handle are withdrawn.

[0089] In this embodiment, the left atrial appendage occlusion device 2 utilizes a sealing disc 22 to cover the opening of the left atrial appendage, while an anchoring disc 21 is fixed within the cavity of the left atrial appendage. Both discs' circumferential surfaces are used to abut against the left atrial appendage tissue for occlusion and fixation. Simultaneously, pulsed ablation or radiofrequency ablation is performed on the left atrial appendage tissue using the first conductive part 2111 on the first skeleton 211 and the second conductive part 2121 on the second skeleton 212, thus achieving a one-stop treatment combining ablation and occlusion functions. In embodiments where the conductive part and the corresponding skeleton are integrated—that is, the first conductive part 2111 and its corresponding first skeleton 211 are integrated, and the second conductive part 2121 and its corresponding second skeleton 212 are integrated—the risk of device thrombosis in the conductive area of ​​the left atrial appendage occlusion device is reduced, and the phenomenon of the ablation electrode detaching from the skeleton is avoided, improving the reliability of the application.

[0090] It is understood that in some variant structures of this embodiment, the second skeleton 212 may also be provided on the sealing disk 22. In this case, the first insulating connector 213 may be used to connect the sealing disk 22 and the anchoring disk 21.

[0091] In this embodiment, the annular insulating region formed by the arrangement of the first insulating connectors 213 is coaxial with the axis of the anchor plate 21. At this time, the projection of the insulating region on the axis is perpendicular to the axis.

[0092] It is understandable that, in some variant structures of this embodiment, the projection of the insulating area formed by the arrangement of the first insulating connectors 213 onto the plane containing the axis forms an angle with the axis of the anchor plate 21, that is, compared to Figure 2 In the case where the second insulating connector 213 is arranged horizontally, the first insulating connector 213 can be arranged at a more inclined angle. In this case, the projection of the insulating region onto the axis of the anchoring plate 21 forms an acute angle with the axis. That is, the angle formed by the projection of the inclined insulating region formed by the first insulating connector 213 from the proximal end to the distal end onto the axis of the anchoring plate 21 from the proximal end to the distal end is an acute angle. In some variant structures, the first insulating connector 213 can also be arranged in a spiral around the axis of the anchoring plate 21.

[0093] See Figures 5 to 7 ,in, Figure 5 This is a schematic diagram of the left atrial appendage occlusion device provided by the present invention in a second embodiment; Figure 6 for Figure 5 A schematic diagram of the disassembled structure of the central anchor plate; Figure 7 for Figure 6 A top view of the anchoring plate. The left atrial appendage occlusion device 3 in this embodiment includes an anchoring plate 31 located at the distal end and a sealing plate 32 located at the proximal end. Both the anchoring plate 31 and the sealing plate 32 are frame structures, and the first frame 311 and the second frame 312 are both located on the anchoring plate 31. The first frame 311 and the second frame 312 are coaxial.

[0094] The difference from the left atrial appendage occluder 2 in the first embodiment is that in the left atrial appendage occlusion device 3, the first frame 311 and the second frame 312 are separated in the circumferential direction. The first frame 311 and the second frame 312 each include an inner end 315 and a peripheral end 316 that are connected to each other. The peripheral end 316 is arranged adjacent to the periphery of the first frame 311 and the second frame 312 relative to the inner end 315.

[0095] The first frame 311 and the second frame 312 are connected to each other by a first insulating connector 313 and a second insulating connector 314. The first insulating connector 313 is connected between the peripheral end of the first frame 311 and the peripheral end of the second frame 312, and the second insulating connector 314 is connected between the inner end of the first frame 311 and the inner end of the second frame 312.

[0096] like Figure 6 As shown, the first frame 311 is located on the left half, the second frame 312 is located on the right half, and a first insulating connector 313 and a second insulating connector 314 are disposed between the two. Figure 7The first frame 311 and the second frame 312 are arranged in equal halves so that they are semicircular structures in a top view. A first insulating connector 313 is located near the periphery of the first frame 311 and the second frame 312, while a second insulating connector 314 is provided near the axis of the first frame 311 and the second frame 312 to connect them. Thus, electrically, the first insulating connector 313 separates the peripheral ends of the first frame 311 and the second frame 312, while the second insulating connector 314 separates the inner ends of the first frame 311 and the second frame 312. In this embodiment, the first frame 311 and the second frame 312 are fused together by the first insulating connector 313, and the first frame 311 and the second frame 312 are fused together by the second insulating connector 314. In an altered embodiment, the first insulating connector 313 includes a first snap-fit ​​unit disposed on the first frame 311 and a second snap-fit ​​unit disposed on the second frame 312. The first snap-fit ​​unit and the second snap-fit ​​unit engage, thereby enabling the first frame 311 and the second frame 312 to be snap-fit ​​connected through the first insulating connector 313. Similarly, the second insulating connector 314 may include a third snap-fit ​​unit disposed on the first frame 311 and a fourth snap-fit ​​unit disposed on the second frame 312. The third snap-fit ​​unit and the fourth snap-fit ​​unit engage, thereby enabling the first frame 311 and the second frame 312 to be snap-fit ​​connected through the second insulating connector 314. Here, the second insulating connector 314 can also be used to connect the distal end of the first sealing disc 32 to the inner end of the first frame 311 and the inner end of the second frame 312. The second insulating connector 314 may be a snap-fit ​​structure with a sleeve.

[0097] In this embodiment, both the first frame 311 and the second frame 312 include multiple interconnected support rods, which form a mesh with hexagonal openings. The support rods of the first frame 311 are first support rods, and the support rods of the second frame 312 are second support rods. Figure 5 As shown, the first frame 311 is provided with a first conductive part 3111, which specifically includes a first support rod 3112 for forming hexagonal mesh holes; that is, the first support rod 3112 is a conductive rod body. Similarly, the second frame 312 is provided with a second conductive part 3121, which specifically includes a second support rod 3122 for forming hexagonal mesh holes; the second support rod 3122 is also a conductive rod body.

[0098] In this embodiment, the proximal end of the sealing disc 32 is secured by a bolt head 33, and the distal end of the sealing disc 32 is secured by another bolt head 34. That is, the multiple support rods in the sealing disc 32 are secured in the bolt head 33 at the proximal end and in the other bolt head 34 at the distal end. The specific structural form of the bolt head 33 and the other bolt head 34 can be a double-layer steel sleeve, with the ends of the multiple support rods sandwiched in the gap between the double-layer steel sleeve.

[0099] Furthermore, the distal end of the sealing disc 32 is connected to the inner end of the first frame 311 and the inner end of the second frame 312 via a second insulating connector 314. In this embodiment, the plug head at the distal end of the sealing disc 32 is connected to the inner end of the first frame 311 and the inner end of the second frame 312 via the second insulating connector 314. Thus, the second insulating connector 314 connects the sealing disc 32, the first frame 311, and the second frame 312, which helps to reduce the number of connectors in the left atrial appendage occlusion device 3 and facilitates device structure optimization.

[0100] Since the structures of the sealing disc 32 and the plug head 33 are similar to those of the sealing disc in the first embodiment, they will not be described again here.

[0101] It is understood that the sealing disc 32 can be made of metal. In this case, either the first skeleton 311 or the second skeleton 312 can be made from a single metal tube, thereby reducing the number of separate components in the left atrial appendage occlusion device, which is beneficial for improving the reliability of the device and reducing the number of connecting parts. It is also understood that the first skeleton 311, the second skeleton 312, and the sealing disc 32 can all be made of superelastic shape memory alloy wire. For details regarding the materials of the anchoring disc 31 and the sealing disc 32, please refer to the description in the first embodiment.

[0102] It is understood that the first conductive part 3111 and the second conductive part 3121 in this embodiment can be configured in accordance with the configuration methods in the various cases of the first embodiment, and therefore will not be described in detail.

[0103] In this embodiment, the left atrial appendage occlusion device 3 uses a sealing disc 32 to cover the opening of the left atrial appendage, while an anchoring disc 31 is fixed inside the cavity of the left atrial appendage. Both discs have circumferential surfaces that abut against the left atrial appendage tissue to achieve occlusion and fixation. Simultaneously, pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue using the first conductive part 3111 on the first frame 311 and the second conductive part 3121 on the second frame 312, thus achieving a one-stop treatment combining ablation and occlusion functions. Compared to the first embodiment, the left atrial appendage occlusion device 3 in this embodiment has fewer first insulating connectors 313 and 314 than the first insulating connector 213 in the first embodiment, thus offering greater flexibility in assembly and disassembly.

[0104] See Figure 8 This is a schematic diagram of the left atrial appendage occlusion device provided by the present invention in a third embodiment. The left atrial appendage occlusion device 4 in this embodiment includes an anchoring part 41 located at the distal end and a sealing part 42 located at the proximal end. Both the anchoring part 41 and the sealing part 42 are frame structures, and a first insulating connector 43 is provided between the anchoring part 41 and the sealing part 42.

[0105] The difference from the aforementioned implementation method is as follows:

[0106] In this embodiment, the left atrial appendage occlusion device 4 includes an integrally formed anchoring part 41 and a sealing part 42. A first frame 411 is located on the anchoring part 41, and a second frame 421 is located on the sealing part 42. A first insulating connector 43 is located between the anchoring part 41 and the sealing part 42, and includes multiple connecting rods made of insulating polymer material, which are fused to the first frame 411 and the second frame 421 respectively.

[0107] like Figure 8 As shown, the left atrial appendage occlusion device 4 is a hollow cage-like structure, including an anchoring portion 41 at the distal end and a sealing portion 42 at the proximal end. A first plug head 44 is provided at the proximal end of the sealing portion 42, and a second plug head 45 is provided at the distal end of the anchoring portion 41. Both the first plug head 44 and the second plug head 45 are used to gather the ends of the multiple wires in the occlusion device 4.

[0108] The first conductive part 4111 includes multiple interconnected first support rods 4112, which are wavy in shape, with their troughs connected to one end of the connecting rod of the first insulating connector 43. Similarly, the second conductive part 4121 includes multiple interconnected second support rods 4122, which are also wavy in shape, with their crests connected to the other end of the first insulating connector 43.

[0109] In this embodiment, the first skeleton 411 is further provided with outwardly folded barbs 4113, and the barbs 4113 point to one side of the second skeleton 421.

[0110] Compared with the aforementioned embodiments, the left atrial appendage occlusion device 4 in this embodiment has a simpler structure and is more integrated.

[0111] In this embodiment, the first frame 411 and the second frame 421 are separated in the axial direction. In a modified embodiment, referring to the second embodiment, the first frame 411 and the second frame 421 are separated in the circumferential direction, or the projection of the insulating area formed by the first insulating connector 43 on the axis of the left atrial appendage occlusion device 4 forms an acute angle with the axis. That is, the angle formed by the projection of the inclined insulating area formed by the first insulating connector 43 from the proximal end to the distal end on the axis of the first frame 411 from the proximal end to the distal end and the axis is an acute angle.

[0112] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A left atrial appendage occlusion device, characterized in that, include: An anchoring disc located at the distal end and a sealing disc located at the proximal end; A first skeleton having a first conductive portion, the first conductive portion being used to transmit first ablation energy to tissue; A second skeleton having a second conductive portion for transmitting a second ablation energy to tissue, wherein the first ablation energy and the second ablation energy have opposite polarities. and A first insulating connector is used to connect the first skeleton and the second skeleton. The material of the first insulating connector is a fusible implantable insulating polymer material. The first frame, the second frame, and the first insulating connector are all located on the anchoring plate; the first frame and the second frame each include multiple support rods, which are interconnected and form a mesh with holes with the first insulating connector; the support rods of the first frame and the support rods of the second frame are fused together through the first insulating connector; the first frame and the second frame are axially separated, and the first insulating connector forms an annular insulating area, which is arranged around the axis of the first frame and the axis of the second frame; The first insulating connector includes multiple connecting rods. A barb that is elastic and can be embedded in the rod body is further provided on the outer peripheral side of the connecting rod. The first conductive part and the second conductive part are respectively disposed on the upper and lower sides of the barb. The support rod of the first frame is a first support rod, and the support rod of the second frame is a second support rod. Each connecting rod is connected between the corresponding first support rod and the corresponding second support rod.

2. The left atrial appendage occlusion device according to claim 1, characterized in that, The projection of the insulating region onto the plane containing the axis of the anchor plate is perpendicular to the axis of the anchor plate.

3. The left atrial appendage occlusion device according to claim 1, characterized in that, The projection of the insulating region onto the plane containing the axis of the anchoring plate forms an acute angle with the axis of the anchoring plate.

4. The left atrial appendage occlusion device according to any one of claims 1 to 3, characterized in that, The first conductive part and the first frame are either an integral structure or separate structures; and The second conductive part and the second skeleton are either an integral structure or separate structures.

5. The left atrial appendage occlusion device according to any one of claims 1 to 3, characterized in that, The ablation energy of the first ablation energy and the second ablation energy is any one of the following: high voltage pulse energy and radio frequency energy.

6. The left atrial appendage occlusion device according to any one of claims 1 to 3, characterized in that, It includes a flow-blocking membrane, which is disposed on the first skeleton and / or the second skeleton.

7. A left atrial appendage occlusion system, characterized in that, It includes a delivery device and a left atrial appendage occlusion device as described in any one of claims 1 to 6, wherein the delivery device is used to deliver the left atrial appendage occlusion device to the opening of the left atrial appendage.

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