A left atrial appendage occluder

Abstract

The application discloses a left auricle plugging device, which comprises a sealing part and an anchoring part comprising a plurality of supporting rods, the sealing part and the anchoring part are respectively provided with connecting parts, and the connecting parts of the sealing part and the anchoring part are connected with each other. The left auricle plugging device improves the connecting mode of the sealing part and the anchoring part, shortens the overall distance between the sealing part and the anchoring part, avoids and delays the axial lengthening of the left auricle plugging device as a whole, and further guarantees that the sealing part is attached to and plugs the left auricle port.

Description

TECHNICAL FIELD

[0001] The present application relates to a medical device, in particular to an interventional treatment device for occluding left atrial appendage. BACKGROUND

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia. The incidence of AF increases with age, and can reach 10% in people over 75 years old. When in atrial fibrillation, the frequency of atrial activation is 300-600 times per minute, and the heart rate is often fast and irregular, and the atrium loses effective contraction function. When in atrial fibrillation, the left atrial appendage contraction force decreases, and the left atrial appendage itself has morphological characteristics and uneven muscle trabecula, which causes vortex and slow flow of blood in the left atrial appendage, promoting thrombosis. More than 90% of left atrial thrombi in non-valvular atrial fibrillation patients exist in the left atrial appendage. After the thrombus is detached, it will enter the brain artery through the aorta to form cerebral embolism, i.e. stroke.

[0003] In view of the risk of stroke in atrial fibrillation patients, three methods are currently mainly used for prevention and treatment in clinic, i.e. anticoagulant drug treatment, surgical treatment and percutaneous left atrial appendage occlusion treatment. The anticoagulant drug treatment refers to inhibiting blood coagulation by taking anticoagulant drugs to reduce the risk of thrombosis in the left atrial appendage, thereby reducing the probability of occurrence of stroke. Clinical trials show that anticoagulant drug treatment can significantly reduce the probability of occurrence of stroke, but anticoagulant drug treatment is a long process, and there are obvious complications, mainly bleeding complications, and there can be more serious cases. Surgical treatment includes surgical resection or suturing of the left atrial appendage, but surgical trauma is large, and is generally completed when other operations such as valve replacement or coronary artery bypass are performed, and patients generally cannot accept simple left atrial appendage surgery, especially elderly patients. The percutaneous left atrial appendage occlusion treatment refers to delivering a left atrial appendage occlusion device to the left atrial appendage located in the right atrium of the heart by using a small-diameter delivery sheath tube through percutaneous puncture, and releasing it. The left atrial appendage occlusion device can occlude the opening position of the left atrial appendage, and the blood flow in the atrium cannot enter the left atrial appendage, so that thrombosis cannot be formed, thereby achieving the purpose of preventing atrial fibrillation thromboembolism. Since 2001, percutaneous left atrial appendage occlusion treatment has been put into use, and animal experiments and clinical trials have been carried out. Clinical trials show that left atrial appendage occlusion can effectively reduce the probability of occurrence of stroke in atrial fibrillation patients.

[0004] From the structure, the left atrial appendage occluder on the market at present mainly divided into two types: plug structure and double disc structure. The left atrial appendage occluder of double disc structure is usually composed of a sealing part and an anchoring part, the sealing part occludes the left atrial appendage opening position after release, and the anchoring part is released in the left atrial appendage and has barbs, which plays a role in fixing the sealing part. The sealing part of the left atrial appendage occluder after release is closely attached to the left atrial appendage opening position, and the left atrial appendage opening is occluded. If the sealing part cannot be closely attached to the left atrial appendage opening, the sealing part may be suspended in the left atrium, cannot effectively occlude the left atrial appendage opening, and may further increase the risk of thrombosis. And one of the main factors that cause the sealing part to be unable to effectively attach to the left atrial appendage opening position is related to the connection mode between the sealing part and the anchoring part, that is, the anchoring part and the sealing part cannot be connected together compactly, the overall length of the product is relatively long, the anchoring part is radially compressed after release, further increasing the overall length of the product after release, and at the same time, the axial distance between the sealing part and the anchoring part is increased, the sealing part cannot be effectively attached to the left atrial appendage opening after release, and residual shunt is caused. SUMMARY

[0005] The left atrial appendage occluder provided by the application improves the connection mode of the sealing part and the anchoring part, can shorten the overall distance between the sealing part and the anchoring part, can avoid and delay the axial lengthening of the left atrial appendage occluder as a whole, and further ensures that the sealing part is attached to and occludes the left atrial appendage opening.

[0006] A left atrial appendage occluder comprises a sealing part and an anchoring part comprising a plurality of support rods, the sealing part and the anchoring part each have a connecting part, and the connecting parts of the two are connected to each other in interpenetration.

[0007] In the prior art, the connecting parts of the sealing part and the anchoring part are generally aligned with each other, and if directly connected, the end faces directly abut each other, and of course a transition connecting piece can also be used. This structure will cause the occluder to have an excessively long axial length as a whole, which is not conducive to sealing.

[0008] In the application, the connecting parts of the sealing part and the anchoring part are arranged in interpenetration, that is, misalignment, which can avoid spatial interference during the approach of the sealing part and the anchoring part, greatly reduce the distance between the sealing part and the anchoring part, and improve the sealing effect.

[0009] Optionally, the sealing part and the anchoring part and the connecting parts thereof are in an integral structure or a fixed split structure.

[0010] The sealing part and the anchoring part can be processed by weaving or cutting respectively. The sealing part (anchoring part) can adopt a regular or irregular wire frame structure. When adopting a wire frame structure, a skeleton can be set at an appropriate position as needed to improve strength. The skeleton can have an increased cross-sectional area or at least higher strength relative to other parts. The mesh structure can be regular or irregular cells, preferably rhomboid or approximately rhomboid cells, and can at least be compressed radially to facilitate recycling and release. The mesh structure has a clear warp and weft structure. The intersection of warp and weft can be a fixed node, and more preferably a non-fixed method, that is, the warp and weft can be staggered and slipped to provide compliance and deformation capability.

[0011] The sealing and anchoring parts can be integrated with their respective connecting parts after cutting or weaving, or the connecting parts can be assembled and fixed as independent components by welding or other means. The preferred method is an integrated structure, which facilitates processing and ensures overall strength.

[0012] Optionally, the connection between the sealing part and the anchoring part is formed by their respective shape convergence, which can be either overall convergence or partial convergence.

[0013] The sealing and anchoring parts have a certain diameter range because they need to block the left atrial appendage, while the connecting parts have a smaller diameter. The diameter changes between them can be gradual or abrupt. For example, when the overall convergence method is used, the position of the diameter change presents a conical structure, while local convergence can be regarded as an abrupt change in diameter, such as a sudden change from a larger cross-sectional area to a thinner rod or bundle.

[0014] Optionally, the connecting parts on both the sealing part and the anchoring part are all at one point and are connected to each other; or the connecting parts on both the sealing part and the anchoring part are multiple and are connected to each other in a one-to-one correspondence; or one of the sealing part and the anchoring part has one connecting part and the other has multiple connecting parts, forming a one-to-many connection.

[0015] There are no strict restrictions on the number and location of the connection parts; when only one connection is used, it is generally located at the sealing part or...

[0016] Optionally, the connecting portions of the sealing portion and the anchoring portion may directly intersect each other or intersect each other relative to a connector.

[0017] Direct interlocking means that the connecting parts of the two parts are in contact with each other and are fixed to each other by welding, clamping, or intertwining. However, when connected by a connector, the connecting parts of the two parts may not be in contact with each other, but are fixed to each other relative to the connector. The connector can be a single component or a component composed of multiple components.

[0018] Optionally, the connection between the sealing part and the anchoring part extends in a straight line; or

[0019] One of them extends along a straight line, while the extension of the other extends along a curve; or

[0020] The connection between the two extends along the curve.

[0021] The sealing part and the anchoring part are arranged opposite to each other, and their connecting parts extend close to each other and connect. During the extension process, their paths are not strictly restricted. In order to simplify the structure, the preferred method is that the connecting parts of both the sealing part and the anchoring part extend in a straight line.

[0022] The shape of the connecting part itself may be a simple straight rod or a more complex three-dimensional structure. Therefore, the straight extension here should be understood as the overall trend, that is, the extension process does not have an overall detour or bend.

[0023] As a further preferred embodiment, the connection between the sealing part and the anchoring part both extend along the axis of the left atrial appendage occluder.

[0024] Optionally, the connecting parts of the sealing part and the anchoring part may be nested or offset from each other at their mating locations.

[0025] The connection between the sealing part and the anchoring part is staggered, and they can be nested or offset from each other, allowing them to continue to extend without spatial interference. The offset here is relative to nesting and should not be understood as being far apart. For example, on a cross section perpendicular to the axis of the left atrial appendage occluder, the connection between the sealing part and the anchoring part can be close to each other or have a certain gap.

[0026] Optionally, the connecting portions of the sealing portion and the anchoring portion extend toward each other and over each other's ends.

[0027] When one of the connecting parts crosses the other's end, it also means that the end of the other connecting part crosses its own end. Thus, the connecting parts of the two parts are arranged side by side or at least partially overlap at the points where they cooperate with each other, along the projection of the direction perpendicular to the axis of the left atrial appendage occluder.

[0028] When the connecting parts of the sealing part and the anchoring part are nested together, their projections will definitely overlap. When they are offset from each other, the shape of the projection is related to the viewing angle. Therefore, they may be side by side or partially overlapped. If the sealing part and the anchoring part are misaligned but do not continue to extend beyond each other's ends, there is still space to further pull them closer to the sealing part and the anchoring part, and the product structure is not compact enough.

[0029] Optionally, in conjunction with existing technology, one or more flow-blocking membranes may be provided inside the sealing part.

[0030] Optionally, the outer periphery of the anchoring part is covered with a film. For example, the outer surface of the anchoring plate may be fully or partially covered with a film.

[0031] Preferably, the covering extends from the outer periphery of the anchoring portion to the end of the anchoring portion facing away from the sealing portion. The extended portion of the covering can completely or partially wrap the end of the anchoring portion facing away from the sealing portion. Unless otherwise specified, the shapes and positional relationships described in this invention refer to the state of the left atrial appendage occluder after release and expansion in the body, which can also be referred to as the release state or expansion state. Before release, the left atrial appendage occluder is compressed within the delivery device, which can be referred to as the compression state or pre-release state.

[0032] Optionally, the sealing part and the anchoring part can each be independently a wire frame structure or a mesh structure.

[0033] Optionally, the anchoring part is cut from a metal tube, with the side away from the sealing part cut and then radially curled to form the multiple support rods, and the end facing the sealing part being an uncut tube head that serves as a connecting part.

[0034] Optionally, the multiple support rods are cross-linked wire frame structures.

[0035] Optionally, the sealing part has a woven structure and is shaped as a disc, an inverted cone, or a column.

[0036] Here, "disc" and "column" can be understood as general shape characteristics. For example, the disc is flat, and its outer edge shape basically conforms to the physiological structure characteristics of the left atrial appendage, such as being round or other shapes according to actual needs.

[0037] For example, the column has a certain thickness, such as an approximate cylinder or frustum, but the shape of its outer periphery or generatrix is ​​not strictly limited. On the one hand, it can refer to the existing technology, and on the other hand, it can be based on actual needs. The shape of the sealing part itself is not the focus of the improvement of this invention. Of course, the present invention provides preferred or improved solutions.

[0038] Optionally, in the connection between the sealing part and the anchoring part, one of them has a guide channel, and the other extends through the guide channel, and is provided with an anti-detachment head that is blocked by the guide channel at the extended part; or the other extends into and is fixed in the guide channel.

[0039] Optionally, the wall of the guide channel is annular, and the annulus can be closed or open.

[0040] Optionally, the anti-detachment head is a ring-shaped hoop.

[0041] Optionally, the anchoring portion extends radially towards the sealing portion at its central part and converges, with the guide channel located at this converged portion.

[0042] Optionally, the sealing portion has a convergence structure on the side facing the anchoring portion, which extends through the threading channel.

[0043] This convergence is reflected in the structural features and also includes the corresponding steps in the processing, namely, bringing together multiple filaments into a bundle.

[0044] Optionally, the support rod is equipped with anchor spikes.

[0045] Preferably, the sealing part includes a disc surface facing away from the anchoring part, a disc bottom facing the anchoring part, and a waist part connecting the disc surface and the disc bottom, wherein the disc bottom is flat or the middle of the disc bottom protrudes towards the anchoring part.

[0046] The plate surface, plate bottom, and waist section together form a cage-like structure. One or more flow-blocking membranes can be placed inside the cage-like structure. Except for necessary perforated parts, the cage-like structure can be closed or partially open. When weaving and processing the sealing part, there can be a converging end on the plate bottom and plate surface.

[0047] Because the cage-like structure has a certain amount of internal space, it can maintain a sealing effect even with some deformation.

[0048] In the cage-like structure, the diameter of the waist is roughly the same as the diameter of the anchoring part, while the diameter of the disc is slightly larger than the diameter of the waist to improve the sealing effect at the end.

[0049] The diameter of the disc surface or the bottom of the disc mentioned here can be approximated as a circle. If it is another shape, it can be understood as the relative relationship of the cross-sectional area or the overall thickness. Taking a circle as an example, since the diameter of the disc surface is larger than the diameter of the bottom of the disc, it is a frustum shape as a whole. Its top surface is slightly larger and it tapers towards the bottom, while its bottom surface is slightly smaller. In this way, when it abuts against the anchoring part, it can fit snugly against the anchoring part.

[0050] The connector and anti-detachment head can be made of stainless steel, nickel-titanium alloy, or other metal materials that meet biocompatibility requirements.

[0051] The left atrial appendage occluder described in this invention is delivered to the left atrial appendage of the heart via a delivery sheath through percutaneous puncture to occlude the left atrial appendage, thereby preventing the risk of stroke caused by thrombus formation in the left atrial appendage in patients with atrial fibrillation.

[0052] Optionally, the connector is an elastic element.

[0053] Preferably, the sealing part and the anchoring part are in contact with each other.

[0054] Mutual contact can further shorten the overall axial length of the product and delay seal failure caused by deformation during use.

[0055] As a further preferred embodiment, the sealing portion and the anchoring portion abut against each other.

[0056] The sealing part and the anchoring part can be tightly connected and pressed together by applying pre-tightening force. After the plug is released, it can better adhere to and block the left atrial appendage. Even if the anchoring part or the sealing part is radially compressed and lengthened, the sealing part and the anchoring part can still be kept close to each other to ensure the sealing effect.

[0057] Preferably, the sealing part has a pre-assembly state where it is not abutting against the anchoring part and a post-assembly state where it abuts against the anchoring part; relative to the pre-assembly state, the middle part of the post-assembly sealing part has a deformation that protrudes axially towards the anchoring part.

[0058] The pre-assembly state refers to the shape obtained by heat setting after the sealing part is processed without assembly or external force. After assembly, it deforms after being pressed against the anchoring part in order to increase or maintain the pre-tightening force.

[0059] Preferably, the anchoring part has a pre-assembly state where it is not abutting against the sealing part and a post-assembly state where it is abutting against the sealing part; relative to the pre-assembly state, the post-assembly support rod has deformation caused by the pressure of the sealing part.

[0060] On the longitudinal section through the axis of the anchoring part, the support rod is U-shaped, with one end near the center of the sealing part and the other end near the edge of the sealing part after being radiated outward. The deformation of the support rod occurs at least at the bottom of the U-shape or on the side near the outer edge of the anchoring part.

[0061] The deformation of the support rod is also due to the presence of preload, which causes the support rod, which has a certain degree of elasticity, to deform. The support rod of the present invention can be a simple linear structure in which each rod is independent, or a complex structure formed by mutual cross-linking.

[0062] Preferably, the ends of the support rod that radiate outwards have a smooth structure.

[0063] As a further preferred option, the end of the support rod that radiates outwards and curls is an enlarged ball head.

[0064] When the anchor is released, the end of the support rod is released first inside the body, and the ball head structure can avoid injury to the body cavity.

[0065] Preferably, each support rod has an arc-shaped curled section at the end of the outwardly radiating curl, and the convex side of the curled section abuts against the corresponding side of the sealing part.

[0066] Preferably, in the connection between the sealing part and the anchoring part, one of them has a through-channel, the other extends through the through-channel, and an anti-detachment head that is blocked by the through-channel is provided on the extended part.

[0067] In the axial direction of the left atrial appendage occluder, the anti-dislodgement head is further away from the seal than the coiled section.

[0068] This allows the connecting part of the anchoring part to be further away from the sealing part in the axial position, improving the mutual clamping effect between the anchoring part and the sealing part and maintaining the preload.

[0069] Preferably, the outer periphery of the anchoring part is provided with a film around each support rod, and the film extends axially toward the curled section and wraps the contact area between the curled section and the sealing part.

[0070] This can further prevent the contact area between the support rod and the sealing part from penetrating into the sealing part.

[0071] Preferably, the central angle corresponding to the curled segment is 90 to 270 degrees.

[0072] As a further preferred embodiment, the central angle corresponding to the curled segment is 120 to 180 degrees.

[0073] Preferably, the portion of the support rod that abuts against the sealing portion is adjacent to the outer periphery of the sealing portion.

[0074] If the contact area is too close to the axis of the sealing part, the deformation of the sealing part that can form a pre-tightening force is too small. However, if it is too close to or at the edge of the sealing part, there is a risk of slippage.

[0075] As a further preferred embodiment, the distance from the abutting part to the axis of the sealing part is in the ratio of 1 / 2 to 7 / 8 of the radius of the sealing part.

[0076] As a further preferred embodiment, the distance from the abutting portion to the axis of the sealing portion is in the ratio of 3 / 4 to 5 / 6 to the radius of the sealing portion.

[0077] This invention achieves an alternating connection between the sealing part and the anchoring part through an improved connection method, which allows the sealing part to adhere more tightly to the left atrial appendage and seal the opening of the left atrial appendage, thereby reducing the incidence of internal leakage and residual shunting. Attached Figure Description

[0078] Figure 1 This is a schematic diagram of the sealing part in Example 1;

[0079] Figure 2 This is a schematic diagram of the anchoring part in Example 1;

[0080] Figure 3 for Figure 2 A schematic diagram of the anchoring part from another angle;

[0081] Figure 4 This is a schematic diagram showing the assembly process of the sealing part and the anchoring part in Example 1;

[0082] Figure 5 for Figure 4 Schematic diagram of the middle sealing part and anchoring part after assembly;

[0083] Figure 6 for Figure 5 A partial cross-sectional view of the connection between the sealing part and the anchoring part;

[0084] Figure 7 This is a schematic diagram from another angle after the left atrial appendage occluder of Example 1 has been assembled;

[0085] Figure 8 This is a schematic diagram of the sealing part in Example 2;

[0086] Figure 9 This is a schematic diagram showing the assembly process of the sealing part and the anchoring part in Example 2;

[0087] Figure 10 for Figure 9 Schematic diagram of the middle sealing part and anchoring part after assembly;

[0088] Figure 11 for Figure 10 A partial cross-sectional view of the connection between the sealing part and the anchoring part;

[0089] Figure 12 This is a schematic diagram from another angle after the left atrial appendage occluder is assembled in Example 2;

[0090] Figure 13a This is a schematic diagram of the left atrial appendage occluder in Example 3;

[0091] Figure 13b for Figure 13a A partial cross-sectional view of the left atrial appendage occluder after diaphragm covering;

[0092] Figure 14 This is a schematic diagram of the left atrial appendage occluder in Example 4;

[0093] Figure 15 This is a schematic diagram of the sealing part in Example 5;

[0094] Figure 16 This is a schematic diagram showing the assembly process of the sealing part and the anchoring part in Example 5;

[0095] Figure 17 for Figure 16 Schematic diagram of the middle sealing part and anchoring part after assembly;

[0096] Figure 18 for Figure 17 A partial cross-sectional view of the connection between the sealing part and the anchoring part. Detailed Implementation

[0097] Example 1

[0098] See Figures 1 to 7This embodiment provides a left atrial appendage occlusion device, which includes a sealing part and an anchoring part connected to each other. The sealing part is a flat sealing disc 1 made of woven metal wire, and a flow-blocking membrane is provided inside the sealing disc 1.

[0099] The top of the sealing disc 1, i.e. the side facing away from the anchor, converges to a connector 3, which is used to connect to the conveying device.

[0100] The bottom of the sealing disc 1, i.e. the side facing the anchoring part, is tapered to form a tapering 2. The tapering 2 is used to interlock with the anchoring part, i.e., it serves as a connecting part of the sealing disc 1, or at least as part of the connecting part.

[0101] The anchoring part is cut from a nickel-titanium alloy tube, with an uncut tube head 5 left on the top side facing the sealing disc 1. The tube head 5 serves as the connection part of the anchoring part, and the inner cavity of the tube head 5 serves as a passage for the convergence 2 to pass through.

[0102] After being cut away from the sealing part, the support rods are radially curled in the opposite direction to form multiple interlinked support rods 4. The end of the support rod 4 has a curled section 41 with a small radius of curvature. The curled section 41 can prevent damage to the inner wall of the body cavity during the release process to a certain extent. The part of the support rod 4 that is in contact with the inner wall of the left atrial appendage is provided with an anchor 42 for positioning.

[0103] The support rod 4 extends from the side of the pipe head 5 away from the sealing part, and gradually deviates from the axis of the anchoring part as it extends.

[0104] After reaching the position furthest from the sealing part, it extends radially outward, bends towards the sealing part after a certain distance, and gradually approaches the sealing part along the axial direction until the end has a curled section 41 that bends towards the axial direction.

[0105] In existing technologies, the connection between the sealing part and the anchoring part is generally aligned with each other and then directly abutted and fixed or aligned and fixed through a connector. This structure will result in the sealing device having an excessively long axial length, which is not conducive to sealing.

[0106] In this embodiment, the connecting part of the anchoring part, i.e., the tube head 5, has a through-channel; while the connecting part of the sealing disc 1, i.e., the constriction 2, is offset from the tube head 5 in cross-section, thus avoiding the tube wall of the tube head 5 and extending to the other end through the through-channel, achieving a so-called interlocking connection. Spatial interference can be avoided as the sealing part and the anchoring part approach each other, significantly reducing the distance between the sealing part and the anchoring part and improving the sealing effect.

[0107] The sealing part and the anchoring part can be an integral structure with their respective connecting parts, or they can be separate structures that are fixed to each other.

[0108] In terms of overall shape, the tube head 5 is located in the radial middle of the anchoring part and converges towards the sealing part; while the constriction 2 is located in the radial middle of the sealing part and converges towards the anchoring part.

[0109] In this embodiment, the connecting parts on both the sealing part and the anchoring part are one and connected to each other; in another embodiment, there can be multiple connecting parts, and the connecting parts on both the sealing part and the anchoring part are connected to each other in a one-to-one correspondence.

[0110] Both the tube head 5 and the retractor 2 extend along the axis of the left atrial appendage occluder and are nested together at their respective mating points.

[0111] Combination Figures 4 to 6 During the assembly process, the coil 2 passes through the tube head 5 and is tightened to a predetermined degree. Then, an annular hoop 6 is placed over the coil 2. The annular hoop 6 abuts against the tube head 5 and holds the coil 2 tightly. The excess length of the coil 2 is then cut short. The head of the coil 2 can be treated by melting or adding a cap 61 to prevent the ends of the metal wires in the coil 2 from becoming scattered.

[0112] The annular hoop 6 and the end cap 61 can be fixed by means of threaded connection, welding or other methods.

[0113] The annular clamp 6 and the tube head 5 act against each other along the axial direction to prevent the constriction 2 from coming off the tube head 5. The annular clamp 6 and the constriction 2 can be fixed by means of compression, welding or other methods.

[0114] The main function of the ring clamp 6 is to prevent the coil 2 from coming off the tube head 5. Other methods can also be used here, such as directly welding the end of the coil 2 to fix it to the tube head 5, or melting and then upsetting the head, or directly compressing the tube head 5 to deform and tighten the coil 2.

[0115] When the tube head 5 and the retractor 2 extend towards each other along the axis of the left atrial appendage occluder, they pass over each other's ends. That is, the retractor 2 passes over the bottom end of the tube head 5, which also means that the top end of the tube head 5 passes over the end of the retractor 2. In this way, the connection between the two is more compact at the point where they fit together.

[0116] The outer periphery of the anchoring part, that is, around each support rod, is covered with a membrane.

[0117] The left atrial appendage occluder of the present invention is delivered to the left atrial appendage of the heart via a delivery sheath through percutaneous puncture to occlude the left atrial appendage, thereby preventing the risk of stroke caused by thrombus formation in the left atrial appendage in patients with atrial fibrillation.

[0118] Example 2

[0119] See Figures 8 to 12This embodiment provides a left atrial appendage occlusion device, which includes a sealing part and an anchoring part connected to each other. The anchoring part can adopt the structure in Embodiment 1, but the difference lies in the shape of the sealing part. Compared with the flat disc shape in Embodiment 2, the sealing part in this embodiment is an inverted cone shape, and the assembly process can also refer to the relevant description in Embodiment 1.

[0120] In this embodiment, the top diameter of the sealing part is relatively large. As it moves closer to the anchoring part, the diameter of the sealing part gradually decreases until it forms a contraction 2, so the overall shape is an inverted cone.

[0121] Example 3

[0122] See Figure 13a This embodiment provides a left atrial appendage occlusion device, which includes a sealing part and an anchoring part connected to each other. The sealing part can adopt the structure in Embodiment 1. The difference between the sealing part and the anchoring part in Embodiment 1 is that the end of the support rod 4 that is radiating outward is a smooth structure. This end is released first in the body. The smooth structure can avoid damage to the body cavity. In this embodiment, it is specifically an enlarged ball head 43.

[0123] In this embodiment, the sealing part and the anchoring part are in contact with each other. Moreover, during the assembly process, the sealing part is tightened and the tube head of the anchoring part is pulled towards each other, and then the end cap is fixed, which will make the sealing part and the anchoring part press against each other, further shortening the overall axial length of the product. After the plug is released, it can better adhere to and block the left atrial opening. Even if the anchoring part or the sealing part is radially compressed and lengthened, the sealing part and the anchoring part can still be kept close to each other, ensuring the sealing effect.

[0124] On the longitudinal section through the axis of the anchoring part, the support rod 4 is approximately U-shaped, with one end near the center of the sealing part and the other end radiating outwards and curling up to the edge of the sealing part. The edge of the sealing part has a curled section 41 with a small radius of curvature. The convex side of the curled section 41 abuts against the corresponding side 11 of the sealing disc 1 (i.e., the side facing the anchoring part). The central angle corresponding to the curled section 41 is 90 to 270 degrees, and in this embodiment, it is preferably approximately 120 degrees.

[0125] In this embodiment, the end cap 61 can be positioned below the highest point of the curled section 41 of the support rod 4, thereby allowing the sealing part and the anchoring part to be closer together, further enhancing the sealing effect. Figure 13a As can be seen, not only the end cap 61, but also the pipe head 5 and the annular clamp 6 are axially lower than the highest point of the curled section 41. That is, relative to the contact part or the highest point of the curled section 41 and the sealing part, the connection part of the anchoring part is further away from the sealing part in the axial position.

[0126] See Figure 13bIn this embodiment, a film 7 is provided around each support rod on the outer periphery of the anchoring part. One side of the film 7 extends toward the sealing part and continues to wrap around the curled section 41 to form an inner roll 71. The inner roll 71 can wrap the curled section 41 of the support rod, further preventing the contact part between the support rod and the sealing part from piercing into the sealing disc.

[0127] The sealing part has a pre-assembly state where it is not abutting against the anchoring part and a post-assembly state where it abuts against the anchoring part; relative to the pre-assembly state, the middle part of the post-assembly sealing part has a deformation that protrudes axially towards the anchoring part.

[0128] In the figure, the sealing disc 1 is roughly in a flat state. If a pre-tightening force is applied during assembly, the middle part of the sealing disc 1 will bulge towards the anchoring part.

[0129] Similarly, the anchoring part has a pre-assembly state where it is not tightly abutted against the sealing part and a post-assembly state where it is tightly abutted against the sealing part; relative to the pre-assembly state, the post-assembly support rod has deformation caused by the pressure of the sealing part.

[0130] The deformation of the support rod 4 may occur at the bottom of the U-shape, that is, on the side of the anchoring part facing away from the sealing part, or on the side of the support rod 4 near the outer edge of the anchoring part, that is, the side with the anchor spike. This is related to the strength distribution of the support rod itself. The deformation of the support rod is also the result of the preload.

[0131] The curled section 41 of the support rod abuts against the sealing part, near the outer periphery of the sealing part. In this embodiment, the distance from the abutting part to the axis of the sealing part is approximately 5 / 6 of the radius of the sealing part.

[0132] Example 4

[0133] See Figure 14 This embodiment provides a left atrial appendage occlusion device, which includes a sealing part and an anchoring part connected to each other. Compared with embodiment 3, the difference in this embodiment is that the sealing part adopts the inverted cone shape of embodiment 2, and the assembly process is similar to the relevant description in embodiment 3, that is, the sealing part is tightened and the tube head of the anchoring part is pulled towards each other, so that the sealing part and the anchoring part abut against each other, further shortening the overall axial length of the product.

[0134] In this embodiment, because the sealing part and the anchoring part abut against each other, the inverted conical sealing part also deforms relative to before assembly. The part of the inverted conical part that is pressed by the support rod will sink further, so that the diameter of the abutting part slightly converges.

[0135] Example 5

[0136] See Figures 15 to 18 This embodiment provides a left atrial appendage occlusion device, comprising a sealing portion and an anchoring portion connected to each other.

[0137] Compared to Embodiment 4, the difference in this embodiment is that the sealing part is a woven columnar structure, including a disc surface 12 facing away from the anchoring part, a disc bottom 14 facing the anchoring part, and a waist part 13 connecting the disc surface 12 and the disc bottom 14, wherein the disc bottom 14 is flat before assembly.

[0138] The plate 12, the bottom 14, and the waist 13 together form a cage-like structure, and one or more flow-blocking membranes can be installed inside the cage-like structure.

[0139] The top of the disc 12 converges to a connector for connection with the conveying device. The side of the disc 12 facing the anchoring part forms a convergence 2, which is used for interlocking connection with the anchoring part, that is, as a connection part, or at least as part of the connection part.

[0140] The anchoring part is cut from a nickel-titanium alloy tube, with an uncut tube head 5 left at its top, on the side facing the sealing part. This tube head 5 serves as the connection part of the anchoring part, and the inner cavity of the tube head 5 serves as a passage for the convergence 2 to pass through.

[0141] After the anchoring part is cut away from the sealing part, it is radially curled in the opposite direction to form multiple interlinked support rods 4. The end of the support rod 4 has a curled section 41 with a small radius of curvature. The curled section 41 can prevent damage to the inner wall of the body cavity during the release process to a certain extent. The part of the support rod 4 that is in contact with the inner wall of the left atrial appendage is provided with anchor spikes for positioning.

[0142] The assembly process in this embodiment is similar to the relevant description in Embodiment 3, that is, the sealing part is tightened and the tube head of the anchoring part is pulled towards each other, so that the sealing part and the anchoring part abut against each other and maintain this pre-tightening force, further shortening the overall axial length of the product.

[0143] In this embodiment, because the sealing part and the anchoring part abut against each other, the sealing part also deforms relative to its state before assembly. Figure 16 and Figure 17 It can be seen that the waist 13 and the bottom 14 converge radially, and the part of the bottom 14 near the outer edge presses against the curled section 41 at the end of each support rod 4.

[0144] The above description discloses only specific embodiments of the present invention, but the present invention is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Obviously, all such modifications and variations should fall within the protection scope claimed by the present invention. Furthermore, although some specific terms are used in this specification, these terms are only for convenience of explanation and do not constitute any special limitation on the present invention.

Claims

1. A left atrial appendage occlusion device, comprising a sealing part and an anchoring part including multiple support rods, wherein the sealing part and the anchoring part each have a connecting part, characterized in that, The sealing part and the anchoring part are interlocked and fixedly connected; in the connection between the sealing part and the anchoring part, the anchoring part has a through-channel, the sealing part extends through the through-channel, and an anti-detachment head is provided on the extended part that is blocked by the through-channel. The anchoring part is cut from a metal tube. The side away from the sealing part is cut and then radially curled to form the multiple support rods. The end facing the sealing part is an uncut tube head and serves as a connecting part. The anti-detachment head and the tube head abut against each other along the axial direction. The sealing part and the anchoring part abut against each other, and the anchoring part has a pre-assembly state where it is not abutting against the sealing part and a post-assembly state where it is abutting against the sealing part. Compared to before assembly, the assembled support rod undergoes deformation due to pressure from the sealing part.

2. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part and the anchoring part are integrated with their respective connecting parts, or they are separate structures that are fixed to each other.

3. The left atrial appendage occlusion device as described in claim 1, characterized in that, The connection between the sealing part and the anchoring part is formed by their respective shape convergence, which is either overall convergence or partial convergence.

4. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part and the anchoring part each have one connection point and are connected to each other; or the sealing part and the anchoring part each have multiple connection points and are connected to each other in a one-to-one correspondence; or one of the sealing part and the anchoring part has one connection point and the other has multiple connection points, forming a one-to-many connection.

5. The left atrial appendage occlusion device as described in claim 1, characterized in that, The connection between the sealing part and the anchoring part is directly interlocked with each other or interlocked with each other relative to a connector.

6. The left atrial appendage occlusion device as described in claim 1, characterized in that, The connection between the sealing part and the anchoring part extends in a straight line; or One of them extends along a straight line, while the extension of the other extends along a curve; or The connection between the two extends along the curve.

7. The left atrial appendage occlusion device as described in claim 1, characterized in that, The connection between the sealing part and the anchoring part extends towards each other and extends beyond each other's ends.

8. The left atrial appendage occlusion device as described in claim 1, characterized in that, The multiple support rods are cross-linked wireframe structures.

9. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part has a woven structure and is shaped as a disc, an inverted cone, or a column.

10. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part includes a disc surface facing away from the anchoring part, a disc bottom facing the anchoring part, and a waist part connecting the disc surface and the disc bottom, wherein the disc bottom is flat or the middle of the disc bottom protrudes towards the anchoring part.

11. The left atrial appendage occlusion device as described in claim 1, characterized in that, The threading channel is annular, and the annularity can be either closed or open.

12. The left atrial appendage occlusion device as described in claim 1, characterized in that, The anti-detachment head is a ring-shaped hoop.

13. The left atrial appendage occlusion device as described in claim 1, characterized in that, The anchoring portion extends radially towards the sealing portion from the center and converges, with the guide channel located at the converged portion.

14. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part has a convergence structure on the side facing the anchoring part, which extends and passes through the guide channel.

15. The left atrial appendage occlusion device as described in claim 1, characterized in that, The support rod is equipped with anchor spikes.

16. The left atrial appendage occlusion device as described in claim 1, characterized in that, One or more flow-blocking membranes are provided inside the sealing part.

17. The left atrial appendage occlusion device as described in claim 1, characterized in that, The outer periphery of the anchoring part is covered with a membrane.

18. The left atrial appendage occlusion device as described in claim 17, characterized in that, The covering extends from the outer periphery of the anchoring part to the end of the anchoring part facing away from the sealing part.

19. The left atrial appendage occlusion device as described in claim 1, characterized in that, The sealing part and the anchoring part are in contact with each other.

20. The left atrial appendage occlusion device as described in claim 19, characterized in that, The sealing part has a pre-assembly state where it is not abutting against the anchoring part and a post-assembly state where it abuts against the anchoring part; relative to the pre-assembly state, the middle part of the post-assembly sealing part has a deformation that protrudes axially towards the anchoring part.

21. The left atrial appendage occlusion device as described in claim 19, characterized in that, The ends of the support rod that radiate outwards and curl outwards have a smooth structure.

22. The left atrial appendage occlusion device as described in claim 21, characterized in that, The support rod radiates outwards and curls to form an enlarged ball head at its end.

23. The left atrial appendage occlusion device as described in claim 19, characterized in that, Each support rod has an arc-shaped curled section at the end of its outwardly radiating curl, and the convex side of the curled section abuts against the corresponding side of the sealing part.

24. The left atrial appendage occlusion device as described in claim 23, characterized in that, In the axial direction of the left atrial appendage occluder, the anti-dislodgement head is further away from the seal than the coiled section.

25. The left atrial appendage occlusion device as described in claim 23, characterized in that, The outer periphery of the anchoring part is covered with a film around each support rod. The film extends axially toward the curled section and wraps the contact area between the curled section and the sealing part.

26. The left atrial appendage occlusion device as described in claim 23, characterized in that, The central angle corresponding to the curled segment is 90~270 degrees.

27. The left atrial appendage occlusion device as described in claim 24, characterized in that, The central angle corresponding to the curled segment is 120~180 degrees.

28. The left atrial appendage occlusion device as described in claim 19, characterized in that, The support rod abuts against the sealing part at a location adjacent to the outer periphery of the sealing part.

29. The left atrial appendage occlusion device as described in claim 28, characterized in that, The distance from the abutting part to the axis of the sealing part is in the ratio of 1 / 2 to 7 / 8 to the radius of the sealing part.

30. The left atrial appendage occlusion device as described in claim 29, characterized in that, The distance from the abutting part to the axis of the sealing part is in the ratio of 3 / 4 to 5 / 6 to the radius of the sealing part.

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