An interleaved left atrial appendage occluder and its assembly method

Abstract

The present invention discloses a left atrial appendage occluder with an interleaved connection and an assembly method thereof. The left atrial appendage occluder includes a sealing part and an anchoring part which are connected to each other. The anchoring part has a reticular structure formed by cutting. The sealing part and the anchoring part respectively have connection parts formed by shape convergence. The connection parts of the sealing part and the anchoring part extend towards each other and are fixed in a staggered manner. By improving the connection method, the present invention realizes the interleaved connection between the sealing part and the anchoring part, which can make the sealing part adhere more closely to the left atrial appendage and block the opening of the left atrial appendage, so as to reduce the incidence of internal leakage and residual shunt.

Description

Technical Field

[0001] The present invention relates to medical devices, and particularly to an interventional therapeutic device for occluding the left atrial appendage. Background Art

[0002] Atrial fibrillation (referred to as AF) is the most common persistent arrhythmia. With the increase of age, the incidence of AF is continuously increasing, reaching 10% in people over 75 years old. During AF, the atrial activation frequency reaches 300 - 600 beats per minute, the heart rate is often fast and irregular, and the atrium loses its effective contraction function. During AF, the contractility of the left atrial appendage decreases. Coupled with the morphological characteristics of the left atrial appendage itself and the uneven trabeculae in it, the blood flow in the left atrial appendage generates vortices and the flow velocity slows down, promoting thrombus formation. More than 90% of the left atrial thrombi in non-valvular AF patients are present in the left atrial appendage. After the thrombus detaches, it will enter the cerebral artery through the aortic blood vessel to form a cerebral embolism, that is, stroke.

[0003] For the risk of stroke in AF patients, currently three main methods are mainly used for preventive treatment clinically, namely anticoagulant drug treatment, surgical treatment, and percutaneous left atrial appendage occlusion treatment. Anticoagulant drug treatment refers to taking anticoagulant drugs to inhibit blood coagulation, so as to reduce the risk of thrombus formation in the left atrial appendage, and thus reduce the occurrence probability of stroke. Clinical trials show that anticoagulant drug treatment can significantly reduce the occurrence probability of stroke. However, anticoagulant drug treatment is a long process, and there are also obvious complications, mainly manifested as bleeding complications, and more serious situations may occur. Surgical treatment includes surgical resection or suture of the left atrial appendage. However, surgical trauma is large, and it is generally completed during other surgeries such as valve replacement or coronary artery bypass grafting. Patients generally have difficulty accepting a simple left atrial appendage surgery, especially elderly patients. Percutaneous left atrial appendage occlusion treatment refers to delivering a left atrial appendage occluder to the left atrial appendage located in the right atrium of the heart through a percutaneous puncture method using a delivery sheath with a smaller diameter and releasing it. The left atrial appendage occluder can occlude the opening position of the left atrial appendage, and the blood flow in the atrium cannot enter the left atrial appendage, so thrombus cannot be formed, thus achieving the purpose of preventing thromboembolism in atrial fibrillation. Since 2001, percutaneous left atrial appendage occlusion treatment has been put into use, and animal experiments and clinical trials have been carried out successively. Clinical trials show that left atrial appendage occlusion can effectively reduce the occurrence probability of stroke in AF patients.

[0004] In terms of structure, currently, left atrial appendage occluders on the market are mainly divided into two types: plug structure and double-disk structure.

[0005] Since the application time of left atrial appendage occluders is relatively short and the technology is relatively immature, some complications may occur after the operation, affecting the quality of life of patients. Among them, device residual shunt is one of the main complications of left atrial appendage occlusion. Regarding the plug structure, according to the 6-month follow-up results, 8% of patients have residual shunt complications. According to the 12-month follow-up results, 32% - 34.5% of patients in different centers have residual shunt complications to some extent. For the left atrial appendage occluder with a double-disk structure, according to the 6-month clinical follow-up results in different centers, 2% - 16.2% of patients have moderate residual shunt complications. The incidence of residual shunt complications is relatively high, which will affect the quality of life of patients. Therefore, reducing the residual shunt after left atrial appendage occlusion is one of the main goals to improve the clinical application value of left atrial appendage occluders.

[0006] The left atrial appendage occluder with a double-disk structure is usually composed of a sealing part and an anchoring part. After release, the sealing part occludes the opening position of the left atrial appendage, and the anchoring part is released inside the left atrial appendage and has barbs to play a role in fixing the sealing part. After release, the sealing part of the left atrial appendage occluder should closely fit the opening position of the left atrial appendage to occlude the left atrial appendage orifice. If the sealing part cannot closely fit the left atrial appendage orifice, it may cause the sealing part to hang in the left atrium, unable to effectively occlude the left atrial appendage orifice, and may further increase the risk of thrombus formation. One of the main factors causing the sealing part to not effectively adhere to the left atrial appendage orifice is related to the connection method between the sealing part and the anchoring part, that is: the anchoring part and the sealing part cannot be tightly connected together, the overall length of the product is relatively long, after release, the anchoring part is radially compressed, further increasing the overall length of the product after release, and at the same time, it can cause an increase in the axial distance between the sealing part and the anchoring part. After the sealing part is released, it cannot effectively adhere to the left atrial appendage orifice, resulting in residual shunt. Summary of the Invention

[0007] The present invention proposes a left atrial appendage occluder, which improves the connection method between the sealing part and the anchoring part, can avoid and delay the overall axial elongation of the left atrial appendage occluder, and further ensure that the sealing part adheres to and occludes the left atrial appendage orifice.

[0008] An interlaced-connected left atrial appendage occluder includes a sealing part and an anchoring part connected to each other. The anchoring part has a reticular structure formed by cutting. The sealing part and the anchoring part respectively have connection parts formed by shape convergence. The connection parts of the sealing part and the anchoring part extend towards each other and are fixed in a staggered manner.

[0009] In the prior art, the connection parts of the sealing part and the anchoring part are generally aligned with each other. If directly connected, the end faces directly abut. Of course, a transitional connecting piece can also be used. This structure will cause the overall axial length of the occluder to be too long, which is not conducive to sealing.

[0010] In the present invention, the connection part between the sealing part and the anchoring part is arranged in a dislocation manner, which can avoid spatial interference during the approaching process, greatly reduce the distance between the sealing part and the anchoring part, and improve the sealing effect.

[0011] Optionally, the sealing part and the anchoring part are of an integral structure with their respective connection parts, or are split structures fixed to each other.

[0012] The sealing part can be processed by weaving or cutting. The sealing part (or the anchoring part) can adopt a regular or irregular mesh structure. When adopting a mesh structure, a framework can be set at an appropriate position as needed to improve the strength. The framework can have an increased cross-sectional area or at least higher strength compared to other parts. The mesh structure can have regular or irregular cells, preferably rhombic or approximately rhombic cells, and at least can be compressed radially to facilitate recovery and release. The mesh structure has an obvious warp and weft structure, and the intersection of the warp and weft can be a fixed node. More preferably, a non-fixed manner is adopted, that is, the warp and weft can be misaligned and slid relative to each other to provide compliance and deformation ability.

[0013] The sealing part and the anchoring part can be of an integral structure after cutting or weaving with their respective connection parts, or the connection part is an independent component and is assembled and fixed by means such as welding. The preferred method is an integral structure, which is convenient for processing and also ensures the overall strength.

[0014] Optionally, the shape convergence is overall convergence or local convergence.

[0015] Since the sealing part and the anchoring part are used to block the left atrial appendage, they have a certain diameter range, while the diameter of the connection part is relatively thin. The diameter change between them can be gradual or sudden. For example, when adopting the overall convergence method, the position of the diameter change presents a conical structure, and the local convergence can be regarded as a sudden change in diameter, such as suddenly changing from a larger cross-sectional area to a thinner rod or bundle.

[0016] Optionally, the connection parts on both the sealing part and the anchoring part are both in one place and are connected to each other; or the connection parts on both the sealing part and the anchoring part are in multiple places and are connected to each other in a one-to-one correspondence.

[0017] The number and position of the connection parts are not strictly limited. When only one place is adopted, it is generally in the middle of the sealing part or the anchoring part.

[0018] Optionally, the connection parts of both the sealing part and the anchoring part are directly connected or connected through a connecting piece.

[0019] Direct connection means that the connection parts of the two are in contact with each other and are fixed to each other by means such as welding, hoop, and winding around each other. When connected through a connecting piece, the connection parts of the two may not be in contact with each other, but are respectively fixed relative to the connecting piece. The connecting piece can be a single component or an assembly composed of multiple components.

[0020] Optionally, the connecting portions of both the sealing portion and the anchoring portion extend in a straight line; or

[0021] the connecting portion of one of them extends in a straight line, and the extending portion of the other extends in a curve; or

[0022] the connecting portions of both extend in a curve.

[0023] The sealing portion and the anchoring portion are arranged opposite to each other, and the connecting portions of both extend towards each other and are connected. During the extension process, their paths are not strictly restricted. For the sake of simplifying the structure, preferably, the connecting portions of both the sealing portion and the anchoring portion extend in a straight line.

[0024] The shape of the connecting portion itself may be a simple straight rod or a more complex three-dimensional structure. Therefore, the straight-line extension here should be understood as the overall trend, that is, there is no overall detour or bending during the extension process.

[0025] As a further preference, the connecting portions of both the sealing portion and the anchoring portion extend along the axis direction of the left atrial appendage occluder.

[0026] Optionally, at the cooperating portions, the connecting portions of both the sealing portion and the anchoring portion are nested with each other or deviate from each other.

[0027] Since the connecting portions of the sealing portion and the anchoring portion are arranged in a staggered manner, both nesting with each other and deviating from each other can achieve continuous extension on the premise of staggering without spatial interference. Here, the mutual deviation is relative to nesting and should not be understood as moving away from each other. For example, in a cross-section perpendicular to the axis of the left atrial appendage occluder, the connecting portions of the sealing portion and the anchoring portion can be in contact with each other or have a certain gap.

[0028] Optionally, the connecting portions of both the sealing portion and the anchoring portion extend towards each other and cross the ends of each other.

[0029] After one connecting portion crosses the end of the other, it also means that the end of the other connecting portion crosses the end of its own side. In this way, at the cooperating portions of the two connecting portions, they are arranged side by side or at least partially overlapped in the projection along the direction perpendicular to the axis of the left atrial appendage occluder.

[0030] When the connecting portions of the sealing portion and the anchoring portion are nested with each other, their projections must also overlap. When they deviate from each other, the projection shape is related to the viewing angle. Therefore, being side by side or partially overlapping is possible. If the sealing portion and the anchoring portion are staggered but do not continue to extend and cross the ends of each other, there is still room for further lifting and approaching the sealing portion and the anchoring portion, and the product structure is not compact enough.

[0031] Optionally, the sealing portion and the anchoring portion are in contact with each other in the peripheral regions of their respective connecting portions.

[0032] Mutual abutment can seal the gaps between both the sealing part and the anchoring part, improving the sealing effect.

[0033] As a further preference, both the sealing part and the anchoring part abut against each other in the peripheral area of their respective connecting parts.

[0034] The mutual abutment between the sealing part and the anchoring part can be understood as that at least a part of the sealing part and the sealing part are in contact with each other, and due to the abutting force, the sealing part has deformation.

[0035] The mutual abutment between the sealing part and the anchoring part can be achieved by applying a pre-tightening force. After the occluder is released, it can better adhere to and seal the left atrial appendage orifice. Even if the anchoring part or the sealing part is radially compressed and elongated, the sealing part and the anchoring part can still maintain contact, ensuring the sealing effect.

[0036] At least one flow-blocking film is provided in the sealing part, and the sealing part is a wire-frame structure formed by cutting or a mesh structure formed by weaving.

[0037] Combined with the prior art, one or more flow-blocking films are provided in the sealing part; the periphery of the anchoring part can also be covered with a film, such as covering all or part of the outer surface of the anchoring disc.

[0038] On the premise of no special description, the shapes and positional relationships described in the present invention are the states of the left atrial appendage occluder after being released and expanded in the body, which can also be simply referred to as the released state or the expanded state. Before being released, the left atrial appendage occluder is compressed in the delivery device, which can be called the compressed state or the state before release.

[0039] Optionally, the sealing part is a sealing disc or a sealing plug.

[0040] The "disc" and "plug" here are understood as general shape characteristics. For example, the disc is flat, and the outer edge shape basically conforms to the physiological structure characteristics at the left atrial appendage, such as circular or other shapes according to actual needs.

[0041] For example, the plug is columnar with a certain thickness, such as approximately cylindrical, frustum-shaped, etc. However, the shape of its outer circumference or generatrix is not strictly limited. On the one hand, it can refer to the prior art, and on the other hand, it can also be based on actual needs. As for the shape of the sealing part itself, it is not the key improvement point of the present invention. Of course, the present invention provides preferred or improved solutions.

[0042] As a preference, the sealing part is a sealing disc, which has a pre-shaped state not in contact with the anchoring part and an abutting state in contact with the anchoring part. Relative to the pre-shaped state, the bottom surface of the sealing disc in the abutting state has deformation toward the side of the anchoring part.

[0043] Preferably, the sealing portion is a sealing disk having a predetermined forming state in which it is not in contact with the anchoring portion and a pressed state in which it is in contact with the anchoring portion; relative to the predetermined forming state, the middle portion of the sealing disk in the pressed state has a deformation that is axially protruding toward the anchoring portion.

[0044] Preferably, the sealing portion includes a disk surface facing away from the anchoring portion, a disk bottom facing the anchoring portion, and a waist connecting the disk surface and the disk bottom, wherein the disk bottom is flat or the middle of the disk bottom is convex toward one side of the anchoring portion.

[0045] The disk surface, disk bottom and waist constitute a cage structure as a whole. One or more flow-blocking membranes can be arranged inside the cage structure. The cage structure can be closed or partially open except for the necessary hollow parts. When weaving the sealing part, there can be a convergent end at the disk bottom and the disk surface.

[0046] Since the cage-shaped structure has a certain space inside, it can ensure the sealing effect even if there is a certain deformation, which is particularly suitable for the feature of being tightly pressed against the anchoring part in the present invention.

[0047] The diameter of the cage structure is mainly the diameter of the waist which is basically equivalent to the diameter of the anchoring part, while the diameter of the disk surface is slightly larger than the diameter of the waist to improve the sealing effect of the end.

[0048] Preferably, the diameter of the waist is substantially equal to or slightly larger than the diameter of the anchoring portion, and flow-blocking membranes are provided on both the disk surface and the waist.

[0049] The waist has a sufficient outer diameter so that it can come into contact with the inner cavity of the left atrial appendage when in use, and cooperate with the disk surface to form a double sealing effect.

[0050] Optionally, the sealing portion has a predetermined forming state in which it is not in contact with the anchoring portion and a pressed state in which it is in contact with the anchoring portion. In the predetermined forming state, the diameter of the disk surface is larger than the diameter of the disk bottom.

[0051] The diameter of the disk surface or the disk bottom described here can be approximately circular. If it is other shapes, it can be understood as the relative relationship between the cross-sectional area or the overall thickness. Taking the circle as an example, since the diameter of the disk surface is larger than the diameter of the disk bottom, the overall shape is a truncated cone, with a slightly larger top surface at the top, which converges more downwards, and a slightly smaller bottom surface at the bottom, so that when it is in contact with the anchoring part, it can fit in with the anchoring part in a conforming manner.

[0052] Optionally, the sealing portion has a predetermined forming state in which it is not in contact with the anchoring portion and a pressed state in which it is in contact with the anchoring portion. Relative to the predetermined forming state, the sealing portion in the pressed state has deformation at the waist and / or the bottom of the disc.

[0053] The pre-shaped state refers to the shape obtained by heat setting after the sealing part is processed by itself without assembly or external force. After assembly, due to being pressed against the anchoring part and in order to increase or maintain this pre-tightening force, deformation occurs after being pressed against the anchoring part.

[0054] Optionally, relative to the pre-shaped state, the sealing part in the tightened state has a radially converging deformation at the waist.

[0055] When the sealing part and the anchoring part move away from each other or are radially compressed, the radially converging deformation can offset or delay the tendency of axial extension to ensure the sealing performance at the opening of the left atrial appendage. The radially converging deformation can cause a certain taper at the waist and better fit with the left atrial appendage to improve the sealing effect.

[0056] Optionally, relative to the pre-shaped state, the sealing part in the tightened state has a deformation with the bottom disc axially protruding towards the anchoring part.

[0057] By a similar principle, the deformation with the bottom disc axially protruding towards the anchoring part can also offset or delay the axial extension of the whole left atrial appendage occluder. Keep the sealing part in contact with the anchoring part as much as possible to ensure the sealing effect.

[0058] Optionally, the sealing part abuts against the anchoring part at least at the outer edge of the bottom disc. The outer edge of the bottom disc abutting against the anchoring part can obtain a greater deformation of the sealing part under the same pre-tightening force, which is more conducive to compensating and offsetting the axial extension.

[0059] Optionally, the anchoring part is formed by cutting a pipe; the mesh structure is a hexagonal grid or a rhombic grid structure or a combination of a hexagonal grid and a rhombic grid.

[0060] Optionally, the pipe is made of nitinol alloy.

[0061] The mesh structure is convenient for radial compression, loading and in-vivo delivery. There is no strict limitation on the mesh structure itself. Hexagon, rhombus or their combination are preferred forms. In addition, the mesh structure can also adopt a segmented form as a whole. Taking the pre-release state as an example, it can be axially divided into multiple segments according to the structural characteristics. For each segment, a grid structure with interlaced warp and weft or an obvious cell form is adopted, and axially extending connecting rods are used between adjacent segments.

[0062] Optionally, the side of the sealing part facing the anchoring part is the bottom, and one end of the pipe is provided with an annular connecting part, and this connecting part is connected to the bottom of the sealing part.

[0063] Optionally, the connecting part of the anchoring part and the rest of the anchoring part are of an integral structure or a split structure fixed to each other, that is, the converging part at the bottom of the sealing part serves as the connecting part of the sealing part.

[0064] The bottom of the sealing part converges and passes through the connecting part of the anchoring part, and an axial limiting part restricted by the connecting part of the anchoring part is provided on the passing-out part.

[0065] The connecting part of the anchoring part is an annular structure, and the central area thereof facilitates the partial extension of the bottom of the sealing part to pass through. When the connecting part of the anchoring part and the rest of the anchoring part are an integral structure, the rest of the anchoring part is cut, and one end is reserved without cutting at the end part, and this end part serves as the connecting part of the anchoring part; in addition, the connecting part of the anchoring part can also be a split structure and is fixedly connected to the rest of the anchoring part in forms such as welding, hooking or binding.

[0066] Optionally, the anchoring part extends from its own connecting part away from the sealing part to form an extension section, and the side of the extension section away from the sealing part turns outwards and folds back to the bottom of the sealing part to form a folding-back section, and this folding-back section abuts against the bottom of the sealing part.

[0067] The whole of the anchoring part is an outwards-turning structure, and the folding-back section surrounds the periphery of the extension section to form a double-layer structure. There is a certain space inside the double-layer structure, which can absorb and allow deformation after the anchoring part abuts against the sealing part, but does not weaken its anchoring effect.

[0068] Optionally, the anchoring part extends from the connecting piece away from the sealing part to form an extension section, and the side of the extension section away from the connecting section turns outwards and folds back to the bottom of the sealing part to form a folding-back section. The folding-back section is inwardly folded and closed at the bottom position of the sealing part to form a closing section, and this closing section abuts against the bottom of the sealing part.

[0069] The closing section extends roughly radially inwards and contacts the bottom of the sealing part, which is more conducive to applying a pre-tightening force.

[0070] Optionally, the closing section floats on the periphery of the extension section or is connected to the extension section.

[0071] "Floating" means that there is no connection relationship with the periphery of the extension section or only contact, and they can move freely relative to each other during deformation. If there is a connection, it can be a fixed connection or a sliding and rotating fit, which all restrict the relative movement mode of the two to a certain extent.

[0072] Since the closing section floats on the periphery of the extension section, the anchoring part can be straightened into a single-layer structure before release for easy loading into the sheath tube and recovery. After the distal end of the anchoring part is disengaged from the sheath tube during release, it has a tendency to turn up towards the proximal end; as the release process progresses, the distal end further turns up towards the proximal end; after the release is completed, the distal end turns up to the proximal end and the edge of the distal end remains open.

[0073] Optionally, the extension section is conical, and its large-head side (i.e., the conical bottom side) is away from the sealing part and is open.

[0074] The extension section is trumpet-shaped for easy recycling, and the flared opening can also improve the strength and structural stability.

[0075] Optionally, the anchoring portion has a pre-shaped state where it does not abut against the sealing portion and a tightened state where it is in contact with the sealing portion. In the pre-shaped state, in the axial direction of the anchoring portion, the connecting portion of the anchoring portion is farther from the sealing portion than the necking section; relative to the pre-shaped state, in the tightened state, in the axial direction of the anchoring portion, the connecting portion of the anchoring portion is further closer to the sealing portion relative to the necking section.

[0076] That is, when the sealing portion and the anchoring portion approach each other relatively, the necking section first contacts the bottom of the sealing portion. Since there is still a certain distance between the connecting portion of the anchoring portion and the sealing portion, this distance also leaves room and possibility for the formation of a pre-tightening force for further pulling.

[0077] Optionally, in the tightened state, in the axial direction of the anchoring portion, the connecting portion of the anchoring portion is flush with the necking section or farther from the sealing portion than the necking section.

[0078] Optionally, the mesh structure branches from the connecting portion of the anchoring portion into multiple support bars, and the support bars form the mesh structure after multiple pairwise intersections and then further branching.

[0079] Optionally, in the mesh structure, the intersection angle between two support bars at the intersection site is 20° - 70°.

[0080] Since it is in a compressed state in the radial direction before release and each support bar converges towards the center, the intersection angle between two support bars at the intersection site generally refers to the release state.

[0081] Optionally, the width of the shown support bar is 0.18 - 0.3 mm.

[0082] Optionally, the anchoring portion abuts against the sealing portion at the intersection site of the support bars.

[0083] The intersection site has better strength and deformation resistance. By abutting the sealing portion through the intersection site, the anchoring portion can avoid large deformation at the contact site and absorbing the expected pre-tightening force.

[0084] Optionally, the support bars start from the connecting portion of the anchoring portion and extend to the end, and intersect pairwise 2 - 6 times in between; the ends of the support bars intersect pairwise at one point.

[0085] The more times of pairwise intersection and then further branching, the denser the grid; conversely, the more times, the sparser the grid. Combining the width of the support bar and the general dimensions of the left atrial appendage, each intersection is equivalent to extending one cell in the axial direction (taking the pre-release state as a reference).

[0086] The pairwise intersections at the ends can prevent the generation of spiky structures, avoiding puncturing the lesion site during release, and the intersection parts at the ends can be polished into rounded corner structures.

[0087] Optionally, a reinforcing hoop is provided around the connecting part.

[0088] The reinforcing hoop can further improve the strength of the connecting part. The reinforcing hoop can be fixed around the connecting part by means such as threading, welding or interference fit. In terms of the axial dimension, the reinforcing hoop can be larger than, equal to or smaller than the connecting part.

[0089] Optionally, the reinforcing hoop axially extends at least to the cutting part of the anchoring part.

[0090] At the part adjacent to the connecting part of the cutting part, there will be a situation of local stress concentration. In order to avoid tearing or unnecessary bending at the starting part of the cutting during assembly, the reinforcing hoop axially extends and wraps the starting part of the cutting. For example, it can extend axially beyond the starting part of the cutting by 2 - 5 mm.

[0091] Optionally, a film is provided on the outer periphery of the anchoring part and / or on the side facing away from the sealing part.

[0092] The film can make the anchoring part have a plugging effect. The film-covered part can be a circle around the outer periphery of the anchoring part, or on the side of the anchoring part facing away from the sealing part, or both parts are covered. Of course, the films on the two parts can extend and approach each other to form a continuous piece and wrap the entire anchoring part.

[0093] Optionally, barbs are provided on the outer side of the anchoring part.

[0094] The barbs can stably hold the position of the left atrial appendage occluder in the left atrial appendage. In the case of having a film, the barbs penetrate through the film and extend to the outside.

[0095] Optionally, the barbs are located at the intersection points of the mesh structure.

[0096] Optionally, the barbs and the anchoring part are of an integral structure.

[0097] That is, the barbs are also cut and formed as part of the support bar. At the part where the barbs are formed, the support bar can be cut through. For example, a straight cut is made on the side of the support bar, or a V-shaped cut is made in the middle of the support bar transversely.

[0098] Optionally, the bottom of the sealing part converges and passes through the connecting part, and an axial limiting part restricted by the connecting part is provided on the part passing through.

[0099] If the sealing part is a woven mesh structure, the filaments used to weave the sealing part converge and gather together at the bottom of the sealing part. This gathering not only reflects the structural characteristics but also includes the corresponding steps during processing, that is, converging multiple filaments into a bundle.

[0100] If the sealing part is a wire frame structure formed by cutting a pipe, the ends of the pipe of the sealing part can be used as the gathering parts.

[0101] Optionally, the axial limiting part is an anti - detachment head tightly fixed on the outer periphery of the gathered part of the sealing part.

[0102] The outer diameter of the anti - detachment head is larger than the inner diameter of the connecting part, which limits the sealing part in a state of being in contact with the anchoring part and can maintain the necessary pre - tightening force.

[0103] The anti - detachment head and the reinforcing hoop can be made of stainless steel, nitinol alloy or other metal materials meeting the requirements of biocompatibility.

[0104] Preferably, the sealing part and the anchoring part are tightly abutted against each other.

[0105] Preferably, the anchoring part has a tightening part that abuts tightly against the sealing part. The anchoring part is in a cylindrical structure in the compressed state, and the tightening part is located on the inner wall side of the cylindrical structure.

[0106] After release, due to the outward curling of the anchoring part, the originally inner - wall - side tightening part is on the outer side and faces the sealing part after curling and abuts tightly against the sealing part.

[0107] In the compressed state, if the tightening part is on the outer wall side of the cylindrical structure, a more complex curling method is required, otherwise it is difficult to take into account obtaining a large outer diameter of the anchoring part to support and anchor the inner wall of the left atrial appendage.

[0108] However, in the form of complex curling, the outward expansion trend of the end (the distal end in the compressed state) of the anchoring part during release can be changed, which can avoid puncturing the inner wall of the left atrial appendage and relatively improve safety.

[0109] Preferably, the anchoring part and the sealing part are in a state of direct contact and tight abutment.

[0110] Under normal use conditions, the anchoring part and the sealing part may be in direct contact and tight abutment, but direct contact and tight abutment are not the only use states. Under the action of special physiological structures or after using for a period of time, the anchoring part and the sealing part may also move away from each other or even have a gap.

[0111] Preferably, the sealing part is a double - layer structure. The layer facing the anchoring part is the bottom layer, and the layer facing away from the anchoring part is the top layer. The sealing part is connected to the anchoring part through the bottom layer.

[0112] In the relative case, the anchoring part partially penetrates through the sealing part and is connected to the top of the sealing part. In the present invention, the anchoring part is connected to the bottom of the sealing part, and it is easier to obtain the pre-deformation of the sealing part when the anchoring part and the sealing part are pressed against each other, or in other words, it has a higher deformation acquisition efficiency.

[0113] As a further preference, one or more flow-blocking membranes are provided inside the double-layer structure.

[0114] Since the sealing part is more likely to loosen and stretch axially when adopting a double-layer structure, the present invention is also preferably applicable to the sealing part with a double-layer structure. Whether it is disc-shaped or columnar, it can be regarded as a double-layer structure and is internally provided with a flow-blocking membrane.

[0115] As a preference, the anchoring part and the sealing part are of a split structure.

[0116] As a further preference, the anchoring part and the sealing part are pressed against each other during the assembly process.

[0117] Adopting a split structure, heat treatment and shaping are carried out separately, and then assembly is carried out, and the pre-deformation effect after pressing can be obtained during the assembly process. If an integral structure is adopted, although the pressing effect can also be obtained, since there is no assembly process, the pressing effect needs to be obtained after heat setting, so higher requirements are put forward for the heat setting process. Generally, the anchoring part and the sealing part need to be heat-treated separately, increasing the processing difficulty.

[0118] In order to obtain better support and anchoring effects, the anchoring parts are continuously distributed in the circumferential direction.

[0119] Although there will be gaps in the axial direction for a net or rod-shaped structure, in terms of the overall structure and distribution, it should be continuously distributed in the axial direction to strive for a more uniform force distribution and stable support, and to avoid relying only on the local circumferential part to provide support.

[0120] As a preference, the parts where the anchoring part and the sealing part are in contact with each other are adjacent to the outer edge of the sealing part.

[0121] As a preference, the parts where the anchoring part and the sealing part are in contact with each other are also adjacent to the outer edge of the anchoring part.

[0122] The contact of the outer edge parts is more likely to obtain axial deformation or radial convergence, and the deformation amount is increased under the same force.

[0123] As a preference, after the sealing part and the anchoring part are heat-set, assembly is carried out. When assembling, the sealing part and the anchoring part have a first state of initial contact;

[0124] The connection part between the sealing part and the anchoring part also has a second state after moving a predetermined distance axially towards each other.

[0125] In the first state, the sealing part and the anchoring part have just come into contact. Since both the sealing part and the anchoring part have completed heat setting, if the two move axially towards each other further, one of them will deform and maintain the stress caused by the deformation in the second state.

[0126] Preferably, the connecting parts between the sealing part and the anchoring part are respectively located in the middle of their respective radial directions. In the first state, the sealing part and the anchoring part are in contact in the peripheral area of the connecting part.

[0127] The above-mentioned stress is also the source of the pre-tightening force. If there is no heat setting before, but heat setting is carried out after assembly, then the stress will disappear during heat treatment and the required pre-tightening force cannot be generated.

[0128] Therefore, it should be emphasized that in the second state, the relative positional relationship after assembly is obtained between the sealing part and the anchoring part, and no heat treatment is carried out after the second state.

[0129] Since the anchoring part has better rigidity, generally the generation of stress mainly comes from the deformation of the sealing part.

[0130] Preferably, relative to the first state, in the second state, the part of the sealing part connected to the anchoring part moves closer to the side of the anchoring part.

[0131] When transitioning to the second state, the distance that the connecting part between the sealing part and the anchoring part moves axially towards each other affects the magnitude of the stress. Therefore, it needs to be expressed and controlled in an appropriate manner during assembly.

[0132] Preferably, the expression of the predetermined distance is as follows:

[0133] The axial acting force of the connecting part between the sealing part and the anchoring part; or

[0134] The pressure at the contact part between the sealing part and the anchoring part; or

[0135] The amount of deformation of the part of the sealing part connected to the anchoring part.

[0136] The amount of deformation is the axial change amount of a predetermined part of the sealing part, or the angle between a predetermined part of the sealing part and the axis of the sealing part.

[0137] The predetermined part of the sealing part is the part that deforms when transitioning from the first state to the second state. For the convenience of expression and measurement, a part with a relatively large amount of deformation can be selected. For example, the predetermined part of the sealing part is the part where the sealing part and the anchoring part are in contact in the first state.

[0138] During assembly, by detecting the change amount of the expression of the predetermined distance, it can correspond to the magnitude of the obtained stress.

[0139] In the absence of such stress, even if there is local contact between the sealing part and the anchoring part during assembly, when the left atrial appendage occluder is axially elongated as a whole during use, that is, when the sealing part and the anchoring part move away from each other, the internal restoring force between the sealing part and the anchoring part is small, and only the elasticity of their respective materials is relied on to overcome the axial elongation as a whole.

[0140] In the present invention, by means of pre-heat setting first, then assembly and retaining the axial stress during assembly, it is possible to better overcome the axial elongation of the left atrial appendage occluder during subsequent use, and the restoring force is increased by the superposition of the elasticity and the pre-tightening force of the materials of the sealing part and the anchoring part, ensuring the occlusion effect during long-term use.

[0141] Correspondingly, the present invention also provides an assembly method for the left atrial appendage occluder with the staggered connection described above. After the sealing part and the anchoring part are heat-set, they are assembled. During assembly, the sealing part and the anchoring part are brought closer to each other and are in the first state when they are initially in contact; on the basis of the first state, the connecting part between the sealing part and the anchoring part moves axially towards each other by a predetermined distance and then reaches the second state;

[0142] The connecting part between the sealing part and the anchoring part is fixed to each other, and the connecting part is kept in the second state to complete the assembly.

[0143] Since the sealing part and the anchoring part have been in local contact with each other in the first state, when changing from the first state to the second state, the axial position between the sealing part as a whole and the anchoring part may not change, and only the stress generated by local deformation occurs.

[0144] The left atrial appendage occluder described in the present invention is delivered to the position of the left atrial appendage of the heart through a percutaneous puncture method by means of a delivery sheath tube to occlude the left atrial appendage, so as to prevent the risk of thrombus formation in the left atrial appendage of patients with atrial fibrillation and thus cause stroke.

[0145] The present invention realizes the staggered connection between the sealing part and the anchoring part through an improved connection method, which can make the sealing part adhere to the left atrial appendage more tightly and occlude the opening of the left atrial appendage, so as to reduce the incidence of internal leakage and residual shunt. Description of the Drawings

[0146] Figure 1 It is a schematic diagram of the left atrial appendage occluder in Embodiment 1;

[0147] Figure 2 It is a schematic diagram of the sealing part after heat setting in Embodiment 1;

[0148] Figure 3 It is a schematic diagram of the anchoring part after heat setting in Embodiment 1;

[0149] Figure 4a It is a schematic diagram of the connection process between the anchoring part and the sealing part (on the side of the anchoring part) in Embodiment 1;

[0150] Figure 4b For Figure 4a Enlarged view of part A in

[0151] Figure 5 Schematic diagram of the connection process between the anchoring part and the sealing part (on one side of the sealing part) in the first embodiment;

[0152] Figure 6 Schematic diagram of the start of docking between the anchoring part and the sealing part in the first embodiment;

[0153] Figure 7a Schematic diagram of the completion of the connection between the anchoring part and the sealing part in the first embodiment;

[0154] Figure 7b Schematic diagram of the connection between the sealing part and the anchoring part in the prior art;

[0155] Figure 7c For Figure 7a Partial omission schematic diagram of

[0156] Figure 8 Schematic diagram of placing the left atrial appendage occluder into the left atrial appendage for occlusion in the first embodiment;

[0157] Figure 9a Schematic diagram of the left atrial appendage occluder in the second embodiment;

[0158] Figure 9b For Figure 9a Enlarged view of part A in

[0159] Figure 10 Schematic diagram of the connection process between the anchoring part and the sealing part in the second embodiment;

[0160] Figure 11a Schematic diagram of the left atrial appendage occluder in the third embodiment;

[0161] Figure 11b For Figure 11a Enlarged view of part A in

[0162] Figure 12a Schematic diagram of the connection process between the anchoring part and the sealing part in the third embodiment;

[0163] Figure 12b For Figure 12a Enlarged view of part A in

[0164] Figure 13 Schematic diagram of the connection process between the anchoring part and the sealing part in the third embodiment;

[0165] Figure 14 Schematic diagram of the left atrial appendage occluder in the fourth embodiment.

[0166] Figure 15aSchematic diagram of the left atrial appendage occluder in Embodiment 5;

[0167] Figure 15b Side view of the sealing part in Embodiment 5;

[0168] Figure 15c Three-dimensional view of the sealing part in Embodiment 5;

[0169] Figure 16 Schematic diagram of the left atrial appendage occluder in Embodiment 6;

[0170] Figure 17a to Figure 17c Schematic diagram of the release process of the anchoring part in Embodiment 7, where the sealing part is shown in the released state in the figure;

[0171] Figure 18 to Figure 20 Schematic diagram of the sealing parts with different bottom plate shapes in Embodiment 7;

[0172] Figure 21 to Figure 25 Comparison schematic diagram of the bottom plate before and after deformation in Embodiment 7;

[0173] Figure 26 to Figure 28 Comparison schematic diagram of the bottom plate with another shape before and after deformation in Embodiment 7;

[0174] Figure 29 to Figure 30 Comparison schematic diagram of the bottom plate before and after deformation in Embodiment 8;

[0175] Figure 31 to Figure 40 Schematic diagrams of before and after assembly with different connection methods in Embodiment 9. Detailed implementation mode

[0176] Embodiment 1:

[0177] As Figure 1 shown, the left atrial appendage occluder 1000 of Embodiment 1 of the present invention includes a sealing part 1100 and an anchoring part 1200 which are connected to each other. The sealing part 1100 is woven from nitinol wires, and the anchoring part 1200 is formed by cutting a pipe.

[0178] The sealing part 1100 includes a disk surface 1110, a waist part 1120 and a disk bottom 1170. There is a bolt head 1130 at the end of the disk surface, a layer of PET flow-blocking film 1140 is sewn inside the disk surface, a layer of flow-blocking film 1150 is sewn in the middle of the waist part, and a layer of flow-blocking film 1160 is sewn inside the disk bottom.

[0179] The anchoring portion 1200 is composed of an inner-layer net-shaped cone 1210, an outer-layer net-shaped cylinder 1220, an outer-layer end bending portion 1230, an arc transition portion 1240 between the inner-layer net-shaped cone 1210 and the outer-layer net-shaped cylinder 1220, and an arc transition portion 1250 between the outer-layer net-shaped cylinder 1220 and the end bending portion 1230. There are evenly distributed barbs 1270 on the outer surface circumference of the outer-layer net-shaped cylinder 1220.

[0180] Among them, the inner-layer net-shaped cone 1210 is equivalent to the extension section; the outer-layer net-shaped cylinder 1220 is equivalent to the folding-back section; the outer-layer end bending portion 1230 is equivalent to the closing section.

[0181] The distal end of the bottom of the sealing portion is connected to the proximal end of the inner-layer net cone of the anchoring portion, and this connection method can be connected by a rigid sleeve fastening or laser welding method.

[0182] Before the sealing portion and the anchoring portion are connected, the sealing portion is formed by heat treatment of a cylindrical braided nickel-titanium net through a mold at high temperature. Figure 2 It can be seen that the sealing portion 1100 after heat treatment and shaping of the occluder 1000 has a distal nickel-titanium wire 1171 and is subjected to a bunching treatment, which is equivalent to the connecting portion of the sealing portion.

[0183] When the anchoring portion is cut, a section is reserved at the end without cutting. After heat treatment and shaping at high temperature, the reserved part serves as the connecting portion of the annular anchoring portion. During installation, the distal nickel-titanium wire 1171 of the sealing portion 1100 is passed through the annular connecting portion, and after passing through, the excess part is cut off and axially limited to each other with the annular connecting portion by welding or installing a rigid sleeve at the end.

[0184] In another method, the anchoring portion is also formed by heat treatment of a cylindrical braided nickel-titanium net through a mold at high temperature. See Figure 3 , the inner-layer net-shaped cone 1210 of the anchoring portion 1200 has a proximal nickel-titanium wire 1261 and is subjected to a bunching treatment. During installation, the distal nickel-titanium wire 1171 of the sealing portion 1100 and the proximal nickel-titanium wire 1261 of the anchoring portion 1200 are interspersed and connected to each other through a connecting piece.

[0185] Whether the anchoring portion is in a cutting method or a braiding method, its shape characteristics and working principles are similar. The main difference is that when using the braiding method, the part where the warp and weft are interlaced is movable, that is, the warp and weft are only in contact with each other by overlapping and are not fixed to each other, while when using the cutting method, the part where the warp and weft are interlaced is fixed because it is an integral structure before cutting.

[0186] Of course, it is also possible to perform a layered treatment on the part where the warp and weft are interlaced, that is, to cut the pipe wall into two layers at the part where the warp and weft are interlaced, which can enable the warp and weft to move and separate relatively, similar to the braided structure.

[0187] Figure 4a to Figure 7c This is a connection method for the sealing portion 1100 and the anchoring portion 1200 of the left atrial appendage occluder 1000 in the first embodiment of the present invention.

[0188] For example, the anchoring part adopts a braiding method, and the proximal nickel-titanium wire 1261 of the anchoring part is bundled between an outer steel sleeve 1262 (equivalent to an outer ring) and an inner steel sleeve 1263 (equivalent to an inner ring). It can be seen in the figure that the nickel-titanium wire used for braiding the anchoring part is bundled at the proximal end of the extension section and is connected to the inner and outer steel sleeves serving as connectors. Figure 4a It can be seen that the inner and outer steel sleeves serving as connectors are further away from the sealing portion than the closing section. The anchoring portion of the roll-up structure is generally bowl (or nest) shaped, and the connector is located inside the bowl, that is, sunk below the bowl mouth.

[0189] Then, the inner and outer steel sleeves and the proximal nickel-titanium wire 1261 therebetween are fixed together by welding or pressing. The inner steel sleeve 1263 is a hollow structure. Then, the nickel-titanium wire outside the proximal end of the outer steel sleeve 1262 is removed by cutting or laser processing.

[0190] like Figure 5 and Figure 6 The distal nickel-titanium wire 1171 of the sealing part is gathered in the middle of the bottom of the disc and then passes through the inner steel sleeve 1263, which can apply a certain pulling force to tightly connect the sealing part 1100 and the anchoring part 1200, forming a certain pre-tightening force. The waist of the sealing part is stretched into a tapered structure through this pre-tightening force, and the overall height of the left atrial appendage occluder can be reduced at the same time.

[0191] In other embodiments, the distal nickel-titanium wire 1171 of the sealing portion is gathered in the middle of the bottom of the disc and then passes through the inner steel sleeve 1263. Since the distal nickel-titanium wire 1171 and the inner steel sleeve 1263 are staggered in space, the sealing portion 1100 and the anchoring portion 1200 can be brought as close as possible to reduce the axial size of the left atrial appendage occluder, and there is no strict restriction on the need for tight pressing.

[0192] In other embodiments, the distal nickel-titanium wire 1171 of the sealing portion is gathered in the middle of the bottom of the disc and then passes through the inner steel sleeve 1263. Since the distal nickel-titanium wire 1171 and the inner steel sleeve 1263 are staggered in space, the sealing portion 1100 and the anchoring portion 1200 can be brought as close as possible until they are in contact to reduce the axial size of the left atrial appendage occluder. The sealing portion 1100 and the anchoring portion 1200 are in contact with each other but are not strictly required to be pressed tightly.

[0193] For example, the anchoring part adopts a cutting method, and the structure with an axial channel in the middle formed by assembling the proximal nickel-titanium wire 1261, the outer steel sleeve 1262, and the inner steel sleeve 1263 can be regarded as the uncut part reserved at the end when the pipe is cut, that is, the annular connecting part.

[0194] The distal nickel-titanium wire 1171 of the sealing part converges in the middle of the bottom of the disc and then passes through the annular connecting part. Then, a certain pulling force can be applied to tightly connect the sealing part 1100 and the anchoring part 1200, forming a certain pre-tightening force.

[0195] As Figure 6 shown in the structural form of the sealing part; the distal nickel-titanium wires 1171 of the sealing part are fixed together through a steel sleeve 1172 (equivalent to an anti-disengagement head). The steel sleeve 1172 should slide and abut against the distal end of the inner steel sleeve 1263 and then be fixed to the distal nickel-titanium wire 1171. The outer diameter of this steel sleeve 1172 is larger than the inner diameter of the inner steel sleeve 1263 to prevent the distal nickel-titanium wire 1171 from slipping out of the inner steel sleeve 1263.

[0196] For example, if the anchoring part is cut, the distal nickel-titanium wires 1171 of the sealing part are fixed together through a steel sleeve 1172 (equivalent to an anti-disengagement head). The steel sleeve 1172 should slide and abut against the distal end of the connecting part of the anchoring part to prevent the distal nickel-titanium wire 1171 from slipping out of the annular connecting part.

[0197] After that, the redundant distal nickel-titanium wires 1171 at the distal end of the sealing part are cut off or processed by laser. The steel sleeve material described in the present invention can be stainless steel, nickel-titanium alloy or other metal materials meeting the biocompatibility requirements. In this embodiment, stainless steel material is selected.

[0198] During the assembly process, when the sealing part 1100 and the anchoring part 1200 approach each other, the moment they just come into contact can be regarded as the first state. As the distal nickel-titanium wire 1171 is further axially pulled, the side of the sealing part 1100 facing the anchoring part 1200 will gradually abut against the anchoring part 1200 to generate stress, that is, pre-tightening force. After the distal nickel-titanium wire 1171 is axially pulled a predetermined distance, it reaches the second state. At this time, the sealing part 1100 and the anchoring part 1200 are kept in the second state through the steel sleeve 1172, that is, the stress is maintained.

[0199] The predetermined axial pulling distance can be directly measured, or can be obtained by expressing the shape change of the side of the sealing part 1100 facing the anchoring part 1200, that is, the bottom of the disc 1170. It can also directly measure the pulling force of the distal nickel-titanium wire 1171 or the pulling force between the sealing part 1100 and the anchoring part 1200.

[0200] The shape change of the bottom of the disc 1170 can be either with reference to its own shape in the first state, or with reference to the included angle with the waist 1120 or the axis of the sealing part 1100 in different states.

[0201] Comparing Figure 6 with Figure 7a it can be clearly known that in the first state (at Figure 6The sealing portion 1100 and the anchoring portion 1200 are brought closer together, but since they are just in contact, the shape of the sealing portion 1100 does not change. Figure 6 shape.) The bottom 1170 is substantially perpendicular to the waist 1120, and Figure 7a In the second state, the angle between the bottom 1170 and the waist 1120 increases, and the radial middle part of the bottom 1170 further bulges toward the anchoring part 1200. Therefore, the predetermined distance of the axial pulling of the distal nickel-titanium wire 1171 can also be expressed and controlled by changing the angle.

[0202] After the sealing part 1100 is connected to the anchoring part 1200, a layer of PET flow-blocking film 1140 is sutured inside the sealing part of the left atrial appendage occluder by suturing, and a layer of PET flow-blocking film 1150 and a layer of PET flow-blocking film 1160 are sutured in the middle of the waist of the sealing part and the bottom of the disk respectively. Figure 1 shown.

[0203] The sealing part 1100 is a cage-shaped structure with a certain internal space. In the pre-formed state, the waist is roughly cylindrical. Figure 2 and Figure 7a It can be seen that after assembly, the bottom of the disc and the closing section are pressed against each other, and the distal side of the waist is radially contracted and deformed with a certain taper, forming a roughly inverted frustum structure. Not only that, under the action of the preload force, the middle part of the bottom of the disc also bulges toward the anchoring part.

[0204] See also Figure 7b In the prior art, the sealing portion 1100 has a connecting portion 1180, and the anchoring portion 1200 has a connecting portion 1280. The connecting portions of the sealing portion 1100 and the anchoring portion 1200 extend toward each other and align with each other, and are fixed by welding or annular hoops after extending to contact each other.

[0205] As can be seen from the figure, there is a large gap between the sealing portion 1100 and the anchoring portion 1200, and the sealing effect needs to be improved.

[0206] In this embodiment, the convergent portions of the sealing portion 1100 and the anchoring portion 1200 serve as the connecting portion, or the uncut portion of the anchoring portion 1200 serves as the connecting portion. For ease of operation, the anchoring portion 1200 can also be cut to improve flexibility. After cutting, the connection method is the same as when braiding, that is, the inner and outer steel sleeves are used to clamp and secure the ends.

[0207] See also Figure 7c, after completion of the assembly, the connecting part of the anchoring part 1200 is fixed between the outer steel sleeve 1262 and the inner steel sleeve 1263, while the connecting part of the sealing part 1100 passes through the inner steel sleeve 1263 and is fixed by the steel sleeve 1172. The steel sleeve 1172 abuts against the distal side of the inner steel sleeve 1263. From this connection method, it can be seen that the connecting part of the sealing part 1100 is in the central area, and the connecting part of the anchoring part 1200 is in its peripheral area. The connecting parts of the two are staggered inside and outside and cross over each other's end parts.

[0208] When projected along the axial direction of the left atrial appendage occluder, i.e., Figure 7c in the A direction in Figure 7c , the connecting part of the anchoring part 1200 and the connecting part of the sealing part 1100 are nested with each other, and their respective extension paths are both straight lines, that is, extending along the axial direction of the left atrial appendage occluder. Due to the staggered arrangement, there is no spatial interference during their respective extensions, and the distance between the sealing part 1100 and the anchoring part 1200 is shortened as much as possible until they abut against each other in the peripheral area of the connecting parts of the two.

[0209] When projected along the direction perpendicular to the axis of the left atrial appendage occluder, i.e., Figure 7c in the B direction in Figure 7c , the connecting part of the anchoring part 1200 and the connecting part of the sealing part 1100 overlap each other, and the connecting part of the sealing part 1100 is within the projection area of the connecting part of the anchoring part 1200.

[0210] In this embodiment, the sealing part 1100 and the anchoring part 1200 and their respective connecting parts are of an integral structure. Moreover, a split form can also be adopted, that is, there is no convergent extension in the opposite direction, but connecting rods are fixed in the middle of the opposite sides of the two. The connecting rod of one of them is of a hollow structure, and the connecting rod of the other passes through it, so that an internal and external staggered fixed connection can also be realized.

[0211] As Figure 8 shown, after the left atrial appendage occluder 1000 of this embodiment is delivered into the left atrial appendage through a percutaneous catheter delivery system, the left atrial appendage occluder is anchored in the left atrial appendage. The connection method between the anchoring part and the sealing part forms a pre-tightening force between the two parts. The tapered structure of the waist 1120 of the left atrial appendage occluder can better adhere to the opening position of the left atrial appendage. The pre-tightening force can make the sealing part disk surface 1110 adhere more closely to the left atrial appendage, so that the three-layer film effectively blocks the blood flow from flowing into the left atrial appendage, thereby reducing the incidence of endoleak.

[0212] Embodiment Two:

[0213] The left atrial appendage occluder 2000 of the second embodiment of the present invention is composed of a sealing part 2100 and an anchoring part 2200. The structural shapes of the sealing part and the anchoring part after heat setting are the same as those in Embodiment One. The difference from Embodiment One lies in the different connection methods between the anchoring part and the sealing part. The following will be described in detail by taking the braiding method as an example.

[0214] As Figure 9a and Figure 9b shown.

[0215] In the second embodiment of the present invention, the sealing portion 2100 and the anchoring portion 2200 of the left atrial appendage occluder 2000 after heat treatment and shaping, wherein the sealing portion 2100 has a distal nickel-titanium wire convergence, and the anchoring portion 2200 has a proximal nickel-titanium wire convergence.

[0216] As Figure 10 shown, in this embodiment, the distal nickel-titanium wire 2171 of the sealing portion and the proximal nickel-titanium wire 2261 of the anchoring portion respectively pass through a steel sleeve 2272 (equivalent to the connector body) from opposite directions (towards each other) after convergence.

[0217] Along Figure 10 the directions of the arrows in, tensile forces are applied to the two bundles of nickel-titanium wires respectively, so that the sealing portion 2100 and the anchoring portion 2200 are tightly connected to form a certain pre-tightening force, and through this pre-tightening force, the waist 2120 of the sealing portion is stretched into a tapered structure; then as Figure 9b , the proximal nickel-titanium wire 2261 of the anchoring portion can be fixed together through the steel sleeve 2263 by pressing or welding.

[0218] After the distal nickel-titanium wire 2171 of the sealing portion is fixed together through the steel sleeve 2172 by pressing or welding, it is then clamped on both sides of the steel sleeve 2272, and the excess nickel-titanium wire is cut off or processed by laser treatment.

[0219] When the anchoring disc is cut, the proximal end of the anchoring portion 2200 can not be cut, and after passing through the steel sleeve 2272, it is flanged by itself and limited to one side of the steel sleeve 2272, so that the steel sleeve 2263 can also be omitted.

[0220] In order to improve flexibility and facilitate operation, the proximal end of the anchoring portion can also be cut into several nickel-titanium alloy strips or a nickel-titanium alloy mesh, and corresponding convergence treatment is carried out. The proximal end of the anchoring portion 2200 directly penetrates into the steel sleeve 2272, a tensile force is applied to tightly connect the sealing portion 2100 and the anchoring portion 2200, and the proximal end of the anchoring portion is fixed together through the steel sleeve 2263 by pressing or welding and clamped on one side of the steel sleeve 2272.

[0221] Referring to Figure 9b , in this embodiment, the sealing portion 2100 and the anchoring portion 2200 also adopt a similar manner to that in the first embodiment, having a connecting portion with an integral structure and extending towards each other, the difference being that the connecting portions of the two are staggered in a mutually deviated manner. Taking the orientation in the figure as an example, one is on the left and the other is on the right.

[0222] Similarly, the spatial interference during the extension towards each other can be avoided, and the sealing portion 2100 and the anchoring portion 2200 are pulled as close to each other as possible.

[0223] Embodiment 3:

[0224] In Embodiment 3 of the present invention, the left atrial appendage occluder 3000 is composed of a sealing part 3100 and an anchoring part 3200. The structural shapes of the sealing part 3100 and the anchoring part 3200 after heat setting are the same as those in Embodiment 1 and Embodiment 2. The difference from Embodiment 1 and Embodiment 2 lies in the different connection methods between the anchoring part and the sealing part. The following takes the braiding method as an example for detailed description.

[0225] As Figure 11a and Figure 11b shown.

[0226] In Embodiment 3 of the present invention, for the sealing part 3100 and the anchoring part 3200 of the left atrial appendage occluder 3000 after heat treatment and setting, there is a distal nickel-titanium wire bunching in the sealing part 3100, and a proximal nickel-titanium wire bunching in the anchoring part 3200. Figure 12a to Figure 13 This is another connection method between the sealing part 3100 and the anchoring part 3200 of the left atrial appendage occluder 3000 in Embodiment 3 of the present invention.

[0227] In this embodiment of the left atrial appendage occluder 3000, the distal nickel-titanium wire 3171 of the sealing part 3100 bunches and passes through between the outer steel sleeve 3172 and the inner steel sleeve 3173, and then the nickel-titanium wires of the outer steel sleeve 3172 and the inner steel sleeve 3173 are fixed together by welding or pressing. The inner steel sleeve 3173 is a hollow structure, and then the nickel-titanium wires outside the distal end are removed by cutting or laser treatment.

[0228] The proximal nickel-titanium wire 3261 of the anchoring part bunches and passes through the inner steel sleeve 3173 at the distal end of the sealing part, and penetrates into the middle of the mesh of the sealing part. A certain pulling force can be applied to tightly connect the sealing part and the anchoring part, forming a certain pre-tightening force, and through this pre-tightening force, the waist of the sealing part is stretched into a tapered structure; then the proximal nickel-titanium wire bundle of the anchoring part is fixed together by the steel sleeve 3162. The outer diameter of this steel sleeve 3162 is larger than the inner diameter of the inner steel sleeve 3173 of the sealing part, and the redundant nickel-titanium wires at the proximal end of the anchoring part are cut off or removed by laser treatment.

[0229] When the anchoring disc adopts the cutting method, the proximal end of the anchoring part 2200 can not be cut. After passing through the inner steel sleeve 3173, it flips itself and is limited to one side of the inner steel sleeve 3173, so that the steel sleeve 3162 can also be omitted. In order to improve flexibility and facilitate operation, the proximal end of the anchoring part can also be cut into several nickel-titanium alloy thin strips or nickel-titanium alloy meshes, and corresponding bunching treatment is carried out. The proximal end of the anchoring part 2200 directly penetrates into the inner steel sleeve 3173 and is fixed and limited by the steel sleeve 3162.

[0230] Embodiment 4:

[0231] The difference between this embodiment and the first embodiment lies in the shape of the sealing part 4100, as Figure 14 shown.

[0232] In this embodiment, the sealing part 4100 is a flat disc-shaped, that is, a sealing disc. The sealing disc is a double-layer structure, and a flow-blocking film is arranged inside. Under the action of the pre-tightening force, the middle part of the bottom surface of the sealing disc bulges towards the anchoring part.

[0233] The anchoring part is a rhombic cell structure cut from a pipe. The proximal end of the anchoring part is the uncut part of the pipe, and it serves as an annular connecting part. There is a reinforcing hoop outside the connecting part, and a part of the reinforcing hoop wraps the cutting starting area of the anchoring part adjacent to the connecting part to improve the local strength.

[0234] During assembly, the distal end nickel-titanium wire of the sealing part 4100 is bundled and passes through the annular connecting part. An anti-disconnection head is arranged at the passing-out part, and the outer diameter of the anti-disconnection head is larger than the inner diameter of the connecting part. The end of the bundled nickel-titanium wire can be fixed by welding and tightening methods.

[0235] Embodiment Five:

[0236] As Figure 15a to 15c shown, the left atrial appendage occluder of the fifth embodiment of the present invention includes a sealing part 5100 and an anchoring part 5200 which are connected to each other. The sealing part 5100 is woven from nickel-titanium wire, and the anchoring part 5200 is a wire frame structure cut from a pipe.

[0237] In this embodiment, the sealing part and the assembly method of the sealing part and the anchoring part adopt the method of the first embodiment and are tightly abutted against the anchoring part. The main difference lies in that the anchoring part adopts a cutting method.

[0238] The sealing part 5100 includes a disc surface 5110, a waist part 5120 and a disc bottom 5170. There is a bolt head 5130 at the end of the disc surface. A layer of PET flow-blocking film 5140 is sewn inside the disc surface, a layer of flow-blocking film 5150 is sewn in the middle of the waist part, and a layer of flow-blocking film 5160 is sewn inside the disc bottom.

[0239] The anchoring part is composed of an inner-layer reticulated cone 5210, an outer-layer reticulated cylinder 5220, an outer-layer end bending part 5230, an arc transition part 5240 between the inner-layer reticulated cone 5210 and the outer-layer reticulated cylinder 5220, and an arc transition part 5250 between the outer-layer reticulated cylinder 5220 and the end bending part 5230. There are evenly distributed barbs 5270 on the outer surface of the outer-layer reticulated cylinder 5220.

[0240] Among them, the inner-layer reticulated cone 5210 is equivalent to the extension section; the outer-layer reticulated cylinder 5220 is equivalent to the turning-back section; the outer-layer end bending part 5230 is equivalent to the closing section.

[0241] The distal end of the bottom of the sealing part is connected to the conical proximal end of the inner layer net of the anchoring part.

[0242] The sealing part 5100 has a distal end nitinol wire 5171 which is subjected to a bunching treatment. The proximal end of the anchoring part is the uncut part of the pipe, and serves as an annular connecting part 5260. An enhancing hoop 5280 is provided outside the connecting part 5260. A part of the enhancing hoop 5280 wraps the cutting starting area of the anchoring part adjacent to the connecting part 5260 to improve the local strength.

[0243] During assembly, the distal end nitinol wire 5171 passes through the connecting part 5260. An anti-disengagement head 5172 is provided at the passing-out part. The outer diameter of the anti-disengagement head 5172 is larger than the inner diameter of the connecting part 5260. The end of the distal end nitinol wire 5171 can be fixed by means of welding and tightening.

[0244] The anti-disengagement head 5172 can be limited relative to the connecting part 5260 and tighten the sealing part 5100, tightly connect the sealing part 5100 and the anchoring part 5200 to form a certain pre-tightening force, and make the waist of the sealing part stretch into a tapered structure through this pre-tightening force. At the same time, the overall height of the left atrial appendage occluder can be reduced.

[0245] The anchoring part is a mesh structure, having a rhombic cell structure. It bifurcates from the connecting part into multiple support bars, and the width of each support bar is 0.18 - 0.3 mm.

[0246] For example, starting from the connecting part, one support bar 51 bifurcates into a support bar 511 and a support bar 512 after extending a certain distance. After the support bar 511 and the support bar 512 each extend, they intersect with the support bars at adjacent positions. For example, the support bar 511 and the support bar 513 intersect, and barbs 5270 are provided at the intersection part. The corresponding support bars bifurcate and extend respectively after the first intersection at the barb 5270 part, and intersect again at the end 5290 for the second time. The intersection angle between the support bar 511 and the support bar 513 at the intersection part is 20° - 70°.

[0247] Embodiment Six:

[0248] As Figure 16 shown, the difference between this embodiment and Embodiment Five lies in the shape of the sealing part 6100. As Figure 16 shown, in this embodiment, the sealing part 6100 is a flat disc shape, that is, a sealing disc. The sealing disc is a double-layer structure, and a flow-blocking film is arranged inside. Under the action of the pre-tightening force, the middle part of the bottom surface of the sealing disc bulges towards the side of the anchoring part 6200 to form a pre-tightening force.

[0249] Embodiment Seven:

[0250] This embodiment mainly illustrates the release of the anchoring part and the change in the shape of the sealing part during the assembly process. For the specific structures of the anchoring part and the sealing part, without special instructions, they can be combined with at least one of the other embodiments.

[0251] Refer to Figure 17a to Figure 17c , in this embodiment, the left atrial appendage occluder includes a sealing part 5100 and an anchoring part 5200 which are connected to each other. Before release, the anchoring part 5200 is compressed in the sheath tube to facilitate traveling in the body and entering the lesion site. In the compressed state, the anchoring part 5200 is cylindrical, and part A is on the inner wall of the cylinder. As the anchoring part 5200 unfolds and releases (the unfolding direction can be seen from the arrow indication), part A gradually turns outwards from the inner wall of the cylinder and finally abuts against the bottom part of the disc of the sealing part 5100.

[0252] Refer to Figure 18 to Figure 20 , the sealing part 1100 includes a disc surface, a waist and a disc bottom 5110. The central area of the disc bottom 5110 converges to form a distal nitinol wire 5120, and the distal nitinol wire 5120 passes through the connecting part 5210 of the anchoring part (such as in the form of a steel sleeve, etc.).

[0253] In different embodiments, the middle area of the disc bottom 5110 can bulge away from the anchoring part, as shown in Figure 18 ; the middle area of the disc bottom 5110 can be flat, as shown in Figure 19 ; the middle area of the disc bottom 5110 can also bulge towards the anchoring part, as shown in Figure 20 .

[0254] The above are all the shape characteristics of the disc bottom 5110 when the assembly is not completed, that is, when the pre-tightening force has not been applied. After the pre-tightening force is applied, the middle area of the disc bottom 5110 has different degrees of deformation and generally moves closer to the anchoring part further.

[0255] Refer to Figure 21 to Figure 25 , taking one of the disc bottom shapes as an example, after the sealing part and the anchoring part are processed and heat-treated and shaped respectively, the assembly starts. First, the distal nitinol wire 5120 is passed through the connecting part 5210 of the anchoring part so that the sealing part and the anchoring part approach each other axially.

[0256] As shown in Figure 22 , when they first contact and no pre-tightening force is applied, it is the first state. At this time, the middle area C of the disc bottom 5110 has a tendency to bulge away from the anchoring part. Then, the distal nitinol wire 5120 is pulled down along the Figure 23 arrow direction, while the connecting part 5210 of the anchoring part moves relatively upward along the arrow direction. The middle area C is deformed by the force until the predetermined deformation or pre-tightening force requirement is reached, and then the anti-disengagement head 5130 is used to fix the distal nitinol wire 5120. At this time, it is the second state, as shown in Figure 24 , and the middle area C is deformed by the force and is basically in a flat-bottom state.

[0257] To control the assembly process, the change of angle B or the axial change amount H of the middle region C can be monitored when applying the pre-tightening force. The deformation of the middle region C under force is reflected more obviously through Figure 25 comparison. The dotted line represents the position of the middle region C in the first state.

[0258] See Figure 26 to Figure 28 , in another embodiment, when the sealing part and the anchoring part just come into contact and no pre-tightening force is applied, it is the first state. At this time, the middle region C of the bottom plate 5110 has a tendency to bulge away from the anchoring part. During assembly, the distal nitinol wire is pulled downward, and the connecting part of the anchoring part moves relatively upward. The middle region C deforms under force until the predetermined deformation or pre-tightening force requirement is reached, and then the distal nitinol wire is fixed by the anti-disengagement head. At this time, it is the second state. When the middle region C deforms under force, the waist of the sealing part converges radially along the Figure 27 arrow direction. In the second state, together with the bottom plate, it is in an inverted cone shape as a whole. It is reflected more obviously through Figure 28 comparison. The dotted line represents the position of the waist and the middle region C in the first state.

[0259] Embodiment Eight:

[0260] See Figure 29 and Figure 30 , in this embodiment, the left atrial appendage occluder includes a sealing part 6100 and an anchoring part 6200. One side of the sealing part 6100 facing the anchor-shaped part is an inverted cone-shaped bottom plate 6110 in the first state. The central region of the bottom plate 6110 converges to form a distal nitinol wire 6120. The distal nitinol wire 6120 passes through the connecting part 6210 of the anchoring part 6200 (such as in the form of a steel sleeve, etc.).

[0261] In the second state after assembly, the middle part of the bottom plate 6110 gets closer to the connecting part 6210, and the taper increases. The distal nitinol wire 6120 locks the axial position through the anti-disengagement head of 6130.

[0262] Embodiment Nine:

[0263] This embodiment mainly shows different connection methods of the anchoring part and the sealing part. For the specific structures of the anchoring part and the sealing part, without special instructions, they can be combined with at least one of the other embodiments.

[0264] In the attached drawings of this embodiment, the left atrial appendage occluder includes a sealing part 7100 and an anchoring part 7200 which are connected to each other. The sealing part 7100 includes a disk surface, a waist and a bottom plate 7110.

[0265] Figure 31 、 Figure 32In it, the central region of the bottom plate 7110 converges in shape to form a connecting part, that is, the central region converges to form the distal nickel-titanium wire 7120. The middle part of the anchoring part converges in shape as a whole to form a connecting part, and its end is fixed through a connecting piece 7210 (for example, a steel sleeve). During assembly, the distal nickel-titanium wire 7120 passes through the hollow part of the connecting piece 7210 of the anchoring part and is relatively tightened to form a pre-tightening force. After the anchoring part and the sealing part are pressed against each other, the middle region of the bottom plate deforms further and bulges towards the anchoring part. Finally, the distal nickel-titanium wire 7120 is fixed using an anti-disengagement head 7130 (for example, a steel hoop), and then the excess part of the distal nickel-titanium wire 7120 is cut off to complete the assembly.

[0266] In another embodiment, refer to Figure 33 、 Figure 34 , the central region of the bottom plate 7110 converges in shape to form a connecting part, that is, the central region converges to form the distal nickel-titanium wire 7120. The middle part of the anchoring part converges in shape as a whole, that is, it converges to form the proximal nickel-titanium wire 7220. Using a connecting piece 7210 with two side-by-side arranged channels, the distal nickel-titanium wire 7120 and the proximal nickel-titanium wire 7220 pass through the corresponding channels in opposite directions and are relatively tightened to form a pre-tightening force. After the anchoring part and the sealing part are pressed against each other, the middle region of the bottom plate deforms further and bulges towards the anchoring part. Finally, the distal nickel-titanium wire 7120 is fixed using an anti-disengagement head 7130 (for example, a steel hoop), and then the excess part of the distal nickel-titanium wire 7120 is cut off; the proximal nickel-titanium wire 7220 is fixed using an anti-disengagement head 7230 (for example, a steel hoop), and then the excess part of the proximal nickel-titanium wire 7220 is cut off to complete the assembly.

[0267] In another embodiment, refer to Figure 35 、 Figure 36 , the central region of the bottom plate 7110 converges in shape to form a connecting part, and its end is fixed through a connecting piece 7140 (for example, a steel sleeve). The middle part of the anchoring part converges in shape as a whole, that is, it converges to form the proximal nickel-titanium wire 7220. The proximal nickel-titanium wire 7220 passes through the hollow region of the connecting piece 7140 and is relatively tightened to form a pre-tightening force. After the anchoring part and the sealing part are pressed against each other, the middle region of the bottom plate deforms further and bulges towards the anchoring part. The proximal nickel-titanium wire 7220 is fixed using an anti-disengagement head 7230 (for example, a steel hoop), and then the excess part of the proximal nickel-titanium wire 7220 is cut off to complete the assembly.

[0268] In another embodiment, refer to Figure 37 、 Figure 38 , the central region of the bottom plate 7110 converges in shape to form a connecting part, that is, the central region converges to form the distal nickel-titanium wire 7120. The middle part of the anchoring part converges in shape as a whole, that is, it converges to form the proximal nickel-titanium wire 7220.

[0269] The distal nitinol wire 7120 and the proximal nitinol wire 7220 are directly connected, that is, the connecting piece is omitted. It can be seen in the figure that the proximal nitinol wire 7220 is bolt-wound around the outer periphery of the distal nitinol wire 7120. An anti-disconnection head 7130 (such as a steel hoop) can be arranged at the end of the distal nitinol wire 7120. The end of the proximal nitinol wire 7220 can be fixed at the bottom of the disc of the sealing part by welding. It can also be that its spiral shape is pre-shaped by heat treatment, and it overcomes its elasticity and unfolds during winding and is rewound around the outer periphery of the distal nitinol wire 7120. Moreover, the distal nitinol wire 7120 can also be in a spiral shape and wound around the proximal nitinol wire 7220 reciprocally.

[0270] In another embodiment, refer to Figure 39 , Figure 40 , the overall shape of the bottom of the disc 7110 converges to form a connecting part, that is, the overall converges to form the distal nitinol wire 7120. The middle part of the anchoring part converges in shape to form a connecting part, and its end is fixed by a connecting piece 7210 (such as a steel sleeve). During assembly, the distal nitinol wire 7120 passes through the hollow part of the connecting piece 7210 of the anchoring part and is relatively tightened to form a pre-tightening force. Finally, the distal nitinol wire 7120 is fixed by using an anti-disconnection head 7130 (such as a steel hoop), and then the redundant part of the distal nitinol wire 7120 is cut off to complete the assembly.

[0271] The specific embodiments of the present invention disclosed above are only for illustration. However, the present invention is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Obviously, these changes and modifications should fall within the protection scope required by the present invention. In addition, although some specific terms are used in this specification, these terms are only for convenience of description and do not constitute any special limitation to the present invention.

Claims

1. An interleaved left atrial appendage occluder, comprising a sealing portion and an anchoring portion connected to each other, characterized in that, The anchoring part has a reticular structure formed by cutting, and the sealing part and the anchoring part respectively have connecting parts formed by shape convergence. The connecting parts of both the sealing part and the anchoring part extend towards each other and are fixed in a staggered manner; The sealing part and the anchoring part are pressed against each other to generate a pre-tightening force, thereby causing the sealing part to undergo pre-deformation. The sealing part and the anchoring part are pressed against each other in the peripheral area of their respective connecting parts; The connecting part of the sealing part has opposite distal and proximal ends, and the connecting part of the anchoring part has opposite distal and proximal ends, The distal end of the connecting part of the sealing part extends between the proximal end and the distal end of the connecting part of the anchoring part; Or, the distal end of the connecting part of the sealing part crosses the proximal end and the distal end of the connecting part of the anchoring part; Or, the proximal end of the connecting part of the anchoring part extends between the proximal end and the distal end of the connecting part of the sealing part; Or, the proximal end of the connecting part of the anchoring part crosses the proximal end and the distal end of the connecting part of the sealing part.

2. The cross-connected left atrial appendage occluder according to claim 1, wherein The connecting parts of both the sealing part and the anchoring part are directly connected or connected through a connecting piece.

3. The cross-connected left atrial appendage occluder according to claim 1, wherein The connecting parts of both the sealing part and the anchoring part are nested or deviated from each other at the parts where they cooperate with each other.

4. The cross-connected left atrial appendage occluder according to claim 1, wherein, The sealing part includes a disk surface facing away from the anchoring part, a disk bottom facing the anchoring part, and a waist connecting the disk surface and the disk bottom, wherein the disk bottom is a flat bottom, or the middle part of the disk bottom bulges towards the anchoring part side, or the middle part of the disk bottom bulges away from the anchoring part side.

5. The overlapping left atrial appendage occluder according to claim 4, wherein, The sealing part has a pre-shaped state where it does not contact the anchoring part and a pressed state where it contacts the anchoring part. Relative to the pre-shaped state, the sealing part in the pressed state has deformation in the waist and / or the disk bottom.

6. The cross-connected left atrial appendage occluder according to claim 1, wherein The sealing part is a sealing disk, having a pre-shaped state where it does not contact the anchoring part and a pressed state where it contacts the anchoring part. Relative to the pre-shaped state, the disk bottom of the sealing part facing the anchoring part has an axial deformation towards the anchoring part.

7. The cross-connected left atrial appendage occluder according to claim 1, wherein The anchoring part is formed by cutting a pipe, and the reticular structure is a hexagonal grid or a rhombic grid structure or a combination of a hexagonal grid and a rhombic grid.

8. The cross-connected left atrial appendage occluder according to claim 7, wherein The side of the sealing part facing the anchoring part is the bottom, and one end of the pipe is provided with an annular connecting part, and this connecting part is connected to the bottom of the sealing part.

9. The staggeringly-connected left atrial appendage occluder according to claim 8, wherein, The anchoring part extends away from the sealing part from the connecting piece to form an extension section, and the side of the extension section away from the connecting section turns outwards and folds back to the bottom of the sealing part to form a folding-back section. The extension section is conical, and its large-head side is away from the sealing part and is open.

10. The cross-linked left atrial appendage occluder according to claim 8, characterized in that, The anchoring part extends away from the sealing part from the connecting piece to form an extension section, and the side of the extension section away from the connecting section turns outwards and folds back to the bottom of the sealing part to form a folding-back section. The folding-back section is inwardly folded and closed at the bottom position of the sealing part to form a closed section, and this closed section abuts against the bottom of the sealing part.

11. The stagger-connected left atrial appendage occluder according to claim 10, wherein The anchoring part has a pre-shaped state where it is not pressed against the sealing part and a pressed state where it contacts the sealing part. In the pre-shaped state, in the axial direction of the anchoring part, the connecting part of the anchoring part is farther away from the sealing part than the closed section; relative to the pre-shaped state, in the pressed state, in the axial direction of the anchoring part, the connecting part of the anchoring part is relatively closer to the sealing part than the closed section.

12. The stagger-connected left atrial appendage occluder according to claim 11, wherein, In the pressed state, in the axial direction of the anchoring part, the connecting part of the anchoring part is flush with the closed section or farther away from the sealing part than the closed section.

13. The staggeredly connected left atrial appendage occluder according to claim 3, characterized in that, The anchoring part has a pressing part that abuts against the sealing part. The anchoring part is in a cylindrical structure in the compressed state, and the pressing part is located on the inner wall side of the cylindrical structure.

14. The cross-linked left atrial appendage occluder according to claim 8, characterized in that, The mesh structure branches from the connecting part of the anchoring part into multiple support bars, and the support bars form the mesh structure after multiple pairwise intersections and then further branching.

15. The cross-connected left atrial appendage occluder according to claim 13, wherein In the mesh structure, the crossing angle between two support bars at the intersection part is 20° - 70°.

16. The cross-linked left atrial appendage occluder according to claim 14, wherein The anchoring part abuts against the sealing part at the intersection part of the support bars.

17. The overlapping left atrial appendage occluder according to claim 16, wherein The support bars extend from the connecting part of the anchoring part to the ends, and pairwise intersect with each other 2 to 6 times in between, and the ends of the support bars intersect pairwise at one place.

18. The cross-connected left atrial appendage occluder according to claim 8, wherein, A reinforcing hoop is provided around the connecting part, and the reinforcing hoop extends at least to the cutting part of the anchoring part in the circumferential axial direction.

19. The stagger-connected left atrial appendage occluder according to claim 16, wherein The bottom of the sealing part converges and passes through the connecting part, and an axial limiting part restricted by the connecting part is provided on the part that passes through. The axial limiting part is an anti - detachment head tightly fixed on the outer periphery of the converged part of the sealing part.

20. The cross-connected left atrial appendage occluder according to claim 1, wherein, The anchoring part and the sealing part are of a split structure; the anchoring part and the sealing part abut against each other during the assembly process.

21. The overlapping left atrial appendage occluder according to claim 20, wherein, The sealing part and the anchoring part are assembled after heat setting. During assembly, the sealing part and the anchoring part have a first state of initial contact. The sealing part and the anchoring part also have a second state after the connecting part between the sealing part and the anchoring part moves a predetermined distance axially towards each other.

22. The cross-linked left atrial appendage occluder according to claim 21, wherein The connecting parts between the sealing part and the anchoring part are respectively located in the middle of their respective radial directions. In the first state, the sealing part and the anchoring part are in contact in the peripheral area of the connecting part.

23. The cross-connected left atrial appendage occluder according to claim 22, wherein, Relative to the first state, in the second state, the part of the sealing part connected to the anchoring part moves closer to the side of the anchoring part.

24. An assembly method of the stagger-connected left atrial appendage occluder as described in claim 1, characterized in that, The sealing part and the anchoring part are assembled after heat setting. During assembly, the sealing part and the anchoring part approach each other and are in the first state at the initial contact; based on the first state, after the connecting part between the sealing part and the anchoring part moves a predetermined distance axially towards each other, the sealing part and the anchoring part reach the second state. The connecting parts between the sealing part and the anchoring part are fixed to each other, so that the sealing part and the anchoring part are kept in the second state to complete the assembly.

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