Left atrial appendage occluder

Abstract

The application relates to a left auricle occluder, which comprises an occlusion stent, the occlusion stent comprises a net stent body and a tail connected with the stent body, the stent body has a skirt at a distal end, the skirt comprises a plurality of circumferentially connected grids, and the heights of at least two grids in the skirt are different; the tail comprises a plurality of circumferentially arranged ribs, one end of each rib is connected with the skirt, and the other end of each rib is folded into a blunt shape, and at least part of the grids in the skirt are connected with at least two ribs in this way, so that the damage of the distal end of the occlusion stent to tissues is reduced, and the mutual nesting or winding problems of the distal end of the occlusion stent are avoided.

Description

Technical Field

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

[0002] Atrial fibrillation is the most common sustained arrhythmia, and the incidence increases with age. When atrial fibrillation occurs, blood flow to the atria is impaired, leading to the formation of a blood clot in the left atrial appendage. Patients with atrial fibrillation are 5-6 times more prone to blood clots than the general population. Therefore, preventing atrial fibrillation is of great importance. Currently, 90% of patients with non-valvular atrial fibrillation have a chance of developing a blood clot in the left atrial appendage. Recent studies have shown that occlusion of the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation.

[0003] Existing surgical instruments for left atrial appendage occlusion fall into two categories: one is the cage-like internal occluder, primarily based on the Watchman brand, which is inserted into the left atrial appendage during implantation and fixed in place with anchoring pins; the other is the umbrella-shaped external occluder, which consists of two parts: an occluder disc for insertion into the left atrial appendage, serving the primary occlusion function, and a positioning structure that conforms to the opening of the left atrial appendage, potentially providing some occlusion as well. However, these occluders still present issues with safety and operability during use. Summary of the Invention

[0004] In order to solve one or more technical problems in the prior art, the present invention aims to provide a left atrial appendage occluder that reduces damage to tissues by the distal end of the stent and avoids the problem of stents nesting or entanglement, thereby improving the safety, stability and consistency of the occluder.

[0005] To achieve the above objectives, the present invention provides a left atrial appendage occlusion device, including an occlusion stent, the occlusion stent including a mesh stent body and a tail connected to the stent body;

[0006] The support body has a skirt at the distal end, the skirt comprising a plurality of circumferentially connected grids, and at least two of the grids in the skirt have different heights;

[0007] The tail section includes multiple circumferentially arranged ribs, one end of each rib is connected to the skirt, and the other end of each rib is folded into a blunt shape; at least two ribs are connected to the mesh in the skirt.

[0008] Optionally, the mesh in the skirt includes a first mesh with a first height and a second mesh with a second height, the first height being greater than the second height, and all the first meshes are connected by at least two ribs.

[0009] Optionally, at least two of the ribs connected to the first grid are folded from the farthest vertex of the first grid toward the same side of the first grid, and an angle is formed between adjacent ribs.

[0010] Optionally, one or more second grids may be set between two adjacent first grids, or one or more first grids may be set between two adjacent second grids.

[0011] Optionally, the second height is less than or equal to 0.9 times the first height.

[0012] Optionally, the other end of each rib is folded inward into a blunt shape and then connected to the support body.

[0013] Optionally, at least two of the ribs connected to the same grid are folded inward from the farthest vertex of the grid into a blunt shape and extend along two adjacent sides of the grid, with the other end connected to the support body at the junction of adjacent grids.

[0014] Optionally, the mesh in the skirt includes a first mesh with a first height and a second mesh with a second height, the first height being greater than the second height; at least a portion of the first mesh is connected to at least two ribs, and at least a portion of the second mesh is connected to at least two ribs;

[0015] The furthest position of the rib connected to the first grid after unfolding and elongation is further away from the proximal end of the support body than the furthest position of the rib connected to the second grid after unfolding and elongation.

[0016] Optionally, at least two of the ribs connected to the same mesh may have different elongation lengths after unfolding.

[0017] Optionally, at least two of the ribs connected to the first grid are folded inward from the farthest vertex of the first grid into a blunt shape and then connected to the support body to form at least two first connection points;

[0018] At least two of the ribs connected to the second grid are folded inward from the farthest vertex of the second grid into a blunt shape and then connected to the support body to form at least two second connection points;

[0019] The distance from the second connection point and the first connection point to the proximal end of the support body is the same.

[0020] Optionally, a second grid is set between two adjacent first grids, and one or more first grids are set between two adjacent second grids.

[0021] Optionally, at least part of the mesh is connected by three ribs, one end of each of the three ribs being connected to the farthest vertex of the mesh; wherein the two outer ribs are folded inward from the farthest vertex of the mesh into an obtuse shape and extend along two adjacent sides of the mesh, and the other end is connected to the support body at the connection point of the adjacent mesh; the middle rib is folded inward from the farthest vertex of the mesh into an obtuse shape and extends along the diagonal of the mesh, and the other end is connected to the support body at the nearest vertex of the mesh.

[0022] Optionally, the middle rib is thicker than the two ribs on either side.

[0023] Optionally, the width of the middle rib is 1.1 to 2.0 times the width of the two outer ribs.

[0024] Optionally, at least two of the ribs connected to the same mesh have different elongations after unfolding.

[0025] Optionally, one end of each rib is connected to the farthest vertex of the grid, and the other end is folded inward from the vertex into a blunt shape and connected to the support body at the connection of adjacent grids. The other end further passes through the support body from the inside of the blocking support and protrudes from the outer surface of the support body to form an anchoring spike.

[0026] In the aforementioned left atrial appendage occluder, at least a portion of the mesh in the distal skirt of the occluder is connected by at least two ribs, making the deployed left atrial appendage occluder more stable. Simultaneously, setting at least two meshes of different heights in the skirt creates a grid with varying heights, reducing the surface area of ​​contact between the occluder and tissue at the bends, further minimizing damage to tissue from the distal end of the occluder. Furthermore, a higher mesh facilitates better conformation of the left atrial appendage occluder to the left atrial appendage wall, resulting in better compliance and occlusion. A lower mesh helps reduce nesting or entanglement of the distal end of the occluder. Because nesting or entanglement of the distal end of the occluder is less likely to occur, after detachment from the delivery sheath, the distal end of the occluder can more easily and smoothly open to fully conform to the left atrial appendage wall, improving the support, stability, and consistency of the left atrial appendage occluder, thereby enhancing occlusion performance.

[0027] In the aforementioned left atrial appendage occluder, preferably, the first grid (high grid) in the skirt is connected to at least two ribs, so that when the left atrial appendage occluder is released, the high grid is blunted by the ribs to avoid damage to the left atrial appendage, while the low grid does not need to be reinforced.

[0028] In the aforementioned left atrial appendage occluder, it is preferable that all ribs are folded inward, and even more preferably that they are connected to the stent body after folding. This configuration can reduce the folding size of the left atrial appendage occluder, making it easier to deliver it in the body. Moreover, the inward folding takes up less space, making it easier to fold and retrieve the left atrial appendage occluder. At the same time, since the folding point after inward folding is hidden inside the left atrial appendage occluder, the damage to the left atrial appendage is less. Attached Figure Description

[0029] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0030] Figure 1a This is a front view of a left atrial appendage occluder according to a preferred embodiment of the present invention, wherein the tail is a three-sided fold, and the part above the dotted line L1 is a skirt, and the tail is connected to the distal end of the skirt;

[0031] Figure 1b This is a perspective view of a left atrial appendage occluder according to a preferred embodiment of the present invention, wherein the tail is folded on three sides;

[0032] Figure 2a This is a schematic diagram of the tail of a standard left atrial appendage occluder implanted in the left atrial appendage. If the stent is pushed forward, the tail will puncture the tissue.

[0033] Figure 2b This is a schematic diagram of the tail of the left atrial appendage occluder during implantation of the present invention, wherein if the occluder is advanced forward, the tail will not puncture the tissue.

[0034] Figure 3 This is a partial planar view of the case where the skirt heights are equal according to a preferred embodiment of the present invention;

[0035] Figure 4 A partial structural diagram of a preferred embodiment of the present invention showing that after two adjacent left and right side reinforcing bars are partially connected, the other end of the reinforcing bar protrudes from the inside of the sealing bracket and out of the bracket body to form an anchoring spike on the outer surface.

[0036] Figure 5 This is a partial structural diagram of a preferred embodiment of the present invention when the skirt heights are not equal;

[0037] Figure 6 This is a perspective view of a left atrial appendage occluder according to a preferred embodiment of the present invention, wherein at least two grids in the skirt have different heights, and each grid is connected to two ribs;

[0038] Figure 7 This is a partial planar view of a case where the skirt heights are not equal according to a preferred embodiment of the present invention;

[0039] Figure 8This is a front view of a left atrial appendage occluder provided by the present invention according to a preferred embodiment, wherein the tail is folded on three sides and the skirt is composed of a grid with one high and one low, wherein the part above the dotted line L1 is the skirt and the tail is connected at the far end of the skirt.

[0040] Figure 9 yes Figure 8 A three-dimensional view of the left atrial appendage occluder shown;

[0041] Figure 10 This is a perspective view of a left atrial appendage occluder according to a preferred embodiment of the present invention, wherein the tail is folded on three sides and the skirt is composed of a grid with one high and one low side.

[0042] [The annotations in the attached figures are explained below]:

[0043] 100 - Occlusive stent; 10 - Standard stent; 20 - Left atrial appendage; 11 - Tail end of standard stent;

[0044] 110 - Support body; 120 - Tail end; 121 - Rib; 1211 - Left rib; 1212 - Middle rib; 1213 - Right rib; 1214 - First mounting hole; 1215 - Second mounting hole; 130 - Skirt; a - Far end of the support body; b - Proximal end of the support body; c - Connection point of adjacent grids; d - Position where the first mounting hole connects to the first connecting hole; e - Position where the second mounting hole connects to the second connecting hole; P1 - Farthest position of the equal-height grid; P2 - Position of the farthest end of the first grid; P3 - Position of the farthest end of the second grid; P4 - Position of the closest ends of the first and second grids;

[0045] 111-Anchoring area; 1111-Anchor spike; 1112-Support rod; 1113-First connecting hole; 1114-Second connecting hole; 112-Support area; 113-Chassis area; 1131-Proximal connector; 101-First grid; 102-Second grid; 1011-Long rib; 1012-Third mounting hole; 1115-Third connecting hole; 1116-Fourth connecting hole; 1021-Short rib; 1022-Fourth mounting hole. Detailed Implementation

[0046] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are simplified and not drawn to scale, and are only used to facilitate and clarify the illustration of the embodiments of the present invention. As used in this specification, the singular forms "a," "an," and "the" include plural objects unless otherwise expressly indicated. As used in this specification, the term "or" is generally used to include the meaning of "and / or" unless otherwise expressly indicated.

[0047] In the following description, for ease of description, the terms "distal" and "proximal," "axial," and "circumferential" are used; "distal" refers to the side away from the operator of the left atrial appendage occluder; "proximal" refers to the side closer to the operator of the left atrial appendage occluder; "axial" refers to the direction along the longitudinal axis of the occlusion stent of the left atrial appendage occluder; "circumferential" refers to the direction around the longitudinal axis of the occlusion stent of the left atrial appendage occluder; "inward" refers to the direction closer to the longitudinal axis of the occlusion stent; and "outward" is the side opposite to "inward." In the description of this invention, unless otherwise stated, "a plurality of" means two or more, and "several" means the number is not limited. Furthermore, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, some technical features well-known in the art have not been described to avoid confusion with the invention.

[0048] The present invention will be further described below with reference to the accompanying drawings and preferred embodiments. Unless otherwise specified, the following embodiments and features may complement or combine with each other. Furthermore, the ribs mentioned in the following description include long ribs, short ribs, intermediate ribs, left ribs, or right ribs.

[0049] Figure 1a and Figure 1b A schematic diagram of a left atrial appendage occluder according to a preferred embodiment of the present invention is shown. Figure 1a and Figure 1b As shown, a preferred embodiment of the present invention provides a left atrial appendage occluder, including an occlusion stent 100. Preferably, the left atrial appendage occluder further includes a covering (the covering is not shown for ease of explanation of the occlusion stent). The covering is used to cover the entire or part of the inner and / or outer surface of the occlusion stent 100 to more effectively prevent thrombi from passing through the left atrial appendage opening. The left atrial appendage occluder of this embodiment is an open-type cage-like inner plug structure, that is, the left atrial appendage occluder is completely embedded in the left atrial appendage during implantation and is anchored to the left atrial appendage with anchoring spikes, thereby achieving fixation within the left atrial appendage. More specifically, the distal end a of the expanded occlusion stent 100 opens to form an opening, and the proximal end b is brought together by the stent rod and combined with the covering to achieve a sealing effect. This structure, with the proximal end b closed and the distal end a open, allows the left atrial appendage occluder to adapt to the constantly beating environment of the heart during implantation, avoiding the problem of cardiac arrest caused by the left atrial appendage occluder dislodging, ensuring safety and reliability.

[0050] The occlusion stent 100 includes a mesh stent body 110 and a tail 120 connected to the stent body 110, with the tail 120 located at the distal end a of the occlusion stent 100. It should also be understood that, functionally, the stent body 110 includes an anchoring region 111, a support region 112, and a chassis region 113 distributed axially from the distal end a to the proximal end b, wherein the tail 120 is connected to the anchoring region 111; the tail 120 is a blunt tail region used to prevent tissue contusion at the distal end of the occlusion stent 100; the anchoring region 111 has anchoring spikes 1111 for inserting into the left atrial appendage tissue to achieve stable anchoring of the left atrial appendage occluder; the support region 112 assists in providing partial support; the chassis region 113 provides superior support, and the chassis region 113 is provided with a proximal connector 1131 for detachable connection with the delivery device. This section only divides the occlusion stent 100 functionally, without specifying the exact size of each region. The anchoring region 111 can be understood as the portion extending upwards from the base of the anchoring spikes 1111, with this portion accounting for approximately 10-30% of the total length of the occlusion stent. The base region 113 is concave inwards, providing the occlusion stent 100 with a certain degree of support and deformation recovery, ensuring that the left atrial appendage occluder can return to its original shape after exiting the sheath. The support region 112 consists of several grids that assist in providing support; it can be parallel to the longitudinal axis of the stent body 110 or at a certain angle to it. If the support region 112 is parallel to the longitudinal axis, it provides better support. The anchoring region 111 bulges outwards, providing some support and ensuring that the anchoring spikes 1111 can hook into the internal tissues of the left atrial appendage, preventing them from dislodging.

[0051] The stent body 110 has a skirt 130 located at the distal end, the skirt 130 comprising a plurality of circumferentially connected grids. It should be understood that the skirt 130 is the outermost ring of grids at the stent body 110, and the tail 120 is directly connected to the skirt 130. The number of grids in the skirt 130 is set according to actual needs, and this application does not require it. The tail 120 specifically includes a plurality of ribs 121 arranged circumferentially along the stent body 110. One end of each rib 121 is connected to the skirt 130, and the other end of each rib 121 is folded (or bent) into a blunt shape. Preferably, the other end of each rib 121 is folded into a blunt shape and then connected to the stent body 110 to enhance the support performance of the left atrial appendage occluder. Here, "blunt" refers to the rib 121 being blunt and not sharp, forming an inward or outward rolled arc or near-arc structure, so that the tail 120 of the occlusion stent 100 forms a non-traumatic surface, avoiding damage to the left atrial appendage. Furthermore, at least a portion of the mesh in the skirt 130 is connected by at least two ribs 121. Generally, one end of each rib 121 connects to a vertex at the farthest end of the mesh in the skirt 130, preventing a sharp point from forming at the farthest vertex of the mesh in the skirt 130. Here, the vertex of the mesh is the node of the mesh, and the node farthest from the proximal end b is used as the vertex. The shape of the mesh in the skirt 130 is not limited; it can be triangular, quadrilateral, hexagonal, etc. In this embodiment, the mesh is quadrilateral, but the quadrilateral is not limited to a rhombus.

[0052] In one example, each grid in the skirt 130 is connected by at least two of the ribs 121, typically one grid is connected by two or three ribs 121.

[0053] In another example, a portion of the mesh in the skirt 130 is connected to at least two of the ribs 121, while the remaining meshes are not connected to any ribs 121. In this case, the heights of at least two meshes in the skirt 130 are preferably not equal, and generally only at least two ribs 121 are connected to the higher mesh. Ribs 121 may or may not be connected to the lower mesh, but preferably no ribs 121 are connected to the lower mesh. Generally, two ribs 121 connected to the same mesh are folded into a blunt shape from the farthest vertex of the mesh toward the same side (preferably the inner side) of the mesh, and an angle is formed between adjacent ribs 121. Further, a rib 121 is provided between two ribs 121 connected to the same mesh, and the middle rib 121 is folded into a blunt shape from the farthest vertex of the mesh toward the diagonal direction of the mesh.

[0054] In practical implementation, the rib 121 can be folded inward into a blunt shape either towards the inside of the occlusion stent 100 or outward into a blunt shape. Folding inward into a blunt shape reduces the folding size of the left atrial appendage occluder, facilitating its delivery within the body. Furthermore, the inward fold occupies less space, making it easier to fold and retrieve the occluder. Since the folding point is hidden inside the occluder, it causes less damage to the left atrial appendage and improves its support performance. Conversely, folding outward into a blunt shape also improves the support performance of the occluder, providing better support than the inward fold.

[0055] Preferably, the other end of each rib 121 is folded into a blunt shape and then connected to the stent body 110 to further enhance the support performance of the left atrial appendage occluder. More preferably, the other end of each rib 121 is folded inward into a blunt shape and then connected to the stent body 110. In this case, the folded size of the left atrial appendage occluder is small, and it is less likely to damage the left atrial appendage, while also improving the support performance of the left atrial appendage occluder. The connection method between the rib 121 and the stent body 110 is not limited, such as a detachable connection like a snap, stitch, or binding, or a non-detachable connection like welding, riveting, or bonding.

[0056] It should be understood that the left atrial appendage occluder in this embodiment, through the folding of the tail 120, prevents damage to the left atrial appendage wall at its distal end during implantation, thus avoiding the risk of postoperative pericardial effusion. In particular, the inward folding of the tail 120 provides greater maneuverability for the surgeon, resulting in a higher success rate. Furthermore, the inward folding shortens the length of the left atrial appendage occluder in its compressed state, allowing it to adapt to different patients and offering good flexibility. Simultaneously, when the left atrial appendage occluder is retracted into the delivery sheath, its distal end remains blunt and not sharp, enabling a push-in method during delivery. When using this push-in method, even if the surgeon misplaces the occluder during surgery, it can be partially retracted and continued to be advanced without risk of tissue puncture. In other words, each rib 121 in the tail portion 120 of this invention is folded inward into a blunt shape, so that the left atrial appendage occluder will also form a blunt distal end in the unreleased state, avoiding damage to the left atrial appendage wall during implantation. In this way, the delivery sheath can be prevented from retracting to release the left atrial appendage occluder during implantation, thereby ensuring the accuracy of the left atrial appendage occluder release position and avoiding the risk of the left atrial appendage occluder falling off later.

[0057] In some embodiments, the tail portion 120, after folding inward, can be connected to any one of the chassis area 113, the support area 112, and the anchoring area 111. Preferably, the tail portion 120 is connected to either the support area 112 or the anchoring area 111 to facilitate the entry and exit of the left atrial appendage occluder from the delivery sheath. However, in practice, a suitable connection area should be selected based on actual strength requirements to form a blunt tail.

[0058] In this embodiment of the invention, the tail portion 120 preferably forms an angle A of 90° to 180° with the longitudinal axis of the stent body 110, which can better improve the support performance of the left atrial appendage occluder. Here, assuming the direction from the proximal end b to the distal end a of the occluder is taken as the positive direction of the longitudinal axis, then the bending angle of each rib 121 relative to the positive direction of the longitudinal axis is in the range of 90° to 180°. More preferably, the angle A between the tail portion 120 and the longitudinal axis of the stent body 110 is in the range of 110° to 150°. Angle A refers to the angle between the line connecting the farthest bending point to the starting point of each rib 121 and the longitudinal axis, such as... Figure 1a As shown. Limiting the included angle A to a suitable range effectively enhances the ability of the left atrial appendage occluder to anchor and fix within the left atrial appendage, thereby ensuring the reliability of the occluder during use. Furthermore, the included angle A can be, for example, 110°, 135°, or 150°.

[0059] The following will further combine Figure 2a and Figure 2b The left atrial appendage occluder shown for comparison illustrates in detail the advantages achievable by the preferred embodiments of the invention, and for the sake of brevity, Figures 2a to 2b The structures of each part are simplified or some structures are omitted, but those skilled in the art should be able to understand the specific implementation based on the content disclosed in this application and existing knowledge.

[0060] like Figure 2a As shown, the tail 11 of the conventional stent 10 is sharp and pointed during implantation into the left atrial appendage 20. Therefore, the conventional stent 10 is prone to puncturing the left atrial appendage tissue during implantation, causing pain to the patient and, more seriously, pericardial effusion or even perforation. However, as Figure 2b As shown, in this embodiment, the occlusion stent 100 is implanted into the left atrial appendage 20. The tail 120 is blunt and not sharp, so it will not puncture the left atrial appendage tissue.

[0061] In this embodiment of the invention, the stent body 110 and the tail portion 120 are preferably integrally molded structures, meaning the entire occlusion stent 100 is manufactured as a single piece, such as through integral cutting. The integrally molded occlusion stent 100 ensures sufficient support from the left atrial appendage occluder and simplifies the manufacturing process, reducing production costs. The occlusion stent 100 can be a self-expanding structure, preferably made of elastic or hyperelastic materials, more preferably elastic materials with shape memory function, such as nickel-titanium alloys. The occlusion stent 100 can be formed by cutting a metal tube, providing good support strength and effectively occluding the left atrial appendage; laser cutting is the preferred cutting method.

[0062] Return to reference Figure 1a and Figure 1b In one exemplary embodiment, three independent ribs 121 are connected to the farthest vertex of each grid in the skirt 130 of the support body 110, achieving a three-sided fold. That is, the three ribs 121 are grouped together, one end of each group of ribs is connected to the farthest vertex of the grid in the skirt 130, and the other end is folded into a blunt shape from the farthest vertex of the grid.

[0063] Preferably, the three ribs 121 connected to the same grid are folded inward into a blunt shape and then connected to the support body 110. The connection points of the three ribs 121 and the support body 110 are distributed at three points. Among them, the other end of the middle, longer rib 121 (i.e., the middle rib) is folded inward into a blunt shape from the farthest vertex of the grid and extends along the diagonal direction of the grid. Finally, the other end connects to the support body 110 at the nearest vertex of the grid for support. The other ends of the two shorter ribs 121 on the sides (i.e., the left rib and the right rib) are folded inward into a blunt shape from the farthest vertex of the grid and extend along the two adjacent sides of the grid. Finally, the other end connects to the support body 110 at the junction of the adjacent grids for support.

[0064] Preferred, such as Figure 4 As shown, the other ends of two adjacent shorter ribs 121 of adjacent grids are connected and then connected to the support body 110. Optionally, the other ends of the two adjacent shorter ribs 121 of adjacent grids are connected to the support rod 1112 of the support body 110 at the connection point c of the adjacent grids. Preferably, the other ends of the two adjacent shorter ribs 121 of adjacent grids further pass through the support body 110 from the inside of the occlusion support and finally protrude from the outer surface of the support body 110 to form anchoring spikes 1111. This eliminates the need for additional anchoring, thereby simplifying the structure and reducing costs. The present invention does not limit the number of anchoring spikes 1111, which are fixed to the support body 110 and used to hook onto the left atrial appendage to fix the left atrial appendage occluder.

[0065] Furthermore, the inventors discovered that when the tail portion 120 is folded (e.g., folded inward or outward) into a blunt shape and connected to the stent body 110, it is prone to nesting or entanglement with each other during delivery within the delivery sheath or under other compression conditions. Especially after detaching from the delivery sheath within the body, the tail portion cannot open smoothly, resulting in incomplete unfolding and failure to conform to the left atrial appendage wall. This leads to poor stability and consistency of the left atrial appendage occluder, affecting its occlusion performance. Therefore, this invention constructs at least two grids in the skirt portion 130 with different heights; the different grid heights can mean that all grids are different, or that some grids are the same height and some are different heights. The varying heights of the grids in the skirt 130 can be understood as follows: after the occlusion stent 100 is fully expanded, the furthest points of the grids in the skirt 130 are not on the same straight line. In other words, after the left atrial appendage occluder expands, the furthest points of the grids in the skirt 130 are not on the same circumference, resulting in at least two grids in the skirt 130 having different distances from their furthest points to the proximal end of the occluder. It should be understood that forming a grid with varying heights reduces the surface area of ​​contact between the bending points and the tissue, further reducing damage to the tissue from the distal end of the occlusion stent. A higher grid also facilitates better contact between the left atrial appendage occluder and the left atrial appendage wall, resulting in better compliance and occlusion. A lower grid, on the other hand, helps reduce the problem of nesting or entanglement at the distal end. Because nesting or entanglement at the distal end of the occlusion stent is less likely to occur, after detachment from the delivery sheath, the distal end of the occlusion stent can more easily open and fully conform to the left atrial appendage wall, improving the support, stability, and consistency of the left atrial appendage occluder, thereby improving occlusion performance. However, the present invention does not limit the specific arrangement of the grid height. For example, it can use two different heights of grid, or more different heights of grid. Generally, it is sufficient to use two different heights of grid.

[0066] In some embodiments of the present invention, such as Figure 1a and Figure 1b As shown, the height of the grids in the skirt 130 is the same, and each grid is connected to three ribs 121, which increases the surface area of ​​the tail in contact with the tissue at the bend, further reducing the damage to the tissue at the distal end of the scaffold.

[0067] Figure 3 A partial structure of the sealing support 110 with a uniform height grid, after being unfolded in plane, is shown. Figure 3 At position P1, the position of the farthest end of all grids in skirt 130 is shown by a straight line. The positions are axially aligned, that is, the distance from the farthest end of all grids to the near end of the sealing bracket is the same, and three independent ribs 121 are connected from the vertex of the farthest end of each grid.

[0068] For ease of explanation, the three independent ribs 121 at the farthest vertex of each grid in the skirt 130 are defined as the left rib 1211, the middle rib 1212, and the right rib 1213, respectively. Here, left and right are only used to distinguish the middle rib 121 from the two ribs 121 on the sides.

[0069] Preferably, the other ends of a left rib 1211 and a right rib 1213 of adjacent grids are connected to form a common connecting portion, and a first mounting hole 1214 is provided on the common connecting portion. The first mounting hole 1214 is connected to the first connecting hole 1113 on the support rod 1112 of the support body 110 (see reference). Figure 1a (The location indicated by the reference numeral d). Preferably, a second mounting hole 1215 is provided at the other end of the intermediate rib 1212 (see reference). Figure 3 The second mounting hole 1215 is connected to the second connecting hole 1114 on the support rod 1112 (see the position marked by numeral e in 1a). The second connecting hole 1114 is closer to the proximal end b than the first connecting hole 1113. In this embodiment, after the intermediate rib 1212 is bent inward into a blunt shape, the second mounting hole 1215 and the second connecting hole 1114 are aligned and fixed by binding with wire. Similarly, the adjacent left rib 1211 and right rib 1213 are bent inward into blunt shapes, and the first mounting hole 1214 and the first connecting hole 1113 are aligned and fixed by binding with wire. Therefore, the length of the intermediate rib 1212 is generally longer than the lengths of its two sides, the left rib 1211 and the right rib 1213.

[0070] like Figure 1a and Figure 1b As shown, the intermediate rib 1212 is bent into an obtuse shape and extends along the diagonal of the grid. The diagonal of the grid is the line connecting the farthest vertex and the nearest vertex of the grid. Therefore, the intermediate rib 1212 divides the grid into two parts and provides support at the diagonal position, making the grid less prone to lateral deformation. This reduces the risk of the two ribs on both sides of the intermediate rib 1212 folding inward and becoming entangled or nested in the delivery sheath. It also reduces the risk of grid nesting, ensuring that the occlusion stent 100 can open smoothly and fully unfold after the sheath is detached, thus achieving good adhesion between the distal end and the left atrial appendage wall, improving both stability and occlusion. Moreover, the three ribs 121 on the same grid are bent inward into an obtuse shape, increasing the surface area at the bend and making it less likely to damage the left atrial appendage tissue.

[0071] The unfolded elongations of the left-side rib 1211 and the right-side rib 1213 on the same grid can be the same or different. Preferably, at least two ribs 121 connected to the same grid have different unfolded elongations. For example, all ribs 121 connected to the same grid may have different unfolded elongations, or some ribs 121 connected to the same grid may have different unfolded elongations, while others may have the same unfolded elongation.

[0072] In one specific embodiment, the left rib 1211 and the right rib 1213 on the same grid have different lengths after unfolding. The shorter rib 121 of the left rib 1211 and the right rib 1213 forms a small elliptical ring after being bent inward into a blunt shape, while the longer rib 121 of the left rib 1211 and the right rib 1213 forms a large elliptical ring after being bent inward into a blunt shape. The minor axis of the small elliptical ring is smaller than that of the large elliptical ring. The small elliptical ring with a smaller minor axis is not easy to embed into the large elliptical ring with a larger minor axis. Therefore, even if the tail 120 is folded inward during use, it is less likely to nest or entangle with each other, further increasing the stability and consistency of the device implantation.

[0073] Preferably, the other ends of the two adjacent left-side reinforcing bars 1211 and right-side reinforcing bars 1213 in two adjacent grids, after being bent into blunt shapes, are connected and then further connected to the support body 110. The connection method with the support body 1100 can be through the connecting hole of the support rod 1112 and fixedly connected by welding, sewing, snap-fitting, etc. Of course, in other embodiments, the other ends of the two adjacent left-side reinforcing bars 1211 and right-side reinforcing bars 1213 in two adjacent grids after being bent into blunt shapes can also be independent of each other and not connected.

[0074] More specifically, the advantages of folding the three ribs 121 connected to the same mesh inward into a blunt shape are as follows: First, the contact surface area between the distal bend of the tail 120 and the tissue is larger, making it less likely to damage the tissue; second, by folding the independent intermediate rib 1212 and fixing it to the stent body 110, the nesting or entanglement of the two ribs adjacent to the intermediate rib 1212 (i.e., the left rib 1211 and the right rib 1213) is reduced, allowing the left atrial appendage occluder to open smoothly after being removed from the delivery sheath, and allowing the tail 120 to better fit against the left atrial appendage wall; furthermore, the occlusion stent 100 is typically cut from a metal tube containing radiopaque material, making... The entire occlusion stent 100 is radiopaque. When the intermediate rib 1212 is set, its longer length makes it more visible under X-ray imaging, making it easier for doctors to identify. This is especially true when the intermediate rib 1212 is thicker than the ribs on both sides, further enhancing its radiopaqueness. Under X-ray imaging, the operator can identify the opening status of the tail 120 based on the radiopaqueness of the intermediate rib 1212, increasing the safety of the device during use. In addition, the independent intermediate rib 1212 provides better support for the tail 120, ensuring the consistency and stability of the entire occlusion stent implantation. It should be understood that without the central rib 1212, the left ribs 1211 and right ribs 1213, when fully compressed, tend to intertwine or nest with each other upon unfolding. Adding a central rib 1212 avoids this intertwining or nesting problem. Furthermore, a thicker central rib 1212 provides stronger torsional resistance and greater stability, effectively reducing the deformation caused by the mesh's left-right swaying and further mitigating the risk of nesting or intertwining at the tail ribs 120. It should also be understood that among the three ribs 121 connected to the same mesh, the central rib 121 being thicker than the two outer ribs 121 means that the width or diameter of the central rib 121 is greater than the corresponding width or diameter of the two outer ribs 121.

[0075] In some embodiments, the width of the intermediate rib 1212 is 0.5 to 2.0 times the width of the two outer ribs, more preferably 1.0 to 1.5 times. In other embodiments, the width of the intermediate rib 1212 is 1.1 to 2.0 times the width of the two outer ribs. In this embodiment, with the same thickness, the width of the intermediate rib 1212 is larger than the width of the left rib 1211 and the right rib 1213, preferably 1.1 to 1.5 times the width of the left rib 1211 and the right rib 1213, such as 1.1 times, 1.2 times, 1.3 times, or 1.5 times.

[0076] As previously mentioned, it is preferable to set at least two grids in the skirt 130 to have different heights. In one specific embodiment, such as Figure 5As shown, the skirt 130 is composed of grids of two different heights, specifically including a first grid 101 with a first height and a second grid 102 with a second height, the first height being greater than the second height. Preferably, all first grids 101 are connected by at least two ribs 121. Generally, the at least two ribs 121 connected to the first grid 101 are folded inward from the farthest vertex of the first grid 101, forming an angle between the two ribs 121. Preferably, they are folded inward into a blunt shape and then connected to the support body 110. Further, a third rib 121 is provided between the two ribs 121 connected to the first grid 101. This middle rib 121 is folded inward from the farthest vertex of the first grid 101 and extends along the diagonal direction of the first grid 101. Preferably, it is folded inward, and its other end is connected to the support body 110 at the nearest vertex of the first grid 101.

[0077] The distribution of the first grid 101 and the second grid 102 is not limited. For example, one or more second grids 102 may be placed between two adjacent first grids 101, or one or more first grids 101 may be placed between two adjacent second grids 102. The distribution of high and low grids is preferably one high and one low, or multiple high and one low. For example, one first grid 101 may be placed between two adjacent second grids 102, or at least two first grids 101 may be placed between two adjacent second grids 102. The second height is preferably less than or equal to 0.9 times the first height. Generally, the higher the grid connected to the tail 120, that is, the longer its length, the better the adhesion to the left atrial appendage. Therefore, the height of the second grid 102 after unfolding should not be too short, and should be slightly shorter than that of the first grid 101.

[0078] Figures 5 to 7 The illustration shows a case where at least two grids in the skirt 130 of the support body 110 have unequal heights. In this embodiment, the skirt 130 is composed of grids of two different heights, with a second grid 102 positioned between every two adjacent first grids 101, and a first grid 101 positioned between every two adjacent second grids 102. That is, the first grids 101 and second grids 102 appear alternately, forming a repeating arrangement of first grid 101, second grid 102, first grid 101, second grid 102, and so on. This unequal grid structure better solves the problem of nesting or entanglement between adjacent grids and the tail section, and better addresses the issue of incomplete opening of the tail section of the sealing support, thereby preventing unstable anchoring of the sealing support within the body. Furthermore, the folded ribs on adjacent lower grids are less likely to get caught in the elliptical rings of the folded ribs on higher grids.

[0079] exist Figure 7In the partially unfolded diagram, at position P2, the farthest point of the first grid 101 is indicated by a straight line, and at position P3, the farthest point of the second grid 102 is indicated by a straight line. The farthest points of the first grid 101 and the second grid 102 are not aligned axially. Position P2 of the first grid 101 is further away from the proximal end b than position P3 of the second grid 102. Furthermore, at position P4, the closest points of the first grid 101 and the second grid 102 are indicated by a straight line. The closest points of the first grid 101 and the second grid 102 are aligned axially, meaning that the distances from the closest points of the first grid 101 and the second grid 102 to the proximal end b of the occlusion support are the same.

[0080] exist Figure 7In the exemplary embodiment shown, each first grid 101 has two independent long ribs 1011 connected to its farthest vertex. The other ends of these two long ribs 1011 are each provided with a third mounting hole 1012. The two long ribs 1011 connected to the first grid 101 are bent inwards into a blunt shape and then connected to a third connecting hole 1115 on the support rod 1112 through the third mounting hole 1012. The two long ribs 1011 connected to the first grid 101 are respectively connected to different third connecting holes 1115, such as by binding. Simultaneously, each second grid 102 has two independent short ribs 1021 connected to its farthest vertex. The other ends of these two short ribs 1021 are each provided with a fourth mounting hole 1022. The two short ribs 1021 connected to the second grid 102 are bent inwards into a blunt shape and then connected to a fourth connecting hole 1116 on the support rod 1112 through the fourth mounting hole 1022. Two short ribs 1021 connected to the second grid 102 are respectively connected to different fourth connecting holes 1116, and fixedly connected by means such as binding. The third connecting hole 1115 and the fourth connecting hole 1116 are usually axially aligned, that is, the distance from both to the proximal end of the occlusion bracket is the same. It can be understood that at least two long ribs 1011 connected to the first grid 101 are folded inward into a blunt shape and then connected to the bracket body 110 to form at least two first connection points, and at least two short ribs 1021 connected to the second grid 102 are folded inward into a blunt shape and then connected to the bracket body 110 to form at least two second connection points. The distance from the second connection point and the first connection point to the proximal end of the bracket body 110 is the same. Furthermore, the length of the short rib 1021 connected to the second grid 102 after unfolding and elongation is less than the length of the long rib 1011 connected to the first grid 101 after unfolding and elongation. Also, the furthest point of the long rib 1011 connected to the first grid 101 after unfolding and elongation is further away from the proximal end of the support body than the furthest point of the short rib 1021 connected to the second grid after unfolding and elongation. The short rib 1021 folds inward into a blunt shape to form a small elliptical ring, while the long rib 1011 folds inward into a blunt shape to form a large elliptical ring. Therefore, the minor axis of the small elliptical ring of the short rib 1021 is smaller than the minor axis of the large elliptical ring of the long rib 1011, making it difficult for the small elliptical ring with a smaller minor axis to be embedded in the large elliptical ring with a larger minor axis.

[0081] It should be understood that setting high and low grids further reduces nesting issues caused by folded tails. Nesting mainly occurs when the delivery sheath space is limited and the tail occupies a large volume; reducing the space occupied by tails at the same horizontal position reduces nesting. The elliptical rings formed by folding ribs on low grids have smaller minor axes, while those on high grids have larger minor axes. Elliptical rings with smaller minor axes are less likely to embed into those with larger minor axes. Especially when intermediate ribs are used, better anti-torsional performance is provided, helping the occluder deploy more completely. The likelihood of nesting at the folded tail increases with the number of grids around the device. The denser the grid, the better the occlusion effect, but the greater the risk of nesting. Therefore, even when the tail 120 is folded inwards, it is less likely to nest or entangle with each other, further increasing the stability and consistency of device implantation.

[0082] However, in other embodiments, only a portion of the first grid 101 may be connected to the reinforcing bars 121, while the other first grids 101 may not be connected to any reinforcing bars 121. Similarly, the second grid 102 may only be partially connected to the reinforcing bars 121, while the other second grids 102 may not be connected to any reinforcing bars 121. Alternatively, all second grids 102 may not be connected to any reinforcing bars 121, with at least two reinforcing bars 121 connected only to at least a portion of the first grids 101. Furthermore, when constructing an arrangement of high and low grids, the grid may not be limited to only two reinforcing bars 121 connected; three reinforcing bars 121 may also be connected.

[0083] like Figure 8 and Figure 9 As shown, in another exemplary embodiment, three ribs 121 are connected to the first grid 101 and the second grid 102 respectively, with the middle rib 1212 preferably being thicker and extending along the diagonal direction of the grid. Of course, in other embodiments, two ribs may also be connected to the first grid 101 and the second grid 102 respectively, such as... Figures 5 to 7 As shown, one end of each of the two ribs 121 connected to the same grid is connected to the farthest vertex of the grid, and the other end is folded inward from the farthest vertex into a blunt shape and then extends along the two adjacent sides of the corresponding grid. Finally, the other ends of the two ribs are connected to the support body 110 at the connection of adjacent grids.

[0084] It's also important to understand that when the grid density is low, a staggered arrangement of high and low grids is preferred. However, as the grid density increases, a staggered arrangement of multiple high and low grids can be chosen, such as... Figure 10As shown. "Multiple high and one low" refers to the arrangement of a second grid 102 after every two or more first grids 101, i.e., first grid 101, first grid 101, second grid 102, first grid 101, first grid 101, second grid 102… and so on. Therefore, one or more first grids 101 can be placed between two adjacent second grids 102, such as one first grid 101 or two or more first grids 102, or three first grids 101 between two adjacent second grids 102. Higher grids facilitate better fit of the device to the left atrial appendage wall, resulting in better compliance and occlusion, while lower grids help reduce nesting at the tail. Therefore, more high grids are chosen to minimize nesting.

[0085] See also Figure 4 In the double-sided or triple-sided folding, the support rods 1112 forming the grid are provided with connection holes. These connection holes can be formed at the nodes (including vertices) of the grid or along the sides of the grid. Preferably, the connection holes are set at the nodes, that is, the ribs 121 are preferably connected to the support body 110 at the nodes of the grid, which provides better support. Moreover, after each rib 121 passes through a corresponding connection hole, it can be connected to the support rod 1112 using stitching, wire, buckles, rivets, etc. Preferably, these ribs 121 further protrude out of the connection holes and protrude from the outer surface of the support body 110 to form anchoring spikes 1111. This eliminates the need for additional anchoring, thereby simplifying the structure and reducing costs.

[0086] In summary, in the left atrial appendage occluder of the present invention, at least two ribs are connected to at least a portion of the mesh on the distal skirt of the occluder stent, making the deployed left atrial appendage occluder more stable. Simultaneously, setting at least two meshes of different heights in the skirt creates a mesh with varying heights, reducing the surface area of ​​contact between the bending point and tissue, further minimizing damage to tissue from the distal end of the occluder stent. Furthermore, a higher mesh facilitates better fit of the device to the left atrial appendage wall, resulting in better compliance and occlusion, while a lower mesh helps reduce distal nesting or entanglement. Since distal nesting or entanglement is less likely to occur, the distal end of the occluder stent can more easily and fully open to fit the left atrial appendage wall after detachment from the delivery sheath, improving the stability and consistency of the occluder. In particular, the tail of the occluder stent is folded inward into a blunt shape, reducing the length of the occluder and thus increasing the range of patients suitable for use, especially those with relatively short left atrial appendages. In addition, the inward folding of the tail also helps to increase the compression ratio of the stent, making the occlusion stent more supportive. This not only results in better implantation, but also allows it to adapt to left atrial appendages of different shapes and sizes, thus broadening its application range.

[0087] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A left atrial appendage occlusion device, characterized in that, The occlusion support includes a mesh support body and a tail portion connected to the support body. The support body has a skirt at the distal end, the skirt comprising a plurality of circumferentially connected grids, and at least two of the grids in the skirt have different heights; The tail section includes multiple circumferentially arranged ribs, one end of each rib is connected to the skirt, and the other end of each rib is folded into a blunt shape; at least a portion of the mesh in the skirt is connected to at least two of the ribs; The mesh in the skirt includes a first mesh with a first height and a second mesh with a second height, the first height being greater than the second height; at least a portion of the first mesh is connected to at least two ribs, and at least a portion of the second mesh is connected to at least two ribs; The furthest position of the rib after unfolding and elongation connected to the first grid is further away from the proximal end of the support body than the furthest position of the rib after unfolding and elongation connected to the second grid; At least two of the ribs connected to the same mesh have different elongation lengths after unfolding.

2. The left atrial appendage occlusion device according to claim 1, characterized in that, All of the first mesh connections have at least two of the aforementioned ribs.

3. The left atrial appendage occlusion device according to claim 2, characterized in that, At least two of the ribs connected to the first grid are folded from the farthest vertex of the first grid toward the same side of the first grid, and an angle is formed between adjacent ribs.

4. The left atrial appendage occlusion device according to claim 2, characterized in that, One or more second grids may be set between two adjacent first grids, or one or more first grids may be set between two adjacent second grids.

5. The left atrial appendage occlusion device according to claim 2, characterized in that, The second height is less than or equal to 0.9 times the first height.

6. The left atrial appendage occlusion device according to any one of claims 1-5, characterized in that, The other end of each rib is folded inward into a blunt shape and then connected to the support body.

7. The left atrial appendage occlusion device according to claim 6, characterized in that, At least two of the ribs connected to the same grid are folded inward from the farthest vertex of the grid into a blunt shape and extend along two adjacent sides of the grid, with the other end connected to the support body at the junction of adjacent grids.

8. The left atrial appendage occlusion device according to claim 1, characterized in that, At least two of the ribs connected to the first grid are folded inward from the farthest vertex of the first grid into a blunt shape and then connected to the support body to form at least two first connection points; At least two of the ribs connected to the second grid are folded inward from the farthest vertex of the second grid into a blunt shape and then connected to the support body to form at least two second connection points; The distance from the second connection point and the first connection point to the proximal end of the support body is the same.

9. The left atrial appendage occlusion device according to claim 1, characterized in that, A second grid is set between two adjacent first grids, and one or more first grids are set between two adjacent second grids.

10. The left atrial appendage occlusion device according to claim 1 or 2, characterized in that, At least part of the mesh is connected by three ribs, one end of each of the three ribs being connected to the farthest vertex of the mesh; wherein the two outer ribs are folded inward from the farthest vertex of the mesh into an obtuse shape and extend along the two adjacent sides of the mesh, and the other end is connected to the support body at the connection of the adjacent mesh; the middle rib is folded inward from the farthest vertex of the mesh into an obtuse shape and extends along the diagonal of the mesh, and the other end is connected to the support body at the nearest vertex of the mesh.

11. The left atrial appendage occlusion device according to claim 10, characterized in that, The middle rib is thicker than the two ribs on either side.

12. The left atrial appendage occlusion device according to claim 11, characterized in that, The width of the middle rib is 1.1 to 2.0 times the width of the two outer ribs.

13. The left atrial appendage occlusion device according to claim 1 or 2, characterized in that, One end of each rib is connected to the farthest vertex of the grid, and the other end is folded inward from the vertex into a blunt shape and connected to the support body at the connection of adjacent grids. The other end further passes through the support body from the inside of the blocking support and protrudes from the outer surface of the support body to form an anchoring spike.

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