Occluder and occlusion system

Abstract

Provided are an occluder (1) and an occlusion system. The occluder comprises a grid body (10) and a plurality of buffering parts (20). The occluder (1) has an open end and a closed end along an axis. The occluder (1) has a folded state and an expanded state. When the occluder (1) is in the expanded state, the grid body (10) is arranged in a circle around the axis, and the plurality of buffering parts (20) are circumferentially arranged at the open end around the axis. The buffering parts (20) define a reference plane (30) via the middle perpendicular plane of the axis, and the buffering part (20) is asymmetric about the reference plane (30). The arrangement that the buffering part (20) is asymmetric about the reference plane (30) can effectively reduce the situation of entanglement or nesting of the buffering parts (20) and improve the stability of the product while retaining the functionality of the product. In addition, the arrangement of the buffering parts (20) can help reduce tissue damage and improve the safety of the product.

Description

Occluders and occlusion systems Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an occluder and an occluding system. Background Art

[0002] Studies have shown that left atrial appendage occlusion can effectively prevent the risk of ischemic stroke caused by atrial fibrillation.

[0003] An occluder is a device used to block the left atrial appendage. Prior art has disclosed a cage-shaped plug-in occluder, which is embedded in the left atrial appendage during implantation and fixed in place within the left atrial appendage using an anchoring hook on the occluder.

[0004] However, the distal end of the cage-shaped plug-in occluder has a high density, which makes it easy for adjacent structures to become nested and entangled when it is put into the sheath and then unsheathed, which may cause the stent of the occluder to open incompletely, so that the actual size of the stent after deployment cannot well meet the size of the cavity that needs to be filled. This further leads to a decrease in the wall adhesion of the stent, which may lead to a decrease in stability. The high density of the distal end also makes it difficult for the occluder to be compressed and loaded into the sheath, and there are certain difficulties in retrieving and pushing it. In addition, the distal end of the existing cage-shaped plug-in occluder is prone to damage to the tissue. Summary of the Invention

[0005] The object of the present invention is to provide an occluder and an occluding system to solve the problem that existing occluders are prone to nesting and entanglement.

[0006] In order to solve the above technical problems, the present invention provides an occluder, which includes: a grid body and a plurality of buffer parts;

[0007] The occluder has an open end and a closed end along an axis; the occluder has a folded state and an expanded state; when the occluder is in the expanded state, the grid body is annular around the axis, and the plurality of buffer portions are circumferentially arranged around the axis at the open end;

[0008] The buffer portion defines a reference plane through a perpendicular midplane of the axis, and the buffer portion is asymmetrical with respect to the reference plane.

[0009] Optionally, when the occluder is in the expanded state, the buffer portion is inclined inwardly toward the axis in a direction away from the grid body.

[0010] Optionally, when the occluder is in the expanded state, the buffer portion is in a planar shape perpendicular to the reference plane, or the buffer portion is in a spatial three-dimensional shape.

[0011] Optionally, the grid body includes a plurality of first wave rods circumferentially arranged around the axis;

[0012] Each of the buffer parts includes two second wave rods and a bent rod; the first ends of the two second wave rods are respectively connected to two circumferentially adjacent first wave rods, and respectively form two first nodes; the second ends of the two second wave rods are connected to each other to form a second node;

[0013] The first end of the curved rod is connected to the second node, and the second end of the curved rod is connected to the grid body.

[0014] Optionally, the second end of the curved rod is fixed to the first node; and the second ends of the curved rods of the circumferentially adjacent buffer portions are fixed to different first nodes.

[0015] Optionally, the first wave rod is inclined relative to the axis, the inclination directions of the circumferentially adjacent first wave rods are opposite, and multiple first wave rods are connected in sequence to form a zigzag ring; the circumferentially adjacent first wave rods are connected to each other at one end toward the buffer portion, and are connected with the second wave rod to form the first node.

[0016] Optionally, the first wave rods are inclined relative to the axis, and the inclination directions of circumferentially adjacent first wave rods are opposite, and a plurality of the first wave rods are sequentially connected to form a zigzag ring; ends of circumferentially adjacent first wave rods facing the buffer portion are connected to each other and connected to the second wave rod to form the first node; ends of circumferentially adjacent first wave rods away from the buffer portion are connected to each other to form a third node;

[0017] The second end of the curved rod is fixed to the third node; and the second ends of the curved rods of the circumferentially adjacent buffer portions are fixed to different third nodes.

[0018] Optionally, the second end of the curved rod of the buffer portion is connected to the third node formed by two first wave rods connected to two second wave rods of the same buffer portion.

[0019] Optionally, in one of the buffer parts, at least one of the second wave rods includes a curved section at one end away from the first node; and / or the curved rod is bent toward the inside or outside of the truss body.

[0020] To solve the above technical problems, the present invention further provides an occlusion system, which includes the occluder as described above and a conveying device; the conveying device is used to load the occluder in the folded state and to release the occluder.

[0021] In summary, in the occluder and occlusion system provided by the present invention, the occluder includes a grid body and a plurality of buffer parts; the occluder has an open end and a closed end along an axis; the occluder has a folded state and an expanded state; when the occluder is in the expanded state, the grid body is annular around the axis, and the plurality of buffer parts are circumferentially arranged around the axis at the open end; wherein the buffer parts determine a reference plane through the mid-vertical plane of the axis, and the buffer parts are asymmetric with respect to the reference plane.

[0022] This configuration, based on the asymmetric shape of the buffer portion relative to the reference plane, effectively reduces entanglement or nesting of the buffer portion, improving product stability while maintaining its functionality. Furthermore, the buffer portion minimizes tissue damage and enhances product safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0024] FIG1 is a perspective view of an occluder according to an embodiment of the present invention;

[0025] FIG2 is a schematic axial cross-sectional view of an occluder according to an embodiment of the present invention;

[0026] FIG3 is a perspective view of a first example of a buffer portion and a grid body according to an embodiment of the present invention;

[0027] FIG4 is a side view schematically showing a first example of a buffer portion and a grid body according to an embodiment of the present invention;

[0028] FIG5 is a bottom view of a first example of a buffer portion and a grid body according to an embodiment of the present invention;

[0029] FIG6 is a schematic diagram of a blocking system according to an embodiment of the present invention;

[0030] FIG7 is a schematic diagram of the relative relationship between the main body of the grid without a buffer portion and the left atrial appendage;

[0031] FIG8 is a schematic diagram of the relative relationship between the buffer portion and the left atrial appendage according to an embodiment of the present invention;

[0032] FIG9 a is a schematic diagram of the connection between the same first node and two curved rods;

[0033] FIG9 b is a schematic diagram of the same first node connected to only one curved rod;

[0034] FIG10 is a schematic diagram of a second example of a buffer portion and a grid body according to an embodiment of the present invention, wherein the grid body comprises only one row of wave rods;

[0035] FIG11 is a schematic diagram of a second example of a buffer portion and a grid body according to an embodiment of the present invention, wherein the grid body includes two rows of wave bars;

[0036] 12 is a perspective view of a third example of a buffer portion and a grid body according to an embodiment of the present invention;

[0037] 13 is a side view of a third example of a buffer portion and a grid body according to an embodiment of the present invention;

[0038] 14 is a top view of a third example of a buffer portion and a grid body according to an embodiment of the present invention;

[0039] 15 is a schematic diagram of the relative relationship between the buffer portion, the truss body, and the left atrial appendage according to a third example of an embodiment of the present invention;

[0040] FIG16 is a side view of a fourth example of the buffer portion and the grid body according to an embodiment of the present invention.

[0041] In the accompanying drawings: 1-occluder; 10-frame body; 101-first node; 103-third node; 11-first wave rod; 13-third wave rod; 14-fourth wave rod; 20-buffer; 202-second node; 21-second wave rod; 211-bend section; 22-bend rod; 30-reference plane; 40-collecting piece; 41-collecting rod; 42-connecting piece; 50-membrane; 60-delivery device; 62-pushing component; 63-sheath; 70-left atrial appendage. DETAILED DESCRIPTION

[0042] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0043] As used in the present invention, the singular forms "a", "an", "one" and "the" include plural objects, the term "or" is generally used to include the meaning of "and / or", the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features specified as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which not only include endpoints. In addition, as used in the present invention, "installed", "connected", "connected", and one element is "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used relative to the exemplary embodiments as they are shown in the figures, with the upward or upper direction toward the top of the corresponding figure, and the downward or lower direction toward the bottom of the corresponding figure.

[0044] The present invention aims to provide an occluder and an occlusion system to solve the problem that existing occluders are prone to nesting and entanglement. A description will be given below with reference to the accompanying drawings.

[0045] Please refer to Figures 1 to 5. An embodiment of the present invention provides an occluder 1, which is mainly used to occlude the left atrial appendage. The occluder 1 includes a truss body 10 and a plurality of buffer parts 20; the occluder 1 has an open end (the upper end in Figures 1 and 2, for entering the cavity of the left atrial appendage) and a closed end (the lower end in Figures 1 and 2, for occluding the left atrial appendage opening) along an axis A; the occluder 1 has a folded state and an expanded state; when the occluder 1 is in the expanded state, the truss body 10 is annular around the axis A, and the plurality of buffer parts 20 are circumferentially arranged around the axis A at the open end; wherein the buffer parts 20 determine a reference plane 30 (as shown in Figures 4 and 5) through the mid-vertical plane of the axis A, and the buffer parts 20 are asymmetric with respect to the reference plane 30. It should be noted that the reference plane 30 is only a virtual plane, and it is not a physical structure that actually exists on the occluder 1. In addition, in order to more clearly show the reference plane 30, FIG4 does not show the entire structure of the buffer portion 20 and the grid body 10, but only shows a portion (half circumference) on the side facing the observer.

[0046] It should be noted that the connection end of each buffer portion 20 to the truss body 10 has a certain width in the circumferential direction of the truss body 10. For example, each buffer portion 20 is connected to the truss body 10 at two first nodes 101 (see Figure 4 for details, and refer to the following description). The length of the line connecting the two first nodes 101 is the circumferential width of the buffer portion 20 in the truss body 10. The plane passing through the midpoint O of the line connecting the two first nodes 101 and passing through the axis A is called the median perpendicular plane of the buffer portion 20. In some embodiments, the buffer portion 20 is connected to the truss body 10 at three different nodes (as shown in Figures 13 and 16). That is, when each buffer portion 20 is connected to the truss body 10 at two first nodes 101 and one third node 103, the plane passing through the centroid of the three nodes of the buffer portion 20 (the center point of the shape formed by the three nodes) and passing through the axis A is called the median perpendicular plane of the buffer portion 20. The reference plane 30 shown in Figure 4 is perpendicular to the paper. In the occluder 1 provided in this embodiment, the buffer portion 20 is asymmetric with respect to its reference plane 30 .

[0047] It should be understood here that the buffer portion 20 is asymmetric with respect to its reference plane 30, that is, each buffer portion 20 itself is an asymmetric structure. Furthermore, since the multiple buffer portions 20 are arranged circumferentially around the axis A, the combination of all the buffer portions 20 is also asymmetric with respect to the reference plane 30 of any buffer portion 20. That is, it can be understood that the combination of all the buffer portions 20 is also an asymmetric structure. Studies have found that the asymmetric structure of the buffer portion 20 can reduce or avoid the entanglement or nesting of the multiple buffer portions 20 when the occluder 1 is pushed out of the sheath 63, or when the occluder 1 is received in the sheath 63 and then unsheathed, thereby improving the stability of the product while maintaining the product's functionality.

[0048] This configuration, based on the asymmetric shape of the buffer portion 20 relative to the reference plane 30, effectively reduces entanglement or nesting of the buffer portion 20, thereby improving product stability while maintaining product functionality. Furthermore, the buffer portion 20 minimizes tissue damage and improves product safety.

[0049] With reference to Figure 6 , it can be understood that when the occluder 1 is in the folded state, its main frame 10 is also arranged along the axis A. However, the main frame 10 is arranged relatively closely and does not necessarily form a ring. This embodiment does not limit the configuration of the occluder 1 in the folded state; those skilled in the art may configure it based on their actual needs.

[0050] For ease of description, the two ends along axis A are referred to as the proximal end (the left end in FIG6 ) and the distal end (the right end in FIG6 ), respectively. The distal end, or open end, of the occluder 1 is relatively far from the operator, while the proximal end, or closed end, of the occluder 1 is used to detachably connect to a pushing component 62 (e.g., a delivery rod or guidewire) of a delivery device 60 to facilitate delivery and implant detachment. In FIG1 to FIG4 , the upper end of the occluder 1 is the distal end, and the lower end of the occluder 1 is the proximal end.

[0051] In an alternative exemplary embodiment, the occluder 1 further includes a collecting member 40 and a covering 50, wherein the collecting member 40 is connected to the proximal end of the truss body 10. Optionally, the collecting member 40 includes a plurality of collecting rods 41 and a connecting member 42, wherein the connecting member 42 is arranged along the axis A, and the plurality of collecting rods 41 are radially connected to the connecting member 42 around the circumference and are respectively connected to the truss body 10.

[0052] The connector 42 of the collection member 40 is designed to detachably connect to the pusher member 62 of the delivery device 60. Specific connection methods include, but are not limited to, snap fastening, threading, electrolytic release, and magnetic attraction. This allows the pusher member 62 to drive the occluder 1. The coating 50, which covers the outer periphery of the main frame 10, seals the closed end of the occluder 1 and improves the seal between the occluder 1 and the left atrial appendage. The coating 50 can also extend to cover a portion or all of the collection rod 41.

[0053] Optionally, the truss body 10, the buffer portion 20 and the collection piece 40 are made of shape memory metal, which has a certain degree of self-expansion. Referring to Figure 6, when the occluder 1 is compressed, it can be converted to a folded state. At this time, the truss body 10, the buffer portion 20 and the collection piece 40 are squeezed and deformed, and the coating 50 is wrinkled and folded. The outer diameter of the entire occluder 1 is reduced to a size that can be received in the sheath 63 of the delivery device 60, so that it can be inserted through the blood vessel together with the sheath 63. When the sheath 63 is inserted into the target release position (left atrial appendage), the occluder 1 can be driven by the pushing component 62 to push the occluder 1 out of the sheath 63. At this time, the occluder 1 is converted to an expanded state and expanded until the occluder 1 is filled in the cavity of the left atrial appendage. It should be understood that when the occluder 1 is in contact with the wall of the left atrial appendage, the occluder 1 can be fully expanded and in an expanded state, or it can be in an intermediate state from a folded state to an expanded state (i.e., a state in which it is restricted by the wall of the left atrial appendage and is not fully expanded). The present invention does not impose any restrictions on this.

[0054] The occluder 1 is described in its expanded state. At this time, a plurality of buffer portions 20 are arranged circumferentially around the axis A, and the proximal end of the buffer portion 20 is connected to the distal end of the truss body 10. The distal end of the buffer portion 20 is a free end. Preferably, the distal end (i.e., the free end) of the buffer portion 20 is in the shape of a blunt circle, which may be, for example, an arc, an ellipse, or other curved shapes. Referring to Figure 7, when the buffer portion 20 is not provided, the distal end of the truss body 10 often has a sharper end due to the need to fold, which can easily damage the cavity wall of the left atrial appendage 70. Based on the provision of the buffer portion 20, its distal end is in the shape of a blunt circle, which can reduce or avoid damage to the cavity wall of the left atrial appendage 70, as shown in Figure 8.

[0055] Continuing with reference to Figures 1 to 4, optionally, when the occluder 1 is in the expanded state, the buffer portion 20 tilts inwardly toward the axis A in a direction away from the main frame 10. The buffer portion 20 gradually tilts inwardly toward the axis A in a direction away from the main frame 10, i.e., toward the distal end of the buffer portion 20, causing the distal end of the entire occluder 1 to gradually contract. This not only allows the expanded state of the occluder 1 to better conform to the wall of the left atrial appendage, but also helps reduce damage to the wall of the left atrial appendage.

[0056] Optionally, when the occluder 1 is in the expanded state, the buffer portion 20 is a plane perpendicular to the reference plane 30, or the buffer portion 20 is a spatial three-dimensional shape. The buffer portion 20 can optionally be composed of a plurality of rods. In some embodiments, the buffer portion 20 is a two-dimensional planar structure as a whole, and the plane in which it is located is preferably perpendicular to the reference plane 30. It should be understood that at this time, the plane in which the buffer portion 20 is located is not restricted to be parallel to the axis A, but can be angled with the axis A, preferably inclined toward the distal end in the direction close to the axis A. In other embodiments, the buffer portion 20 is a spatial three-dimensional shape as a whole, that is, a spatial three-dimensional structure, for example, some rods in the buffer portion 20 are folded inward or outward. Compared with a two-dimensional planar shape, a spatial three-dimensional shape can provide a larger space for the blunt rounded portion at the distal end of the buffer portion 20, so as to allow the blunt rounded portion to have a larger radius of curvature, so that the buffer portion 20 can reduce or prevent damage to the tissue during and after implantation.

[0057] Several examples of the occluder 1 are described below in conjunction with the accompanying drawings.

[0058] First, please refer to Figure 4. For ease of description and understanding, when the occluder 1 is in its expanded state, the truss body 10 is defined as a spatial network structure consisting of a number of interconnected rods. Rods of the same type at different lateral positions (perpendicular to axis A, also understood as different rows) within the truss body 10 are categorized as the same rod type (including the first rod 11, second rod 21, third rod 13, and fourth rod 14, described below). The connection points between rods are called nodes (including the first node 101, second node 202, and third node 103, described below).

[0059] As shown in Figure 4, in a first optional example, the truss body 10 includes a plurality of first corrugated bars 11 arranged circumferentially around the axis A. Each buffer portion 20 includes two second corrugated bars 21 and a bent bar 22. One end of each of the two second corrugated bars 21 is connected to two circumferentially adjacent first corrugated bars 21, forming two first nodes 101, respectively. The other ends of the two second corrugated bars 21 are connected to each other to form a second node 202. One end of each bent bar 22 is connected to the second node 202, and the other end of each bent bar 22 is connected to the truss body 10. The other end of the bent bar 22 can be connected to the truss body 10 at any location, using methods such as snap fastening, sewing, bonding, or welding. The other end of the bent bar 22 can optionally be connected to a node of the truss body 10. It is understood that in some embodiments, the bent bar 22 can be connected to the truss body 10 by bending inward or outward of the truss body 10. In this case, the buffer portion 20 has a three-dimensional shape. In other embodiments, the curved rod 22 may also be bent laterally on the plane where the two second wave rods 21 are located to achieve connection with the grid body 10. In this case, the buffer portion 20 is a two-dimensional plane.

[0060] Continuing with Figure 4 , in one optional example, the other end of the curved rod 22 is fixed to the first node 101; and the other ends of the curved rods 22 of circumferentially adjacent buffer sections 20 are fixed to different first nodes 101. In the exemplary embodiment shown in Figure 4 , the first wave rod 11 is parallel to the axis A, and the distal end of the first wave rod 11 is connected to the proximal end of the second wave rod 21 to form the first node 101. It will be appreciated that each buffer section 20 includes two second wave rods 21, each connected to one of the two first wave rods 11.

[0061] Referring to Figures 9a and 9b, the other ends of the curved rods 22 of adjacent buffer portions 20 are connected to different first nodes 101. In other words, each first node 101 is actually connected to at most one curved rod 22. It is understandable that when the spacing between circumferentially adjacent first nodes 101 is determined, the greater the number of curved rods 22 connected thereto, the smaller the space allocated to each curved rod 22. This reduced space reduces the radius of curvature of the distal bend of the curved rod 22 (as shown in Figure 9a). Therefore, configuring each first node 101 to be connected to at most one curved rod 22 (as shown in Figure 9b) allows the distal bend of the curved rod 22 to achieve the maximum radius of curvature. It is understandable that a larger radius of curvature provides better tissue protection. It can be understood that when the radius of curvature is infinitely small, it becomes like a sharp thorn, highly damaging. On the other hand, a larger radius of curvature results in a more spherical shape, which is also safer.

[0062] Furthermore, when each buffer section 20 includes only one curved rod 22, each buffer section 20 occupies a relatively small volume after being received in the sheath 63, making it easier to recover and push. When each buffer section 20 includes only one curved rod 22, the distal ends of the buffer section 20 and the truss body 10 can also be easily folded and flattened to reduce the volume of space occupied in the sheath 63. Flattening can be understood as converting the three-dimensional distal end shape into a two-dimensional distal end shape as much as possible. In some cases, multiple rods are prone to overlap, so if each buffer section 20 includes multiple curved rods 22, the flattening of the multiple curved rods 22 cannot reach the level of flatness that can be achieved by a single curved rod 22. Therefore, in terms of the volume share in the sheath 63, the volume share of multiple curved rods 22 in the sheath 63 will be greater than that of the structure with a single curved rod 2263.

[0063] Furthermore, under most conditions, when each buffer portion 20 includes only one curved rod 22, the surface area of ​​the rod of the buffer portion 20 is lower than when it includes multiple curved rods 22. Therefore, configuring each buffer portion 20 to include only one curved rod 22 helps reduce the total area of ​​the implant. This is particularly advantageous for buffer portions 20 that are primarily constructed of metal materials. For example, when the buffer portion 20 is made of nickel-titanium alloy, a smaller surface area helps reduce nickel ion precipitation.

[0064] It should be noted that in some embodiments, the obtuse shape of the distal end of the buffer portion 20 can be completely formed by bending the distal end of the curved rod 22, as shown in Figures 4, 10 and 11. In other embodiments, the obtuse shape of the distal end of the buffer portion 20 can be formed by bending the curved rod 22 and the second wave rod 21 together, as shown in Figures 12 to 15. Factors affecting the curvature radius of the obtuse shape of the distal end of the buffer portion 20 include the length of the curved rod 22 itself, the position of the connection point between the curved rod 22 and the grid body 10, and the length of the second wave rod 21. Specifically, the factors affecting the curvature radius of the obtuse shape of the distal end of the buffer portion 20 (or the curvature radius of the distal bending of the curved rod 22) are mainly:

[0065] 1) Structural Space Size: The number of buffers 20 affects the size of the structural space. The greater the number of buffers 20, the smaller the structural space allocated to each buffer 20 while maintaining the overall structure. This reduction in structural space reduces the maximum radius of curvature that can be formed by the buffers 20.

[0066] 2) Length of the curved rod 22: When the length of the second wave rod 21, the first node 101, the second node 202 and other conditions remain unchanged, the longer the length of the curved rod 22, the larger the curvature radius of the distal end bend.

[0067] 3) Location of the connection point between the curved rod 22 and the truss body 10: Maintaining the length of the curved rod 22, the length of the second wave rod 21, and other conditions unchanged, the closer the connection point between the curved rod 22 and the truss body 10 is to the distal end (the upper end in FIG. 4 ), the greater the curvature radius of the distal end of the curved rod 22. For example, if the proximal end of the curved rod 22 is connected to a node at the proximal end of the first wave rod 11, the curvature radius of the distal end of the curved rod 22 will be smaller than if the connection point is connected to a node at the distal end of the first wave rod 11 (i.e., the first node 101).

[0068] 4) Length of the second wave rod 21: While maintaining the length of the curved rod 22, the connection point position of the curved rod 22 and the grid body 10 and other conditions unchanged, the shorter the length of the second wave rod 21, the larger the curvature radius of the distal end of the curved rod 22.

[0069] Those skilled in the art may configure these factors according to actual conditions to adjust the curvature radius of the blunt-rounded shape of the distal end of the buffer portion 20 (or the curvature radius of the distal bend of the curved rod 22 ).

[0070] Furthermore, the truss body 10 includes a plurality of third wave bars 13, which are inclined relative to the axis A. Circumferentially adjacent third wave bars 13 have opposite inclinations. This allows circumferentially adjacent third wave bars 13 to be connected end-to-end, forming a zigzag ring. The proximal end of each first wave bar 11 is connected to the distal end of a third wave bar 13. The remaining structure of the truss body 10 can be referenced to prior art and will not be further described here.

[0071] Optionally, the distal end of the buffer portion 20 is inclined inward, and the connection between the second wave rod 21 and the first wave rod 11 is angled in the radial direction. In order to reduce the damage to the tissue caused by the sharp turn, the outer side of the first node 101 (i.e., the side away from the axis A) is preferably a smooth transition.

[0072] Please refer to Figures 10 and 11. In another optional example, the first wave rod 11 is inclined relative to the axis A, and the inclination directions of the circumferentially adjacent first wave rods 11 are opposite, and multiple first wave rods 11 are connected in sequence to form a zigzag ring; the circumferentially adjacent first wave rods 11 are connected to each other toward one end (i.e., the distal end) of the buffer portion 20, and are connected with the second wave rod 21 to form the first node 101; the other end of the curved rod 22 is fixed to the first node 101; and the other end of the curved rod 22 of the circumferentially adjacent buffer portions 20 is fixed to different first nodes 101.

[0073] Unlike the example shown in FIG4 , in the examples shown in FIG10 and FIG11 , the first wave bars 11 are arranged obliquely relative to the axis A. Adjacent first wave bars 11 are sequentially connected end to end, forming a zigzag ring. It is understood that at the intersection of each two adjacent first wave bars 11, a distal node (the upper node of the zigzag in FIG10 and FIG11 ) or a proximal node (the lower node of the zigzag in FIG10 and FIG11 ) is formed. The distal node is the first node 101, and the proximal node is the third node 103.

[0074] The proximal ends of the two second wave rods 21 of each buffer portion 20 are respectively connected to two circumferentially adjacent first nodes 101. At the same time, the proximal ends of the curved rods 22 of the buffer portion 20 are also fixed to one of the first nodes 101. Furthermore, the curved rods 22 of circumferentially adjacent buffer portions 20 are fixed to different first nodes 101, ensuring that each first node 101 is connected to at most one curved rod 22.

[0075] Optionally, in some embodiments, the truss body 10 may include only one row of wave bars, that is, the truss body 10 may include only one row of zigzag rings formed by first wave bars 11. In this case, the first wave bars 11 may be directly connected to the connecting piece 40 at the third node 103, as shown in FIG10 . In other embodiments, the truss body 10 may include more than two rows of wave bars, as shown in FIG11 , in which the truss body 10 includes not only one row of zigzag rings formed by first wave bars 11, but also one row of zigzag rings formed by fourth wave bars 14. The structure of the zigzag rings formed by the fourth wave bars 14 may be similar to that of the zigzag rings formed by the first wave bars 11, and may be connected to the proximal end of the zigzag rings formed by the first wave bars 11. In this case, the first wave bars 11 may be connected to the fourth wave bars 14 at the third node 103, and may be connected to the connecting piece 40 through the fourth wave bars 14.

[0076] Please refer to Figures 12 to 15. In a third optional example, the first wave rod 11 is inclined relative to the axis A, and the inclination directions of the circumferentially adjacent first wave rods 11 are opposite, and multiple first wave rods 11 are connected in sequence to form a zigzag ring; the circumferentially adjacent first wave rods 11 are connected to each other at one end (i.e., the distal end) toward the buffer portion 20, and are connected to the second wave rod 21 to form the first node 101; the circumferentially adjacent first wave rods 11 are connected to each other at one end (i.e., the proximal end) away from the buffer portion 20 to form a third node 103; the other end of the curved rod 22 is fixed to the third node 103; and the other end of the curved rod 22 of the circumferentially adjacent buffer portions 20 is fixed to different third nodes 103.

[0077] Unlike the examples shown in Figures 10 and 11, in the examples shown in Figures 12 to 15, the other end of the curved rod 22 is not fixed to the first node 101, but is fixed to the third node 103. This configuration can increase the length of the curved rod 22, thereby allowing the blunt rounded shape of the distal end of the curved rod 22 to have a larger radius of curvature. Preferably, one end of the curved rod 22 is connected to the second node 202, and the other end is bent inward, extending from the inner side of the grid body 10 to the third node 103. Of course, in other embodiments, the curved rod 22 can also be bent toward the outside of the grid body 10 and extend to the third node 103.

[0078] Furthermore, the other end of the curved rod of the buffer portion is connected to the third node 103 formed by the two first wave rods 11 connected to the two second wave rods 21 of the same buffer portion 20. That is to say, the other end of the curved rod 22 of each buffer portion 20 is connected to the third node 103 corresponding to the same buffer portion 20. Since each buffer portion 20 includes two second wave rods 21, it can be understood that the two second wave rods 21 need to be connected to the distal ends of the two first wave rods 11, and the third node 103 formed by the mutual connection of the proximal ends of the two first wave rods 11 corresponds to the buffer portion 20 in the circumferential position (that is, it can be understood as being in the same column). Therefore, the proximal end of the curved rod 22 of the buffer portion 20 is configured to be fixed to the third node 103 corresponding to the circumference of the same buffer portion 20, which can reduce the possibility of the curved rod 22 being entangled and twisted in the circumferential direction.

[0079] Alternatively, referring to FIG16 , in other embodiments, the other end of the curved rod 22 of one buffer portion 20 is connected to the corresponding third node 103 of the circumferentially adjacent buffer portion 20. Unlike the example shown in FIG13 , in the embodiment shown in FIG16 , the curved rod 22 of each buffer portion 20 extends circumferentially toward the adjacent buffer portion 20 and connects to the corresponding third node 103 of the adjacent buffer portion 20. This embodiment can further increase the curvature radius of the curved rod 22.

[0080] Optionally, in one of the buffer sections 20, at least one of the second wave bars 21 includes a curved section 211 at its end distal from the first node 101. When the distal end of the second wave bar 21 includes the curved section 211, it is no longer a straight-line rod. Preferably, the distal end of the second wave bar 21 curves along the direction of connection and extension of the curved bar 22, so that the second wave bar 21 and the curved bar 22 together form a larger, blunt-edged shape. This configuration further increases the curvature radius of the blunt-edged shape.

[0081] It should be understood that Figures 4 and 10 through 16 merely illustrate several exemplary embodiments of the buffers 20 and the truss body 10 and are not intended to limit the buffers 20 and the truss body 10. In other embodiments, the truss body 10 may include more rows of wave bars, and the number of buffers 20 is not limited to that shown in Figures 4 and 10 through 16. Those skilled in the art may configure the structure based on their actual needs.

[0082] Please continue to refer to Figure 6. Based on the occluder 1 described above, an embodiment of the present invention also provides an occlusion system, which includes the occluder 1 described above and also includes a conveying device 60; the conveying device 60 is used to load the occluder 1 in the folded state and to release the occluder 1.

[0083] In an alternative exemplary embodiment, the delivery device 60 includes a connector 61, a pusher 62, and a sheath 63. The pusher 62 may be a delivery rod or a guidewire, and the connector 61 is fixedly disposed at the distal end of the pusher 62. Both the pusher 62 and the connector 61 are movably disposed within the sheath 63. The connector 61 is configured to be detachably connected to the collection member 40 of the occluder 1. When the connector 61 is connected to the collection member 40, the sheath 63 moves distally, thereby storing the occluder 1 within the sheath 63. At this point, the occluder 1 is in a folded state.

[0084] After the distal end of the sheath 63 is inserted through the blood vessel to the left atrial appendage, the occluder 1 can be released by operating the proximal pusher 62, which extends outside the body, to push the occluder 1 out of the distal end of the sheath 63. After release, the connector 61 is separated from the connector 40, and the occluder 1 is left in the left atrial appendage. The implant is then completed by withdrawing the sheath 63.

[0085] In summary, in the occluder and occlusion system provided by the present invention, the occluder includes a grid body and a plurality of buffer parts; the occluder has an open end and a closed end along an axis; the occluder has a folded state and an expanded state; when the occluder is in the expanded state, the grid body is annular around the axis, and the plurality of buffer parts are circumferentially arranged around the axis at the open end; wherein the buffer parts determine a reference plane through the mid-vertical plane of the axis, and the buffer parts are asymmetric with respect to the reference plane. Such a configuration, based on the setting that the buffer parts are asymmetric with respect to the reference plane, can effectively reduce the situation where the buffer parts are entangled or nested, thereby improving the stability of the product while maintaining the product's use function. In addition, the setting of the buffer parts is conducive to reducing damage to tissues and improving the safety of the product.

[0086] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the present invention.

Claims

1. An occluder, characterized in that: include: A grid body and a plurality of buffer parts; The occluder has an open end and a closed end along an axis; the occluder has a folded state and an expanded state; When the occluder is in the expanded state, the grid body is annular around the axis, and the plurality of buffer portions are circumferentially arranged around the axis at the open end; The buffer portion defines a reference plane through a perpendicular midplane of the axis, and the buffer portion is asymmetrical with respect to the reference plane.

2. The occluder according to claim 1, characterized in that: When the occluder is in the expanded state, the buffer portion is inclined inwardly toward the axis in a direction away from the grid body.

3. The occluder according to claim 1, characterized in that: When the occluder is in the expanded state, the buffer portion is in a planar shape perpendicular to the reference plane, or the buffer portion is in a three-dimensional spatial shape.

4. The occluder according to claim 1, characterized in that The grid body includes a plurality of first wave rods arranged circumferentially around the axis; Each of the buffer parts includes two second wave rods and a bent rod; the first ends of the two second wave rods are respectively connected to two circumferentially adjacent first wave rods, and respectively form two first nodes; the second ends of the two second wave rods are connected to each other to form a second node; The first end of the curved rod is connected to the second node, and the second end of the curved rod is connected to the grid body.

5. The occluder according to claim 4, characterized in that: The second end of the curved rod is fixed to the first node; and the second ends of the curved rods of the circumferentially adjacent buffer portions are fixed to different first nodes.

6. The occluder according to claim 5, characterized in that: The first wave rods are inclined relative to the axis, and the inclination directions of the circumferentially adjacent first wave rods are opposite. A plurality of the first wave rods are sequentially connected to form a zigzag ring; the circumferentially adjacent first wave rods are connected to each other at one end facing the buffer portion, and are connected to the second wave rod to form the first node.

7. The occluder according to claim 4, characterized in that: The first wave rods are inclined relative to the axis, and the inclination directions of circumferentially adjacent first wave rods are opposite, and a plurality of the first wave rods are sequentially connected to form a zigzag ring; ends of circumferentially adjacent first wave rods facing the buffer portion are connected to each other and connected to the second wave rod to form a first node; ends of circumferentially adjacent first wave rods away from the buffer portion are connected to each other to form a third node; The second end of the curved rod is fixed to the third node; and the second ends of the curved rods of the circumferentially adjacent buffer portions are fixed to different third nodes.

8. The occluder according to claim 7, characterized in that: The second end of the curved rod of the buffer portion is connected to the third node formed by two first wave rods connected to two second wave rods of the same buffer portion.

9. The occluder according to claim 4, characterized in that: In one of the buffer parts, at least one of the second wave rods includes a curved section at one end away from the first node; and / or the curved rod is bent toward the inside or outside of the grid body.

10. A blocking system, characterized in that: The occluder according to any one of claims 1 to 9 further comprises a conveying device; the conveying device is used to load the occluder in the folded state and to release the occluder.

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