Plugging device and plugging system

Abstract

The invention provides a plugging device and a plugging system. The plugging device comprises a net rack main body and a plurality of buffer parts, the plugging device is provided with an open end and a closed end along an axis; the plugging device has a folded state and an expanded state; when the plugging device is in the expansion state, the net rack body is in an annular shape around the axis, and the multiple buffering parts are arranged at the open end in the circumferential direction around the axis. Wherein the buffer part passes through a middle vertical plane of the axis to determine a reference plane, and the buffer part is asymmetrical relative to the reference plane. And based on the asymmetrical arrangement of the buffer part relative to the reference plane, the situation of winding or nesting of the buffer part can be effectively reduced, and the stability of the product is improved under the condition that the use function of the product is maintained. In addition, the arrangement of the buffer part is beneficial to reducing damage to tissues, and is beneficial to improving the safety of the product.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a plugging device and a plugging system. Background Art

[0002] Research shows that plugging the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation.

[0003] A plugging device is a device used to plug the left atrial appendage. The prior art has disclosed a cage-shaped inner plugging device, which is embedded in the left atrial appendage during implantation and fixed in the left atrial appendage by the anchoring hooks on the plugging device.

[0004] However, the distal end of the cage-shaped inner plugging device has a high density. When it is retracted into the sheath tube and then out of the sheath tube, the adjacent structures are prone to nested entanglement, which may lead to incomplete opening of the stent of the plugging device, so that the actual size of the deployed stent cannot well meet the size of the cavity to be filled. Further, the wall attachment of the stent is reduced, which may lead to a decrease in stability. The high distal density also makes the plugging device difficult to be compressed and loaded into the sheath tube, and there are certain difficulties in recovery and pushing. In addition, the distal end of the existing cage-shaped inner plugging device is prone to damage tissues. Summary of the Invention

[0005] The purpose of the present invention is to provide a plugging device and a plugging system to solve the problem that the existing plugging device is prone to nested entanglement.

[0006] To solve the above technical problems, the present invention provides a plugging device, which includes: a grid frame main body and a plurality of buffer parts;

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

[0008] Among them, a reference plane is determined by the mid-perpendicular plane of the axis passing through the buffer part, and the buffer part is asymmetric with respect to the reference plane.

[0009] Optionally, when the plugging device is in the expanded state, the buffer part inclines inward in the direction of the axis along the direction away from the grid frame main body.

[0010] Optionally, when the plugging device is in the expanded state, the buffer part is a planar shape perpendicular to the reference plane, or the buffer part is a three-dimensional shape in space.

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

[0012] Each of the buffer portions includes two second wave bars and one curved bar; one ends of the two second wave bars are respectively connected to two circumferentially adjacent first wave bars, and respectively form two first nodes; the other ends of the two second wave bars are connected to each other to form a second node.

[0013] One end of the curved bar is connected to the second node, and the other end of the curved bar is connected to the main body of the grid.

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

[0015] Optionally, the first wave bar is inclined relative to the axis, the inclination directions of the circumferentially adjacent first wave bars are opposite, and the plurality of first wave bars are sequentially connected to form a zigzag ring; the ends of the circumferentially adjacent first wave bars facing the buffer portion are connected to each other and are connected to the second wave bar to form the first node.

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

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

[0018] Optionally, the third node formed by connecting the two first wave bars connected to the two second wave bars of one buffer portion is connected to the other end of the curved bar of the same buffer portion.

[0019] Optionally, in one buffer portion, at least one end of one second wave bar away from the first node includes a curved segment; and / or, the curved bar is bent inward or outward with respect to the main body of the grid.

[0020] To solve the above technical problems, the present invention further provides a plugging system, which includes the plugging device as described above, and further includes a conveying device; the conveying device is used for loading the plugging device in the folded state and for releasing the plugging device.

[0021] In summary, in the occluder and occlusion system provided by the present invention, the occluder includes a grid main 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 main body is annular around the axis, and the plurality of buffer parts are arranged circumferentially around the axis at the open end; wherein, a reference plane is determined by a mid-perpendicular plane passing through the axis of the buffer part, and the buffer part is asymmetric with respect to the reference plane.

[0022] With such a configuration, based on the setting that the buffer part is asymmetric with respect to the reference plane, the situation of winding or nesting of the buffer part can be effectively reduced, and the stability of the product can be improved while maintaining the use function of the product. In addition, the setting of the buffer part is beneficial to reducing the damage to tissues and improving the safety of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Those of ordinary skill in the art will understand that the provided drawings are used to better understand the present invention and do not constitute any limitation to the scope of the present invention. Among them:

[0024] Figure 1 is a perspective view of the occluder according to an embodiment of the present invention;

[0025] Figure 2 is an axial cross-sectional schematic view of the occluder according to an embodiment of the present invention;

[0026] Figure 3 is a perspective view of the first preferred example of the buffer part and the grid main body according to an embodiment of the present invention;

[0027] Figure 4 is a side view schematic of the first preferred example of the buffer part and the grid main body according to an embodiment of the present invention;

[0028] Figure 5 is a bottom view schematic of the first preferred example of the buffer part and the grid main body according to an embodiment of the present invention;

[0029] Figure 6 is a schematic view of the occlusion system according to an embodiment of the present invention;

[0030] Figure 7 is a schematic view of the relative relationship between the grid main body without a buffer part and the left atrial appendage;

[0031] Figure 8 is a schematic view of the relative relationship between the buffer part and the left atrial appendage according to an embodiment of the present invention;

[0032] Figure 9a is a schematic view of the connection of the same first node to two curved rods;

[0033] Figure 9bIt is a schematic diagram in which the same first node is only connected to one curved rod;

[0034] Figure 10 It is a schematic diagram of the second preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention, where the main body of the grid structure only includes a row of wave rods;

[0035] Figure 11 It is a schematic diagram of the second preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention, where the main body of the grid structure includes two rows of wave rods;

[0036] Figure 12 It is a perspective view of the third preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention;

[0037] Figure 13 It is a side view of the third preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention;

[0038] Figure 14 It is a top view of the third preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention;

[0039] Figure 15 It is a schematic diagram of the relative relationship between the buffer part, the main body of the grid structure and the left atrial appendage in the third preferred example of the embodiment of the present invention;

[0040] Figure 16 It is a side view of the fourth preferred example of the buffer part and the main body of the grid structure in the embodiment of the present invention.

[0041] In the drawings:

[0042] 1 - occluder; 10 - main body of the grid structure; 101 - first node; 103 - third node; 11 - first wave rod; 13 - third wave rod; 14 - fourth wave rod; 20 - buffer part; 202 - second node; 21 - second wave rod; 211 - curved section; 22 - curved rod; 30 - reference plane; 40 - converging member; 41 - converging rod; 42 - connecting member; 50 - film; 60 - delivery device; 62 - pushing component; 63 - sheath; 70 - left atrial appendage. Detailed implementation manners

[0043] To make the purpose, advantages and features of the present invention clearer, the following further describes the present invention in detail with reference to the drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and not drawn to scale, only for conveniently and clearly assisting in explaining the purpose of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structures. In particular, the focus to be shown in each drawing is different, and sometimes different scales are used.

[0044] As used in the present invention, the singular forms "a", "an", "one" and "the" include plural objects. The term "or" is generally used in the sense of including "and / or". The term "several" is generally used in the sense of including "at least one". The term "at least two" is generally used in the sense of including "two or more". In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first", "second", "third" may explicitly or implicitly include one or at least two of such 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 the endpoints. In addition, as used in the present invention, "mounted", "connected", "coupled", an element "disposed" 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 two elements can be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, an 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 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 shown in the figures. The upward or upper direction faces the top of the corresponding figure, and the downward or lower direction faces the bottom of the corresponding figure.

[0045] The object of the present invention is to provide a plugging device and a plugging system to solve the problem that the existing plugging devices are prone to nesting and entanglement. The following is described with reference to the accompanying drawings.

[0046] Please refer to Figures 1 to 5 , an embodiment of the present invention provides a plugging device 1, which is mainly used for plugging the left atrial appendage. The plugging device 1 includes a grid main body 10 and a plurality of buffer parts 20; the plugging device 1 has an open end ( Figure 1 and Figure 2 the upper end of, for entering the inner cavity of the left atrial appendage) and a closed end ( Figure 1 and Figure 2 the lower end of, for plugging the left atrial appendage ostium); the plugging device 1 has a folded state and an expanded state; when the plugging device 1 is in the expanded state, the grid main body 10 is annular around the axis A, and the plurality of buffer parts 20 are arranged circumferentially around the axis A at the open end; wherein, the buffer part 20 determines a reference plane 30 through the midplane of the axis A (see Figure 4 and Figure 5As shown in the figure, the buffer part 20 is asymmetric with respect to the reference plane 30. It should be noted that the reference plane 30 is only a virtual plane and does not actually exist as an entity structure on the occluder 1. In addition, in order to more clearly show the reference plane 30, Figure 4 the entire structures of the buffer part 20 and the grid framework main body 10 are not shown, and only a partial (half - circumference) view of the side facing the observer is presented.

[0047] It should be noted that the connection end of each buffer part 20 and the grid framework main body 10 has a certain width in the circumferential direction of the grid framework main body 10. For example, each buffer part 20 is connected to the grid framework main body 10 at two first nodes 101 (see Figure 4 and in combination with the following description), then the length of the line connecting the two first nodes 101 is the width of the buffer part 20 in the circumferential direction of the grid framework main body 10. The plane passing through the mid - point O of the line connecting the two first nodes 101 and passing through the axis A is called the central vertical plane of the buffer part 20. In some embodiments, the buffer part 20 is connected to the grid framework main body 10 at three different nodes (as shown in Figure 13 and Figure 16 ), that is, when each buffer part 20 is connected to the grid framework main 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 part 20 (the center point of the shape formed by the three nodes) and passing through the axis A is called the central vertical plane of the buffer part 20. Figure 4 The reference plane 30 shown in the figure is perpendicular to the paper surface. In the occluder 1 provided in this embodiment, the buffer part 20 is asymmetric with respect to its reference plane 30.

[0048] It should be understood here that the buffer part 20 is asymmetric with respect to its reference plane 30, that is, each buffer part 20 itself is an asymmetric structure. Further, since multiple buffer parts 20 are arranged circumferentially around the axis A, at this time, the combined body of all buffer parts 20 is also asymmetric with respect to the reference plane 30 of any buffer part 20. That is, it can be understood that the combined body of all buffer parts 20 is also an asymmetric structure. It has been found that this asymmetric structure of the buffer part 20 can reduce or avoid the situation of mutual entanglement or nesting between multiple buffer parts 20 when the occluder 1 is pushed out of the sheath 63, or when the occluder 1 is retracted into the sheath 63 and then pushed out again, thereby improving the stability of the product while maintaining the product's usage function.

[0049] With such a configuration, based on the setting that the buffer part 20 is asymmetric with respect to the reference plane 30, the situation of entanglement or nesting of the buffer part 20 can be effectively reduced, and the stability of the product can be improved while maintaining the product's usage function. In addition, the setting of the buffer part 20 is beneficial to reducing damage to tissues and improving the safety of the product.

[0050] Please refer to Figure 6 It can be understood that when the occluder 1 is in a folded state, the main body 10 of its wire frame is also preferably arranged along the direction of the axis A. However, at this time, the main body 10 of the wire frame is relatively closely arranged and does not necessarily form a ring. In this embodiment, the shape of the occluder 1 when it is in a folded state is not limited, and those skilled in the art can configure it according to the actual situation.

[0051] For the convenience of description, the two ends along the direction of the axis A are respectively referred to as the proximal end ( Figure 6 the left end in Figure 6 ) and the distal end ( Figures 1 to 4 the right end in

[0052] In an alternative exemplary embodiment, the occluder 1 further includes a converging member 40 and a film 50, wherein the converging member 40 is connected to the proximal end of the main body 10 of the wire frame. Optionally, the converging member 40 includes a plurality of converging rods 41 and a connecting member 42. Preferably, the connecting member 42 is arranged along the direction of the axis A. The plurality of converging rods 41 are radially connected to the connecting member 42 in a circumferential manner and are respectively connected to the main body 10 of the wire frame.

[0053] The connecting member 42 of the converging member 40 is used to be detachably connected to the pushing member 62 of the delivery device 60. The specific connection methods include but are not limited to snap connection, screw connection, electrolytic detachment, magnetic attraction, etc. In this way, the occluder 1 can be driven by the pushing member 62. The film 50 covers the outer periphery of the main body 10 of the wire frame, which plays the role of sealing the closed end of the occluder 1 and improving the sealing performance between the occluder 1 and the left atrial appendage. Preferably, the film 50 can also extend to cover a part or all of the converging rods 41.

[0054] Preferably, the main body 10 of the wire frame, the buffer portion 20 and the converging member 40 are made of shape memory metal, which has a certain self-expanding property. Please refer to Figure 6, when the occluder 1 is compressed, it can be converted to a folded state. At this time, the grid main body 10, the buffer part 20 and the converging part 40 are squeezed and deformed, and the film 50 is wrinkled and folded. The outer diameter of the entire occluder 1 is reduced to be able to be accommodated in the sheath 63 of the delivery device 60, so that it can be interventional via the blood vessel together with the sheath 63. When the sheath 63 is interventional to the target release position (at the left atrial appendage), the occluder 1 can be driven by the pushing member 62 to push the occluder 1 out of the sheath 63. At this time, the occluder 1 is converted to the expanded state and expands until the occluder 1 fills the cavity of the left atrial appendage. It should be understood that when the occluder 1 fits against the cavity wall of the left atrial appendage, the occluder 1 can be fully expanded and in the expanded state, or can be in an intermediate state of conversion from the folded state to the expanded state (that is, a state of not being fully expanded due to being restricted by the cavity wall of the left atrial appendage). The present invention does not limit this.

[0055] The state when the occluder 1 is in the expanded state will be described. At this time, a plurality of buffer parts 20 are arranged circumferentially around the axis A, and the proximal end of the buffer part 20 is connected to the distal end of the grid main body 10. The distal end of the buffer part 20 is a free end. Preferably, the distal end (i.e., the free end) of the buffer part 20 has a blunt circular shape, and the blunt circular shape can be, for example, an arc shape, an oval shape or other curved shapes, etc. Please refer to Figure 7 , in the case where the buffer part 20 is not provided, the distal end of the grid main body 10 often has a relatively sharp end due to the need for folding, which is likely to damage the cavity wall of the left atrial appendage 70. Due to the arrangement of the buffer part 20, its distal end has a blunt circular shape, which can reduce or avoid damage to the cavity wall of the left atrial appendage 70, as Figure 8 shown.

[0056] Please continue to refer to Figures 1 to 4 , optionally, when the occluder 1 is in the expanded state, the buffer part 20 inclines inward in the direction of the axis A along the direction away from the grid main body 10. The direction along which the buffer part 20 is away from the grid main body 10 is also the direction in which the buffer part 20 faces the distal end. It inclines inward in the direction of the axis A gradually towards the distal end, which can make the distal end of the entire occluder 1 gradually contract. On the one hand, it can make the expanded state of the occluder 1 fit better with the cavity wall of the left atrial appendage, and on the other hand, it is also beneficial to reduce damage to the cavity wall of the left atrial appendage.

[0057] Optionally, when the occluder 1 is in the expanded state, the buffer portion 20 is planar and perpendicular to the reference plane 30, or the buffer portion 20 is three-dimensional. The buffer portion 20 is preferably composed of a plurality of rods. In some embodiments, the buffer portion 20 is an overall two-dimensional planar structure, and the plane where it is located is preferably perpendicular to the reference plane 30. It should be understood that at this time, the plane where the buffer portion 20 is located is not necessarily restricted to be parallel to the axis A, but can form an angle with the axis A, and is preferably inclined towards the distal end in a direction closer to the axis A. In other embodiments, the buffer portion 20 is an overall three-dimensional structure, that is, a three-dimensional spatial structure. For example, some rods in the buffer portion 20 are folded inwards or outwards. The three-dimensional shape can provide more space for the blunt round shape at the distal end of the buffer portion 20 compared to the two-dimensional planar shape, allowing the blunt round portion to have a larger radius of curvature, so as to reduce or prevent damage to tissues during and after implantation of the buffer portion 20.

[0058] Several preferred examples of the occluder 1 will be exemplarily described below with reference to the accompanying drawings.

[0059] First, please refer to Figure 4 , for the convenience of description and understanding, when the occluder 1 is in the expanded state, the grid main body 10 is defined as a spatial network structure formed by connecting a plurality of wave rods. At different transverse positions of the grid main body 10 (referring to different positions perpendicular to the axis A, which can also be understood as different rows), the same type of wave rods are classified as the same kind of wave rods (including the first wave rod 11, the second wave rod 21, the third wave rod 13, the fourth wave rod 14, etc. described below). The connection points between the wave rods are called nodes (including the first node 101, the second node 202, the third node 103, etc. described below).

[0060] As Figure 4As shown, in the first preferred example, the grid body 10 includes a plurality of first wave rods 11 arranged circumferentially around the axis A; each buffer portion 20 includes two second wave rods 21 and a bending rod 22; one ends of the two second wave rods 21 are respectively connected to two circumferentially adjacent first wave rods 21, and respectively form two first nodes 101; the other ends of the two second wave rods 21 are connected to each other to form a second node 202; one end of the bending rod 22 is connected to the second node 202, and the other end of the bending rod 22 is connected to the grid body 10. The other end of the bending rod 22 can be connected to the grid body 10 at any part, and the connection method can be, for example, snap connection, stitching, bonding, welding, etc. The other end of the bending rod 22 is preferably connected to a certain node of the grid body 10. It can be understood that in some embodiments, the bending rod 22 can be bent inward or outward of the grid body 10 to realize the connection with the grid body 10. At this time, the buffer portion 20 is a three-dimensional shape. In other embodiments, the bending rod 22 can also be bent laterally on the plane where the two second wave rods 21 are located to realize the connection with the grid body 10. At this time, the buffer portion 20 is a two-dimensional planar shape.

[0061] Please continue to refer to Figure 4 , in a preferred example, the other end of the bending rod 22 is fixed to the first node 101; and the other ends of the bending rods 22 of the circumferentially adjacent buffer portions 20 are fixed to different first nodes 101. In Figure 4 the illustrated exemplary embodiment, 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 and forms a first node 101. It can be understood that each buffer portion 20 includes two second wave rods 21, and the two second wave rods 21 are respectively connected to two first wave rods 11.

[0062] Please refer to Figure 9a and Figure 9b , the other ends of the bending rods 22 of the adjacent buffer portions 20 are connected to different first nodes 101, that is to say, each first node 101 is actually connected to at most one bending rod 22. It can be understood that when the distance between the circumferentially adjacent first nodes 101 is determined, the more the number of bending rods 22 connected to it, the smaller the space that each bending rod 22 can be allocated. The reduction of the space will reduce the curvature radius of the distal end bending of the bending rod 22 (as Figure 9a shown). Therefore, each first node 101 is configured to be connected to at most one bending rod 22 (as Figure 9bAs shown, the distal end of the bending rod 22 can be bent to obtain the maximum radius of curvature. It can be understood that the larger the radius of curvature, the better the protection of the tissue. It can be understood that when the radius of curvature is infinitely small, it is a sharp thorn with strong harmfulness. And when the radius of curvature is larger, the shape is more like a sphere and is also safer.

[0063] Furthermore, when each buffer portion 20 includes only one bending rod 22, the volume occupied by each buffer portion 20 after being received into the sheath 63 is relatively small, and it is easier to recover and push. When each buffer portion 20 includes only one bending rod 22, the distal end of the buffer portion 20 and the main body 10 of the grid are also easily folded and flattened to reduce the space volume occupied in the sheath 63. Flattening can be understood as changing the three-dimensional distal shape into a two-dimensional distal shape as much as possible. In some cases, multiple rods are prone to overlap. Therefore, if each buffer portion 20 includes multiple bending rods 22, the flattening of the multiple bending rods 22 cannot reach the flatness that a single bending rod 22 can achieve. Therefore, for the volume ratio in the sheath 63, the volume ratio of the multiple bending rods 22 in the sheath 63 will be greater than that of a single bending rod 2263's structure.

[0064] Even further, under most conditions, when each buffer portion 20 includes only one bending rod 22, the surface area of the rod of the buffer portion 20 is lower than that when it includes multiple bending rods 22. Therefore, configuring each buffer portion 20 to include only one bending rod 22 is beneficial to reducing the total area of the implanted part, especially having greater advantages for the buffer portion 20 with a metal material as the main structure. For example, when the material of the buffer portion 20 is nickel-titanium alloy, a smaller surface area is beneficial to reducing the precipitation of nickel ions.

[0065] It should be noted that in some embodiments, the distal blunt round shape of the buffer portion 20 can be completely formed by the bending of the distal end of the bending rod 22, as shown in Figure 4 、 Figure 10 and Figure 11 shown. And in some other embodiments, the distal blunt round shape of the buffer portion 20 can be formed by the common bending of the bending rod 22 and the second wave rod 21, as shown in Figures 12 to 15 shown. The factors affecting the radius of curvature of the distal blunt round shape of the buffer portion 20 include the length of the bending rod 22 itself, the position of the connection point between the bending rod 22 and the main body 10 of the grid, and the length of the second wave rod 21, etc. Specifically, the main factors affecting the radius of curvature of the distal blunt round shape of the buffer portion 20 (or the radius of curvature of the bending of the distal end of the bending rod 22) are:

[0066] 1) Dimensions of the structural space: The number of buffer parts 20 affects the dimensions of the structural space. The more the number of buffer parts 20, the smaller the structural space that each buffer part 20 can be allocated under the condition that the overall structure remains unchanged. The reduction of the spatial structure will reduce the maximum curvature radius that the buffer part 20 can form.

[0067] 2) Length of the bending rod 22: Under the condition of maintaining the length of the second wave rod 21, the first node 101, the second node 202, and other conditions unchanged, the longer the length of the bending rod 22, the larger the curvature radius of the distal end bending.

[0068] 3) Position of the connection point of the bending rod 22 and the main body 10 of the grid: Under the condition of maintaining the length of the bending rod 22, the length of the second wave rod 21, and other conditions unchanged, the closer the position of the connection point of the bending rod 22 and the main body 10 of the grid is to the distal end ( Figure 4 the upper end), the larger the curvature radius of the distal end bending of the bending rod 22. For example, if the proximal end of the bending rod 22 selects the node at the proximal end of the first wave rod 11 as the connection point, the curvature radius of the distal end bending of the bending rod 22 is smaller than that when selecting the node at the distal end of the first wave rod 11 (i.e., the first node 101) as the connection point.

[0069] 4) Length of the second wave rod 21: Under the condition of maintaining the length of the bending rod 22, the position of the connection point of the bending rod 22 and the main body 10 of the grid, and other conditions unchanged, the shorter the length of the second wave rod 21, the larger the curvature radius of the distal end bending of the bending rod 22.

[0070] Those skilled in the art can configure these factors according to the actual situation to adjust the curvature radius of the distal blunt circle of the buffer part 20 (or the curvature radius of the distal end bending of the bending rod 22).

[0071] Furthermore, the main body 10 of the grid also includes a plurality of third wave rods 13, the third wave rods 13 are inclined relative to the axis A, and the inclination directions of the circumferentially adjacent third wave rods 13 are opposite, so that the circumferentially adjacent third wave rods 13 can be connected end to end with each other and are connected in sequence to form a zigzag ring. The proximal end of each first wave rod 11 is connected to the distal end of the third wave rod 13. Other structures of the main body 10 of the grid can refer to the prior art and will not be elaborated here.

[0072] Preferably, the distal end of the buffer part 20 inclines inward, and the connection position of its 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 sharp turning, the outer side (i.e., the side far from the axis A) of the first node 101 is preferably smoothly transitioned.

[0073] Please refer to Figure 10 and Figure 11, in another preferred 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. The plurality of first wave rods 11 are sequentially connected to form a zigzag ring; the circumferentially adjacent ends of the first wave rods 11 facing the buffer portion 20 (i.e., the distal ends) are connected to each other and are connected to 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 ends of the curved rods 22 of the circumferentially adjacent buffer portions 20 are fixed to different first nodes 101.

[0074] Unlike Figure 4 the exemplary example shown, in Figure 10 and Figure 11 the exemplary example shown, the first wave rod 11 is arranged inclined relative to the axis A, and the adjacent first wave rods 11 are sequentially connected end to end, that is, a zigzag ring is formed. It can be understood that at the intersection connection of every two adjacent first wave rods 11, nodes facing the distal end ( Figure 10 and Figure 11 are the upper nodes of the zigzag) or nodes facing the proximal end ( Figure 10 and Figure 11 are the lower nodes of the zigzag) will be formed respectively. The node facing the distal end is the first node 101, and the node facing the proximal end is the third node 103.

[0075] 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, and at the same time the proximal end of the curved rod 22 of this buffer portion 20 is also fixed to one of the first nodes 101. Further, the curved rods 22 of the 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.

[0076] Optionally, in some embodiments, the grid body 10 may only include a row of wave rods, that is, the grid body 10 only includes a zigzag ring formed by a row of first wave rods 11. At this time, the first wave rod 11 can be directly connected to the converging member 40 at the third node 103, as Figure 10 shown. In some other embodiments, the grid body 10 may include more than two rows of wave rods, as Figure 11 shown. The grid body 10 not only includes a zigzag ring formed by a row of first wave rods 11, but also includes a zigzag ring formed by a row of fourth wave rods 14. The structure of the zigzag ring formed by the fourth wave rods 14 may be similar to the zigzag ring formed by the first wave rods 11 and is connected to the proximal end of the zigzag ring formed by the first wave rods 11. At this time, the first wave rod 11 can be connected to the fourth wave rod 14 at the third node 103 and is connected to the converging member 40 through the fourth wave rod 14.

[0077] Please refer toFigures 12 to 15 , in the third preferred example, the first wave bar 11 is inclined relative to the axis A, and the inclination directions of the circumferentially adjacent first wave bars 11 are opposite, and the plurality of first wave bars 11 are sequentially connected to form a zigzag ring; the circumferentially adjacent first wave bars 11 are connected to each other at one end (i.e., the distal end) facing the buffer part 20, and are connected to the second wave bar 21 to form the first node 101; the circumferentially adjacent first wave bars 11 are connected to each other at one end (i.e., the proximal end) away from the buffer part 20 and form the third node 103; the other end of the curved bar 22 is fixed to the third node 103; and the other ends of the curved bars 22 of the circumferentially adjacent buffer parts 20 are fixed to different third nodes 103.

[0078] With Figure 10 and Figure 11 the demonstration example shown in Figures 12 to 15 In the demonstration example shown, the other end of the curved bar 22 is not fixed to the first node 101, but is fixed to the third node 103. With such a configuration, the length of the curved bar 22 can be increased, thereby allowing the blunt circle at the distal end of the curved bar 22 to have a larger radius of curvature. Preferably, one end of the curved bar 22 is connected to the second node 202, and the other end is turned inward and bent, extending from the inner side of the grid body 10 to the third node 103. Of course, in some other embodiments, the curved bar 22 can also be bent outward from the grid body 10 and extend to the third node 103.

[0079] Furthermore, the third node 103 formed by connecting the two first wave bars 11 connected to the two second wave bars 21 of one buffer part 20 is connected to the other end of the curved bar 22 of the same buffer part 20. That is to say, the other end of the curved bar 22 of each buffer part 20 is connected to the third node 103 corresponding to the same buffer part 20. Since each buffer part 20 includes two second wave bars 21, it can be understood that these two second wave bars 21 need to be connected to the distal ends of two first wave bars 11, and the third node 103 formed by connecting the proximal ends of these two first wave bars 11 is circumferentially corresponding to this buffer part 20 (it can be understood as being in the same column). Therefore, configuring the proximal end of the curved bar 22 of this buffer part 20 to be fixed to the third node 103 corresponding to the same buffer part 20 in the circumferential direction can reduce the possibility of the curved bar 22 being wound and twisted in the circumferential direction.

[0080] Optionally, please refer to Figure 16 , in some other embodiments, the other end of the curved bar 22 of one buffer part 20 is connected to the third node 103 corresponding to the circumferentially adjacent buffer part 20. With Figure 13 the demonstration example shown in Figure 16In the illustrated embodiment, the curved rod 22 of each buffer portion 20 extends circumferentially towards an adjacent buffer portion 20 and is connected to the third node 103 corresponding to the adjacent buffer portion 20 in the circumferential direction. This embodiment can further increase the radius of curvature of the curved rod 22.

[0081] Preferably, in one of the buffer portions 20, at least one end of the at least one second wave rod 21 away from the first node 101 includes a curved section 211. When the distal end of the second wave rod 21 includes a curved section 211, it is no longer a rod extending in a straight line. Preferably, the distal end of the second wave rod 21 is curved along the direction in which the curved rod 22 is connected and extended, so that the second wave rod 21 and the curved rod 22 can jointly form a larger obtuse circle. Such a configuration can further increase the radius of curvature of the obtuse circle.

[0082] It should be understood that Figure 4 、 Figures 10 to 16 only several exemplary embodiments of the buffer portion 20 and the grid frame body 10 are shown, rather than a limitation on the buffer portion 20 and the grid frame body 10. In some other embodiments, the grid frame body 10 may further include more rows of wave rods, and the number of buffer portions 20 is also not limited to Figure 4 、 Figures 10 to 16 as shown. Those skilled in the art can configure according to the actual situation.

[0083] Please continue to refer to Figure 6 , based on the occluder 1 described above, an embodiment of the present invention further provides an occlusion system, which includes the occluder 1 described above, and further includes a delivery device 60; the delivery device 60 is used to load the occluder 1 in the folded state and is used to release the occluder 1.

[0084] In an alternative exemplary embodiment, the delivery device 60 includes a connecting member 61, a pushing member 62 and a sheath 63. The pushing member 62 can be, for example, a delivery rod or a guide wire. The connecting member 61 is fixedly arranged at the distal end of the pushing member 62. The pushing member 62 and the connecting member 61 are both movably inserted through the sheath 63. The connecting member 61 is used to detachably connect with the collecting member 40 of the occluder 1. When the connecting member 61 is connected to the collecting member 40, the sheath 63 moves distally, and the occluder 1 can be received into the sheath 63. At this time, the occluder 1 is in the folded state.

[0085] After the distal end of the sheath 63 intervenes into the left atrial appendage through the blood vessel, the occluder 1 can be driven to extend from the distal end of the sheath 63 by operating the pushing member 62 extending out of the body proximally to achieve release. After the release is completed, the connecting member 61 is separated from the collecting member 40, and the occluder 1 can be left in the left atrial appendage. Withdrawing the sheath 63 completes the implantation.

[0086] In summary, in the occluder and occlusion system provided by the present invention, the occluder includes a grid main 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 main body is annular around the axis, and the plurality of buffer parts are arranged circumferentially around the axis at the open end; wherein, a reference plane is determined by a mid-perpendicular plane passing through the axis for the buffer part, and the buffer part is asymmetric with respect to the reference plane. With such a configuration, based on the setting that the buffer part is asymmetric with respect to the reference plane, the situation of winding or nesting of the buffer part can be effectively reduced, and the stability of the product can be improved while maintaining the use function of the product. In addition, the setting of the buffer part is beneficial to reducing the damage to tissues and improving the safety of the product.

[0087] It should be noted that the above-mentioned several 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 in any way. Any changes and modifications made by those of ordinary skill in the art of the present invention according to the above disclosure are within the protection scope 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; one end of the two second wave rods is respectively connected to two circumferentially adjacent first wave rods, and respectively forms two first nodes; the other ends of the two second wave rods are connected to each other to form a second node; One end of the curved rod is connected to the second node, and the other end of the curved rod is connected to the grid body.

5. The occluder according to claim 4, characterized in that: The other end of the curved rod is fixed to the first node; and the other 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 other end of the curved rod is fixed to the third node; and the other 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 third node formed by connecting the two first wave rods connected to the two second wave rods of one buffer part is connected to the other end of the curved rod of the same buffer part.

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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