Sealing device

Abstract

This invention relates to an occlusion device comprising a fixing part and a sealing part. The fixing part includes a mesh-woven structure and a plurality of radially extending wings. The occlusion device is provided with an auxiliary structure for enhancing the anchoring effect of the wings. Compared with the traditional fixing part design with a cylindrical outer edge (i.e., a circular cross-section), the fixing part of the occlusion device provided by this invention has a plurality of wings formed on it, which can adaptively engage with the grooves and protrusions of the implantation area, facilitating the anchor to abut or penetrate the surface of the implantation area in the corresponding area, thereby obtaining better anchoring capability.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to an occlusion device. Background Technology

[0002] In recent years, among patients with non-valvular atrial fibrillation, 90% of strokes caused by atrial fibrillation originate from the left atrial appendage. Clinical data shows that resection of the left atrial appendage during cardiac surgery in patients with atrial fibrillation can reduce the incidence of stroke, suggesting the danger of the left atrial appendage in thromboembolism. Since the left atrial appendage is a thrombus-forming site, occluding its opening can eliminate the basis for thrombus formation within the left atrial appendage. Generally, occlusion of the left atrial appendage using a left atrial appendage occluder is an effective way to prevent stroke caused by atrial fibrillation.

[0003] To effectively occlude the left atrial appendage, a left atrial appendage occluder needs to be implanted in the left atrial appendage long-term to achieve the occlusion effect. Therefore, the left atrial appendage occluder must have a certain anchoring structure to ensure its stable occlusion at the opening of the left atrial appendage for a long period of time, while preventing it from falling out and causing problems such as device embolism.

[0004] For split-type occluders, there are generally two parts: a fixing part for fixation and a sealing part for sealing. The fixing part is usually anchored by sharp anchors, without considering the tightness and condition of the contact between the fixing part and the implantation site. When the contact area between the fixing part and the atrial appendage is insufficient, there is still a risk of dislodgement, and the existing technology has not improved this. Summary of the Invention

[0005] Therefore, it is necessary to provide an improved occlusion device to address the problem of poor anchoring caused by insufficient contact area between the fixation part and the implantation site in existing left atrial appendage occlusion devices, as detailed below:

[0006] A sealing device is provided, including a fixing part and a sealing part. The fixing part includes a mesh woven structure and a plurality of radially extending wings. The sealing device is provided with an auxiliary structure for enhancing the anchoring effect of the wings.

[0007] In one embodiment, the auxiliary structure includes a support frame disposed on the fixed portion. The support frame includes a continuous converging section, a unfolding section, and an extension section. The converging section is radially unfolded through the unfolding section and then deflected at the end of the unfolding section to form the extension section.

[0008] In one embodiment, the support frame and the fixing part are relatively independent.

[0009] In one embodiment, the minimum distance from the extended section to the distal side of the fixed part is less than 1 mm, and the minimum distance from the extended section to the radially outer side of the fixed part is greater than 3 mm.

[0010] In one embodiment, the support frame is located on the outer or inner surface of the fixing part.

[0011] In one embodiment, the support frame is located at the middle of the end face of the wing and the outermost radial side.

[0012] In one embodiment, the unfolded section is located on the distal side of the fixed portion, and the extended section extends toward the proximal end.

[0013] In one embodiment, the unfolded section is located on the proximal side of the fixed portion, and the extension section extends toward the distal end.

[0014] In one embodiment, the inner side of the unfolded segment is located at the far end of the outer side of the unfolded segment.

[0015] In one embodiment, the converging segment is suspended inside the fixing portion, or the converging segment extends into the sealing portion and is suspended, or the converging segment extends and is fixed to the proximal center of the sealing portion.

[0016] Compared with the prior art, the present invention provides a sealing device, including a fixing part and a sealing part. The fixing part includes a mesh woven structure and multiple radially extending wings. The sealing device is provided with an auxiliary structure to enhance the anchoring effect of the wings. Compared with the traditional fixing part design with a cylindrical outer edge (i.e., a circular cross-section), the fixing part of the sealing device provided by the present invention has multiple wings that can adaptively fit into the grooves and protrusions of the implantation area, making it easier for the anchor to abut or penetrate the surface of the implantation area in the corresponding area, thereby obtaining better anchoring capability. Attached Figure Description

[0017] Figure 1 This is a front view of the sealing device in its natural state in Embodiment 1 of the present invention;

[0018] Figure 2 This is a top view of the fixing part of the sealing device in Embodiment 1 of the present invention, viewed from the distal end to the proximal end.

[0019] Figure 3 This is a schematic diagram of the deformation state of the fixing part of the sealing device after implantation in Embodiment 1 of the present invention;

[0020] Figure 4 This is a top view of the fixing part of a traditional woven structure from the far end to the near end;

[0021] Figure 5 This is a schematic diagram of the deformation state of the fixing part of a traditional woven structure after implantation;

[0022] Figure 6 This is a top view of the sealing device in Embodiment 2 of the present invention, viewed from the far end to the near end.

[0023] Figure 7 This is a schematic diagram of the fixing part of the sealing device in Embodiment 3 of the present invention;

[0024] Figure 8 This is a top view of the fixing part of the sealing device in Embodiment 3 of the present invention, viewed from the distal end to the proximal end.

[0025] Figure 9 This is a schematic diagram of the anchoring component of the sealing device being installed to the fixing part in another embodiment of the present invention;

[0026] Figure 10 This is a schematic diagram of the structure of various optional anchoring components in Embodiment 3 of the present invention;

[0027] Figure 11 This is a schematic diagram of the structure of other optional anchoring components in Embodiment 3 of the present invention;

[0028] Figure 12 This is a longitudinal schematic diagram of the sealing device after the anchoring component is installed in another embodiment of the present invention;

[0029] Figure 13 This is a schematic diagram of the sealing device in another embodiment of the present invention;

[0030] Figure 14 This is a top view of the blocking device from the distal end to the proximal end in another embodiment of the present invention;

[0031] Figure 15 This is an exploded schematic diagram of the sealing device in Embodiment 4 of the present invention;

[0032] Figure 16 This is a schematic diagram of the sealing device from the main view in Embodiment 4 of the present invention;

[0033] Figure 17 This is a schematic diagram of the sealing device from the distal end to the proximal end in Embodiment 4 of the present invention;

[0034] Figure 18 This is a schematic diagram of the sealing device in another embodiment of the present invention;

[0035] Figure 19 This is an exploded schematic diagram of the sealing device in another embodiment of the present invention;

[0036] Figure 20This is a schematic diagram of the sealing device from the main view in Embodiment 4 of the present invention;

[0037] Figure 21 This is a schematic diagram of the sealing device in Embodiment 5 of the present invention;

[0038] Figure 22 This is a schematic diagram of the sealing device in Embodiment 5 of the present invention, viewed from the far end to the near end. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0040] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.

[0041] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0042] Example 1

[0043] The occlusion device 100 provided in Example 1 can be used to occlude the left atrial appendage, and can also be used to occlude other tissues with openings, including but not limited to atrial septal defects, patent ductus arteriosus, etc. The following will provide a detailed description of the occlusion device 100 using the occlusion of the left atrial appendage as an example.

[0044] Please refer to Figure 1 , Figure 1 This is a front view of the sealing device 100 in its natural state according to Embodiment 1 of the present invention. The sealing device 100 includes a fixing part 110 and a sealing part 120 connected to the fixing part 110. The sealing part 120 and the fixing part 110 are spaced apart along the axial direction of the sealing device 100. The sealing part 120 is located at the proximal end of the sealing device 100, and the fixing part 110 is located at the distal end of the sealing device 100. The sealing device 100 has a compressed state housed within a sheath for easy delivery, and extends from the distal end of the sheath and expands upon self-expansion as... Figure 1 The deployed state is shown. The morphology of the occlusion device 100 after release within the left atrial appendage is similar to... Figure 1They are either completely identical or substantially the same. In other implementations, such as for closure of atrial septal defects, the sealing part 120 and the fixing part 110 can be brought close to each other after release to fix the closure device 100 to the septum between the left and right atria.

[0045] In this embodiment, the fixing part 110 is connected to a connector 130, and the distal end of the sealing part 120 is connected to the connector 130.

[0046] In manufacturing the sealing part 120, multiple braided filaments 121 are first braided into a mesh tube. Both ends of the mesh tube are closed and fixed by a sleeve. The mesh tube is then heat-set into a disc, column, or plug shape to obtain the sealing part 120 used to seal the opening of the left atrial appendage. The sealing part 120 includes a distal disc surface 122 facing the fixing part 110, a proximal disc surface 123 opposite to the distal disc surface 122, and a receiving cavity 124 located between the proximal and distal disc surfaces 122. Preferably, the receiving cavity 124 of the sealing part 120 has at least one thin film (not shown) used as a flow-blocking membrane. The edge of the thin film is fixed to the braided filaments 121 at the edge of the sealing part 120, typically by stitching, and the thin film is located between the distal disc surface 122 and the proximal disc surface 123. The membrane is used to prevent blood flow from one side of the sealing portion 120 to the other side, thereby preventing blood flow between the left atrial appendage and the left atrium. In this embodiment, the distance between the distal disc surface 122 and the proximal disc surface 123 is not limited; therefore, the sealing portion 120 does not necessarily need to be disc-shaped and can also be a cylinder with a certain height.

[0047] Furthermore, referring to Figure 2 , Figure 2This is a top view of the fixing part of the occlusion device in Embodiment 1 of the present invention from the distal end to the proximal end. In this embodiment, the fixing part 110 is formed by woven metal wires. Specifically, one or more metal wires are bent along a specific trajectory to form a mesh-like woven body, thereby enabling the fixing part 110 to obtain better compliance, so as to avoid damage to the auricle of the heart to the greatest extent. It should be noted that, compared to rod structures formed by direct cutting, the braided structure provided in this embodiment has higher conformability for two reasons. First, the diameter of the metal wires used in the braiding is small enough; otherwise, the metal wires cannot be processed to form a braid. Correspondingly, if the rod structure uses the same diameter as the braided structure, the radial support force of the rod structure against the deformation of the auricle is extremely small, which makes it impossible for the fixing part 110 of the rod to achieve the purpose of fixing, causing the entire sealing device 100 to fall off. Second, since the braiding will pre-bend the metal wires, applying stress along the pre-bending direction to the pre-bent metal wires makes it easier for the metal wires to deform. The braided structure utilizes this characteristic to transfer the deformation of the metal wire at a certain position to the adjacent, intersecting metal wire positions, thereby dispersing the concentrated stress. Therefore, the force on a certain point of the braided structure will be better distributed to the whole along the braided structure.

[0048] In this embodiment, in addition to forming a woven structure, the fixing part 110 includes a central region 111 and a plurality of edge regions 112 surrounding the central region 111 in the circumferential direction. The cross-sectional shape of the central region 111 is generally circular. For the central region 111, one side of the edge region 112 extends outward from the central region 111, extends radially outward, extends circumferentially for a certain length, and then retracts towards the central region 111. In other words, in this embodiment, the fixing part 110 includes a plurality of radially outward protruding edge regions 112 distributed around the central region 111. In this embodiment, the edge regions 112 are radially distributed, and a groove 113 is included between two adjacent edge regions 112. In terms of positional distribution, the groove 113 is closer to the axis of the sealing device 100 in the radial direction relative to the radial outer side of the edge region 112.

[0049] Further reference Figure 3 , Figure 3This is a schematic diagram of the deformation state of the fixing part of the occlusion device after implantation in Embodiment 1 of the present invention. Due to the irregular shape of the inner wall of the left atrial appendage, when the occlusion device 100 is implanted as a whole, the fixing part 110 expands radially as a whole. The outer side of the edge region 112 located on the outer side of the fixing part 110 abuts against the inner wall of the atrial appendage. In this embodiment, the edge region 112 extends radially outward. Therefore, on the one hand, the edge region 112 can be partially inserted into the recess 202 of the inner wall 200 of the atrial appendage, increasing the contact between the edge region 112 and the atrial appendage. On the other hand, the groove 113 between adjacent edge regions 112 can also accommodate the protrusion 201 of the inner wall 200 of the atrial appendage, thereby making the adjacent edge regions 112 of the fixing part 110 clamp the protrusion 201 of the inner wall 200 of the atrial appendage, which can also increase the contact between the edge region 112 and the atrial appendage, and increase the radial support force of the fixing part 110 as a whole.

[0050] Furthermore, since the inner wall 200 of the atrial appendage rotates and contracts inward with the contraction of the heart, it can generate new folds, that is, form new protrusions 201 and depressions 202. It can also be adaptively inserted into the grooves 113 between the edge areas 112 and / or inserted into the outer side of the edge areas 112. This greatly increases the contact area between the occlusion device 100 and the inner wall 200 of the atrial appendage, and forms an overall snap-fit ​​through the abutment at multiple positions. This makes the occlusion device 100 of this embodiment have better radial support than the conventional design, that is, it is more tightly integrated with the inner wall 200 of the atrial appendage.

[0051] Combination Figure 4-5 To further describe the effects of this embodiment, Figure 4 This is a top view of the fixing part of a traditional braided structure from the far end to the near end. Figure 5 This is a schematic diagram of the deformation state of the fixation part of the traditional braided structure after implantation. For the fixation part 210a of the traditional braided structure, when it is released from the inner wall 200 of the atrial appendage, as mentioned earlier, the braided structure distributes the concentrated stress to the surrounding area. Therefore, for the braided structure itself, when subjected to pressure, the deformation at the pressure point is the greatest, and the deformation gradually decreases away from the pressure point, thus forming a regional depression. Consequently, when the fixation part 210a expands after being implanted into the atrial appendage, the protrusion 20 of the inner wall 200 of the atrial appendage... The 110a will press against the outer surface of the fixation part 210a, causing the surrounding area of ​​the pressing position to be recessed inward to form a depression 202. Simultaneously, if the inner wall of the atrial appendage 200 is near the protrusion 201 and a depression 202 exists, the protrusion 201 will be compressed and contracted. The bottom surface of the depression 202 will be further away from the surface of the fixation part 210. Therefore, the contact between the conventional fixation part 210a and the inner wall of the atrial appendage 200 after implantation is more of a point-to-surface contact, with a small actual contact area, much smaller than the contactable area of ​​the fixation part 110 in this embodiment. Since the shape of the inner wall of the atrial appendage 200 varies from person to person, this embodiment can achieve better results, especially when there is a significant depression 202 or protrusion 201 on the inner wall of the atrial appendage.

[0052] It should be noted that the shape of the atrial appendage inner wall 200 in the figure is only for illustration. In reality, due to the distribution of the pectinate muscles, the protrusions 201 and depressions 202 of the atrial appendage inner wall 200 are more densely distributed, which results in a significant improvement in the anchoring ability of this embodiment compared to the traditional woven structure with a nearly circular cross-section along the axis. It should also be further noted that the abutting state formed by the edge area 112 and the depressions 202 and / or grooves 113 of the atrial appendage inner wall 200 with the protrusions 201 of the atrial appendage inner wall 200 in this embodiment can also play a limiting role as a whole. This not only prevents the fixing part 110 from being rotated or detached from the atrial appendage inner wall 200, but also forms multiple mutually clamping areas through abutment, increasing the anchoring ability of the fixing part 110.

[0053] Therefore, under certain circumstances, the solution of this embodiment can eliminate the need for sharp anchors and other materials that could easily damage the inner wall 200 of the atrial appendage.

[0054] In this embodiment, the proximal and distal edges of the fixing part 110 are both tapered and closed. The proximal end of the fixing part 110 is tapered and connected to the connector 130, and the distal end of the fixing part 110 is tapered and connected to a steel sleeve.

[0055] In this embodiment, the proximal outer edge surface of the fixing part 110 is located on the proximal side of the connector 130, so that the convergence of the fixing part 110 at the connector 130 position in the direction from the proximal end to the distal end is from the outside to the inside. That is, the central part of the proximal surface of the fixing part is recessed towards the distal end, forming a groove to accommodate the connector 130. When the edge area 112 of the fixing part 110 is squeezed by an external force, the force on the edge area 112 is transmitted to the vicinity of the connector 130. The radially inward squeezing force on the connector 130 is tilted towards the distal end, thereby causing the connector 130 to tighten the sealing part 120 and maintain the anchoring effect of the sealing device 100.

[0056] In this embodiment, in order to achieve a good anchoring effect, the number of edge regions 112 in the fixing part 110 is not less than 4, and in most cases it is preferably 6. That is to say, the number of edge regions 112 is generally between 4 and 6.

[0057] Example 2

[0058] Objectively speaking, the more edge areas the fixing part has, the tighter the connection with the inner wall of the atrial appendage, and the more grooves there will be. The deeper the grooves of the fixing part, that is, the farther the grooves are from the outer side of the edge areas, the more atrial appendage shapes can be accommodated. Combining the above design, Embodiment 1 tends to use more edge areas and deeper grooves, but this also leads to an increase in the overall surface area, a decrease in the ability to adapt to atrial appendage contraction, and a significant increase in the difficulty of sheathing. The difference between this embodiment and Embodiment 1 is that the shape of the fixing part in this embodiment has been further improved.

[0059] Therefore, this embodiment designs a special shape for the fixing part, referring to... Figure 6 , Figure 6 This is a top view of the sealing device in Embodiment 2 of the present invention, viewed from the distal end to the proximal end, as follows:

[0060] In this embodiment, the cross-sectional shape of the central area 311 of the fixing part 310 is still approximately circular, and multiple edge areas 312 extend outward from their roots in a clockwise or counterclockwise direction (i.e., inclined in the same direction). This makes the edge areas 312 of the entire fixing part 310 inclined and radial in the axial cross-section. When the fixing part 310 is sheathed, the edge areas 312 can overlap each other and be stored. This is one of the advantages brought by the inclination in the same direction. Therefore, the design of this embodiment can make each edge area 312 overlap along a preset inclination direction to deform into a smaller volume.

[0061] Therefore, since the shape of the edge region 312 is not limited, in order to achieve that each edge region 312 overlaps in the same direction when the sheath is retracted, this embodiment further limits the tilt. The edge region 312 includes a wing 3111 extending outward. On the cross-section of the fixing part 310, the wing 3111 includes two sides, namely the first side 3112 and the second side 3113. The circumferential top of the wing 3111 serves as the boundary between the two sides. The circumferential top of the wing 3111 refers to the position where the plane of the axis is tangent to the wing 3111 (if there are multiple positions, it is the tangent position on the side closer to the circumferential extension direction of the wing 3111). In the cross-section of the fixing part 310, the curvature of both sides of the wing 3111 is either positive or both negative, meaning that both sides of the wing 3111 extend obliquely in the same direction. Therefore, the extension length of the first side 3112 in this cross-section is greater than the extension length of the second side 3113, meaning that the first side 3112 is the longer side of the wing 3111 along the circumferential direction. In this embodiment, further, for an adjacent set of wings 3111, the curvature of the first side 3112 and the second side 3113 of the adjacent wing 3111 are either both positive or both negative, and the adjacent wings 3111 extend obliquely in the same direction.

[0062] Similarly, since the shape of the edge region 312 is not limited, grooves 3114 may form between adjacent wings 3111. The grooves 3114 or other shape variations cause their bottoms to be closer to or further away from the axis in the radial direction, thus blurring the boundary of the central region 311. In this embodiment, the boundary of the central region 311 is defined by the grooves 3114. That is, the central region 311 is a cylindrical region centered on the axis, with the shortest distance from all grooves 3114 to the axis as its radius. In other words, the central region 311 is a cylinder centered on the axis, with the closest point from the grooves 3114 to the axis as its dividing point. Based on this, the region outside the central region 311 includes multiple edge regions 312, and the wing 3111 refers to the outward-protruding portion of the edge region 312. Each edge region 312 includes one wing 3111, and the outermost edge of the wing 3111 is the outermost edge of the corresponding edge region 312.

[0063] In addition to having good sheathing flexibility, after implantation, the volume of the atrial appendage will shrink to a smaller volume along with the heart. Based on the heart's contraction process, the design of this embodiment also allows the fixing part 310 to be reduced to a smaller volume, thereby adapting to different sizes of left atrial appendages. This prevents adjacent edge areas 312 from approaching and abutting each other in opposite directions, thus avoiding mutual interference and resulting in obstructed contraction, local stress concentration, and damage to the atrial appendage.

[0064] In another embodiment, the distal diameter of the fixing part 110 is smaller than the proximal diameter. That is, there is an inclined slope from the distal side to the proximal side of the fixing part 110, which can adapt to most atrial appendage environments. In other words, the closer to the inner side of the atrial appendage, the smaller the diameter of the atrial appendage. This improves the fit between the wing part 3111 and the pectinate muscle and avoids the fixing part 110 having an excessively large diameter in the area near the inner side of the atrial appendage, which would cause it to directly press against the surface of the pectinate muscle and prevent the wing part 3111 from being able to fit into the pectinate muscle.

[0065] In another embodiment, the central region 311 of the fixing portion 310 has an approximately circular cross-sectional shape, and a plurality of edge regions 312 extend outward from their roots in a clockwise direction along the direction from the distal end to the proximal end.

[0066] In another embodiment, the cross-sectional shape of the central region 311 of the fixing part 310 is still approximately circular, and along the direction from the far end to the near end, a plurality of edge regions 312 extend outward from their roots in a counterclockwise direction.

[0067] In this embodiment, it should also be noted that there is a relatively obvious gap between the wings 3111, which allows for more deformation allowance so that the fixing part 310 can be fully retracted into the sheath. Therefore, in order to ensure smooth entry into the sheath, on the cross-section of the fixing part 310, the radial center circle 315 of the edge region 312 is defined as a virtual circle with the point where the axis of the sealing device is located as the center. For the radial center circle 315, the midpoint of the shortest line segment from the outermost edge region 312 to the boundary line of the center region 311 falls on the radial center circle 315. When the distances from the outermost edge region 312 to the boundary line of the center region 311 are different, the shortest line segment among all edge regions 312 is taken.

[0068] On the cross-section of the fixing part 310, with the point where the axis of the sealing device is located as the center, an arbitrary virtual cutting circle 316 is drawn. The cutting circle 316 intersects the wing 3111 at the first side surface 3112 and the second side surface 3113. The straight-line distance from the intersection of the cutting circle 316 and the first side surface 3112 of the same wing 3111 to the intersection of the cutting circle 316 and the second side surface 3113 is defined as the width of the wing 3111 at that position. Similarly, the straight-line distance from the intersection of the cutting circle 316 and the first side surface 3112 of a certain wing 3111 to the intersection of the cutting circle 316 and the second side surface 3113 of the adjacent wing 3111 is defined as the interval between the adjacent wings 3111 at that position.

[0069] Therefore, this embodiment is preferably as follows: On the cross-section of the fixing part 310, with the radial center circle 315 of the edge region 312 as the dividing line, there is at least one cutting circle 316 on the side of the radial center circle 315 near the axis (i.e., the inner side), such that at this position, the interval between at least one set of adjacent wings 3111 is less than the smaller value of the width of these two adjacent wings 3111. The design of the wings 3111 that satisfies this condition is called the interval design. Thus, when a set of wings 3111 satisfies the interval design, when a certain wing 3111 is deformed by a large compression, the wing 3111 can cross the gap between itself and the adjacent wing, thereby being supported by the adjacent wing, thus ensuring the support strength of the set of wings 3111. Through such a design, the local or overall support strength can be selectively enhanced.

[0070] In another embodiment, on the cross-section of the fixing portion 310, using the radial center circle 315 of the edge region 312 as a dividing line, there is at least one cutting circle 316 on the side of the radial center circle 315 closest to the axis (i.e., the inner side), such that at this location, the interval between all adjacent wings 3111 is less than the width of any single wing 3111. When all wings 3111 adopt a spaced design, the overall support strength can be significantly improved.

[0071] In another embodiment, on the cross-section of the fixing part 310, the radial center circle 315 of the edge region 312 serves as a dividing line. On the side of the radial center circle 315 closest to the axis (i.e., the inner side), for any cutting circle 316, the spacing between all adjacent wings 3111 is less than the width of any wing 3111. This design in this embodiment is called a fully spaced design, and when this design is adopted, the fixing part 310 has optimal support strength.

[0072] In another embodiment, on the cross-section of the fixing part 310, using the radial center circle 315 of the edge region 312 as a dividing line, there is at least one cutting circle 316 on the side of the radial center circle 315 closer to the axis (i.e., the inner side), such that at this location, the interval between at least one set of adjacent wings 3111 is at least less than the width of one of the two adjacent wings 3111 (hereinafter referred to as the specific wing). This embodiment is designed as a semi-spaced design, in which at least the specific wing can cross the gap, thereby being supported by the adjacent wings, and thus at least locally increasing the support strength of the specific wing region. Considering that in some cases the occlusion device may be implanted at an angle, and the fixing part 310 tilts off the axis with the shape of the auricle, the circumferential distribution of the fixing part 310 is not uniform. The sparser side requires greater support strength, so the above-mentioned spaced design can be set in the specific area, while the denser side due to the accumulation itself has better support strength, and therefore no spaced design is required, thus preserving the overall good insertion smoothness of the occlusion device.

[0073] It should be noted that this effect is only achieved when the fixing part 310 forms a distinct wing 3111 and there is a significant gap between adjacent wings 3111. In this embodiment, considering the fixing part 310 as a whole, the radial length of the wing 3111 extends at least more than 1 / 3 of the radius of the fixing part 310 as a whole. This is considered a distinct wing 3111 as described above. The presence of indistinct wings would cause the deformation to be directly transmitted to the root of the wing after deformation, rather than allowing the wing itself to abut against adjacent wings for support. In other words, the wing directly subjected to pressure cannot deform and cross the gap to be supported by adjacent wings 3111. In summary, the design of the fixing part 310 only achieves the aforementioned support effect when distinct wings 3111 are provided.

[0074] Example 3

[0075] In this embodiment, based on the risk control of the implant, in order to further enhance the purpose of preventing displacement, an additional anchoring element 410 may be provided on the wing 3111.

[0076] Reference Figure 7-8 , Figure 7This is a schematic diagram of the fixing part of the sealing device in Embodiment 3 of the present invention. Figure 8 This is a top view of the fixing part of the sealing device in Embodiment 3 of the present invention, viewed from the far end to the near end.

[0077] In this embodiment, the anchor 410 is not part of the fixing part 310. That is, the anchor 410 is neither directly formed on the main body of the fixing part 310 nor extended from a part of the main body, nor is it rigidly fixed to the fixing part 310 by welding or other methods. In this embodiment, the anchor 410 is fixed to the fixing part 310 by a flexible binding method (such as stitching). The advantage of flexible binding is that it can retain some slack in the movement of the anchor 410 and the fixing part 310. In this embodiment, the anchor 410 is fixed to the outside of the wing 3111, so that the free end of the anchor 410 is exposed and extends obliquely, so that it can be inserted into or locked into a predetermined position to achieve anchoring.

[0078] In another embodiment, the anchor 410 is disposed on the long side of the wing 3111 along the circumferential direction, thereby matching the extension direction of the wing 3111 and making it easier to contact the inner wall of the atrial appendage.

[0079] In another embodiment, the hook 420 of the anchor 410 passes through the skeleton of the wing 3111 from the inside to the outside, so that the free end of the anchor 410 is exposed and extends obliquely, so that it can be inserted into a predetermined position to achieve anchoring.

[0080] In this embodiment, the anchoring member 410 includes at least one set of hooks 420. In this embodiment, the anchoring member 410 includes a first hook 411 and a second hook 412. Generally, the hooks 420 extend from the rods 421 (an additional hook can also be fixed to the rods 421). Therefore, the anchoring member 410 also includes a pair of rods 421. A set of rods 421 is connected by at least one connecting rod 422. It should be noted that in addition to playing a basic connecting role, the rods 422 can also distribute the force on the pair of hooks 420. This avoids excessive stress on the implantation site caused by the hooks 420, thus preventing excessive wounds. On the other hand, after the stress is distributed to the two hooks 420 at two different positions, the two hooks 420 are equivalent to pulling each other, thus forming a clamping state similar to a "clamp". With the insertion depth unchanged, the anchoring member 410 with this configuration has a better anchoring effect.

[0081] When the first hook 411 and the second hook 412 of the anchoring member 410 are located in the same axial position (for ease of description, the axial position of the hook refers to the axial position of the free end of the hook), the distance from the first hook 411 and the second hook 412 of the anchoring member to the far end face of the fixing part 310 is less than or equal to 1 / 2 of the overall axial length of the fixing part 310. Preferably, the distance from the first hook 411 and the second hook 412 of the anchoring member to the far end face of the fixing part 310 is 1 / 3 of the overall axial length of the fixing part 310. If the first hook 411 and the second hook 412 of the anchoring member 410 have different heights, the higher first hook 411 is closer to the fixed end face of the fixing part 310 than the lower first hook 411. The distance from the distal end face of part 310 is less than or equal to 1 / 2 of the overall axial length of fixed part 310, and the distance from the lower second hook 412 to the distal end face of fixed part 310 is greater than or equal to 1 / 2 of the overall axial length of fixed part 310. Preferably, the distance from the higher first hook 411 to the distal end face of fixed part 310 is 1 / 3 of the overall axial length of fixed part 310, and the distance from the lower second hook 412 to the distal end face of fixed part 310 is 2 / 3 of the overall axial length of fixed part 310. The above-mentioned anchoring element 410 can ensure reduced contact with tissues during forward movement and retraction, reduce damage to the auricle, and reduce anchor wear.

[0082] Reference Figure 9 , Figure 9 This is a schematic diagram of the anchoring member of the sealing device installed on the fixing part in another embodiment. The anchoring member 410 is sewn to the outer surface of the fixing part 310 by a stitch. When the first hook 411 and the second hook 412 have a height difference, in addition to the stitching point of the first hook 411 and the second hook 412 near the free end, the connecting rod 422 includes at least one stitching point, and the rod 421 of the first hook 411 includes at least one stitching point. Since rod 421 extends generally along the axial direction and connecting rod 422 extends generally along the circumferential direction, based on the characteristics of the stitching, the stitching point of rod 421 mainly restricts the circumferential movement of rod 421, and the restriction on the axial movement of rod 421 is relatively weak. Similarly, the stitching point of connecting rod 422 mainly restricts the axial movement of connecting rod 422, and the restriction on the circumferential movement of connecting rod 422 is relatively weak. It should be noted that, since there is also the possibility that anchor 410 may rotate along the surface of fixing part 310, in this embodiment, the stitching point of the second hook 412 near the free end (i.e., the stitching point closest to the second hook 412) needs to be located at the same position in the axial direction as a certain stitching point on rod 421 (i.e., at the same height of fixing part 310). This reduces the possibility of the second hook 412 moving circumferentially along the surface of fixing part 310, and consequently reduces the possibility of the anchor 410 rotating.

[0083] Reference Figure 10 , Figure 10 This is a schematic diagram of the structure of various optional anchoring elements in Embodiment 3 of the present invention. This embodiment can use various anchoring elements 410 or combinations thereof, as detailed below:

[0084] Typically, symmetrically distributed, roughly "V"-shaped anchors 410a can be used. In this design, the first hook 411a and the second hook 412a of the anchor 410a are located at the same axial position of the fixing part of the sealing device.

[0085] In other cases, a design can also be adopted in which the free ends of the first hook 411b and the second hook 412b of the anchor 410b are located at different heights. In this design, the first hook 411b and the second hook 412b of the anchor 410b are located at different axial positions of the fixing part of the sealing device, with the first hook 411b located on the distal side of the second hook 412b.

[0086] In other cases, a design can also be adopted where the first hook 411c and the second hook 412c of the anchor 410c have different heights and different extension directions. In this design, the first hook 411c and the second hook 412c of the anchor 410c are located at different axial positions of the fixing part of the sealing device. The first hook 411c is located on the far end side of the second hook 412c, and the extension directions of the first hook 411c and the second hook 412c are different. This results in different angles (deflection angles) formed by the tangent direction of the free end of the first hook 411c and the tangent direction of the starting end of the first hook 411c, and the angles (deflection angles) formed by the tangent direction of the free end of the second hook 412c and the tangent direction of the starting end of the second hook 412c. This provides better adaptability.

[0087] Reference Figure 11 , Figure 11 This is a schematic diagram of the structure of other optional anchoring components in Embodiment 3 of the present invention. Anchoring component 410d, anchoring component 410e, and anchoring component 410f are all selectable anchoring component shapes. It should be noted that, in addition to the hook having multiple options, the corresponding rod connected to the hook and the connecting rod used to connect adjacent rods can also be selected according to the actual situation.

[0088] Based on this embodiment, when the extension directions of the first hook 411 and the second hook 412 are different, the anchoring member 410 can contact the anchoring position in multiple directions, thereby achieving a more stable anchoring. It should be noted that this function can only be achieved by setting the anchoring member 410 on the outer periphery of the wing 3111. This is because the wing 3111 itself can extend into the inner side of the pectinate muscle. Thus, the ends of the first hook 411 and the second hook 412 can use ball heads to replace sharp barbs, and still achieve a good anchoring effect. The fixing part of a traditional occlusion device is a complete circumferential surface, which cannot effectively penetrate and fit into the pectinate muscle. As a result, the fixing part of a traditional occlusion device always directly contacts the outer surface of the pectinate muscle. Since it cannot penetrate or snap into the pectinate muscle, the corresponding anchoring element of a traditional occlusion device can only be set along a specific direction. Theoretically, if the traditional occlusion device is set with the anchoring element along different directions, the fixing part of the traditional occlusion device will expand roughly in the circumferential direction after release and fit tightly against part of the pectinate muscle. The anchoring element set in a non-circumferential direction cannot effectively penetrate or snap into the pectinate muscle. In other words, even with the design of hooks 420 in different extension directions in this embodiment, the fixing part of a traditional occlusion device cannot achieve a good anchoring effect.

[0089] Taking the first hook 411 as an example, the deflection angle of the first hook 411 is defined as the angle formed by the tangent direction at the free end and the tangent direction at the starting end of the first hook 411. Furthermore, to further demonstrate its effect, the deflection angle can be defined as the circumferential deflection angle and the axial deflection angle. Specifically, the circumferential deflection angle of the first hook 411 is defined as the angle formed by the tangent direction at the free end and the tangent direction at the starting end of the projection of the first hook 411 on the cross-section of the fixing part 310. The axial deflection angle of the first hook 411 is defined as the angle formed by the tangent direction at the free end and the tangent direction at the starting end of the projection of the first hook 411 on the longitudinal section of the fixing part 310.

[0090] In another embodiment, the first hook 411 and the second hook 412 have the same deflection angle along the axial direction and the same deflection angle along the circumferential direction, so that the operator can choose to insert the first hook 411 and the second hook 412 at a predetermined position, thereby simplifying the operation.

[0091] In another embodiment, the first hook 411 and the second hook 412 have the same deflection angle along the axial direction, but different deflection angles along the circumferential direction, so that the first hook 411 and the second hook 412 can form a state similar to clamping or pulling in the circumferential direction.

[0092] In another embodiment, the first hook 411 and the second hook 412 have different deflection angles along the axial direction and the same deflection angles along the circumferential direction, so that the first hook 411 and the second hook 412 can form a state similar to clamping or pulling in the axial direction.

[0093] In another embodiment, the first hook 411 and the second hook 412 have different deflection angles along the axial direction and different deflection angles along the circumferential direction, so that the first hook 411 and the second hook 412 can simultaneously form a state similar to clamping or pulling in the axial and circumferential directions.

[0094] In all embodiments, although the deflection angles of the first hook 411 and the second hook 412 extending axially or circumferentially can be varied, a preferred range of deflection angles for the first hook 411 and the second hook 412 extending axially is observed, referring to... Figure 12 , Figure 12 This is a longitudinal schematic diagram of the anchoring member 410 of the occlusion device in this embodiment after installation. That is, along the longitudinal section direction of the fixing part, the axial deflection angle of the first hook 411 is A, and the axial deflection angle of the second hook 412 is B. Generally, the range of included angles A and B should be between 120° and 180°. It should be noted that this angle range is based on the design of the wing 3111 in this application. Specifically, after the anchoring member 410 is installed on the wing 3111, it extends along the shape of the wing 3111, thus having a certain inclination relative to the implantation position, and the wing 3111 extends into the pectinate muscle, thereby achieving a larger angle of anchorage. For traditional occlusion devices, included angles A or B should be as small as possible to facilitate the function of the barbs.

[0095] In another embodiment, the distance by which the first hook 411 extends beyond the second hook 412 along the axial direction is between 1 and 3 mm. That is, the first hook 411 will be closer to the inside of the left atrial appendage. Therefore, the axial deflection angle of the first hook 411 can be set to be smaller. In other words, in the preferred state, the included angle A is greater than the included angle B, so as to ensure that the first hook 411 maintains a good anchoring effect while avoiding piercing the inner wall of the atrial appendage.

[0096] In another embodiment, a third hook is also included, located at the distal end of the first hook. The axial deflection angle of the third hook is C, and the included angle values ​​satisfy A < B < C, thereby further increasing the anchoring capability.

[0097] In another embodiment, it can be deduced by analogy that when the anchoring element includes multiple hooks distributed along the axial direction, the deflection angle of the hook on the distal side along the axial direction is smaller than that of the hook on the proximal side along the axial direction in the longitudinal section of the fixing part, which can reduce damage to the auricle while increasing the stable anchoring ability.

[0098] In another embodiment, along the circumferential direction, the hook on one side of the anchor and the hook of the adjacent anchor extend towards or away from each other, allowing the two adjacent anchors to clamp or tighten each other in the circumferential direction, thereby distributing some of the concentrated stress to the adjacent anchors. This is because the outer circumferential surface of the fixing part involved in this application is discontinuous (i.e., not a complete circumference) when it contacts the auricle, resulting in a more concentrated stress compared to conventional circumferentially designed sealing devices, thus making the interaction between adjacent wings and adjacent anchors have a greater impact on the overall anchoring strength.

[0099] In another embodiment, reference Figure 13-14 , Figure 13 This is a schematic diagram of the sealing device in this embodiment. Figure 14 This is a top view of the occlusion device in this embodiment, viewed from the distal end to the proximal end. At least two anchoring elements 410 are provided on each wing 3111, and the two anchoring elements 410 do not completely overlap in the circumferential direction, allowing them to complement each other. That is, hooks 420 are distributed at multiple locations on a single wing 3111, ensuring that each wing 3111 can be anchored. In this embodiment, it should also be noted that because the outer edges of the wing 3111 gradually converge towards the axis, adjacent anchoring elements 410 are not on the same circumference, further enabling the hooks 420 of the anchoring elements 410 to contact the inner wall of the auricle at different angles.

[0100] Preferably, on the same wing 3111, among two adjacent anchoring members 410, the first hook 411 is located on the far end side of the second hook 412, and the first hook 411 is adjacent to the first hook of the adjacent anchoring member 410, so that the area of ​​the entire fixing part that plays the anchoring role is distributed in a high-low state, thereby having a better anchoring effect.

[0101] Because the outer circumference of the fixing part involved in this application is discontinuous (i.e. not a complete circumference) when it contacts the auricle, the stress is more concentrated than that of the sealing device with a traditional circumferential design, which makes the interaction between adjacent anchoring parts have a greater impact on the overall anchoring strength.

[0102] Example 4

[0103] This embodiment further improves the fixing part; see details below. Figure 15 , Figure 15 This is an explosion diagram of the sealing device in Embodiment 4 of the present invention.

[0104] In this embodiment, a support frame 330 is provided inside the fixing part 310. The support frame 330 has a supporting function on the surface of the fixing part 310. Specifically, the support frame 330 includes a continuous converging section 331, a unfolding section 332 and an extension section 333. The support frame 330 starts from the converging section 331, unfolds radially through the unfolding section 332, and then deflects at the end of the unfolding section 332 to form an extension section 333 extending toward the distal or proximal end. In this embodiment, the converging section 331 extends from the proximal end to the distal end, and the extension section 333 extends from the distal end to the proximal end.

[0105] In this embodiment, the converging section 331 can be suspended inside the fixing part 310, or it can extend into the sealing part 320 and be suspended, or it can be further extended and fixed to the proximal center of the sealing part 320, that is, the plug position.

[0106] In this embodiment, as Figure 16-17 As shown, Figure 16 This is a schematic diagram of the sealing device from the front view in Embodiment 4 of the present invention. Figure 17 This is a schematic diagram of the occlusion device in Embodiment 4 of the present invention, showing its structure from distal to proximal. The support frame 330 is depicted as a dashed line, indicating that it is located inside the fixing part 310. The support frame 330 provides support to the fixing part 310 from the inside out. The extended section 332 of the support frame 330 extends approximately along the radial extension direction of the fixing part 310 and connects to the distal end face of the fixing part 310 to support it. The extension section 333 of the support frame 330 supports the radially outer surface of the fixing part 310. In this embodiment, preferably, the extension section 333 is close to the edge of the radially outer surface of the fixing part 310 (i.e., the outermost position) to increase the probability that the extension section 333 will follow the outer side of the fixing part 310 and engage with the pistiloid muscle. Therefore, in this embodiment, no anchoring element is required, thus minimizing damage to the inner wall of the atrial appendage.

[0107] After the fixation part 310 is implanted, its radial outer surface directly contacts the atrial appendage wall, and the stress it receives is directly transmitted to the extension section 333. When there is no support frame 330, the radial outer surface of the fixation part 310 is concave inward, and when it is transmitted to the distal end face, it will cause the distal end face to bulge in the distal direction. However, when there is a support frame 330, the deformation of the distal end face is limited by the unfolding section 332 of the support frame 330. In addition, the extension section 333 of the support frame 330 is also subjected to pressure from the atrial wall. Since the extension section 333 extends from the distal extension section 332 toward the proximal end, when the extension section 332 is horizontally or protruding toward the distal end, the extension section 333 is subjected to radial pressure, which will also cause the extension section 332 of the support frame 330 to have a certain tendency to bulge toward the distal end (it should be noted that the deformation of the extension section 332 is small and will not further push the fixed part to deform). This will further pull the converging section 331 toward the distal end, thereby enhancing the tendency of the fixed part 310 to move toward the distal end as a whole, so as to reduce the risk of the fixed part 310 falling off from the proximal end.

[0108] In another embodiment, the support frame 330 and the fixing part 310 are relatively independent, that is, there is no connection between them. In this configuration, the unfolding part 332 still supports the distal side of the fixing part 310, and the extension section 333 supports the radial outer side of the fixing part 310. In addition, when the fixing part 310 is subjected to radial pressure, it will cause the unfolding section 332 of the support frame 330 to have a certain tendency to protrude towards the distal side, which will further pull the converging section 331 to move towards the distal side, thereby enhancing the overall tendency of the fixing part 310 to move towards the distal side, so as to reduce the risk of the fixing part 310 falling off from the proximal end.

[0109] In another embodiment, in the natural state, there is a gap between the support frame 330 and the fixing part 310. The minimum distance from the unfolded part 332 to the distal side of the fixing part 310 is less than 1 mm, and the minimum distance from the extension section 333 to the radial outer side of the fixing part 310 is greater than 3 mm. As a result, the radial pressure initially received by the fixing part 310 will not be transmitted to the extension section 333. The support frame 330 only plays a supporting role when a large deformation occurs. This allows the fixing part 310 to be better inserted into the pectinate muscle during implantation, avoiding interference from the support frame 330 and thus preventing it from penetrating deep into the pectinate muscle.

[0110] In another embodiment, reference Figure 18 , Figure 18This is a schematic diagram of the sealing device in another embodiment of the present invention. In this embodiment, the support frame 340 is located outside the fixing part 310. In this embodiment, the surfaces of the support frame 340 and the fixing part 310 are connected. When the fixing part 310 is subjected to radial pressure, the pressure is directly applied to the surface of the support frame 340 and then further distributed and transferred by the fixing part 310. When the external force disappears after deformation, the position of the support frame 340 is simultaneously subjected to the radial outward restoring force of the support frame 340 itself and the radial outward restoring force of the fixing part 310. Therefore, when restoring the original shape, the support frame 340 will be restored first. In this embodiment, the preset positions of the extended section 332 and the extended section of the support frame 340 are respectively at the middle of the end face of each wing of the fixing part 310 and the radial outermost side. This makes the middle of the end face of each wing of the fixing part 310 and the radial outermost side the priority to restore when the fixing part 310 restores its shape, which plays a guiding role and reduces the risk of mutual interference or overlapping when the wing is restored due to mutual contact or abutment between the wings.

[0111] In another embodiment, reference Figures 19-20 , Figure 19 This is an exploded schematic diagram of the sealing device in another embodiment of the present invention. Figure 20 This is a schematic diagram of the sealing device from a frontal perspective in Embodiment 4 of the present invention. In this embodiment, the converging section 351 extends from the proximal end to the distal end, and the extending section 353 extends from the distal end to the proximal end. A notable feature is that, since the expanding section 352 is located near the proximal end face of the fixing part 310, the side of the expanding section 352 near the converging section 351 is pre-designed to bulge axially towards the distal end. That is, the inner side of the expanding section 352 is located on its outer distal end side, thereby making the outer side of the expanding section 352 (i.e., its extension section)... When the connection point of segment 353 is subjected to radial inward pressure, the pressure is transmitted along the unfolding segment 352 to the converging segment 351, gradually tilting from the original radial direction towards the distal direction. In this case, when the proximal end faces of the unfolding segment 352 and the fixing part 310 are connected to each other (e.g., through a flexible connector such as a stitch), the unfolding segment 352 can further drive the center of the proximal end face of the fixing part 310 to move towards the distal end. Thus, the center of the proximal end face of the fixing part 310 moving towards the distal end drives the sealing part to move towards the distal end. If the unfolding segment 352 and the fixing part 310 are relatively independent, since the main external force they are subjected to is radial pressure, the radial outer surfaces of the extension segment 353 and the fixing part 310 press against each other when compressed, and there is little displacement between the extension segment 353 and the fixing part 310. However, other parts of the support frame 350 tend to move or move towards the distal end due to the radial external force. At this time, they will also support the fixing part 310 located on the outside, thereby achieving the effect of supporting the fixing part 310 towards the distal end.

[0112] Example 5

[0113] This embodiment further improves the fixing part; see details below. Figure 21 , Figure 21 This is a schematic diagram of the sealing device in Embodiment 5 of the present invention.

[0114] It should be noted that the fixing part 340 in this embodiment adopts a woven structure, which is relatively soft. On the other hand, a special wing 341 is designed so that the fixing part 340 can be embedded in the pectinate muscle without damaging the pectinate muscle as much as possible. From a macroscopic perspective, the fixing part 340 is relatively soft and relies more on the contact between the woven structure and the pectinate muscle to obtain greater frictional force to achieve anchoring (in the absence of anchoring elements such as anchor spikes).

[0115] Under these circumstances, since the fixing part 340 is attached to the inner wall of the atrial appendage, and the contraction and relaxation of the heart are not along a straight line, but are accompanied by rotation, bending and other movements, the part of the fixing part 340 attached to the inner wall of the atrial appendage will also deform synchronously. Since the deformation of the woven body of the fixing part 340 will be transmitted to other parts, and its own ability to resist deformation is weak, during the contraction and relaxation of the heart, a large deformation is likely to accumulate at the fixing part 340. Then, when the external pressure is removed, the deformation of the surface of the fixing part 340 will quickly recover, making the entire fixing part 340 prone to small-amplitude movements similar to jumping. This action is similar to the vibration of a spring that is compressed perpendicular to a table and returns to its original shape when the external force is removed. It is easy for the spring to jump, which will cause the part of the spring that is in contact with the table to leave its original position (that is, the spring will be displaced). Therefore, without the setting of an anchoring structure, as the atrial appendage deforms, the fixing part 340 may jump and be displaced as described above. The displacement of the fixing part 310 can easily cause the part of the fixing part 340 that is stuck inside the pistil muscle to detach or the whole part to tilt.

[0116] The cause of the jumping in the fixing part 340 is that when the area with large deformation returns to its original shape, the forces acting on each area to restore its shape are superimposed, resulting in excessive acceleration in the area with large deformation. Therefore, after returning to the preset size, it continues to move, pulling other areas along the original direction of movement, thus pulling the entire fixing part 340 and causing a jumping motion. In other words, the jumping originates from excessive deformation in some areas. Therefore, in this embodiment, a limiting member 342 is added to the fixing part 340 to solve or reduce this risk.

[0117] like Figure 21As shown, the limiting member 342 is strip-shaped and is located at the outermost radial position of the fixing part 340 (the limiting member 342 can be located on the inner or outer side of the surface of the fixing part 340; the outermost radial position here refers to the radial edge of the fixing part 340). This is also one of the areas with the greatest deformation theoretically after the fixing part 340 is implanted and contacts the inner wall of the atrial appendage. The two ends of the limiting member 342 are fixed to the mesh structure of the fixing part 340 by flexible members. Thus, at least in the corresponding area of ​​the limiting member 342, the mesh spacing of the fixing part 340 cannot be expanded or reduced excessively. Therefore, the limiting member 342 restricts the deformation of the corresponding area of ​​the fixing part 340, thereby limiting the area with the greatest deformation. The deformation of the fixing part 340 is further distributed to other areas, making the overall deformation more uniform. Thus, when the external force is removed and the original shape needs to be restored, the area with the greatest deformation will no longer have excessive stress superposition, the acceleration will decrease, and the probability of beating will decrease or disappear as a whole.

[0118] In another embodiment, a plurality of mutually separated limiting members 342 are provided axially at the radially outermost position of a single wing 341 of the fixing part 340.

[0119] In another embodiment, a single limiting member 342 connects at least two positions of the fixing part 340, thereby affecting the relative movement of the grid between these two positions of the fixing part 340, and thus obtaining a corresponding limiting effect.

[0120] In this embodiment, each of the wings 341 of the fixing part 340 is provided with a limiting member 342.

[0121] In this embodiment, preferably, the limiting member 342 spans at least the mesh of the woven structure of the four fixing parts 340, and the end of the limiting member 342 is fixed to the vertex of a certain mesh. The limiting member 342 configured in this way has the least impact on the fixing parts 340.

[0122] Based on this, refer to Figure 22 , Figure 22 This is a schematic diagram of the occlusion device in Embodiment 5 of the present invention from the perspective of the distal end to the proximal end. The fixing part 340 also includes a second limiting member 343 disposed on the distal end face and / or the proximal end face. The two ends of the second limiting member 343 are also fixed to the mesh structure of the fixing part 340 by flexible members. In order to ensure smooth implantation, the second limiting member 343 extends along the extension direction of the wing part 341.

[0123] In this embodiment, preferably, the second limiting member 343 spans at least the mesh of the woven structure of the two fixing parts 340, and the end of the second limiting member 343 is fixed to the vertex of a certain mesh. The reason for the difference from the limiting member 342 is that the local deformation of the end face where the second limiting member 343 is located is generally smaller than that of the side face.

[0124] In another embodiment, the limiting member 342 may also be provided on the sealing portion 350. Preferably, the limiting member 342 distributed on the surface of the sealing portion 350 is located on the radially outer end face of the sealing portion 350 and extends axially, and / or is located on the proximal end face of the sealing portion 350 and extends radially, so that it can better enter and exit the sheath tube.

[0125] In this embodiment, the limiting member 342 can be made of nickel-titanium metal with low rejection properties or a biodegradable material.

[0126] Overall, the limiting member 342 in this embodiment and the support frame in the previous embodiment are both auxiliary structures used to enhance the anchoring effect. The difference is that the limiting member 342 in this embodiment is used to solve the problem of jumping, while the support frame in the previous embodiment mainly provides support force. It should be noted that the support frame in the previous embodiment uses the transmission and direction of force to gather and then cancel out the external force, while the limiting member 342 in this embodiment is more for restricting the relative movement of the mesh structure of the fixing part 340 to solve the jumping problem that is easy to occur when restoring the shape. Objectively, adding the limiting member 342 can also increase the strength of the fixing part in this area, but this is not the technical problem to be solved by this embodiment. In order to further reflect the unique role of the limiting member 342, in another embodiment, the length of a single limiting member 342 is less than 4mm, and there is no connection between the various limiting members 342, which are independent of each other.

[0127] In this embodiment, furthermore, a fiber member 344 is connected between adjacent wings 341. The fiber member 344 is disposed in the circumferential gap between adjacent wings 341 and can be composed of various flexible materials, including but not limited to sutures, PET films, etc. Its function is to increase the probability of microthrombus formation in the gap between adjacent wings 341, thereby facilitating endothelialization within the fixation part 340 area. It should be noted that only the wing 341 design of this embodiment can leave a circumferential gap, so that cells can more easily adhere through the circumferentially distributed fiber member 344. Traditional complete fixation part designs do not leave space in the circumferential direction, so similar operations can only be carried out at the proximal or distal end in the axial direction. The endothelialization rate is far lower than that of this embodiment. This is also the unique effect of the design of this embodiment.

[0128] In this embodiment, the boundaries of the fiber element 344 are rough, and the surface of the fiber element 344 includes multiple folds and / or pores, thereby further increasing the generation of microthrombi and endothelialization efficiency.

[0129] It should be noted that the technical features of the above embodiments can be combined arbitrarily and can also be applied simultaneously to various left atrial appendage occluders and left atrial appendage occluders with similar structures. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described; however, as long as the combination of these technical features is not contradictory, it should be considered within the scope of this specification.

[0130] It should also be noted that the above embodiments do not exclude the technical solution of adding anchor spikes. In order to meet specific situations, the above embodiments can be equipped with anchor spikes as needed.

[0131] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A sealing device, comprising a fixing part and a sealing part, wherein the fixing part comprises a mesh woven structure, characterized in that, The fixing part includes a plurality of radially extending wings, and the sealing device is provided with an auxiliary structure for enhancing the anchoring effect of the wings.

2. The sealing device according to claim 1, characterized in that, The auxiliary structure includes a support frame disposed on the fixed part. The support frame includes a continuous converging section, a unfolding section, and an extension section. The converging section is radially unfolded through the unfolding section and then deflected at the end of the unfolding section to form the extension section.

3. The sealing device according to claim 2, characterized in that, The support frame and the fixing part are relatively independent.

4. The sealing device according to claim 3, characterized in that, The minimum distance from the extended section to the distal side of the fixed part is less than 1 mm, and the minimum distance from the extended section to the radial outer side of the fixed part is greater than 3 mm.

5. The sealing device according to claim 2, characterized in that, The support frame is located on the outer surface or the inner side of the fixing part.

6. The sealing device according to claim 5, characterized in that, The support frame is located at the middle of the end face and the outermost radial side of the wing.

7. The sealing device according to claim 2, characterized in that, The unfolded section is located on the distal side of the fixed part, and the extended section extends toward the proximal end.

8. The sealing device according to claim 2, characterized in that, The unfolded section is located on the proximal side of the fixed part, and the extended section extends toward the distal end.

9. The sealing device according to claim 8, characterized in that, The inner side of the unfolded segment is located at the far end of the outer side of the unfolded segment.

10. The sealing device according to claim 2, characterized in that, The converging section is suspended inside the fixing part, or the converging section extends into the sealing part and is suspended, or the converging section extends and is fixed to the proximal center of the sealing part.

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