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, a central area, and multiple edge areas surrounding the central area circumferentially. Adjacent edge areas include grooves. Compared to traditional fixing part designs with cylindrical outer edges (i.e., circular cross-sections), the fixing part of the occlusion device provided by this invention has multiple grooves and edge areas, which can adaptively engage with the grooves and protrusions in the implantation area and maintain contact with the surface of the implantation area, thereby increasing the contact area and achieving 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 insufficient contact area between the fixation part and the implantation site in existing left atrial appendage occlusion devices, as follows:

[0006] A sealing device is provided, including a fixing part and a sealing part. The fixing part includes a mesh woven structure, a central area and a plurality of edge areas distributed circumferentially around the central area and extending radially outward. Adjacent edge areas include grooves.

[0007] In one embodiment, both the proximal and distal ends of the fixing portion are constricted and closed.

[0008] In one embodiment, the edge region includes an outwardly extending wing, the wing including a first side and a second side, wherein the curvature of the first side and the second side of the same wing is either both positive or both negative on at least one same cross-section.

[0009] In one embodiment, the number of edge regions of the fixing part is between four and six.

[0010] In one embodiment, the plurality of edge regions of the fixing portion are inclined and radial in cross-section.

[0011] In one embodiment, the plurality of edge regions of the fixing portion extend outward from the root in a clockwise direction, or the plurality of edge regions extend outward from the root in a counterclockwise direction.

[0012] In one embodiment, the edge region includes outwardly extending wings, with the radial centerline of the edge region as a dividing line. Inside the radial centerline of the edge region, there is at least one virtual cutting circle that intersects the wings. At the location of the cutting circle, the interval between at least one set of adjacent wings is less than the width of the two adjacent wings.

[0013] In one embodiment, the edge region includes outwardly extending wings. Using the radial centerline of the edge region as a dividing line, there is at least one virtual cutting circle intersecting the wings along the inner side of the radial centerline of the edge region. At the location of the cutting circle, the interval between all adjacent wings is less than the width of any wing, or, for any cutting circle, the interval between all adjacent wings is less than the width of any wing.

[0014] In one embodiment, the fixing part is equipped with an anchor, which is disposed on the outside of the fixing part.

[0015] In one embodiment, the anchor includes two connected first hooks and second hooks, with the free end of the first hook located at the distal end of the free end of the second hook.

[0016] Compared with the prior art, the present invention provides an occlusion device including a fixing part and a sealing part. The fixing part includes a mesh woven structure, a central area and multiple edge areas surrounding the central area circumferentially, and adjacent edge areas include grooves. 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 the present invention has multiple grooves and edge areas, which can adaptively fit into the grooves and protrusions of the implantation area and maintain contact with the surface of the implantation area, thereby increasing the contact area and obtaining better anchoring ability. 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 sealing device from the distal end to the proximal end in another embodiment of the present invention. Detailed Implementation

[0031] 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.

[0032] 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.

[0033] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0034] Example 1

[0035] 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.

[0036] 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 1 They 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.

[0037] 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.

[0038] 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.

[0039] Furthermore, referring to Figure 2 , Figure 2 This 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.

[0040] 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.

[0041] Further reference Figure 3 , Figure 3 This 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.

[0042] 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.

[0043] 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 5This 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] Example 2

[0050] 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.

[0051] 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:

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] Example 3

[0067] 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.

[0068] Reference Figure 7-8 , Figure 7 This 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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:

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] In another embodiment, reference is made to 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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. An occlusive device comprising a fixation portion and a sealing portion, the fixation portion comprising a mesh braid, wherein, The fixing part includes a central area and a plurality of edge areas distributed circumferentially around the central area and extending radially outward, and two adjacent edge areas include a groove.

2. The sealing device according to claim 1, characterized in that, Both the proximal and distal ends of the fixing part are constricted and closed.

3. The sealing device according to claim 1, characterized in that, The edge region includes an outwardly extending wing, the wing including a first side and a second side, wherein the curvature of the first side and the second side of the same wing is either both positive or both negative on at least one cross-section.

4. The sealing device according to claim 1, characterized in that, The number of edge regions of the fixing part is between four and six.

5. The sealing device according to claim 1, characterized in that, The plurality of edge regions of the fixing part are inclined and radial in cross-section.

6. The sealing device according to claim 1, characterized in that, The plurality of edge regions of the fixing part extend outward from the root in a clockwise direction, or the plurality of edge regions extend outward from the root in a counterclockwise direction.

7. The sealing device according to claim 1, characterized in that, The edge region includes wings extending outwards. Using the radial centerline of the edge region as a dividing line, there is at least one virtual cutting circle intersecting the wings along the radial centerline of the edge region. At the location of the cutting circle, the interval between at least one set of adjacent wings is less than the width of the two adjacent wings.

8. The sealing device according to claim 1, characterized in that, The edge region includes wings extending outwards. Using the radial centerline of the edge region as a dividing line, there is at least one virtual cutting circle intersecting the wings along the radial centerline of the edge region. At the location of the cutting circle, the interval between all adjacent wings is less than the width of any wing, or, for any cutting circle, the interval between all adjacent wings is less than the width of any wing.

9. The sealing device according to claim 1, characterized in that, An anchor is mounted on the fixed part, and the anchor is located on the outside of the fixed part.

10. The sealing device according to claim 9, characterized in that, The anchoring element includes two connected first hooks and second hooks, with the free end of the first hook located at the distal end of the free end of the second hook.

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