Sealing device

Abstract

This invention relates to a sealing device, comprising a fixing part and a sealing part. The fixing part includes a mesh structure woven from braided filaments, a central region, and a plurality of wings extending radially from the central region along the fixing part. The plurality of wings are spaced apart around the central region circumferentially. At least some of the proximal end faces of the wings include edge recesses facing the distal end of the fixing part. The sealing device of this invention has good 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 that addresses the problems of existing left atrial appendage occlusion devices, and this improved occlusion device has good anchoring performance, as detailed below:

[0006] A sealing device includes a fixing part and a sealing part. The fixing part includes a mesh structure woven from braided filaments. The fixing part includes a central region and a plurality of wings extending radially from the central region along the fixing part. The plurality of wings are spaced apart around the central region circumferentially along the fixing part. At least a portion of the proximal end faces of the wings include edge recesses that are recessed toward the distal end of the fixing part.

[0007] In one embodiment, the proximal end face of the central region includes a central recess recessed toward the distal end of the fixing portion, the central recess being connected to one or more of the edge recesses.

[0008] In one embodiment, a groove is included between two circumferentially adjacent wings, the groove having a bottom in the radial direction of the fixing portion, the proximal end of the bottom of the groove including a ridge, the ridge being adjacent to the central recess and the edge recess on the wing connected to the ridge, and the ridge protruding relative to the adjacent central recess and the edge recess toward the proximal end of the sealing device.

[0009] In one embodiment, the fixing part includes a proximal mesh surface, which includes one or more encrypted areas and unencrypted areas. Each encrypted area extends radially, and each encrypted area has an adjacent unencrypted area on both sides of its circumference. Each encrypted area and unencrypted area includes three or more braided threads, and the density of the braided threads in the encrypted area is greater than the density of the braided threads in the unencrypted area.

[0010] In one embodiment, the encryption area extends from the central recess to the edge recess.

[0011] In one embodiment, the encrypted area protrudes toward the distal end of the fixed portion relative to the adjacent unencrypted area.

[0012] In one embodiment, the sealing portion includes a distal disc surface, the distal disc surface of the sealing portion including an outwardly protruding portion protruding toward the fixing portion, wherein when the sealing device is in a fully deployed state, the outwardly protruding portion is at least partially embedded in the central recess, and at least a portion of the outwardly protruding portion abuts against the central recess.

[0013] In one embodiment, the central concave portion includes a first limiting unit, and the convex portion includes a second limiting unit. When the sealing device is in a fully extended state, the first limiting unit and the second limiting unit cooperate with each other to limit the range of circumferential rotation of the fixing portion relative to the sealing portion.

[0014] In one embodiment, the first limiting unit includes a limiting groove, and the second limiting unit includes a limiting protrusion. When the blocking device is in a fully extended state, the limiting protrusion is at least partially embedded in the corresponding limiting groove. Along the circumference of the fixing part, the limiting protrusion can slide within the area defined by the limiting groove.

[0015] In one embodiment, the protrusion further includes an edge protrusion unit that protrudes toward the distal end of the fixing part. When the sealing device is in a fully deployed state, the edge protrusion unit is located in a groove between two adjacent wings, and there is a gap between the edge protrusion unit and the adjacent wing.

[0016] The present invention also provides a sealing device, including a fixing part and a sealing part connected to the fixing part. The fixing part includes a mesh structure woven from braided filaments. The fixing part includes a plurality of radially extending wings, which are spaced apart circumferentially along the fixing part. The fixing part includes a distal mesh surface and a proximal mesh surface. The distal mesh surface and / or the proximal mesh surface of the fixing part includes one or more encrypted areas and unencrypted areas. Each encrypted area extends radially, and each encrypted area has an adjacent unencrypted area on both circumferential sides. Each encrypted area and unencrypted area includes three or more braided filaments. The density of the braided filaments in the encrypted area is greater than the density of the braided filaments in the unencrypted area.

[0017] In one embodiment, the encrypted area includes a first mesh, and the unencrypted area includes a second mesh, wherein the mesh area of ​​any first mesh in the encrypted area is smaller than the mesh area of ​​any second mesh in the unencrypted area.

[0018] In one embodiment, both the proximal and distal mesh surfaces of the fixing part are woven from cross-woven first-direction braided wires and second-direction braided wires. The spacing between any two circumferentially adjacent first-direction braided wires in the encrypted area is smaller than the spacing between any two circumferentially adjacent first-direction braided wires in the unencrypted area; and / or, the spacing between any two circumferentially adjacent second-direction braided wires in the encrypted area is smaller than the spacing between any two circumferentially adjacent second-direction braided wires in the unencrypted area.

[0019] In one embodiment, at least one of the encryption areas extends in a straight line along the radial direction of the fixing portion, and / or, at least one of the encryption areas extends in a curved direction along the radial direction of the fixing portion.

[0020] In one embodiment, each of the encryption zones is configured corresponding to one of the wings.

[0021] In one embodiment, the encryption region has a width along the circumferential direction of the fixing portion, the encryption region includes an outer end closer to the radial outer edge of the fixing portion and an inner end further away from the outer edge of the fixing portion, and the width of the encryption region decreases in the direction from the inner end of the encryption region to the outer end.

[0022] In one embodiment, the distal mesh surface of the fixing part includes a plurality of encryption areas, and the encryption areas provided on the distal mesh surface of the fixing part are referred to as first encryption areas, and the plurality of first encryption areas are arranged at intervals along the circumferential direction; and / or, the proximal mesh surface of the fixing part includes a plurality of encryption areas, and the encryption areas provided on the proximal mesh surface of the fixing part are referred to as second encryption areas, and the plurality of second encryption areas are arranged at intervals along the circumferential direction.

[0023] In one embodiment, the distal mesh surface of the fixing part includes a plurality of encryption areas, and the encryption areas provided on the distal mesh surface of the fixing part are designated as first encryption areas, and the plurality of first encryption areas are arranged at intervals along the circumferential direction; the proximal mesh surface of the fixing part includes a plurality of encryption areas, and the encryption areas provided on the proximal mesh surface of the fixing part are designated as second encryption areas, and the plurality of second encryption areas are arranged at intervals along the circumferential direction; at least a portion of the first encryption areas and at least a portion of the second encryption areas are aligned with each other along the circumferential direction of the fixing part, and / or, at least a portion of the first encryption areas and at least a portion of the second encryption areas are misaligned with each other along the circumferential direction of the fixing part.

[0024] In one embodiment, the encrypted area protrudes toward the distal end of the fixed portion relative to the adjacent unencrypted area.

[0025] In one embodiment, the wing includes two adjacent sides along the circumferential direction of the fixing portion, and the two sides of the wing and the encryption area corresponding to the wing extend obliquely along the same circumferential direction.

[0026] In one embodiment, the fixing part further includes a central region, a plurality of the wings are distributed circumferentially around the central region, and the encryption area extends from the central region to the wings.

[0027] In one embodiment, the wing includes a first side and a second side arranged sequentially along a first circumferential direction of the fixing portion. The first side and the second side extend obliquely along the first circumferential direction. The portion of the encryption area extending to the wing is referred to as an extension segment. The extension segment is located between the first side and the second side. At least a portion of the extension segments have a first distance greater than a second distance between the extension segment and the second side. And / or, at least a portion of the extension segments have a first distance less than a second distance between the extension segment and the second side.

[0028] In one embodiment, the wing includes two adjacent sides along the circumferential direction of the fixing portion, and the braided yarn passing at least partially through the encryption zone includes a bent section along its length direction. A first end of the bent section along its length direction is connected to the encryption zone, and a second end of the bent section along its length direction is connected to the side of the wing. The bent section bends and bulges in a direction away from the central axis of the fixing portion, and the bent section includes a vertex, which is the point on the bent section farthest from the central axis of the fixing portion, and the vertex is located between the first end and the second end of the bent section.

[0029] This invention provides 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, which are spaced apart circumferentially along the fixing part. Compared to conventional fixing part designs with cylindrical outer edges (i.e., circular cross-sections), the fixing part of the occlusion device provided by this invention has grooves formed between the wings, which can adaptively engage with the recesses 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 capability. Furthermore, by providing an inwardly recessed edge on the proximal end face of the wing, the proximal end face of the wing is less likely to deform towards the sealing part when subjected to radial compression, thus better maintaining the radial support force of the wing and giving the fixing part a more stable anchoring capability. Attached Figure Description

[0030] Figure 1 This is a front view of the sealing device in its natural state according to an embodiment of the present invention;

[0031] Figure 2 This is a top view of the fixing part of the sealing device in one embodiment of the present invention, viewed from the distal end to the proximal end.

[0032] Figure 3 This is a schematic diagram of the deformation state of the fixing part of the sealing device after implantation in one embodiment of the present invention;

[0033] Figure 4 This is a top view of the fixing part of a traditional woven structure from the far end to the near end;

[0034] Figure 5 This is a schematic diagram of the deformation state of the fixing part of a traditional woven structure after implantation;

[0035] Figure 6 This is a top view of the blocking device from the distal end to the proximal end in one embodiment of the present invention (only the outline is shown; the mesh of the blocking device's mesh structure is not shown).

[0036] Figure 7This is a front view of the sealing device in its natural state according to an embodiment of the present invention (only the outline is shown; the mesh of the sealing device's mesh structure is not shown).

[0037] Figure 8 This is a top view of the sealing device from the distal end to the proximal end in one embodiment of the present invention (only the outline of the sealing part is shown, and the mesh of the mesh structure of the sealing part is not shown).

[0038] Figure 9 This is a top view of the blocking device from the distal end to the proximal end in one embodiment of the present invention (showing the outline of the encryption zone; the mesh of the blocking device's mesh structure is not shown).

[0039] Figure 10 This is a top view of the blocking device from the distal end to the proximal end in one embodiment of the present invention (showing the braided wires passing through the encryption zone; other braided wires are not shown).

[0040] Figure 11 This is a top view of the blocking device from the distal end to the proximal end in another embodiment of the present invention (showing the braided wires passing through the encryption zone; other braided wires are not shown).

[0041] Figure 12 yes Figure 10 A bottom view of the fixing part of the central sealing device from the proximal end to the distal end (showing the braided wires through the encryption zone; other braided wires are not shown);

[0042] Figure 13 This is a top view of the blocking device from the distal end to the proximal end in another embodiment of the present invention (showing the outlines of the first encryption zone and the second encryption zone; the mesh of the mesh structure of the blocking device is not shown).

[0043] Figure 14 This is a top view of the blocking device from the far end to the near end in another embodiment of the present invention (showing the outlines of the first encryption zone and the second encryption zone; the mesh of the mesh structure of the blocking device is not shown).

[0044] Figure 15 This is a top view of the blocking device from the distal end to the proximal end in another embodiment of the present invention (showing the outline of the encryption zone; the mesh of the blocking device's mesh structure is not shown).

[0045] Figure 16 This is a schematic diagram of the sealing device in one embodiment of the present invention;

[0046] Figure 17 This is a schematic diagram of the sealing device in another embodiment of the present invention;

[0047] Figure 18 This is a schematic diagram of the cooperation between the first limiting unit and the second limiting unit of the sealing device in one embodiment of the present invention;

[0048] Figure 19 This is a schematic diagram showing the distribution of the edge protruding units of the sealing device in another embodiment of the present invention;

[0049] Figure 20 This is a schematic diagram of the structure of the fixing part of the sealing device in one embodiment of the present invention;

[0050] Figure 21 This is a top view of the fixing part of the sealing device in one embodiment of the present invention, viewed from the distal end to the proximal end.

[0051] Figure 22 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;

[0052] Figure 23 This is a schematic diagram of the structure of various optional anchoring components in one embodiment of the present invention;

[0053] Figure 24 This is a schematic diagram of the structure of other optional anchoring components in one embodiment of the present invention;

[0054] Figure 25 This is a longitudinal schematic diagram of the sealing device after the anchoring component is installed in another embodiment of the present invention;

[0055] Figure 26 This is a schematic diagram of the sealing device in another embodiment of the present invention;

[0056] Figure 27 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

[0057] 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.

[0058] 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 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 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. The central axis of the distal end can be used as the central axis of the fixing part.

[0059] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0060] Example 1

[0061] 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.

[0062] 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 as if... Figure 1 The fully 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 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.

[0063] In this embodiment, the proximal end of the fixing part 110 is connected to a connecting part 130, and the distal end of the sealing part 120 is connected to the proximal end of the connecting part 130. The connecting part 130 can be integrally woven with the fixing part 110 and the sealing part 120. In other embodiments, the connecting part 130, the fixing part 110 and the sealing part 120 can be manufactured separately and then connected together.

[0064] In manufacturing the sealing part 120, multiple braided filaments 121 are first woven into a mesh tube, which is then heat-formed into a frustum, disc, column, or plug shape to obtain the sealing part 120 for sealing 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 located between the proximal disc surface 123 and the distal disc surface 122. Preferably, the receiving cavity of the sealing part 120 is provided with 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, generally by sutures, and the thin film is located between the distal disc surface 122 and the proximal disc surface 123. The thin film is used to prevent blood flow from one side of the sealing part 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 part 120 does not necessarily need to be disc-shaped, and can also be a frustum or cylinder with a certain height.

[0065] Furthermore, referring to Figure 2 , Figure 2 This is a top view of the fixing part 110 of the occlusion device 100 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 braiding filaments 121. The braiding filaments 121 can be made of materials such as nickel-titanium alloy and stainless steel. Specifically, one or more braiding filaments 121 are bent along a specific trajectory to form a mesh structure, 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 the rod 421 type structure formed by direct cutting, the braided structure provided in this embodiment has higher conformability for two reasons. First, the diameter of the filaments used in the braiding is small enough; otherwise, the braided filaments 121 cannot be processed to form the braided body 110a. Correspondingly, if the rod 421 type structure uses the same diameter as the braided structure, the radial support force of the rod 421 type structure against the deformation of the heart ear is extremely small, thus making it impossible for the fixing part 110 of the rod 421 type to achieve the purpose of fixing, causing the entire sealing device 100 to fall off. Second, since the braiding will pre-bend the braided filaments 121, applying a force along the pre-bending direction to the pre-bent braided filaments 121 will more easily deform the braided filaments 121. The braided body 110a utilizes this characteristic to transfer the deformation of the braided filaments 121 at a certain position to the adjacent, interlaced braided filaments 121, thereby dispersing the concentrated stress. Therefore, the force on a certain point of the braided body 110a will be better distributed to the whole along the braided structure.

[0066] In this embodiment, in addition to forming a woven structure, the fixing part 110 includes a central region 111 and a plurality of wings 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 wing 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 wings 112 distributed around the central region 111. In this embodiment, the wings 112 are radially distributed, and a groove 113 is included between two adjacent wings 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 wing 112.

[0067] Further reference Figure 3 , Figure 3 This is a schematic diagram of the deformation state of the fixing part 110 of the occlusion device 100 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 wing 112 of the fixing part 110 abuts against the inner wall of the atrial appendage. In this embodiment, the wing 112 extends radially outward. Therefore, on the one hand, the wing 112 can be partially inserted into the recess 202 of the inner wall 200 of the atrial appendage, increasing the contact between the wing 112 and the atrial appendage. On the other hand, the groove 113 between adjacent wings 112 can also accommodate the protrusion 201 of the inner wall 200 of the atrial appendage, thereby making the adjacent wings 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 wing 112 and the atrial appendage, and increase the radial support force of the fixing part 110 as a whole.

[0068] 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 engaged in the grooves 113 between the wings 112 and / or engaged by the outer side of the wings 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 engagement through the contact 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.

[0069] Combination Figure 4-5 To further describe the effects of this embodiment, Figure 4 This is a top view of the fixing part 110 of a traditional weaving structure from the far end to the near end. Figure 5This is a schematic diagram of the deformation state of the traditional fixation part 210a of the traditional braided structure after implantation. When the traditional fixation part 210a of the traditional braided structure is released within 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 traditional fixation part 210a expands after being implanted into the atrial appendage, the protrusion 2 of the inner wall 200 of the atrial appendage... The 01 will press against the outer surface of the conventional fixation part 210a, thereby forming a depression 202 in the surrounding area of ​​the pressing position. At the same time, if there is a depression 202 near the protrusion 201 on the inner wall of the atrial appendage 200, when the protrusion 201 is compressed and contracted, the bottom surface of the depression 202 is farther from the surface of the conventional fixation part 210a. Therefore, after the conventional fixation part 210a is implanted, the contact between it and the inner wall of the atrial appendage 200 is more of a point and surface contact, and the actual contact area is small, 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 the inner wall of the atrial appendage 200 has obvious depressions 202 or protrusions 201.

[0070] It should be noted that the shape of the atrial appendage inner wall 200 in the illustration is for illustrative purposes only. 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, resulting in a significant improvement in the anchoring ability of this embodiment compared to the traditional nearly circular woven structure along the axial cross-section. Furthermore, the contact between the wing portion 112 and the depressions 202 and / or grooves 113 of the atrial appendage inner wall 200 and the protrusions 201 of the atrial appendage inner wall 200 in this embodiment also serves as a limiting function. This not only prevents the fixing part 110 from being damaged by rotation or detached from the atrial appendage inner wall 200, but also creates multiple mutually interlocking areas through contact, increasing the anchoring ability of the fixing part 110. Therefore, under certain circumstances, using the solution of this embodiment can eliminate the need for sharp anchors or other materials that could easily damage the atrial appendage inner wall 200.

[0071] In this embodiment, in order to achieve a good anchoring effect, the number of wings 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 wings 112 is generally between 4 and 6.

[0072] Example 2

[0073] Objectively speaking, the more wings 112 the fixing part 110 has, the tighter the connection with the inner wall 200 of the auricle, and the more grooves 113 there will be. The deeper the grooves 113 of the fixing part 110, that is, the farther the grooves 113 are from the outer side of the wings 112, the more auricle shapes can be accommodated. In combination with the above design, Embodiment 1 tends to use more wings 112 and deeper grooves 113, but at the same time, it will also lead to an increase in the overall surface area, a decrease in the ability to adapt to the contraction of the auricle, and a significant increase in the difficulty of sheathing. For this embodiment, the shape of the fixing part 110 is further improved based on Embodiment 1.

[0074] Therefore, this embodiment designs a special shape for the fixing part 110, referring to... Figure 6 , Figure 6 This is a top view of the blocking device 100 in Embodiment 2 of the present invention, viewed from the distal end to the proximal end, as follows:

[0075] In this embodiment, the cross-sectional shape of the central area 111 of the fixing part 110 is still approximately circular. Multiple wings 112 extend outward from their roots along the clockwise or counterclockwise direction of the fixing part 110 (i.e., tilted in the same direction), so that the wings 112 of the entire fixing part 110 are tilted and radial in the axial cross-section. When the fixing part 110 is sheathed, the wings 112 can overlap each other and be stored. This is one of the advantages brought by the tilting in the same direction. Therefore, the design of this embodiment can make each wing 112 overlap along the preset tilting direction to deform into a smaller volume.

[0076] Therefore, since the shape of the wing 112 is not limited, in order to achieve that each wing 112 is stacked in the same direction when the sheath is retracted, this embodiment further limits the inclination. The wing 112 includes two adjacent side surfaces 1121 along the circumferential direction of the fixing part 110, namely the first side surface 1121a and the second side surface 1121b. On the cross-section of the wing 112 perpendicular to the axis of the fixing part 110, on the cross-section of the fixing part 110, the curvature of the two side surfaces 1121 of the wing 112 is either both positive or both negative, that is, the two side surfaces 1121 of the wing 112 extend incline in the same direction. Thus, the extension length of the first side surface 1121a in this cross-section is greater than the extension length of the second side surface 1121b, that is, the first side surface 1121a is the long side of the wing 112 along the circumferential direction. In this embodiment, further, within the same wing 112, the curvature of the first side surface 1121a and the second side surface 1121b are both positive or both negative. For an adjacent set of wings 112, the curvature of the first side surface 1121a and the second side surface 1121b of the adjacent wing 112 are both positive or both negative, and the adjacent wings 112 extend obliquely in the same direction.

[0077] Similarly, since the shape of the wing 112 is not limited, grooves 113 may form between adjacent wings 112. The grooves 113 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 111. In this embodiment, the boundary of the central region 111 is defined by the grooves 113. That is, the central region 111 is a cylindrical area centered on the central axis, with the shortest distance from all grooves 113 to the central axis as its radius. In other words, the central region 111 is a cylinder centered on the central axis, with the closest point between the grooves 113 and the central axis as its dividing point. Based on this, multiple wings 112 are arranged around the central region 111 and protrude 201 radially outward from the fixing part 110 relative to the central region 111.

[0078] 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 110 to be reduced to a small volume, thereby adapting to different sizes of left atrial appendages. This prevents adjacent wings 112 from approaching and abutting each other in opposite directions, thus avoiding mutual interference, contraction obstruction, and local stress concentration that could lead to damage to the atrial appendage.

[0079] In another embodiment, the central region 111 of the fixing portion 110 has an approximately circular cross-sectional shape, and a plurality of wings 112 extend outward from their roots in a clockwise direction along the direction from the distal end to the proximal end.

[0080] In another embodiment, the cross-sectional shape of the central region 111 of the fixing part 110 is still approximately circular, and along the direction from the far end to the near end, a plurality of wings 112 extend outward from their roots in a counterclockwise direction.

[0081] In this embodiment, it should also be noted that there is a relatively obvious gap between the wings 112, which allows for more deformation allowance so that the fixing part 110 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 110, the radial center circle 315 of the wings 112 is defined as a virtual circle with the point where the central axis of the sealing device 100 is located as the center. For the radial center circle 315, the midpoint of the shortest line segment from the outermost edge of the wing 112 to the boundary line of the central area 111 falls on the radial center circle 315. When the distances from the outermost edge of multiple wings 112 to the boundary line of the central area 111 are different, the shortest line segment among all wings 112 is taken.

[0082] On the cross-section of the fixing part 110, with the point where the central axis of the fixing part 110 is located as the center, an arbitrary virtual cutting circle 101 is drawn. The cutting circle 101 intersects the wing 112 at the first side surface 1121a and the second side surface 1121b. The straight-line distance from the intersection of the cutting circle 101 and the first side surface 1121a of the same wing 112 to the intersection of the cutting circle 101 and the second side surface 1121b is defined as the width of the wing 112 at that position. Similarly, the straight-line distance from the intersection of the cutting circle 101 and the first side surface 1121a of a certain wing 112 to the intersection of the cutting circle 101 and the second side surface 1121b of the adjacent wing 112 is defined as the interval between the adjacent wing 112 at that position.

[0083] Therefore, this embodiment is preferably as follows: On the cross-section of the fixing part 110, with the radial center circle 315 as the dividing line, there is at least one cutting circle 101 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 112 is less than the smaller value of the width of these two adjacent wings 112. The design of the wings 112 that satisfies this condition is called the interval design. Thus, when a set of wings 112 satisfies the interval design, when a certain wing 112 is deformed by a large compression, the wing 112 can cross the gap between itself and the adjacent wing 112, thereby being supported by the adjacent wing 112, thus ensuring the support strength of the set of wings 112. Through such a design, the local or overall support strength can be selectively enhanced.

[0084] In another embodiment, on the cross-section of the fixing part 110, using the radial center circle 315 as a dividing line, there is at least one cutting circle 101 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 112 is less than the width of any single wing 112. When all wings 112 adopt a spaced design, the overall support strength can be significantly improved.

[0085] In another embodiment, on the cross-section of the fixing part 110, using the radial center circle 315 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 101, the interval between all adjacent wings 112 is less than the width of any wing 112. This design of the embodiment is called a fully spaced design, and when this design is adopted, the fixing part 110 has optimal support strength.

[0086] In another embodiment, on the cross-section of the fixing portion 110, using the radial center circle 315 of the edge region 312 as a dividing line, there is at least one cutting circle 101 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 112 is at least less than the width of one of the two adjacent wings 112 (hereinafter referred to as a specific wing 112). This embodiment is designed as a semi-spaced design, in which at least the specific wing 112 can span the gap, thereby being supported by adjacent wings 112, thereby increasing the support strength of the specific wing 112 region at least locally.

[0087] Considering that in some cases, the occlusion device 100 is implanted at an angle, and the fixation part 110 is tilted off the axis according to the shape inside the atrial appendage, the circumferential distribution of the fixation part 110 is not uniform. The sparser side requires greater support strength, so the above-mentioned interval design can be set in a specific area. The denser side, due to the accumulation, has better support strength itself, so there is no need to use the interval design, thus preserving the overall good insertion smoothness of the occlusion device 100.

[0088] It should be noted that this effect is only achieved when the fixing part 110 forms a distinct wing 112 and there is a clear gap between adjacent wings 112. In this embodiment, considering the fixing part 110 as a whole, the ratio of the diameter of the central area 111 to the diameter of the circumscribed circle of the fixing part 110 is less than 0.6. This is considered as a distinct wing 112 as described above. The setting of an indistinct wing 112 will cause the deformation of the wing 112 to be directly transmitted to the root position of the wing 112 after deformation, instead of the wing 112 itself abutting against the adjacent wing 112 to achieve support based on the deformation of the wing 112. That is, the wing 112 directly subjected to pressure cannot deform and cross the gap to be supported by the adjacent wing 112. In summary, the design of the fixing part 110 only has the above-mentioned support effect when a distinct wing 112 is provided.

[0089] In this embodiment, the ratio R between the diameter of the central region 111 and the diameter of the circumscribed circle of the fixing part 110 can be further limited to 0.35 to 0.6. For example, the ratio R can be any one of 0.35, 0.38, 0.4, 0.42, 0.45, 0.47, 0.5, 0.52, 0.55, 0.57, and 0.6. By reasonably setting the range of R to 0.35 to 0.6, the fixing part 110 not only has the above-mentioned support effect, but also has better anchoring stability, and the wing part 112 can more flexibly adapt to deformation.

[0090] For example, as the number of wings 112 increases, the R value can be adaptively increased to improve the radial support force and anchoring stability of the sealing device 100. That is, the R value of the fixing part 110 of a smaller number of wings 112 is smaller, so that the wings 112 of the fixing part 110 have good deformation flexibility, while the R value of the fixing part 110 of a larger number of wings 112 is larger, so that the fixing part 110 has better radial support force and anchoring stability.

[0091] In this embodiment, the two sides 1121 of the wing 112 are a first side 1121a and a second side 1121b arranged sequentially along its inclined direction, referring to... Figure 6 , Figure 6The wing portion 112 is tilted counterclockwise, so the first side surface 1121a and the second side surface 1121b are arranged counterclockwise along the fixing part 110, and both the first side surface 1121a and the second side surface 1121b are curved. The inner end of the wing portion 112 is connected to the central area 111, and the outer end of the wing portion 112 is suspended and can move freely. The outer end of the wing portion 112 is circumferentially deflected relative to the inner end of the wing portion 112 along its tilt direction. The wing portion 112 includes a circumferential tip 1124 and a circumferential tail 1126. The circumferential tip 1124 of the wing portion 112 refers to the tip of the wing portion 112 that is most deflected relative to the proximal end of the wing portion 112 in its tilt direction, and the circumferential tail 1126 of the wing portion 112 refers to the end of the proximal end of the wing portion 112 in the circumferential direction opposite to the tilt direction of the wing portion 112. The portion where the outer end of the wing 112 is tangent to the axial plane passing through the central axis of the fixing part 110 is defined as the circumferential tip 1124. The portion further circumferentially away from the circumferential tip 1124 in the portion where the inner end of the wing 112 is tangent to the edge of the central region 111 is defined as the circumferential tail end 1126. The circumferential tip 1124 can serve as the boundary between the first side surface 1121a and the second side surface 1121b, which meet at the circumferential tip 1124. An axial plane emanating from the central axis of the fixing part 110 and passing through both the central axis of the fixing part 110 and the circumferential top end 1124 is designated as the first axial plane 1127a. An axial plane emanating from the central axis of the fixing part 110 and passing through both the central axis of the fixing part 110 and the circumferential tail end 1126 is designated as the second axial plane 1127b. The wing part 112 is located between the first axial plane 1127a and the second axial plane 1127b. The included angle α between 27b ranges from 65° to 100°. For example, the included angle α can be any one of 65°, 70°, 73°, 75°, 77°, 80°, 82°, 85°, 87°, 90°, 92°, 95°, 97°, or 100°, or any other suitable angle value. This arrangement allows the wing 112 to have a better radial support effect while having sufficient circumferential deflection space, enabling it to flexibly and adaptively deflect and deform when subjected to radial compression. As the number of wings 112 increases, the angle value of the included angle α also decreases to maintain sufficient spacing between the wings 112.

[0092] Example 3

[0093] Reference Figure 7 , Figure 8Based on Embodiments 1 and 2, this embodiment further includes a denser region 114 (or clustered region) where the braided yarns 121 are more tightly packed, and a sparser non-dense region 115 (or non-clustered region) where the braided yarns 121 are more loosely packed. The fixing part 110 includes a distal mesh surface 1101 and a proximal mesh surface 1102. The fixing part 110 also includes a distal end 1103, to which the distal ends of the braided yarns 121 of the fixing part 110 converge and are fixed.

[0094] The distal mesh surface 1101 and / or proximal mesh surface 1102 of the fixing part 110 include one or more encrypted zones 114 and unencrypted zones 115. Each encrypted zone 114 extends radially, and each encrypted zone 114 has an adjacent unencrypted zone 115 on both circumferential sides. Each encrypted zone 114 and unencrypted zone 115 includes three or more braided threads 121, and the density of the braided threads 121 in the encrypted zone 114 is greater than the density of the braided threads 121 in the unencrypted zone 115. "Density" is intended to characterize the degree of spacing of the braided threads 121 in the corresponding area.

[0095] The density of the braided threads 121 in the encrypted area 114 is greater than that in the unencrypted area 115, which can be reflected in one or more ways:

[0096] In some embodiments, the encrypted area 114 includes a first mesh, and the unencrypted area 115 includes a second mesh. The mesh area of ​​any first mesh in the encrypted area 114 is smaller than the mesh area of ​​any second mesh in the unencrypted area 115. The mesh area refers to the maximum cross-sectional area of ​​the mesh. For example, in some embodiments, the ratio of the mesh area of ​​any second mesh in the unencrypted area 115 to the mesh area of ​​any first mesh in the encrypted area 114 is greater than M. M can be any value among 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, and 10. In other embodiments, M can also be a number greater than 10.

[0097] In some embodiments, both the proximal mesh surface 1102 and the distal mesh surface 1101 of the fixing part 110 are cross-woven from first-direction braided yarns 121a and second-direction braided yarns 121b. On the same end face of the fixing part 110, the end of the first-direction braided yarn 121a located at the edge of the fixing part 110 is deflected in a first circumferential direction relative to the end of the first-direction braided yarn 121a located at the distal end 1103 of the fixing part 110. The end of the second-direction braided yarn 121b located at the edge of the fixing part 110 is deflected in a second circumferential direction relative to the end of the second-direction braided yarn 121b located at the distal end 1103 of the fixing part 110. The second circumferential direction is opposite to the first circumferential direction; for example, the first circumferential direction can be counterclockwise and the second circumferential direction can be clockwise, or the first circumferential direction can be clockwise and the second circumferential direction can be counterclockwise. The spacing between any two circumferentially adjacent first-direction braided wires 121a within the encrypted zone 114 is less than the spacing between any two circumferentially adjacent first-direction braided wires 121a within the unencrypted zone 115; and / or, the spacing between any two circumferentially adjacent second-direction braided wires 121b within the encrypted zone 114 is less than the spacing between any two circumferentially adjacent second-direction braided wires 121b within the unencrypted zone 115. The spacing between two braided wires 121 refers to the minimum distance between the two braided wires 121. For example, the ratio of the spacing between any two adjacent first-direction braided wires 121a in any circumferential direction within the unencrypted area 115 to the spacing between any two adjacent first-direction braided wires 121a in any circumferential direction within the encrypted area 114 is greater than N1, and / or the ratio of the spacing between any two adjacent second-direction braided wires 121b in any circumferential direction within the unencrypted area 115 to the spacing between any two adjacent second-direction braided wires 121b in any circumferential direction within the encrypted area 114 is greater than N2. N1 and N2 can be selected from any value among 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, and 10. In other embodiments, N1 and N2 can also be numbers greater than 10.

[0098] For example, the spacing between any two circumferentially adjacent first-direction braided threads 121a in the encrypted area 114 is less than 0.5 mm, while the spacing between any two circumferentially adjacent first-direction braided threads 121a in the unencrypted area 115 is greater than 1 mm; and / or, the spacing between any two circumferentially adjacent second-direction braided threads 121b in the encrypted area 114 is less than 0.5 mm, while the spacing between any two circumferentially adjacent second-direction braided threads 121b in the unencrypted area 115 is greater than 1 mm. For example, the spacing between any two circumferentially adjacent first-direction braided threads 121a within the encrypted area 114 is less than 0.1 mm, while the spacing between any two circumferentially adjacent first-direction braided threads 121a within the unencrypted area 115 is greater than 0.2 mm; and / or, the spacing between any two circumferentially adjacent second-direction braided threads 121b within the encrypted area 114 is less than 0.1 mm, while the spacing between any two circumferentially adjacent second-direction braided threads 121b within the unencrypted area 115 is greater than 0.2 mm. It is understood that in other embodiments, the spacing between two adjacent first-direction braided threads 121a may be different from the spacing between two adjacent second-direction braided threads 121b.

[0099] Understandably, in other embodiments, the first direction braided yarn 121a may be a braided yarn 121 extending radially along the fixing portion 110, and the second direction braided yarn 121b may be a braided yarn 121 extending circumferentially along the fixing portion 110.

[0100] In this embodiment, a radially extending densified area 114 is provided on the proximal mesh surface 1102 and / or distal mesh surface 1101 of the fixing part 110. The density of the braided filaments 121 in the densified area 114 is higher. On the one hand, it can improve the radial support force of the fixing part 110 to a certain extent. In conjunction with the wing part 112, it can further improve the anchoring stability of the fixing part 110. On the other hand, compared with adding a rod-shaped or other shaped reinforcement to the fixing part 110, the densified area 114 in this embodiment also has a certain degree of flexibility, so that the area of ​​the fixing part 110, such as the wing part 112, can still deform accordingly to the heartbeat.

[0101] Reference Figure 8 , Figure 9In this embodiment, the projected area of ​​the encrypted area 114 on the radial plane of the fixed part 110 is smaller than the projected area of ​​any circumferentially adjacent unencrypted area 115 on the radial plane of the fixed part 110. For example, the ratio of the projected area of ​​the encrypted area 114 on the radial plane of the fixed part 110 to the projected area of ​​any circumferentially adjacent unencrypted area 115 on the radial plane of the fixed part 110 is less than or equal to 0.5. For example, this ratio can be any value among 0.5, 0.4, 0.3, 0.2, and 0.1. By making the projected area of ​​the encrypted area 114 on the radial plane of the fixed part 110 smaller than the projected area of ​​any circumferentially adjacent unencrypted area 115 on the radial plane of the fixed part 110, the radial support force of the fixed part 110 can be enhanced while maintaining good flexibility, allowing it to deform better in response to heartbeats.

[0102] Reference Figures 10-12 In this embodiment, the distal mesh surface 1101 of the fixing part 110 includes multiple encryption areas 114. The encryption areas 114 on the distal mesh surface 1101 of the fixing part 110 are designated as first encryption areas 114a, and the multiple first encryption areas 114a are arranged at intervals along the circumferential direction. The proximal mesh surface 1102 of the fixing part 110 includes multiple encryption areas 114. The encryption areas 114 on the proximal mesh surface 1102 of the fixing part 110 are designated as second encryption areas 114b, and the multiple second encryption areas 114b are arranged at intervals along the circumferential direction. For example, the fixing part 110 includes four first encryption areas 114a, and an unencrypted area 115 is provided between two circumferentially adjacent first encryption areas 114a (see reference). Figure 8 If the unencrypted area 115 of the far end mesh surface 1101 of the fixing part 110 is designated as the first unencrypted area 115, then the far end mesh surface 1101 of the fixing part 110 has four first unencrypted areas 115. The fixing part 110 includes four second encrypted areas 114b, and an unencrypted area 115 is provided between two circumferentially adjacent second encrypted areas 114b. If the unencrypted area 115 of the near end mesh surface 1102 of the fixing part 110 is designated as the second unencrypted area 115, then the far end mesh surface 1101 of the fixing part 110 has four second unencrypted areas 115. That is to say, on the same end face of the fixing part 110, the number of encrypted areas 114 and the number of unencrypted areas 115 are equal.

[0103] By providing multiple spaced-apart encrypted zones 114 on the proximal mesh surface 1102 and the distal mesh surface 1101 of the fixing part 110, not only can the radial support force of both ends of the fixing part 110 be improved, but also more uniform radial support can be provided to the fixing part 110 in multiple radial directions. It is understood that in other embodiments, the number of the first encrypted zone 114a and the second encrypted zone 114b is not limited to four, but can be any other suitable number, such as five, six, seven, eight, etc. In other embodiments, the first encrypted zone 114a or the second encrypted zone 114b may be omitted.

[0104] At least a portion of the first encryption areas 114a and at least a portion of the second encryption areas 114b are aligned with each other circumferentially along the fixing part 110, and / or, at least a portion of the first encryption areas 114a and at least a portion of the second encryption areas 114b are misaligned with each other circumferentially along the fixing part 110. Alignment of the first encryption areas 114a and the second encryption areas 114b means that their projections on the same radial plane of the fixing part 110 overlap. Misalignment of the first encryption areas 114a and the second encryption areas 114b means that their projections on the same radial plane of the fixing part 110 do not overlap. Alignment of the first encryption areas 114a and the second encryption areas 114b further enhances the radial support force of the fixing part 110 in the area where the first encryption areas 114a and the second encryption areas 114b are located, and better maintains the shape of that area. The first encryption zone 114a and the second encryption zone 114b are staggered to provide radial support force more evenly to each radial direction of the fixing part 110.

[0105] Exemplarily, all first encryption areas 114a on the distal mesh surface 1101 of the fixing part 110 are aligned with all second encryption areas 114b on the proximal mesh surface 1102 of the fixing part 110. In other embodiments, refer to Figure 13 , Figure 14 All first encryption areas 114a on the distal mesh surface 1101 of the fixed part 110 are misaligned with all second encryption areas 114b on the proximal mesh surface 1102 of the fixed part 110. Alternatively, only some of the first encryption areas 114a on the distal mesh surface 1101 of the fixed part 110 are aligned with the second encryption areas 114b on the proximal mesh surface 1102 of the fixed part 110, and the other first encryption areas 114a do not have any aligned second encryption areas 114b on the proximal mesh surface 1102 of the fixed part 110, that is, they are misaligned with the second encryption areas 114b.

[0106] In this embodiment, the encryption area 114 and the wing 112 are correspondingly provided; for example, each wing 112 is provided with an encryption area 114. Figure 10 , Figure 12 As shown, the fixing part 110 has four wings 112, each wing 112 corresponding to a first encryption area 114a and a second encryption area 114b. In other embodiments, each wing 112 may correspond to three or more encryption areas 114. Alternatively, in other embodiments, the encryption areas 114 do not necessarily correspond to the wings 112; for example, the encryption areas 114 extend only from the central area 111 and point to the bottom of the groove 113 between the two wings 112 in the radial direction of the fixing part 110.

[0107] Since the wing 112 directly contacts the inner wall 200 of the atrial appendage after implantation, when the fixation part 110 is subjected to radial compressive force, the wing 112 resists the radial compressive force through its own deformation and a certain degree of offset. By setting the reinforcement area 114 corresponding to the wing 112, the radial support force of the fixation part 110 in the radial direction of the wing 112 can be improved. When the wing 112 is subjected to excessive radial compressive force, the reinforcement area 114 can better help the fixation part 110 resist the radial compressive force and prevent the fixation part 110 from falling off due to excessive deformation.

[0108] In this embodiment, the encryption area 114 includes an outer end closer to the radial outer edge of the fixing part 110 and an inner end further away from the outer edge of the fixing part 110. In other words, the outer end of the encryption area 114 is further away from the distal end 1103 of the fixing part 110 (see reference). Figure 7 The inner end of the encryption zone 114 is closer to the far end 1103 of the fixing part 110.

[0109] The outer end of the encryption zone 114 extends to the wing 112. This arrangement helps to further enhance the radial support force of the wing 112 and reduces the risk that the wing 112 may detach from the recess 202 of the atrial wall due to excessive deformation or displacement when subjected to excessive radial compression.

[0110] For example, refer to Figure 9 The encryption zone 114 extends from the center zone 111 of the fixing part 110 to the wing part 112, with the inner end of the encryption zone 114 located in the center zone 111 of the fixing part 110 and the outer end of the encryption zone 114 extending to the wing part 112. For example, Figure 11 , Figure 12 The first encryption zone 114a of the fixing part 110 extends from the distal end 1103 of the fixing part 110 to the wing 112. Figure 12The braided threads 121 on the proximal mesh 1102 of the fixing part 110 converge at the ends away from the radial edge of the fixing part 110 and connect to the connecting part 130. The second reinforcement zone 114b of the fixing part 110 extends from the connecting part 130 to the wing 112. This arrangement ensures that the inner ends of the multiple reinforcement zones 114 are close together and converge. When the fixing part 110 is subjected to a large radial compressive force, the inner ends of the reinforcement zones 114 can abut against each other, better helping the fixing part 110 resist radial compression. In other embodiments, the inner end of the first reinforcement zone 114a may be radially distanced from the distal end 1103 of the fixing part 110, and the inner end of the second reinforcement zone 114b may be radially distanced from the connecting part 130. This distance does not exceed 25% of the diameter of the circumscribed circle of the fixing part 110, which also helps the fixing part 110 resist radial compression to a certain extent.

[0111] Reference Figure 9 In this embodiment, the two sides 1121 of the wing 112 are a first side 1121a and a second side 1121b arranged sequentially along its inclined direction. Figure 9 If the wing portion 112 is tilted counterclockwise, then the first side surface 1121a and the second side surface 1121b are arranged counterclockwise along the fixing portion 110. Optionally, in this embodiment, the portion of the encryption area 114 extending to the wing portion 112 is designated as the extension segment 1141. This extension segment 1141 extends between the first side surface 1121a and the second side surface 1121b, and the first distance L1 between the extension segment 1141 and the first side surface 1121a is greater than the second distance L2 between the extension segment 1141 and the second side surface 1121b. The first distance L1 and the second distance L2 can be determined as follows: On the cross-section of the fixed part 110, with the central axis of the fixed part 110 as the center, any virtual cutting circle 101 is drawn to cut the wing part 112. The cutting circle 101 intersects with the first side surface 1121a, the second side surface 1121b of the wing part 112 and the encryption area 114. The length of the shortest straight line connecting the intersection of the cutting circle 101 with the first side surface 1121a of the same wing part 112 and the intersection of the cutting circle 101 with the encryption area 114 is defined as the first distance L1. The length of the shortest straight line connecting the intersection of the cutting circle 101 with the second side surface 1121b of the same wing part 112 and the intersection of the cutting circle 101 with the encryption area 114 is defined as the second distance L2. When the wing 112 is subjected to radial compression, the first side 1121a undergoes tensile bending deformation, while the second side 1121b undergoes compressive bending deformation. Since the extension 1141 is closer to the second side 1121b, it better helps the second side 1121b resist bending deformation, increasing the radial support force of the wing 112 and allowing the wing 112 to be more stably anchored to the inner wall 200 of the auricle. In other embodiments, refer to... Figure 11The first distance between the first side 1121a of the extension 1141 and the second side 1121b is less than the second distance between the extension 1141 and the second side 1121b. That is, the extension 1141 is closer to the first side 1121a. This arrangement allows the wing 112 to bend and deform more flexibly when subjected to radial compression, thus allowing it to enter the narrower left atrial appendage cavity. When the fixing part 110 is subjected to excessive radial compression, the extension 1141 provides a certain radial support force, reducing the possibility of excessive deformation of the wing 112. In other embodiments, the extensions 1141 of a portion of the encryption zones 114 can be closer to the first side 1121a, and the extensions 1141 of a portion of the encryption zones 114 can be closer to the second side 1121b. For example, refer to... Figure 13 In some embodiments, the first distance between the extension 1141 of the first encryption region 114a and the first side surface 1121a in the circumferential direction of the fixing portion 110 is greater than the second distance between the extension 1141 of the first encryption region 114a and the second side surface 1121b in the circumferential direction of the fixing portion 110, and the first distance between the extension 1141 of the second encryption region 114b and the first side surface 1121a in the circumferential direction of the fixing portion 110 is less than the second distance between the extension 1141 of the second encryption region 114b and the second side surface 1121b in the circumferential direction of the fixing portion 110. This arrangement makes the fixing portion 110 more suitable for the left atrial appendage (e.g., cauliflower-shaped left atrial appendage) whose diameter gradually increases from proximal to distal. (See reference...) Figure 14 In some embodiments, the first distance between the extension 1141 of the first encryption region 114a and the first side surface 1121a in the circumferential direction of the fixing part 110 is less than the second distance between the extension 1141 of the first encryption region 114a and the second side surface 1121b in the circumferential direction of the fixing part 110, and the first distance between the extension 1141 of the second encryption region 114b and the first side surface 1121a in the circumferential direction of the fixing part 110 is greater than the second distance between the extension 1141 of the second encryption region 114b and the second side surface 1121b in the circumferential direction of the fixing part 110. This arrangement makes the fixing part 110 more suitable for the left atrial appendage (e.g., chicken wing-shaped left atrial appendage) whose diameter gradually decreases from the proximal end to the distal end.

[0112] Reference Figure 9 The central axis of the fixing part 110 passes through the distal end 1103 of the fixing part 110 and the connecting part 130 (see reference). Figure 7The ratio between the distance from the outer end of the encryption zone 114 to the central axis of the fixing part 110 and the diameter of the circumscribed circle of the fixing part 110 ranges from 0.2 to 0.45. For example, this ratio can be any one of 0.2, 0.23, 0.25, 0.27, 0.3, 0.32, 0.35, 0.37, 0.4, 0.42, and 0.45. By reasonably setting the distance from the outer end of the encryption zone 114 to the central axis of the fixing part 110, the encryption zone 114 can better provide radial support for the wing 112 while better preserving the superior flexibility of the wing 112, allowing the wing 112 to better conform to the shape deformation of the inner wall 200 of the auricle and improving the wall adhesion of the wing 112.

[0113] In this embodiment, refer to Figure 15 At least one encryption zone 114 extends radially along the fixing portion 110, and / or, referring to Figure 9 At least one encryption region 114 extends radially curved along the fixing portion 110. Exemplarily, the first encryption region 114a and the second encryption region 114b may both extend linearly along the radial direction of the fixing portion 110. In other embodiments, the first encryption region 114a and the second encryption region 114b may both extend radially curved along the fixing portion 110. Alternatively, a portion of the first encryption region 114a and a portion of the second encryption region 114 extend linearly along the radial direction of the fixing portion 110, while a portion of the first encryption region 114a and a portion of the second encryption region 114 extend radially curved along the fixing portion 110.

[0114] The straight-line extending reinforcement zone 114 can provide greater radial support to the fixing part 110, while the curved extending reinforcement zone 114 provides radial support while also having good flexibility. In particular, when the two adjacent sides 1121 of the wing 112 in the circumferential direction and the reinforcement zone 114 corresponding to the wing 112 all extend in the same direction (e.g., clockwise or counterclockwise), the wing 112 can retain better flexibility and can better guide the wing 112 to fold in the preset tilt direction when the fixing part 110 is sheathed, thus allowing for smoother sheathing.

[0115] In this embodiment, refer to Figure 9 , Figure 15 The encryption zone 114 has a width along the circumferential direction of the fixing part 110, and the width of the encryption zone 114 decreases from the inner end to the outer end. The smaller width at the outer end increases the flexibility of the wing 112 and makes the wing 112 easier to sheath.

[0116] In this embodiment, the encrypted area 114 protrudes toward the distal end of the fixing portion 110 relative to the adjacent unencrypted area 115 (not shown). Exemplarily, at least a portion of the first encrypted areas 114a protrude toward the distal end of the fixing portion 110 relative to the adjacent first unencrypted areas 115, and at least a portion of the second encrypted areas 114b protrude toward the distal end of the fixing portion 110 relative to the adjacent unencrypted areas 115.

[0117] The reinforced area 114, which protrudes towards the distal end, can improve the circumferential bending strength of the wing 112 to a certain extent, and can reduce the stress on the wing 112 caused by the inner wall 200 of the auricle (refer to...). Figure 3 There is a risk of excessive displacement during compression, causing the part to dislodge from the recess 202 of the inner wall 200 of the auricle. Specifically, the first reinforcement zone 114a, which protrudes distally, guides the fixing part 110 to deform distally when it retracts, allowing for smoother retraction. The second reinforcement zone 114b, also protruding distally, provides better radial support and bending strength to the proximal mesh surface 1102 of the fixing part 110. In other embodiments, the reinforcement zone 114 does not necessarily protrude distally relative to the non-reinforced zone 115; it may be substantially flush with the non-reinforced zone 115, or recessed 202 proximal to the fixing part 110 relative to the non-reinforced zone 115.

[0118] Optionally, in this embodiment, refer to Figure 10The braided filament 121, which at least partially passes through the encryption zone 114, includes a bent section 1211 along its length direction. The first end of the bent section 1211 along its length direction is connected to the encryption zone 114, and the second end of the bent section 1211 along its length direction is connected to the side surface 1121 of the wing 112. For example, a braided filament 121 extends from the distal end 1103 of the fixing part 110, passes through the encryption zone 114 (that is, a segment of the braided filament 121 belongs to a part of the encryption zone 114), and continues to bend and extend towards the side surface 1121 of the wing 112 to form the bent section 1211. The bent segment 1211 bends and bulges towards the radial outer edge of the fixing part 110, that is, the bent segment 1211 bends and bulges away from the central axis of the fixing part 110, and the bent segment 1211 includes a vertex 1212, which is the point on the bent segment 1211 farthest from the central axis of the fixing part 110, and the vertex 1212 is located between the first end and the second end of the bent segment 1211. The bent segment 1211 starts from the first end, bends and extends towards the central axis of the far-end fixing part 110 to the vertex 1212, and then extends towards the central axis of the fixing part 110 to the second end. This design results in a greater curvature of the bent section 1211 compared to the braided yarn 121 that does not pass through the densification zone 114. Furthermore, the two ends of the bent section 1211 are connected to the densification zone 114 and the side surface 1121 of the wing 112, respectively. When the side surface 1121 of the wing 112 is compressed, it can provide a good cushioning effect and work with the densification zone 114 to better maintain the shape of the wing 112. This allows the wing 112 to fit more tightly into the recess 202 of the inner wall of the auricle 200, and thus anchor more stably to the inner wall of the auricle 200.

[0119] The bent segment 1211 on the first direction braided filament 121a is designated as the first bent segment 1211a, and the bent segment 1211 on the second direction braided filament 121b is designated as the second bent segment 1211b. At least one first bent segment 1211a and / or at least one second bent segment 1211b may be included on the same wing 112. Referring to the figures, the distal end face and proximal end face of the wing portion 112 in this embodiment both include a plurality of first bending segments 1211a and a plurality of second bending segments 1211b. The first bending segments 1211a are respectively connected to the encryption zone 114 and the second side surface 1121b, and the second bending segments 1211b are respectively connected to the encryption zone 114 and the first side surface 1121a. Therefore, the wing portion 112 can obtain uniform buffering and support from the bending segments 1211 in multiple directions, and can better maintain the shape of the wing portion 112 in conjunction with the encryption zone 114. This allows the wing portion 112 to fit more tightly into the recess 202 of the atrial appendage inner wall 200 in multiple directions, and thus can be more stably anchored to the atrial appendage inner wall 200.

[0120] In other embodiments, the aforementioned bending segment 1211 may be omitted, and the braided wire 121 extending from the encryption zone 114 may also maintain the same bending shape as the braided wire 121 that does not pass through the encryption zone 114.

[0121] Example 4

[0122] Reference Figure 16 Based on any one of Embodiments 1 to 3, in this embodiment, at least a portion of the proximal end face of the wing 112 (the proximal end face of the wing 112 is part of the proximal mesh 1102 of the fixing part 110) includes an edge recess 1122 facing the distal recess 202 of the fixing part 110.

[0123] In this embodiment, the proximal end face of each wing 112 includes an edge recess 1122. In other embodiments, only one wing 112 or part of the wing 112 may have an edge recess 1122 on its proximal end face.

[0124] In other embodiments, the proximal end face of the wing 112 can be substantially flush. However, when the wing 112 is subjected to a radial compressive force toward the fixing part 110, the proximal end face of the wing 112 is prone to deform toward the direction closer to the sealing part 120, resulting in a weaker radial support force of the wing 112. In this embodiment, by providing an edge recess 1122 on the proximal end face of the wing 112, the proximal end face of the wing 112 is less likely to deform toward the direction closer to the sealing part 120 (i.e., the proximal end of the sealing device 100) when subjected to radial compression, thereby better maintaining the radial support force of the wing 112 and enabling the fixing part 110 to have a more stable anchoring capability.

[0125] Optionally, in this embodiment, the proximal end face of the central region 111 (the proximal end face of the central region 111 is part of the proximal mesh surface 1102 of the fixing part 110 and is connected to the proximal end face of the wing 112) includes a central recess 1123 facing the distal recess 202 of the fixing part 110, which is connected to one or more edge recesses 1122. By providing a central recess 1123 on the proximal end face of the central region 111, and by connecting the central recess 1123 to the edge recesses 1122, the possibility of the wing 112 deforming in the proximal direction of the sealing device 100 when subjected to radial compression can be further reduced, thereby better maintaining the radial support force of the proximal end face of the entire fixing part 110.

[0126] For example, in this embodiment, the central recess 1123 is connected to each edge recess 1122. In other embodiments, the central recess 1123 may be connected to only one or a portion of the edge recesses 1122.

[0127] Referring to the figure, the longitudinal section (the section obtained by cutting the axial plane of the fixing part 110) of the central concave portion 1123 is a parabolic shape with an opening towards the proximal end of the sealing device 100, and its generatrix is ​​a concave curve (a concave curve is a curve located below the tangent at any point on it). This arrangement can further enhance the radial support of the wing 112. In other embodiments, the generatrix of the central concave portion 1123 may be an upward concave curve (an upward concave curve is a curve located above the tangent at any point on it) or any other suitable curve shape, broken line shape, straight line shape, etc.

[0128] In this embodiment, the central region 111 is recessed 202 towards the distal end of the fixing portion 110. The groove 113 between adjacent wings 112 has a bottom in the radial direction of the fixing portion 110, and the bottom of the groove 113 is U-shaped or V-shaped. The proximal end of the bottom of the groove 113 includes a ridge 116, which is adjacent to the central recess 1123 and the edge recess 1122 on the wing 112 connected thereto, and the ridge 116 protrudes towards the proximal end of the sealing device 100 relative to the adjacent central recess 1123 and edge recess 1122. The ridge 116 may be U-shaped, V-shaped, or L-shaped or one or more. The ridge 116 helps maintain the shape of the bottom of the groove 113. When the wing 112 is subjected to radial compression, it can better guide the wing 112 to deform or displace regularly in a predetermined direction, reducing the risk of poor adhesion to the inner wall 200 of the auricle caused by irregular deformation or displacement of the wing 112.

[0129] Optionally, the proximal mesh surface 1102 of the fixing part 110 includes one or more encrypted areas 114 (i.e., second encrypted areas 114b), and each encrypted area 114 has an adjacent unencrypted area 115 on both circumferential sides. The specific structures of the encrypted areas 114 and unencrypted areas 115 are described in Embodiment 3 and will not be repeated here. In this embodiment, the encrypted area 114 extends from the central recess 1123 to the edge recess 1122. The inner end of the encrypted area 114 is located in the central recess 1123, and the outer end of the encrypted area 114 is located within the corresponding edge recess 1122. Alternatively, the encrypted area 114 extends through the edge recess 1122.

[0130] Since the encryption zone 114 extends from the central recess 1123 to the edge recess 1122, the encryption zone 114 can effectively enhance the radial support force of the central recess 1123 and the edge recess 1122, and can also maximize the bending strength of the wing 112.

[0131] Optionally, in this embodiment, at least a portion of the encrypted areas 114 protrude toward the distal end of the fixing portion 110 relative to the adjacent unencrypted areas 115.

[0132] The reinforced region 114, which protrudes distally, can further improve the circumferential bending strength and radial support force of the wing 112, and further reduce the risk that the wing 112 may displace excessively and detach from the recess 202 of the inner wall 200 of the auricle when squeezed by the inner wall 200. In other embodiments, the reinforced region 114 does not necessarily extend into the edge recess 202, and the reinforced region 114 does not necessarily protrude distally toward the fixing part 110 relative to the unreinforced region 115. It may be substantially flush with the unreinforced region 115, or it may be recessed 202 protruding proximally toward the fixing part 110 relative to the unreinforced region 115.

[0133] Optionally, in this embodiment, the distal disc surface 122 of the sealing portion 120 includes an outwardly protruding portion 124 protruding towards the fixing portion 110. When the sealing device 100 is in the fully deployed state, the outwardly protruding portion 124 is at least partially embedded in the central recess 1123, and at least a portion of the outwardly protruding portion 124 abuts against the central recess 1123. After the sealing device 100 is implanted, the outwardly protruding portion 124 can abut against the central recess 1123. Therefore, the outwardly protruding portion 124 can provide radial support force to the fixing portion 110, which is beneficial to improving the anchoring stability of the fixing portion 110.

[0134] The protruding portion 124 includes a central protruding unit 1241, which can be adapted to the shape of the central concave portion 1123 so that when the sealing device 100 is fully extended, the outer wall of the central protruding unit 1241 can fully contact the inner wall of the central concave portion 1123, thereby uniformly increasing the radial support force of the proximal mesh surface 1102 of the fixing portion 110 in multiple directions.

[0135] Understandably, in other embodiments, when the sealing device 100 is fully extended, the protruding portion 124 does not necessarily abut against the central recess 1123. The protruding portion 124 may have a radial gap with the inner wall of the central recess 1123. For example, the size of the radial gap is no more than 15% of the maximum outer diameter of the fixing portion 110. The protruding portion 124 can at least partially embed into the central recess 1123. When the sealing device 100 is implanted, and the fixing portion 110 is subjected to radial compression, the central recess 1123 contracts radially due to radial pressure and abuts against the protruding portion 124. At this time, the protruding portion 124 can also provide radial support force for the fixing portion 110.

[0136] Optionally, refer to Figure 17In this embodiment, the central concave portion 1123 may further include a first limiting unit 1124, and the outward convex portion 124 may further include a second limiting unit 1242. When the occlusion device 100 is in the fully deployed state, the first limiting unit 1124 and the second limiting unit 1242 cooperate with each other to limit the range of circumferential rotation of the fixing portion 110 relative to the sealing portion 120. After the occlusion device 100 is implanted, due to the gap between adjacent wings 112, the fixing portion 110 may have a certain degree of circumferential deflection when it is subjected to radial compression. During the continuous contraction and relaxation of the heart, the fixing portion 110 may have continuous reciprocating circumferential deflection. Especially when the deflection amplitude of the fixing portion 110 is large, the force of this deflection is transmitted to the connecting portion 130, causing the connecting portion 130 to be subjected to continuous large torsional force and resulting in fatigue damage. This embodiment limits the range of axial rotation of the fixing part 110 relative to the sealing part 120 by setting the first limiting unit 1124 and the second limiting unit 1242. On the one hand, it can reduce the risk of fatigue damage to the connecting part 130 due to continuous large torsional force. On the other hand, it allows the fixing part 110 to rotate circumferentially relative to the sealing part 120, which is convenient for adaptive adjustment according to different left atrial appendage morphologies during implantation.

[0137] In some implementations, refer to Figure 18The first limiting unit 1124 includes a limiting groove 11241, and the second limiting unit 1242 includes a limiting protrusion 12421. When the sealing device 100 is in the fully extended state, the limiting protrusion 12421 is embedded in the corresponding limiting groove 11241. Along the circumference of the fixing part 110, the limiting protrusion 12421 can slide within the area defined by the limiting groove 11241. For example, the central concave part 1123 is provided with one or more spaced limiting grooves 11241 along the circumferential direction of the fixing part 110. The limiting grooves 11241 are recessed 202 towards the far end of the fixing part 110 to form a groove. The outer convex part 124 is provided with one or more spaced limiting protrusions 12421. The limiting protrusions 12421 protrude towards the far end of the fixing part 110 and are provided in a one-to-one correspondence with the limiting grooves 11241. The aforementioned limiting groove 11241 extends along the circumferential direction of the fixing part 110. Its length (i.e., the dimension of the limiting groove 11241 along the circumferential direction of the fixing part 110) is greater than the length of the limiting protrusion 12421 (i.e., the dimension of the limiting protrusion 12421 along the circumferential direction of the fixing part 110). The width of the limiting groove 11241 is greater than the width of the limiting protrusion 12421. When the sealing device 100 is in the fully extended state, the limiting protrusion 12421 is at least partially embedded in the corresponding limiting groove 11241. The limiting protrusion 12421 can slide back and forth in the limiting groove 11241 along the circumferential direction of the sealing device 100. The end of the limiting groove 11241 can limit the sliding range of the limiting protrusion 12421 in the limiting groove 11241, thereby limiting the range of circumferential rotation of the fixing part 110 relative to the sealing part 120. In other embodiments, the first limiting unit 1124 may include a limiting protrusion 12421, and the second limiting unit 1242 may include a limiting groove 11241.

[0138] Optionally, in this embodiment, refer to Figure 19 The protruding portion 124 also includes an edge protruding unit 1243, which protrudes toward the distal end of the fixing portion 110. When the sealing device 100 is in the fully deployed state, the edge protruding unit 1243 is located in the groove 113 between two adjacent wings 112, and there is a gap between the edge protruding unit 1243 and the adjacent wing 112. When the fixing portion 110 is subjected to a large radial compression, the adjacent wing 112 can deflect to a certain extent along its tilt direction. When the wing 112 deflects to abut against the edge protruding unit 1243, the edge protruding unit 1243 can provide support for the wing 112, reducing the risk of the wing 112 dislodging from the recess 202 of the atrial appendage inner wall 200 due to excessive displacement. In addition, the edge protruding unit 1243 can also limit the range of circumferential rotation of the fixing portion 110 relative to the sealing portion 120 to a certain extent, thus reducing the distance between the connecting portion 130 (see reference 1243). Figure 17 The risk of fatigue damage due to continuous large torsional forces.

[0139] The cross-sectional shape of the edge protruding unit 1243 can be any suitable shape, such as circular, polygonal, elongated, or teardrop-shaped. For example, the edge protruding unit 1243 in the figure is teardrop-shaped and has the same inclination direction as the wing 112. The two sides of the edge protruding unit 1243 along the circumferential direction of the sealing part 120 are arc-shaped and have the same inclination direction as the wing 112. Since the edge protruding unit 1243 conforms to the inclination direction of the wing 112, it can guide the adjacent wing 112 to deflect and deform regularly in a predetermined direction when the fixing part 110 is subjected to large radial compression, thereby better maintaining the overall shape of the fixing part 110.

[0140] In this embodiment, the number of protruding edge units 1243 is the same as the number of grooves 113 on the fixing part 110. Each protruding edge unit 1243 corresponds one-to-one with a groove 113, so that it can play a corresponding role in multiple directions of the fixing part 110. In other embodiments, the protruding edge units 1243 do not necessarily correspond one-to-one with each groove 113. For example, only one protruding edge unit 1243 can be provided to a certain extent to limit the circumferential rotation range of the fixing part 110 relative to the sealing part 120; or, two or more protruding edge units 1243 can be provided for each groove 113.

[0141] Example 5

[0142] 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 112.

[0143] Reference Figure 20-21 , Figure 20 This is a schematic diagram of the structure of the fixing part 110 of the sealing device 100 in Embodiment 5 of the present invention. Figure 21 This is a top view of the fixing part 110 of the sealing device 100 in Embodiment 5 of the present invention, viewed from the far end to the near end.

[0144] In this embodiment, the anchor 410 is not part of the fixing part 110. That is, the anchor 410 is neither directly formed on the main body of the fixing part 110 nor extended from a part of the main body, nor is it rigidly fixed to the fixing part 110 by welding or other means. In this embodiment, the anchor 410 is fixed to the fixing part 110 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 110. In this embodiment, the anchor 410 is fixed to the outside of the wing 112, 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.

[0145] In another embodiment, the anchor 410 is disposed on the long side of the wing 112 along the circumferential direction, thereby matching the extension direction of the wing 112 and making it easier to contact the inner wall 200 of the atrial appendage.

[0146] In another embodiment, the hook 420 of the anchor 410 passes through the skeleton of the wing 112 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.

[0147] 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 hooks 420 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 421 and 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 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.

[0148] If 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 420 refers to the axial position of the free end of the hook 420), the distance from the first hook 411 and the second hook 412 of the anchoring member 410 to the far end face of the fixing part 110 is less than or equal to 1 / 2 of the overall axial length of the fixing part 110. Preferably, the distance from the first hook 411 and the second hook 412 of the anchoring member 410 to the far end face of the fixing part 110 is 1 / 3 of the overall axial length of the fixing part 110. If the first hook 411 and the second hook 412 of the anchoring member 410 have different heights, the higher first hook... The distance from the first hook 411 to the distal end face of the fixing part 110 is less than or equal to 1 / 2 of the overall axial length of the fixing part 110, and the distance from the lower second hook 412 to the distal end face of the fixing part 110 is greater than or equal to 1 / 2 of the overall axial length of the fixing part 110. Preferably, the distance from the higher first hook 411 to the distal end face of the fixing part 110 is 1 / 3 of the overall axial length of the fixing part 110, and the distance from the lower second hook 412 to the distal end face of the fixing part 110 is 2 / 3 of the overall axial length of the fixing part 110. The above-mentioned anchoring member 410 can ensure reduced contact with tissues during forward movement and retraction, reduce damage to the auricle, and reduce the wear of the anchor.

[0149] Reference Figure 22 , Figure 22This is a schematic diagram of the anchoring member 410 of the sealing device 100 installed on the fixing part 110 in another embodiment. The anchoring member 410 is sewn to the outer surface of the fixing part 110 by stitches. 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. 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 110, in this embodiment, the stitching point of the second hook 412 near the free end (that is, 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 (that is, at the same height of fixing part 110). This reduces the possibility of the second hook 412 moving circumferentially along the surface of fixing part 110, and consequently reduces the possibility of the anchor 410 rotating.

[0150] Reference Figure 23 , Figure 23 This is a schematic diagram of the structure of various optional anchoring elements 410 in Embodiment 5 of the present invention. This embodiment can use various anchoring elements 410 or combinations thereof, as detailed below:

[0151] 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 110 of the sealing device 100.

[0152] 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 110 of the sealing device 100, with the first hook 411b located at the distal end of the second hook 412b.

[0153] 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 110 of the sealing device 100. 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.

[0154] Reference Figure 24 , Figure 24 This is a schematic diagram of the structure of other optional anchoring elements 410 in Embodiment 5 of the present invention. Anchoring elements 410d, 410e, and 410f are all selectable shapes of anchoring elements 410. It should be noted that, in addition to the hook 420 having multiple options, the corresponding rod 421 connected to the hook 420 and the connecting rod 422 used to connect adjacent rods 421 can also be selected according to the actual situation.

[0155] 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 112, because the wing 112 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 be replaced with ball heads 50 to still achieve a good anchoring effect. The fixing part 110 of the conventional occlusion device 100 is a complete circumferential surface, which cannot extend into and fit well into the interior of the pectinate muscle. As a result, the fixing part 110 of the conventional occlusion device 100 always directly contacts the outer surface of the pectinate muscle. Since it cannot extend into or be inserted into the pectinate muscle, the corresponding anchoring member 410 of the conventional occlusion device 100 can only be set along a specific direction. Theoretically, if the conventional occlusion device 100 is set with the anchoring member 410 in different directions, the fixing part 110 of the conventional occlusion device 100 will expand and fit tightly into part of the pectinate muscle in a roughly circumferential direction after being released. The anchoring member 410 set in a non-circumferential direction cannot penetrate or be inserted into the pectinate muscle well. In other words, the fixing part 110 of the conventional occlusion device 100 adopts the design of hooks 420 with different extension directions in this embodiment, which also cannot achieve a good anchoring effect.

[0156] 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 110. 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 110.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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 25 , Figure 25This is a longitudinal schematic diagram of the anchoring member 410 of the sealing device 100 in this embodiment after installation. Specifically, along the longitudinal section of the fixing part 110, 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 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 112 in this application. Specifically, after the anchoring member 410 is installed on the wing 112, it extends along the shape of the wing 112, thus having a certain inclination relative to the implantation position, and the wing 112 extends into the pectinate muscle, thereby achieving a larger angle of anchorage. For a conventional sealing device 100, the included angles A or B should be as small as possible to facilitate the function of the barb 420.

[0162] 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 200 of the atrial appendage.

[0163] In another embodiment, a third hook 420 is also included at the distal end of the second hook 412. The axial deflection angle of the third hook 420 is C, and the included angle values ​​satisfy A < B < C, thereby further increasing the anchoring capability.

[0164] In another embodiment, it can be deduced by analogy that when the anchoring member 410 includes a plurality of hooks 420 distributed along the axial direction, the deflection angle of the hook 420 on the distal side along the axial direction on the longitudinal section of the fixing part 110 is smaller than the deflection angle of the hook 420 on the proximal side along the axial direction, so that damage to the auricle can be reduced while increasing the stable anchoring ability.

[0165] In another embodiment, along the circumferential direction, the hook 420 on one side of the anchor 410 and the hook 420 of the adjacent anchor 410 extend towards or away from each other in the circumferential direction, so that the two adjacent anchors 410 can clamp or tighten each other in the circumferential direction, thereby distributing some of the concentrated stress to the adjacent anchors 410. This is because the outer circumferential surface of the fixing part 110 involved in this application is discontinuous (i.e., not a complete circumference) when it contacts the auricle, resulting in a greater concentration of stress compared to the conventional circumferentially designed sealing device 100, thus making the interaction between adjacent wings 112 and adjacent anchors 410 have a greater impact on the overall anchoring strength.

[0166] In another embodiment, reference Figure 26-27 , Figure 26This is a schematic diagram of the sealing device 100 in this embodiment. Figure 27 This is a top view of the sealing device 100 in this embodiment, viewed from the distal end to the proximal end. At least two anchoring elements 410 are provided on each wing 112, 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 112 to ensure that each wing 112 can be anchored. In this embodiment, it should also be noted that because the outer edges of the wing 112 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 200 of the auricle at different angles.

[0167] Preferably, on the same wing 112, 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 411 of the adjacent anchoring member 410, so that the area of ​​the entire fixing part 110 that plays an anchoring role is distributed in a high-low state, thereby having a better anchoring effect.

[0168] Because the outer peripheral surface of the fixing part 110 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 100 with a conventional circumferential design, which makes the interaction between adjacent anchoring members 410 have a greater impact on the overall anchoring strength.

[0169] 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.

[0170] 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. The above embodiments only illustrate several implementations of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be pointed out that for those skilled in the art, several modifications and improvements can be made 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 structure woven from braided filaments, characterized in that, The fixing part includes a central region and a plurality of wings extending radially from the central region along the fixing part, the plurality of wings being spaced apart around the central region circumferentially along the fixing part; at least a portion of the proximal end face of the wings includes an edge recessed portion that is recessed toward the distal end of the fixing part.

2. The occlusion device of claim 1, wherein, The proximal end face of the central region includes a central recess that is recessed toward the distal end of the fixing portion, and the central recess is connected to one or more of the edge recesses.

3. The sealing device according to claim 2, characterized in that, A groove is included between two circumferentially adjacent wings, the groove having a bottom in the radial direction of the fixing part, the proximal end of the bottom of the groove including a ridge, the ridge being adjacent to the central recess and the edge recess on the wing connected to the ridge, and the ridge protruding relative to the adjacent central recess and the edge recess toward the proximal end of the sealing device.

4. The sealing device according to claim 2, characterized in that, The fixing part includes a proximal mesh surface, which includes one or more encrypted areas and unencrypted areas. Each encrypted area extends radially, and each encrypted area has an adjacent unencrypted area on both sides of its circumference. Each encrypted area and unencrypted area includes three or more braided threads, and the density of the braided threads in the encrypted area is greater than the density of the braided threads in the unencrypted area.

5. The sealing device according to claim 4, characterized in that, The encryption area extends from the central recess to the edge recess.

6. The sealing device according to claim 4, characterized in that, The encrypted area protrudes towards the far end of the fixed part relative to the adjacent unencrypted area.

7. The sealing device according to claim 2, characterized in that, The sealing part includes a distal disc surface, and the distal disc surface of the sealing part includes an outwardly protruding portion protruding in the direction of the fixing part. When the sealing device is in the fully extended state, the outwardly protruding portion is at least partially embedded in the central recess, and at least a portion of the outwardly protruding portion is in contact with the central recess.

8. The sealing device according to claim 7, characterized in that, The central concave portion includes a first limiting unit, and the outward convex portion includes a second limiting unit. When the sealing device is in a fully extended state, the first limiting unit and the second limiting unit cooperate with each other to limit the range of circumferential rotation of the fixing portion relative to the sealing portion.

9. The sealing device according to claim 8, characterized in that, The first limiting unit includes a limiting groove, and the second limiting unit includes a limiting protrusion. When the sealing device is in a fully extended state, the limiting protrusion is at least partially embedded in the corresponding limiting groove. Along the circumference of the fixing part, the limiting protrusion can slide within the area defined by the limiting groove.

10. The sealing device according to claim 7, characterized in that, The protruding part also includes an edge protruding unit, which protrudes toward the distal end of the fixing part. When the sealing device is in the fully deployed state, the edge protruding unit is located in the groove between two adjacent wings, and there is a gap between the edge protruding unit and the adjacent wing.

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