Occlusion device

Abstract

The present application relates to an occlusion device comprising a fixing portion and a sealing portion. The fixing portion comprises a plurality of support bodies. The sealing portion comprises a main body portion and a wing portion arranged around the periphery of the main body portion. The wing portion comprises a root portion connected to the main body portion and a free end extending outward and distally from the root portion. During implantation, the wing portion can enlarge the contact area between the main body portion and an implantation site, thereby enhancing the supporting effect of the main body portion. Simultaneously, the main body portion is compressed to a smaller volume due to the presence of the wing portion, consequently generating greater radial supporting force.

Description

Blocking device

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 29, 2023, with application number 2023118653675 and invention name “Sealing Device”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of interventional medical devices, and in particular to a blocking device. Background Art

[0003] In recent years, 90% of strokes caused by atrial fibrillation in patients with non-valvular atrial fibrillation have originated in the left atrial appendage (LAA). Clinical data show that resection of the LAA during cardiac surgery can reduce the incidence of stroke in patients with atrial fibrillation, highlighting the LAA's role in thromboembolism. Since the LAA is a reservoir for thrombi, blocking its opening eliminates the basis for thrombus formation within the LAA. LAA occlusion with a LAA occluder is generally an effective method for preventing stroke caused by atrial fibrillation.

[0004] To effectively block the left atrial appendage (LAA), a LAA occluder must be implanted in the LAA for a long period of time. Therefore, the LAA occluder must have a certain anchoring structure to ensure long-term and stable occlusion at the LAA opening, while also preventing it from falling off and causing device embolism.

[0005] For the split-type occluder, the connection and constraint between its fixing component and the sealing component are such that, in addition to the connection relationship, the fixing component mainly plays a fixing role, and the sealing component mainly plays a sealing role. Generally, the sealing components are relatively soft to adapt to and fit the sealing position. However, the relatively soft nature also leads to excessive flexibility of the sealing component. As the left atrial appendage continues to deform, the squeezing of the sealing component can easily cause the sealing component to leak and fall off, forming a blood leakage channel between the left atrium and the left atrial appendage, thereby failing to achieve the optimal sealing effect, thereby causing the thrombus in the left atrial appendage to flow out of the left atrial appendage, causing a stroke. Summary of the Invention

[0006] Based on this, it is necessary to provide an improved occlusion device to address the problem of leakage caused by traction in existing left atrial appendage occluders, as follows:

[0007] A sealing device is provided, comprising a fixing portion and a sealing portion, wherein the fixing portion comprises a plurality of supporting bodies, and wherein the sealing portion comprises a main body portion, and a wing portion arranged on the outside of the main body portion and connected to the main body portion, wherein the wing portion comprises a root portion connected to the main body portion and a free end extending outward and distally from the root portion.

[0008] In one embodiment, the sealing portion includes a blocking film, a projection of the blocking film on the main body portion completely covers the main body portion, and an edge of the blocking film is fixed to the wing portion.

[0009] In one embodiment, the wing is rod-shaped.

[0010] In one embodiment, the wing portion extends toward the distal end and is curved.

[0011] In one embodiment, the free end of the wing extends in a direction inclined relative to the axis and deflected in the circumferential direction.

[0012] In one embodiment, the deflection angle of the extension direction of the free end of the wing relative to the axial direction is between 0-40°.

[0013] In one embodiment, the free end of the wing is located at the same position as the support body in the circumferential direction.

[0014] In one embodiment, the free ends of the wings are alternately distributed with the support body in the circumferential direction.

[0015] In one embodiment, the wing portion has two free ends.

[0016] In one embodiment, the free end of the wing comprises a ball head.

[0017] Compared with the prior art, the present application provides a sealing device, which includes a fixing part and a sealing part. The fixing part includes a plurality of support bodies, and the sealing part includes a main body and a wing part arranged around the periphery of the main body. The wing part includes a root part connected to the main body and a free end extending from the root part to the outside and distal side. When implanted, the wing part can expand the contact area between the main body and the implantation position, thereby making the support effect of the main body better. At the same time, the main body will be compressed to a smaller volume due to the presence of the wing part, thereby obtaining a greater radial support force. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG1 is a schematic structural diagram of the blocking device in a natural state in Example 1 of the present application;

[0019] FIG2 is a schematic diagram of the blocking device in Example 1 of the present application in a blocking state;

[0020] FIG3 is a schematic diagram of the sealing portion of the blocking device in Example 2 of the present application in a natural state;

[0021] FIG4 is a schematic structural diagram of the sealing portion of the blocking device in Example 3 of the present application in a natural state;

[0022] FIG5 is a schematic diagram of the blocking device in Example 3 of the present application in a blocking state;

[0023] FIG6 is a schematic diagram of a state of a blocking device in the prior art in a closed mouth state;

[0024] FIG7 is a schematic diagram of the blocking device in Example 3 of the present application in a closed mouth state;

[0025] FIG8 is a schematic structural diagram of the sealing portion of the blocking device in a natural state in another embodiment of the present application. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solutions and advantages of this application more clearly understood, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0027] 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 referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device. "Axial" generally refers to the length of the medical device during delivery, and "radial" generally refers to the direction perpendicular to the "axial direction" of the medical device. This principle is used to define the "axial" and "radial" directions of any component of a medical device. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.

[0028] The technical solution of the present application will be further described in detail below with reference to specific embodiments.

[0029] Example 1

[0030] The occlusion device provided in Example 1 can be used to occlude the left atrial appendage, and can also be used to occlude other body tissues with openings, including but not limited to atrial septal defects, patent ductus arteriosus, etc. The occlusion device will be described in detail below using the occlusion of the left atrial appendage as an example.

[0031] Please refer to Figure 1, which is a schematic structural diagram of the occluding device 100 in Example 1 of the present application in its natural state. The occluding device 100 includes a fixing portion 120 and a sealing portion 110 connected to the fixing portion 120. The sealing portion 110 and the fixing portion 120 are spaced apart along the axial direction of the occluding device 100. The sealing portion 110 is located at the proximal end of the occluding device 100, and the fixing portion 120 is located at the distal end of the occluding device 100. The occluding device 100 has a compressed state housed in a sheath for easy transportation, and an expanded state as shown in Figure 1 after extending from the distal end of the sheath and self-expanding. The shape of the occluding device 100 after being released in the cavity of the left atrial appendage is exactly the same or substantially the same as that in Figure 1. In other implementations, for example, when used for occluding atrial septal defects, the sealing portion 110 and the fixing portion 120 can be close to each other after release to fix the occluding device 100 on the interval between the left atrium and the right atrium.

[0032] In this embodiment, the sealing portion 110 is woven into a mesh tube by a plurality of braided wires 111, and the ends of the braided wires 111 are respectively closed and fixed by a sleeve at both ends of the mesh tube. The mesh tube is then heat-formed into a disc-like, columnar or plug-like shape, thereby obtaining a sealing portion 110 for sealing the opening of the left atrial appendage. The sealing portion 110 includes a distal disk surface 112 facing the fixing portion 120, and a proximal disk surface 113 opposite to the distal disk surface 112. The interior of the sealing portion 110 is provided with at least one layer of a thin film body (not shown) used as a flow-blocking membrane, and the edge of the thin film body is fixed on the braided wire 111 at the edge of the sealing portion 110, generally fixed by sutures, and the thin film body is between the distal disk surface 112 and the proximal disk surface 113.

[0033] In another embodiment, the film body is in close contact with the proximal disk surface 113 or the distal disk surface 112. When there are multiple films, the positions of the films can be selected arbitrarily.

[0034] The thin film is used to prevent blood from flowing from one side of the sealing portion 110 to the other side, so as to prevent blood from flowing between the left atrial appendage and the left atrium.

[0035] In another embodiment, the total number of braided wires 111 used in the sealing portion 110 is increased. On the one hand, a larger number of braided wires can objectively better block the blood flow and support the flow-blocking membrane, thereby achieving a better sealing effect. On the other hand, the disk edge of the woven sealing portion 110 can be made up of more wires, thereby further filling the gaps at the edge, thereby obtaining a smoother disk edge, and then making it fit more closely with the inner wall of the left atrial appendage than the traditional setting. In another embodiment, the total number of braided wires 111 exceeds 72 strands, that is, the sealing frame of the sealing portion 110 is a dense mesh structure, preferably 114 strands of wire.

[0036] In another embodiment, when the sealing frame of the sealing portion 110 is a dense mesh structure, the mesh structure formed by the braided wires 111 is dense enough to prevent the blood clots in the atrial appendage from flowing out, thereby eliminating the need for a flow-blocking membrane.

[0037] The fixing portion 120 includes at least one support 121 and a coating covering the surface of the support 121. The sealing portion 110 is directly or indirectly connected to the fixing portion 120. The support 121 on the fixing portion 120 can be a rod obtained by cutting a metal alloy tube or a polymer tube, or a rod made by braiding or winding braided wire. In this embodiment, the specific shape of the support 121 is not limited. To enhance the anchoring ability of the fixing portion 120, anchor spikes are provided on the fixing portion 120 in this embodiment.

[0038] In this embodiment, the distal disk surface 112 of the sealing portion 110 facing the fixing portion 120 is converged, and the proximal end of the fixing portion 120 is also converged, and the direct or indirect connection position between the two is the converged position.

[0039] In this embodiment, the sealing portion 110 and the fixing portion 120 are fixedly connected by a connecting portion 130 .

[0040] In another embodiment, the sealing portion 110 and the fixing portion 120 are connected by a connecting portion 130 , and the fixing portion 120 and the sealing portion 110 can rotate relative to each other.

[0041] In another embodiment, the sealing portion 110 and the fixing portion 120 are integrally formed.

[0042] Using the occlusion device 100 of this embodiment, after the implantation is completed, refer to Figure 2, which is a schematic diagram of the occlusion device 100 in Example 1 of the present application in an occlusion state. For this embodiment, the support body 121 of the fixing part 120 expands to support the inner wall of the left atrial appendage 11, and the anchor thorn penetrates into the inner wall of the left atrial appendage 11, thereby helping the fixing part 120 to be fixed. When the occlusion device is working normally, the sealing part 110 is relied upon to achieve sealing of the left atrial appendage 11.

[0043] Returning to Figure 1, this embodiment improves the sealing portion 110. The sealing portion 110 includes a main body 1110 and a wing 1120 arranged around the main body 1110. Specifically, the main body 1110 is generally cylindrical, and the wing 1120 includes a root 1121 (i.e., a transition portion) connected to the main body 1110 and a free end 1122 extending outward from the root 1121. Since the sealing portion 110 in this embodiment uses a woven mesh, the free end 1122 here points to the edge of the woven mesh. In this embodiment, the free end 1122 of the wing 1120 is preferably inclined toward the outside and the distal side, and since the wing 1120 is flexible, the free end 1122 of the wing 1120 is rotatable relative to the root 1121 (rotatable here means that the free end 1122 can reach a different circumferential position with the root 1121 as the center relative to the natural state).

[0044] In another embodiment, the wing 1120 is a rigid structure or has weak flexibility, but the free end 1122 of the wing 1120 is still rotatable relative to the root 1121 .

[0045] The deflection angle of the extension direction of the free end 1122 of the wing 1120 relative to the axial direction can be between 0-90°. When the deflection angle of the extension direction of the wing 1120 relative to the axial direction is between 0-40°, the sealing part 110 is easier to sheath, so the deflection angle is preferably 0-40°.

[0046] As shown in the implanted state of Figure 2, when the occlusion device 100 is implanted in the left atrial appendage 11, the free end 1122 of the wing 1120 is located at the distal end, and can also be regarded as further folded toward the distal side and inward, so that the wing 1120 is clamped by the inner wall of the left atrial appendage 11 and the main body 1110. From the overall point of view, the overall diameter of the sealing portion 110 in the area where the wing 1120 is located becomes larger, and the occlusion effect is better. Moreover, since the filamentous surfaces of the wing 1120 and the main body 1110 overlap and block each other, part of the mesh of the main body 1110 is blocked by the wing 1120, while part of the mesh of the wing 1120 is blocked by the main body 1 110 is blocked, thereby making the sealing effect of the sealing part 110 better as a whole. From another perspective, the wing part 1120 is squeezed and deformed, and the force is also transmitted to the position of the main body 1110. Compared with the design without the wing part 1120, the main body 1110 will be compressed to a smaller volume due to the presence of the wing part 1120, thereby obtaining a greater radial supporting force. That is to say, the design of the wing part 1120 makes the main body 1110 in the state of Figure 2 compressed to a smaller size, the mesh volume of the main body 1110 becomes smaller, and the radial supporting force of the overlapping area of ​​the main body 1110 and the wing part 1120 becomes greater.

[0047] In addition, it should be noted that in this embodiment, the axial position of the wing 1120 is located on the proximal side of the main body 1110. Since the wing 1120 is further folded toward the proximal end from the transition position between the main body 1110 and the wing 1120, after the wing 1120 is flipped and pressed, relative to the free end 1122 of the wing 1120, which is the position with the greatest force, the root 1110 of the wing 1120 has a tendency to move toward the distal end relative to its free end 1120. Further explanation is given in conjunction with the movement of the left atrial appendage 11. When the left atrial appendage 11 is compressed, the sealing part 110 is compressed into a smaller volume as a whole, the mesh becomes smaller, and the surface pressure of the sealing part 110 and the supporting force against deformation also increase accordingly. The sealing effect will also be improved accordingly, and the possibility of falling off will also be reduced. When the left atrial appendage 11 is relaxed, that is, expanded, the sealing part 110 rebounds as a whole and expands to a larger volume. The mesh becomes larger, and the surface pressure of the sealing part 110 and the supporting force against deformation also decrease accordingly. The sealing effect will also be worse accordingly, and the possibility of falling off will also increase. Therefore, for the sealing part 110, it is more valuable to consider its stress conditions when it is in the relaxation stage of the left atrial appendage 11.

[0048] In this embodiment, in the state of Figure 2, the wing portion 1120 has been completely folded over and is squeezed together by the inner wall of the left atrial appendage 11 and the main body 1110. If the left atrial appendage 11 is further compressed in the state of Figure 2, then as mentioned above, the sealing portion 110 is compressed into a smaller volume as a whole, the mesh becomes smaller, the surface pressure of the sealing portion 110 and the supporting force to resist deformation also increase, the sealing effect will also be correspondingly improved, and the possibility of falling off will also be reduced; at this time, if the left atrial appendage 11 is further relaxed in the state of Figure 2, the following changes will occur: First, the free end 1122 is the area with the greatest force, and the possibility of being fixed on the inner wall of the left atrial appendage 11 is greater, relative to its Its position is more difficult to move. When the left atrial appendage 11 expands, the free end 1122 of the sealing portion 110 always presses against the inner wall of the left atrial appendage 11 when the sealing portion 110 has not completely separated from the inner wall of the left atrial appendage 11, resulting in leakage or sealing failure. In the state of Figure 2, the left atrial appendage 11 further relaxes, and the wing portion 1120 has a tendency to return to its original state. Relative to the free end 1122, the root portion 1121 has a tendency to move toward the inner side and the distal side to return to its original state, so that the component of the internal force in the axial direction is toward the distal side, thereby maintaining the trend of the sealing portion 110 toward the distal side, and reducing the possibility of the sealing portion 110 falling off (that is, falling out of the left atrial appendage 11 area toward the proximal end).

[0049] It should be noted that FIG2 is intended to illustrate the position of the occlusion device 100 after implantation, and does not fully illustrate the actual released state. Because the frame of the sealing portion 110 is flexible, the outer edge of the entire sealing portion 110 is substantially in close contact with the inner wall of the left atrial appendage 11. In other words, the area of ​​the main body 1110 not covered by the wing portion 1120 is generally also in close contact with the inner wall of the left atrial appendage 11. Therefore, considering the overall situation, the design of the wing portion 1120 simultaneously increases the sealing effect and supporting force on the proximal side of the sealing portion 110, thereby significantly improving the overall effect of the sealing device 100.

[0050] In this embodiment, the root 1121 of the wing 1120 is located on the proximal side of the main body 1110. This is to prevent the root 1121 from being located on the distal side from affecting the close contact between the proximal side of the main body 1110 and the inner wall of the left atrial appendage 11. In addition, to ensure smooth deployment of the occlusion device 100 and the adaptability of insertion and removal from the sheath, the length of the wing 1120 (i.e., the distance from the root 1121 to the free end 1122) is less than or equal to the height of the main body 1121 (i.e., the distance from the proximal disk 113 to the distal disk 112).

[0051] In another embodiment, the main body 1110 and the wing 1120 are integrally formed, or woven from the same braided wire.

[0052] In another embodiment, a variety of shapes can be selected for the wing 1120, such as a cross-section of a slender cylinder, a cone, a trapezoid, a truncated cone, etc. The shape is not limited, but the cross-sectional thickness of the root 1121 of the wing 1120 must be less than or equal to the cross-sectional thickness of the remaining parts, so as to obtain the best supplementary support force and auxiliary sealing effect.

[0053] In another embodiment, the wire diameter of the nickel-titanium wire of the wing 1120 is smaller than the wire diameter of the main body 1110. Preferably, the wire diameter of the nickel-titanium wire of the wing 1120 is 1 / 2 to 4 / 5 of the wire diameter of the main body 1110. Specifically, a post-weaving processing method can be used to first determine the nickel-titanium wire segment in the area of ​​the wing 1120, and then refine the area segment of the wing 1120 of the nickel-titanium wire through physical methods such as sandblasting and grinding, or chemical methods such as polishing, pickling, and refinement.

[0054] In another embodiment, the sealing portion can be braided in sections using nickel-titanium wires of different diameters. Before braiding, the area of ​​the wing portion 1120 of the sealing portion 110 is determined. The sealing portion 110 is braided in sections, wherein the wing portion 1120 area is braided using nickel-titanium wires with smaller diameters, and the main body 1110 is braided using nickel-titanium wires with larger diameters. The transition area between the main body 1110 and the wing portion 1120 can be connected by entanglement, compression sleeves, welding, etc.

[0055] In another embodiment, a treatment method of weaving first and then thinning can also be adopted, that is, the shape of the sealing portion 110 is first woven into the shape, and then the regional segment of the wing portion 1120 of the nickel-titanium wire is thinned by physical methods such as sandblasting and grinding, or chemical methods such as polishing, pickling, and thinning.

[0056] In summary, due to the design of the wing 1120, the sealing ability and supporting ability of the proximal side of the sealing part 110 are improved. Therefore, compared with other similar structures, the sealing part 110 can use thinner nickel-titanium wire to achieve the same sealing ability and supporting ability as ordinary sealing parts, which in turn increases the flexibility of the sealing part 110, making it easier to enter and exit the sheath and follow the deformation of the heart.

[0057] In another embodiment, the overall diameter of the sealing portion 110 is increased due to the addition of the wing portion 1120. When the sealing portion 110 is partially sheathed, the overall axial length after compression and stretching will also increase. In order to control the length of the sealing portion 110 of the occluding device in the sheath, a plurality of flexible limiters, such as sutures, are added. In a natural state, one end of the flexible limiter is fixed to the distal surface of the root of the wing portion 1120, and the other end is fixed to the proximal surface of the root of the wing portion 1120. Since the sealing portion 110 is elongated as a whole from the natural state to the state of being retracted into the sheath, and the flexible limiter limits the distance between its two fixed ends (i.e., the proximal surface and the distal surface of the root of the wing portion 1120), the wing portion 1120 will not be stretched and lengthened when the sheath is retracted, but will maintain the shape of the wing portion 1120 and be directly compressed, thereby reducing the overall length of the sealing portion 110 retracted into the sheath.

[0058] Example 2

[0059] The improvements of Example 2 relative to Example 1 are concentrated in the sealing part, specifically referring to FIG3 , which is a schematic diagram of the sealing part 110 of the sealing device in Example 2 of the present application in its natural state. For this embodiment, the main body 1110 of the sealing part 110 has an additional inner disk 1130 on the basis of Example 1. The wire diameter of the inner disk 1130 is larger than the wire diameter of the main body 1110, so that the inner disk 1130 has higher rigidity (it can also be achieved through quenching, welding of nodes between wires, and other methods, as long as the rigidity of the inner disk 1130 is greater). In other words, the main body 1110 has better flexibility than the inner disk 1130, and the inner disk 1130 can better support the main body 1110 and the wing 1120. In other words, the main body 1110 and the wing 1120 in this embodiment can use thinner nickel-titanium wire to achieve a better sealing effect. The lack of supporting force is supplemented by the inner disk 1130. It should be noted that, in the unassembled state, the diameter of the inner disk 1130 may preferably be larger than the main body 1110, so that the inner disk 1130 always supports the main body 1110 after assembly. Furthermore, due to the presence of the inner disk 1130, the flow-blocking membrane corresponding to the sealing portion 110 can be set on the inner side of the inner disk 1130 or covered on the outer side of the inner disk 1130, thereby being clamped between the inner disk 1130 and the main body 1110, thereby facilitating the complete deployment of the flow-blocking membrane and the blocking support for blood.

[0060] In this embodiment, the distal diameter of the inner disk 1130 is larger than the proximal diameter, thereby cooperating with the main body 1110 and the wing 1120 to achieve a more balanced force on the outer side of the sealing portion 110.

[0061] Example 3

[0062] The improvements of Example 3 relative to Example 1 are concentrated in the sealing part, specifically referring to Figure 4, which is a structural schematic diagram of the sealing part of the sealing device in Example 3 of the present application in a natural state. For this embodiment, the sealing part 210 of this embodiment is roughly rod-shaped, and this embodiment is preferably cut from a nickel-titanium tube. The sealing part 210 includes a plurality of main bodies 2110 radially expanding from the center to the surrounding outsides, and the main body 2110 is covered with a flow-blocking film 2113. In this embodiment, the flow-blocking film 2113 covers at least the outermost side of the main body 2110, that is, the projection of the flow-blocking film 2113 on the main body 2110 completely covers the main body 2110 itself.

[0063] In this embodiment, the rod-shaped sealing portion 210 formed by cutting has greater rigidity than a braided body in general, and the outer side of the main body 2110 is bent and extended to form the wing portion 2120. In this embodiment, the wing portion 2120 still extends and bends toward the distal side, and it should be noted that the wing portion 2120 in this embodiment extends from the rod-shaped main body 2110. The wing portion 2120 and the main body 2110 in this embodiment are integrated, but in another embodiment, the transition area between the main body 2110 and the wing portion 2120 can still be combined by entanglement, pressing, welding, etc., that is, the wing portion 2120 can also be a braided body or other forms.

[0064] Combined with Figure 5, Figure 5 is a schematic diagram of the state of the occlusion device in Example 3 of the present application in a occlusion state. As mentioned above, the baffle film 2113 at least covers the outermost side of the main body 2110, that is, the edge of the baffle film 2113 is fixed in the wing 2120 area, preferably to the outer edge of the wing 2120. Therefore, when the sealing part 210 is implanted, the wing 2120 is folded and pressed against the inner wall of the left atrial appendage, so that the baffle film 2113 completely covers the atrial appendage opening. In addition, since the wing 2120 is folded as a whole and pressed against the inner wall of the atrial appendage, sufficient margin is left for the edge of the baffle film 2113. Furthermore, compared to a structure without wings 2120, wings 2120 also transfer the pressure of the inner wall of the atrial appendage in the area where wings 2120 are located to the edge of the main body 2110, thereby increasing the edge pressure of the main body 2110 and the corresponding radial support force exerted on the edge of the main body 2110, thereby overall improving the radial support force of the sealing portion 210. Furthermore, when wings 2120 are tilted and expanded outward relative to the main body 2110, wings 2120 also objectively expand the overall radius of the sealing portion 210, thereby increasing the compression of the sealing portion 210 after implantation and increasing the radial support force of the sealing portion 210 after implantation.

[0065] In this embodiment, the extension direction of the free end of the wing 2120 is not only inclined relative to the axis, but also deflected in the circumferential direction, so that it has more circumferential contact with the inner wall of the auricle compared to the state of extending along the axis. Due to the circumferential deformation caused by the contraction of the heart, the wing 2120 has more complete contact with the inner wall of the auricle and better adhesion.

[0066] In another embodiment, the free end of the wing 2120 extends in a direction parallel to the axis.

[0067] For this embodiment, in addition to the implantation method similar to that of embodiment 1 to obtain a good sealing effect, this embodiment is also optimized relative to the sealing device of the traditional disc-type sealing disc design. In order to better illustrate the effect of this embodiment, the stress conditions of the prior art are first analyzed. Please refer to Figure 6 first. Figure 6 is a schematic diagram of the state of the sealing device in the closed mouth state in the prior art. In the existing commonly used sealing methods, one situation is that the sealing part 310 is basically located outside the mouth of the left atrial appendage, used to close the opening of the left atrial appendage. Specifically, in the prior art, the sealing part 310 is disc-shaped, the distal end face of the disc body abuts the edge of the atrial appendage opening, and the remaining positions are adaptively deformed, relying on the contact between the distal end face of the disc body and the atrial appendage to achieve sealing. The abutting position 3101 of the sealing part 310 is generally located at the distal end face of the disc body, and is generally located on the side of the middle part toward the outer edge. For this type of sealing method, on the one hand, the sealing disk 310 is required to have sufficient flexibility to fit the atrial appendage opening, thereby having to reduce the supporting capacity of the sealing disk 310. On the other hand, the edge of the flow-blocking membrane is generally fixed at the edge position of the sealing disk 310. Under such a design, there is a certain distance between the supporting position 3101 of the sealing part 310 and the edge fixing position 3102 of the flow-blocking membrane. Since the sealing part 310 is disc-shaped and flexible, its edge cannot be well pressed against the atrial appendage opening, so that the flow-blocking membrane cannot completely achieve a sealing effect.

[0068] In addition, in the existing disc-shaped design, the sealing portion 310 deforms as the atrial appendage deforms, and the deformation of its braided body will cause relative sliding between the braided wires, that is, the contact part with the inner wall of the atrial appendage will also slip, which may cause damage to the atrial appendage, and the continuous sliding with the inner wall of the atrial appendage will also reduce the cell attachment effect.

[0069] In this regard, in Example 3, when a sealing method that covers the atrial appendage opening is selected, refer to Figure 7, which is a schematic diagram of the state of the sealing device in Example 3 of the present application when the opening is closed. The sealing portion 210 of this embodiment includes a main body 2110 and a wing 2120 located on the outside of the main body. Since the wing 2120 extends toward the distal end, after release, the edge of the wing 2120 presses against the outer edge of the atrial appendage opening, and since the free end of the wing 2120 is at the farthest end, when the free end presses against the atrial appendage opening, part of the stress of the adjacent free end of the wing 2120 is concentrated toward the free end, thereby causing the free end of the wing 2120 to be stably pressed against the opening of the left atrial appendage, and the free end of the wing 2120 is unlikely to slide relative to the surface of the atrial appendage.

[0070] In this embodiment, it is particularly important to note that after the edge of the wing 2120 abuts the atrial appendage opening, the end of the wing 2120 will be continuously pressed against the atrial appendage opening because the main body 2110 is pulled by the connecting portion 230, so that the edge of the wing 2120 always abuts the atrial appendage opening, which also drives the flow-blocking membrane to stick to the atrial appendage opening.

[0071] In this embodiment, the most special thing is that since the rod-shaped stress is most concentrated, the wing portion 2120 is preferably rod-shaped in this embodiment, so that the stress of the sealing portion is concentrated at the free end of the wing portion 2120, and the support body 221 of the fixing portion 220 of this embodiment is also a rod-shaped structure formed by cutting. The support body 221 is against the inner wall of the atrial appendage. At the same time, since the pulling force of the sealing portion 210 on the fixing portion 220 is toward the proximal side, the position where the support body 221 exerts the greatest pressure on the atrial appendage is located at the proximal end where the support body 221 is in contact with the inner wall of the atrial appendage, that is, the proximal side of the support body 221. For the support body 221, the pressure of the support body 221 on the atrial appendage is inclined toward the proximal end, while the pressure of the free end of the wing 2120 on the atrial appendage is inclined toward the distal end. Therefore, the proximal side of the support body 221 of the fixing portion 220 and the free end of the wing 2120 tend to approach each other, and jointly clamp the edge of the atrial appendage opening with the connection position of the two (that is, the connection portion 230) as the center. The free end of the wing 2120 presses against the atrial appendage opening from the proximal end to the distal end, and the proximal side of the support body 221 presses against the atrial appendage opening from the inside and from the distal end to the proximal end, thereby clamping the edge of the atrial appendage opening. The reason why this embodiment emphasizes the rod shape is that only a stress-concentrating design such as a rod shape can achieve clamping of the atrial appendage opening. If it is designed to be a mesh braided structure similar to Example 1, it will more often use fillers to increase stress and contact with the inner wall of the atrial appendage to enhance the overall friction. This is because the volume of the braided mesh is too large. In order to ensure its transportation and recovery and release process, it is unlikely to adopt means to increase the strength. That is, the mesh braided body naturally has the characteristic of high flexibility. This is also the reason why the split left atrial appendage occluder generally must rely on an additional fixing part to achieve anchoring.

[0072] Relatively speaking, in this embodiment, the stress concentration position between the sealing disk 210 and the auricle and the stress concentration position between the fixing portion and the auricle are both ends, and no slippage will occur, that is, the contact position with the auricle is stable, which is conducive to the realization of cell attachment.

[0073] In this embodiment, the free end of the wing 2120 and the support body 221 are in the same circumferential position (which can also be regarded as being arranged relative to each other in the direction from the proximal end to the distal end), so that the free end of the wing 2120 and the support body 221 (or the proximal side of the support body 221, that is, the contact position between the support body 221 and the inner wall of the atrial appendage) are located in the same longitudinal cross-section, so that the pressure of the free end of the wing 2120 on the edge of the atrial appendage opening is exactly opposite to the pressure of the proximal side of the support body 221 on the inner wall of the atrial appendage, so that the clamping force formed by the two is the largest and the state of the occlusion device is the most stable.

[0074] In another embodiment, referring to Figure 8, Figure 8 is a structural schematic diagram of the sealing portion of the occlusion device in another embodiment of the present application in a natural state. The wing 2120 is divided into two free ends 2121. On this basis, the end of the main body 2110 (that is, the end connected to the wing 2120) is in the same position as the support body 221 in the circumferential direction, and the free ends 2121 of each wing 2120 are evenly distributed on both sides of the circumference of the corresponding support body 221. On the one hand, the contact position between the wing 2120 and the atrial appendage opening is increased as a whole, and part of the stress is shared. On the other hand, the clamping of the free end 2121 of the wing 2120 and the proximal side of the support body 221 is made more balanced and stable.

[0075] In this embodiment, the free end of the wing 2120 includes a ball head, which can be embedded in the pectinate muscle inside the atrial appendage, and can also press the muscle near the atrial appendage opening so that the muscle wraps around the ball head, maintaining the supporting position without damaging the atrial appendage.

[0076] In another embodiment, an inner disk may be added to the enclosed space formed by the main body 2110 and the wing 2120 to further enhance the supporting force and sealing effect.

[0077] It should be noted that the various technical features of the above-described embodiments may be arbitrarily combined and may be simultaneously applied to the various types of left atrial appendage occluders described above, as well as left atrial appendage occluders with similar structures. For the sake of brevity, not all possible combinations of the various technical features in the above-described embodiments are described. However, as long as there are no conflicts in the combinations of these technical features, they should be considered to be within the scope of this specification.

[0078] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art could make various modifications and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A plugging device, comprising a fixing part and a sealing part, wherein the fixing part includes a plurality of support bodies, characterized in that, The sealing portion includes a main body portion, and wing portions disposed outside the main body portion and connected to the main body portion. The wing portions include roots connected to the main body portion and free ends extending outwardly and distally from the roots.

2. The plugging device according to claim 1, characterized in that, The sealing portion includes a flow blocking film, the projection of the flow blocking film on the main body portion completely covers the main body portion, and the edge of the flow blocking film is fixed to the wing portion.

3. The plugging device according to claim 1, characterized in that, The wing portion is rod-shaped.

4. The plugging device according to claim 1, wherein, The wing portion extends and bends toward the distal side.

5. The plugging device according to claim 1, characterized in that, The extending direction of the free end of the wing portion is inclined with respect to the axis and is deflected circumferentially.

6. The plugging device according to claim 1, wherein The deflection angle of the extending direction of the free end of the wing portion with respect to the axis is between 0 - 40°.

7. The plugging device according to claim 1, characterized in that, The free end of the wing portion is in the same position circumferentially as the support body.

8. The plugging device according to claim 1, wherein The free ends of the wing portion and the support body are alternately distributed circumferentially.

9. The plugging device according to claim 1, characterized in that, The wing portion has two free ends.

10. The plugging device according to claim 1, wherein, The free end of the wing portion includes a ball head.

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