Occlusion device
By designing the fixing part of the mesh braided structure, including the fixing part of the central area and multiple edge areas, the problem of insufficient contact area between the left atrial occlusion fixing part and the implanted position in the prior art is solved, and better anchoring ability and stability are achieved.
Patent Information
- Application Number
- PCT/CN2024/121766
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-09-27
- Filing Date
- 2024-09-27
- Publication Date
- 2025-04-03
AI Technical Summary
The contact area between the fixing part of the existing left atrial appendage occlusion device and the implanted position is insufficient, which leads to the occlusion device being easily shedded, increasing the risk of device embolism.
A fixing portion including a mesh braided structure is designed, the fixing portion has a central area and a plurality of edge areas, and adjacent edge areas include grooves, which can adapt to the grooves and raised positions of the implanted area, thereby expanding the contact area and improving anchoring capacity.
By increasing the contact area and anchoring capacity of the fixing part and the atrium, the stability and safety of the sealing device are significantly improved, and the risks of shedding and device embolization are reduced.
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Figure CN2024121766_03042025_PF_FP_ABST
Abstract
Description
Blocking device Technical Field
[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a blocking device. Background Art
[0002] 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.
[0003] 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.
[0004] A split-type occluder generally includes a fixing portion that performs a fixing function and a sealing portion that performs a sealing function. As for the fixing portion, anchoring is generally achieved only through sharp anchor spikes or the like, without considering the contact tightness and state between the fixing portion and the implantation position itself. When the contact area between the fixing portion and the atrial appendage is insufficient, there is still a risk of falling off, and the existing technology has failed to improve it.
[0005] Summary of the Invention
[0006] Based on this, it is necessary to provide an improved occlusion device to address the problem of insufficient contact area between the fixing portion and the implantation site of the existing left atrial appendage occluder, as follows:
[0007] A sealing device is provided, comprising a fixing portion and a sealing portion, wherein the fixing portion comprises a mesh woven structure, the fixing portion comprises a central area and a plurality of edge areas circumferentially surrounding the central area, and two adjacent edge areas comprise grooves.
[0008] In one embodiment, the groove is radially closer to the axis of the blocking device than to the radial outer side of the edge region.
[0009] In one embodiment, the proximal end and the distal end of the fixing portion are both contracted and closed.
[0010] In one embodiment, the edge region includes wings extending outward, and adjacent side surfaces between adjacent wings extend obliquely in the same direction on the same cross section.
[0011] In one embodiment, the number of the edge regions of the fixing portion is between 4 and 6.
[0012] In one embodiment, the edge regions of the fixing portion are inclined and radial in an axial cross section.
[0013] In one embodiment, the plurality of edge regions of the fixing portion extend outward in a clockwise direction from the root, or the plurality of edge regions extend outward in a counterclockwise direction from the root.
[0014] In one embodiment, the radial center line of the edge region is used as a dividing line, and on the inner side of the edge region along the radial center line, the maximum distance between adjacent wing portions is less than the maximum circumferential width of adjacent wing portions.
[0015] In one embodiment, the radial center line of the edge region is used as a dividing line, and on the inner side of the edge region along the radial center line, the maximum distance between adjacent wing portions is less than the maximum circumferential width of any wing portion.
[0016] In one embodiment, an anchoring member is mounted on the fixing portion, the anchoring member is bound to the fixing portion via a flexible member, and the free end of the anchoring member is exposed.
[0017] In one embodiment, the anchoring element includes two connected first hooks and a second hook, wherein the first hook is located at the distal end of the second hook.
[0018] Compared with the prior art, the present invention provides a sealing device including a fixing portion and a sealing portion, wherein the fixing portion includes a mesh woven structure, the fixing portion includes a central area and multiple edge areas circumferentially surrounding the central area, and two adjacent edge areas include grooves; relative to the traditional fixing portion design with a cylindrical outer edge (that is, a circular boundary in cross section), the fixing portion of the sealing device provided by the present invention is formed with multiple grooves and edge areas, which can adaptively fit into the grooves and protrusions of the implantation area and maintain contact with the surface of the implantation area accordingly, thereby expanding the contact area and obtaining better anchoring capability. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG1 is a front view of the blocking device in a natural state according to Example 1 of the present invention;
[0020] FIG2 is a schematic top view from the distal end to the proximal end of the fixing portion of the occlusion device in Example 1 of the present invention;
[0021] FIG3 is a schematic diagram of the deformation state of the fixing portion of the occlusion device in Example 1 of the present invention after implantation;
[0022] FIG4 is a schematic top view of a fixing portion of a conventional braided structure from the distal end to the proximal end;
[0023] FIG5 is a schematic diagram of a deformed state of a fixing portion of a conventional braided structure after implantation;
[0024] FIG6 is a schematic top view from the distal end to the proximal end of the occlusion device in Example 2 of the present invention;
[0025] FIG7 is a schematic structural diagram of a fixing portion of a blocking device in Example 3 of the present invention;
[0026] FIG8 is a schematic top view from the distal end to the proximal end of the fixing portion of the occlusion device in Example 3 of the present invention;
[0027] FIG9 is a schematic structural diagram of various optional anchoring members in Example 3 of the present invention;
[0028] FIG10 is a schematic structural diagram of a blocking device according to another embodiment of the present invention;
[0029] FIG11 is a schematic top view from the distal end to the proximal end of the occlusion device in another embodiment of the present invention. DETAILED DESCRIPTION
[0030] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present 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 only used to explain the present invention and are not intended to limit the present invention.
[0031] 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.
[0032] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.
[0033] Example 1
[0034] The occlusion device 100 provided in Example 1 can be used to occlude the left atrial appendage (LAA), and can also be used to occlude other body tissues with openings, including but not limited to atrial septal defects and patent ductus arteriosus. The occlusion device 100 will be described in detail below using the occlusion of the LAA as an example.
[0035] Please refer to Figure 1, which is a front view of the occlusion device 100 in a natural state in Example 1 of the present invention. The occlusion device 100 includes a fixing portion 110 and a sealing portion 120 connected to the fixing portion 110. The sealing portion 120 and the fixing portion 110 are spaced apart along the axial direction of the occlusion device 100. The sealing portion 120 is located at the proximal end of the occlusion device 100, and the fixing portion 110 is located at the distal end of the occlusion device 100. The occlusion 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 occlusion device 100 after being released from 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 120 and the fixing portion 110 can be close to each other after release to fix the occlusion device 100 on the interval between the left atrium and the right atrium.
[0036] In this embodiment, the fixing portion 110 is connected to a connecting member 130 , and the distal end of the sealing portion 120 is converged and connected to the connecting member 130 .
[0037] When making the sealing portion 120, a plurality of braided wires 121 are first woven into a mesh tube, and the ends of the braided wires 121 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 the sealing portion 120 for sealing the opening of the left atrial appendage. The sealing portion 120 includes a distal disk surface 122 facing the fixing portion 110, and a proximal disk surface 123 opposite to the distal disk surface 122. Preferably, the interior of the sealing portion 120 is provided with at least one layer of a thin film body (not shown) used as a flow-blocking membrane, the edge of the thin film body being fixed to the braided wires 121 at the edge of the sealing portion 120, generally fixed by sutures, and the thin film body being interposed between the distal disk surface 122 and the proximal disk surface 123. The thin film body is used to prevent blood from flowing from one side of the sealing portion 120 to the other side, thereby preventing blood from flowing between the left atrial appendage and the left atrium. In this embodiment, the distance between the distal disk surface 122 and the proximal disk surface 123 is not limited. Therefore, the sealing portion 120 does not need to be disk-shaped, and may also be a cylinder with a certain height.
[0038] Further, referring to Figure 2, Figure 2 is a schematic top view from the distal end to the proximal end of the fixing portion of the occlusion device in Example 1 of the present invention. In this embodiment, the fixing portion 110 is formed by weaving metal wires. Specifically, one or more metal wires are bent along a specific trajectory to form a mesh-like woven body, so that the fixing portion 110 has better compliance to avoid damage to the atrial appendage to the greatest extent. It should be noted that the reason why the braided structure provided in this embodiment has higher compliance compared to the rod-type structure formed by direct cutting is that, on the one hand, the wire diameter of the metal wire selected for braiding is small enough, otherwise the metal wire cannot be processed to form a braided body. Accordingly, if the rod-type structure uses the same diameter as the braided structure, the radial support force of the rod-type structure to resist the deformation of the atrial appendage is extremely small, so that the fixing portion 110 of the rod cannot achieve the purpose of fixation, causing the entire occlusion device 100 to fall off; on the other hand, since braiding will pre-bend the metal wire, applying force along the pre-bending direction to the pre-bent metal wire will make it easier to deform the metal wire. The braided body uses this feature to transfer the deformation of the metal wire at a certain position to the adjacent and staggered metal wire position, thereby dispersing the concentrated stress. Therefore, the force applied to a certain point of the braided body will be better dispersed to the whole along the braided structure.
[0039] For this embodiment, in addition to forming a woven structure, the fixing portion 110 includes a central area 111 and a plurality of edge areas 112 circumferentially surrounding the central area 111. The cross-sectional shape of the central area 111 is generally circular. For the central area 111, one side of the edge area 112 extends from the central area 111, extends radially outward, and then retracts toward the central area 111. In other words, in this embodiment, the fixing portion 110 includes a plurality of radially outwardly protruding edge areas 112 distributed around the central area 111. In this embodiment, the edge areas 112 are radially distributed along the radial direction, and a groove 113 is included between two adjacent edge areas 112. In terms of position distribution, the groove 113 is radially closer to the axis relative to the radial outer side of the edge area 112.
[0040] With further reference to FIG3 , FIG3 is a schematic diagram of the deformation state of the fixing portion of the occlusion device in Example 1 of the present invention after implantation. 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 portion 110 expands radially as a whole, and the outer side of the edge area 112 located on the outer side of the fixing portion 110 abuts against the inner wall of the atrial appendage. For this embodiment, the edge area 112 extends radially outward. Therefore, on the one hand, the edge area 112 can be partially stuck in the recess 201 of the inner wall 200 of the atrial appendage, thereby increasing the contact between the edge area 112 and the atrial appendage. On the other hand, the groove 113 between adjacent edge areas 112 can also accommodate the protrusion 202 of the inner wall 200 of the atrial appendage, so that the adjacent edge areas 112 of the fixing portion 110 clamp the protrusion 202 of the inner wall 200 of the atrial appendage, thereby increasing the contact between the edge area 112 and the atrial appendage, thereby increasing the radial supporting force of the fixing portion 110 as a whole.
[0041] In addition, since the inner wall 200 of the atrial appendage will rotate and contract inward as the heart contracts, new wrinkles will be generated, that is, new protrusions 202 and depressions 201 will be formed, and it can further adaptively fit into the grooves 113 between the edge areas 112 and / or be clamped by the outside of the edge areas 112, which not only greatly increases the contact area between the occluding device 100 and the inner wall 200 of the atrial appendage, but also forms an overall clamping connection through abutment at multiple positions, so that the occluding device 100 of this embodiment has better radial support than the traditional design, that is, it is more tightly combined with the inner wall 200 of the atrial appendage.
[0042] The effect of this embodiment is further described in conjunction with Figures 4-5. Figure 4 is a schematic top view of the fixed portion of the traditional braided structure from the distal end to the proximal end, and Figure 5 is a schematic diagram of the deformation state of the fixed portion of the traditional braided structure after implantation. For the fixed portion 210 of the traditional braided structure, when it is released on the inner wall 200 of the auricle, as mentioned above, the braided structure will distribute the concentrated stress to the surrounding area, so that for the braided structure itself, when receiving pressure, the deformation of the pressure point is the largest, and the deformation away from the pressure point gradually decreases, thereby forming a regional concave as a whole. Therefore, when the fixing portion 110 is implanted into the atrial appendage and expands, the protrusion 202 of the atrial appendage inner wall 200 presses against the outer surface of the fixing portion 110, causing the surrounding area of the pressing position to be recessed inward 201 to form a pit. The recess 201 of the atrial appendage inner wall 200 near the protrusion 202 is farther away from the surface of the fixing portion 210, so that the contact between the conventional fixing portion 210 and the atrial appendage inner wall 200 after implantation is more point and surface contact, with a small actual contact area, which is far smaller than the contact area of the fixing portion 110 of this embodiment. Because the shape of the atrial appendage inner wall 200 varies from person to person, this embodiment can achieve better results, especially when the atrial appendage inner wall has a more obvious recess 201 or protrusion 202.
[0043] It should be noted that the shape of the atrial appendage inner wall 200 shown in the figure is for illustration only. In fact, due to the distribution of the pectinate muscles on the atrial appendage inner wall 200, the protrusions 202 and recesses 201 on the atrial appendage inner wall 200 are more densely distributed, resulting in a significantly improved anchoring ability of this embodiment compared to the traditional woven structure with a nearly circular cross-section along the axis. It should be further noted that the abutment state formed by the edge area 112 and the recess 201 and / or groove 113 of the atrial appendage inner wall 200 and the protrusion 202 of the atrial appendage inner wall 200 of this embodiment can also play a limiting role as a whole, not only preventing the fixing part 110 from being damaged by rotation or detaching from the atrial appendage inner wall 200, but also forming a plurality of mutually clamped areas through abutment, thereby increasing the anchoring ability of the fixing part 110.
[0044] Therefore, under certain circumstances, the solution of this embodiment can eliminate the need for sharp anchor spikes and other sharp objects that may easily damage the inner wall 200 of the auricle.
[0045] In this embodiment, the edges of the proximal and distal ends of the fixing portion 110 are both converged and closed. The proximal end of the fixing portion 110 is converged and connected to the connector 130 , and the distal end of the fixing portion 110 is converged and connected to a steel sleeve.
[0046] In this embodiment, the proximal edge surface of the fixing portion 110 is located on the proximal side of the connector 130, so that the convergence of the fixing portion 110 at the connector 130 is from the proximal end toward the distal end and from the outside to the inside. When the edge area 112 of the fixing portion 110 is subjected to force, the edge area 112 is transmitted to the vicinity of the connector 130 after being subjected to force. The stress received by the connector 130 is inclined toward the distal end, so that the connector 130 tightens the sealing portion 120 to maintain the anchoring effect of the occluding device 100.
[0047] In another embodiment, the distal edge of the fixing portion 110 is open, and the proximal end is entirely closed.
[0048] In another embodiment, the proximal edge of the fixing portion 110 is open, and the distal end is entirely closed.
[0049] In this embodiment, in order to achieve a good anchoring effect, the number of edge regions 112 in the fixing portion 110 is no less than 4, and preferably 6 in most cases, that is, the number of edge regions 112 is between 4 and 6 as a whole.
[0050] Example 2
[0051] Objectively speaking, the more edge regions the fixing portion has, the tighter the connection with the inner wall of the atrial appendage, and the greater the number of grooves. The deeper the grooves in the fixing portion, that is, the farther the grooves are from the outer side of the edge regions, the more atrial appendage shapes can be accommodated. In combination with the above-mentioned designs, Example 1 tends to use more edge regions and deeper grooves, but this also results in an increase in the overall surface area, a decrease in the ability to adapt to atrial appendage contraction, and a significant increase in the difficulty of sheathing. The difference between this embodiment and Example 1 is that the shape of the fixing portion of this embodiment has been further improved.
[0052] Therefore, a special shape of the fixing portion is designed in this embodiment. Referring to FIG6 , FIG6 is a schematic top view from the distal end to the proximal end of the blocking device in Example 2 of the present invention, as follows:
[0053] In this embodiment, the cross-sectional shape of the central area 311 of the fixing portion 310 is still approximately circular, and multiple edge areas 312 extend outward from its root in a clockwise or counterclockwise direction, so that the edge areas 312 of the entire fixing portion 310 are inclined and radial in the axial cross-section. When the fixing portion 310 is sheathed, the edge areas 312 can overlap with each other and be stored. Compared with the non-unidirectional tilted setting, the design of this embodiment can make the edge areas 312 overlap along the preset tilt direction and thus deform into a smaller volume.
[0054] Therefore, since the shape of the edge area 312 is not limited, in order to achieve the overlapping of each edge area 312 in the same direction when the sheath is retracted, this embodiment further defines the inclination. The edge area 312 includes a wing portion 3111 extending toward the outside, and the adjacent two side surfaces 3112 included between adjacent wings 3111. On the cross section of the axis of the fixing portion 310, the curvature of the two side surfaces 3112 between adjacent wings 3111 is the same positive or the same negative, that is, the two side surfaces 3112 between adjacent wings 3111 generally extend in the same direction.
[0055] Similarly, since the shape of the edge region 312 is not limited, grooves 3113 may form between adjacent wings 3111. The grooves 3113 or other shape changes may cause their radial bottoms to be closer to or further away from the axis, thereby blurring the boundary of the center region 311. In this embodiment, the boundary of the center region 311 is defined by the grooves 3113. In other words, the center region 311 is a cylindrical region centered on the axis and formed with the shortest distance from all grooves 3113 to the axis as the radius. In other words, the center region 311 is a cylinder centered on the axis and with the position of the fixing portion 110 closest to the axis as the dividing point. On this basis, the area outside the center region 311 belongs to the edge region 312, and the wings 3111 refer to the portion of the edge region 312 that clearly protrudes outward, and a single wing 3111 corresponds to a single edge region 312.
[0056] In addition to having good flexibility when entering the sheath, after the implantation is completed, since the volume of the atrial appendage will shrink to a smaller volume along with the heart, based on the contraction process of the heart, the design of this embodiment can also enable the fixing portion 310 to shrink to a small volume, thereby adapting to left atrial appendages of different sizes, and there will be no adjacent edge areas 312 approaching and abutting in opposite directions, thereby causing mutual influence and resulting in obstruction of contraction, and local stress concentration causing damage to the atrial appendage.
[0057] In another embodiment, the cross-sectional shape of the central region 311 of the fixing portion 310 is approximately circular, and a plurality of edge regions 312 extend outward in a clockwise direction from the root thereof in a direction from the distal end to the proximal end.
[0058] In another embodiment, the cross-sectional shape of the central region 311 of the fixing portion 310 is still approximately circular, and a plurality of edge regions 312 extend counterclockwise outward from the root thereof in the direction from the distal end to the proximal end.
[0059] In this embodiment, it should also be noted that there is a significant spacing between the wings 3111, which allows for more deformation margin, facilitating the overall insertion of the fixing portion 310 into the sheath. Therefore, to ensure smooth insertion into the sheath, in the cross section of the fixing portion 310, the radial centerline 315 of the edge region 312 is defined as a virtual circle extending from the radial midpoint of the edge region 312, with the radial centerline 315 of the edge region 312 serving as the dividing line. On the side of the edge region 312 closer to the axis (i.e., the inner side) along the radial centerline 315, the maximum spacing between adjacent wings 3111 is less than the maximum circumferential width of the two adjacent wings 3111. A design of wings 3111 that meets this condition is referred to as a spacing design. Thus, under this spacing design, when a single wing 3111 is deformed by significant compression, it can bridge the gap between adjacent wings, thereby being supported by the adjacent wings 3111, thereby ensuring the support strength of the entire fixing portion 310.
[0060] In another embodiment, further, in the side of the edge region 312 close to the axis along the radial center line 315 (ie, the inner side), the maximum spacing distance between adjacent wings 3111 is less than the maximum circumferential width of any wing 3111 among all the wings 3111 .
[0061] It should be noted that this effect can only be achieved when the fixing portion 310 forms obvious wings 3111 and there is a clear gap between adjacent wings 3111. In this embodiment, looking at the fixing portion 310 as a whole, the distance that the wings 3111 extend radially is at least more than 1 / 3 of the radius of the fixing portion 310 as a whole. This situation is regarded as the obvious wings 3111 in the above description. The setting of the inconspicuous wings will cause the deformation of the wings to be directly transferred to the root position of the wings after deformation, and the wings themselves will not be supported by the adjacent wings based on the deformation of the wings. That is, the wings directly under pressure cannot deform and cross the gap to be supported by the adjacent wings 3111. In summary, only when the obvious wings 3111 are set, the design of the fixing portion 310 has the above-mentioned support effect.
[0062] Example 3
[0063] In this embodiment, based on risk control of the implant, in order to further enhance the anti-displacement purpose, an additional anchor 410 may be provided on the wing 3111.
[0064] 7-8 , FIG. 7 is a schematic structural diagram of the fixing portion of the blocking device in Example 3 of the present invention, and FIG. 8 is a schematic top view of the fixing portion of the blocking device in Example 3 of the present invention from the distal end to the proximal end.
[0065] In this embodiment, the anchor 410 is not part of the fixing portion 310. In other words, the anchor 410 is neither formed directly on the main body of the fixing portion 310 nor extended from a portion of the main body, nor is it rigidly fixed to the fixing portion 310 by welding or other means. In this embodiment, the anchor 410 is fixed to the fixing portion 310 by binding with flexible members (such as sutures). In this embodiment, the anchor 410 is fixed to the outside of the wing 3111, leaving the free end of the anchor 410 exposed and extending obliquely so that it can be inserted into a predetermined position for anchoring.
[0066] In another embodiment, the hook 420 of the anchor 410 passes through the skeleton of the wing 3111 from the inside to the outside, so that the free end of the anchor 410 is exposed and extends obliquely, so that it can penetrate into a predetermined position to achieve anchoring.
[0067] In this embodiment, the anchor 410 includes hooks 420 arranged in pairs, namely hooks 411 and hooks 412. Generally speaking, the hooks 420 extend from the rods 421 (additional hooks can also be fixed to the rods 421). Therefore, the anchor 410 also includes rods 421 arranged in pairs, and a group of rods 421 are connected by at least one rod 422. It should be noted that in addition to playing a basic connecting role, the rods 422 can also share the force exerted on the pair of hooks 420. On the one hand, this avoids excessive stress on the implantation position caused by the hooks 420, and on the other hand, after the stress is shared to the hooks 420 at two different positions, the two hooks 420 are equivalent to pulling each other, thereby forming a mutual clamping state similar to a "clip". When the insertion depth remains unchanged, the anchor 410 arranged in this way has a better anchoring effect.
[0068] Referring to Figure 9, Figure 9 is a schematic diagram of the structure of various optional anchors in Example 3 of the present invention. In this embodiment, multiple anchors 410 can be selected or combined. Generally, a symmetrically distributed, substantially V-shaped anchor 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 fixed portion of the occlusion device. Alternatively, a design in which the first hook 411b and the second hook 412b of the anchor 410b are located at different heights can be used. In this design, the first hook 411b and the second hook 412b of the anchor 410b are located at different heights. At different axial positions of the fixing part of the blocking device, the first hook 411b is located on the distal side of the second hook 412b. A design in which the first hook 411c and the second hook 412c of the anchor 410c in the figure have different heights and different extension directions can also be adopted. In this design, the first hook 411c and the second hook 412c of the anchor 410c are located at different axial positions of the fixing part of the blocking device, the first hook 411c is located on the distal side of the second hook 412c, and the first hook 411c and the second hook 412c have different extension directions.
[0069] Based on this embodiment, when the extension directions of the first hook 411 and the second hook 412 are different, the anchor 410 can contact the anchor position in multiple directions, so that anchoring can be achieved more stably. It should be noted that this function can only be achieved by setting the anchor 410 at the peripheral position of the wing 3111, because the wing 3111 itself can extend into the inner side of the pectinate muscle. The fixing portion of the traditional occluding device is a complete circular surface, which cannot extend into and fit the interior of the pectinate muscle well, resulting in the fixing portion of the traditional occluding device always directly contacting the outer surface of the pectinate muscle. Since it cannot extend into or get stuck in the pectinate muscle, the corresponding anchor of the traditional occluding device can only be set along a specific direction. Theoretically, if the traditional occluding device is directly set to anchor along different directions, at this time, because the fixing portion of the traditional occluding device expands roughly in the circumferential direction and fits closely to part of the pectinate muscle after being released, the anchor set in the non-circumferential direction cannot penetrate well. In other words, the fixing portion of the traditional occluding device adopts the design of the hook 420 with different extension directions of this embodiment, and cannot achieve a good anchoring effect.
[0070] In another embodiment, referring to Figures 10-11, Figure 10 is a schematic diagram of the structure of the blocking device in this embodiment, and Figure 11 is a schematic diagram of the top view of the blocking device from the distal end to the proximal end in this embodiment. At least two anchors 410 are provided on one wing 3111, and the two anchors 410 do not completely overlap in the circumferential direction, so that the two can complement each other. In other words, hooks 420 are distributed at multiple positions on a single wing 3111, so as to ensure that each wing 3111 can achieve anchoring. In this embodiment, it should also be noted that since the outer edge of the wing 3111 gradually converges toward the axis, adjacent anchors 410 will not be on the same circumferential surface as a whole, further realizing that the hooks 420 of the anchors 410 are fixed to the same circumferential surface.
[0071] Preferably, on the same wing 3111, in two adjacent anchors 410, the first hook 411 is located on the distal side of the second hook 412, and the first hook 411 is adjacent to the first hook of the adjacent anchor 410, so that the area of the entire fixing part that plays an anchoring role is distributed in high and low, thereby having a better anchoring effect.
[0072] 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.
[0073] It should also be noted that the above embodiment does not exclude the technical solution of adding anchor spikes. In order to meet specific circumstances, the above embodiment can provide anchor spikes as needed.
[0074] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.
Claims
1. A blocking device, comprising a fixing portion and a sealing portion, wherein the fixing portion comprises a mesh woven structure, characterized in that: The fixing portion includes a central area and a plurality of edge areas distributed circumferentially around the central area and extending radially outward, and two adjacent edge areas include grooves.
2. The blocking device according to claim 1, characterized in that: The proximal end and the distal end of the fixing part are both contracted and closed.
3. The blocking device according to claim 1, characterized in that: The edge area includes wing portions extending outward, and two adjacent side surfaces are included between adjacent wing portions. On the same cross section, the two side surfaces between adjacent wing portions extend obliquely in the same direction.
4. The blocking device according to claim 1, characterized in that: The number of the edge regions of the fixing portion is between four and six.
5. The blocking device according to claim 1, characterized in that: The plurality of edge regions of the fixing portion are inclined and radial in an axial cross section.
6. The blocking device according to claim 1, characterized in that: The plurality of edge regions of the fixing portion extend outwardly in a clockwise direction from a root portion, or the plurality of edge regions extend outwardly in a counterclockwise direction from a root portion.
7. The blocking device according to claim 3, characterized in that: With the radial center line of the edge zone as a dividing line, on the inner side of the edge zone along the radial center line, the maximum distance between adjacent wing portions is smaller than the maximum circumferential width of adjacent wing portions.
8. The blocking device according to claim 7, characterized in that: With the radial center line of the edge zone as a dividing line, on the inner side of the edge zone along the radial center line, the maximum distance between adjacent wing portions is less than the maximum circumferential width of any wing portion.
9. The blocking device according to claim 1, characterized in that: The fixing part is provided with an anchoring member, which is bound to the fixing part through a flexible member, and the free end of the anchoring member is exposed.
10. The blocking device according to claim 9, characterized in that: The anchoring member includes two connected first hooks and a second hook, wherein the first hook is located at a distal end side of the second hook.
Citation Information
Patent Citations
Medical implantable occlusion device, and method for implantation thereof
CN103945774A
Expandable occlusion devices and methods of use
CN104039246A
A left auricle occluding device
CN104958087A
Left aurcle plugging device
CN105662516A
Systems and methods for embolization of body structures
CN110944587A
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