Plugging device

Abstract

The utility model relates to the technical field of medical instruments, and discloses a plugging device which mainly comprises a first supporting net capable of shrinking in the radial direction. When the supporting net is in a natural state, the peripheral face of the middle of the supporting net is bent outwards to form a main body cambered surface outline adaptive to the outline of the left auricle, and the end faces of the two sides of the supporting net are bent inwards to form end cambered surface outlines, so that the plugging device is matched with a left auricle opening more easily in the implanting process, the problem that the plugging device is prone to displacement is effectively solved, and the plugging effect is improved. The safety and the success rate of the operation are improved; meanwhile, the end cambered surface outline of the near end of the first supporting net is gradually smooth in the implanting process to form a roughly planar structure, obvious protruding or sinking is avoided, the first supporting net can be smoothly connected with the inner wall of the implanting position, and the possibility of generating instrument-related thrombus is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and further to an occluder. Background Art

[0002] Atrial fibrillation (AF) is a common and serious heart rhythm disorder that not only increases the risk of death but can also lead to multiple complications, including stroke, heart failure, cognitive impairment, and dementia, seriously threatening patients' health and quality of life. With the accelerated aging of the population, the prevalence of AF is on the rise, placing unprecedented pressure on the healthcare system.

[0003] Although percutaneous left atrial appendage closure (LAAC) provides an effective minimally invasive surgical option for preventing stroke caused by atrial fibrillation, existing technologies still face some challenges. For example, many existing occluders are difficult to achieve an ideal match with the left atrial appendage orifice, resulting in the risk of the occluder falling off or being difficult to successfully implant into place after implantation. Summary of the Invention

[0004] In response to the above technical problems, the purpose of this application is to provide an occluder that aims to solve the related problems in the existing technology, so that the occluder can adapt to the shape of the left atrial appendage opening more naturally during implantation, reduce the risk of falling off, and improve the success rate and stability of implantation.

[0005] The present application provides an occluder, comprising:

[0006] a radially shrinkable first support mesh, the first support mesh being woven by a plurality of braided wires;

[0007] In a natural state, the central circumference of the first support net is bent outward along its circumference to form a main body arc surface profile, and the two side end surfaces of the first support net are bent inward to form the same or different end arc surface profiles.

[0008] Optionally, the main body arc surface profile is divided into a middle section and two edge sections located at both ends of the middle section along the central axis of the first supporting net, and the curvature of the middle section is smaller than the curvature of any of the edge sections.

[0009] Optionally, the curvature of any of the edge segments is 2-10 times the curvature of the middle segment.

[0010] Optionally, the arc length of the middle segment is 3-7 times the arc length of any edge segment.

[0011] Optionally, the proximal end of the first supporting net is converged by a first converging element, and the distal end of the first supporting net is converged by a second converging element.

[0012] Optionally, a concave first space is formed at the proximal end of the first supporting net, a concave second space is formed at the distal end of the first supporting net, the first bundling element is located or partially located in the first space, and the second bundling element is located or partially located in the second space;

[0013] During the implantation of the occluder, the central circumference of the first support mesh is compressed, so that the volume of the first space and / or the second space is reduced, and the proximal end surface of the first support mesh is transformed from the end arc surface profile to a plane-like profile.

[0014] Optionally, the plurality of braided wires include a plurality of first braided wires and a plurality of second braided wires, the number of the first braided wires is greater than the number of the second braided wires, and the radial size of the second braided wires is greater than the radial size of the first braided wires.

[0015] Optionally, the occluder further includes a second supporting mesh, which is located inside the first supporting mesh, and the second supporting mesh and the first supporting mesh are directly or indirectly closely attached to each other to form a composite supporting mesh structure.

[0016] Optionally, the occluder further includes an anchoring structure, and the anchoring structure is provided on the outer wall of the first supporting net.

[0017] Optionally, the anchoring structure has a plurality of;

[0018] The plurality of anchoring structures are respectively distributed on both sides of the radial midline of the first supporting net; or, the plurality of anchoring structures are arranged between the radial midline of the first supporting net and its distal end.

[0019] The above occluder adopts the middle circumference of the first support mesh to bend outward along its circumference to form a main body arc surface contour, so that the occluder is better supported in the implantation position without displacement, and the deformation and collapse of the first support mesh are avoided, thereby enhancing the stability and adaptability of the occluder. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The following is a brief description of the drawings used in describing the embodiments of this application:

[0021] Figure 1 This is a schematic diagram of a treatment application scenario used in an embodiment of the present application;

[0022] Figure 2 This is a schematic structural diagram of an occluder provided in an embodiment of the present application;

[0023] Figure 3 and Figure 4 This is a schematic structural diagram of another occluder provided in an embodiment of the present application in different states;

[0024] Figure 5 is a schematic diagram of a braiding method of braided wire provided in an embodiment of the present application;

[0025] Figure 6 is a schematic cross-sectional view of a braided yarn provided in an embodiment of the present application;

[0026] Figure 7 is a schematic cross-sectional view of another braided yarn provided in an embodiment of the present application;

[0027] Figure 8 This is a partial structural diagram of an occluder provided in an embodiment of the present application;

[0028] Figure 9 This is a partial structural diagram of another occluder provided in an embodiment of the present application;

[0029] Figure 10 This is a partial cross-sectional view of an occluder provided in an embodiment of the present application;

[0030] Figure 11 It is a schematic diagram of the partial structure of an occluder provided in an embodiment of the present application.

[0031] Explanation of the accompanying drawings: 10, first supporting mesh; 100, braided wire; 101, first braided wire; 102, second braided wire; 110, first space; 111, flow blocking portion; 120, second space; 130, first converging element; 140, second converging element; 150, middle section; 160, edge section; 20, second supporting mesh; 201, third braided wire; 301, anchoring structure; 40, flow blocking layer; 401, first flow blocking layer; 402, second flow blocking layer; 4021, first section; 4022, second section; 41, suture;

[0032] 501. Aorta; 502. Aortic valve; 503. Left ventricle; 504. Left atrium; 505. Mitral valve; 506. Left atrial appendage; 507. Right ventricle; 508. Right atrium; 509. Tricuspid valve; 510. Atrial septum; 511. Superior vena cava; 512. Inferior vena cava. DETAILED DESCRIPTION

[0033] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without inventive work.

[0034] To simplify the drawings, only the portions relevant to the application are schematically depicted in each figure; they do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one component with the same structure or function is schematically depicted or labeled. In this document, "one" not only means "only one" but also "more than one."

[0035] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0036] It should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0037] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0038] In the embodiments of the present application, "proximal" and "distal" are used to describe the position or direction of the associated (or described) object (hereinafter referred to as the associated object) relative to the operator from the perspective of the operator (e.g., a physician or surgeon). For example, the "proximal" refers to the end of a medical device that is close to the operator during normal operation of the medical device; the "distal" refers to the end that is away from the operator during normal operation of the medical device, or the end that first enters the patient's body. For example, the "proximal" end of A refers to the end of A that is close to the operator; the "distal" end of A refers to the end of A that is away from the operator. Alternatively, the "proximal" end of A refers to the end of A that is away from the patient (or the affected area, or the location where the occluder is implanted); the "distal" end of A refers to the end of A that is close to the patient (or the affected area, or the location where the occluder is implanted).

[0039] Atrial fibrillation (AF) is a common clinical arrhythmia, the prevalence of which increases significantly with age. AF not only increases a patient's risk of death but can also lead to a range of serious complications, including stroke, heart failure, cognitive impairment, and dementia, severely threatening their quality of life and health. With the accelerating aging of the global population, the prevalence of AF is expected to continue to rise, posing unprecedented challenges to healthcare systems.

[0040] See also Figure 1 The heart is a hollow, muscular organ with four chambers: the left atrium 504, the left ventricle 503, the right atrium 508, and the right ventricle 507. Each of the heart's four chambers is connected to different blood vessels. The left ventricle 503 connects to the aorta 501, the opening of which is located above and to the right of the left atrioventricular opening, with a semilunar aortic valve 502 attached to its edge. The left atrium 504 connects to the pulmonary veins, the right ventricle 507 connects to the pulmonary artery, and the right atrium 508 connects to the superior vena cava 511 and the inferior vena cava 512. The left atrium 504 and right atrium 508 are separated by the atrial septum 510. The protruding portion of the front of the left atrium 504 to the right is the left atrial appendage 506. The left ventricle 503 and right ventricle 507 are separated by the ventricular septum. Between the atria and ventricles are atrioventricular valves (hereafter referred to as valves). During ventricular diastole, the valves open, allowing blood to flow from the atria into the ventricles. During ventricular systole, the valves close, preventing blood from flowing back into the atria. The valve between the left atrium 504 and the left ventricle 503 is the mitral valve 505, and the valve between the right atrium 508 and the right ventricle 507 is the tricuspid valve 509.

[0041] Theoretically, through left atrial appendage occlusion surgery, an interventional surgical method is used to puncture the femoral vein, and the occluder is delivered through the femoral vein to the landing area in the left atrial appendage 506, and then deployed to block the left atrial appendage 506. This can prevent the thrombus formed in the left atrial appendage 506 from dislodging and forming an embolism, and can reduce the chance of atrial fibrillation embolism by at least 90%.

[0042] Currently, existing occluder designs often ignore the complex geometry of the left atrial appendage 506 and the dynamic changes of the left atrial appendage 506 during heartbeat. This may result in the occluder not fitting tightly to the left atrial appendage 506 after implantation, increasing the risk of postoperative occluder migration or thrombosis.

[0043] Based on the problems in the existing technology, the occluder provided in this application can improve the matching degree between the occluder and the left atrial appendage orifice, and by optimizing the shape of the supporting mesh, enhance the stability and adaptability of the occluder, reduce the risk of vascular damage during implantation, and provide a safer and more effective treatment option for patients with atrial fibrillation.

[0044] The design of the first support net part in this application is described below with reference to the accompanying drawings:

[0045] Please refer to the instruction manual Figure 2 The occluder includes a first radially shrinkable support mesh 10.

[0046] Among them, the central circumferential surface of the first support mesh 10 is bent outward along its circumference to form a main arc surface contour so as to naturally fit the anatomical structure of the left atrial appendage opening. This setting not only optimizes the implantation process of the occluder, but also significantly improves the matching degree between the occluder and the left atrial appendage opening, thereby reducing the risk of postoperative displacement and thrombosis.

[0047] At the same time, the end faces on both sides (proximal end and distal end) of the first support mesh 10 are bent inward to form the same or different end arc surface profiles, and the end arc surface profile facing the proximal end can be used to enhance the flow blocking effect of the occluder, effectively blocking the blood flow into the left atrial appendage 506, and reducing the risk of thrombosis.

[0048] Based on the above content, the proximal end of the first support mesh 10 is formed with a concave first space 110, and the distal end of the first support mesh 10 is formed with a concave second space 120. During the implantation of the occluder, the circumference of the first support mesh 10 is radially compressed by the anatomical structure of the left atrial appendage 506. Figures 3 and 4 During the transformation process, the volume of the first space 110 and the second space 120 gradually decreases during the deployment of the occluder, causing the proximal end of the first support mesh 10 to change from its previous curved profile to a smoother profile. The proximal end of the first support mesh 10 can adapt to the shape of the left atrial appendage orifice, forming a roughly planar structure, avoiding obvious protrusions or depressions, allowing it to smoothly connect with the inner wall of the implantation site, reducing the possibility of device-related thrombosis. During the implantation process, the distal end of the first support mesh 10 generally also changes from its previous curved profile to a smoother profile. However, the opening of the second space 120 is facing the distal end, so it does not play a major role in flow obstruction.

[0049] The smooth proximal end of the first support mesh 10 facilitates the endothelialization process of the device, as endothelial cells grow more easily on a smooth surface. Furthermore, the smooth surface reduces the likelihood of blood stagnation, thereby reducing the risk of device-related thrombosis. Furthermore, the design of this occluder also takes into account the needs of one-stop ablation procedures such as circumferential pulmonary vein isolation and / or left atrial appendage isolation. Because the occluder can be stably implanted without the need for re-puncture or establishment of a new delivery channel, the efficiency and safety of the procedure are greatly improved.

[0050] In one embodiment, the main curved surface profile formed by the central circumference of the first support net 10 is subdivided into three parts along the central axis of the first support net 10 : a middle section 150 and two edge sections 160 .

[0051] In particular, the middle segment 150 has a smaller curvature, while the two edge segments 160 have a larger curvature, and the curvature of the middle segment 150 is smaller than the curvature of any edge segment 160, so that the occluder can achieve a smoother and more uniform fit in the middle area of the left atrial appendage orifice, reducing the pressure on the endocardium or stimulation of the heart tissue. At the same time, the larger curvature of the edge segment 160 helps the occluder adapt to the form and shape at the entrance and exit of the left atrial appendage orifice, and helps to form a more effective blood flow blockage, because the edge segment 160 can fit the opening of the left atrial appendage 506 more closely, reducing the possibility of blood flowing into the left atrial appendage 506, so as to ensure the sealing of the occluder; at the same time, the larger curvature means that the edge segment 160 is easier to form a mechanical interlock with the unevenness of the left atrial appendage orifice, which to a certain extent enhances the anti-displacement ability and stability of the occluder, and effectively prevents the displacement of the occluder caused by heart contraction and blood flow.

[0052] Alternatively, the curvature of any edge segment 160 is approximately 2-10 times that of the middle segment 150, thereby increasing the anchoring capability of the edge segment 160 while maintaining the flexibility and adaptability of the occluder. The arc length of the middle segment 150 is approximately 3-7 times that of any edge segment 160, thereby ensuring sufficient coverage of the occluder in the middle of the left atrial appendage 506 while allowing the edge segment 160 to form a tight seal at the entrance and exit of the left atrial appendage 506.

[0053] The occluder is also provided with a first converging element 130 and a second converging element 140. The first converging element 130 is located in or partially located in the first space 110 and is used to converging the proximal end of the first support mesh 10 to ensure a tight fit and stability of the occluder at the entrance of the left atrial appendage 506. The second converging element 140 is located in or partially located in the second space 120 and is used to converging the distal end of the first support mesh 10 to adapt to the distal anatomical structure of the left atrial appendage 506 while providing the necessary fixing force. By adjusting the converging element, the radial dimension of the occluder can be controlled and adjusted to adapt to the morphology of the left atrial appendage 506 of different patients.

[0054] For further information, please refer to the attached manual. Figures 3 to 5 , which is a schematic structural diagram of another occluder provided in an embodiment of the present application. The core improvement of this occluder lies in the braiding structure of the first support mesh 10. By using a specific number and radial size of braided wires 100 for weaving, a certain angle is set between the intersecting braided wires 100, which helps to increase the contact area and friction between the braided wires 100. The occluder can remain stable when impacted by blood flow and is not prone to displacement or deformation, thereby improving the overall stability and durability of the occluder. On the other hand, it also helps to improve the biocompatibility of the occluder. Since the angle between the braided wires 100 can provide a larger surface area, this is conducive to tissue growth and endothelialization, thereby reducing inflammatory reactions and improving patient comfort.

[0055] More specifically, the occluder includes multiple first braided wires 101 and multiple second braided wires 102, wherein the number of first braided wires 101 is greater than that of second braided wires 102, and the radial size of the second braided wires 102 is greater than that of the first braided wires 101, so that the first support mesh 10 can form a denser braided structure while maintaining a certain structural strength, thereby improving the flow blocking effect.

[0056] Due to the special structural shape of the left atrial appendage 506, the occluder must be able to provide sufficient radial support force to ensure that it can closely fit the inner wall of the left atrial appendage 506 after implantation, prevent thrombus from falling off and effectively seal the left atrial appendage 506.

[0057] In this embodiment, the first braided wire 101 primarily forms the overall contour of the occluder, providing the necessary support and stability. The second braided wire 102 primarily provides radial support, and its radial dimensions are no smaller than those of the first braided wire 101, ensuring that the occluder adheres closely to the inner wall of the left atrial appendage 506 after implantation. This design not only helps prevent displacement or deformation of the occluder but also effectively reduces the possibility of thrombus dislodgement, thereby reducing the risk of stroke.

[0058] At the same time, by optimizing the structure and material selection of the braided wire 100 , it is possible to ensure that the occluder can provide a stable and lasting radial support force after implantation, thereby achieving effective occlusion of the left atrial appendage 506 .

[0059] The braiding method between the braided wires 100 can also have various forms, which can be referred to in the attached Figure 5 In this embodiment, the braided wires 100 are arranged in a manner that adjacent opposing braided wires 100 cross each other in sequence to form a solid support mesh. This cross-weaving form not only enhances the structural integrity of the support mesh, but also provides the flexibility and adaptability required for the support mesh.

[0060] Specifically, one of the weaving methods is a single alternating cross weaving method, in which each braided wire 100 alternately crosses above and below the opposite single braided wire 100 to form a uniform and regular grid structure. This weaving method is more suitable for areas on the first support mesh 10 that require uniform coverage or moderate flow obstruction, such as areas on the occluder that require better flexibility and adaptability; there is also a weaving method that is a multiple alternating cross weaving form, in which each braided wire 100 alternately crosses above and below with at least two opposite braided wires 100, increasing the crossing density of the braided wire 100, so that the first support mesh 10 can form a denser structure in a specific area, further improving the flow obstruction effect and support force. Of course, there are other weaving methods in other embodiments. Although specific weaving methods are described in this specification, the scope of protection of the present utility model is not limited to these examples.

[0061] Furthermore, in order to optimize the effect of the above embodiment, the radial size of the number of the first braiding wires 101 and the second braiding wires 102 is further limited.

[0062] First, the radial size of the first braided wire 101 ranges from 0.025 mm to 0.250 mm, preferably from 0.050 mm to 0.125 mm. This thinner radial size helps to improve the flexibility and adaptability of the support mesh, enabling it to better fit the complex shape of the left atrial appendage 506 while reducing pressure on surrounding tissues.

[0063] In contrast to the first braided wire 101 , the radial dimension of the second braided wire 102 ranges from 0.075 mm to 0.750 mm, preferably from 0.100 mm to 0.400 mm. This thicker wire diameter provides the necessary structural strength and radial support force to ensure that the occluder remains stable under continuous pressure from the heart.

[0064] On the other hand, the number range of the first braided wires 101 and the second braided wires 102 also needs to be specifically set and selected. The number of first braided wires 101 ranges from 48 to 480, with a preferred number being 72 to 216. Increasing the number of first braided wires 101 can improve the overall coverage and flexibility of the support mesh, help more evenly distribute the stress points of the support mesh, and reduce local stress concentration.

[0065] In contrast, the number of second braided wires 102 ranges from 2 to 20, with a preferred number being 6 to 16. Although the number of second braided wires 102 is relatively small, their thicker wire diameter provides key structural support points for the support mesh, helping to maintain the shape and stability of the occluder. However, since too many second braided wires 102 may increase the difficulty of implantation and the risk of thrombosis, while too few second braided wires 102 may not provide sufficient radial support, the number of second braided wires 102 should be comprehensively considered based on factors such as the overall size and specific performance of the occluder.

[0066] More preferably, based on the above, the braided wires 100 (first and second braided wires 101, 102) are woven together to form a flow blocking portion 111 on the first support mesh 10. This flow blocking portion 111 is a key component of the occluder, responsible for achieving its primary function—blocking blood flow into the left atrial appendage 506, thereby preventing thrombus formation. Here, the flow blocking portion 111 woven on the first support mesh 10 can be evenly distributed across the entire mesh surface, providing a consistent blood flow blocking effect and ensuring that the entire surface of the occluder effectively blocks blood flow into the left atrial appendage 506.

[0067] The flow blocking portion 111 in this embodiment achieves a better flow blocking effect by increasing the coverage area of the braided wires in the first support mesh 10. Increasing the coverage area can be achieved by increasing the number of braided wires, adjusting the diameter of the braided wires, or changing the braiding pattern. For example, the density of the braided wires 100 in the flow blocking portion 111 is higher than the density of the braided wires 100 in other areas of the first support mesh 10. This high-density braiding forms a tight mesh structure in the flow blocking portion 111, providing stronger flow blocking capabilities and ensuring that blood cannot flow into the left atrial appendage 506 through the gaps between the braided wires 100.

[0068] In some embodiments, the blocking portion 111 can be specifically arranged at a local position of the first support mesh 10, such as the proximal end of the first support mesh 10, to adapt to the anatomical characteristics of the left atrial appendage 506. This locally enhanced blocking effect helps to form a more effective blood flow blockage at the entrance of the left atrial appendage 506 and reduce blood retention.

[0069] Specifically, if Figure 3 and Figure 4As shown, the flow blocking portion 111 is located at the proximal end of the first support mesh 10, i.e., near the opening of the left atrial appendage 506, so that the flow blocking portion 111 can directly face the blood flow and impact, effectively intercepting blood that may enter the left atrial appendage 506. More importantly, the density of the braided wires 100 in the flow blocking portion 111 is higher than the density of the braided wires 100 in other areas of the first support mesh 10. This high-density weaving forms a tight mesh structure in the flow blocking portion 111, providing stronger flow blocking ability, ensuring that blood cannot flow into the left atrial appendage 506 through the gaps between the braided wires 100.

[0070] In the flow-blocking portion 111, a mixed weaving of the first braided wire 101 and the second braided wire 102 can also be used at the same time. The density of the first braided wire 101 is relatively high, which helps to increase the overall stiffness and stability of the flow-blocking portion 111; and the radial dimension of the second braided wire 102 is relatively large, so that the second braided wire 102 can provide stronger support for the flow-blocking portion 111, making the structure of the flow-blocking portion 111 more stable and firm, and then by combining the advantages of the two braided wires 100, the mixed weaving can improve the overall strength and stiffness of the flow-blocking portion 111, so that it can better resist the impact force from the blood after implantation.

[0071] Furthermore, this mixed braiding method can adjust the material composition of the braided wire 100 as needed to ensure that the flow-blocking portion 111 has good biocompatibility and safety, which helps to reduce possible complications after implantation, such as inflammatory reactions, thrombosis, etc. At the same time, based on the above content, it can be seen that the second braided wire 102 provides a strong radial support force due to its larger radial size, ensuring that after the occluder is implanted, the outer peripheral surface of the first support mesh 10 will not bend inward due to pressure, so that the volume of the first space 110 and / or the second space 120 shrinks, and the radial support force provided by the braided wire 100 work together to keep the occluder stable at the implantation position, reducing the risk of displacement.

[0072] In one embodiment, the reference Figure 6 and Figure 7 The cross-sectional shape of the braided wire 100 is elliptical or quasi-elliptical. The elliptical or quasi-elliptical cross-sectional shape increases the area of the braided wire 100 in contact with blood. This means that under the same blood flow velocity and pressure, the braided wire 100 with an elliptical or quasi-elliptical cross-sectional shape can provide greater resistance, thereby more effectively blocking blood flow and improving the flow-blocking effect of the occluder.

[0073] In this embodiment, the braided wire 100 with this cross-sectional design, due to its unique geometric properties, can improve the support performance and deformability of the occluder without adjusting the number of braided wires 100. Specifically, the long radius or width side of the elliptical or quasi-elliptical braided wire is used to form the circumference of the first support mesh 10, thereby maintaining structural integrity while improving the coverage of the circumference. At the same time, because the width side of the elliptical or quasi-elliptical cross-section plays a dominant role in forming the circumference, the radial thickness of the first support mesh 10 is reduced.

[0074] Through this design in the present embodiment, the radial thickness of the first support mesh 10 can be greatly reduced, which directly reduces the mechanical stress of the occluder when passing through the delivery catheter, allowing the occluder to pass more easily through delivery catheters with smaller diameters, such as 10F and below catheters, thereby reducing the impact on human blood vessels. In addition, the increase in the circumferential coverage of the support mesh helps to reduce the retention of blood at the occluder position, thereby reducing the possibility of thrombosis.

[0075] Furthermore, in one embodiment, the braided wire 100 forming the proximal end of the first support mesh 10 can be an elliptical braided wire or a quasi-elliptical braided wire, and the bottom of the first space 110 extends along the long radius direction of the braided wire 100 forming the proximal end of the first support mesh 10.

[0076] First of all, it is necessary to explain that in the flow-blocking portion 111, the local flow-blocking capacity is enhanced by increasing the density of the braided wire 100, that is, the number of braided wires 100 per unit area. This design makes the blood flow encounter greater resistance when encountering the flow-blocking portion 111, thereby improving the blocking effect.

[0077] In this embodiment, the longer radius or width of the elliptical or quasi-elliptical braided wire provides a larger cross-sectional area, which naturally forms a larger coverage area when woven into a mesh. Therefore, even without increasing the number or density of the braided wires 100, this characteristic of the elliptical or quasi-elliptical braided wires helps to improve the flow resistance effect because they provide a wider physical barrier on the circumference.

[0078] In addition, as attached Figure 8 As shown, in some cases, relatively flat elliptical braided wires can be used to weave diamond-shaped pores similar to a grid on the first support mesh 10, so that the first support mesh 10 has better compressibility, and the first support mesh 10 can be flattened when it is completely contracted and enters the catheter, reducing the diameter requirement of the occluder for the catheter; at the same time, when the first support mesh 10 is unfolded, the bottom contour of the first space 110 can also be smoother, which helps the occluder to better adapt to the anatomical structure of the left atrial appendage 506, so as to promote the coverage and growth of endothelial cells, thereby accelerating the biological integration process of the occluder.

[0079] In other embodiments, the cross-sectional size range of the elliptical braided wire and the elliptical-like braided wire in this embodiment can be further limited. For example, when the cross-section of the braided wire 100 is elliptical, the long radius w of the elliptical braided wire is preferably in the range of 0.050 to 0.125 mm, and the short radius t is preferably in the range of 0.035 to 0.095 mm. This size ratio provides sufficient mechanical strength and flexibility for the braided wire 100, while reducing the radial pressure on the inner wall of the left atrial appendage 506. The larger size of the long radius helps to increase the circumferential coverage area, while the smaller size of the short radius ensures the radial compactness of the occluder, which work together to improve the occlusion efficiency and reduce interference with surrounding tissues.

[0080] When the cross-section of the braided wire 100 is elliptical, it may have a plane in its length direction, and the width w is preferably in the range of 0.050 to 0.125 mm, while the thickness t is preferably in the range of 0.025 to 0.085 mm. Generally speaking, the thickness of the elliptical braided wire is thinner, which allows the occluder to achieve a thinner radial thickness while maintaining appropriate radial strength, thereby reducing interference with the patient's body during implantation. In addition, since it may have a plane, it can provide a more suitable setting and fixing area for the anchoring structure 301 of the occluder, which helps to fix the occluder to the inner wall of the left atrial appendage 506 and improve the reliability of the occlusion.

[0081] It should also be noted that the cross-sectional setting of the braided wire 100 and the setting of the flow-blocking portion 111 in the above embodiment can be used in combination, that is, the two implementation methods of improving the flow-blocking effect, namely, adjusting the density of the braided wire 100 and adjusting the cross-sectional shape of the braided wire 100, can be used separately or in combination.

[0082] The following describes the relevant design of the anchoring structure part in the embodiment of the present application with reference to the accompanying drawings:

[0083] Refer to the instruction manual Figure 2 and Figure 4 The first support mesh 10 is provided with an anchoring structure 301, which interacts with the tissue characteristics of the left atrial appendage 506 to provide a stable fixation force, thereby improving the stability of the occluder after implantation and reducing the risk of displacement caused by heartbeats. The anchoring structure 301 may include barbs, thorns, or anchoring claws, which help grasp tissue and prevent the occluder from dislodging.

[0084] Among them, the anchoring structure 301 can be arranged between the distal end of the first support mesh 10 and its radial midline. This layout enables the anchoring structure 301 to cover a wide area from the distal end to the middle of the first support mesh 10, providing continuous fixing force, so that the occluder can fit more closely to the inner wall of the left atrial appendage 506, reducing the chance of blood flowing into the left atrial appendage 506.

[0085] In addition, the anchoring structures 301 can also be symmetrically arranged on both sides of the radial midline of the first support mesh 10 to ensure balanced fixation of the occluder in the left atrial appendage 506. The symmetrical distribution helps to evenly distribute the fixing force, avoid local excessive stretching or compression, and thus reduce the risk of damage to the inner wall of the left atrial appendage 506. More specifically, the distribution range of the anchoring structures 301 on each side occupies 1 / 4 to 1 / 3 of the axial length of the occluder. This distribution ratio ensures that the anchoring structures 301 are evenly covered along the entire length of the occluder, providing uniform fixing force while maintaining the necessary flexibility, thereby improving the adaptability and stability of the occluder.

[0086] Furthermore, the anchoring structure 301 is arranged on the second braided wire 102. According to the above content, the second braided wire 102 has a larger radial dimension than the first braided wire 101, so the anchoring structure 301 can use its larger radial dimension to provide a stronger anchoring force. At the same time, the larger radial dimension increases the surface area of the braided wire 100 in contact with the left atrial appendage 506 tissue, which helps to improve the stability and fixing force of the anchoring structure 301.

[0087] It should be noted that the anchoring structure 301 can be combined with the second braided wire 102 in an integrally formed or split-formed manner.

[0088] In the one-piece molding method, the anchoring structure 301 and the second braided wire 102 are formed simultaneously during the manufacturing process as a continuous single component. The advantage of this molding method is that it can ensure a seamless connection between the anchoring structure 301 and the braided wire 100, providing higher structural stability and consistency.

[0089] Based on the above, one forming method is to locally arrange microplanes on the second braided wire 102, and then form the anchoring structure 301 through a cutting and shaping process. In addition, one or more anchoring structures 301 can be formed on a single second braided wire 102 to enhance the fixation ability and adaptability of the occluder according to needs. Specifically, the second braided wire 102 is provided with microplanes in specific areas. These microplanes are the starting points for the formation of the anchoring structure 301. By precisely controlling the position and size of the microplanes, the distribution and characteristics of the anchoring structure 301 can be customized. Based on the microplanes, the braided wire 100 is cut into a predetermined shape through a cutting process, and then the anchoring structure 301 is shaped into the desired form and size, such as a barb shape, through a shaping process.

[0090] Furthermore, when multiple anchoring structures 301 are designed on a single second braided wire 102, these structures can be arranged at regular intervals along the length direction to achieve optimal fixation. For second braided wires 102 that cross in opposite directions, adjacent anchoring structures 301 may appear. To prevent adjacent anchoring structures 301 from interlocking with each other, especially when the anchoring structures 301 are in the form of barbs, the free ends of the barbs are arranged to point in opposite directions or at a certain angle. This design ensures that the anchoring structures 301 do not interfere with each other when the occluder is deployed.

[0091] In the split molding method, the anchoring structure 301 and the second braided wire 102 are manufactured separately and then connected together through mechanical or chemical methods. This molding method provides greater design flexibility, allowing the anchoring structure 301 and the braided wire 100 to be optimized separately. After the split molding, assembly can be achieved in a variety of ways, including but not limited to welding, bonding, mechanical locking, or the use of connectors to ensure a secure connection between the two.

[0092] The following describes the relevant design of the second supporting net part in the embodiment of the present application with reference to the accompanying drawings:

[0093] like Figure 9 As shown, the second support mesh 20 is woven by the third braided wire 201 to form the inner layer structure of the occluder, while the first support mesh 10 is located at the outermost part of the occluder structure and is woven by the first braided wire 101 and the second braided wire 102 to form the outer contour and main support structure of the occluder. It not only carries the anchoring structure 301, but is also responsible for direct contact and fixation with the inner wall of the left atrial appendage 506. The two layers of support mesh can be directly or indirectly tightly attached to form a composite support mesh structure to improve the durability and adaptability of the occluder.

[0094] The radial dimensions of the third braided wire 201 forming the second support mesh 20 are generally smaller than the radial dimensions of the first braided wire 101 and the second braided wire 102 forming the first braided mesh. The smaller radial dimensions of the third braided wire 201 help to reduce the radial thickness of the occluder in the left atrial appendage 506, making it easier for the occluder to pass through the delivery catheter during implantation, while reducing the risk of damage to the blood vessels.

[0095] In addition, in the above embodiment, the preferred radial size range and number range of the first braided wire 101 and the second braided wire 102 have been given. In this embodiment, the radial size range of the third braided wire 201 is between 0.025 and 0.125 mm, so that the third braided wire 201 can maintain a smaller volume, thereby reducing the pressure on the inner wall of the left atrial appendage 506, and the preferred range can be between 0.050 and 0.09 mm. More specifically, the number of the third braided wire 201 ranges from 48 to 480, and the preferred range can be 96 to 192, ensuring the uniformity and stability of the second support mesh 20, while avoiding excessively increasing the radial thickness of the occluder, making it easier for the occluder to pass through the delivery catheter during implantation, while reducing the risk of damage to the blood vessel.

[0096] In one embodiment, the first support mesh 10 and the second support mesh 20 are staggered, that is, the two support meshes are not simply superimposed in spatial layout, but staggered to form a complementary grid structure, wherein the grid gaps of the second support mesh 20 are covered by the first support mesh 10.

[0097] Since the first support mesh 10 is woven from the first braided wire 101 and the second braided wire 102 with a larger radial dimension, its main function is to provide the radial support force required by the occluder to ensure that the occluder can be firmly fixed at the left atrial appendage opening; the second support mesh 20 is woven from the third braided wire 201 with a smaller radial dimension, and its main function is to cover the grid pores of the first support mesh 10. Through this staggered distribution arrangement between the support meshes, the second support mesh 20 effectively blocks the potential channel for blood flow through the first support mesh 10, thereby enhancing the sealing performance of the occluder.

[0098] More importantly, this double-layer structural design allows the first support mesh 10 to mainly provide the necessary support force, while the second support mesh 20 mainly functions to improve the blood flow blocking effect of the occluder. The synergistic effect of the two layers of support mesh not only ensures the stability of the occluder, but also ensures the reliability of the blocking effect.

[0099] In one embodiment, at least one layer of intermediate support mesh (not shown) is provided between the first support mesh 10 and the second support mesh 20, thereby forming a multi-layer support mesh. The intermediate support mesh is provided to provide additional support and a covering layer, further enhancing the stability of the occluder and its blood flow blocking effect.

[0100] Moreover, the multi-layer support mesh achieves more uniform stress distribution and tighter pore coverage through the mutual cooperation of different layers, thereby improving the overall performance of the occluder.

[0101] For example, in some implementations, adjacent intermediate support meshes are staggered, and the mesh gaps of each layer of intermediate support mesh are covered by the woven structure of the adjacent layer, thereby forming a seamless or nearly seamless multi-layer network that effectively blocks blood flow. In addition, one of the intermediate support meshes can also cover the mesh gaps of the first support mesh 10, ensuring the continuity and integrity of the occluder surface and further improving the occlusion effect. It should be noted that the above two layout forms related to the intermediate support meshes can be used alone or in combination, and can even be modified to a certain extent. The angle of the staggered position between adjacent layers during weaving can be adjusted to change the coverage pattern and density. Alternatively, by changing the weaving density and number of each layer of support mesh, the flexibility and radial strength of the occluder can be adjusted while maintaining the staggered distribution.

[0102] The following describes the relevant design of the flow-blocking layer in the embodiment of the present application with reference to the accompanying drawings:

[0103] like Figure 10 and Figure 11 As shown, the flow-blocking layer 40 is disposed between the first support mesh 10 and the second support mesh 20 to form an additional blood flow blocking barrier, which at least enhances the proximal blocking capability of the occluder and reduces the risk of thrombosis.

[0104] The flow-blocking layer 40 may be a polymer film, which has excellent biocompatibility and a fine microporous structure, providing the occluder with a uniform and effective blood flow blocking barrier. These micropores are small enough to prevent blood cells and thrombi from passing through, while allowing blood components to form a stable covering on the surface of the occluder, promoting the endothelialization process, thereby accelerating the integration of the occluder with the patient's own tissues.

[0105] It should be noted that in order to adapt to different clinical needs and improve the occlusion efficiency, the flow-blocking layer 40 is not limited to one form of polymer film. In addition to the polymer film described above, the flow-blocking layer 40 can also adopt a metal film, a biomaterial membrane, or a composite material membrane, etc., to ensure the optimal biocompatibility, mechanical strength and blood flow blocking effect of the occluder.

[0106] In one embodiment, if Figure 11 As shown, the flow blocking layer 40 is fixedly connected to the first support net 10, and the connection method may include but is not limited to sewing, bonding, welding, etc. Figure 10As shown, suture connection uses sutures 41 to precisely sew the flow-blocking layer 40 to the pre-set nodes on the first support mesh 10. The pre-set nodes are formed by cross-weaving the braided wires 100, which can provide strong fastening force to ensure the firmness of the flow-blocking layer 40. Adhesive connection uses a biocompatible adhesive to adhere the flow-blocking layer 40 to the first support mesh 10, which can achieve a good fixation effect without penetrating the material. The selection and application of these connection methods depends on the material of the flow-blocking layer 40, the structure of the first support mesh 10, and the expected clinical effect.

[0107] Based on the above content, in one embodiment, the flow-blocking layer 40 includes a first flow-blocking layer 401, and the first flow-blocking layer 401 is arranged corresponding to the proximal end of the support mesh structure formed by the first support mesh 10 and the second support mesh 20, that is, the first flow-blocking layer 401 is located in the structure of the occluder toward the entrance of the left atrial appendage 506, and can more directly block the blood.

[0108] Furthermore, the flow-blocking layer 40 further includes a second flow-blocking layer 402 , which is arranged along the circumference of the support mesh structure and cooperates with the first flow-blocking layer 401 to enhance the overall flow-blocking effect of the occluder.

[0109] Among them, such as Figure 10 As shown, one end of the second flow-blocking layer 402 transitions with the first flow-blocking layer 401, and the other end extends at least to the radial midline of the support mesh structure. This ensures the continuity of the flow-blocking layer 40 from the proximal end to the distal end of the occluder, providing uniform blood flow blockage. Furthermore, the second flow-blocking layer 402 can be made of the same material as the first flow-blocking layer 401, such as a polymer film, a metal film, or a biomaterial film, to ensure consistency and coordination across the entire flow-blocking layer 40.

[0110] The second flow-blocking layer 402 can be divided into a first section 4021 and a second section 4022. The first section 4021 is located between the radial midline and the distal end of the supporting mesh structure, and the second section 4022 is located between the radial midline and the proximal end of the supporting mesh structure. In some embodiments, the flow-blocking layer 40 can be composed of the first flow-blocking layer 401, so that the flow-blocking layer 40 is more suitable for situations where key protection needs to be provided at the entrance of the left atrial appendage 506; the flow-blocking layer 40 can also be composed of the first flow-blocking layer 401 and the second section 4022 to provide continuous blood flow blocking from the proximal end to the middle of the occluder; the flow-blocking layer 40 can also be composed of the first flow-blocking layer 401, the second section 4022 and the first section 4021 to achieve a more comprehensive flow-blocking effect.

[0111] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be noted that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be considered as the scope of protection of the present application.

Claims

1. An occluder, characterized in that: include: a radially shrinkable first support mesh, wherein the first support mesh is formed by weaving a plurality of braided wires; In a natural state, the central circumference of the first support net is bent outward along its circumference to form a main body arc surface profile, and the two side end surfaces of the first support net are bent inward to form the same or different end arc surface profiles.

2. The occluder according to claim 1, characterized in that: The main body arc surface profile is divided into a middle section and two edge sections located at both ends of the middle section along the central axis of the first supporting net. The curvature of the middle section is smaller than the curvature of any of the edge sections.

3. The occluder according to claim 2, characterized in that: The curvature of any of the edge segments is 2-10 times the curvature of the middle segment.

4. The occluder according to claim 2, characterized in that: The arc length of the middle segment is 3-7 times the arc length of any edge segment.

5. The occluder according to claim 1, characterized in that: The proximal end of the first supporting net is converged by a first converging element, and the distal end of the first supporting net is converged by a second converging element.

6. The occluder according to claim 5, characterized in that: A concave first space is formed at the proximal end of the first supporting net, a concave second space is formed at the distal end of the first supporting net, the first converging element is located or partially located in the first space, and the second converging element is located or partially located in the second space; During the implantation of the occluder, the central circumference of the first support mesh is compressed, so that the volume of the first space and / or the second space is reduced, and the proximal end surface of the first support mesh is transformed from the end arc surface profile to a plane-like profile.

7. The occluder according to claim 1, characterized in that: The plurality of braided wires include a plurality of first braided wires and a plurality of second braided wires, the number of the first braided wires is greater than the number of the second braided wires, and the radial size of the second braided wires is greater than the radial size of the first braided wires.

8. The occluder according to any one of claims 1 to 7, characterized in that: The occluder further includes a second supporting mesh, which is located inside the first supporting mesh. The second supporting mesh and the first supporting mesh are directly or indirectly tightly attached to each other to form a composite supporting mesh structure.

9. The occluder according to any one of claims 1 to 7, characterized in that: The occluder further includes an anchoring structure, which is arranged on the outer wall of the first supporting net.

10. The occluder according to claim 9, characterized in that: The anchoring structure has a plurality of parts; The plurality of anchoring structures are respectively distributed on both sides of the radial center line of the first supporting net; or, The plurality of anchoring structures are arranged between the radial midline of the first supporting mesh and the distal end thereof.

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