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, the supporting net is formed by weaving a plurality of weaving wires, and included angles are formed between the crossed weaving wires. The weaving wires are composed of a large number of first weaving wires and a small number of second weaving wires with a large radial size, the number of the first weaving wires is larger than that of the second weaving wires, and the radial size of the second weaving wires is larger than that of the first weaving wires, so that the better plugging effect and adaptability are achieved; according to the structural design, the stability and effectiveness of the plugging device are improved, the first supporting net can form a denser woven structure while keeping certain structural strength, and therefore the flow choking effect is improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and further relates to a occluder. Background Art

[0002] Atrial fibrillation (AF) is a common and serious arrhythmia that not only increases the risk of death in patients but also may lead to various complications, including stroke, heart failure, cognitive impairment, and dementia, seriously threatening the health and quality of life of patients. With the accelerating aging of the population, the prevalence of AF is on the rise, bringing unprecedented pressure to the healthcare system.

[0003] Although percutaneous left atrial appendage closure (LAAC) provides an effective minimally invasive surgical solution for preventing stroke caused by AF, there are still some challenges in the existing technology. For example, some occluders usually rely on specific flow-blocking elements to achieve blood flow interruption, making the structure of the occluder more complex and prone to affecting the adaptability and flexibility of the occluder. Utility Model Content

[0004] In view of the above technical problems, the purpose of this application is to provide an occluder, aiming to solve the related problems in the existing technology by simplifying the flow-blocking setting in the occluder and reducing the influence of the flow-blocking element on the occluder.

[0005] This application provides an occluder, including: a first support mesh formed by co-weaving a plurality of braided wires, and two intersecting braided wires are arranged at an angle;

[0006] The 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 dimension of the second braided wire is greater than the radial dimension of the first braided wire.

[0007] Optionally, the first support mesh forms a flow-blocking part through the weaving of the corresponding braided wires, the flow-blocking part at least corresponds to the proximal end of the first support mesh, and in the first support mesh, the area of the covering region formed by the braided wires in the flow-blocking part is greater than the area of the covering region formed by the braided wires not in the flow-blocking part.

[0008] Optionally, the radial dimension range of the first braided wire is between 0.025 and 0.250 mm;

[0009] And / or

[0010] The radial dimension range of the second braided wire is between 0.075 and 0.750 mm.

[0011] Optionally, the cross-sectional shape of the first braided wire is oval or quasi-oval;

[0012] and / or

[0013] The cross-sectional shape of the second braided wire is oval or quasi-oval.

[0014] Optionally, a first space is formed at the proximal end of the first support mesh, and the bottom of the first space extends along the major radius direction or the width direction of the braided wire forming the proximal end of the first support mesh.

[0015] Optionally, an anchoring structure is provided on the first support mesh, and the anchoring structure is provided on the second braided wire;

[0016] Wherein, the anchoring structure is disposed between the distal end of the first support mesh and the radial midline of the first support mesh;

[0017] Or

[0018] The anchoring structure is distributed on both sides of the radial midline of the first support mesh.

[0019] Optionally, the occluder further includes a second support mesh woven by a third braided wire, wherein the second support mesh is located inside the first support mesh, and the first support mesh and the second support mesh are directly or indirectly closely attached to form a composite support mesh structure.

[0020] Optionally, the radial dimension of the third braided wire ranges from 0.025 to 0.125 mm.

[0021] Optionally, there is at least one intermediate support mesh and / or flow blocking layer between the first support mesh and the second support mesh, so as to form a multi-layer support mesh.

[0022] The above occluder adopts a first support mesh woven by a plurality of first braided wires and a plurality of second braided wires, so that the first support mesh has sufficient flow blocking performance and takes into account structural strength and stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The following briefly describes the drawings used in the description of the embodiments of the present application:

[0024] Figure 1 is a schematic diagram of a treatment application scenario to which the embodiment of the present application is applied;

[0025] Figures 2 to 4 is a schematic diagram of the process of the occluder provided by the embodiment of the present application during transportation;

[0026] Figure 5 and Figure 6 are schematic diagrams of the structure of an occluder provided by the embodiment of the present application in different states;

[0027] Figure 7 It is a schematic diagram of the braiding method of the braided wire provided by the embodiment of the present application;

[0028] Figure 8 It is a schematic cross-sectional view of a braided wire provided by the embodiment of the present application;

[0029] Figure 9 It is a schematic cross-sectional view of another braided wire provided by the embodiment of the present application;

[0030] Figure 10 It is a schematic structural diagram of another occluder provided by the embodiment of the present application;

[0031] Figure 11 It is a schematic structural diagram of one of the occluders provided by the embodiment of the present application;

[0032] Figure 12 It is a cross-sectional view of an occluder provided by the embodiment of the present application;

[0033] Figure 13 It is a schematic diagram of a partial structure of an occluder provided by the embodiment of the present application.

[0034] Explanation of the reference numerals in the drawings: 10, the first support mesh; 100, the braided wire; 101, the first braided wire; 102, the second braided wire; 110, the first space; 111, the flow blocking part; 120, the second space; 130, the first constricting element; 140, the second constricting element; 150, the middle section; 160, the edge section; 20, the second support mesh; 201, the third braided wire; 301, the anchoring structure; 40, the flow blocking layer; 401, the first flow blocking layer; 402, the second flow blocking layer; 4021, the first section; 4022, the second section; 41, the suture thread;

[0035] 501, the aorta; 502, the aortic valve; 503, the left ventricle; 504, the left atrium; 505, the mitral valve; 506, the left atrial appendage; 507, the right ventricle; 508, the right atrium; 509, the tricuspid valve; 510, the interatrial septum; 511, the superior vena cava; 512, the inferior vena cava; 601, the delivery catheter; 602, the pushing device. Detailed implementation manners

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the specific implementation manners of the present application will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained according to these drawings, and other implementation manners can also be obtained.

[0037] To make the drawings concise, only the parts related to the application are schematically shown in each drawing, and they do not represent the actual structure of the product as a whole. Additionally, to make the drawings concise and easy to understand, for components with the same structure or function in some drawings, only one of them is schematically illustrated, or only one of them is labeled. In this document, "one" not only means "only this one", but also can mean "more than one" situation.

[0038] It should also be further understood that the term "and / or" used in the specification and appended claims of this application refers to any combination and all possible combinations of one or more of the related listed items, and includes these combinations.

[0039] In this document, it should be noted that unless otherwise clearly specified and defined, the terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0040] In the embodiments shown in the drawings, the indication of directions (such as up, down, left, right, front, and back, etc.) when describing the structure and movement of each component is not absolute but relative, and does not limit the direction of the product in actual use.

[0041] In the embodiments of this application, "proximal" and "distal" are used to describe the position or direction of the associated (or described) object (referred to as the associated object) relative to the operator from the perspective of the operator (such as a doctor or operator). For example, "proximal" refers to the end closer to the operator during the normal operation of the medical device by the operator; "distal" refers to the end farther from the operator during the normal operation of the medical device by the operator, or the end that first enters the patient's body. Exemplarily, the "proximal" of A refers to the end of A closer to the operator; the "distal" of A refers to the end of A farther from the operator. Or, the "proximal" of A refers to the end of A farther from the patient (or the affected area, or the position where the occluder is implanted); the "distal" of A refers to the end of A closer to the patient (or the affected area, or the position where the occluder is implanted).

[0042] Atrial fibrillation (AF) is a common clinical arrhythmia, and its prevalence increases significantly with age. AF not only increases the risk of death of patients, but also may cause a series of serious complications such as stroke, heart failure, cognitive dysfunction, and dementia, seriously threatening the quality of life and health and safety of patients. With the accelerating aging of the global population, the prevalence of AF is expected to continue to rise, bringing unprecedented challenges to the healthcare system.

[0043] See also Figure 1 The heart is a hollow muscular organ with four chambers, namely the left atrium 504, the left ventricle 503, the right atrium 508 and the right ventricle 507. The four chambers of the heart are connected to different blood vessels. The left ventricle 503 is connected to the aorta 501. The aorta 501 orifice is located above and right in front of the left atrioventricular orifice, and the semilunar aortic valve 502 is attached to the periphery. The left atrium 504 is connected to the pulmonary vein, the right ventricle 507 is connected to the pulmonary artery, and the right atrium 508 is connected to the superior vena cava 511 and the inferior vena cava 512. The left atrium 504 and the right atrium 508 are separated by an atrial septum 510. The part of the front of the left atrium 504 that protrudes to the right front is the left atrial appendage 506. The left ventricle 503 and the right ventricle 507 are separated by a ventricular septum. There is an atrioventricular valve (hereinafter referred to as valve) between the atrium and the ventricle. When the ventricle relaxes, the valve opens and blood flows from the atrium to the ventricle; when the ventricle contracts, the valve closes to prevent blood from flowing back from the ventricle to the atrium. 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.

[0044] 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 blood clot 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%.

[0045] At present, the traditional occluder designs are mainly "plug-type" and "cap-type"; the "plug-type" left atrial appendage occluder is carved and shaped by tubing; the "cap-type" adds a proximal covering structure compared to the "plug-type", which can be carved by the distal structure, woven by the proximal structure, or both the distal and proximal structures are woven; blood flow blocking is mainly achieved by a polymer flow blocking membrane arranged inside or outside the occluder. The "plug-type" left atrial appendage occluder carved by tubing is radially compressed inward to reach the size of entering the delivery catheter 601 when in use, and expands radially outward to restore the preset shape at the implantation position.

[0046] This utility model adopts a braided structure to design a "plug-type" occluder. Please refer to the attached manual for details. Figures 2 to 4 When in use, under the action of the pushing device 602, the occluder is stretched and deformed from the proximal end into a slender delivery shape, at the implantation position in the left atrial appendage, and then gradually exposed from the distal end to the proximal end outside the delivery catheter 601, and gradually restores the preset shape.

[0047] During use, the occluder undergoes two deformation processes. In a single deformation, each part of the occluder has a relatively large deformation stroke. For the flow-blocking film in the prior art, due to its lack of elasticity and recovery performance adapted to the occluder, when the occluder returns to its preset shape, the flow-blocking film may not fully return to its preset shape, resulting in a reduction or loss of the flow-blocking effect.

[0048] Based on the problems in the prior art, an occluder provided by the present application needs to achieve an ideal flow-blocking effect, and the flow-blocking film itself or its elasticity and recovery performance should not affect the flow-blocking effect. On the one hand, a simple weaving method cannot form an effective flow-blocking barrier, allowing blood to still flow through the occluder; on the other hand, blindly increasing the number or density of the weaving wires to improve the flow-blocking effect will lead to a complex structure of the occluder, increasing the implantation difficulty and potentially affecting the patient's postoperative comfort. Therefore, it is necessary to maintain the simplicity of the structure and ease of implantation at the same time. Meanwhile, attention must be paid to its structural strength and stability to ensure the stability of the occluder in the left atrial appendage and effectively block the entrance of the left atrial appendage 506.

[0049] The design of the first support mesh part in the present application is described below with reference to the drawings:

[0050] Refer to the appended Figures 5 to 7 This is a schematic structural diagram of an occluder provided by an embodiment of the present application. The core improvement of this occluder lies in the weaving structure of the first support mesh 10. By using weaving wires 100 with specific quantities and radial dimensions for weaving, there is a certain angle setting between the intersecting weaving wires 100, which helps to increase the contact area and friction between the weaving wires 100. When the occluder is impacted by blood flow, it can maintain stability 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 weaving wires 100 can provide a larger surface area, this helps the growth of tissues and endothelialization, thereby reducing the inflammatory response and improving the patient's comfort.

[0051] More specifically, the occluder includes multiple first weaving wires 101 and multiple second weaving wires 102. The number of the first weaving wires 101 is greater than that of the second weaving wires 102, and the radial dimension of the second weaving wires 102 is greater than that of the first weaving wires 101, so that the first support mesh 10 can form a denser weaving structure while maintaining a certain structural strength, thereby improving the flow-blocking effect.

[0052] 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 and effectively close the left atrial appendage 506 to prevent thrombus detachment.

[0053] In this embodiment, the first braided wire 101 is mainly responsible for forming the overall contour of the occluder, providing necessary support and stability for the occluder. The second braided wire 102 mainly provides radial support force, and its radial dimension is not less than that of the first braided wire 101 to ensure that the occluder can closely fit the inner wall of the left atrial appendage 506 after implantation. This design not only helps to prevent the displacement or deformation of the occluder, but also effectively reduces the possibility of thrombus detachment, thereby reducing the risk of stroke.

[0054] At the same time, by optimizing the structure and material selection of the braided wire 100, it can be ensured that the occluder can provide stable and lasting radial support force after implantation, realizing effective occlusion of the left atrial appendage 506.

[0055] Among them, the braiding method between the braided wires 100 can also have various forms, which can be referred to in the appendix Figure 7 , in this embodiment, the braided wire 100 adopts the way that adjacent opposing braided wires 100 cross in turn, thereby constructing a strong support network. This form of cross braiding not only enhances the structural integrity of the support network, but also provides the flexibility and adaptability required by the support network.

[0056] Specifically, one of the braiding methods is the single wire alternating cross braiding method. In this braiding method, each braided wire 100 crosses alternately above and below with the single opposing braided wire 100, forming a uniform and regular grid structure. This braiding method is more suitable for areas on the first support network 10 that need to be evenly covered or moderately blocked, such as parts of the occluder that require better flexibility and adaptability; there is also a braiding method that is the multi-wire alternating cross braiding form. In this braiding method, each braided wire 100 crosses alternately above and below with at least two opposing braided wires 100, increasing the cross density of the braided wires 100, enabling the first support network 10 to form a denser structure in a specific area, further improving the blocking effect and support force. Of course, there are also other braiding methods in other embodiments. Although specific braiding methods are described in this specification, the protection scope of the present utility model is not limited to these examples.

[0057] Furthermore, in order to optimize the effects of the above embodiment, the radial dimensions of the quantities of the first braided wire 101 and the second braided wire 102 are further defined.

[0058] First of all, the radial dimension range of the first braided wire 101 is from 0.025 mm to 0.250 mm, and the preferred range is from 0.050 mm to 0.125 mm. This relatively thin radial dimension helps to improve the flexibility and adaptability of the support network, enabling it to better fit the complex shape of the left atrial appendage 506 while reducing the compression on the surrounding tissues.

[0059] Opposite to the first braided wire 101, the radial dimension range of the second braided wire 102 is from 0.075 mm to 0.750 mm, and the preferred range is from 0.100 mm to 0.400 mm. Such a thicker wire diameter provides the necessary structural strength and radial support force, ensuring that the occluder remains stable under the continuous pressure of the heart.

[0060] On the other hand, the quantity ranges of the first braided wire 101 and the second braided wire 102 also need to be specifically set and selected. The quantity range of the first braided wire 101 is from 48 to 480, and the preferred quantity is from 72 to 216. Increasing the quantity of the first braided wire 101 can improve the overall coverage area and flexibility of the support mesh, help to more evenly distribute the stress points of the support mesh, and reduce local stress concentration.

[0061] Opposite to this, the quantity range of the second braided wire 102 is from 2 to 20, and the preferred quantity is from 6 to 16. Although the quantity of the second braided wire 102 is small, its thicker wire diameter provides key structural support points for the support mesh, helping to maintain the shape and stability of the occluder. Since too many second braided wires 102 may increase the implantation difficulty and the risk of thrombus formation, while too few second braided wires 102 may not provide sufficient radial support force, when setting the quantity of the second braided wire 102, it is necessary to comprehensively consider factors such as the overall size and specific performance of the occluder.

[0062] More preferably, based on the above content, a flow-blocking portion 111 located on the first support mesh 10 is formed by braiding the braided wires 100 (the first braided wire 101, the second braided wire 102). The flow-blocking portion 111 is a key part of the occluder, responsible for realizing the main function of the occluder - preventing blood from flowing into the left atrial appendage 506, thereby preventing the formation of thrombus. Here, the flow-blocking portion 111 formed by braiding on the first support mesh 10 can be evenly distributed on the overall mesh surface, providing a consistent blood flow blocking effect, ensuring that the entire surface of the occluder can effectively prevent blood from flowing into the left atrial appendage 506.

[0063] In this embodiment, the flow-blocking portion 111 in the first support mesh 10 achieves a better flow-blocking effect by increasing the coverage area of the braided wires. The increase in the coverage area can be achieved by implementing methods such as increasing the quantity of the braided wires, adjusting the diameter of the braided wires, or changing the braiding pattern. For example, in the flow-blocking portion 111, the density of the braided wires 100 is higher than that 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 a stronger flow-blocking ability and ensuring that blood cannot flow into the left atrial appendage 506 through the gaps between the braided wires 100.

[0064] In some embodiments, the flow-blocking portion 111 can be specifically disposed 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 flow-blocking effect helps to form a more effective blood flow block at the entrance of the left atrial appendage 506 and reduce blood stasis. Specifically, as Figure 5 and Figure 6 shown, the flow-blocking portion 111 is located at the proximal end of the first support mesh 10, that is, at a position close to the opening of the left atrial appendage 506, so that the flow-blocking portion 111 can directly face the blood flow and impact, and effectively intercept the blood that may enter the left atrial appendage 506.

[0065] In the flow-blocking portion 111, a hybrid weaving of the first weaving wire 101 and the second weaving wire 102 can also be adopted. The density of the first weaving wire 101 is relatively high, which helps to increase the overall stiffness and stability of the flow-blocking portion 111; while the radial dimension of the second weaving wire 102 is relatively large, so that the second weaving 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. Furthermore, by combining the advantages of the two weaving wires 100, the hybrid weaving can improve the overall strength and stiffness of the flow-blocking portion 111, enabling it to better resist the impact force from the blood after implantation.

[0066] Furthermore, this hybrid weaving method can adjust the material composition of the weaving 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.

[0067] In one embodiment, referring to the attached drawings of the specification Figure 8 and Figure 9 , the cross-sectional shape of the weaving wire 100 is oval or quasi-oval. The oval or quasi-oval cross-sectional shape increases the contact area between the weaving wire 100 and the blood, which means that under the same blood flow velocity and pressure, the weaving wire 100 with an oval or quasi-oval cross-section can provide greater resistance, thus more effectively blocking the blood flow and improving the flow-blocking effect of the occluder.

[0068] In this embodiment, the weaving wire 100 with this cross-sectional design, based on its unique geometric characteristics, can improve the support performance and deformability of the occluder without adjusting the number of the weaving wires 100. Specifically, the long radius or the width side of the oval or quasi-oval weaving wire is used to form the peripheral surface of the first support mesh 10, thereby improving the coverage rate on the peripheral surface while maintaining the structural integrity; at the same time, since the width side of the oval or quasi-oval cross-section plays a dominant role in the formation of the peripheral surface, the radial thickness of the first support mesh 10 is reduced.

[0069] With this design in this embodiment, the radial thickness of the first support mesh 10 can be significantly reduced, directly reducing the mechanical stress of the occluder when passing through the delivery catheter, enabling the occluder to more easily pass through delivery catheters with smaller diameters, such as catheters of 10F and below, thereby reducing the impact on human blood vessels. Moreover, the increase in the circumferential surface coverage rate of the support mesh helps reduce blood stasis at the occluder position, thus reducing the possibility of thrombus formation.

[0070] In one embodiment, as Figure 5 and Figure 6 shown, the circumferential surface of the first support mesh 10 is bent outward along its circumferential direction to form an arc-shaped contour. At the same time, a first space 110 is formed at the proximal end of the first support mesh 10 by the weaving of the braided wires 100, and a second space 120 is formed at the distal end of the first support mesh 10 by the weaving of the braided wires 100. When the occluder is in the natural state, the braided wires 100 at the proximal end of the first support mesh 10 will form a concave space, which is the first space 110. During the process of implanting the occluder in place, restricted by the anatomical structure of the left atrial appendage 506, the circumferential surface of the first support mesh 10 is radially compressed, and the volume of the first space 110 will gradually shrink during its deployment process, making the proximal end of the first support mesh 10 have a relatively smooth contour, forming a generally planar structure, avoiding obvious protrusions or depressions, enabling it to be smoothly connected to the inner wall of the implantation position, and reducing the possibility of device-related thrombus; the change of the second space 120 is the same in principle, but the opening of the second space 120 faces the distal end, so it does not play the main flow-blocking role.

[0071] This smooth shape at the proximal end of the first support mesh 10 helps the process of device endothelialization because endothelial cells are more likely to grow on a smooth surface. At the same time, the smooth surface reduces the possibility of blood stasis, thereby reducing the risk of device-related thrombus. On the other hand, the design of this occluder also takes into account the needs of ablation procedures such as one-stop circumferential pulmonary vein isolation and / or left atrial appendage 506 ostium isolation. Since the occluder can be stably implanted without the need for re-puncturing or establishing a new delivery channel, the efficiency and safety of the operation are greatly improved.

[0072] Reference can be made to Att Figure 5 and Figure 6 , the arc-shaped contour formed by the circumferential surface of the first support mesh 10 is subdivided into three parts along the central axis direction of the first support mesh 10: an intermediate section 150 and two edge sections 160.

[0073] In particular, the middle section 150 has a smaller curvature, while the two edge sections 160 have a larger curvature, and the curvature of the middle section 150 is less than that of either edge section 160, so that the occluder can achieve a smoother and more uniform fit in the middle region of the mouth of the left atrial appendage 506, reducing the pressure on the endocardium or the irritation of the cardiac tissue. At the same time, the larger curvature of the edge sections 160 helps the occluder to adapt to the morphology and shape at the inlet and outlet of the mouth of the left atrial appendage 506, contributing to a more effective blood flow block, because the edge sections 160 can fit more closely to the opening of the left atrial appendage 506, reducing the possibility of blood flowing into the left atrial appendage 506 to ensure the sealing performance of the occluder. At the same time, the larger curvature means that the edge sections 160 are more likely to form a mechanical interlock with the uneven parts at the mouth of the left atrial appendage 506, enhancing the anti-displacement ability and stability of the occluder to a certain extent and effectively preventing the displacement of the occluder caused by cardiac contraction and blood flow.

[0074] Optionally, the curvature of either edge section 160 is about 2-10 times that of the middle section 150, increasing the anchoring ability of the edge sections 160 while maintaining the flexibility and adaptability of the occluder. The arc length of the middle section 150 is about 3-7 times that of either edge section 160, ensuring that the occluder has sufficient coverage in the middle of the left atrial appendage 506 while allowing the edge sections 160 to form a tight seal at the inlet and outlet of the left atrial appendage 506.

[0075] At the same time, based on the above, the second braided wire 102 provides a strong radial supporting force due to its large 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 shrinkage of the volume of the first space 110 and / or the second space 120, together with the radial supporting force provided by the braided wire 100, act together to keep the occluder stable at the implanted position and reduce the risk of displacement.

[0076] In addition, the occluder is also provided with a first constricting element 130 and a second constricting element 140. The first constricting element 130 is located in or partially located in the first space 110 for constricting the braided wire 100 at the proximal end of the first support mesh 10 to ensure the tight fit and stability of the occluder at the inlet of the left atrial appendage 506. The second constricting element 140 is located in or partially located in the second space 120 for constricting the braided wire 100 at the distal end of the first support mesh 10 to adapt to the distal anatomical structure of the left atrial appendage 506 and at the same time provide the necessary fixing force. By adjusting the constricting elements, the tightness of the braided wire 100 can be precisely controlled, thereby adjusting the radial size of the occluder to adapt to the morphology of the left atrial appendage 506 of different patients.

[0077] Further, in one embodiment, the braided wire 100 forming the proximal end of the first support mesh 10 may be an oval braided wire or a quasi-oval braided wire, and the bottom edge 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.

[0078] First, it should be noted that in the flow blocking portion 111, the local flow blocking ability 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 passing through the flow blocking portion 111, thereby improving the occlusion effect.

[0079] In this embodiment, the long radius or the wider side of the oval or quasi-oval 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 oval braided wire and the quasi-oval braided wire helps to improve the flow blocking effect because they provide a wider physical barrier on the circumferential surface.

[0080] Such as Figure 10 , in some cases, a rhombic pore similar to a grid can be woven on the first support mesh 10 through a relatively flat quasi-oval braided wire, so that the first support mesh 10 has better compressibility, enabling the first support mesh 10 to be more flattened when shrinking into the catheter as a whole, reducing the diameter requirement of the occluder for the catheter; at the same time, when the first support mesh 10 is deployed, 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.

[0081] In other embodiments, the cross-sectional size range of the oval braided wire and the quasi-oval braided wire in this embodiment can be further defined. For example, when the cross-section of the braided wire 100 is oval, the long radius w size of the oval braided wire is preferably in the range of 0.050 to 0.125 mm, and the short radius t size 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, jointly acting to improve the occlusion efficiency and reduce the interference to the surrounding tissues.

[0082] When the cross-section of the braided wire 100 is quasi-elliptical, it may have a plane in its length direction. The width w is preferably in the range of 0.050 to 0.125 mm, and the thickness t is preferably in the range of 0.025 to 0.085 mm. Generally speaking, the thickness of the quasi-elliptical braided wire is relatively thin, which enables the occluder to achieve a thinner radial thickness while maintaining appropriate radial strength, thereby reducing the interference with the patient's body during the implantation process. In addition, due to the possible presence of 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 on the inner wall of the left atrial appendage 506 and improve the reliability of occlusion.

[0083] It should also be noted that the cross-section setting of the braided wire 100 and the setting of the flow-blocking part 111 in the above embodiment can be used in combination, that is, the two embodiments of improving the flow-blocking effect by adjusting the density of the braided wire 100 and adjusting the cross-section shape of the braided wire 100 can be used alone or in combination.

[0084] The following describes the related designs of the anchoring structure part in the embodiments of the present application with reference to the drawings:

[0085] Refer to the attached drawings of the specification Figure 5 and Figure 6 , an anchoring structure 301 is provided on the first support mesh 10, which is used to interact with the tissue characteristics of the left atrial appendage 506 to provide a stable fixing force, improve the stability of the occluder after implantation, and reduce the risk of displacement caused by heart beating. Among them, the anchoring structure 301 may include barbs, spines, or anchoring claws, etc., and these designs help to grasp the tissue and prevent the occluder from shifting.

[0086] Specifically, 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 compared with the first braided wire 101. Then, the anchoring structure 301 can utilize its larger radial dimension to provide a stronger anchoring force. At the same time, the larger radial dimension increases the surface area of contact between the braided wire 100 and the tissue of the left atrial appendage 506, which helps to improve the stability and fixing force of the anchoring structure 301.

[0087] 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 a continuous fixing force, enabling the occluder to fit more closely to the inner wall of the left atrial appendage 506, and reducing the chance of blood flowing into the left atrial appendage 506.

[0088] In addition, the anchoring structure 301 can also be disposed on both sides of the radial center line of the first support mesh 10, ensuring the balanced fixation of the occluder in the left atrial appendage 506, helping to evenly distribute the fixation force, avoiding local overstretching or compression, and thus reducing the risk of damage to the inner wall of the left atrial appendage 506. More specifically, the distribution range of the anchoring structure 301 on each side occupies 1 / 4 to 1 / 3 of the axial length of the occluder. This distribution ratio ensures that the anchoring structure 301 is evenly covered over the entire length of the occluder, providing a uniform fixation force while maintaining the necessary flexibility, thereby improving the adaptability and stability of the occluder.

[0089] It should be noted that the anchoring structure 301 can be combined with the second braided wire 102 in an integrally formed or separately formed manner.

[0090] In the integrally formed manner, 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 forming 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.

[0091] Based on the above, there is a forming method in which microplanes are arranged locally on the second braided wire 102, and then the anchoring structure 301 is formed through cutting and shaping processes. Moreover, 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 requirements. Specifically, the second braided wire 102 is provided with microplanes in specific areas, and these microplanes are the starting points for forming 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 barbed shape, through a shaping process.

[0092] Furthermore, when multiple anchoring structures 301 are designed on a single second braided wire 102, these structures can be arranged at a certain interval along the length direction to achieve the best fixation effect. For the second braided wires 102 that cross each other in opposite directions, adjacent anchoring structures 301 may occur. To avoid the interlocking between adjacent anchoring structures 301, especially when the anchoring structure 301 is in the form of barbs, the free ends of the barbs are set to point in opposite directions or have a certain included angle. This design ensures that the anchoring structures 301 do not interfere with each other when the occluder is deployed.

[0093] In the split forming method, the anchoring structure 301 and the second braided wire 102 are manufactured separately and then connected together by mechanical or chemical methods. This forming method provides greater design flexibility, allowing the anchoring structure 301 and the braided wire 100 to be optimized separately. The assembly after split forming can be achieved in various ways, including but not limited to welding, bonding, mechanical locking, or using connectors, etc., to ensure a firm connection between the two.

[0094] The following describes the related design of the second support mesh part in the embodiments of the present application with reference to the accompanying drawings:

[0095] As Figure 11 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 the main support structure of the occluder. It not only bears the anchoring structure 301 but also is responsible for the direct contact and fixation with the inner wall of the left atrial appendage 506. The two support meshes can be directly or indirectly closely attached to form a firm and composite support mesh structure to improve the durability and adaptability of the occluder.

[0096] Generally, the radial dimension of the third braided wire 201 forming the second support mesh 20 is smaller than that of the first braided wire 101 and the second braided wire 102 forming the first braided mesh. The smaller radial dimension of the third braided wire 201 helps 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 and at the same time reducing the risk of damage to blood vessels.

[0097] In addition, in the above embodiments, the preferred radial dimension range and the number range of the first braided wire 101 and the second braided wire 102 have been given. In this embodiment, the radial dimension 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 compression 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 range of the third braided wire 201 is between 48 and 480, and the preferred range can be between 96 and 192, ensuring the uniformity and stability of the second support mesh 20, while avoiding excessive increase in the radial thickness of the occluder, making it easier for the occluder to pass through the delivery catheter during implantation and at the same time reducing the risk of damage to blood vessels.

[0098] In one embodiment, the first support mesh 10 and the second support mesh 20 are staggeredly distributed, that is, the two support meshes are not simply superimposed in the spatial layout but are staggered with each other to form a complementary grid structure, in which the grid gaps of the second support mesh 20 are covered by the first support mesh 10.

[0099] Since the first support net 10 is woven from the first woven wire 101 and the second woven wire 102 with a larger radial dimension, its main function is to provide the radial support force required for the occluder, ensuring that the occluder can be firmly fixed at the orifice of the left atrial appendage 506; the second support net 20 is woven from the third woven wire 201 with a smaller radial dimension, and its main role is to cover the grid pores of the first support net 10. Through this arrangement form of staggered distribution between the support nets, the second support net 20 effectively blocks the potential channels for blood flow through the first support net 10, enhancing the sealing performance of the occluder.

[0100] More importantly, this double-layer structure design enables the first support net 10 to mainly act on providing the necessary support force, while the second support net 20 mainly acts on improving the blood flow blocking effect of the occluder. The synergistic effect of the two-layer support nets ensures both the stability of the occluder and the reliability of the occlusion effect.

[0101] In one embodiment, there is at least one intermediate support net (not shown in the drawings) between the first support net 10 and the second support net 20, thus forming a multi-layer support net. The setting of the intermediate support net is intended to provide additional support force and covering layer, further enhancing the stability of the occluder and the blood flow blocking effect.

[0102] Moreover, through the mutual cooperation of different layers of the multi-layer support net, a more uniform stress distribution and a more compact pore coverage are achieved, thereby improving the overall performance of the occluder.

[0103] For example, in some implementation cases, the adjacent intermediate support nets are distributed in a staggered manner, and the grid voids of each layer of the intermediate support net are covered by the woven structure of the adjacent layer, thus forming a seamless or nearly seamless multi-layer network to effectively block blood flow. Additionally, one of the intermediate support nets can also cover the grid voids of the first support net 10, ensuring the continuity and integrity of the surface of the occluder and further improving the occlusion effect. It should be noted that the above two layout forms related to the intermediate support net can be used alone, combined, or even deformed to a certain extent. The angle of stagger between adjacent layers during weaving can be adjusted to change the coverage pattern and density. Or, by changing the weaving density and quantity of each layer of the support net, while maintaining the staggered distribution, the flexibility and radial strength of the occluder can be adjusted.

[0104] The following describes the related design of the flow blocking layer part in the embodiments of the present application with reference to the drawings:

[0105] As Figure 11 and Figure 12As shown, the flow-blocking layer 40 is disposed between the first support mesh 10 and the second support mesh 20, forming an additional blood flow blocking barrier, which at least enhances the proximal blocking ability of the occluder and reduces the risk of thrombus formation.

[0106] The flow-blocking layer 40 may be a polymer membrane. The polymer membrane has excellent biocompatibility and a fine microporous structure, providing a uniform and effective blood flow blocking barrier for the occluder. These micropores are small enough to prevent blood cells and thrombi from passing through, while allowing blood components to form a stable coverage on the surface of the occluder, promoting the endothelialization process, and thus accelerating the integration of the occluder with the patient's own tissue.

[0107] 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 the form of a polymer membrane. In addition to the polymer membrane described above, the flow-blocking layer 40 can also adopt a metal membrane, a biomaterial membrane, or a composite material membrane, etc., to ensure the best biocompatibility, mechanical strength, and blood flow blocking effect of the occluder.

[0108] In one embodiment, the flow-blocking layer 40 is fixedly connected to the first support mesh 10, and the connection methods may include but are not limited to suture, adhesion, welding, etc. As Figure 13 shown, among them, the suture connection precisely sutures the flow-blocking layer 40 to the preset nodes on the first support mesh 10 by using a suture 41. The preset nodes are formed by the cross-weaving of each braided wire 100, which can provide strong fastening force to ensure the firmness of the flow-blocking layer 40; the adhesion connection is to paste the flow-blocking layer 40 to the first support mesh 10 by using a biocompatible adhesive, which can achieve a good fixing effect without penetrating the material. The selection and application of these connection methods depend on the material of the flow-blocking layer 40, the structure of the first support mesh 10, and the expected clinical effect, etc.

[0109] Based on the above, in one embodiment, the flow-blocking layer 40 includes a first flow-blocking layer 401, and the first flow-blocking layer 401 is disposed 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 at the position facing the entrance of the left atrial appendage 506 in the structure of the occluder, and can more directly block the blood flow.

[0110] Furthermore, the flow-blocking layer 40 further includes a second flow-blocking layer 402, which is disposed along the circumferential direction of the support mesh structure and works together with the first flow-blocking layer 401 to enhance the overall blood flow blocking effect of the occluder.

[0111] Among them, as Figure 12As shown, one end of the second flow-blocking layer 402 is transitionally connected to the first flow-blocking layer 401, and the other end extends at least to the radial midline of the support mesh structure, ensuring the continuity of the flow-blocking layer 40 from the proximal end to the distal end of the occluder and providing uniform blood flow interruption. At the same time, 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 biological material film, to ensure the consistency and coordination of the entire flow-blocking layer 40.

[0112] The second flow-blocking layer 402 can be distinguished 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 support mesh structure, and the second section 4022 is located between the radial midline and the proximal end of the support mesh structure. Then, in some embodiments, the flow-blocking layer 40 can be composed of the first flow-blocking layer 401, making the flow-blocking layer 40 more suitable for those cases that require key protection 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 interruption from the proximal end to the middle of the occluder; the flow-blocking layer 40 can also be jointly 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.

[0113] It should be noted that the above embodiments can be freely combined according to needs. The above are only the preferred embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present application, several improvements and refinements can still be made, and these improvements and refinements should also be regarded as the protection scope of the present application.

Claims

1. A occluder, characterized in that, Comprising: A first support net, which is formed by co-weaving a plurality of weaving filaments, and two intersecting said weaving filaments are arranged at an angle; The weaving filaments include a plurality of first weaving filaments and a plurality of second weaving filaments, the number of the first weaving filaments is greater than the number of the second weaving filaments, and the radial dimension of the second weaving filaments is greater than the radial dimension of the first weaving filaments.

2. The occluder according to claim 1, wherein The first support net forms a flow blocking part through the weaving of the corresponding weaving filaments, and the flow blocking part at least corresponds to the proximal end of the first support net. In the first support net, the area of the covering region formed by the weaving filaments in the flow blocking part is greater than the area of the covering region formed by the weaving filaments not in the flow blocking part.

3. The occluder according to claim 1, wherein The radial dimension of the first weaving filaments ranges from 0.025 to 0.250 mm; And / or The radial dimension of the second weaving filaments ranges from 0.075 to 0.750 mm.

4. The occluder according to claim 2, wherein The cross-sectional shape of the first weaving filaments is oval or quasi-oval; And / or The cross-sectional shape of the second weaving filaments is oval or quasi-oval.

5. The occluder according to claim 4, wherein A first space is formed at the proximal end of the first support net, and the bottom of the first space extends along the long radius direction or the width direction of the weaving filaments forming the proximal end of the first support net.

6. The occluder according to claim 1, wherein An anchoring structure is arranged on the first support net, and the anchoring structure is arranged on the second weaving filaments; Wherein, the anchoring structure is arranged between the distal end of the first support net and the radial midline of the first support net; Or The anchoring structure is distributed on both sides of the radial midline of the first support net.

7. The occluder according to any one of claims 1-6, wherein The occluder further includes a second support net woven by third weaving filaments. Among them, the second support net is located inside the first support net, and the first support net and the second support net are directly or indirectly closely attached to form a composite support net structure.

8. The occluder according to claim 7, wherein The radial dimension of the third weaving filaments ranges from 0.025 to 0.125 mm.

9. The occluder according to claim 7, wherein There is at least one intermediate support net and / or flow blocking layer between the first support net and the second support net, so as to form a multi-layer support net.

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