Occluder

Abstract

The present invention relates to an occluder, comprising a support net, a distal end cap, a proximal end cap and an occluding membrane, wherein the distal end cap and the proximal end cap are respectively arranged at both ends of the support net, a distal marking structure is embedded in the distal end cap, the occluding membrane is arranged in the support net, a first marking structure is arranged on the surface of the occluding membrane, when the occluder is in a stretched state, the center of the occluding membrane extends toward the distal end cap or toward the proximal end cap, and the edge of the occluding membrane shrinks to form a bag-like structure, and the first marking structure is located inside the bag-like structure. The occluder prevents the marking structure from falling off, and under X-ray imaging equipment, the overall shape of the occluder and the accurate relative position of the occluder and the defect site can be judged.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an occluder. Background Art

[0002] A heart defect occluder (hereinafter referred to as an occluder) is an implantable medical device for treating congenital heart defects. The implantation of an occluder usually requires surgery under the guidance of X-ray imaging equipment such as DSA (Digital Subtraction Angiography), so the occluder is required to have good visibility under X-rays.

[0003] Traditional occluders are usually made of metals such as nickel-titanium alloys, and have good visibility under DSA equipment. However, occluders made of polymer materials have poor radiation immunity under X-rays, resulting in poor visibility, and it is difficult to determine the exact position and release state of the occluder under DSA. Therefore, for occluders made of polymer materials, it is usually necessary to set a marking structure on the occluder to assist in determining the exact position and release state of the occluder. Existing occluders made of polymer materials generally have a marking structure embedded in the distal head and / or proximal head of the occluder. The marking structure is wrapped inside the distal head and / or proximal head to prevent the marking structure from rubbing or scratching against the inner wall of the sheath during transportation, thereby preventing the marking structure from falling off the distal head and / or proximal head.

[0004] However, the marking structure is embedded in the distal head and / or the proximal head. Under the DSA device, only the approximate position of the distal head and / or the proximal head can be determined, and it is difficult to determine the overall shape of the occluder and the accurate relative position relationship between the occluder and the defect. Summary of the invention

[0005] Based on this, it is necessary to provide an occluder that can prevent the marking structure from falling off and can determine the overall shape of the occluder and the accurate relative position of the occluder and the defect under X-ray imaging equipment.

[0006] An occluder comprises a supporting net, a distal head and a proximal head, wherein the distal head and the proximal head are respectively arranged at two ends of the supporting net, and a distal marking structure is embedded in the distal head. The occluder also comprises an occluding membrane arranged in the supporting net, and a first marking structure is arranged on the surface of the occluding membrane. When the occluder is in a stretched state, the center of the occluding membrane extends toward the distal head or toward the proximal head, and the edge of the occluding membrane shrinks to form a bag-like structure, and the first marking structure is located inside the bag-like structure.

[0007] The above-mentioned occluder is provided with a distal marking structure on the distal end cap and a first marking structure in the occluding membrane. The combination of the distal marking structure and the first marking structure is conducive to judging the overall shape of the occluder and the accurate relative position of the occluder and the defect. In addition, in the delivery state, the distal marking structure is embedded in the distal end cap, and the first marking structure is located inside the bag-like structure formed by the occluding membrane, which can prevent the distal marking structure and the first marking structure from directly contacting the sheath, thereby preventing the distal marking structure and the first marking structure from rubbing and scratching against the inner wall of the sheath, causing the distal marking structure and the first marking structure to fall off. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a schematic structural diagram of an occluder according to an embodiment;

[0009] Figure 2 for Figure 1 The structural schematic diagram of the first distal disk of the occluder is shown;

[0010] Figure 3 for Figure 1 A schematic diagram of the structure of the occluding membrane of the occluder shown;

[0011] Figure 4 for Figure 1 Schematic diagram of the occluder in the sheath is shown;

[0012] Figure 5 for Figure 1 The schematic diagram of the structure of the occluder in a stretched state is shown;

[0013] Figure 6 for Figure 2 A partial enlarged view of

[0014] Figure 7 is a schematic structural diagram of a first distal disk of an occluder in another embodiment;

[0015] Figure 8 for Figure 7 A partial enlarged view of

[0016] Fig. 9 A schematic diagram of the routing of a second suture in one embodiment;

[0017] Fig.10 It is a schematic diagram of a fixing method of an occluding membrane, a proximal occluding membrane and a middle occluding membrane in one embodiment;

[0018] Fig.11 for Figure 1 The schematic diagram of the state in which the occluding membrane of the occluding device is fixed on the first proximal disk surface;

[0019] Figure 12a to Figure 12dA schematic diagram of a release process of an occluder according to an embodiment;

[0020] Figure 13a to Figure 13d A schematic diagram of a configuration of a first marking structure of an occluder on an occluding membrane according to an embodiment;

[0021] Fig.14 for Fig.13b and Fig.13c A schematic diagram of a released state of the occluder according to the embodiment shown;

[0022] Fig.15 The figure is a schematic diagram of a fixing method of an occluding membrane of an occluding device according to one embodiment. DETAILED DESCRIPTION

[0023] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0025] See also Figure 1 The occluder 100 of one embodiment includes a support net 10, a distal end cap 20, a proximal end cap 30 and an occluding membrane 40. The distal end cap 20 and the proximal end cap 30 are respectively disposed at both ends of the support net 10. The occluding membrane 40 is disposed in the support net 10.

[0026] In this embodiment, the support net 10 includes a distal blocking unit 11, a proximal blocking unit 12 and a waist 13, and the two ends of the waist 13 are respectively connected to the distal blocking unit 11 and the proximal blocking unit 12. The widths of the distal blocking unit 11 and the proximal blocking unit 12 are both greater than the width of the waist 13. In the natural state (also the state of blocking the heart defect), the support net 10 has a structure with large ends and a small middle, and the distal blocking unit 11 and the proximal blocking unit 12 are circular, and the waist 13 is roughly cylindrical.

[0027] Specifically, the distal blocking unit 11 includes a first distal disk 111, a first proximal disk 112, and a first ridge 113 connecting the first distal disk 111 and the first proximal disk 112. The proximal blocking unit 12 includes a second distal disk 121, a second proximal disk 122, and a second ridge 123 connecting the second distal disk 121 and the second proximal disk 122.

[0028] The distal end cap 20 is arranged on the distal end plugging unit 11, the proximal end cap 30 is arranged on the proximal end plugging unit 12, and the plugging membrane 40 is arranged in the distal end plugging unit 11. A distal marking structure 51 is arranged in the distal end cap 20. The distal marking structure 51 is used to mark the position of the distal end cap 20 during the implantation process. The material of the distal marking structure 51 is a material that is visible under X-ray imaging equipment such as DSA. It can be a metal material or a non-metallic material that is visible under X-ray imaging equipment such as DSA. For example, the material of the distal marking structure 51 is at least one of platinum, platinum alloy, gold, tantalum, iron, tungsten, stainless steel, nickel-titanium alloy, cobalt-chromium alloy, gold alloy, tungsten-based alloy and iron-based alloy. Alternatively, the material of the distal marking structure 51 can also be a non-metallic material such as sodium bromide and sodium iodide.

[0029] The shape of the distal marking structure 51 is not limited, as long as it can meet the setting requirement of the distal marking structure 51 being embedded in the distal head 20. Such a setting can prevent the distal marking structure 51 from falling off during transportation while meeting the visibility requirement.

[0030] The occluder 100 further includes a locking member 50. The locking member 50 is disposed in the support net 10, and one end of the locking member 50 is fixedly connected to the distal end cap 20, and the other end is detachably connected to the proximal end cap 30. A through hole is provided on the proximal end cap 30, and when the locking member 50 passes through the through hole and is connected to the proximal end cap 30, the distance between the distal end capping unit 11 and the proximal end capping unit 12 is fixed.

[0031] In this embodiment, the support net 10 is a woven structure. The support net 10 is formed by cross-weaving a plurality of polymer filaments, and the plurality of polymer filaments cross to form a plurality of circles of intersections. Each circle of intersections includes a plurality of intersections, and the plurality of intersections of the same circle of intersections are evenly distributed along the circumference of the circle (i.e., the distances between two adjacent intersections are equal), and each intersection is formed by the intersection of two groups of woven filaments with different rotation directions. The distal free ends of the polymer filaments of the support net 10 converge and are fixed in the distal end cap 20, and the proximal free ends of the polymer filaments converge and are fixed in the proximal end cap 30.

[0032] The material of the polymer filament can be a degradable material such as polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxyalkanoate (PHA), polydioxanone (PDO) or polycaprolactone (PCL).

[0033] In another embodiment, the support mesh 10 may also be woven from metal wires, for example, woven from nickel-titanium alloy wires.

[0034] The distal blocking unit 11, the proximal blocking unit 12 and the waist 13 of the support net 10 are all mesh structures.

[0035] like Figure 2 As shown, the braided wires of the first distal disk surface 111 cross to form multiple circles of intersections, and the multiple circles of intersections include the outermost circle intersection 110 ( Figure 2 The outermost circle dotted line represents the circumference) and the first circle intersection point 120 (which is closest to the outermost circle intersection point 110) Figure 2 The multiple circle intersections also include the second circle intersection, the third circle intersection, etc. The second circle intersection is located in the inner circle of the first circle intersection, the third circle intersection is located in the inner circle of the second circle intersection, and so on.

[0036] The weaving method of the first proximal disk 112, the second distal disk 121 and the second proximal disk 122 is the same as the weaving method of the first distal disk 111 mentioned above, and all include the outermost circle intersection point, the first circle intersection point and the second circle intersection point, the third circle intersection point, etc. which are closest to the outermost circle intersection point. The second circle intersection point is located in the inner ring of the first circle intersection point, the third circle intersection point is located in the inner ring of the second circle intersection point, and so on, which will not be repeated here.

[0037] See also Figure 3 The blocking film 40 is a circular sheet structure, and the size of the blocking film 40 is adapted to the size of the distal blocking unit 11, so that when the blocking film 40 is arranged in the distal blocking unit 11, the outer peripheral surface 41 of the blocking film 40 abuts against the inner surface of the first ridge 113 of the distal blocking unit 11 (such as Figure 1 As shown), it is beneficial to improve the occlusion effect and avoid residual shunt after the occluder 100 is implanted.

[0038] The occluding membrane 40 is fixed in the distal occluding unit 11. In this embodiment, the occluding device 100 further includes a first suture 211 and a second suture 212. The occluding membrane 40 is fixedly connected to the distal occluding unit 11 through the first suture 211 and the second suture 212, and the first suture 211 is closer to the edge of the first distal occluding unit 11 than the second suture 212, that is, the first suture 211 is closer to the outer peripheral surface 41 of the occluding membrane 40 than the second suture 212, so that when the occluding device 100 is loaded in the sheath tube 200 in a stretched state (such as Figure 4 As shown in FIG. 1 ), the center of the blocking film 40 extends toward the direction close to the distal end cap 20, and the edge of the blocking film 40 shrinks to form a bag-like structure (as shown in FIG. 1 ). Figure 4 and Figure 5 shown).

[0039] Please also read Figure 2 and Figure 6 Specifically, the occluding membrane 40 is sutured at the outermost intersection 110 and the first intersection 120 of the first distal disk surface 111 by the first suture 211. The suture position of the first suture 211 on the occluding membrane 40 is as follows: Figure 3 As shown in the circumference 410 and circumference 420 in FIG. The small circles on the circumference 410 and circumference 420 represent specific suture points. The multiple intersection points 2112 of the first suture 211 and the distal occlusion unit 11 are distributed on the outermost circle intersection point 110 and the first circle intersection point 120, that is, not on the same circumference and not on the same cross section.

[0040] For the occluder 100 woven from polymer filaments, since the polymer filaments themselves have no elasticity or weak elasticity, the resilience of the occluder 100 is poor. Under the action of external force, the grid is easily uneven and cannot return to the original shape. The occluding membrane 40 is easily displaced and deformed. Finally, after implantation into the human body, the occluding membrane 40 will have poor adhesion to the wall of the heart defect, thereby causing residual shunt. The above-mentioned external force comes from the pushing effect of the sheath opening on the intersection 2112 of the first suture 211 and the distal occluding unit 11 during the process of putting the occluder 100 into the sheath 200, causing the grid to be displaced and deformed along with the intersection 2112, and the edge of the occluding membrane 40 will also be displaced, deformed, curled, etc.

[0041] The first suture 211 and the multiple intersections 2112 of the distal occluding unit 11 are staggered so that the first suture 211 and the multiple intersections 2112 of the distal occluding unit 11 are not on the same circumference. In this way, the force of the sheath tube port on the intersection 2112 during the sheathing process of the occluder 100 can be dispersed, and the force can be dispersed on different cross sections, so that the resistance and squeezing effect of the sheath tube port on the first suture 211 and the occluding film 40 during the sheathing can be reduced. At the same time, due to the reduction in the number of intersections 2112 in the same cross section, the number of points of action of the sheath tube port on the first suture 211 is greatly reduced, and the possibility of the intersection of the first suture 211 and the occluding film 40 being displaced toward the distal end of the occluder 100 due to the sheath tube port pushing the intersection 2112 when the occluder 100 is retracted into the sheath tube 200 is reduced, thereby effectively reducing the possibility of the occluding film 40 curling phenomenon.

[0042] It should be noted that, in the present embodiment, the first suture 21 is a continuous suture, and in other embodiments, the first suture 21 may be a discontinuous suture. When the first suture 21 is a discontinuous suture, the first suture 211 and the distal occluding unit 11 form a plurality of dispersed intersections 2112, and there is no connection between any two intersections 2112. In this way, the first suture 211 and the plurality of intersections 2112 of the distal occluding unit 11 may be located on the same circumference, or may be distributed on different circumferences. Even if the first suture 211 and the plurality of intersections 2112 of the distal occluding unit 11 may be located on the same circumference, the possibility of curling of the occluding membrane 40 may be reduced.

[0043] In this embodiment, the intersections 2112 of the first sutures 211 on the outermost circle intersections 110 are distributed at equal intervals. The intersections 2112 of the first sutures 211 on the second circle intersections 120 are distributed at equal intervals.

[0044] In another embodiment, the intersections 2112 of the plurality of first sutures 211 on the outermost circle intersection 110 may be distributed at non-equidistant intervals. At this time, the intersections 2112 of the plurality of first sutures 211 on the second circle intersection 120 may be distributed at equal intervals or non-equidistant intervals.

[0045] In this embodiment, on the outermost circle intersection 110, all the intersections of the braided wire are the intersections 2112 of the first suture 211 and the first distal disk surface 111, that is, on the outermost circle intersection 110, all the intersections of the braided wire are entangled by the first suture 211. On the second circle intersection 110, all the intersections of the braided wire are the intersections 2112 of the second suture 212 and the first distal disk surface 111, that is, on the first circle intersection 120, all the intersections of the braided wire are entangled by the first suture 211. When suturing, taking the first suture 211 as an example, first hook a certain intersection of the outermost circle intersection 110, then walk to the intersection adjacent to the second circle intersection 120 to hook it, then walk to the intersection adjacent to the outermost circle intersection 110 to hook it, then walk to the intersection adjacent to the second circle intersection 120 to hook it, and alternately hook the two circle intersection nodes, repeat the above actions, and tie the two thread ends after walking the needle along the circumference for one circle.

[0046] In another embodiment, the stitching method may also be performed at one or several intersections, rather than each intersection intersecting with the first stitch line 211 or the second stitch line 222. Figure 7 and Figure 8The first suture 211 is sewn in the manner that the first suture 211 is sewn at every other intersection on the outermost circle intersection 110, and the first suture 211 is also sewn at every other intersection on the second circle intersection 120. When sewing, firstly, the first suture 211 is hooked at a certain intersection of the outermost circle intersection 110, and then the first suture 211 is moved to the intersection of the second circle intersection 120 and hooked, then one intersection is skipped up and down, and then the line is moved to the intersection of the outermost circle intersection 110 and hooked, and then the line is moved to the intersection adjacent to the second circle intersection 120 and hooked, and the above actions are repeated, and the two thread ends are knotted after the needle moves along the circumference for one circle. In this suturing method, the number of intersection points 2112 on the outermost intersection point 110 and the number of intersection points 2112 on the first intersection point 110 are reduced. Under the premise that the occluding membrane 40 is fixed in the distal occluding unit 11, the force exerted by the sheath tube port on the intersection points 2112 when the occluder 100 is sheathed can be reduced. This is because the fewer the intersection points 2112 on the same circular cross-section, the smaller the force, and the possibility of displacement and deformation of the occluding membrane 40 will be lower.

[0047] The second suture 212 may form only one intersection with the distal occluding unit 11 (eg Figure 5 As shown), it can also form multiple intersections with the distal blocking unit 11, see Fig. 9 The second suture 212 may be a continuous suture and form a plurality of intersections with the distal occluding unit 11, such as Fig. 9 and Fig.10 In this embodiment, the intersections of the second suture 212 and the distal occluding unit 11 are not on the same circumference, but are distributed on two circumferences, and the intersections of the second suture 212 and the distal occluding unit 11 are closer to the geometric center of the occluding membrane 40 than the intersections of the first suture 211 and the distal occluding unit 11. In another embodiment, the second suture 212 is a discontinuous suture, and the second suture 212 and the distal occluding unit 11 form a plurality of dispersed intersections, and there is no connection between any two intersections.

[0048] The second suture 212 is closer to the geometric center of the occluding membrane 40 than the first suture 211. The second suture 212 and the first suture 211 are set simultaneously in the above manner, which can ensure that when the occluder 100 is in a stretched state, the center of the occluding membrane 40 extends in a direction close to the distal end cap 20, and the edge of the occluding membrane 40 shrinks to form a bag-like structure. When the second suture 212 is a continuous suture or forms multiple intersections with the second suture 212 and the distal occluding unit 11, it is helpful to improve the reliability of the occluding membrane 40 shrinking into the above-mentioned bag-like structure. Furthermore, when the intersections of the second suture 212 and the distal occluding unit 11 are not on the same circumference, but are distributed on two circumferences, the reliability of the occluding membrane 40 shrinking into the above-mentioned bag-like structure is higher.

[0049] Please refer again Figure 1 The blocking film 40 is fixedly connected to the first distal disk surface 111 of the distal blocking unit 11 through the first suture 211 and the second suture 212, and the blocking film 40 is not fixedly connected to the first proximal disk surface 112 of the distal blocking unit 11. The blocking film 40 is only in physical contact with the first proximal disk surface 112 of the distal blocking unit 11.

[0050] Please refer again Figure 3 The suture points of the first suture 211 on the occluding membrane 40 are respectively on the circumference 410 and the circumference 420, wherein the distance between the circumference 410 and the outer peripheral surface 41 of the occluding membrane 40 (the distance from the outer edge of the occluding membrane 40) is 1 to 2 mm, so as to ensure that the first suture 211 and the occluding membrane 40 are reliably sutured without causing the first suture 211 to fall off from the edge of the occluding membrane 40, and avoid the curling phenomenon of the occluding membrane 40.

[0051] A distal through hole 42 is provided in the middle of the blocking membrane 40, and the aperture of the distal through hole 42 is adapted to the size of the locking member 50, so that the proximal end of the locking member 50 can pass through the distal through hole 42 and be detachably connected to the proximal end cap 30. In this embodiment, the distal through hole 42 is a circular hole. The aperture of the distal through hole 42 is 0.5 to 1 mm, so as to ensure that the locking member 50 can pass through while avoiding the opening being too large to affect the blocking effect of the blocking membrane 40. It can be understood that in other embodiments, the distal through hole 42 is not limited to a circular hole, and can be a through hole of other shapes, such as a square hole, a bar hole, a cross slit, etc.

[0052] Please refer again Figure 1 The occluder 100 further includes a first marking structure 52. The first marking structure 52 is disposed on the occluding membrane 40, and the first marking structure 52 is disposed on the surface of the occluding membrane 40 close to the proximal end cap 30. Figure 5 In this embodiment, the first marking structure 52 includes two first marking objects 522 arranged at intervals. In a natural state, the line connecting the two first marking objects 522 and the distal marking structure 51 is a triangle.

[0053] Taking atrial septal defect closure as an example, when the distal closure unit 11 is deployed in the left atrium LA, by adjusting the angle of the X-ray imaging device, a triangle can be formed between the distal marking structure 51 and the two first markers 522, such as Fig.12a As shown. Under the guidance of X-ray, the operator pulls the occluder 100 proximally to make it close to the position of the atrial septum 2. When the occluder 100 is pulled proximally until the first proximal disk 112 of the distal occluding unit 11 partially abuts against the atrial septum 2, the line connecting the two first markers 522 and the distal marker structure 51 still forms a triangle, as shown in FIG. Figure 12bAt this time, if the occluder 100 is still pulled, the two first markers 522 are close to the atrial septum 2 and their movement is restricted, while the movement of the distal end cap 20 is not restricted. In this case, the shape of the triangle formed by the distal marker structure 51 and the two first markers 522 will change, as shown in FIG. Fig.12c If the occluder 100 is still pulled at this time, the distal end closure head 20 may pass over the atrial septal defect position, which may easily cause the occluder 100 to fall off. Fig.12d As shown. Therefore, a distal marker structure 51 and a first marker structure 52 including two first markers 522 are provided, and in a natural state, the line connecting the two first markers 522 and the distal marker structure 51 is formed into a triangle. When the triangle changes into a straight line during operation, it means that the occluder 100 is well attached to the atrial septum 2, and the pulling operation can be stopped while continuing to release the proximal occluding unit 12 of the occluder 100. A distal marker structure 51 and a first marker structure 52 including two first markers 522 are provided, and in a natural state, the line connecting the two first markers 522 and the distal marker structure 51 is formed into a triangle, which is conducive to accurately positioning the occluder 100 and obtaining a better occluding effect. In addition, it can prevent the occluder 100 from falling off due to inaccurate positioning, thereby improving the safety of clinical application.

[0054] In one embodiment, see Fig.13a , the two first markers 522 are both located at the edge of the occluding membrane 40, and the length of the line connecting the two first markers 522 is equal to the diameter of the occluding membrane 40, that is, the two first markers 522 are located at the two ends of the same diameter of the occluding membrane 40. Such a setting is more conducive to accurately positioning the occluder 100, so as to improve the occluding effect and improve the safety of clinical application. Regardless of the shape of the occluding membrane 40, the two first markers 522 are located at the two points of the occluding membrane 40 with the largest distance in the radial direction, and the line connecting the two first markers 522 passes through the geometric center of the occluding membrane 40, so as to accurately determine whether the occluder 100 is attached to the defect site. It can be understood that in other embodiments, when the shape of the occluding membrane 40 is not circular, but other shapes, the two first markers 522 are still located at the two points of the occluding membrane 40 with the largest distance in the radial direction. For example, when the occluding membrane 40 is elliptical, the two first markers 522 are located at the two ends of the long axis of the elliptical occluding membrane 40.

[0055] In one embodiment, the first marker 522 is a circular metal sheet. For example, it can be a circular gold sheet, platinum sheet, stainless steel sheet, etc. Further, the thickness of the metal sheet is 50 to 500 microns and the diameter is 100 to 600 microns to ensure the visibility of the occluder 100 under X-ray imaging equipment such as DSA, and the metal sheet is not too large to affect the transportation of the occluder 100.

[0056] The first marking structure 52 is fixed on the surface of the blocking film 40 close to the proximal end cap 20 by bonding. In this way, the processing is relatively simple and the preparation efficiency is high.

[0057] In other embodiments, the number of first markers 522 is not limited to two, and may be more. For example, the number of first markers 522 is an even number in the range of 2 to 12. Fig.13b , multiple first markers 522 are arranged at intervals, and multiple first markers 522 are located on the same diameter of the occluding membrane 40, and the two first markers 522 with the largest distance are located at the two ends of the diameter. Since the sheath tube 200 is a cylindrical tube and has no directionality, during the operation, when the distal occluding unit 11 of the occluding device 100 is released, multiple first markers 522 are arranged on the same diameter of the occluding membrane 40 in the above manner, which can ensure that the occluding membrane 40 is located along the distal end of the occluding unit 11. Figure 5 On the cross section of the VI-VI line, the line connecting the two first markers 522 of the occluder 100 with the largest distance, that is, the diameter where the two first markers 522 are located, is perpendicular to the locking member 50, so that the line connecting the two first markers 522 with the largest distance and the distal marker structure 51 is a triangle. In this way, the surgical operation is relatively simple, which is conducive to reducing the operation of adjusting the angle of X-ray imaging equipment such as DSA, and can quickly locate the occluder 100.

[0058] In another embodiment, the plurality of first markers 522 are distributed circumferentially, such as Fig.13c As shown. The number of the first markers 522 is an even number greater than 2, and the even number of first markers 522 greater than 2 are arranged in pairs on the occluding membrane 40, and the connecting line of each pair of first markers 522 passes through the geometric center of the occluding membrane 40. Since the sheath tube 200 is a cylindrical tube with no directionality, when the distal occluding unit 11 of the occluding device 100 is released during the operation, the multiple first markers 522 are arranged symmetrically in pairs in the above manner, which can ensure that the occluding membrane 40 is located along the distal end of the occluding unit 11. Figure 5 On the cross section of the VI-VI line, the line connecting the two first markers 522 of the occluder 100, i.e., the diameter where the two first markers 522 are located, is perpendicular to the locking member 50, so that the line connecting the two first markers 522 with the largest distance and the distal marker structure 51 forms a triangle. In this way, the operation of adjusting the angle of X-ray imaging equipment such as DSA can be reduced, and the occluder 100 can be positioned more quickly.

[0059] It is understandable that in other embodiments, the number of the first markers 522 may also be an odd number, as long as the lines connecting at least two first markers 522 and the distal marking structure 51 form a triangle.

[0060] In another embodiment, the first marking structure 52 may also be ring-shaped, such as Fig.13d For example, the first marking structure 52 is a ring-shaped metal sheet, the outer ring diameter of the ring-shaped metal sheet is equal to the diameter of the blocking film 40, or the outer ring diameter of the ring-shaped metal sheet is smaller than the diameter of the blocking film 40, and the outer edge of the ring-shaped metal sheet is close to the outer edge of the blocking film 40 or the outer edge of the ring-shaped metal sheet coincides with the outer edge of the blocking film 40. In this way, it can also be ensured that in a natural state, along the Figure 5 On the cross section of the VI-VI line, the line connecting the two points with the largest distance between the first marking structure 52 of the occluder 100 is perpendicular to the locking member 50, so that the lines connecting the two ends of the annular metal sheet and the distal marking structure 51 form a triangle.

[0061] See also Fig.14 When multiple first markers 522 are located on the same diameter of the occluding membrane 40, the two first markers 522 with the largest distance are located at the two ends of the diameter or the multiple first markers 522 are distributed in a circle, a triangle can be formed between the distal marking structure 51 and the multiple first markers 522, which is conducive to the accurate release of the occluder 100.

[0062] The above-mentioned occluder 100 is provided with a distal marking structure 51 on the distal end cap 20 and a first marking structure 52 in the occluding film 40. The combination of the distal marking structure 51 and the first marking structure 52 is conducive to judging the overall shape of the occluder 100 and the accurate relative position of the occluder 100 and the defect site. In addition, in the delivery state, the distal marking structure 51 is embedded in the distal end cap 20, and the first marking structure 52 is located inside the bag-like structure formed by the occluding film 40, which can prevent the distal marking structure 51 and the first marking structure 52 from directly contacting the sheath tube 200, thereby preventing the distal marking structure 51 and the first marking structure 52 from rubbing and scratching against the inner wall of the sheath tube 200, which may cause the distal marking structure 51 and the first marking structure 52 to fall off.

[0063] It should be noted that in the present embodiment, the supporting mesh 10 of the occluder 100 is a structure of two disks and one waist. In other embodiments, the supporting mesh 10 may be other structures, such as a structure with a T-shaped cross-section, including an occluding disk and a waist connected to the occluding disk. In this case, the occluding membrane 40 is arranged in the occluding disk.

[0064] Please refer again Figure 1The occluder 100 also includes a proximal occluding membrane 60 to further improve the occluding effect and avoid the residual shunt phenomenon. The proximal occluding membrane 60 is arranged in the proximal occluding unit 12. The proximal occluding membrane 60 is also a circular sheet structure, and the size of the proximal occluding membrane 60 is adapted to the size of the proximal occluding unit 12, so that when the proximal occluding membrane 60 is arranged in the proximal occluding unit 12, the outer peripheral surface of the proximal occluding membrane 60 abuts against the inner surface of the second ridge 123 of the proximal occluding unit 12, which is beneficial to improve the occluding effect and avoid the residual shunt after the occluder 100 is implanted.

[0065] The proximal occluding membrane 60 is fixed in the proximal occluding unit 12. In this embodiment, the occluder 100 further includes a third suture 213 and a fourth suture 214. The proximal occluding membrane 60 is fixedly connected to the proximal occluding unit 12 through the third suture 213 and the fourth suture 214, and the third suture 213 is closer to the outer peripheral surface of the proximal occluding membrane 60 than the fourth suture 214, so that when the occluder 100 is loaded in the sheath 200 in a stretched state, the center of the proximal occluding membrane 60 extends toward the direction close to the distal end cap 20, and the edge of the proximal occluding membrane 60 shrinks to form a bag-like structure, such as Figure 5 shown.

[0066] The fixing method of the proximal blocking membrane 60 in the proximal blocking unit 12 is substantially the same as the fixing method of the blocking membrane 40 in the distal blocking unit 11 .

[0067] Specifically, the proximal occluding membrane 60 is sutured to the outermost intersection and the first intersection of the second distal disk 121 by the third suture 213. The intersections of the third suture 213 and the proximal occluding unit 12 are distributed at the outermost intersection and the first intersection, that is, not on the same circumference and not on the same cross section.

[0068] The third suture 213 and the multiple intersections of the proximal occluding unit 12 are staggered so that the multiple intersections of the third suture 213 and the proximal occluding unit 12 are not on the same circumference. In this way, the force of the sheath tube port on the intersection during the sheathing process of the occluder 100 can be dispersed, and the force can be dispersed on different cross sections, so that the resistance and squeezing effect of the sheath tube port on the third suture 213 and the proximal occluding film 60 during the sheathing can be reduced. At the same time, due to the reduction in the number of intersections in the same cross section, the number of points of action of the sheath tube port on the third suture 213 is greatly reduced, and the possibility of the intersection of the third suture 213 and the proximal occluding film 60 being displaced toward the distal end of the occluder 100 due to the sheath tube port pushing the intersection when the occluder 100 is retracted into the sheath tube 200 is reduced, thereby effectively reducing the possibility of curling of the proximal occluding film 60.

[0069] The fourth suture 214 may form only one intersection with the proximal occluding unit 12, or may form multiple intersections with the proximal occluding unit 12. The fourth suture 214 may be a continuous suture, and may form multiple intersections with the proximal occluding unit 12. In this embodiment, the intersections of the fourth suture 214 and the proximal occluding unit 12 are not on the same circumference, but are distributed on two circumferences. In another embodiment, the fourth suture 214 is a discontinuous suture, and the fourth suture 214 forms one or more scattered intersections with the proximal occluding unit 12, and there is no connection between any two intersections.

[0070] Please refer again Figure 1 The proximal occluding membrane 60 is fixedly connected to the second distal disk 121 of the proximal occluding unit 12 through the third suture 213 and the fourth suture 214, and the proximal occluding membrane 60 is not fixedly connected to the second proximal disk 122 of the proximal occluding unit 12, and the two are only in physical contact. In this way, it can be avoided that when the occluder 100 is axially stretched, the edge of the proximal occluding membrane 60 is turned up to form two layers of curling.

[0071] The suture points of the third suture 213 on the proximal occluding membrane 60 are on the same circumference, and the distance between the circumference and the outer circumference of the proximal occluding membrane 60 is 1 to 2 mm, so as to ensure that the third suture 213 and the proximal occluding membrane 60 are reliably sutured without the third suture 213 falling off from the edge of the proximal occluding membrane 60, and avoid curling of the proximal occluding membrane 60.

[0072] The fixing method and routing method of the third suture 213, the fourth suture 214, the proximal occluding membrane 60 and the second distal disk 121 can be set according to the fixing method and routing method of the first suture 211, the second suture 212, the occluding membrane 40 and the first distal disk 111 described above. However, it should be noted that on the same occluder 100, the fixing method and routing method of the third suture 213, the fourth suture 214, the proximal occluding membrane 60 and the second distal disk 121 can be the same as or different from the fixing method and routing method of the first suture 211, the second suture 212, the occluding membrane 40 and the first distal disk 111. For example, at the outermost intersection 110 of the first distal disk 111, all intersections of the braided wire are wrapped by the first suture 211, while at the outermost intersection of the second distal disk 121, all intersections of the braided wire may be wrapped by the third suture 213, or only some intersections of the braided wire may be wrapped by the third suture 213.

[0073] In one embodiment, a proximal through hole is formed in the middle of the proximal blocking film 60 for the locking member 50 to pass through. The shape of the proximal through hole is not limited and can be the same as or different from the shape of the distal through hole 42. The diameter of the proximal through hole is 0.5 to 1 mm.

[0074] In one embodiment, the occluder 100 further includes a second marking structure 53. The second marking structure 53 is disposed on the surface of the proximal occluding membrane 60 close to the proximal sealing head 30, so that in the stretched state, the second marking structure 53 is located inside the bag-like structure formed by the proximal occluding membrane 60.

[0075] The structure of the second marking structure 53 is the same as that of the first marking structure 52 , and the second marking structure 53 is fixed on the surface of the proximal occluding membrane 60 close to the proximal end cap 20 by bonding.

[0076] In one embodiment, see Figure 5 , the second marking structure 53 includes a plurality of second markers 532. The second marker 532 is a circular metal sheet with a thickness of 50 to 500 microns and a diameter of 100 to 600 microns. The second marking structure 53 includes an even number of second markers 532 in the range of 2 to 12, and the plurality of second markers 532 are arranged at intervals along the circumference, and the even number of second markers 532 are arranged in pairs on the proximal occluding membrane 60, and the connecting line of each pair of second markers 532 passes through the geometric center of the proximal occluding membrane 60. Alternatively, the plurality of second markers 532 are arranged at intervals on the same diameter of the proximal occluding membrane 60, and the two second markers 532 with the largest distance are located at both ends of the diameter. In this embodiment, the number of second markers 532 is two, and the two second markers 532 are located at both ends of the same diameter of the proximal occluding membrane 60, and the connecting line of the two second markers 532 passes through the geometric center of the proximal occluding membrane 60.

[0077] It is understandable that in other embodiments, the number of the second markers 532 may also be an odd number, as long as the lines connecting at least two second markers 532 and the distal marking structure 51 form a triangle.

[0078] In another embodiment, the second marking structure 53 is annular. For example, the second marking structure 53 is an annular metal sheet. In this case, the size of the second marking structure 53 and the location of the second marking structure 53 on the proximal occluding film 60 are the same as the size of the first marking structure 52 and the location of the first marking structure 52 on the occluding film 40, and will not be described in detail.

[0079] Please refer again Figure 1In one embodiment, the occluder 100 further includes a middle occluding membrane 70 to further improve the occluding effect and avoid residual shunt. The middle occluding membrane 70 is arranged in the waist 13. The middle occluding membrane 70 is also a circular sheet structure, and the size of the middle occluding membrane 70 is adapted to the size of the waist 13, so that when the middle occluding membrane 70 is arranged in the waist 13, the outer peripheral surface of the middle occluding membrane 70 abuts against the inner surface of the waist 13, which is conducive to improving the occluding effect and avoiding residual shunt after the occluder 100 is implanted.

[0080] See also Fig.10 In this embodiment, the occluder 100 further includes a fifth suture 215 and a sixth suture ( Fig.10 The middle occluding membrane 70 is fixedly connected to the waist 13 by the fifth suture 215 and the sixth suture, and the fifth suture 215 is closer to the distal end cap 20 than the sixth suture, so that when the occluder 100 is loaded in the sheath 200 in a stretched state, the center of the middle occluding membrane 70 extends toward the direction close to the distal end cap 20, and the edge of the middle occluding membrane 70 shrinks to form a bag-like structure.

[0081] The fixing method of the middle blocking membrane 70 in the waist 13 is substantially the same as the fixing method of the blocking membrane 40 in the distal blocking unit 11 .

[0082] Specifically, the middle occluding membrane 70 is sutured to the intersection of two adjacent circles in the middle of the waist 13 through the fifth suture 215. The intersection of the fifth suture 215 and the waist 13 is not on the same circumference and the same cross section.

[0083] The multiple intersections of the fifth suture 215 and the waist 13 are staggered so that the multiple intersections of the fifth suture 215 and the waist 13 are not on the same circumference. In this way, the force of the sheath tube port on the intersection of the sutures during the sheathing process of the occluder 100 can be dispersed, and the force can be dispersed on different cross sections, so that the resistance and squeezing effect of the sheath tube port on the fifth suture 215 and the middle occluding membrane 70 during the sheathing can be reduced. At the same time, due to the reduction in the number of intersections in the same cross section, the number of points of action of the sheath tube port on the fifth suture 215 is greatly reduced, and the possibility of the intersection of the fifth suture 215 and the middle occluding membrane 70 being displaced toward the distal end of the occluder 100 due to the sheath tube port pushing the intersection when the occluder 100 is retracted into the sheath is reduced, thereby effectively reducing the possibility of the middle occluding membrane 70 curling phenomenon.

[0084] It should be noted that, in another embodiment, the intersection of the fifth suture 215 and the waist 13 can be located on the same circumference. Since the diameter of the waist 13 is relatively small, the size of the middle occluding membrane 70 is also relatively small. When the occluder 100 is stretched into the sheath, relative to the distal occluding unit 11 and the proximal occluding unit 12, the waist 13 will not generate a large sheathing force when entering the sheath tube 200. In addition, since the waist 13 is roughly cylindrical, it is difficult for the middle occluding membrane 70 to fit strictly with the waist 13. Compared with the distal occluding unit 11 and the proximal occluding unit 12, it is not easy to produce grid deformation and cause the middle occluding membrane 70 to shift or curl.

[0085] The sixth suture may form only one intersection with the waist 13, or may form multiple intersections with the waist 13. The sixth suture may be a continuous suture, and may form multiple intersections with the waist 13. In this embodiment, the intersections of the sixth suture and the waist 13 are not on the same circumference, but are distributed on two circumferences. In another embodiment, the sixth suture is a discontinuous suture, and the sixth suture 216 forms multiple scattered intersections with the waist 13, and there is no connection between any two intersections.

[0086] In one embodiment, a middle through hole is provided in the middle of the middle blocking film 70 for the locking member 50 to pass through. The shape of the middle through hole is not limited, and can be the same as or different from the shape of the through hole 42. The diameter of the middle through hole is 0.5 to 1 mm. The locking member 50 passes through the distal through hole 42, the middle through hole and the proximal through hole in sequence and is detachably connected to the proximal end cap 30.

[0087] In one embodiment, the occluder 100 further includes a third marking structure 54. The third marking structure 54 is disposed on the surface of the middle occluding membrane 70 close to the proximal end cap 30, so that in the stretched state, the third marking structure 54 is located inside the bag-like structure formed by the middle occluding membrane 70.

[0088] The structure of the third marking structure 54 is the same as that of the first marking structure 52 , and the third marking structure 54 is fixed on the surface of the middle blocking membrane 70 close to the proximal end cap 30 by bonding.

[0089] Please also read Figure 1 and Figure 5In one embodiment, the third marking structure 54 includes a plurality of third markers 542. The third marker 542 is a circular metal sheet with a thickness of 50 to 500 microns and a diameter of 100 to 600 microns. In one embodiment, the third marking structure 54 includes an even number of third markers 542 in the range of 2 to 12, and the plurality of third markers 542 are arranged at intervals along the circumference, and the even number of third markers 542 are arranged in pairs on the middle blocking film 70, and the connecting line of each pair of third markers 542 passes through the geometric center of the middle blocking film 70. Alternatively, the plurality of third markers 542 are arranged at intervals on the same diameter of the middle blocking film 70, and the two third markers 542 with the largest distance are located at both ends of the diameter. In this embodiment, the number of the third markers 542 is two, and the two third markers 542 are located at both ends of the same diameter of the middle blocking film 70, and the connecting line of the two third markers 542 passes through the geometric center of the middle blocking film 70.

[0090] It is understandable that in other embodiments, the number of the third markers 542 may also be an odd number, as long as the lines connecting at least two third markers 542 and the distal marking structure 51 form a triangle.

[0091] In another embodiment, the third marking structure 54 is annular. For example, the third marking structure 54 is an annular metal sheet. In this case, the size of the third marking structure 54 and the location of the third marking structure 54 on the middle blocking film 70 are the same as the size of the first marking structure 52 and the location of the first marking structure 52 on the blocking film 40, and will not be repeated here.

[0092] In one embodiment, the occluder 100 further includes a proximal marking structure 55, which is embedded in the proximal end cap 30. The proximal end cap 30 is detachably connected to the delivery cable 300. During implantation, the proximal end cap 30 is fixedly connected to the delivery cable 300 (e.g., Figure 4 After implantation, and after the occluder 100 is completely released and attached to the defect, the proximal end cap 30 is separated from the delivery cable 300. The proximal marking structure 55 is provided to assist in identifying the overall shape of the occluder 100, and is helpful in determining whether the occluder 100 is successfully separated from the delivery cable 300, so as to ensure the smooth progress of the implantation operation. In addition, when an extreme situation occurs, the distal marking structure 51 and the proximal marking structure 55 are provided at the same time, which is conducive to the recovery of the occluder 100.

[0093] Further, the proximal marking structure 55 can be embedded on the wall of the proximal end cap 30, or can be embedded in the inner cavity of the proximal end cap 30. When the proximal marking structure 55 is embedded in the inner cavity of the proximal end cap 30, the proximal marking structure 55 is annular, so that the locking member 50 passes through the proximal end cap 30.

[0094] The above-mentioned occluder 100 is provided with a distal marking structure 51 and a first marking structure 52, wherein the distal marking structure 51 is provided on the distal end cap 20, and the first marking structure 52 is provided on the occluding film 40, so as to avoid only realizing auxiliary positioning or marking of the local position of the occluder 100, but failing to help judge the overall, three-dimensional form of the occluder 100 during the delivery process and after release. Moreover, in the delivery state, the distal marking structure 51 is embedded in the distal end cap 20, and the first marking structure 52 is located inside the bag-like structure formed by the occluding film 40, so as to avoid the distal marking structure 51 and the first marking structure 52 from directly contacting the sheath 200, thereby avoiding the distal marking structure 51 and the first marking structure 52 from rubbing and scratching against the inner wall of the sheath 200, which may cause the distal marking structure 51 and the first marking structure 52 to fall off. Furthermore, the occluder 100 also includes a proximal occluding film 60 and / or a middle occluding film 70, which can further improve the occluding effect. In addition, the thickness distribution of the occluding film 40, the proximal occluding film 60 and the middle occluding film 70 is controlled within the range of 5 to 100 microns, so that the radial dimension of the occluder 100 in the stretched state is not too large to excessively increase the matching dimension of the sheath 200 while ensuring the occluding effect. In one embodiment, the thickness distribution of the occluding film 40, the proximal occluding film 60 and the middle occluding film 70 is 20 to 70 microns.

[0095] Further, the proximal occluding film 60 is provided with a second marking structure 53 and / or the middle occluding film 70 is provided with a third marking structure 54. Compared with the method of only locally providing the marking structure, the marking structure is dispersed on the proximal end cap 20, the occluding film 40, the proximal occluding film 60 and the middle occluding film 70, so that the marking structure matches the contour configuration of the occluder 100, which is beneficial for the operator to judge the release position and form of the occluder 100 as a whole. Further, when the occluding film 40 is provided with a first marking structure 52, the proximal occluding film 60 is provided with a second marking structure 53, and the middle occluding film 70 is provided with a third marking structure 54, the first marking structure 52 includes two first markers 522 provided at two ends of the same diameter on the occluding film 40, the second marking structure 53 includes two second markers 532 provided at two ends of the same diameter on the proximal occluding film 60, and the third marking structure 54 includes two third markers 542 provided at two ends of the same diameter on the middle occluding film 70. The first marker 522, the second marker 532 and the third marker 542 are all circular metal sheets with a thickness of 50 to 500 microns and a diameter of 100 to 600 microns. The above arrangement ensures that the line connecting the two first markers 522 and the distal marking structure 51 on the distal end cap 20 changes from a triangle to a straight line so that the operator can accurately determine the relative position of the distal occluding unit 11 and the atrial septum 2, and can accurately identify the overall shape of the occluder 100, which is conducive to more accurate release of the occluder 100, and does not increase the radial size or total volume of the occluder 100 in the stretched state, thereby ensuring that the occluder 100 can be smoothly delivered.

[0096] It can be understood that in other embodiments, the proximal occluding membrane 60 and / or the middle occluding membrane 70 can be omitted, and the effect of blocking blood flow can also be achieved by only providing the occluding membrane 40 in the distal occluding unit 11.

[0097] It can be understood that in other embodiments, when the occluder 100 further includes a proximal occluding film 60 and / or a middle flow-blocking film 70, the second marking structure 53 on the proximal occluding film 60 and / or the third marking structure 54 on the middle flow-blocking film 70 can be omitted. The occluder 100 can also be accurately positioned by cooperating with the distal marking structure 51 and the first marking structure 52.

[0098] It should be noted that the occluding membrane 40 is fixed to the first distal disk 111 of the distal occluding unit 11 by the first suture 211 and the second suture 212, the proximal occluding membrane 60 is fixed to the second distal disk 121 of the proximal occluding unit 12 by the third suture 213 and the fourth suture 214, and the middle occluding membrane 70 is fixed to the waist 13 by the fifth suture 215 and the sixth suture, so that in the stretched state, the centers of the occluding membrane 40, the proximal occluding membrane 60 and the middle occluding membrane 70 all extend toward the direction close to the distal head 20, and the edges of the three shrink to form bag-like structures respectively, thereby better avoiding the first marking structure 52 on the occluding membrane 40, the second marking structure 53 on the proximal occluding membrane 60 and the third marking structure 54 on the middle occluding membrane 70 from scratching the inner wall of the sheath 200. In other embodiments, the first suture 211, the second suture 212, the third suture 213, the fourth suture 214, the fifth suture 215 and / or the sixth suture 216 may be omitted, and the above-mentioned effect may be achieved by bonding the occluding membrane 40, the proximal occluding membrane 60 and the middle occluding membrane 70 to corresponding positions with an adhesive.

[0099] Specifically, the adhesive forms a first fixed node and a second fixed node on the occluding membrane 40, and the first fixed node and the second fixed node are used to connect the occluding membrane 40 and the first distal disk 111 of the distal occluding unit 11, and the second fixed node is farther away from the outer peripheral surface of the occluding membrane 40 than the first fixed node, that is, the second fixed node is closer to the geometric center of the occluding membrane 40 than the first fixed node. The adhesive forms a third fixed node and a fourth fixed node on the proximal occluding membrane 60 to connect the proximal occluding membrane 60 and the second distal disk 121, and the fourth fixed node is farther away from the outer peripheral surface of the proximal occluding membrane 60 than the third fixed node, that is, the fourth fixed node is closer to the geometric center of the proximal occluding membrane 60 than the third fixed node. In this way, the occluding device 100 can also be stretched in the axial state, and the centers of the occluding membrane 40 and the proximal occluding membrane 60 both extend in the direction close to the distal end cap 20, and the edges of the two shrink to form bag-like structures respectively.

[0100] It should be noted that when the occluder 100 is an occluder that can be degraded in a living body and the degradation products can be absorbed by the living body, the occluding membrane 40, the proximal occluding membrane 60 and the middle occluding membrane 70 are made of bioabsorbable materials. Correspondingly, the first suture 211, the second suture 212, the third suture 213, the fourth suture 214, the fifth suture 215 and the second six sutures are all made of bioabsorbable materials. When the occluding membrane 40 and the proximal occluding membrane 60 are fixed to the distal occluding unit 11 and the proximal occluding unit 12 by means of adhesive distribution, the adhesive is a bioabsorbable occluder.

[0101] It can be understood that in other embodiments, the blocking film 40 can be fixed on the first distal disk 112 of the distal blocking unit 11, and the first marking structure 52 is arranged on the surface of the blocking film 40 close to the distal end cap 20. The proximal blocking film 60 can also be fixed on the second proximal disk 122 of the proximal blocking unit 12, and the third marking structure 53 is arranged on the surface of the proximal blocking film 60 close to the distal end cap 20. In the stretched state, when the blocking film 40 and the proximal blocking film 60 are deformed to form a bag-like structure, the first marking structure 52 is located inside the bag-like structure, and the third marking structure 53 is also located inside the bag-like structure. In this way, the first marking structure 52 and the third marking structure 53 can also avoid friction and scratches with the sheath.

[0102] However, when the occluding membrane 40 is fixed on the first distal disk 112 of the distal occluding unit 11, in the stretched state, the occluding membrane 40 is deformed and approaches the middle occluding membrane 70 in the waist 13. Since the waist 13 is relatively small in size, no matter how the middle occluding membrane 70 is deformed, it is possible that the occluding membrane 40 and the middle occluding membrane 70 overlap, and the cross-sectional area of ​​the overlapping portion increases, which will increase the sheath resistance of the occluder 100 or increase the sheath specifications. When the proximal blocking membrane 60 is fixed on the second proximal disk 122 of the proximal blocking unit 12, in the stretched state, the proximal blocking membrane 70 is deformed and approaches the proximal head 30. In the process of the occluder 100 changing from the stretched state to the natural state, when the locking piece 50 is fastened, the proximal blocking membrane 70 blocks the opening of the proximal head 30, resulting in the locking piece 50 being unable to smoothly extend into the proximal head 30, so that the locking piece 50 is unable to lock the proximal blocking unit 11 and the distal blocking unit 12, resulting in the occluder 100 being unable to be formed.

[0103] And, if Fig.15 As shown, when the occluding membrane 40 is fixed on the first proximal disk 112 and the occluder 100 is stretched into the sheath, the distal occluding unit 11 is subjected to a pulling force directed toward the distal end cap 20, and at the same time, the first suture 211 and the second suture 212 ( Fig.15 The occluding film 40 is pulled by the suture position of the occluding film 40 and prevented from extending and deforming in the direction close to the distal end cap 20, which makes it difficult for the suture position of the occluding film 40 to extend in the direction close to the distal end cap 20, so that a two-layer curling phenomenon will occur. The two-layer curling phenomenon causes the cross-sectional area of ​​the stretched occluder 100 to increase, thereby increasing the matching size of the sheath tube 200, and ultimately increasing the risk of damage to the blood vessel during transportation. In addition, when the matching size of the sheath tube 200 increases to a certain extent, it may not be suitable for patients with smaller blood vessels.

[0104] The occluding membrane 40 of the above-mentioned occluder 100 is fixed on the first distal disk 111 of the distal occluding unit 11, so that in the stretched state, the center of the occluding membrane 40 extends in the direction close to the distal end cap 20, and the edge of the occluding membrane 40 shrinks to form a bag-like structure, which can avoid the occluding membrane 40 and the middle occluding membrane 70 overlapping, thereby increasing the sheath resistance of the occluder 100 or increasing the sheath specifications. The proximal occluding membrane 60 is fixed on the second distal disk 121 of the proximal occluding unit 12, so that in the stretched state, the proximal occluding membrane 60 is deformed and away from the distal occluding membrane 60, which is conducive to avoiding the proximal occluding membrane 60 blocking the through hole of the proximal end cap 30 in the process of the occluder 100 changing from the stretched state to the natural state, resulting in the occluder 100 being unable to be formed, and at the same time, it can avoid the occluding membrane 40 from curling. Therefore, in one embodiment, the blocking film 40 is fixed to the first distal disk surface 111 of the distal blocking unit 11 by the first suture 211 and the second suture 212 (or the first fixed node and the second fixed node formed by the adhesive), the proximal blocking film 60 is fixed to the second distal disk surface 121 of the proximal blocking unit 12 by the third suture 213 and the fourth suture 214 (or the third fixed node and the fourth fixed node formed by the adhesive), and the middle blocking film 70 is fixed to the waist 13 by the fifth suture 215 and the sixth suture, so that in the stretched state, the centers of the blocking film 40, the proximal blocking film 60 and the middle blocking film 70 all extend in the direction close to the proximal head 20, as shown in FIG. Fig.10 Furthermore, by respectively controlling the positions of the first marking structure 52, the second marking structure 53 and the third marking structure 54 on the occluding film 10, the proximal occluding film 60 and the middle occluding film 70, the occluder 100 can be accurately positioned during the implantation operation and the friction and scratch between the first marking structure 52, the second marking structure 53 and the third marking structure 54 and the sheath tube 200 can be avoided. In addition, the sheathing resistance of the occluder 100 can be reduced, and the occluder 100 can be smoothly changed from the stretched state to the natural state (i.e., the occluding state), thereby achieving the occlusion of the defect.

[0105] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0106] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An occluder, comprising a support net, a distal end cap and a proximal end cap, wherein the distal end cap and the proximal end cap are respectively arranged at two ends of the support net, and a distal end marking structure is embedded in the distal end cap, characterized in that: It also includes an occluding membrane arranged in the supporting net, and a first marking structure is arranged on the surface of the occluding membrane. When the occluder is in a stretched state, the center of the occluding membrane extends toward the distal end cap or toward the proximal end cap, and the edge of the occluding membrane shrinks to form a bag-like structure, and the first marking structure is located inside the bag-like structure.

2. The occluder according to claim 1, characterized in that: The first marking structure includes at least two first markers. In the natural state of the occluder, the line connecting the at least two first markers and the distal marking structure forms a triangle.

3. The occluder according to claim 1, characterized in that: The supporting net includes a distal blocking unit, a proximal blocking unit and a waist, the two ends of the waist are respectively connected to the distal blocking unit and the proximal blocking unit, the distal head is arranged on the distal blocking unit, the proximal head is arranged on the proximal blocking unit, and the blocking membrane is arranged in the distal blocking unit.

4. The occluder according to claim 3, characterized in that: The occluder also includes a locking piece arranged in the supporting net, one end of the locking piece is fixedly connected to the distal end sealing head, and the other end of the locking piece is detachably connected to the proximal end sealing head.

5. The occluder according to any one of claims 3 or 4, characterized in that: The distal blocking unit includes a first distal disk, a first proximal disk, and a first ridge connecting the first distal disk and the first proximal disk, and the blocking membrane is disposed in the distal blocking unit. The occluder further includes a first suture and a second suture, the occluding membrane and the distal occluding unit are fixedly connected via the first suture and the second suture, the first suture and the second suture are arranged at intervals, and the second suture is farther away from the outer peripheral surface of the occluding membrane than the first suture; or, The blocking membrane is fixedly connected to the distal blocking unit by an adhesive, and the adhesive forms a first fixed node and a second fixed node on the blocking membrane. The first fixed node and the second fixed node are used to connect the blocking membrane and the distal blocking unit, and the second fixed node is farther away from the outer peripheral surface of the blocking membrane than the first fixed node.

6. The occluder according to claim 5, characterized in that: The first marking structure is disposed on the surface of the occluding membrane close to the proximal end cap; The blocking membrane is fixedly connected to the first distal disk surface of the distal blocking unit through the first suture and the second suture, and the blocking membrane is not fixedly connected to the first proximal disk surface of the distal blocking unit; or, The blocking membrane is connected to the first distal disk surface of the distal blocking unit via the first fixed node and the second fixed node, and the blocking membrane is not fixedly connected to the first proximal disk surface of the distal blocking unit.

7. The occluder according to claim 5, characterized in that: The intersection point of the first suture and the distal occluding unit is not on the same circumference.

8. The occluder according to claim 4, characterized in that: The proximal blocking unit includes a second distal disk, a second proximal disk and a second ridge connecting the second distal disk and the second proximal disk. The blocking membrane also includes a proximal blocking membrane. The proximal blocking membrane is arranged in the proximal blocking unit, and the outer peripheral surface of the proximal blocking membrane abuts against the inner surface of the second ridge.

9. The occluder according to claim 8, characterized in that: The occluder further comprises a third suture and a fourth suture, the proximal occluding membrane is fixed to the second distal disk surface of the proximal occluding unit by the third suture and the fourth suture, and the fourth suture is farther away from the outer peripheral surface of the proximal occluding membrane than the third suture; or The proximal blocking membrane is fixedly connected to the second distal disk of the proximal blocking unit by an adhesive, and the adhesive forms a third fixed node and a fourth fixed node on the proximal blocking membrane connecting the proximal blocking membrane and the second distal disk, and the fourth fixed node is farther away from the outer peripheral surface of the proximal blocking membrane than the third fixed node.

10. The occluder according to claim 9, characterized in that: The intersection point of the third suture line and the second distal disk surface is not on the same circumference.

11. The occluder according to claim 8, characterized in that: The occluder further includes a second marking structure, which is disposed on the surface of the proximal occluding membrane.

12. The occluder according to claim 11, characterized in that: The second marking structure includes at least two second markers. In the natural state of the occluder, the line connecting the at least two second markers and the distal marking structure forms a triangle.

13. The occluder according to claim 10, characterized in that: The occluder further includes a middle occluding membrane, which is arranged in the waist portion, and the outer peripheral surface of the middle occluding membrane abuts against the inner wall of the waist portion.

14. The occluder according to claim 13, characterized in that: The occluder also includes a fifth suture, the middle occluding membrane and the waist are fixedly connected through the fifth suture, and the intersection of the fifth suture and the waist is not on the same cross section.

15. The occluder according to claim 14, characterized in that: The occluder also includes a sixth suture, which fixes the middle occluding membrane to the waist, and the sixth suture is closer to the distal end closure head than the fifth suture.

16. The occluder according to claim 14, characterized in that: The occluder further comprises a third marking structure. In the natural state of the occluder, the third marking structure is arranged on the surface of the middle occluding membrane.

17. The occluder according to claim 16, characterized in that: The third marking structure includes at least two third markers. In the natural state of the occluder, the line connecting the at least two third markers and the distal marking structure forms a triangle.

18. The occluder according to claim 13, characterized in that: The blocking membrane is provided with a distal through hole, the middle blocking membrane is provided with a middle through hole, and the proximal blocking membrane is provided with a proximal through hole. The locking piece passes through the distal through hole, the middle through hole and the proximal through hole in sequence and is detachably connected to the proximal head.

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