Occluders and occlusion systems

Abstract

The present invention provides an occluder comprising an occluding member and a tightening member. The occluding member comprises at least one occluding disc, the at least one occluding disc being used to cover the atrial septal channel of the atrial septal tissue, and the tightening member securing the at least one occluding disc to the atrial septal tissue. The occluding disc can stably adhere to the surface of the atrial septal tissue and cover the atrial septal channel, effectively preventing displacement or detachment of the occluding disc and reducing the generation of residual shunts. The present invention also provides an occluding system for delivering and releasing the occluder.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an occluder and a occlusion system for occluding an atrial septal channel, defect, or opening in the human body. The occluder can occlude a patent foramen ovale, a patent ductus arteriosus, an atrial septal defect, a ventricular septal defect, and the like. Background Art

[0002] A patent foramen ovale (PFO) is a malformation in which the foramen ovale valve fails to adhere and fuse with the septum secundum after birth, fully closing the foramen ovale and resulting in a horizontal atrial shunt. In some healthy adults, the two layers of the septum in the fossa ovale fail to fully fuse, leaving a permanent, fissure-like defect in between. This forms a PFO.

[0003] With the advancement of science and technology, especially the development of cardiac catheterization technology, transcatheter interventional occluders have become an important method for minimally invasive treatment of congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus and patent foramen ovale. Transcatheter interventional occluders are medical devices commonly used in transcatheter interventional treatment methods. The occluders in the prior art generally include two parallel disc occluding surfaces. After release, they are only fixed by clamping the two disc occluding surfaces. For the shapes and thicknesses of residual walls of different structures and tunnels of different lengths, the use of a double disc occluding surface with a uniform contour will inevitably not be able to automatically adapt. In addition, the occluder may deform and has poor resilience. The occluder with a double disc occluding surface is at risk of displacement, defect, or even falling off. When the occluder is displaced or defective, the occluder with a double disc occluding surface may produce residual shunts due to the deformation of the double disc occluding surface for defects of unequal or uneven widths due to the parallel double disc surfaces. Summary of the Invention

[0004] An object of the present invention is to provide an occluder capable of reducing residual shunt, and an occluding system for releasing the occluder.

[0005] In order to solve the above technical problems, the present invention provides an occluder, which includes an occluding member and a tightening member, wherein the occluding member includes at least one occluding disk, at least one of the occluding disks is used to cover the atrial septal channel of the atrial septal tissue, and the tightening member fixes at least one of the occluding disks to the atrial septal tissue.

[0006] The present invention further provides an occlusion system, which includes an occlusion device. The occlusion system also includes a delivery device and a suturing device. The delivery device is used to release the occlusion member, and the suturing device is used to release the tightening member.

[0007] The occluding disc of the occluder provided by the present invention covers the atrial septal channel of the atrial septal tissue, and the tightening member secures the occluding disc to the atrial septal tissue. Therefore, the occluding disc can stably adhere to the surface of the atrial septal tissue and cover the atrial septal channel, effectively preventing displacement or dislodgment of the occluding disc and reducing the generation of residual shunts. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0009] Figure 1 It is a schematic structural diagram of the occluder provided by the first embodiment of the present invention when released.

[0010] Figure 2 It is a schematic diagram of one structure of the supporting frame of the occluder provided in the first embodiment of the present invention.

[0011] Figure 3 FIG. 1 is a schematic diagram of another structure of the support frame of the occluder provided in the first embodiment of the present invention.

[0012] Figure 4 yes Figure 3 Schematic diagram of the structure in which a flow-blocking membrane is arranged on the supporting frame.

[0013] Figure 5 FIG. 1 is a schematic diagram of another structure of the support frame of the occluder provided in the first embodiment of the present invention.

[0014] Figure 6 FIG. 1 is a schematic diagram of another structure of the support frame of the occluder provided in the first embodiment of the present invention.

[0015] Figure 7 FIG. 1 is a schematic diagram of another structure of the support frame of the occluder provided in the first embodiment of the present invention.

[0016] Figure 8 FIG. 1 is a schematic diagram of another structure of the support frame of the occluder provided in the first embodiment of the present invention.

[0017] Figure 9 It is a schematic structural diagram of the occluder provided by the first embodiment of the present invention after being released.

[0018] Figure 10 It is a schematic structural diagram of the occluder provided by the second embodiment of the present invention after being released.

[0019] Figure 11It is a schematic structural diagram of the occluder provided by the third embodiment of the present invention when released.

[0020] Figure 12 It is a schematic structural diagram of the occluder provided by the fourth embodiment of the present invention after being released.

[0021] Figure 13 It is a schematic structural diagram of the occluder provided by the fifth embodiment of the present invention when released.

[0022] Figure 14 It is a schematic structural diagram of the occluder provided by the fifth embodiment of the present invention after being released.

[0023] Figure 15 It is a schematic structural diagram of the occluder provided by the sixth embodiment of the present invention after release.

[0024] Figure 16 It is a schematic structural diagram of the occluder provided by the seventh embodiment of the present invention when released.

[0025] Figure 17 It is a schematic structural diagram of the occluder provided by the seventh embodiment of the present invention after release.

[0026] Figure 18 It is a schematic structural diagram of the occluder provided by the eighth embodiment of the present invention after being released. DETAILED DESCRIPTION

[0027] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0028] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0029] See also Figure 1 , Figure 1It is a structural schematic diagram of the occluder provided by the first embodiment of the present invention when it is released. The present invention provides an occluder 100, which includes an occluding member 20 and a tightening member 40, and the occluding member 20 includes at least one occluding disc 22 and a connecting member 24 connected to at least one of the occluding discs 22. At least one of the occluding discs 22 is used to cover the atrial septal channel 201 of the atrial septal tissue 200, and the connecting member 24 is located in the atrial septal channel 201. The tightening member 40 fixes at least one of the occluding discs 22 to the atrial septal tissue 200. The end of the connecting member 24 away from the occluding disc 22 is connected to a conveying device to facilitate the release of the occluding member 20. The occluder 100 of the present invention is used to occlude the atrial septal channel of a patent foramen ovale.

[0030] In this embodiment, the occluding disc 22 of the occluding device 100 covers the atrial septal channel 201 of the atrial septal tissue 200, and the tightening member 40 fixes the occluding disc 22 to the atrial septal tissue 200. Therefore, the occluding disc 22 can stably adhere to the surface of the atrial septal tissue 200 and cover the atrial septal channel 201, preventing the occluding disc 22 from being displaced or falling off, thereby reducing the generation of residual shunt.

[0031] like Figure 1 As shown, the occluding disc 22 is disposed in the left atrium and adhered to the surface of the atrial septal tissue 200 having the atrial septal channel 201. One end of the connector 24 is connected to the occluding disc 22, and the other end of the connector 24 passes through the atrial septal channel 201 and is connected to the delivery device.

[0032] The end of the connector 24 away from the delivery device can be connected to the middle of the occluding disc 22 or any position outside the middle. In this embodiment, the end of the connector 24 away from the delivery device is connected to the middle of the occluding disc 22, allowing the occluding disc 22 to evenly cover the periphery of the atrial septal channel.

[0033] The surface shape of the blocking disk 22 can be set to be circular, elliptical, triangular or other irregular shapes. The blocking disk 22 includes a support frame 221. Further, the inner surface and / or outer surface of the support frame 221 can be fixed with a flow blocking film 224. Figures 2 to 4 , Figure 2 is a schematic diagram of one structure of the support frame of the occluder provided in the first embodiment of the present invention; Figure 3 is a schematic diagram of another structure of the support frame of the occluder provided by the first embodiment of the present invention; Figure 4 yes Figure 3Schematic diagram of a support frame with a flow-blocking membrane. The support frame 221 is a woven mesh structure or a frame structure. The connector 24 is connected to the woven mesh structure or the frame structure, and the tightening member 40 is connected between the woven mesh structure or the frame structure and the atrial septum tissue 200.

[0034] In this embodiment, the connecting member 24 is connected to the middle of the woven mesh structure or the frame structure, that is, the connecting member 24 is connected to the center point 2214 of the supporting skeleton 221 .

[0035] The braided mesh structure or frame structure is a petal-shaped structure, that is, the support frame 221 is a petal-shaped structure. The petal-shaped structure is composed of a plurality of support screws 2212, which are arranged in a circular array along the center point 2214 of the braided mesh structure or frame structure, and each support screw 2212 passes through the center point 2214. The support frame 221 can be made of various biocompatible materials, that is, each support screw 2212 can be made of various biocompatible materials, including materials commonly used in the manufacture of releasable medical devices, such as memory alloys, preferably nickel-titanium alloys. The support frame 221 can also be made of degradable materials, that is, each support screw 2212 is made of a degradable material, such as polylactic acid (PL), polycaprolactone (PCL), polyglycolide (PGA), or polydioxanone (PDO). The support frame 221 can also be made of polymer materials.

[0036] In this embodiment, each of the support screw rods 2212 is circular, and the support skeleton 221 is generally woven from 4 to 50 support screw rods 2212 . Figure 2 The support frame 221 is composed of 30 circular support screw rods 2212 in a circular array. Figure 3 and Figure 4 The support frame 221 is composed of 6 circular support screw rods 2212 in a circular array.

[0037] like Figure 4 As shown, the inner and / or outer surfaces of at least one of the occluding discs 22 are provided with a flow-blocking membrane 224 for blocking blood flow. Specifically, the inner and / or outer surfaces of the woven mesh structure or frame structure are provided with the flow-blocking membrane 224. The flow-blocking membrane 224 can be made of a non-degradable polymer material with good biocompatibility, such as ePTFE or PET. Alternatively, the flow-blocking membrane 224 can be made of an absorbable polymer material, such as polylactic acid, polycaprolactone, or a polylactic acid-caprolactone copolymer.

[0038] In other embodiments, each of the support screws 2212 may be elliptical, semicircular, prismatic or irregular in shape. Figure 5 As shown, the support frame 221a is composed of a plurality of elliptical support screws 2212 arranged in a circular array along the center point of the support frame 221a, and one of the top ends of each support screw 2212 passes through the center point; the inner surface and / or outer surface of the support frame 221a is provided with the flow-blocking film. Figure 6 As shown, the support frame 221b is composed of a plurality of semicircular support screw rods 2212 arranged in a circular array along the center point of the support frame 221, and one of the arc endpoints of each support screw rod 2212 passes through the center point; the inner surface and / or outer surface of the support frame 221b is provided with the flow-blocking film. Figure 7 As shown, the support frame 221c is composed of a plurality of prismatic support screw rods 2212 arranged in a circular array along the center point of the support frame 221, and one of the top ends of each support screw rod 2212 passes through the center point; the inner surface and / or outer surface of the support frame 221c is provided with the flow-blocking film. Figure 8 As shown, the support skeleton 221d is composed of a number of irregularly shaped support screw rods 2212 arranged in a circular array along the center point of the support skeleton 221, and one of the top ends of each support screw rod 2212 passes through the center point; the inner surface and / or outer surface of the support skeleton 221d is provided with the flow-blocking film.

[0039] In other embodiments, each of the support screw rods 2212 may be triangular, polygonal, etc.

[0040] The supporting frame of the occluding disc 22 is a woven mesh structure or a frame structure, which enables the occluding disc 22 to fully fit the surface of the atrial septal tissue 200.

[0041] The connecting member 24 is a connecting structure that can be deformed in the radial and / or axial directions. Specifically, the connecting structure is a connecting wire, a connecting strip or a connecting belt. In this embodiment, a connecting wire made of an elastic material or an elastic braided structure is used. One end of the connecting wire is connected to the occluding disk 22, and the other end is connected to the delivery device.

[0042] In other embodiments, when the atrial septal channel 201 of the atrial septal tissue 200 is linear, the connector 24 may also be a bolt connected between the occluding disk 22 and the atrial septal tissue 200 .

[0043] In other embodiments, the connector 24 may also be a connector in other forms, as long as one end of the connector 24 is connected to the sealing disk 22 and the other end is connected to the delivery device.

[0044] In this embodiment, the tightening member 40 includes a suture 42 and a knot 44. The knot 44 can also be replaced by a locking structure. The suture 42 can sew at least one of the occluding discs 22 and the atrial septal tissue 200 together. The knot 44 is used to fix the suture 42 and is located on the side of the atrial septal tissue 200 away from the at least one occluding disc 22. The suture 42 can be a non-absorbable biocompatible suture, such as metal wire, cotton thread, polyester, polypropylene, etc.; the suture 42 can also be an absorbable suture, such as catgut, polyglycolide, multifilament non-biodegradable suture, etc.; the suture 42 can also be a forced-wound fiber thread, etc. The suture 42 can fix the occluding disc 22 to the atrial septal tissue 200 to prevent the occluding disc 22 from shifting or falling off, thereby further enhancing the occluding effect of the occluding disc 22.

[0045] The position of the suture line 42 on the occlusion disk 22 can be determined as needed, and can be a number of discontinuous points, a number of lines, or at least one continuous suture around the center of the occlusion disk 22 .

[0046] Please also refer to Figure 1 and Figure 9 , Figure 9 This is a schematic diagram of the structure of the occluder provided by the first embodiment of the present invention after release. The present invention also includes an occlusion system, which includes a delivery device, a suturing device, and a thread cutter. The delivery device is used to deliver and release the occluder 100. The suturing device 308 also has a knotter inside.

[0047] The occlusion system needs to be used in conjunction with the guide wire, delivery sheath 300, dilator, etc. The surgical procedure is as follows:

[0048] A. First, place the guide wire into the left upper pulmonary vein. Retain the guide wire and place the delivery sheath and dilator into the middle of the left atrium. Remove the dilator and guide wire.

[0049] B. Keep the delivery sheath 300 stationary, connect the delivery device carrying the occluding disk 22 to the rear end of the delivery sheath 300, and then push the delivery device forward, first pushing the front end of the delivery device out of the delivery sheath 300;

[0050] C. Release the occluding disc 22, then retract the delivery sheath 300 and the delivery device. When the occluding disc 22 reaches the patent foramen ovale, it is pulled toward the atrial septal channel 201 of the atrial septal tissue 200 via the connector 24, closing the opening of the atrial septal channel 201 and remaining parallel to the atrial septal tissue 200. Maintaining a certain tension on the connector 24, the occluding disc 22 is now positioned at the right end of the opening of the atrial septal channel 201 of the atrial septal tissue 200 via the connector 24. Retain the connector 24 and remove the delivery device.

[0051] D. The suturing device, equipped with a suturing needle, is then delivered along the delivery sheath 300. When the front end of the suturing device reaches the right atrial surface and is at any position of the projection of the occluding disk 22 on the atrial septal tissue 200, the suturing needle is released from the front end of the suturing device to penetrate the atrial septal tissue 200 and the occluding disk 22, thereby suturing the atrial septal tissue 200 and the occluding disk 22. Depending on the occlusion situation, intermittent or continuous suturing can be performed at one or more locations on the surface of the occluding disk 22.

[0052] E. Use the knotter to tie the suture 42 on the side of the atrial septal tissue 200 facing away from the occlusion disk 22; or tie the suture 42 at the position where it passes through the right atrium.

[0053] F. After knotting is complete, push the thread cutter through the delivery sheath 300 along the suture 42 to the right atrium, cut the suture 3 to 5 mm from the end of the thread, withdraw the thread cutter, and then push the thread cutter through the delivery sheath 300 along the connector 24 to the right atrium, cut the connector 24 1 to 5 mm from the atrial septum, withdraw the delivery sheath 300 and the thread cutter, and complete the closure of the atrial septal channel 201 of the atrial septal tissue 200. Figure 10 , Figure 10 2 is a schematic diagram of the structure of the occluder provided by the second embodiment of the present invention after release. The structure of the occluder provided by the second embodiment of the present invention after release is similar to that of the first embodiment, except that: in the second embodiment, the occluding disk 22 occludes the right end opening of the atrial septal channel 201 of the atrial septal tissue 200, the suture 42 sutures the atrial septal tissue 200 and the occluding disk 22, and the suture 42 is knotted by the knotter on the side of the atrial septal tissue 200 facing away from the occluding disk 22.

[0054] See also Figure 11 , Figure 11: is a schematic diagram of the structure of the occluder provided by the third embodiment of the present invention when released. The structure of the occluder provided by the third embodiment of the present invention after release is similar to that of the first embodiment, except that: in the third embodiment, the occluding member 20a of the occluder 100a includes two occluding discs 22 and a connecting member 24 connected between the two occluding discs 22. The two occluding discs 22 respectively cover the opposite ends of the atrial septal channel 201 of the atrial septal tissue 200, that is, the two occluding discs 22 respectively cover the openings at the left and right ends of the atrial septal channel 201 of the atrial septal tissue 200. The tightening member 40 fixes the two occluding discs 22 to the atrial septal tissue 200 so that the two occluding discs 22 clamp the atrial septal tissue 200. The length of the connecting member 24 between the two occluding discs 22 can be adjusted by the delivery device, that is, by adjusting the length of the connecting member 24 between the two occluding discs 22, the distance between the two occluding discs 22 can be changed.

[0055] In this embodiment, the tightening member 40 is a suture 42, which sews the two occluding disks 22 and the atrial septal tissue 200 together. That is, the suture 42 passes through the two occluding disks 22 and the atrial septal tissue 200 and then is tied with a knot 44 on the side of one of the occluding disks 22 facing away from the atrial septal tissue 200. In this embodiment, the knot 44 is located on the side of the occluding disk 22 in the right atrium facing away from the atrial septal tissue 200.

[0056] The steps for using Example 3 are as follows:

[0057] A. First, place the guide wire into the left upper pulmonary vein. Retain the guide wire and place the delivery sheath 300 and dilator into the middle of the left atrium. Remove the dilator and guide wire.

[0058] B. Keep the delivery sheath 300 stationary, connect the delivery device carrying the occluding disk 22 to the rear end of the delivery sheath 300, and then push the delivery device forward, first pushing the front end of the delivery device out of the delivery sheath 300;

[0059] C. Release an occluding disc 22 relatively far from the delivery device into the left atrium, then retract the delivery sheath 300 and the delivery device together. When the occluding disc 22 in the left atrium reaches the unclosed foramen ovale, the occluding disc 22 is pulled toward the atrial septal channel 201 of the atrial septal tissue 200 via the connector 24, closing the opening at the left end of the atrial septal channel 201 and remaining parallel to the atrial septal tissue 200. Maintaining a certain tension on the connector 24, the delivery sheath 300 is further retracted until another occluding disc 22 is deployed in the right atrium. Tighten the connector 24 connected between the two occluding discs 22, so that the two occluding discs 22 clamp the atrial septal tissue 200. Disconnect the connector 24 from the delivery device, and remove the delivery device.

[0060] D. The suturing device, equipped with a suturing needle, is then delivered along the delivery sheath 300. When the front end of the suturing device reaches the right atrial surface and is at any position of the projection of the occluding disk 22 on the atrial septal tissue 200, the suturing needle is released from the front end of the suturing device to penetrate the atrial septal tissue 200 and the occluding disk 22, thereby suturing the atrial septal tissue 200 and the occluding disk 22. Depending on the occlusion situation, intermittent or continuous suturing can be performed at one or more locations on the surface of the occluding disk 22.

[0061] E. Use the knotter to tie the suture 42 on the side of the atrial septal tissue 200 facing away from the occlusion disk 22; or tie the suture 42 at the position where it passes through the right atrium.

[0062] F. After knotting is completed, push the thread cutter along the suture line 42 to the right atrium through the delivery sheath 300, cut the suture line 3 to 5 mm away from the thread end, withdraw the delivery sheath 300 and the thread cutter, and complete the closure of the atrial septal channel 201 of the atrial septal tissue 200.

[0063] See also Figure 12 , Figure 12 2 is a schematic diagram of the structure of the occluder provided by the fourth embodiment of the present invention after release. The structure of the occluder provided by the fourth embodiment of the present invention after release is similar to that of the third embodiment, except that in the fourth embodiment, the end of the connector 24 distal from the two occluding discs 22 is connected to the knot 44. That is, the end of the connector 24 extending beyond the occluding disc 22 in the right atrium is connected to the knot 44, thereby more firmly securing the occluder 100a to the atrial septal tissue 200.

[0064] See also Figure 13 and Figure 14 , Figure 13 is a schematic structural diagram of the occluder provided in the fifth embodiment of the present invention when released; Figure 142 is a schematic diagram of the structure of the occluder provided by the fifth embodiment of the present invention after release. The structure of the occluder provided by the fifth embodiment of the present invention after release is similar to that of the third embodiment, except that: in the fifth embodiment, the tightening member 40a of the occluder 100b includes at least one gasket 46 and a locking member 42. The gasket 46 is attached to the side of one of the occluding discs 22 facing away from the atrial septal tissue 200, and the locking member 42 passes through the two occluding discs 22 and the atrial septal tissue 200 and is fixed to at least one gasket 46.

[0065] In this embodiment, the locking member 42 is a suture that can lock at least one gasket 46, the two occluding discs 22, and the atrial septal tissue 200. At least one gasket 46 is disposed on the side of the occluding disc 22 positioned within the left atrium that faces away from the atrial septal tissue 200. The gasket 46 can ensure more uniform force on the tissue at the locking point.

[0066] The release method of the occluding member 20a in this embodiment is the same as that in the third embodiment and will not be described here. Only the suturing process of the tightening member 40a will be described: a suturing device is delivered along the delivery sheath 300. The suturing device is provided with a suturing needle. When the front end of the suturing device reaches the right atrial surface, the gasket 46 is released before suturing. The gasket 46 can be released by the suturing needle or through a separate channel. The gasket 46 can be released at any position of the projection of the occluding disc 22 on the atrial septal tissue 200. The suturing needle released from the front end of the suturing device passes through the occluding disc 22 and atrial septal tissue 200 in the right atrium, and the occluding disc 22 and gasket 46 in the left atrium, and suturing the atrial septal tissue 200, the occluding disc 22, and the gasket 46. Depending on the occlusion situation, one or more locations on the surface of the two occluding discs 22 can be selected for intermittent or continuous suturing.

[0067] In other embodiments, at least one of the gaskets 46 may be attached to the side of the occluding disk 22 in the right atrium that faces away from the atrial septal tissue 200 .

[0068] See also Figure 15 , Figure 15 FIG2 is a schematic diagram of the structure of the occluder provided by the sixth embodiment of the present invention after release. The structure of the occluder provided by the sixth embodiment of the present invention after release is similar to that of the fifth embodiment, except that in the sixth embodiment, the end of the connector 24 distal from the two occluding discs 22 is connected to the knot 44, that is, the end of the connector 24 distal from at least one of the spacers 46 is connected to the knot 44, thereby more firmly securing the occluder 100b to the atrial septal tissue 200.

[0069] In other embodiments, two or more tightening members 40a can be released on the occluding member 20a as needed to make the connection between the two occluding disks 22 and the atrial septal tissue 200 more firmly, and better block the atrial septal channel 201 of the atrial septal tissue 200, so as to close the atrial septal channel 201 and reduce the generation of residual shunt.

[0070] Seventh embodiment

[0071] See also Figure 16 and Figure 17 , Figure 16 is a schematic structural diagram of the occluder provided by the seventh embodiment of the present invention when released; Figure 17 Schematic diagram of the structure of the occluder provided by the seventh embodiment of the present invention after release. The structure of the occluder provided by the seventh embodiment of the present invention after release is similar to that of the fifth embodiment, except that: in the seventh embodiment, the tightening member 40b of the occluder 100c includes two gaskets 46 and a locking member 42. The two gaskets 46 are respectively attached to the sides of the two occluding discs 22 away from the atrial septal tissue 200. The ends of the locking member 42 are respectively fixed to the two gaskets 46, so that the two occluding discs 22 are more firmly attached to the left and right sides of the atrial septal tissue 200. The size, shape, and material of the two gaskets 46 can be the same or different.

[0072] The releasing method of the blocking member 20a in this embodiment is the same as the releasing method of the blocking member 20a in the third embodiment, and will not be described here; the releasing method of the tightening member 40b in this embodiment is similar to the releasing method of the tightening member 40a in the fifth embodiment, that is, the suture device is delivered along the delivery sheath 300, and the suture device is provided with a suture needle. When the front end of the suture device reaches the right atrial surface, one of the gaskets 46 is released before suturing. The gasket 46 can be released by the suture needle or by using a separate channel. The gasket 46 can be released at any position of the projection of the left atrial occlusion disk 22 on the atrial septal tissue 200, and then the other gasket 46 is released at a position on the side of the right atrial occlusion disk 22 away from the atrial septal tissue corresponding to the previously released gasket 46. The suture needle released by the front end of the suture device passes through the atrial septal tissue 200, the blocking disk 22 and the gasket 46, and sutures the atrial septal tissue 200, the blocking disk 22 and the gasket 46. Depending on the occlusion situation, one or more locations on the surface of the occlusion disk 22 can be selected for intermittent or continuous suturing and fixation.

[0073] See also Figure 18 , Figure 18: is a schematic diagram of the structure of the occluder provided by the eighth embodiment of the present invention after release. The structure of the occluder provided by the eighth embodiment of the present invention after release is similar to that of the seventh embodiment, except that: in the eighth embodiment, the two occluding discs 22 are provided with two positions for releasing tightening members 40b, and the sutures 42 of the two tightening members 40b are tied with a knot 44 on the side of the occluding disc 22 in the right atrium facing away from the atrial septal tissue 200. The end of the connecting member 24 away from the two occluding discs 22 is connected to the knot 44, that is, the end of the connecting member 24 extending out of the occluding disc 22 in the right atrium is connected to the knot 44, thereby more firmly fixing the occluder 100c to the atrial septal tissue 200.

[0074] In other embodiments, the tightening member 40 can be released at one or more suitable positions on the two occluding disks 22 as needed, thereby further strengthening the closure of the irregular atrial septal channel 201 of the atrial septal tissue 200 by the occluding disk 22 .

[0075] In other embodiments, the two gaskets 46 may be locked together by means of a buckle or a bolt.

[0076] Due to the presence of the tightening member, the occluder of the present invention has a very stable closure and is difficult to shift. In addition, the occluder can be made entirely of degradable materials. After release, the endothelium crawls over the device, and the autologous tissue forms an effective closure for the position. At the same time, the released device will degrade, and no residual foreign matter will remain in the body.

[0077] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An occluder comprising an occluding member and a tightening member, wherein the occluding member comprises at least one occluding disc and a connector connected to at least one of the occluding discs, wherein at least one of the occluding discs comprises a support frame made of a biocompatible material and is used to cover an atrial septal channel of atrial septal tissue, wherein the connector is located within the channel of the atrial septal tissue. The tightening member fixes at least one of the occluding discs to the atrial septal tissue. The tightening member includes at least one gasket and a locking member. The gasket is attached to the side of one of the occluding discs facing away from the atrial septal tissue. The locking member passes through the occluding disc and the atrial septal tissue and is fixed to at least one of the gaskets.

2. The occluder according to claim 1, characterized in that: When the occluder is implanted, the end of the connector away from the occluding member is connected to a delivery device.

3. The occluder according to claim 2, characterized in that: The support frame is a woven mesh structure or a frame structure. The tightening member fits the support frame to the atrial septum tissue. The connecting member is connected to the middle of the support frame or any position outside the middle or both sides.

4. The occluder according to claim 3, characterized in that: The supporting frame is in a petal-shaped structure.

5. The occluder according to claim 4, characterized in that: The petal-shaped structure is composed of a plurality of supporting screw rods, which are arranged in a circular array along the center point of the supporting frame, and each of the supporting screw rods passes through the center point.

6. The occluder according to claim 5, characterized in that: Each of the supporting screw rods is circular, elliptical, semicircular or prismatic.

7. The occluder according to claim 3, characterized in that: The inner surface and / or outer surface of at least one of the support frames is provided with a flow-blocking membrane for blocking blood flow.

8. The occluder according to claim 7, characterized in that: The flow-blocking membrane is a non-absorbable polymer membrane; or a bioabsorbable membrane.

9. The occluder according to claim 8, characterized in that: The non-absorbable polymer membrane is PET non-woven fabric or textile membrane, expanded polytetrafluoroethylene membrane; the bioabsorbable membrane is polylactic acid, polycaprolactone or polylactic acid-caprolactone copolymer membrane.

10. The occluder according to claim 3, characterized in that: The supporting frame is made of memory alloy and high molecular polymer material.

11. The occluder according to claim 2, characterized in that: The connecting piece is a connecting structure that can be deformed in radial direction and / or axial direction.

12. The occluder according to claim 11, characterized in that: The connecting structure is a connecting line, and the connecting line is made of elastic material.

13. The occluder according to claim 11, characterized in that: The occluding member includes two occluding disks, the connecting member is connected between the two occluding disks, the two occluding disks respectively cover the two ends of the channel of the atrial septum tissue on the left and right sides of the atrial septum, and the tightening member fixes the two occluding disks to the atrial septum tissue so that the two occluding disks clamp the atrial septum tissue.

14. The occluder according to any one of claims 2 to 13, characterized in that: The tightening member is a suture, which can sew at least one of the occlusion disks and the atrial septal tissue together.

15. The occluder according to claim 14, characterized in that: The atrial septal tissue is provided with a knot for fixing the suture thread on a side facing away from at least one of the occlusion discs.

16. The occluder according to claim 15, characterized in that: One end of the connecting member away from at least one sealing disk is connected to the knot.

17. The occluder according to claim 2, characterized in that: The locking member is a suture thread capable of locking at least one of the gasket, the blocking member and the atrial septum tissue.

18. The occluder according to claim 17, characterized in that: The suture is provided with a knot on the side of the occlusion disk away from at least one of the spacers and facing away from the atrial septal tissue.

19. The occluder according to claim 18, characterized in that: One end of the connecting member away from at least one of the gaskets is connected to the knot.

20. The occluder according to any one of claims 2 to 13, characterized in that: The tightening member includes two gaskets and a locking member. The two gaskets are respectively attached to the side surfaces of the occluding disk away from the atrial septal tissue, and the two ends of the locking member are respectively fixed to the two gaskets.

21. The occluder according to claim 20, characterized in that: The locking member is a suture, a buckle structure or a bolt structure capable of locking the two gaskets.

22. An occlusion system comprising the occlusion device according to any one of claims 1 to 21, the system further comprising a delivery device and a suturing device, the delivery device being used to release the occlusion member, and the suturing device being used to release the tightening member.

23. The occlusion system according to claim 22, wherein the delivery device further comprises a wire cutter, wherein the wire cutter is used to cut the tightening member.

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