A patent foramen ovale closure device

Abstract

The application belongs to the field of medical devices, and discloses a patent foramen ovale occluder. The occluder comprises a first occlusion member, a second occlusion member and a connecting member. The first occlusion member has a first central axis, the second occlusion member has a second central axis, one end of the connecting member is connected with the first occlusion member, the other end of the connecting member is connected with the second occlusion member, the connecting member is tubular and has flexibility, so that the patent foramen ovale occluder has a preset state and a deformed state. In the preset state, the first central axis, the central axis of the connecting member and the second central axis are approximately coincident. In the deformed state, the connecting member does not have a central axis, and the first central axis deviates from the second central axis. The connecting member has flexibility and has radial and axial deformation capacity. After implantation, the connecting member can be deformed and adapt to the shape of the patent foramen ovale fissure, so that there is no gap between the connecting member and the inner wall of the patent foramen ovale, and residual blood does not affect the effectiveness of the occluder.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 2023100592304, filed on January 18, 2023, entitled "An Oval Foramen Occlusion Plugging Device". Technical Field

[0002] This invention relates to the field of medical device technology, and more particularly to a patent foramen ovale occluder. Background Technology

[0003] The secundum, located on the primary septum at the atrial septum, is a normal blood flow channel in infancy. It forms the foramen ovale on the right side of the primary septum. When the primary and secundum fail to adhere and fuse, the resulting gap is the foramen ovale, or patent foramen ovale.

[0004] Because emboli can enter the left ventricular system and cause corresponding clinical symptoms through a patent foramen ovale (PFO), there may be a close link between PFO and patients with unexplained stroke. Closing the PFO in high-risk individuals could potentially reduce the incidence of embolism. Furthermore, PFO has been found to be associated with decompression sickness and migraines; closing the PFO may be beneficial for these patients.

[0005] Currently, closure devices can be implanted via a minimally invasive transvascular approach to artificially adhere the primary and secondary septa, promoting their fusion. However, residual blood shunting at the foramen ovale after device implantation is a common cause of hindered device effectiveness. To avoid these problems, continuous improvement of occluders is still necessary. Summary of the Invention

[0006] The purpose of this invention is to provide a patent foramen ovale occluder that can prevent residual blood shunting after occluder implantation, which would reduce the effectiveness of device implantation.

[0007] The technical solution provided by this invention is as follows: On the one hand, a patent foramen ovale occluder is provided, comprising a first occluder, a second occluder, and a connector. The first occluder has a first central axis, the second occluder has a second central axis, one end of the connector is connected to the first occluder, and the other end of the connector is connected to the second occluder. The connector is tubular and flexible, allowing the patent foramen ovale occluder to have a preset state and a deformable state. In the preset state, the first central axis, the central axis of the connector, and the second central axis are approximately coincident; In the deformed state, the connector does not have a central axis, and the first central axis is offset from the second central axis.

[0008] In some embodiments, the connector is knitted or braided from flexible thread or flexible thread bundle.

[0009] In some embodiments, the outer diameter of the connector gradually decreases from the proximal end to the middle of the connector and gradually increases from the middle of the connector to the distal end.

[0010] In some embodiments, the first sealing element includes a first frame, which is a double-layer structure and includes a proximal face and a distal face; The second sealing element includes a second frame, which is a double-layer structure and includes a proximal face and a distal face.

[0011] In some embodiments, the first blocking member further includes a first flow-blocking element disposed on the first frame; the second blocking member further includes a second flow-blocking element disposed on the second frame.

[0012] In some embodiments, the second occlusion element further includes a second convergence element and a third convergence element, the second convergence element being disposed at the proximal end of the second frame to converge the free end of the proximal face of the second frame, and the third convergence element being disposed at the distal end of the second frame to converge the free end of the distal face of the second frame.

[0013] In some embodiments, the first occlusion element further includes a first convergence element disposed at the proximal end of the first frame for converging the free ends of the proximal and distal surfaces of the first frame.

[0014] In some embodiments, the second convergence element does not protrude from the proximal end face of the second frame along the axial direction of the second frame.

[0015] In some embodiments, in the deformed state, the angle between the line connecting the first convergent element and the third convergent element and the first central axis or the second central axis is 30° to 90°.

[0016] In some embodiments, the proximal and distal surfaces of the first frame are planar and approximately fitted together.

[0017] In some embodiments, one end of the connector is connected to the proximal end face of the first frame, and the other end is connected to the distal end face of the second frame.

[0018] In some embodiments, additional flow-blocking elements are also included, which are provided on the proximal end face of the first frame and / or the distal end face of the second frame.

[0019] In some embodiments, one end of the connector is connected to the first frame or to an additional flow-blocking element on the first frame, and the other end of the connector is connected to the second frame or to an additional flow-blocking element on the second frame.

[0020] In some embodiments, the connector includes a first connector and a second connector, wherein the first connector is tubular and the second connector is linear, and the second connector is disposed within the first connector; One end of the first connector is connected to the proximal end face of the first frame, and one end of the second connector is connected to the first convergence element; The other end of the first connector is connected to the distal end face of the second frame, and the other end of the second connector is connected to the third convergence element.

[0021] In some embodiments, the first convergence element and the third convergence element are fixedly or rotatably connected to the second connector.

[0022] In some embodiments, the outer diameter of the first connector gradually decreases from the proximal end to the middle of the first connector and gradually increases from the middle of the first connector to the distal end.

[0023] The technical advantages of this invention are as follows: The connector of this invention is flexible and has radial and axial deformation capabilities. When the connector is located within the foramen ovale slit between the primary and secondary septa, the connector can deform under the action of human tissues such as the primary and secondary septa, causing the first central axis to deviate from the second central axis. This allows the connector to adapt to the shape of the foramen ovale slit, eliminating gaps between the connector and the inner wall of the foramen ovale. Consequently, the connector effectively blocks blood flow within the foramen ovale slit, preventing blood from flowing through the gaps between the connector and the inner wall of the foramen ovale, thus avoiding affecting the effectiveness of the occluder. Simultaneously, the first occluder is located in the left atrium and blocks blood flow on the left atrial side, while the second occluder is located in the right atrium and blocks blood flow on the right atrial side. The connector, the first occluder, and the second occluder form a flow-blocking combination for a better flow-blocking effect. Attached Figure Description

[0024] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments: Figure 1 This is a schematic diagram illustrating the application environment of the occluder; Figure 2 This is a schematic diagram of the structure of the ovoid aperture; Figure 3 This is a schematic diagram of abnormal blood flow at the foramen ovale; Figure 4 This is a schematic diagram of the delivery sheath for the sealing device; Figure 5 This is a schematic diagram of the structure of a patent foramen ovale occluder used in the prior art for sealing the patent foramen ovale; Figure 6 This is a schematic diagram of the preset state structure of the unclosed orifice occluder according to an embodiment of this application; Figure 7 This is a schematic diagram of the deformed state structure of the unclosed orifice occluder according to an embodiment of this application; Figure 8 This is a schematic diagram of the structure of the unclosed orifice occluder of this application in which the first central axis deviates from the second central axis when it is in a deformed state; Figure 9 This is a schematic diagram of a braiding method for the connectors in this application; Figure 10 This is a schematic diagram of another weaving method for the connectors in this application; Figure 11 This is a structural schematic diagram of a preferred shape of the connector in this application; Figure 12 This is a schematic diagram of the structure of one embodiment of the second framework of this application; Figure 13 This is a schematic diagram of another embodiment of the second framework of this application; Figure 14 yes Figure 13 A simplified structural diagram after the metal mesh has been removed; Figure 15 This is a structural schematic diagram of yet another embodiment of the second framework of this application; Figure 16 This is a schematic diagram of the first framework of this application; Figure 17 This is a schematic diagram of the second frame of this application; Figure 18 This is a schematic diagram of the structure of the patent foramen ovale occluder not entering the delivery sheath in this application; Figure 19 This is a schematic diagram of the structure of the second sealing element of the patent foramen ovale occluder entering the delivery sheath; Figure 20 This is a schematic diagram of the connection of the unclosed orifice of ovum plug of this application entering the delivery sheath; Figure 21 This is a schematic diagram of the structure of the patent foramen ovale occluder fully entering the delivery sheath of this application; Figure 22 This is a schematic diagram showing the angle between the line connecting the first and third convergent elements and the first central axis in the deformed state when the second frame of this application is an embodiment; Figure 23This is a schematic diagram showing the angle between the line connecting the first and third convergent elements and the first central axis in the deformed state when the second frame of this application is an alternative embodiment. Figure 24 This is a schematic diagram of the structure of the second frame of this application with additional flow-blocking elements provided; Figure 25 This is a schematic diagram of the structure of the second connector and the third gathering element rotatably connected in this application; Figure 26 This is a schematic diagram of the structure in which the second connector and the third gathering element are fixedly connected.

[0025] Explanation of icon numbers: a. Proximal end; b. Distal end; 100. Delivery sheath; 200. Pushing device; 10. First sealing element; 101. First central axis; 102. First proximal end face; 103. First distal end face; 11. First frame; 12. First flow-blocking element; 13. First converging element; c. Metal wire; 20. Second sealing element; 201. Second central axis; 202. Second proximal end face; 203. Second distal end face; 21. Second frame; 22. Second flow-blocking element; 23. Second converging element; 24. Third converging element; 30. Connector; 31. First connector; 32. Second connector; 40. Additional flow-blocking element. Detailed Implementation

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0028] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0029] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0030] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0031] In this application, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or actions relative to each other from the perspective of a physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, while "distal" generally refers to the end that is farther from the physician, i.e., the end that first enters the patient's body. Figure 6 In the diagram, 'a' represents the proximal end of the patent foramen occluder of the present invention, and 'b' represents the distal end of the patent foramen occluder of the present invention.

[0032] Application environments of plugging devices, such as Figure 1 As shown, the specific structure at the oval aperture is as follows: Figure 2 As shown, the primary septum is located on the left atrium, and the secondary septum is located on the right atrium. The secundum on the primary septum is a normal blood passage in infancy. When the primary and secondary septa fail to fuse properly, an unclosed, narrow slit forms between them. Abnormal blood flow may pass through this slit from the foramen ovale and then out through the secundum, or vice versa. Figure 3 As can be seen, the two ends of the aforementioned fissure are offset from each other, extending from the right atrium to the left atrium, with the fissure extending towards the top of the atrium. Figure 4 As shown, when the occluder is delivered via a transvascular minimally invasive method, the distal end of the delivery sheath passes sequentially through the fossa ovalis and the secundum. During this process, the lower edge of the secundum above the primary septum is often pushed towards the left atrium.

[0033] like Figure 5 As shown, when the occluder is implanted at the patent foramen ovale, the tension of the occluder itself will compress and deform the secondary septum and the primary septum to a certain extent, so that the fossa ovale and the secundum partially overlap. The waist of the occluder is placed in the space after the two holes partially overlap. A gap is often formed around the waist of the occluder. Abnormal blood flow can continue to flow through the above gap, which will hinder the effectiveness of the occluder.

[0034] To address the issue of residual blood at the foramen ovale hindering the effectiveness of the occluder, such as... Figures 6 to 8As shown, this embodiment of the invention provides a patent foramen ovale occluder, including a first occluder 10, a second occluder 20, and a connector 30. The first occluder 10 has a first central axis 101, the second occluder 20 has a second central axis 201, one end of the connector 30 is connected to the first occluder 10, and the other end of the connector 30 is connected to the second occluder 20. The connector 30 is tubular and flexible, allowing the patent foramen ovale occluder to have a preset state and a deformed state. In the preset state, the first central axis 101, the central axis of the connector 30, and the second central axis 20 are approximately coincident. In the deformed state, the connector 30 does not have a central axis, and the first central axis 101 is offset from the second central axis 201.

[0035] refer to Figure 6 In the preset state, the first central axis 101 and the second central axis 201 approximately coincide; (Reference) Figure 7 and Figure 8 In the deformed state, the first occluder 10 is located in the left atrium 700, the second occluder 20 is located in the right atrium 600, and the connector 30 is located in the gap between the primary septum 200 and the secondary septum 300. The connector 30 is tubular and flexible, which gives it radial and axial deformation capabilities. When the connector 30 is located in the gap of the orifice 100 between the primary septum 200 and the secondary septum 300, the connector 30 can deform under the action of human tissues such as the primary septum 200 and the secondary septum 300 to adapt to the shape of the unclosed gap. At this time, the first central axis 101 deviates from the second central axis 201, and the unclosed gap does not undergo significant deformation due to the implantation of the occluder. The connector 30 fills the gap in a compliant form, which plays a better role in blocking blood flow and preventing blood from flowing through the gap between the connector 30 and the inner wall of the orifice 100. Simultaneously, the first occluder 10 is located in the left atrium 700 and blocks blood flow on the left atrium 700 side, while the second occluder 20 is located in the right atrium 600 and blocks blood flow on the right atrium 600 side. The connector 30, the first occluder 10, and the second occluder 20 form a flow-blocking combination to achieve a better flow-blocking effect. The first occluder 10 and the second occluder 20 clamp the primary septum 200 and the secondary septum 300 together to facilitate fusion.

[0036] In the deformed state, as the connector 30 conforms to the shape of the crack, after the first central axis 101 deviates from the second central axis 201, the first central axis 101 and the second central axis 201 may have an angle between them, or they may be parallel or non-parallel. In some embodiments, the connector 30 may be made of flexible yarn knitting, for example, a flow-blocking membrane of polyester fiber.

[0037] In some embodiments, the connector 30 may also be made of flexible braided wire, with a loop structure wound around one end of a flexible wire to fix that end, and the main body of the flexible wire braided in layers around the loop structure to form a flexible tubular flow-blocking membrane. For example, as Figure 9 The braiding method shown mainly includes the following steps: the main body of the flexible thread first forms a first braided loop; then the main body of the flexible thread wraps around the adjacent lower layer of flexible thread to form a second braided loop; finally, the main body of the flexible thread passes through the first and second braided loops to form a new braided loop; repeating the above steps yields the tubular connector 30. Or as... Figure 10 The steps shown are used to weave together a flexible flow-blocking membrane, which is formed by... Figure 10 The connector 30, woven using the steps shown, is more flexible.

[0038] The wire segments of connector 30 can be single-strand flexible wires or multi-strand flexible wires. The material of the flexible wires can be biocompatible medical fibers such as polyester, polytetrafluoroethylene, polypropylene, and polyurethane, or biodegradable fibers such as polyhydroxyacetic acid, polylactic acid, and polylactic-hydroxyacetic acid.

[0039] In some embodiments, such as Figure 11 As shown, in the preset state, the connector 30 is not deformed by external force. The outer diameter of the connector 30 gradually decreases from the proximal end to the middle and gradually increases from the middle to the distal end. The distal or proximal end of the connector 30 is a roughly circular plane, and the radial dimensions of the distal and proximal ends of the connector 30 can be approximately the same. The radial dimensions of the proximal and distal ends of the connector 30 can be 5% to 15% of the radial dimension of the distal end face of the second sealing member 20. The connector 30 is a roughly tubular shape with a continuously changing external radial dimension, extending from the proximal end to the distal end. The radial dimension first gradually decreases from the proximal end and then gradually increases to the distal end, with the smallest radial dimension in the middle part of the connector 30. With this configuration, the middle part of the connector 30 can more easily adapt to the unclosed narrow gap at the oval hole 100, strengthening the flow obstruction effect in the middle, while the increased diameter at both ends strengthens the flow obstruction effect at both ends.

[0040] Preferably, a filler can be provided inside the connector 30 to enhance the flow resistance effect of the connector 30. The filler can be a sponge made of PVA, PU or PTFE, or a flow-resistant membrane, or a biodegradable polymer fiber.

[0041] In some embodiments, such as Figure 15 As shown, the first sealing element 10 includes a first frame 11, a first flow-blocking element 12, and a first converging element 13. The structure of the first frame 11 is as follows: Figure 16As shown, the first flow-blocking element 12 is disposed within the first frame 11, which is woven from fine filaments. The first frame 11 has a double-layer structure and has a proximal end face and a distal end face. The first gathering element 13 is disposed at the proximal end of the first frame 11 and is used to gather the free ends of the fine filaments on the proximal end face and the distal end face of the first frame 11. The distal end of the first connector 31 is connected to the proximal end face of the first frame 11, and the connection method can be sewing, bonding, etc.

[0042] The first frame 11 is approximately symmetrically distributed around the first central axis 101, and the first flow-blocking element 12 is a flow-blocking membrane. The first frame 11 can be configured as a double-layer structure. The first frame 11 is a mesh structure woven from fine filaments such as metal wires. The first frame 11 includes a proximal end face and a distal end face, namely the first proximal end face 102 and the first distal end face 103, respectively. The proximal end face of the first frame 11 is the side located at the proximal end of the first frame 11, and the distal end face of the first frame 11 is the side located at the distal end of the first frame 11. The proximal end face and the distal end face of the first frame 11 are approximately planar, and the proximal end face and the distal end face of the first frame 11 are approximately in contact. The first frame 11 has only one gathering element, namely the first gathering element 13. The first gathering element 13 is located at the proximal end of the first frame 11 and within the connector 30. The free ends of the filaments on both the proximal and distal surfaces of the first frame 11 are housed within the first gathering element 13. That is, the first frame 11 only has a proximal endpoint, and the distal end of the first frame 11 has no endpoint. During delivery, when the first frame 11 returns from the constrained state to the unfolded shape of the preset state, it is similar to the unfolding process of an umbrella.

[0043] Understandably, in some embodiments, the first frame 11 may be a non-woven structure, such as a metal frame formed by engraving, or it may have a double-layer structure, with its free end gathered by the first gathering element 13. In some embodiments, the first flow-blocking element 12 may also be disposed on the outside of the first frame 11, such as on the proximal or distal surface of the first frame 11.

[0044] In such Figure 15 In the illustrated embodiment, the second blocking element 20 includes a second frame 21, a second flow-blocking element 22, a second convergence element 23, and a third convergence element 24. The structure of the second frame 21 is as follows: Figure 17As shown, the second flow-blocking element 22 is disposed within the second frame 21. The second flow-blocking element 22 can be a flow-blocking membrane. The second frame 21 is a mesh structure woven from fine filaments such as metal wires. The second frame 21 has a double-layer structure and has a proximal end face and a distal end face. The proximal end face of the second frame 21 is the second proximal end face 202, and the distal end face of the second frame 21 is the second distal end face 203. The second gathering element 23 is disposed at the proximal end of the second frame 21 and is used to gather the free ends of the fine filaments at the proximal end face of the second frame 21. The proximal end of the second gathering element 23 does not protrude from the proximal end face of the second frame 21 along the axial direction of the second frame 21, and the second gathering element 23 is located within the second frame 21. The main body of the second gathering element 23 is... The second frame 21 is covered by a mesh, and the proximal end face of the second gathering element 23 is exposed outside the second frame 21 for setting a connection position for connecting the delivery system. The third gathering element 24 is located at the distal end of the second frame 21 and inside the connector 30. The proximal and distal ends of the second frame 21 are roughly arc-shaped, but the curvature is small, close to a plane. This design makes the thickness of the second frame 21 smaller, which is more conducive to the endothelialization process after device implantation. The third gathering element 24 is used to gather the free ends of the filaments on the second distal end face 203 of the second frame 21, and can be kept from protruding from the plane formed by the radial boundary of the second frame. The proximal end of the connector 30 is connected to the distal end face of the second frame 21.

[0045] Understandably, in some embodiments, the second frame 21 may be a non-woven structure, such as a metal frame formed by engraving, or it may have a double-layer structure, with the second converging element 23 converging the free end of the proximal face of the second frame 21 and the third converging element 24 converging the free end of the distal face of the second frame 21. In some embodiments, the second flow-blocking element 22 may be disposed on the outside of the second frame 21, such as on the proximal or distal face of the second frame 21.

[0046] In some embodiments, such as Figure 13 As shown, the second sealing element 20 includes a second frame 21, a second flow-blocking element 22, a second converging element 23, and a third converging element 24. The proximal and distal surfaces of the second frame 21 are generally arc-shaped. The proximal central region of the proximal surface has a generally annular recess. The second converging element 23 is located within this annular recess and outside the second frame 21. The proximal end of the second converging element 23 does not protrude beyond the proximal surface of the second frame along the axial direction of the second frame 21. A connection position is provided at the proximal end for connection to the delivery system. Other configurations in these embodiments are similar to those in other embodiments.

[0047] In some embodiments, such as Figure 12As shown, the proximal and distal surfaces of the second frame 21 are planes. The maximum radial boundary of the second frame 21 is approximately symmetrically distributed around the second central axis 201, and the proximal and distal surfaces of the second frame 21 are approximately in contact. The second frame 21 has a distal end point and a proximal end point. The proximal central region has a generally annular recess. The second convergent element 23 is disposed within the proximal annular recess of the second frame 21, and the third convergent element 24 is disposed at the distal end of the second frame 21. The proximal end point of the second frame 21 (i.e., the second convergent element 23) does not significantly protrude from the proximal surface of the second frame 21. Other configurations in these embodiments are similar to those in other embodiments.

[0048] During the process of the plugging device entering the delivery sheath 100, such as Figure 18 As shown, the pushing device 200 is connected to the proximal end of the second frame 21. The second frame 21 is pulled open from the proximal end, extending into a long strip and entering the delivery sheath 100, as shown. Figure 19 and Figure 20 As shown, when the second frame 21 begins to enter the delivery sheath 100 near its distal end, the connector 30 begins to enter the delivery catheter, pulling the proximal end of the first frame 11 into the delivery sheath 100. The edges of the first frame 11 are compressed and compressed into the delivery sheath 100, unlike the second frame 21 which is elongated. The structure of the occluder fully entering the delivery sheath 100 is as follows. Figure 21 As shown, during the process of the plug leaving the delivery sheath 100, the edge of the first frame 11 first moves away from the first central axis 101 and returns to the preset shape, the connector 30 leaves the delivery sheath 100, and the second frame 21 then returns to the preset shape from the far end to the near end.

[0049] In this embodiment, the distal ends of the first frame 11 and the second frame 21 do not protrude from the structure of the occluder, and the proximal ends do not protrude significantly from the structure of the occluder. This is beneficial to shorten the endothelialization time after the occluder is implanted, that is, the time for the secondary septum 300 and the primary septum 200 to adhere together and then fuse is shortened.

[0050] The first frame 11 has only a proximal end point. Its unfolding and folding method is similar to that of an umbrella. When folded, the edge of the first frame 11 moves directly toward the first central axis 101 and is compressed into the delivery sheath 100. When unfolded, the edge of the first frame 11 moves directly away from the first central axis 101 and unfolds. Compared with the double-endpoint unfolding method of the second frame 21, the first frame 11 requires a smaller axial distance and takes less time, which is more conducive to the operation of the occluder in the human heart. In the application scenario of atrial septal defect, it can avoid the "buttoning" effect.

[0051] During interventional treatment of atrial septal defect (ASD), the left atrial fimbriae of the occluder (first occluder 10) are first opened in the left atrium, and the delivery system is withdrawn so that the left atrial fimbriae are tightly pressed against the atrial septum. Then, the right atrial fimbriae (second occluder 20) are released. Due to the downward and backward pulling force generated during the withdrawal of the delivery system, when the ASD is an elongated ellipse parallel to the long axis of the atrial septum, this downward and backward pulling force makes the ASD shape more elongated, preventing the occluder from easily dislodging from the left atrium. When the ASD is a flattened ellipse perpendicular to the long axis of the atrial septum, this downward and backward pulling force makes the ASD shape more rounded and larger, making the occluder easily dislodged from the left atrium. This phenomenon is similar to the principle of unbuttoning a button in everyday life, hence we call it the "button-unbuttoning phenomenon" in atrial septal defect occlusion treatment.

[0052] In the preset state, the first frame 11 and the second frame 21 are symmetrically distributed around their respective central axes, and the connecting member 30 is in a relaxed state. In the deformed state, as... Figure 22 and Figure 23 As shown, the first frame 11, connector 30, and second frame 21 are adapted to the implantation position structure. The first connector 31 and second connector 32 are in a stretched state. The first central axis 101 and the second central axis 201 are deviated. The deviated first convergent element 13 and third convergent element 24 are the two endpoints of a line segment, and have an included angle α with the first central axis 101 or the second central axis 201. The connector 30 is deviated from the central axis, presenting a configuration adapted to the deformation state. The included angle α ranges from 30° to 90°.

[0053] In some embodiments, such as Figure 24 As shown, it also includes an additional flow-blocking element 40. The near end face of the first frame 11 and / or the far end face of the second frame 21 are respectively provided with the additional flow-blocking element 40. One end of the connector 30 is connected to the additional flow-blocking element 40 on the first frame 11, and the other end of the connector 30 is connected to the additional flow-blocking element 40 on the second frame 21.

[0054] In addition to being directly connected to the proximal end face of the first frame 11 and the distal end face of the second frame 21, the connector 30 can also be provided with additional flow-blocking elements 40 on the first frame 11 and / or the second frame 21, with the connector 30 connected to the additional flow-blocking elements 40. In a preferred embodiment, one end of the connector 30 is connected to the first plugger frame 11 or the second frame 21 together with the corresponding additional flow-blocking element 40, or the additional flow-blocking elements 40 are first connected to both ends of the connector 30, and then the additional flow-blocking elements 40 are connected to the first frame 11 and the second frame 21. The additional flow-blocking elements 40 can be connected to the connector 30, the first frame 11 and the second frame 21 by stitching, or formed by spraying, sputtering or dipping. The shape of the additional flow-blocking elements 40 can be circular, elliptical, polygonal or spaced-apart blades, etc., with an area larger than the planar area of ​​both ends of the connector 30.

[0055] Additional flow-blocking elements 40 can be respectively disposed on the proximal end face of the first frame 11 and / or the distal end face of the second frame 21. In a preferred embodiment, the additional flow-blocking elements 40 are located at approximately the center of the first frame 11 and / or the second frame 21, distributed around the corresponding endpoints, and covering a portion of the proximal end face of the first frame 11 and / or the distal end face of the second frame 21. In other embodiments, the additional flow-blocking elements 40 can also cover the entire proximal end face of the first frame 11 and / or the entire distal end face of the second frame 21, thus eliminating the need for flow-blocking membranes disposed inside the corresponding frames.

[0056] By setting the additional flow-blocking element 40, not only can the effect of blocking blood flow be enhanced, but the connection strength between the connector 30 and the first frame 11 and the second frame 21 can also be increased.

[0057] In some embodiments, such as Figure 13 and Figure 14 As shown, the connector 30 includes a first connector 31 and a second connector 32. The first connector 31 is tubular, and the second connector 32 is linear, such as straight, spiral, or wavy. The second connector 32 is disposed within the first connector 31. The distal end of the first connector 31 is connected to the proximal end face of the first frame 11, and the distal end of the second connector 32 is connected to the first convergent element 13. The proximal end of the first connector 31 is connected to the distal end face of the second frame 21, and the proximal end of the second connector 32 is connected to the third convergent element 24.

[0058] The first connector 31 can be a tubular element made of flexible yarn knitted or braided. The flexible yarn can be made of biocompatible medical fibers such as polyester, polytetrafluoroethylene, polypropylene, and polyurethane, or biodegradable fibers such as polyhydroxyacetic acid, polylactic acid, and polylactic-hydroxyacetic acid.

[0059] In some embodiments, the second connector 32 may be a flexible filament or a bundle of filaments. The material of the second connector 32 may be an elastic metal such as nickel-titanium alloy, or an elastic polymer. The second connector 32 is disposed within the first connector 31, connecting the first occluder 10 and the second occluder 20. This enhances the tension between the first occluder 10 and the second occluder 20, thereby increasing the clamping force of the first occluder 10 and the second occluder 20 on the primary septum 200 and the secondary septum 300 in the deformed state, and improving the implantation effect.

[0060] Preferably, the second connector 32 can also be helical or toothed, such as a helical spring, to reduce the axial space required by the second connector 32. In the deformed state, when the first central axis 101 deviates from the second central axis 201, the second connector 32 elongates. Under the action of the elastic force of the second connector 32, the first sealing member 10 and the second sealing member 20 can be tightened, so as to provide better tissue fixation performance for the occluder and adapt to the distance between the first sealing member 10 and the second sealing member 20 required to accommodate the ovoid aperture 100 fissure.

[0061] In the preset state, the first frame 11 and the second frame 21 are symmetrically distributed around their respective central axes, and the connecting member 30 is in a relaxed state. In the deformed state, as... Figure 22 and Figure 23 As shown, the first frame 11, connector 30, and second frame 21 are adapted to the implantation position structure. The first connector 31 and second connector 32 are in a stretched state, and the first central axis 101 and the second central axis 201 are offset. The first convergent element 13 and the third convergent element 24, after offset, are the two endpoints of a line segment and have an included angle α with the first central axis 101 or the second central axis 201. The connector 30 is offset from the central axis, presenting a configuration adapted to the deformation state. The included angle α ranges from 30° to 90°. In some embodiments, the first convergent element 13 and the third convergent element 24 are fixedly connected or rotatably connected to the second connector 32. When the second connector 32 is rotatably connected to the first convergent element 13 and the third convergent element 24, displacement elements can be provided at the endpoints of the second connector 32, and receiving elements can be provided at the corresponding endpoints of the first convergent element 13 and the third convergent element 24. Through the cooperation of the displacement elements and the receiving elements, a connection structure similar to a universal joint is formed, thereby increasing the angular displacement flexibility of the second connector 32. A schematic diagram of the rotatable connection between the second connector 32 and the third convergent element 24 is shown below. Figure 25 As shown, one end of the third gathering element 24 is used to receive the metal wire c of the second distal end face 203 of the second frame 21, and the other end of the third gathering element 24 is rotatably connected to the second connector 32. A schematic diagram of the structure in which the second connector 32 and the third gathering element 24 are fixedly connected is shown below. Figure 26 As shown.

[0062] In some embodiments, the first frame 11, the second frame 21, and the connector 30 are separately arranged. The first frame 11, the second frame 21, and the connector 30 can be made of different materials as needed to simultaneously meet the flexibility requirements of the connector 30 and the strength requirements of the first frame 11 and the second frame 21, so that the first frame 11 and the second frame 21 can clamp the primary septum and the secondary septum.

[0063] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A patent foramen occlusion device, characterized in that, It includes a first sealing element, a second sealing element, and a connecting element; The connector has a tubular structure and is made of a knitted or woven non-elastic, non-metallic flexible flow-blocking membrane. Its distal end is connected to the first sealing member, and its proximal end is connected to the second sealing member. The connector has radial and axial deformation capabilities. The external radial dimension of the connector gradually decreases from the proximal end to the middle part and gradually increases from the middle part to the distal end. The first and second sealing components are woven from elastic metal wires. The first sealing component has a first frame, a first flow-blocking element, and a first converging element. The first frame has a double-layer structure and includes a proximal end face and a distal end face. The first flow-blocking element is disposed within the first frame. The second sealing element has a second frame, a second flow-blocking element and a third converging element. The second frame has a double-layer structure and includes a proximal end face and a distal end face. The second flow-blocking element is disposed within the second frame. The distal end of the connector is connected to the proximal end of the first frame, and the proximal end is connected to the distal end of the second frame. The first and third convergent elements are both located within the connector.

2. The unclosed orifice plugging device according to claim 1, characterized in that, The connector is made of flexible thread or flexible thread bundle knitted or woven.

3. The unclosed orifice plugging device according to claim 2, characterized in that, The second frame has a proximal free end and a distal free end, and the second occlusion element further includes a second convergence element that converges the proximal free end of the second frame, and a third convergence element that converges the distal free end of the second frame.

4. The unclosed orifice plugging device according to claim 3, characterized in that, The first frame has a proximal free end, and the first condensing element condenses the proximal free end of the first frame.

5. A patent foramen occlusion device according to any one of claims 2-4, characterized in that, The proximal and distal surfaces of the first frame are approximately planar and fit together; the proximal and distal surfaces of the second frame are either arc-shaped or planar and fit together.

6. The unclosed orifice plugging device according to claim 4, characterized in that, The second convergence element does not protrude significantly from the near end face of the second frame along the axial direction of the second frame.

7. The unclosed orifice plugging device according to claim 6, characterized in that, It also includes additional flow-blocking elements disposed on the proximal end face of the first frame and / or the distal end face of the second frame.

8. The unclosed oval aperture plugging device according to claim 7, characterized in that, The distal end of the connector is connected to the proximal end face of the first frame or to an additional flow-blocking element on the first frame, and the proximal end of the connector is connected to the proximal end face of the second frame or to an additional flow-blocking element on the second frame.

9. The unclosed oval aperture plugging device according to claim 4, characterized in that, The connector also has an internal component, the distal end of which is connected to the first gathering element and the proximal end of which is connected to the third gathering element.

10. The unclosed orifice plugging device according to claim 9, characterized in that, The internal components are linear.

11. The unclosed orifice plugging device according to claim 10, characterized in that, The internal components are fixedly or rotatably connected to the first and third gathering elements, respectively.

12. The unclosed orifice plugging device according to claim 11, characterized in that, The internal component is a single elastic metal wire, or a non-metallic flexible wire or wire bundle.

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