A retrievable occlusion device

Abstract

The application relates to the field of medical devices, in particular to a convenient-to-recover occlusion device. The occlusion device comprises a first occlusion piece and a second occlusion piece. The first occlusion piece comprises a first support framework, a second support framework and a connecting member connecting the two. The first support framework comprises a stable structure diverging from the center. The second support framework comprises a radially arranged support piece. The connecting member is connected with the outer end of the support piece and the stable structure at both ends.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a sealing device that is easy to recycle. Background Technology

[0002] The foramen ovale (PFO) is a physiological passage in the atrial septum during embryonic development. Around 5-7 months after birth, in most individuals, the primordial and secondary septa of the atrial septum adhere and fuse to form a permanent atrial septum. If fusion fails, a patent foramen ovale (PFO) is formed. Studies have shown a close link between PFO and unexplained stroke. Through a patent foramen ovale, the following emboli can enter the left ventricular system, causing corresponding clinical symptoms: 1. Thrombosis in the deep veins of the lower extremities or pelvic veins; 2. Air emboli caused by decompression sickness or diving; 3. Fat emboli formed after surgery or trauma. Furthermore, the risk of recurrent thrombotic events remains high for patients with a history of PFO. Therefore, treating the underlying cause and closing the open foramen ovale in high-risk individuals may reduce the incidence of these conditions. Additionally, research has found that PFO is associated with decompression sickness, migraines, and other conditions; closing the foramen ovale may also benefit patients with these conditions.

[0003] Currently, most interventional devices used for closing the foramen ovale are double-disc occluders. The anatomical structure and shape of the defect vary depending on the location of the defect in different congenital heart diseases, and the thickness is uneven. Generally, the left and right discs of the occluder after release cannot fit well against the left and right sides of the cardiac septum. Moreover, the discs of the occluder are made of metal and have many grids or gaps on the surface, making it difficult for endothelial cells to adhere to and climb on such occluders. Also, because the disc surface is grid-like, there is no space for a secondary interventional procedure.

[0004] Patent 202211738818.4 discloses a patent foramen ovale (PFO) occluder, which includes two occlusion discs: a left atrial occlusion disc and a right atrial occlusion disc. The elastic metal wire comprises a first, second, and third segment connected sequentially. The first and third segments are woven to form the support framework for the two occlusion discs, and the second segment forms the waist structure connecting the two occlusion discs. The design flaw of this scheme is that, firstly, the support framework is woven from multiple elastic metal wires. Due to limitations in the weaving process, the actual length of the elastic metal wire used in each frame of the cross-shaped structure is not the same, or different frames may have different lengths of elastic metal wire. The elastic metal wires at the same location have different densities. When the operating conveying steel cable pulls the retrieval nut to retrieve the support frame, the elastic metal wires are stretched into the conveying sheath and rub against the sheath. Due to the different lengths of the metal wires or the different forces on each elastic metal wire, the support frame is difficult to enter the conveying sheath evenly, causing the support frame to deform, bend, or even get stuck, making it impossible to retrieve into the conveying sheath. Secondly, each occlusion disc has two cross-shaped structures, and the two cross-shaped structures are staggered, which increases the metal ratio of the disc surface, reduces the space available for secondary intervention, and is not conducive to subsequent transseptal puncture surgery.

[0005] As can be seen from the above, the existing technology has problems such as poor fitting effect of the occlusion device, difficulty in performing a second puncture at the interventional device site, and difficulty in retrieving the right atrial occlusion disc after it is released during the operation. Summary of the Invention

[0006] The purpose of this invention is to provide a sealing device that is easy to recycle, in order to solve the problems mentioned in the background art.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: a sealing device that is easy to recycle, the sealing device comprising a first sealing element and a second sealing element, the first sealing element comprising a first support frame, a second support frame and a connecting member connecting the two, the first support frame comprising a stabilizing structure radiating from the center, the second support frame comprising a radially arranged support member, and the connecting member connecting the outer ends of the support member and the stabilizing structure at both ends.

[0008] In one embodiment, the connecting member includes a high-strength flexible connector; and the first support frame and the second support frame are not integrally connected.

[0009] In one embodiment, the stabilizing structure includes a stabilizing member and a blocking member, the blocking member being connected to the connecting member; and, when the first sealing member is retrieved, the blocking member abuts or supports the outer end of the support member to prevent the support member and the stabilizing member from overlapping axially.

[0010] In one embodiment, the area formed by the blocking member on the axial projection plane of the first sealing member is a first region, and the movable space of the outer end of the support member connected to the connecting member is a second region; and the second region is within the first region.

[0011] In one embodiment, the blocking member includes a blocking unit and a stabilizing unit, the stabilizing unit being connected to the connecting member; and the stabilizing unit is in the form of a closed loop.

[0012] In one embodiment, the stabilizing member is made of woven metal wire.

[0013] In one embodiment, the stabilizing structure further includes a bonding filament connected to the stabilizing member and / or the blocking member; and the stabilizing member, the blocking member, and the bonding filament are integrally woven together.

[0014] In one embodiment, the number of metal wires wound and woven in pairs at the stabilizing member is greater than the number of the bonding wire positions.

[0015] In one embodiment, the outer end of the bonding wire is provided with a protective structure, which is in the shape of an arc or a circle.

[0016] In one embodiment, the blocking member includes a ring-shaped unit, the ring-shaped unit comprising a plurality of ring-shaped members, adjacent ring-shaped members being interconnected; and the connecting member is connected to the central portion of the ring-shaped unit.

[0017] In one embodiment, the ring-shaped unit includes four ring-shaped members. When the first sealing member is retracted, the end of the support member is restricted by the ring-shaped unit and can only move within the range of the ring-shaped members.

[0018] In one embodiment, the maximum permissible diameter of the ring-shaped unit is smaller than the diameter of the end of the support member.

[0019] In one connection method, the loop-shaped member and the fitting wire are connected in a manner similar to the connection between the metacarpal and phalangeal bones of the hand.

[0020] In one embodiment, the ring-shaped member is connected to the bonding wire.

[0021] In one embodiment, the blocking member includes a ring-shaped unit; and a plurality of the bonding wires are respectively connected to the ring-shaped unit, and the bonding wires are arranged in a divergent manner.

[0022] In one embodiment, the circular unit is made of several metal wires wound together, and each bonding wire is wound around the circular unit and then spread outward.

[0023] In one embodiment, the ring-shaped unit is circular.

[0024] In one embodiment, the connecting member includes a plurality of branched connecting units, each connecting unit including an even number of connecting wires at a certain angle to the support member; and the first support frame, the second support frame and the connecting wires are integrally connected.

[0025] In one embodiment, each stabilizing structure has two connecting wires at its divergence point, and the divergence stops at the outer periphery of the first sealing member and connects to the support member.

[0026] In one embodiment, the connecting ribbon is actuated to adhere to the first adhesive membrane to the foramen ovale tissue.

[0027] In one embodiment, the first sealing member includes a first adhesive film and a second adhesive film respectively connected to the first support frame and the second support frame; and the first support frame and the first adhesive film are combined to form a bowl shape.

[0028] In one embodiment, the first bonding film further includes a reinforcing film connected to the barrier member.

[0029] In one embodiment, the strength of the reinforcing membrane is greater than the strength of membranes at other locations.

[0030] In one embodiment, the area of ​​the first bonding film is larger than the area of ​​the second bonding film.

[0031] In one embodiment, the first support frame includes five stabilizing members, and the second support frame includes five supporting members.

[0032] In one embodiment, the pre-set direction of the bonding filament is towards the tissue to be closed, and the bonding filament is divergent; furthermore, the bonding filament drives the first bonding film portion connected to it to be positioned towards the distal end.

[0033] In one embodiment, the system further includes a waist structure connecting the first sealing member and the second sealing member; and the waist structure includes an elastic member and a filling membrane, wherein the filling membrane is connected to the first sealing member and the second sealing member.

[0034] In one embodiment, the sealing device further includes a delivery system, a release structure is provided at the center of the first support frame and the release structure is connected to the delivery system; and a connector is provided at the center of the second support frame and the connector is connected to at least a portion of the waist structure.

[0035] In one embodiment, the release structure is disposed at the proximal end of the first support frame, and the connector is disposed at the distal end of the second support frame.

[0036] In one embodiment, the connecting member is detachably connected to the first support frame or the second support frame; and, when the connecting member is detached, the first support frame separates from the sealing device.

[0037] In one embodiment, the connecting member is disassembled, and the second support frame is attached to the foramen ovale tissue.

[0038] In one embodiment, the first support frame and the second support frame at least partially overlap in projection; and the support member and the stabilizing member overlap in axial projection, and the two are provided in the same number and are not staggered.

[0039] In one embodiment, at least the outer periphery of the first support frame and the second support frame is made of a biodegradable material.

[0040] In one embodiment, the delivery system includes an outer sheath and a control tube, wherein the first sealing element, the waist structure, and the second sealing element are pre-installed in the outer sheath from proximal to distal end, and the control tube is connected to the release structure.

[0041] In one embodiment, the bonding wire is disposed on the outer side of the outer peripheral end of the stabilizing member.

[0042] In one embodiment, when the sealing device is pre-installed or the first sealing member is retrieved, the bonding wire and the support member overlap axially.

[0043] In one embodiment, when the sealing device is pre-installed or the first sealing member is recycled, the first sealing membrane connected to the bonding wire spatially wraps around or surrounds the outer end portion of the support member.

[0044] In one embodiment, when the sealing device is pre-installed or the first sealing member is retrieved, the first sealing membrane connected to the blocking member spatially wraps around or surrounds the outer end of the support member.

[0045] In one embodiment, the blocking structure is disposed at the outer end of the stabilizing member.

[0046] In one embodiment, the maximum diameter of the first support frame is greater than the maximum diameter of the second support frame.

[0047] In one embodiment, the second sealing element includes a sealing structure and a sealing membrane, wherein the sealing structure is integrally woven from metal wires and is formed radiating from the center.

[0048] In one embodiment, the diameter of the ring-shaped unit is equal to or similar to the diameter of the end of the support member; and the ring-shaped unit is connected to the end of the support member via the flexible connector.

[0049] In one embodiment, the diameter of the ring-shaped unit is less than 2 mm.

[0050] Compared with the prior art, the advantages of the present invention are as follows:

[0051] 1. In existing technologies, the first occluding element of a patent foramen ovale occluder is integrally woven from metal wire. If the surgeon needs to retrieve and re-release the first occluding element during the operation, the existing process makes it difficult to achieve uniform weaving due to the large length of the metal wire. Furthermore, the uneven stress on the wires on different members during retrieval makes it difficult to retract the first occluding element evenly, easily damaging its surface structure and even causing deformation or jamming, thus reducing the success rate of the operation. The technical solution of this application avoids these problems. Although the first and second support frames of the occluding device in this application are also woven, they are not integrally connected. They are connected by a connecting component. The advantages of this design are: firstly, the connecting component is a high-strength flexible connecting wire, which not only has good connection performance but also has a "compensation" function. If the occluding element needs to be retrieved during the operation... When the first support frame is retrieved, some stabilizing components may enter the outer sheath before others. In this case, the flexible connectors that are connected to the stabilizing components that have already entered will be gradually stretched and enter the outer sheath along with the remaining stabilizing components. This prevents the first support frame from "tilting" due to uneven entry into the sheath. This not only allows for the smooth retrieval of the first support frame but also avoids damage to the stabilizing components. Similarly, it also facilitates the retrieval of the second support frame into the outer sheath. Secondly, since the first and second support frames are two separate structures, the length of the metal wire required during manufacturing is reduced by at least half, and there is no need to bend, fold, or deflect the metal wire, which reduces the difficulty of the weaving process. Therefore, the metal braided wires at various positions of the stabilizing components and support components are relatively uniform, and the density of the elastic metal wires at the same position of different stabilizing components is small, which facilitates the uniform retrieval of the first support frame.

[0052] 2. Unlike existing technologies, the stabilizing structure of this application also includes a blocking member. Since the first support frame and the second support frame are two separate structures, the distal end of the stabilizing member and the proximal end of the support member may overlap when the first support frame is retracted. More specifically, the proximal end of the support member is located outside the distal end of the stabilizing member, and the support member forms a step outside the stabilizing member, causing the support member to get stuck on the outer sheath and making it difficult to complete the retraction action. Therefore, setting a blocking member can effectively prevent the support member and the stabilizing member from overlapping in the axial direction. The area formed by the blocking member on the axial projection plane of the first sealing member is the first area, and the activity space of the outer end of the support member connected to the connecting member is the second area. Within the second area of ​​the first area, the support member will not move outside the stabilizing member, avoiding the problem of the support member getting stuck with the transport system. Moreover, the blocking structure is set at the outer end of the stabilizing member, which will not affect other functions of the sealing device, while also improving the structural stability of the first support frame.

[0053] 3. Unlike existing technologies, the stabilizing structure also includes fitting wires connected to the stabilizing components and / or blocking components. The advantages of this design are: fewer stabilizing components and fewer metal implants on the projected surface, facilitating subsequent secondary interventional surgeries. However, the fewer stabilizing components somewhat affect the fit of the first occlusion component. The fitting wires improve the fit. The preset direction of the fitting wires is towards the tissue to be closed, and the fitting wires are arranged in a divergent manner on the outside of the stabilizing components. The fitting wires are shaped on the first adhesive membrane, and the fitting wires drive the portion of the first adhesive membrane connected to them to be positioned distally. Thus, the first adhesive membrane positioned on the outside can fit with the foramen ovale tissue, resulting in good leakage prevention. On the other hand, since the fitting wires are connected to the blocking components, the fitting wires can also play a certain blocking role on the support component during the retrieval of the first occlusion component, applying force to the support component and promoting the closure of the second skeleton.

[0054] 4. Unlike existing technologies, the blocking component is also connected to the connecting component. On the one hand, the blocking component provides a connection position for the connecting component. On the other hand, the other end of the connecting component is connected to the end of the support component. The movement of the connecting component restricts the movement range of the end of the support component. The two components work together to ensure that the end of the support component will not be separated from the control of the blocking component.

[0055] 5. Unlike existing technologies, the blocking component includes a ring-shaped unit, which includes several ring-shaped components. Adjacent ring-shaped components are connected to each other, forming a stable structure with a wide control range. At the same time, the maximum passable diameter of the ring-shaped unit is smaller than the diameter of the end of the support member, and the support member cannot pass through the blocking component and overlap with the stabilizing component.

[0056] 6. Unlike existing technologies, the first and second support frames are detachably connected, and the connecting components are also detachable. The advantage of this design is that when the two are connected, the first occlusion component includes both the first and second support frames, allowing the surgeon to repeatedly operate the first occlusion component to retrieve and release it until the optimal implantation position is reached. After the two are separated, the implanted first occlusion component only includes the second support frame, resulting in fewer metal implants and facilitating secondary interventional procedures.

[0057] 7. Unlike existing technologies, the flexible connector can adapt to different shapes of foramen ovale tunnels. Since the outer end of each support is connected to the flexible connector, the first support frame and the second support frame can be misaligned, and their center lines are not necessarily on the same axis, which can adapt to the foramen ovale tissue of different patients. Attached Figure Description

[0058] Figure 1 This is a schematic diagram of the overall structure of the sealing device of the present invention.

[0059] Figure 2 This is a schematic diagram of the structure of the first support frame and the second support frame in the first sealing component of the present invention.

[0060] Figure 3 for Figure 2 Enlarged view of part A in the middle.

[0061] Figure 4 This is a schematic diagram of the structure of the first sealing element in the sealing device of the present invention after it has been coated with a film.

[0062] Figure 5 This is a schematic diagram of the stable structure of the present invention.

[0063] Figure 6 This is a schematic diagram of the structure of the second support frame of the present invention.

[0064] Figure 7 and Figure 8 These are two embodiments of the second sealing component of the present invention.

[0065] Figure 9 and Figure 10 This is a schematic diagram of the principle of the second region of the present invention within the first region.

[0066] Figure 11 This is a pre-assembly diagram of the sealing device of the present invention.

[0067] Figure 12 for Figure 11 Enlarged view of section B in the middle.

[0068] Figure 13 A schematic diagram illustrating the complete recovery of the first sealing element using the invented sealing device.

[0069] Figure 14 This is a schematic diagram of the partial recovery of the first sealing element in the sealing device of the present invention.

[0070] Figures 15-17 This is a schematic diagram of the operation process of the sealing device of the present invention.

[0071] Figure 18 This is a schematic diagram of the structure of the first sealing element in another embodiment of the present invention.

[0072] Figure 19 for Figure 18 Enlarged view of section C.

[0073] Figure 20 This is another embodiment of the circular unit of the present invention.

[0074] Figure 21 This is a schematic diagram illustrating the disassembly and separation of the first support frame and the second support frame according to another embodiment of the present invention.

[0075] Figure 22 and Figure 23 This is a schematic diagram of another embodiment of the present invention.

[0076] The parts referred to by the numbers in the attached diagram are as follows: 1-First sealing element, 11-First bonding membrane, 12-Second bonding membrane, 2-Second sealing element, 21-Sealing structure, 22-Sealing membrane, 3-First support frame, 31-Stabilizing structure, 311-Stabilizing component, 312-Blocking component, 3121-Circular unit, 3122-Circular component, 3123-Blocking unit, 3124-Stabilizing unit, 313-Bonding wire, 3131-Protective structure, 314-Release structure, 4-Second support frame, 41-Supporting element, 42-Connector, 5-Connecting component, 51-Flexible connector, 52-Connecting unit, 521-Connecting wire, 6-Waist structure, 61-Elastic element, 62-Filling membrane, 7-Conveying system, 71-Outer sheath tube, 72-Control tube, 8-First region, 9-Second region. Implementation

[0077] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0078] In this application, the end closer to the surgical operator is defined as the "proximal end," and the end farther from the surgical operator is defined as the "distal end." Specific Implementation Example 1

[0079] like Figure 1As shown, during PFO interventional treatment, a retrievable occlusion device is used. The occlusion device includes a first occlusion element 1 and a second occlusion element 2. The first occlusion element 1 includes a first support frame 3, a second support frame 4, and a connecting member 5 connecting the two. The first support frame 3 includes a stabilizing structure 31 radiating from the center. The second support frame 4 includes radially arranged support members 41. The connecting member 5 connects the outer ends of the support members 41 to the stabilizing structure 31 at both ends. Figure 2 As shown.

[0080] In this embodiment, the connecting member 5 includes a high-strength flexible connector 51; and the first support frame 3 and the second support frame 4 are not integrally connected.

[0081] In this embodiment, the stabilizing structure 31 includes a stabilizing member 311 and a blocking member 312, wherein the blocking member 312 is connected to the connecting member 5, as shown below. Figure 2 and Figure 3 As shown; and, when the first sealing member 1 is retrieved, the blocking member 312 abuts or supports the outer end of the support member 41 to prevent the support member 41 from overlapping the stabilizing member 311 in the axial direction, as shown. Figure 14 As shown.

[0082] In this embodiment, the stabilizing component 311 is made of woven metal wire.

[0083] In this embodiment, the stabilizing structure 31 further includes a bonding yarn 313 connected to the stabilizing member 311 and / or the blocking member 312; and the stabilizing member 311, the blocking member 312, and the bonding yarn 313 are integrally woven together, such as... Figure 2 and Figure 5 As shown.

[0084] In this embodiment, the number of metal wires wound and woven in pairs at the stabilizing member 311 is greater than the number of wires at the bonding wire position 313.

[0085] In this embodiment, the outer end of the bonding wire 313 is provided with a protective structure 3131, which is in the shape of an arc or a circle.

[0086] In this embodiment, the blocking member 312 includes a ring-shaped unit 3121, which includes a plurality of ring-shaped members 3122, and adjacent ring-shaped members 3122 are connected to each other; and the connecting member 5 is connected to the central portion of the ring-shaped unit 3121, such as... Figure 3 As shown.

[0087] In this embodiment, the circular unit 3121 includes four circular components 3122, such as... Figure 3 As shown, when the first sealing member 1 is recovered, the end of the support member 41 is restricted by the ring-shaped unit 3121, as... Figure 14 As shown, it can only move within the range of the ring-shaped member 3122.

[0088] In this embodiment, the maximum passable diameter of the ring-shaped unit 3121 is smaller than the diameter of the end of the support member 41.

[0089] In this embodiment, the ring-shaped component 3122 and the fitting wire 313 are connected in a manner similar to the connection between the metacarpal and phalangeal bones of a hand.

[0090] In this embodiment, the ring-shaped component 3122 is connected to the bonding wire component 313.

[0091] In this embodiment, the first sealing member 1 includes a first bonding film 11 and a second bonding film 12 respectively connected to the first support frame 3 and the second support frame 4, such as... Figure 4 As shown; and the first support frame 3 and the first bonding film 11 are combined to form a bowl shape.

[0092] In this embodiment, the laying area of ​​the first bonding film 11 is greater than the laying area of ​​the second bonding film 12.

[0093] In this embodiment, the first support frame 3 includes five stabilizing members 311, and the second support frame 4 includes five supporting members 41, such as... Figure 5 and Figure 6 As shown.

[0094] In this embodiment, the preset direction of the bonding wire 313 is to bond towards the tissue to be closed, and the bonding wire 313 is in a divergent shape; furthermore, the bonding wire 313 drives the first bonding film 11 connected to it to be positioned towards the distal end.

[0095] In this embodiment, a waist structure 6 connecting the first sealing member 1 and the second sealing member 2 is also included; and the waist structure 6 includes an elastic member 61 and a filling membrane 62, wherein the filling membrane 62 is connected to the first sealing member 1 and the second sealing member 2, as shown below. Figure 1 As shown.

[0096] In this embodiment, the sealing device further includes a conveying system 7, such as... Figure 11 As shown, the first support frame 3 has a release structure 314 at its center, which is connected to the conveying system 7; and the second support frame 4 has a connector 42 at its center, which is connected to at least part of the waist structure 6.

[0097] In this embodiment, the release structure 314 is disposed at the proximal end of the first support frame 3, and the connector 42 is disposed at the distal end of the second support frame 4, as shown below. Figure 2 and Figure 4 As shown.

[0098] In this embodiment, the first support frame 3 and the second support frame 4 at least partially overlap in projection; and the support member 41 and the stabilizing member 311 overlap in axial projection, and the two are provided in the same number and are not staggered.

[0099] In this embodiment, the blocking member 312 includes a blocking unit 3123 and a stabilizing unit 3124. The stabilizing unit 3124 is connected to the connecting member 5 and is in the shape of a closed loop. Furthermore, the area formed by the blocking member 312 on the axial projection plane of the first sealing member 1 is a first region 8, and the movable space at the outer end of the support member 41 connected to the connecting member 5 is a second region 9. The second region 9 is located within the first region 8. Figure 9 and Figure 10 As shown.

[0100] In this embodiment, the delivery system 7 includes an outer sheath 71 and a control tube 72. The first sealing member 1, the waist structure 6, and the second sealing member 2 are pre-installed in the outer sheath 71 from proximal to distal end. The control tube 72 is connected to the release structure 314. Figure 11 As shown.

[0101] In this embodiment, the bonding wire 313 is disposed on the outer side of the outer peripheral end of the stabilizing member 311.

[0102] In this embodiment, when the sealing device is pre-installed or the first sealing component 1 is retrieved, the bonding wire 313 and the support component 41 overlap axially, such as... Figure 12 and Figure 15 As shown, the first bonding film 11 connected to the bonding wire 313 is partially wrapped around the second bonding film 12 connected to the support member 41.

[0103] In this embodiment, the blocking structure is disposed at the outer end of the stabilizing member 311.

[0104] In this embodiment, the second sealing element 2 includes a sealing structure 21 and a sealing membrane 22. The sealing structure 21 is integrally woven from metal wires, and the sealing structure 21 is formed radiating from the center. Figure 7 or Figure 8 As shown.

[0105] The exemplary operation process of the conveying system 7 in this embodiment is as follows:

[0106] (1) The delivery system 7 enters the right atrium via the femoral vein, passes through the foramen ovale to the left atrium, and then the outer sheath 71 is withdrawn to release the second occlusion member 2, as follows. Figure 15 As shown.

[0107] (2) Operate the delivery system 7 so that the second sealing member 2 fits against the left room surface, and retract the outer sheath tube 71 to release the waist structure 6 located in the oval hole tunnel.

[0108] (3) Retract the outer sheath tube 71 to release the first sealing member 1 from the right chamber surface, as shown. Figure 16 As shown.

[0109] (4) If the release position of the first sealing element 1 is ideal, proceed directly to step (5); if the release position is not suitable, pull the control tube 72 and simultaneously push the outer sheath tube 71 to move towards the distal end to retract the first sealing element 1. Figure 14 As shown; and rotate the control tube 72 to adjust the position of the first sealing member 1, as shown. Figure 13 As shown, proceed to step (3) again.

[0110] (5) Disconnect the control tube 72 from the release structure 314, retrieve the delivery system 7, and complete the implantation, as follows. Figure 17 As shown. Example 2

[0111] The difference from Embodiment 1 is that the structure of the blocking structure is different, and the first support frame 3 and the second support frame 4 are detachably connected.

[0112] The composition and connection method of each component in this embodiment will be described in detail below with reference to the accompanying drawings:

[0113] When performing PFO interventional therapy, such as Figure 18 and Figure 21 As shown, a sealing device that is easy to recycle includes a first sealing element 1 and a second sealing element 2. The first sealing element 1 includes a first support frame 3, a second support frame 4, and a connecting member 5 connecting the two. The first support frame 3 includes a stabilizing structure 31 radiating from the center. The second support frame 4 includes a radially arranged support member 41. The two ends of the connecting member 5 are respectively connected to the outer ends of the support member 41 and the stabilizing structure 31.

[0114] In this embodiment, the blocking member 312 includes a ring-shaped unit 3121; and a plurality of bonding wires 313 are respectively connected to the ring-shaped unit 3121, and the bonding wires 313 are arranged in a divergent manner.

[0115] In this embodiment, the circular unit 3121 is made of several metal wires wound together. Each bonding wire 313 is wound around the circular unit 3121 and then radiates outwards. Figure 20 As shown.

[0116] In this embodiment, the ring-shaped unit 3121 is in the shape of a ring.

[0117] In this embodiment, the connecting member 5 is detachably connected to the first support frame 3 or the second support frame 4; and, by disassembling the connecting member 5, the first support frame 3 separates from the sealing device, as shown below. Figure 19 As shown.

[0118] In this embodiment, the connecting member 5 is disassembled, the second support frame 4 is attached to the foramen ovale tissue, and the first support frame 3 is retracted into the delivery system 7. Figure 21 As shown. Example 3

[0119] The difference from Embodiment 1 is that the first support frame 3 and the second support frame 4 are fixedly connected.

[0120] The composition and connection method of each component in this embodiment will be described in detail below with reference to the accompanying drawings:

[0121] During PFO interventional treatment, an easily retrievable occlusion device, such as... Figure 22 and Figure 23 As shown, the sealing device includes a first sealing element 1 and a second sealing element 2. The first sealing element 1 includes a first support frame 3, a second support frame 4, and a connecting member 5 connecting the two. The first support frame 3 includes a stabilizing structure 31 radiating from the center. The second support frame 4 includes a radially arranged support member 41. The two ends of the connecting member 5 are respectively connected to the outer ends of the support member 41 and the stabilizing structure 31.

[0122] In this embodiment, the first sealing member 1 includes a first adhesive film 11 and a second adhesive film 12 that are respectively connected to the first support frame 3 and the second support frame 4; and the first support frame 3 and the first adhesive film 11 are combined to form a bowl shape.

[0123] In this embodiment, the connecting member 5 includes several sets of forked connecting units 52, each connecting unit 52 including two connecting wires 521 at a certain angle to the support member 41; and the first support frame 3, the second support frame 4 and the connecting wires 521 are integrally connected.

[0124] In this embodiment, each stabilizing structure 31 has two connecting wires 521 at its divergence point, and the divergence stops at the outer periphery of the first sealing member 1 and connects to the support member 41.

[0125] In this embodiment, the connecting wire 521 drives the first adhesive membrane 11 connected to it to adhere to the foramen ovale tissue.

[0126] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations, structures, and / or steps disclosed. Obviously, based on the teachings above, those skilled in the art can make various modifications and improvements without departing from the inventive concept, and these all fall within the scope of protection of this invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A sealing device that is easy to recycle, the sealing device comprising a first sealing element and a second sealing element, characterized in that: The first sealing component includes a first support frame, a second support frame, and a connecting member connecting the two. The first support frame includes a stabilizing structure radiating from the center, and the second support frame includes a radially arranged support member. The connecting member connects the outer ends of the support member to the stabilizing structure at both ends. The connecting member includes a high-strength flexible connector. The first and second support frames are not integrally connected. The stabilizing structure includes a stabilizing member and a blocking member. The blocking member is connected to the connecting member. Furthermore, when the first sealing component is retrieved, the blocking member presses against or supports the outer end of the support member to prevent the support member and the stabilizing member from overlapping axially.

2. The sealing device for easy recycling according to claim 1, characterized in that: The blocking member includes a blocking unit and a stabilizing unit, the stabilizing unit being connected to the connecting member; and the stabilizing unit is in the form of a closed loop.

3. The sealing device for easy recycling according to claim 1, characterized in that: The stabilizing structure further includes a bonding filament connected to the stabilizing member and / or the blocking member; and the stabilizing member, the blocking member, and the bonding filament are integrally woven together.

4. The sealing device for easy recycling according to claim 3, characterized in that: The blocking member includes a ring-shaped unit, which includes a plurality of ring-shaped components, with adjacent ring-shaped components connected to each other; and the connecting member is connected to the central portion of the ring-shaped unit.

5. A sealing device for easy recycling according to claim 3, characterized in that: The blocking member includes a ring-shaped unit; and a plurality of the bonding wires are respectively connected to the ring-shaped unit, and the bonding wires are arranged in a divergent manner.

6. The sealing device for easy recycling according to claim 1, characterized in that: The connecting component includes several sets of branched connecting units, each connecting unit including an even number of connecting wires at a certain angle to the support member; and the first support frame, the second support frame and the connecting wires are integrally connected.

7. The sealing device for easy recycling according to claim 3, characterized in that: The first sealing member includes a first bonding film and a second bonding film respectively connected to the first support frame and the second support frame; and the first support frame and the first bonding film are combined to form a bowl shape; and the first bonding film also includes a reinforcing film, which is connected to the blocking member.

8. The sealing device for easy recycling according to claim 7, characterized in that: The pre-set direction of the bonding filament is towards the tissue to be closed, and the bonding filament is divergent; furthermore, the bonding filament drives the first bonding film portion connected to it to be positioned towards the distal end.

9. The sealing device for easy recycling according to claim 1, characterized in that: It also includes a waist structure connecting the first sealing member and the second sealing member; and the waist structure includes an elastic member and a filling membrane, and the filling membrane is connected to the first sealing member and the second sealing member.

10. A sealing device for easy recycling according to claim 9, characterized in that: The sealing device also includes a conveying system, and the center of the first support frame is provided with a release structure, which is connected to the conveying system; and the center of the second support frame is provided with a connector, which is connected to at least part of the waist structure.

11. The sealing device for easy recycling according to claim 1, characterized in that: The connecting member is detachably connected to the first support frame or the second support frame; and, when the connecting member is detached, the first support frame separates from the sealing device.

12. The sealing device for easy recycling according to claim 1, characterized in that: The first support frame and the second support frame at least partially overlap in projection; and the support member and the stabilizing member overlap in axial projection, and the two are provided in the same number and are not staggered.

13. The sealing device for easy recycling according to claim 1, characterized in that: The area formed by the blocking member on the axial projection surface of the first sealing member is the first region, and the movable space of the outer end of the support member connected to the connecting member is the second region. Furthermore, the second region is located within the first region.

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