A closure device with a constraining structure

Abstract

The application relates to the field of medical devices, in particular to a blocking device with a constraint structure, the blocking device comprising a first blocking piece and a second blocking piece, the first blocking piece comprising a first support framework and a second support framework, the constraint structure being arranged at a middle part or a part close to an edge of the first support framework, and the second support framework comprising a support piece arranged in a radial direction; and an outer end part of the support piece is provided with a connecting unit, the constraint structure is movably connected with the connecting unit and limits the movable range of the connecting unit.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a sealing device with a constraint structure. 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] Those skilled in the art are dedicated to researching occlusion devices that facilitate secondary interventional procedures, while also ensuring the right atrial disc of the occlusion device can be retrieved after deployment. Therefore, a radially arranged support frame woven from metal wires has been designed. However, due to limitations in the weaving process, the actual length of the metal wires used in each support frame varies, or the density of the metal wires at different locations on the support frame is uneven. Furthermore, the different frictional forces experienced by different frames during retrieval cause the support frame to not enter the delivery system evenly, leading to deformation, bending, or even jamming, preventing its retrieval into the delivery system. Additionally, to provide the function of retraction after deployment, the support frame of the right atrial disc is generally designed in a V-shape, requiring the use of longer metal braided wires, essentially adding an extra layer of metal implant, which is detrimental to patient recovery.

[0005] As can be seen from the above, the existing technology has the following problems: 1. The fitting effect of the occlusion device is not good; 2. It is difficult to perform a second puncture surgery at the implantation site of the occlusion device; 3. The right atrial occlusion disc is not easy to be retrieved after being released during the operation; 4. The amount of metal implanted is increased due to the design of the retrieval function. Summary of the Invention

[0006] The purpose of this invention is to provide a sealing device with a constraint structure 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 with a constraint structure, the sealing device including a first sealing member and a second sealing member, the first sealing member including a first support frame and a second support frame, the constraint structure being disposed in the middle part or near the edge part of the first support frame, the second support frame including a radially disposed support member; and, the outer end of the support member being provided with a connecting unit, the constraint structure being movably connected to the connecting unit and restricting the range of motion of the connecting unit.

[0008] In one embodiment, the first support frame and the second support frame are connected separately.

[0009] In one embodiment, the size of the second support frame is smaller than the size of the first support frame.

[0010] 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.

[0011] In one embodiment, part or all of the first support skeleton and / or part or all of the second support skeleton are covered with a polymer membrane.

[0012] In one embodiment, the first sealing member includes a first bonding membrane connected to the first support frame, the first bonding membrane being a polymer membrane.

[0013] In one embodiment, 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 further includes a reinforcing film, which is connected to the constraint structure.

[0014] In one embodiment, the surface of the second bonding film is provided with micropores.

[0015] In one embodiment, the first support frame includes a stabilizing structure and a bonding structure, and the constraint structure connects the stabilizing structure and the bonding structure; and the stabilizing structure includes a plurality of radially arranged stabilizing members radiating from the center, and the bonding structure includes a plurality of sets of bonding wires.

[0016] In one embodiment, the bonding structure is positioned distally relative to the stabilizing structure.

[0017] In one embodiment, the first support frame is bowl-shaped, the stabilizing structure is the bowl bottom, and the fitting structure is the bowl wall.

[0018] In one embodiment, the constraint structure includes a connecting unit and a guiding unit, the connecting unit being connected to the stabilizing structure and / or the fitting structure; and the guiding unit being at a certain angle to the connecting unit.

[0019] In one embodiment, the surface extending toward the outer end of the stabilizing member and forming a critical surface is a critical surface, and the guide unit is disposed on the far end side of the critical surface or within the critical surface.

[0020] In one embodiment, the guide unit is arc-shaped, and the connecting unit is annular or closed arc-shaped; furthermore, the connecting unit is looped around the guide unit, and the length of the movement path of the connecting unit on the guide unit is L1.

[0021] In one embodiment, the guide unit is arc-shaped with an arc angle of less than 180°.

[0022] In one embodiment, the guiding unit provides the motion path for the connecting unit.

[0023] In one embodiment, the end of the guide unit closer to the stabilizing structure is the first end, and the end of the guide unit closer to the fitting structure is the second end; in its natural state, the connecting unit is connected to the first end; during the process of retrieving the first sealing member, the connecting unit moves from the first unit to the second end.

[0024] In one embodiment, the length of the support member is L2, and the second support frame includes several support members. The sum of L2 of different support members and L1 of the corresponding guide unit is the same, ensuring the uniform recycling of the second support frame.

[0025] In one embodiment, the radius length of the stabilizing structure is L3, and the radial width of the bonding structure is L4; and L3 > L4, and L2-L1 > L4.

[0026] In one embodiment, each set of bonding wires includes several bonding guide wires, each bonding guide wire having a connecting end and a free end. The connecting end is interlaced, twisted, wound, or braided with the connecting unit; and the free end is oriented toward the tissue to be closed.

[0027] In one embodiment, the free end is in the shape of a ring or arc to prevent the outer periphery of the first support frame from scratching the heart tissue.

[0028] In one embodiment, the stabilizing structure, the constraining structure, and the bonding structure are integrally woven, integrally laser-engraved, or combined in pairs.

[0029] In one embodiment, the wire diameter used in the stabilizing structure, the constraining structure, and the bonding structure is 0.1 mm.

[0030] In one embodiment, the constraint structure is a ring with a diameter of 0.6 mm; and a portion of the constraint structure is bent to form a guide unit.

[0031] In one embodiment, the wire diameter of the constraint structure is 0.1 mm.

[0032] In one embodiment, the connecting unit is a ring with a diameter of 0.25 mm.

[0033] In one embodiment, the system further includes a waist structure connecting the first sealing member and the second sealing member. The waist structure includes an elastic member and a filling membrane, the filling membrane being connected to the first sealing member and the second sealing member. Furthermore, the second sealing member includes a third support frame, the third support frame being similar in structure to the first support frame.

[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 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.

[0036] In one embodiment, the stabilizing member is woven from several metal wires and is rod-shaped.

[0037] In one implementation, different sets of bonding wires do not contact each other but are relatively close.

[0038] In one embodiment, the bonding guide wires of different groups of bonding wires are arranged in a cross manner.

[0039] In one embodiment, the connecting unit is located on the critical surface.

[0040] In one embodiment, the connecting unit is disposed at the distal end of the critical surface.

[0041] In one embodiment, the connecting unit and the guiding unit are a single integral piece that undergoes bending deformation, and the two are not on the same plane.

[0042] In one embodiment, the stabilizing structure and the bonding structure are connected, and the constraint structure is disposed on the stabilizing structure or the bonding structure.

[0043] In one embodiment, the constraint structure is not located at the end of the first support frame.

[0044] In one embodiment, the flexibility of the guide wire is greater than that of the stabilizing member. The guide wire does not obstruct the puncture of the secondary interventional catheter and can deflect during puncture. Furthermore, the guide wire can provide support for the secondary interventional catheter, fixing it in place at the puncture position.

[0045] Compared with the prior art, the advantages of the present invention are as follows:

[0046] 1. In the prior art, to enable the occluder to simultaneously facilitate secondary puncture and be retrievable after release, the right disc structure generally adopts a radially arranged support skeleton woven from metal wire, with the support skeleton rods being V-shaped. However, this design requires a large length of metal wire, and existing processes make it difficult to weave uniform rods. During the retrieval of the support skeleton, due to uneven weaving of the metal wire rods or uneven friction between different rods and the delivery system tubing, the support skeleton is difficult to be uniformly retrieved into the delivery system, leading to deformation, jamming, or breakage of the support skeleton, reducing the success rate of the surgery. This application avoids the above problems through the following technical solution: First, the first occlusion component includes a first support skeleton and a second support skeleton. The two are not connected in a V-shape, but a constraint structure is set in the middle part or near the edge of the first support skeleton, which uses less metal wire than the end-to-end connection method. The second support skeleton includes a support member, and the connection unit of the constraint structure and the support member is movably connected. The movable connection between the two is equivalent to giving the first occlusion a certain degree of stability. The constraint structure has a "compensation" function. For example, when retrieving the first support frame, if some members of the first support frame enter the outer sheath first, while others do not, the constraint structure connected to the members that have already entered the first support frame will shift with the corresponding connecting unit and enter the outer sheath along with the members that have not yet entered. This prevents the first support frame from being pulled too hard and damaged, and also prevents the first support frame from "tilting" due to uneven entry into the sheath. On the other hand, since the support member is not fixedly connected to the first support frame, there is a possibility that when retrieving the first sealing member, the outer end of the support member may move to the outside of the outer surface of the first support frame. This would create a step between the support member and the first support frame, causing the support member to get stuck outside the outer sheath and preventing the first sealing member from being retrieved. To avoid this problem, the constraint structure of this application, in addition to providing a movable connection function, can also limit the range of motion of the connecting unit, preventing the connecting unit from moving outside the first support frame and creating a step, thereby ensuring that the first sealing member can be retrieved smoothly.

[0047] 2. Unlike existing technologies, the first support frame includes a stabilizing structure and an adhesive structure. The stabilizing structure includes several radially arranged stabilizing members radiating from the center. Because the stabilizing members are radially arranged and rod-shaped, the metal implant in the first support frame occupies a small area, avoiding the problem of insufficient space on the disc for secondary interventional surgery. Secondly, the adhesive structure of this application includes several sets of adhesive wires, each including several adhesive guide wires. The preset direction of the adhesive guide wires is towards the tissue to be closed, and the adhesive guide wires can drive the first adhesive membrane connected to them to adhere towards the tissue to be closed. The adhesive guide wires are shaped on the first adhesive membrane, resulting in good adhesion. Furthermore, it is worth mentioning that the adhesive guide wires include a connecting end and a free end. The connecting end connects to the connecting unit, distinguishing the connecting unit from the guiding unit. The connecting end, to a certain extent, delineates the two ends of the guiding unit and provides obstruction to the support member. Therefore, the adhesive guide wires and the constraint structure are interconnected and mutually supportive, demonstrating a clever design.

[0048] 3. Unlike existing technologies, the constraint structure includes a connecting unit and a guiding unit. First, the connecting unit is connected to the stabilizing structure and the fitting structure, ensuring that the constraint structure is fixed on the first support frame. Second, the guiding unit is designed so that the surface extending towards the outer end of the stabilizing component of the first support frame is the critical surface. Once the connecting unit of the support component moves beyond the critical surface, the second support frame will get stuck on the outer sheath. To prevent this from happening, the guiding unit is set on the far side of the critical surface or within the critical surface. Since the guiding unit guides the movement path of the connecting unit, the problem of jamming is avoided in space. At the same time, the guiding unit is arc-shaped, which facilitates the movement of the connecting unit and makes the retraction of the first support frame more free and flexible.

[0049] 4. Unlike existing technologies, L3 > L4 and L2-L1 > L4, ensuring that after the first sealing component is recovered, i.e. when the first sealing component enters the outer sheath, the connector of the second support frame is located at the far end of the fitting structure. The recovery of the first sealing component will not affect the waist structure already in the oval hole tunnel.

[0050] 5. Unlike existing technologies, the constraint structure and the connecting unit can move relative to each other, which makes it easier for the first sealing element to adapt to different shapes of foramen ovale tunnels. The relative movement between the two can be erroneous relative to the first support frame and the second support frame, thus adapting to the foramen ovale tissue of different patients. Attached Figure Description

[0051] Figure 1 This is a schematic diagram of the overall structure of the sealing device of the present invention.

[0052] 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.

[0053] Figure 3 This is a schematic diagram of the structure of the second support frame of the present invention.

[0054] Figure 4 This is a schematic diagram of the structure of the second sealing component of the present invention.

[0055] Figure 5 This is a pre-assembly diagram of the sealing device of the present invention.

[0056] Figure 6 This is a schematic diagram of the partial recovery of the first sealing element in the sealing device of the present invention.

[0057] Figures 7-11 This is a schematic diagram of the operation process of the sealing device of the present invention.

[0058] Figure 12 This is a schematic diagram showing the dimensional relationship of the first support frame of the present invention.

[0059] The parts referred to by the numbers in the attached diagram are as follows: 1-First sealing element, 11-First bonding membrane, 2-Second sealing element, 21-Third support frame, 22-Sealing membrane, 3-First support frame, 31-Stabilizing structure, 311-Stabilizing component, 32-Bonding structure, 321-Bonding wire, 322-Bonding guide wire, 323-Connecting end, 324-Free end, 4-Second support frame, 41-Supporting component, 411-Connecting unit, 5-Constraint structure, 51-Connecting unit, 52-Guiding unit, 521-First end, 522-Second end, 6-Waist structure, 61-Elastic component, 62-Filling membrane, 7-Conveying system, 71-Outer sheath tube, 72-Control tube, 8-Critical surface. Implementation

[0060] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0061] 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

[0062] like Figure 1 and Figure 2 As shown, during PFO interventional treatment, a closure device with a constraint structure 5 is used. The closure device includes a first closure element 1 and a second closure element 2. The first closure element 1 includes a first support frame 3 and a second support frame 4. The constraint structure 5 is disposed in the middle portion or near the edge portion of the first support frame 3. The second support frame 4 includes a radially arranged support member 41. Furthermore, the outer end of the support member 41 is provided with a connecting unit 411, such as... Figure 3As shown, the constraint structure 5 is movably connected to the connection unit 411 and restricts the range of motion of the connection unit 411.

[0063] In this embodiment, the first support frame 3 and the second support frame 41 are connected separately.

[0064] In this embodiment, the size of the second support frame 41 is smaller than the size of the first support frame 3; and the first support frame 3 and the second support frame 41 at least partially overlap in projection; and the support member 41 and the stabilizing member 311 overlap in axial projection, and the two are arranged in the same number and are not staggered.

[0065] In this embodiment, the first sealing member 1 includes a first adhesive membrane 11 connected to the first support frame 3.

[0066] In this embodiment, the first support frame 3 includes a stabilizing structure 31 and a fitting structure 32, and the constraint structure 5 connects the stabilizing structure 31 and the fitting structure 32; furthermore, the stabilizing structure 31 includes a plurality of radially arranged stabilizing members 311 radiating from the center, and the fitting structure 32 includes a plurality of sets of fitting wires 321, such as... Figure 2 As shown.

[0067] In this embodiment, the bonding structure 32 is positioned further away from the stabilizing structure 31, and the bonding structure 32 is in a converging shape.

[0068] In this embodiment, the constraint structure 5 includes a connecting unit 51 and a guiding unit 52. The connecting unit 51 is connected to the stabilizing structure 31 and the fitting structure 32. Furthermore, the guiding unit 52 is at a certain angle to the connecting unit 51.

[0069] In this embodiment, the surface extending towards the outer end of the stabilizing member 311 and forming a critical surface 8 is the guide unit 52, which is disposed on one side of the distal surface of the critical surface 8 or within the critical surface 8. Figure 2 As shown.

[0070] In this embodiment, the critical surface 8 is tangent to the outer surface of the stabilizing member 311.

[0071] In this embodiment, the guide unit 52 is arc-shaped, and the connecting unit 411 is annular or closed arc-shaped; furthermore, the connecting unit 411 is looped around the guide unit 52, and the length of the movement path of the connecting unit 411 on the guide unit 52 is L1.

[0072] In this embodiment, the guide unit 52 provides the movement path of the connecting unit 411; and the guide unit 52 is arc-shaped with an arc angle of less than 180°.

[0073] In this embodiment, the end of the guide unit 52 near the stabilizing structure 31 is the first end 521, and the end of the guide unit 52 near the fitting structure 32 is the second end 522; in its natural state, the connecting unit 411 is connected to the first end 521, such as... Figure 2 As shown; during the process of recovering the first sealing component 1, the connecting unit 411 moves from the first unit to the second end 522, as shown. Figure 6 As shown.

[0074] In this embodiment, the length of the support member 41 is L2, and the second support frame 41 includes a plurality of support members 41. The sum of L2 of different support members and L1 of the corresponding guide unit 52 is the same, ensuring the uniform recycling of the second support frame 41.

[0075] In this embodiment, the radius length of the stabilizing structure 31 is L3, and the radial width of the bonding structure 32 is L4; furthermore, L3 > L4, and L2 - L1 > L4, as shown. Figure 12 As shown.

[0076] In this embodiment, each set of bonding wires 321 includes five bonding guide wires 322. Each bonding guide wire 322 includes a connecting end 323 and a free end 324. The connecting end 323 is interlaced, twisted, wound, or braided with the connecting unit 51, such as... Figure 2 As shown; and the free end 324 is positioned toward the tissue to be closed.

[0077] In this embodiment, the diameter of the bonding guide wire 322 is smaller than the diameter of the stabilizing member 311; and the bonding guide wire 322 is divergent.

[0078] In this embodiment, the free end 324 is in the shape of a ring or an arc to prevent the outer periphery of the first support frame 3 from scratching the heart tissue.

[0079] In this embodiment, the stabilizing structure 31, the constraint structure 5, and the bonding structure 32 are integrally woven, integrally laser-engraved, or combined in pairs.

[0080] In this embodiment, the constraint structure 5 is a ring; and a portion of the constraint structure 5 is bent to form a guide unit 52; the diameter of the ring is larger than the diameter of the connecting unit 411.

[0081] In this embodiment, a waist structure 6 connecting the first sealing member 1 and the second sealing member 2 is also included. The waist structure 6 includes an elastic member 61 and a filling membrane 62. 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; and, the second sealing member 2 includes a third support frame 21, which has a similar structure to the first support frame 3, as shown. Figure 4 As shown.

[0082] In this embodiment, the second sealing member 2 further includes a sealing membrane 22 connected to the third support frame 21, and the sealing membrane 22 is in close contact with the left room surface.

[0083] In this embodiment, the sealing device further includes a conveying system 7, and a release structure is provided at the center of the first support frame 3. The release structure is connected to the conveying system 7, such as... Figure 1 As shown; and, the second support frame 41 has a connector at its center, which is connected to at least part of the waist structure 6.

[0084] 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, as shown below. Figure 5 As shown.

[0085] The exemplary operation process of the conveying system 7 in this embodiment is as follows:

[0086] (1) The delivery system 7 enters the right atrium via the femoral vein, passes through the foramen ovale and reaches the left atrium, and then the outer sheath 71 is withdrawn to release the second occluder 2.

[0087] (2) Operate the conveying system 7 so that the second sealing member 2 fits against the left atrial surface, and retract the outer sheath tube 71 to release the waist structure 6 from the oval tunnel, as shown. Figure 7 As shown.

[0088] (3) Retract the outer sheath tube 71 to release the first sealing member 1 from the right chamber surface, as shown. Figure 8 As shown.

[0089] (4) If the release position of the first sealing member 11 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 member 1, such as Figure 6 As shown; and rotate the control tube 72 to adjust the position of the first sealing member 1, as shown. Figure 9 As shown, proceed to step (3) again, as follows. Figure 10As shown.

[0090] (5) Disconnect the control tube 72 from the release structure, retrieve the delivery system 7, and complete the implantation, as follows. Figure 11 As shown.

[0091] 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 with a constraint structure, 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 and a second support frame. The constraint structure is disposed in the middle portion or near the edge portion of the first support frame. The second support frame includes radially arranged support members. Furthermore, the outer end of the support member is provided with a connecting unit. The constraint structure is movably connected to the connecting unit and restricts the range of motion of the connecting unit. The first support frame includes a stabilizing structure and a fitting structure. The constraint structure connects the stabilizing structure and the fitting structure. The stabilizing structure includes several radially arranged stabilizing members radiating from the center. The fitting structure includes several sets of fitting wires. The constraint structure includes a connecting unit and a guiding unit. The connecting unit is connected to the stabilizing structure and / or the fitting structure. The guiding unit is at a certain angle to the connecting unit.

2. The sealing device with a constraint structure according to claim 1, characterized in that: The surface extending toward the outer end of the stabilizing member is a critical surface, and the guiding unit is disposed on the far end side of the critical surface or within the critical surface.

3. The sealing device with a constraint structure according to claim 1, characterized in that: The guide unit is arc-shaped, and the connecting unit is annular or closed arc-shaped; furthermore, the connecting unit is looped around the guide unit, and the length of the movement path of the connecting unit on the guide unit is L1.

4. The sealing device with a constraint structure according to claim 1, characterized in that: The length of the support member is L2. The second support frame includes several support members. The sum of L2 of different support members and L1 of the corresponding guide unit is the same.

5. The sealing device with a constraint structure according to claim 4, characterized in that: The radius length of the stabilizing structure is L3, and the radial width of the bonding structure is L4; and L3 > L4, and L2 - L1 > L4.

6. The sealing device with a constraint structure according to claim 4, characterized in that: Each set of bonding wires includes several bonding guide wires, each bonding guide wire having a connecting end and a free end. The connecting end is interlaced, twisted, wound, or braided with the connecting unit; and the free end is oriented toward the tissue to be closed.

7. The sealing device with a constraint structure according to claim 2, characterized in that: The stabilizing structure, the constraining structure, and the bonding structure are integrally woven, integrally laser-engraved, or combined in pairs.

8. The sealing device with a constraint structure according to claim 1, characterized in that: Part or all of the first support skeleton, and / or part or all of the second support skeleton, are covered by a polymer membrane.

9. The sealing device with a constraint structure according to claim 1, characterized in that: It also includes a waist structure connecting the first sealing member and the second sealing member, the waist structure including an elastic member and a filling membrane, the filling membrane being connected to the first sealing member and the second sealing member; and the second sealing member including a third support frame, the third support frame being similar in structure to the first support frame.

10. The sealing device with a constraint structure 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.

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