A sealing device with a filling structure

Abstract

The present application relates to the field of medical devices, and in particular to a blocking device with a filling structure. The blocking device includes a blocking structure and a connecting structure, and also includes a filling structure that is sleeved outside the connecting structure and connected to the blocking structure. The blocking structure includes a supporting frame and a bonding film, and the supporting frame includes a supporting part and a bonding part; and the filling structure includes a covering part and a filler, the covering part is connected to the bonding part and / or the supporting part, and the filler is adaptively adjusted according to the force applied to the covering part.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a closure device with a filling structure. Background Art

[0002] Patent foramen ovale is currently the most common congenital heart anomaly in adults, affecting approximately 1 in 4 individuals in the general population. For a long time, it was believed that patent foramen ovale generally did not cause interatrial shunts and had no impact on cardiac hemodynamics, thus being considered "insignificant." Recent studies have demonstrated a close association between patent foramen ovale and unexplained stroke. This is because through a patent foramen ovale, the following emboli can enter the left ventricle and cause clinical symptoms: 1. thrombosis in the deep veins of the lower limbs or pelvic veins; 2. air emboli caused by decompression sickness or decompression sickness; 3. fat emboli formed after surgery or trauma. Furthermore, the risk of recurrence remains high in patients with patent foramen ovale who have experienced a thrombotic event. Therefore, targeted treatment of the underlying cause and closure of the patent foramen ovale in high-risk individuals may reduce the incidence of these conditions. Furthermore, patent foramen ovale has also been associated with decompression sickness, migraines, and other conditions, and closure of the foramen ovale may be beneficial for these patients.

[0003] Traditionally, a PFO occluder utilizes two circular or other regularly shaped clamping discs to plug the holes at either end of the foramen ovale, effectively closing the foramen ovale and blocking blood flow. However, the shape and tunnel size of the foramen ovale vary from patient to patient. After implantation, a cavity is formed between the connecting structure, the occluding structure, and the tissue to be occluded, resulting in poor occlusion and the risk of residual shunt. Furthermore, the existing occlusion device's excessively large disc space makes secondary puncture difficult or even impossible, as well as inaccurate and restricted puncture placement. Summary of the Invention

[0004] The purpose of the present invention is to provide a blocking device with a filling structure to solve the problems raised in the above background technology.

[0005] In order to solve the above technical problems, the present application solves them through the following technical solutions: a sealing device with a filling structure, the sealing device including a sealing structure and a connecting structure, and also including a filling structure which is sleeved outside the connecting structure and connected to the sealing structure, the sealing structure including a supporting frame and a bonding film, the supporting frame including a supporting part and a bonding part; and the filling structure including a covering part and a filler, the covering part being connected to the bonding part and / or the supporting part.

[0006] In one embodiment, one end of the fitting is connected to the supporting member, and the other end extends toward the tissue to be closed; and the arrangement direction of the fitting guides the fitting film to be arranged toward the tissue to be closed.

[0007] In one embodiment, after the occlusion device is implanted, the left and right atrial surfaces of the secondary septum are bonded from top to bottom by the bonding film and the covering member, and the left and right atrial surfaces of the primary septum are bonded from top to bottom by the covering member and the bonding film.

[0008] In one embodiment, the covering member includes an attachment portion and a filling portion, and the filling portion is located in the open channel after the occlusion device is implanted.

[0009] In one embodiment, one end of the attachment portion is connected to the filling portion, and the other end is connected to the fitting.

[0010] In one embodiment, the other end of the attachment portion is connected to the root of the fitting.

[0011] In one embodiment, the other end of the attachment portion is connected to any position of the fitting.

[0012] In one embodiment, the attachment portion and / or the filling portion are stacked in a natural state; and the connecting structure is an elastic member, and when the elastic member is stretched, the attachment portion and / or the filling portion gradually stretches.

[0013] In one embodiment, the attachment portion is movably connected to the fitting member, so that the covering member is displaced to adapt to different shapes of the foramen ovale tissue.

[0014] In one embodiment, the elastic member is a tension spring, a compression spring, a torsion spring or a bending spring.

[0015] In one embodiment, the center line of the elastic member is a vertical line.

[0016] In one embodiment, the center line of the elastic member is a bending line.

[0017] In one embodiment, the filler moves freely in the cover; and the filler moves according to the force applied to the cover.

[0018] In one embodiment, micropores are provided on a portion of the surface of the cover.

[0019] In one embodiment, the filler is expandable; and after the filler expands, the covering member fits the tissue to be closed more closely.

[0020] In one embodiment, the filler has water-swelling properties.

[0021] In another embodiment, the filler has adaptive expansion properties.

[0022] In one embodiment, the filler is in the shape of a sphere.

[0023] In one embodiment, the filler, after expansion, drives the cover toward the heart tissue.

[0024] In one embodiment, the support frame includes a plurality of generally radially arranged support members, and the laminating film includes a first unit and a second unit, wherein the first unit is connected to the support members, and the second unit is disposed at the outer edge of the sealing structure and is not connected to the support frame.

[0025] In one embodiment, the second unit is directly pierceable.

[0026] In one embodiment, the first unit is in a strip shape, and the first unit is fixedly connected to the support member by heat sealing, adhesion, or the like.

[0027] In one embodiment, the laminating film further includes a third unit disposed inside the second unit, and the third unit is not connected to the supporting frame, and the third unit and / or the second unit can be punctured.

[0028] In one embodiment, the axial projection area of ​​the supporting frame and the blocking structure accounts for less than 10%.

[0029] In one embodiment, the support member divides the support frame into a plurality of intervention areas; and the fitting member can be displaced or deflected along the tissue to be closed within the intervention area after receiving a force.

[0030] In one embodiment, the blocking device further comprises a flexible portion connecting the blocking structure and the connecting structure, wherein the flexible portion comprises a fixing member and a sliding member; and the sliding member can translate or move in a circular motion relative to the fixing member.

[0031] In one embodiment, the support member includes a first support portion, a second support portion, and a clamping portion, wherein the clamping portion connects the first support portion and the second support portion; and the covering member is connected to the second support portion.

[0032] In one embodiment, the first support portion and the second support portion have the same length when pre-assembled and released.

[0033] In one embodiment, the support frame further includes a connecting member connected to the first support portion, and the connecting member is connected to the first support portion.

[0034] In one embodiment, the fixing member is connected to the second supporting portion.

[0035] In one embodiment, the fixing member includes a hollow seat and a fixing shaft.

[0036] In one embodiment, the fixing member includes a base and a notch, wherein the notch forms a circumferential track on the base, and the sliding member is sleeved on the circumferential track.

[0037] In one embodiment, the support member is a braided metal wire, which is formed by braiding and winding two or more metal wires.

[0038] In one embodiment, the covering element of the filling structure is in a tiger's mouth shape in the axial cross section.

[0039] In one embodiment, the first unit and the third unit are arranged sequentially in the circumferential direction.

[0040] In one embodiment, the area occupied by the third unit is larger than the area occupied by the first unit.

[0041] In one embodiment, during the secondary interventional surgery, the puncture tube partially passes through the adhesive film and then passes through the heart tissue, and partially passes through the heart tissue directly.

[0042] Furthermore, during the secondary interventional surgery, part of the puncture tube passes through the second unit and the third unit and then passes through the heart tissue, and part of the puncture tube passes directly through the heart tissue.

[0043] In one embodiment, the adaptor is in the form of a wire, and at least part of the end of the guide wire is in the form of a pigtail.

[0044] In one embodiment, a bifurcation is provided on the fitting, one end of the bifurcation is provided on the fitting, and the other end is free and unconnected.

[0045] In one embodiment, the adhesive member is arranged in a divergent shape; and the adhesive member is at least partially connected to the adhesive film, and the adhesive member guides the adhesive film to be arranged in contact with the tissue to be closed.

[0046] In one embodiment, the delivery system comprises a control member, and the control member is detachably connected to the connecting member.

[0047] In one embodiment, the control member and the connecting member are threadedly connected.

[0048] In one embodiment, the laminating film is connected to the outer surface of the first supporting part and the outer surface of the second supporting part.

[0049] In one embodiment, the support member is a braided metal wire or a strip-shaped metal member.

[0050] In one embodiment, during pre-assembly, the first supporting portion, the clamping portion, and the second supporting portion are sequentially arranged in the conveying system.

[0051] In one embodiment, the support frame includes at least three support members, and each support member is connected to at least two fitting members.

[0052] In one embodiment, the support frame comprises four or five support members.

[0053] In one embodiment, five supports divide the support frame into five intervention areas.

[0054] In one embodiment, when the operator performs a transseptal puncture on a patient who has implanted the occlusion device, the puncture tube can deflect the adhesive component, and the adhesive component can restrict the puncture tube to maintain its position during puncture without expanding the punctured area of ​​the adhesive film.

[0055] In one embodiment, the occlusion structure includes a first support frame and a second support frame; and after the occlusion device is implanted, the first support frame is located on the right atrial surface, and the second support frame is located on the left atrial surface.

[0056] In one embodiment, the delivery system includes an outer sheath and a control tube, and the first support frame, the connecting structure, and the second support frame are pre-installed in the outer sheath in sequence from the proximal end to the distal end.

[0057] In one embodiment, during the process of releasing the occlusion device, first, the control tube is pulled, the outer sheath is withdrawn, the second support frame is released to fit the left atrial surface, and the outer sheath is continued to be withdrawn, the connecting structure is released to fill the foramen ovale channel, then, the control tube is gradually pushed to make the first support frame fit the right atrial surface, and finally, the control tube is operated to separate from the connecting piece.

[0058] In one embodiment, the fittings are evenly or randomly arranged on both sides of the supporting member.

[0059] In one embodiment, the connection structure further includes a limiting member, which is provided at both ends of the elastic member to prevent the elastic member from being overstretched.

[0060] In one embodiment, the laminating member is connected to the third unit of the laminating film.

[0061] In one embodiment, the fitting is made of shape memory alloy material.

[0062] In one embodiment, the connecting structure is a flexible wire.

[0063] In one embodiment, the connection structure is covered with a film to prevent the filler from affecting the movement of the connection structure.

[0064] Compared with the prior art, the advantages of the present invention are:

[0065] 1. In the prior art, after the occluder is implanted into the foramen ovale tissue, there will be gaps between the connecting structure, the occluding structure and the tissue to be closed, resulting in poor fitting effect and even bleeding, which is not conducive to the formation of endothelialization. In addition, many occluding structures are in the shape of grid discs, which are not only difficult to fit the secondary septa and primary septa of different shapes, but also inconvenient to perform a secondary puncture operation at the location after implantation. The present application solves the above problems. The occluding device of the present application includes an occluding structure with a supporting frame and a bonding film, and the supporting frame includes a supporting member and a bonding member connected to the bonding film. Since the setting direction of the bonding member can guide the arrangement direction of the bonding film, the bonding film can be tightly attached to the tissue to be closed after implantation; at the same time, the bonding member and the filling structure arranged outside the connecting structure are The filling material in the filling structure can move with the force applied to the covering part, so that the covering part can adapt to secondary septal tissues of different shapes. There will be no gap among the fitting part, the covering part and the foramen ovale tissue, and the fitting effect is excellent. Thirdly, the fitting membrane includes a first unit, a third unit and a second unit arranged at the peripheral edge of the occluding structure. The second unit is not connected to the supporting frame, that is, there is no metal object to restrict the second unit. If a secondary intervention is performed on the patient at this position, the puncture tube can be punctured through the third unit, or through the second and third units, or partially through the second and third units and partially directly puncture the heart tissue. The puncture position is very optional, which reduces the patient's concerns about puncture and helps to improve the success rate of the operation.

[0066] 2. Different from the prior art, one end of the adhesive member is connected to the support member, and the other end extends toward the tissue to be closed, and the adhesive member is arranged in a divergent shape, so that the support member and the adhesive member are snowflake-shaped as a whole. The advantage of this design is that: during a secondary interventional surgery, the adhesive member is displaced or deflected when subjected to the force of the puncture tube. At the same time, the movable space of the puncture tube limited by the adhesive member enables the puncture tube to be positioned at the puncture position and will not shake at will, avoiding the problem of expanding the puncture opening of the adhesive film due to the displacement of the puncture tube. In summary, the setting of the adhesive member enables the puncture tube to puncture at the target position and remain stable, which has certain clinical value.

[0067] 3. Different from the prior art, the filling structure can not only roughly fit the foramen ovale tissue, but also further fit after implantation. The filler of the filling structure has water absorption and expansion properties. After implantation, the filler will gradually absorb blood and expand its own volume. Moreover, since the filler can support the covering part to fit toward the heart tissue, the gap between the covering part and the foramen ovale will be completely filled, avoiding the bleeding problem in the prior art. It is worth mentioning that the secondary septum is connected to the fitting membrane and the covering part from top to bottom respectively. The fitting membrane is affected by the setting shape of the fitting part and is tightly attached to the tissue. Since the fitting part is connected to the covering part, not only the fitting part and the covering part have a good fitting effect, there is no gap between the two, so there will be no thrombus. Similarly, the fitting effect of the primary septum position is also excellent. The structural design of this application has excellent clinical effects.

[0068] 4. Different from the existing technology, the connecting structure is an elastic part. Through the spring characteristics, the first support frame and the second support frame are respectively fitted to the right atrial surface and the left atrial surface. The elastic part is elastic and adaptable, will not damage the tissue to be closed, and ensures a certain clamping force, which is extremely effective in the operation of closing the foramen ovale channel.

[0069] 5. In the prior art, when performing a puncture operation through an occluder disc, the puncture tube will produce a certain amount of shaking after puncture, which can easily pull the adhesive film and expand the puncture channel, resulting in a series of adverse reactions. The technical solution of the present application avoids the above problems. The occluding structure includes an adhesive member connected to the support member. The setting of the adhesive member not only facilitates the puncture tube to perform puncture at the target position and stabilizes the intervention position of the puncture tube, but also improves the adhesion effect of the occluding structure. The specific reasons are as follows: first, the adhesive member is connected to the adhesive film in a divergent manner, and the adhesive member is equivalent to being "buried" in the adhesive film. The adhesive component is inside the membrane and the two form an integral whole. When the puncture tube is subjected to the force, the adhesive component will deflect and constrain the puncture tube at the same time, so that the intervention position of the puncture tube is accurate, it will not shake randomly, and it will not automatically move to the center position of the adjacent support member, and the problem of subsequent operations tearing the adhesive film is avoided; secondly, the other end of the adhesive component extends toward the tissue to be closed, and the setting direction of the adhesive component guides the adhesive film to be arranged toward the tissue to be closed. After the occlusion device is implanted, the adhesive film can adhere to the tissue to be closed and follow the heartbeat. The outer periphery of the occlusion device completely adheres to the atrial septum tissue, and the occlusion effect is good.

[0070] 6. In the prior art, after the occlusion device is implanted, the frames located on the left and right atrial surfaces are in a grid-like shape, and the frames occupy a very large proportion, which is extremely unsuitable for secondary interventional surgery. However, the axial projection area of ​​the support frame and the occlusion structure of the present application accounts for less than 10%, which not only provides puncture space for the subsequent secondary interventional surgery, but also reduces the metal implants and reduces the surgical impact on the patient.

[0071] 7. Different from the prior art, the occlusion device also includes a flexible portion connecting the occlusion structure and the connection structure. The flexible portion includes a fixed part and a sliding part. In addition, the sliding part can translate or move in a circular motion relative to the fixed part. The advantage of this design is that compared with a fixed connection between the occlusion structure and the connection structure, the relative motion of the two makes it easier for the laminating membrane and the support frame to fit the secondary and primary septal tissues to be closed, adapting to PFO channels of different shapes and openings, and achieving a good occlusion effect.

[0072] 8. Different from the existing technology, after the first support frame is released, if the surgeon thinks the release position is not good, the first support frame can be recovered to the delivery system, and the first support part, clamping part and second support part are recovered to the outer sheath in turn, and released again after adjusting the position until it is released to the optimal position, thereby improving the success rate of the operation and ensuring good postoperative expectations.

[0073] 9. Different from the existing technology, the covering part includes an attachment part, and the end of the attachment part is connected to the root of the fitting. The advantage of this design is that the filler can expand arbitrarily in the covering part to adapt to the foramen ovale tunnel, but the filler should not affect the fit between the fitting and the atrial surface. The outermost end of the attachment part is set at the root of the fitting to prevent the filler from over-expanding and causing the fitting to tilt up, resulting in bleeding. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] Figures 1a to 1e It is a schematic diagram of the overall structure of the blocking device of the present invention and a schematic diagram of the combination of various components.

[0075] Figures 2a to 2d It is a structural schematic diagram of the filling structure, elastic member and flexible part of the present invention.

[0076] Figures 3a to 3d Schematic diagram of the structure of the laminating film of the present invention and schematic diagram of the deflection of the laminating part during secondary intervention.

[0077] Figures 4a to 4g It is a schematic diagram of the structure of the conveying system of the present invention and a schematic diagram of the process of operating the conveying system to release the blocking structure.

[0078] Figure 5a and 5b This is another embodiment of the present invention.

[0079] The numbers in the accompanying drawings indicate the following parts: 1-blocking device, 2-blocking structure, 21-support frame, 211-support member, 2111-first support portion, 2112-second support portion, 2113-clamping portion, 212-fitting member, 213-connecting member, 22-fitting film, 221-first unit, 222-second unit, 223-third unit, 23-intervention area, 3-connecting structure, 31- Elastic part, 32-limiting part, 4-filling structure, 41-covering part, 411-attaching part, 412-filling part, 42-filler, 5-flexible part, 51-fixing part, 511-base, 512-slot, 513-circular track, 514-hollow seat, 515-fixed shaft, 52-sliding part, 6-delivery system, 61-outer sheath, 62-control tube, 7-first support frame, 8-second support frame. Implementation Method

[0080] The present application is further described in detail below with reference to the accompanying drawings and embodiments.

[0081] 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 embodiments Example 1

[0082] like Figures 1a to 1e As shown, during PFO interventional treatment, a closure device 1 with a filling structure 4 is provided. The closure device 1 includes a closure structure 2 and a connecting structure 3, and also includes a filling structure 4 that is sleeved outside the connecting structure 3 and connected to the closure structure 2. The closure structure 2 includes a support frame 21 and a fitting film 22, and the support frame 21 includes a support member 211 and a fitting member 212; and the filling structure 4 includes a covering member 41 and a filler 42, and the covering member 41 is connected to the fitting member 212 and / or the support member 211.

[0083] In this embodiment, one end of the fitting member 212 is connected to the support member 211, and the other end extends toward the tissue to be closed; and the setting direction of the fitting member 212 guides the fitting film 22 to be arranged toward the tissue to be closed, such as Figure 1c and 1d shown.

[0084] In this embodiment, the other end of the fitting member 212 is free. Figure 1c shown.

[0085] In this embodiment, after the occlusion device 1 is implanted, the left and right atrial surfaces of the secondary septum are bonded from top to bottom by the bonding film 22 and the covering member 41, and the left and right atrial surfaces of the primary septum are bonded from top to bottom by the covering member 41 and the bonding film 22. Figure 1eAs shown, the covering member 41 includes an attachment portion 411 and a filling portion 412 . The filling portion 412 is located in the open channel after the occluding device 1 is implanted. One end of the attachment portion 411 is connected to the filling portion 412 , and the other end is connected to the fitting member 212 .

[0086] In this embodiment, the other end of the attachment portion 411 is connected to the root of the fitting 212 .

[0087] In this embodiment, the attaching portion 411 and / or the filling portion 412 are stacked in a natural state, such as Figure 2a and, the connecting structure 3 is an elastic member 31. When the elastic member 31 is stretched, the attachment portion 411 and / or the filling portion 412 gradually stretches.

[0088] In this embodiment, the elastic member 31 is a tension spring.

[0089] In this embodiment, the connection structure 3 further includes a limiting member 32, which is provided at both ends of the elastic member 31 to prevent the elastic member 31 from being overstretched. Figure 2b and 2c shown.

[0090] In this embodiment, the center line of the elastic member 31 is a vertical line.

[0091] In this embodiment, the filler 42 moves freely in the cover 41 ; and the filler 42 moves according to the force applied to the cover 41 .

[0092] In this embodiment, micropores are provided on a portion of the surface of the cover 41 .

[0093] In this embodiment, the filler 42 has water absorbing and expanding properties. Figure 1b and 1e and, after the filler 42 expands, the covering member 41 fits the tissue to be closed more closely.

[0094] In this embodiment, the filler 42 is spherical; after the filler 42 expands, it drives the covering member 41 to adhere to the heart tissue.

[0095] In this embodiment, the support frame 21 includes a plurality of support members 211 that are substantially radially arranged, and the laminating film 22 includes a first unit 221 and a second unit 222. Figure 3a and 3b As shown, the first unit 221 is connected to the support member 211, and the second unit 222 is arranged at the peripheral edge of the blocking structure 2, and the second unit 222 can be directly punctured.

[0096] In this embodiment, the first unit 221 is in a strip shape, and the first unit 221 is fixedly connected to the support member 211 by heat sealing, adhesion, or the like.

[0097] In this embodiment, the laminating film 22 further includes a third unit 223 arranged inside the second unit 222, and the third unit 223 and / or the second unit 222 can be punctured; and the laminating member 212 is connected to the third unit 223 of the laminating film 22.

[0098] In this embodiment, the axial projection area of ​​the support frame 21 and the blocking structure 2 accounts for less than 10%.

[0099] In this embodiment, the five support members 211 divide the support frame 21 into five intervention areas 23; and the fitting member 212 can be displaced or deflected in the intervention area 23 along the tissue to be closed after receiving a force.

[0100] In this embodiment, the blocking device 1 further includes a flexible portion 5 connecting the blocking structure 2 and the connecting structure 3 . The flexible portion 5 includes a fixing member 51 and a sliding member 52 . The sliding member 52 can translate or move in a circular motion relative to the fixing member 51 .

[0101] In this embodiment, the support member 211 includes a first support portion 2111, a second support portion 2112 and a clamping portion 2113. Figure 1b As shown, the clamping portion 2113 connects the first supporting portion 2111 and the second supporting portion 2112 ; and the covering member 41 is connected to the second supporting portion 2112 .

[0102] In this embodiment, the support frame 21 further includes a connecting member 213 connected to the first supporting portion 2111 , and the connecting member 213 is connected to the first supporting portion 2111 .

[0103] In this embodiment, the fixing member 51 is connected to the second supporting portion 2112 .

[0104] In this embodiment, the fixing member 51 includes a base 511 and a notch 512. Figure 2d As shown, the notch 512 forms a circumferential track 513 on the base 511 , and the sliding member 52 is sleeved on the circumferential track 513 .

[0105] In this embodiment, the covering member 41 of the filling structure 4 is in a tiger's mouth shape in the axial cross section.

[0106] In this embodiment, the fitting 212 is made of shape memory alloy material.

[0107] In this embodiment, when the surgeon performs a transseptal puncture on a patient who has been implanted with the occlusion device 1, the puncture tube can cause the fitting 212 to deflect, and the fitting 212 can limit the puncture tube to maintain its position during puncture and will not expand the punctured area of ​​the fitting film 22. Figure 3c shown.

[0108] In this embodiment, during the secondary interventional surgery, part of the puncture tube passes through the adhesive film 22 and then passes through the heart tissue, and part of the puncture tube passes directly through the heart tissue, such as Figure 3d shown.

[0109] In this embodiment, the fitting members 212 are arranged in a divergent shape; and the fitting members 212 are connected to the fitting film 22, and the fitting members 212 guide the fitting film 22 to be fitted toward the tissue to be closed.

[0110] In this embodiment, the conveying system 6 includes a control tube 62 , and the control tube 62 is detachably connected to the connecting member 213 .

[0111] In this embodiment, the laminating film 22 is connected to the outer surface of the first supporting portion 2111 and the outer surface of the second supporting portion 2112 .

[0112] In this embodiment, during pre-assembly, the first supporting portion 2111, the clamping portion 2113 and the second supporting portion 2112 are sequentially arranged in the conveying system 6, as shown in FIG. Figure 4a shown.

[0113] In this embodiment, the blocking structure 2 includes a first support frame 7 and a second support frame 8; and after the blocking device 1 is implanted, the first support frame 7 is located on the right atrial surface, and the second support frame 8 is located on the left atrial surface.

[0114] In this embodiment, the delivery system 6 includes an outer sheath 61 and a control tube 62 , and the first support frame 7 , the connecting structure 3 , and the second support frame 8 are pre-installed in the outer sheath 61 in sequence from the proximal end to the distal end.

[0115] In this embodiment, in the process of releasing the occlusion device 1, first, the control tube 62 is pulled, the outer sheath 61 is withdrawn, the second support frame 8 is released to fit the left atrial surface, and the outer sheath 61 is continued to be withdrawn, the connecting structure 3 is released to fill the oval foramen channel, and then, the control tube 62 is gradually pushed to make the first support frame 7 fit the right atrial surface, and finally, the control tube 62 is operated to separate from the connecting piece 213.

[0116] The exemplary operation process of the conveying system 6 of this embodiment is as follows: Figures 4b to 4g As shown:

[0117] (1) The delivery system 6 enters the right atrium through the femoral vein, passes through the foramen ovale and reaches the left atrium, such as Figure 4b and 4c As shown, the outer sheath 61 is then withdrawn to release the second support frame 8. Figure 4d shown.

[0118] (2) Operate the delivery system 6 so that the second support frame 8 is attached to the left atrial surface, and withdraw the outer sheath 61 to release the connecting structure 3 to be located in the open channel, such as Figure 4e shown.

[0119] (3) withdraw the outer sheath 61 and release the first support frame 7 to fit the right atrial surface. Figure 4f shown.

[0120] (4) Separate the control tube 62 from the connector 213, reclaim the delivery system 67, and complete the implantation. Figure 4g shown. Example 2

[0121] The difference from the first embodiment is that the connecting structure 3 is a curved spring.

[0122] The following describes in detail the composition and connection of the various components in this embodiment with reference to the accompanying drawings:

[0123] During PFO interventional treatment, Figure 5a As shown, a blocking device 1 with a filling structure 4, the blocking device 1 includes a blocking structure 2 and a connecting structure 3, and also includes a filling structure 4 that is sleeved outside the connecting structure 3 and connected to the blocking structure 2, the blocking structure 2 includes a supporting frame 21 and a bonding film 22, the supporting frame 21 includes a supporting member 211 and a bonding member 212; and the filling structure 4 includes a covering member 41 and a filler 42, the covering member 41 is connected to the bonding member 212 and / or the supporting member 211.

[0124] In this embodiment, the center line of the elastic member 31 is a curved line.

[0125] In this embodiment, the fixing member 51 includes a hollow seat 514 and a fixing shaft 515 , and the sliding member 52 can translate or move in a circular motion relative to the fixing member 515 .

[0126] The foregoing description of several embodiments of the present application is provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, structures, and / or steps disclosed. Clearly, based on the foregoing teachings, a person of ordinary skill in the art will be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A plugging device with a filling structure, comprising a plugging structure and a connecting structure, characterized in that: It also includes a filling structure that is sleeved outside the connecting structure and connected to the blocking structure, the blocking structure includes a support frame and a fitting film, the support frame includes a support member and a fitting member; and the filling structure includes a covering member and a filler, the covering member is connected to the fitting member and / or the support member, the filler is adaptively adjusted according to the force applied to the covering member, the support frame includes a plurality of substantially radially arranged support members, the fitting film includes a first unit and a second unit, the first unit is connected to the support member, the second unit is arranged at the peripheral edge of the blocking structure, and the second unit is not connected to the support frame, the fitting film also includes a third unit arranged on the inner side of the second unit, and the third unit is not connected to the support frame, the third unit and / or the second unit can be punctured, and the axial projection area of ​​the support frame and the blocking structure accounts for less than 10%.

2. The occluding device with a filling structure according to claim 1, characterized in that: One end of the fitting is connected to the supporting member, and the other end extends toward the tissue to be closed; Furthermore, the arrangement direction of the bonding member guides the bonding film to be bonded toward the tissue to be closed.

3. The occlusion device with a filling structure according to claim 1 or 2, characterized in that: After the occlusion device is implanted, the left and right atrial surfaces of the secondary septum are bonded from top to bottom by the bonding film and the covering member, and the left and right atrial surfaces of the primary septum are bonded from top to bottom by the covering member and the bonding film.

4. The occluding device with a filling structure according to claim 1, characterized in that: The covering member includes an attachment portion and a filling portion. The filling portion is located in the open channel after the occluding device is implanted. One end of the attachment portion is connected to the filling portion, and the other end is connected to the attachment member.

5. The occluding device with a filling structure according to claim 4, characterized in that: The attaching portion and / or the filling portion are stacked in a natural state; and the connecting structure is an elastic member. When the elastic member is stretched, the attaching portion and / or the filling portion gradually stretches.

6. The occluding device with a filling structure according to claim 1, characterized in that: The filler moves freely in the cover; and micropores are provided on part of the surface of the cover.

7. The occlusion device with a filling structure according to claim 1 or 6, characterized in that: The filler is expandable; and after the filler expands, the covering member fits the tissue to be closed more closely.

8. The occluding device with a filling structure according to claim 1, characterized in that: The support member divides the support frame into a plurality of intervention areas; and the fitting member can be displaced or deflected along the tissue to be closed within the intervention area after being subjected to a force.

9. The occluding device with a filling structure according to claim 1, characterized in that: The blocking device further comprises a flexible portion connecting the blocking structure and the connecting structure, wherein the flexible portion comprises a fixing member and a sliding member; and the sliding member can translate or move in a circular motion relative to the fixing member.

10. The occluding device with a filling structure according to claim 1, characterized in that: The support member includes a first support portion, a second support portion, and a clamping portion, wherein the clamping portion connects the first support portion and the second support portion; and the covering member is connected to the second support portion.

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