A blocking device with a deflection and fitting structure

Abstract

The present application relates to the field of medical devices, and in particular to a sealing device with a deflected fitting structure. The sealing device includes a first skeleton, a sealing structure and a connecting structure connecting the two. The first skeleton is connected to the deflected fitting structure, and the deflected fitting structure includes a deflected fitting member and a fitting film. Moreover, the deflected fitting member is at least partially connected to the fitting film, one end of the deflected fitting member is connected to the first skeleton, and the other end extends toward the tissue to be closed, and the setting direction of the deflected fitting member guides the fitting film to be arranged toward the tissue to be closed, so as to achieve a good sealing effect.

Description

Technical Field

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

[0002] Patent foramen ovale (PFO) is a common congenital heart defect. The foramen ovale is an abnormal channel in the atrial septum between the left and right atria. It forms when the atrial septal tissues fail to adhere to each other during growth, resulting in an oblique channel with overlapping myocardial membranes. This channel can allow venous thrombi to flow into the left heart, potentially causing migraines, transient ischemic attacks, and even cerebral infarction. In recent years, its potential harm has led to increasing attention and treatment efforts. Currently, for patients with embolic ischemic stroke caused by patent foramen ovale, strategies to prevent recurrent stroke include antithrombotic medications, percutaneous closure of the defect, and, occasionally, surgical closure.

[0003] In conventional technology, two circular or other regularly shaped clamping discs of a PFO occluder are used to occlude the foramen ovale, thereby closing the foramen ovale and blocking blood flow. However, the anatomical morphology of patent foramen ovale is complex, and most of the time it is a flat and narrow tunnel formed by the misalignment of two unconnected atrial septa. Therefore, when using traditional PFO occluders to close the foramen ovale, the following problems are likely to occur: First, since the clamping disc is generally a septal structure, it is difficult or even impossible to perform atrial septal puncture on the patient, making it difficult to perform left heart interventional surgery; second, even if the occluder can be punctured a second time, the existing occluder disc design limits the secondary intervention position, and the puncture position cannot be determined according to the situation during the secondary surgery; third, since the outer edge of the clamping disc is made of metal wire, the intervention position during the secondary intervention can only be selected inside or outside the disc, but sometimes the best position is at the outer edge, so accurate puncture positioning cannot be achieved; fourth, the outer edge of the occluder disc limits the intervention size of the puncture tube, resulting in the inability to meet the puncture requirements of large-size sheaths (such as ≥28Fr); fifth, the clamping disc has poor fit with the heart tissue, and the occlusion effect is poor. Summary of the Invention

[0004] The purpose of the present invention is to provide a blocking device with a deflection and fitting 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 deflected fitting structure, the sealing device includes a first skeleton, a sealing structure and a connecting structure connecting the two, the first skeleton is connected to the deflected fitting structure, the deflected fitting structure includes a deflected fitting member and a fitting film; and the deflected fitting member is at least partially connected to the fitting film, one end of the deflected fitting member is connected to the first skeleton, and the other end extends toward the tissue to be closed, and the setting direction of the deflected fitting member guides the fitting film to be arranged toward the tissue to be closed.

[0006] In one embodiment, the first skeleton includes at least two supporting members, each of which is connected to at least two deflection fittings, and the supporting members divide the first skeleton into a plurality of fitting units; and the deflection fittings can be deflected against the tissue to be closed within the fitting unit after being subjected to a force.

[0007] In one embodiment, the deflection center of the deflection fit is located at the connection point between the deflection fit and the support member; and the deflection direction of the deflection fit is within the plane of the first skeleton, either toward the distal direction or toward the proximal direction.

[0008] In one embodiment, the support member can also deflect after being subjected to a force; and the deflection center of the support member is located at the center of the first skeleton; and the fitting deflects before the support member.

[0009] In one embodiment, the deflection fitting member is flexible; and the other end of the deflection fitting member is a free end.

[0010] In one embodiment, the deflecting fitting is in soft contact with the foramen ovale tissue and does not forcibly change the morphology of the foramen ovale tissue, thereby reducing the probability of arrhythmia.

[0011] In one embodiment, the deflecting fitting members are generally arranged in a divergent shape; and the deflecting fitting members drive the fitting film to be in an arc shape, a concave shape, a concave-convex shape, or a wavy shape in a natural state.

[0012] In one embodiment, the supporting members are all connected to the first connecting member.

[0013] In one embodiment, the first frame includes four supporting members, and the supporting members divide the first frame into four fitting units.

[0014] In one embodiment, the first frame includes five supporting members, and the supporting members divide the first frame into five fitting units.

[0015] In one embodiment, the first skeleton further includes a reinforcement member connected to the first connecting member.

[0016] In one embodiment, the reinforcement members are evenly arranged between adjacent support members.

[0017] In one embodiment, the supporting member divides the first skeleton into a plurality of fitting units; and the deflecting fitting member can be displaced or deflected in the fitting unit against the tissue to be closed after receiving a force.

[0018] In one embodiment, when the operator performs a transseptal puncture on a patient who has been implanted with the occlusion device, the puncture sheath can deflect the deflection patch, and at the same time, the deflection patch can limit the puncture sheath to maintain its position during puncture and will not expand the punctured area of ​​the patch membrane.

[0019] In one embodiment, the laminating film includes a free segment disposed at the outer peripheral edge, and the free segment is not connected to the supporting member.

[0020] In one embodiment, the free section is concave in a natural state, and the free section is concave toward the tissue to be closed, so that the free section can be tightly attached to the tissue to be closed when it touches the tissue to be closed.

[0021] In one embodiment, two deflection fitting members are connected to both sides of the support member, one end of the deflection fitting member is connected to the support member, and the other end is connected to the free section.

[0022] In one embodiment, the free segment is not constrained by the first skeleton.

[0023] In one embodiment, any position of the laminating film of the laminating unit can be punctured, and the laminating film can be partially punctured.

[0024] In one embodiment, after the occlusion device is implanted, when the patient undergoes secondary interventional treatment, a portion of the puncture sheath passes through the adhesive membrane, and the other portion directly passes through the atrial septum tissue.

[0025] In one embodiment, the laminating film is a polymer composite material.

[0026] In one embodiment, deflection fittings are arranged on both sides of the support member, or the ends of the support member are connected to the deflection fittings; and the deflection fittings are generally filamentous and made of shape memory alloy material or degradable material.

[0027] In one embodiment, the support member includes a first support member, a second support member, and a clamping portion connecting the first support member and the second support member; and after the occlusion device is implanted, the second support member is in contact with the tissue.

[0028] In one embodiment, the laminating film is laminated to the outer surface of the second supporting member.

[0029] In one embodiment, the laminating film is laminated to the outer surface of the first support member and the outer surface of the second support member.

[0030] In one embodiment, the support member is a braided wire.

[0031] In one embodiment, the support member is an integrally formed rod.

[0032] In one embodiment, the middle region of the support member is made of a shape memory material, and the outer edge region of the support member is made of a degradable material; and the different materials are connected by a transition connection structure.

[0033] In one embodiment, the connection structure includes an elastic member, and a blocking membrane is provided outside the elastic member; and the blocking membrane is stacked in a natural state.

[0034] In one embodiment, the elastic member is a spring.

[0035] In one embodiment, the blocking device further includes a limiting structure, which is provided on the connecting structure to prevent the connecting structure from being overstretched.

[0036] In another embodiment, the limiting structure is provided between the first skeleton and the blocking structure.

[0037] In one embodiment, the blocking structure includes braided metal wires and a flow-blocking film fused to the braided metal wires.

[0038] In another embodiment, the occluding structure includes a second skeleton that is identical or similar to the first skeleton structure.

[0039] In one embodiment, the first skeleton includes a connecting portion connected to one end of the connecting structure, and the end of the connecting structure can slide relative to the connecting portion.

[0040] In one embodiment, it also includes a delivery system, which includes an outer sheath, a control tube and an inner tube, the first skeleton includes a first connector connected to the control tube, and the sealing structure includes a second connector connected to the inner tube; and, by keeping the inner tube stationary and pulling the control tube, the first skeleton released in the heart can be recovered into the outer sheath.

[0041] In one embodiment, the second connecting member is sleeved inside the connecting structure.

[0042] In one embodiment, the second skeleton also includes a connecting portion, which is connected to the other end of the connecting structure, and the end of the connecting structure can slide relative to the connecting portion.

[0043] In one embodiment, the connecting portion and the connecting structure are connected via a flexible member.

[0044] In one embodiment, the connecting portion includes a notch and a sliding track, and the end of the connecting structure is connected to the sliding track.

[0045] In another embodiment, the connecting portion includes a sliding shaft, and the connecting structure is connected to the sliding shaft and can move relative to the sliding shaft.

[0046] In one embodiment, the first frame and the deflection fitting are both made of metal materials, and the deflection fitting is more flexible than the first frame.

[0047] In one embodiment, the support member has a greater rigidity than the deflecting fit.

[0048] In one embodiment, the deflecting fittings are evenly or randomly arranged on both sides of the supporting member.

[0049] In one embodiment, the deflecting fittings connected to the support member are of uniform length.

[0050] In one embodiment, the deflecting fitting members connected to the support member are of different lengths.

[0051] In one embodiment, after the occlusion device is implanted, the occlusion structure is located on the left atrial surface, and the first skeleton is located on the right atrial surface.

[0052] In one embodiment, the limiting structure is a flexible wire.

[0053] In one embodiment, the flexibility of the deflecting fitting is better than the flexibility of the supporting member, and the hardness of the supporting member is large.

[0054] In one embodiment, the metal density of the support member is greater than the metal density of the deflecting affixed element.

[0055] In one embodiment, the deflecting fit member is made of a degradable material.

[0056] In one embodiment, the deflection fittings are arranged in an upper and lower staggered manner or are connected in a sleeve manner, and the adjacent deflection fittings can move relative to each other without interfering with each other; and the free ends of the deflection fittings are provided with a protective structure, which is in the shape of a ball, a ring, a pig tail, a hook, an S shape or a heart shape, and the protective structure prevents the deflection fittings from damaging heart tissue.

[0057] Compared with the prior art, the advantages of the present invention are:

[0058] 1. In the prior art, the occluding device is usually composed of an occluding membrane and an occluding disc, and the occluding disc has a poor fitting effect. At the same time, due to the design of the occluding disc and the occluding membrane, no matter where the initial puncture position of the secondary intervention is, the puncture sheath will eventually be located between the two adjacent components of the occluding disc, resulting in failure to puncture at the optimal position and only being able to puncture at a restricted position. It is also easy to tear the occluding membrane and expand the puncture opening, resulting in a series of problems. The technical solution of the present application avoids the above problems. The occluding structure of the present application includes a first skeleton, a connecting structure and an occluding structure, and the first skeleton is connected to the deflection fitting structure. Since the deflection fitting structure includes a deflection fitting part and a fitting membrane that are connected and cooperated with each other, the surgeon can not only implant the occluding device with a good fitting effect, but also perform a secondary puncture at the desired position (the occluding device has been implanted), specifically as follows: On the one hand, one end of the deflection fitting part is connected to the first skeleton. The metal memory of the deflection fitting enables it to guide the bonding membrane to be bonded to the tissue to be closed. After the deflection fitting of the first skeleton is bonded to the heart tissue, it will move slightly toward the right atrium, which is adaptable and provides a certain clamping force, so that the bonding membrane can adhere to the tissue to be closed and follow the heartbeat. On the other hand, since the deflection fitting is at least partially connected to the bonding membrane, the deflection fitting is "buried" in the bonding membrane and the bonding membrane forms a whole. When the surgeon punctures the atrial septum where the occlusion device has been implanted, the deflection fitting will be deflected by the action of the puncture sheath and the puncture sheath will be constrained at the same time, so that the intervention position of the puncture sheath is accurate, will not shake randomly, and will not automatically correct to the center position of the adjacent supporting structure. It also avoids the problem of subsequent operations tearing the bonding membrane. The structural design is ingenious, which improves the success rate of the operation and has clinical promotion value.

[0059] 2. Different from the existing technology, after the occlusion device is implanted, the elastic member is connected to the first skeleton and the occlusion structure, so that the support member is in close contact with the tissue to be closed. Then, the support member has high rigidity and can provide supporting force to fit with the heart tissue. Therefore, there is enough space on the disk surface of the first skeleton to set a deflection fitting member connected to the support member and having flexibility. The preset direction of the deflection fitting member drives the fitting membrane to fit toward the foramen ovale tissue, which has a better auxiliary fitting effect. On the other hand, when the deflection fitting member is subjected to the force of the secondary intervention tube, in order to restore its original shape, it can exert a certain force on the secondary intervention tube, thereby stabilizing the position of the puncture point.

[0060] 3. Unlike the prior art, the outer edges of the occlusion devices located on the left and right atrial surfaces are not restricted by metal structures but are instead composed of a conformable membrane. Furthermore, the conformable membrane includes a free segment disposed at the outer periphery, which is not connected to the support member. In its natural state, the free segment is concave (compared to a conformable membrane connected to the support member, the free segment faces toward the foramen ovale tissue). This concave shape is achieved by the directional guidance of the free end of the deflecting conformable member. The conformable membrane is coated along the direction of the deflecting conformable member. Because the deflecting conformable member is made of a shape-memory metal material, the conformable membrane can maintain conformity to the heart tissue and exhibit a certain degree of adaptability. During heartbeat, the conformable membrane can move with the tissue of the atrial septum, accelerating endothelialization and achieving a good occlusion effect. Furthermore, the presence of the free segment does not affect the puncture position of the puncture sheath during secondary intervention. The puncture sheath can partially pass through the occlusion device and penetrate the atrial septum tissue, while partially passing directly through the atrial septum tissue. This allows for flexible selection of the secondary intervention location and can accommodate the puncture requirements of large-sized sheaths (e.g., ≥28 Fr).

[0061] 4. Different from the existing technology, after the first skeleton is released, if the surgeon thinks the release position is not good, the first skeleton can be recovered to the delivery system, and the first support member, the clamping part and the second support member 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.

[0062] 5. Different from the prior art, the first skeleton includes a connecting portion connected to one end of the connecting structure, and the connecting structure can slide or roll relative to the connecting portion. The advantage of this design is that compared with a fixed connection between the first skeleton and the connecting structure, the relative movement of the two makes it easier for the laminating membrane and the second support member to fit the secondary septal tissue and the primary septal tissue to be closed, adapting to PFO channels of different shapes and openings, and achieving a good occlusion effect.

[0063] 6. Different from the existing technology, after the occlusion device is implanted, the metal implant located on the left atrial surface only consists of a supporting member and several deflection fitting parts. The small number of implants not only has little impact on the human body, but also makes it easier to perform secondary interventional surgery on the patient.

[0064] 7. Different from the existing technology, the connecting structure includes an elastic member and a naturally wrinkled occluding membrane. The elastic member enables the first skeleton and the occluding structure to squeeze the secondary septum and the primary septum against each other, ensuring the fit between the occluding device and the tissue to be closed, while the occluding membrane can be used to fill the channel between the secondary septum and the primary septum, so that there is no gap in the secondary hole and the occluding effect is good.

[0065] 8. Different from the prior art, the free end of the deflection fitting of the present application is provided with a protective structure. In addition to preventing damage to the myocardial tissue, the protective structure also enhances the sealing effect to a certain extent; moreover, the protective structure is at least partially fitted with the tissue, thereby enhancing the overall stability of the occlusion device.

[0066] 9. Different from the existing technology, the deflecting fitting will be driven to move distally when the puncture tube of the secondary intervention enters, which can further drive the fitting membrane to fit the foramen ovale tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Figures 1a to 1c This is a schematic diagram of the overall structure of the blocking device of the present invention. The arrangement direction of the deflection laminating member affects the overall arrangement direction of the laminating film.

[0068] Figures 2a to 2c This is a schematic diagram of the principle of the deflection and fitting structure of the present invention to facilitate secondary intervention.

[0069] Figures 3a to 3f It is a structural schematic diagram of the connecting part, the limiting structure and the blocking structure of the present invention.

[0070] 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.

[0071] Figures 5a to 5e This is another embodiment of the present invention.

[0072] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-sealing device, 2-first skeleton, 21-support member, 211-first support member, 212-second support member, 213-clamping part, 214-first connecting member, 22-fitting unit, 23-reinforcement member, 3-connecting structure, 31-elastic member, 32-sealing membrane, 4-sealing structure, 41-braided metal wire, 42-flow-blocking membrane, 43-second connecting member, 5-deflection fitting structure, 51-deflection fitting member, 511-protective structure, 52-fitting membrane, 521-free section, 6-second skeleton, 7-delivery system, 71-outer sheath, 72-control tube, 73-inner tube, 8-connecting part, 81-notch, 82-sliding track, 83-sliding shaft, 9-limiting structure. DETAILED DESCRIPTION

[0073] The present application is further described in detail below with reference to the accompanying drawings and embodiments.

[0074] 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".

[0075] In this application, "extension" is defined as setting in a predetermined direction in a two-dimensional plane or a three-dimensional space. Example 1

[0076] like Figures 1a to 1c As shown, during PFO interventional treatment, a closure device 1 with a deflection-fitting structure 5 is provided. The closure device 1 includes a first skeleton 2, a connecting structure 3 and a closure structure 4. The connecting structure 3 includes an elastic member 31. The first skeleton 2 is connected to the deflection-fitting structure 5. The deflection-fitting structure 5 includes a deflection-fitting member 51 and a fitting film 52. Moreover, the deflection-fitting member 51 is at least partially connected to the fitting film 52. One end of the deflection-fitting member 51 is connected to the first skeleton 2, and the other end extends toward the tissue to be closed. The setting direction of the deflection-fitting member 51 guides the fitting film 52 to be arranged toward the tissue to be closed.

[0077] In this embodiment, the first skeleton 2 includes four supporting members 21 , and each supporting member 21 is connected to at least two deflection fitting members 51 ; the supporting members 21 divide the first skeleton 2 into four fitting units 22 .

[0078] In this embodiment, the deflecting fitting member 51 is flexible; and the other end of the deflecting fitting member 51 is a free end.

[0079] In this embodiment, the deflection fitting member 51 can be deflected against the tissue to be closed in the fitting unit 22 after receiving a force. Figure 2a and 2b shown.

[0080] In this embodiment, when the surgeon performs a transseptal puncture operation on a patient who has been implanted with the occlusion device 1, the puncture sheath can cause the deflection fitting 51 to deflect, and at the same time, the deflection fitting 51 can limit the puncture sheath to maintain its position during puncture and will not expand the punctured area of ​​the fitting film 52.

[0081] In the present application, the deflection center of the deflection fitting 51 is located at the connection point between the deflection fitting 51 and the support member 21 .

[0082] In this embodiment, the outer peripheral portion of the laminating film 52 that is not connected to the supporting member 21 is a free segment 521; and the free segment 521 is concave in a natural state, such as Figure 1c shown.

[0083] In this embodiment, two deflection fitting members 51 are connected to both sides of the support member 21. One end of the deflection fitting member 51 is connected to the support member 21, and the other end is connected to the free section 521. The free section 521 is not constrained by the first skeleton 2.

[0084] In this embodiment, any position of the adhesive film 52 of the adhesive unit 22 can be punctured, and the adhesive film 52 can be punctured locally; after the occlusion device 1 is implanted, when the patient undergoes secondary interventional treatment, a portion of the puncture sheath passes through the adhesive film 52, and the other portion directly passes through the atrial septum tissue, such as Figure 2a and 2c shown.

[0085] In this embodiment, the support member 21 includes a first support member 211, a second support member 212 and a clamping portion 213 connecting the first support member 211 and the second support member 212. After the occlusion device 1 is implanted, the second support member 212 is in contact with the tissue.

[0086] In this embodiment, deflection fitting members 51 are arranged on both sides of the support member 21 ; and the deflection fitting members 51 are generally thread-shaped, and the size of the deflection fitting members 51 is smaller than the size of the first support member 211 and the second support member 212 .

[0087] In this embodiment, the laminating film 52 is laminated to the outer surface of the first support member 211 and the outer surface of the second support member 212 .

[0088] In this embodiment, the connecting structure 3 includes an elastic member 31, such as Figure 1b As shown, a blocking film 32 is provided outside the elastic member 31; and the blocking film 32 is stacked in a natural state; and the elastic member 31 is a spring.

[0089] In this embodiment, the first skeleton 2 includes a connecting portion 8, and the connecting portion 8 is connected to one end of the connecting structure 3. The end of the connecting structure 3 can slide relative to the connecting portion 8. Figure 3a and 3b shown.

[0090] In this embodiment, the connecting portion 8 includes a notch 81 and a sliding track 82. The end of the connecting structure 3 is connected to the sliding track 82. The first frame 2 can slide relative to the connecting structure 3. Figures 3a to 3c shown.

[0091] In this embodiment, the blocking device 1 further includes a limiting structure 9, such as Figure 3d and 3eAs shown, the limiting structure 9 is provided on the spring 31 to prevent the spring from being overstretched during operation.

[0092] In this embodiment, the blocking structure 4 includes a braided metal wire 41 and a flow-blocking membrane 42 connected to the braided metal wire 41 ; the two are connected in a manner of: interlacing, covering, heat sealing or adhesion.

[0093] In this embodiment, the blocking structure 4 is generally in the shape of petals. Figure 3f shown.

[0094] In this embodiment, a conveying system 7 is also included. Figure 4a As shown, the delivery system 7 includes an outer sheath 71, a control tube 72 and an inner tube 73, the first skeleton 2 includes a first connector 214 connected to the control tube 72, and the blocking structure 4 includes a second connector 43 connected to the inner tube 73; and, by keeping the inner tube 73 stationary and pulling the control tube 72, the first skeleton 2 released in the heart can be recovered into the outer sheath 71.

[0095] In this embodiment, when the operator releases the occlusion device 1, the operator pulls the inner tube 73 toward the proximal end so that the occlusion structure 4 is attached to the secondary septum and the primary septum. Since the inner tube 73 is connected to the second connecting member 43, the inner tube 73 is directly pulled, and the occlusion structure 4 is subjected to a more direct force, and the fitting effect is good. Figure 4d and 4e shown.

[0096] In this embodiment, a plurality of the supporting members 21 are all connected to the first connecting member 214 .

[0097] In this embodiment, the second connecting member 43 is sleeved inside the connecting structure 3 .

[0098] In this embodiment, the first frame 2 and the deflection fitting 51 are both made of metal materials, and the flexibility of the deflection fitting 51 is greater than that of the first frame 2; the deflection fitting 51 connected to the supporting member 21 has the same length.

[0099] The exemplary operation process of the conveying system 71 of this embodiment is as follows: Figures 4b to 4g As shown:

[0100] (1) The delivery system 7 enters the right atrium through the femoral vein, passes through the foramen ovale and reaches the left atrium, as shown in FIG. Figure 4b and 4c As shown, the outer sheath 71 is then withdrawn to release the blocking structure 4. Figure 4d shown.

[0101] (2) Pull the inner tube 73 toward the proximal end and operate the outer sheath 71 at the same time, so that the blocking structure 4 is close to the secondary septum and the primary septum, as shown in FIG. Figure 4e shown.

[0102] (3) withdraw the outer sheath 71 to release the connecting structure 3 and the first skeleton 2, as shown in FIG. Figure 4f As shown, the connecting structure 3 enters the open channel, and the bonding membrane 52 is closely attached to the septum secundum and septum primum of the right atrial surface.

[0103] (4) Separate the inner tube 73 from the second connector 43, separate the control tube 72 from the first connector 214, recycle the delivery system 7, and complete the implantation. Figure 4g shown. Example 2

[0104] The difference from the first embodiment is that the blocking structure 4 includes a second skeleton 6 having the same or similar structure as the first skeleton 2 .

[0105] The following describes in detail the composition and connection of the various components in this embodiment with reference to the accompanying drawings:

[0106] During interventional treatment of PFO, a closure device 1 with a deflection-fitting structure 5 is provided. The closure device 1 includes a first skeleton 2, a connecting structure 3, and a closure structure 4. The connecting structure 3 includes an elastic member 31. The first skeleton 2 is connected to the deflection-fitting structure 5. The deflection-fitting structure 5 includes a deflection-fitting member 51 and a fitting film 52. Furthermore, the deflection-fitting member 51 is at least partially connected to the fitting film 52. One end of the deflection-fitting member 51 is connected to the first skeleton 2, and the other end extends toward the tissue to be closed. The setting direction of the deflection-fitting member 51 guides the fitting film 52 to be arranged toward the tissue to be closed.

[0107] In this embodiment, the blocking structure 4 includes a second skeleton 6 having the same or similar structure as the first skeleton 2. Figure 5a and, the second skeleton 6 also includes a connecting portion 8, the connecting portion 8 is connected to the other end of the connecting structure 3, the end portion of the connecting structure 3 can slide relative to the connecting portion 8, as shown Figure 5b shown.

[0108] In this embodiment, the connecting portion 8 includes a sliding shaft 83 , and the connecting structure 3 is connected to the sliding shaft 83 and can move relative to the sliding shaft 83 .

[0109] In this embodiment, the blocking device 1 further includes a limiting structure 9 , which is disposed between the first frame 2 and the second frame 6 .

[0110] In this embodiment, the first skeleton 2 includes five supporting members 21, which divide the first skeleton 2 into five fitting units 22; and four deflection fitting members 51 are provided on each of the supporting members 21, and the deflection fitting members 51 provided at one location have the same length.

[0111] In this embodiment, the first frame 2 further includes a reinforcement member 23, such as Figure 5c As shown, the reinforcement 23 is connected to the first connecting member 214 , and the reinforcement 23 is evenly arranged between adjacent supporting members 21 .

[0112] In this embodiment, a delivery system 7 is also included, which includes an outer sheath 71 and a control tube 72. The first skeleton 2 includes a first connecting piece 214 connected to the control tube 72. After the first skeleton 2 and the second skeleton 6 are released in the PFO channel, pulling the control tube 72 can recover the released first skeleton 2 into the outer sheath 71.

[0113] In this embodiment, the middle portion of the support member 21 is made of shape memory material, and the outer edge portion of the support member 21 is made of degradable material.

[0114] In this embodiment, the deflection fitting members 51 are arranged in an up-down staggered manner or are connected in a sleeve manner, and the adjacent deflection fitting members 51 can move relative to each other; and the free ends of the deflection fitting members 51 are provided with a protective structure 511, and the protective structure 511 is in the shape of a ball, a ring, a pig tail, a hook, an S shape or a heart shape. The protective structure 511 prevents the deflection fitting members 51 from damaging the heart tissue, such as Figures 5c-5e shown.

[0115] 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 blocking device with a deflection and fitting structure, comprising a first frame, a blocking structure, and a connecting structure connecting the first frame and the blocking structure, characterized in that: The first skeleton is connected to the deflection fitting structure, and the deflection fitting structure includes a deflection fitting member and a fitting film; and the deflection fitting member is at least partially connected to the fitting film, one end of the deflection fitting member is connected to the first skeleton, and the other end extends toward the tissue to be closed, and the setting direction of the deflection fitting member guides the fitting film to be arranged toward the tissue to be closed, the first skeleton includes at least two supporting members, each supporting member is connected to at least two deflection fitting members, and the support members divide the first skeleton into a plurality of fitting units; and the deflection fitting member can be deflected against the tissue to be closed in the fitting unit after being subjected to a force, the fitting film includes a free section arranged at the periphery, and the free section is not connected to the supporting member, the middle part area of ​​the supporting member is a shape memory material, and the outer edge area of ​​the supporting member is a degradable material; and different materials are connected by a transition connection structure.

2. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The deflection center of the deflection fitting is located at the connection point between the deflection fitting and the supporting member; and the deflection direction of the deflection fitting is within the plane where the first skeleton is located, either toward the distal direction or toward the proximal direction.

3. The blocking device with a deflection and fitting structure according to claim 2, characterized in that: The support member can also deflect after being subjected to an applied force; and the deflection center of the support member is located at the center of the first skeleton; and the fitting deflects before the support member.

4. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The deflection fitting piece is flexible; and the other end of the deflection fitting piece is a free end.

5. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The deflecting fitting members are generally arranged in a divergent shape; and the deflecting fitting members drive the fitting film to be in an arc shape, a concave shape, a concave-convex shape, or a wavy shape in a natural state.

6. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: Any position of the laminating film of the laminating unit can be punctured, and the laminating film can be partially punctured.

7. The blocking device with a deflection and fitting structure according to claim 2, characterized in that: Deflection fittings are arranged on both sides of the support member, or the ends of the support member are connected to the deflection fittings; and the deflection fittings are generally filamentous and are made of shape memory alloy material or degradable material.

8. The blocking device with a deflection and fitting structure according to claim 2, characterized in that: The supporting member includes a first supporting member, a second supporting member and a clamping portion connecting the first supporting member and the second supporting member; and after the occlusion device is implanted, the second supporting member is in contact with the tissue.

9. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The connection structure includes an elastic member, and a blocking membrane is provided on the outside of the elastic member; and the blocking membrane is stacked in a natural state.

10. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The blocking structure includes braided metal wires and a flow-blocking membrane fused with the braided metal wires; or, the blocking structure includes a second skeleton structure that is identical to the first skeleton structure.

11. The blocking device with a deflection and fitting structure according to claim 1, characterized in that: The deflection fittings are arranged in an up-and-down staggered manner or are connected in a sleeve manner, and adjacent deflection fittings can move relative to each other; and the free ends of the deflection fittings are provided with protective structures, which are in the shape of a ball, a ring, a pig tail, a hook, an S shape or a heart.

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