Plugging system

Abstract

The embodiment of the invention provides a plugging system which is used for plugging tissue defects and comprises a plugging device and a conveying device, and the conveying device is used for conveying and releasing the plugging device to the tissue defects; the conveying device comprises an outer sheath tube and an inner sheath core, and the inner sheath core is arranged in an inner cavity of the outer sheath tube in a penetrating mode. In the conveying state, the plugging device is contained in the inner cavity of the outer sheath tube, and the plugging device is arranged on the far side of the far end of the inner sheath core and connected with the inner sheath core. The plugging device comprises a far-side plugging piece, the far-side plugging piece comprises a first stacking part and a second stacking part, and the first stacking part and the second stacking part are used for being stacked in the far-side direction of the tissue defect so as to plug a far-side notch of the tissue defect.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a blocking system. Background Art

[0002] In some treatments, it is necessary to perforate the patient's skin and blood vessel walls, such as using a hollow needle to penetrate the patient's skin and penetrate into the blood vessels. After vascular interventional surgery, the blood vessels that were punctured during the surgery need to be sealed or blocked. How to quickly and safely stop bleeding at the puncture point remains a clinical challenge. For a long time, artificial compression hemostasis was the only option for surgeons. This method requires the surgeon to continuously apply nearly blood flow blocking pressure to the vascular puncture point for 10 to 20 minutes and strictly brake for 6 to 24 hours; its hemostatic effect is definite, and it is still the gold standard for puncture point hemostasis.

[0003] However, traditional artificial compression of blood vessels will increase patient discomfort such as pain, insomnia and dysuria, and the hemostatic effect is affected by the experience and skills of the compression implementer and the degree of cooperation of the patient. Traditional artificial compression of blood vessels is also believed to increase the risk of complications such as bleeding (including hematoma), pseudoaneurysm, infected venous fistula and arteriovenous thrombosis. Especially for patients who need complete anticoagulation after surgery, even if the risk of complications is not increased, the cost of hospitalization will increase. Patients need to stay in bed for a long time (more than 12 to 16 hours), and the immobilization of the punctured limb also brings inconvenience and pain to the patient, and adds a burden to the nursing work.

[0004] Therefore, there is an urgent need for a new type of vascular hemostasis device to facilitate doctors' operation and shorten the occlusion time. Summary of the invention

[0005] An embodiment of the present invention provides a sealing system for sealing tissue defects, comprising a sealing device and a conveying device, wherein the conveying device is used to convey the sealing device and release it at the tissue defect; the conveying device comprises an outer sheath tube and an inner sheath core, and the inner sheath core is inserted into the inner cavity of the outer sheath tube; in the conveying state, the sealing device is accommodated in the inner cavity of the outer sheath tube, and the sealing device is arranged at the distal side of the distal end of the inner sheath core and is connected to the inner sheath core; the sealing device comprises a distal sealing member, and the distal sealing member comprises a first stacking portion and a second stacking portion, and the first stacking portion and the second stacking portion are used to be stacked in the distal direction of the tissue defect to seal the distal gap of the tissue defect.

[0006] The blocking system provided in the embodiment of the present application is used to block tissue defects, and its delivery device is used to deliver the blocking device and release it at the tissue defect. The distal blocking piece of the blocking device can be used to block the distal gap of the tissue defect, so that the operator can use the distal blocking piece to block the tissue defect, which is convenient for operation and saves operation time. In the delivery state, the blocking device is accommodated in the inner cavity of the outer sheath tube, which is convenient for the blocking device to be delivered into the body; in the delivery state, the blocking device is arranged at the distal side of the distal end of the inner sheath core and connected to the inner sheath core. The delivery device is connected to the blocking device through the inner sheath core, and the blocking device can be pushed in the distal direction through the distal end of the inner sheath core, which is conducive to simplifying the release process. Furthermore, the distal sealing component includes a first stacking portion and a second stacking portion, which are used to be stacked in the distal direction of the tissue defect to form a multi-layer structure for sealing the distal gap. Compared with the single-layer sealing structure, the multi-layer structure formed by the distal sealing component can prevent excessive gaps from appearing between the distal sealing component and the tissue wall, thereby reducing the risk of bleeding and improving the sealing performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0008] Figure 1A A schematic structural diagram of a blocking system provided in the first embodiment of the present application;

[0009] Figure 1B for Figure 1A A schematic structural diagram of the second laminated portion shown;

[0010] Figure 1C for Figure 1A The structural schematic diagram of the blocking system in the conveying state is shown;

[0011] Figure 1D for Figure 1A The structural schematic diagram of the blocking system shown in another angle in the conveying state;

[0012] Figure 1E for Figure 1A A schematic diagram of the structure of the blocking system in the release process;

[0013] Figure 1F for Figure 1A The occlusion system shown is a schematic diagram of the structure of a tissue defect to be occluded;

[0014] Figure 1G for Figure 1E Schematic diagram of the structure of the occluding device occluding the defective tissue after the middle occluding system is released;

[0015] Figure 1H for Figure 1G Schematic diagram of the enlarged structure of region VIII;

[0016] Fig. 1I for Figure 1B A schematic structural diagram of the second stacking portion in a modified embodiment;

[0017] Figure 1J for Figure 1B A schematic structural diagram of the second stacking portion in another modified embodiment;

[0018] Figure 1K for Figure 1B A schematic structural diagram of the second stacking portion in another modified embodiment;

[0019] Figure 1L for Figure 1B A schematic structural diagram of the second stacking portion in yet another modified embodiment;

[0020] Figure 1M for Figure 1B A schematic diagram of the structure of the second stacked portion in other modified embodiments;

[0021] Figure 2A A schematic structural diagram of a blocking system provided in a second embodiment of the present application;

[0022] Figure 2B for Figure 2A The schematic diagram of the structure of the distal blocking member and the fixing member in a state to be assembled;

[0023] Figure 2C for Figure 2B A front view of the distal blocking member and the fixing member after being assembled;

[0024] Figure 2D for Figure 2B A rear view of the distal blocking member and the fixing member after being assembled;

[0025] Figure 2E for Figure 2B A side view of the distal blocking member and the fixing member after being assembled;

[0026] Figure 2F for Figure 2A The structural schematic diagram of the blocking system shown is in a conveying state;

[0027] Figure 2G for Figure 2AThe structural schematic diagram of the blocking system shown is another angle in the conveying state;

[0028] Figure 2H for Figure 2A The structural schematic diagram of the blocking system shown is in a released state;

[0029] Fig.2I for Figure 2A A schematic diagram of the structure of the occlusion device occluding the defective tissue after the occlusion system is released;

[0030] Figure 2J for Figure 2B A schematic structural diagram of a distal blocking member in a modified embodiment shown in FIG.

[0031] Figure 2K for Figure 2B A schematic structural diagram of the distal blocking member in another modified embodiment shown in FIG.

[0032] Figure 2L for Figure 2B A schematic structural diagram of a distal blocking member in another modified embodiment shown in FIG.

[0033] Figure 2M for Figure 2B A schematic structural diagram of a distal blocking member in yet another modified embodiment shown in FIG.

[0034] Figure 3A A schematic structural diagram of a distal blocking member provided in a third embodiment of the present application;

[0035] Figure 3B for Figure 3A A schematic diagram of the structure of the mid-distal blocking member in a modified implementation mode;

[0036] Figure 3C for Figure 3A A schematic structural diagram of a mid-distal blocking member in another modified implementation manner;

[0037] Figure 3D A schematic structural diagram of a blocking system provided in a third embodiment of the present application;

[0038] Figure 3E for Figure 3D A schematic diagram of the structure of the blocking system in the conveying state;

[0039] Figure 3F for Figure 3D A schematic structural diagram of the blocking system in another angle in a conveying state;

[0040] Figure 4 A schematic structural diagram of a blocking system provided in a fourth embodiment of the present application;

[0041] Figure 5A A schematic structural diagram of a blocking system provided in a fifth embodiment of the present application;

[0042] Figure 5B for Figure 5A A schematic diagram of the structure of the plugging system in the conveying state;

[0043] Figure 5C for Figure 5B A schematic diagram of the structure of the blocking system in a transport state in a modified implementation mode;

[0044] Figure 5D A schematic diagram of the structure of the blocking system provided in the fifth embodiment in a modified embodiment;

[0045] Fig. 6A A schematic structural diagram of a blocking system provided in a sixth embodiment of the present application;

[0046] Figure 6B for Fig. 6A A schematic diagram of the structure of the plugging system in the conveying state;

[0047] Figure 6C for Fig. 6A A schematic diagram of the structure of the occluding device occluding the defective tissue after the occluding system is released;

[0048] Fig.6D for Fig. 6A A schematic diagram of the structure of the blocking system in a modified implementation mode;

[0049] Fig. 6E for Fig. 6A A schematic structural diagram of the blocking system in another modified implementation mode;

[0050] Fig. 7A A schematic structural diagram of a blocking system provided in a seventh embodiment of the present application;

[0051] Figure 7B for Fig. 7A A schematic structural diagram of the blocking system in a modified implementation manner. DETAILED DESCRIPTION

[0052] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0053] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0054] It should be noted that the same or similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not require further definition and explanation in the subsequent drawings.

[0055] In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear to indicate an orientation or position relationship, they are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0056] In addition, the terms “first”, “second”, etc., if used, are merely used to distinguish between the descriptions and should not be understood as indicating or implying relative importance.

[0057] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0058] Definitions:

[0059] Proximal end and distal end: Along the conveying path of the medical device, the end of the medical device or a component thereof that is relatively close to the operator is the proximal end, and the end that is relatively far away from the operator is the distal end. Specifically, in an embodiment of the present application, a blocking system is provided, and the blocking system includes a blocking device and a conveying device. The blocking device is used to block tissue defects, and the conveying device is used to convey and release the blocking device to the tissue defect. Along the conveying path of the blocking system, the distal end of the conveying device is connected to the proximal end of the blocking device; in the blocking device or its component, the end that is closer to the conveying device is the proximal end, and the end that is farther from the conveying device is the distal end; in the conveying device or its component, the end that is closer to the operator is the proximal end, and the end that is farther from the operator is the distal end.

[0060] Proximal and distal: Along the delivery path of the medical device, the side of the medical device or its component that is relatively close to or facing the operator is the proximal side, and the side that is relatively far away from or away from the operator is the distal side. Specifically in the present application, along the delivery path of the occluding system, the delivery device is used to connect the proximal end of the occluding device from the proximal side of the occluding device; in the occluding device or its component, the side that is close to or facing the delivery device is the proximal side, and the side that is far away from or away from the delivery device is the distal side; in the delivery device or its component, the side that is close to or facing the operator is the proximal side, and the side that is far away from or away from the operator is the distal side.

[0061] The term "axial" or "axial direction" used in the embodiments and claims herein refers to the direction of the central axis of a device or component; or refers to the direction passing through the geometric center of a device or component and extending between its proximal end and distal end. In the present application, the axial direction of the delivery device and the occlusion device coincide.

[0062] Radial: the radial direction of a device or component, which is perpendicular to the axial space.

[0063] Circumferential direction refers to the circumferential direction of a device or component, that is, the direction around the axis of the device or component. The circumferential direction is perpendicular to the axial direction and the radial direction at the same time.

[0064] "Circumferential" together with "axial" and "radial" constitute the three orthogonal directions of a device or component.

[0065] The occluding system provided in this embodiment is used to occlude tissue defects, and can be used to occlude tissue defects such as vascular punctures (such as arterial punctures, venous punctures), aortic dissections, heart defects (such as patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, etc.) in a living body. The following embodiment uses the occluding system used to occlude vascular punctures as an example to illustrate the specific structure of the occluding system. It can be understood that the occluding system provided in the embodiment of the present application can also be used to occlude other tissue defects in a living body mentioned or not mentioned above.

[0066] First embodiment

[0067] See also Figures 1A to 1MThe present embodiment provides a blocking system 10 for blocking a tissue defect 996, including a blocking device 100 and a delivery device 900, wherein the delivery device 900 is used to deliver the blocking device 100 and release it at the tissue defect 996. The delivery device 900 includes an outer sheath tube 910 and an inner sheath core 930, wherein the inner sheath core 930 is arranged in the inner cavity of the outer sheath tube 910; in the delivery state, the blocking device 100 is accommodated in the inner cavity of the outer sheath tube 910, and the blocking device 100 is arranged at the distal end of the inner sheath core 930 and connected to the inner sheath core 930. The blocking device 100 includes a distal blocking member 101, wherein the distal blocking member 101 includes a first laminated portion 110 and a second laminated portion 130, wherein the first laminated portion 110 and the second laminated portion 130 are arranged in a laminated manner in the distal direction of the defect 996 to block the distal notch 997 of the defect 996.

[0068] The occluding system 10 provided in the embodiment of the present application is used to occlude the tissue defect 996, and the delivery device 900 is used to deliver the occluding device 100 and release it at the tissue defect 996. The distal occluding member 101 of the occluding device 100 can be used to occlude the distal notch 997 of the tissue defect 996, so that the operator can use the distal occluding member 101 to occlude the tissue defect 996, which is convenient for operation and saves operation time. In the delivery state, the occluding device 100 is accommodated in the inner cavity of the outer sheath tube 910, which is convenient for the occluding device 100 to be delivered into the body; in the delivery state, the occluding device 100 is arranged at the distal side of the distal end of the inner sheath core 930 and connected to the inner sheath core 930. The delivery device 900 is connected to the occluding device 100 through the inner sheath core 930, and the occluding device 100 can be pushed in the distal direction through the distal end of the inner sheath core 930, which is conducive to simplifying the release process. Furthermore, the distal sealing component 101 includes a first stacking portion 110 and a second stacking portion 130, and the first stacking portion 110 and the second stacking portion 130 are used to be stacked in the distal direction of the tissue defect 996, so as to form a multi-layer structure for sealing the distal gap 997. Compared with the single-layer sealing structure, the multi-layer structure formed by the distal sealing component 101 can prevent excessive gaps from appearing between the distal sealing component 101 and the tissue wall (such as the blood vessel wall), thereby reducing the risk of bleeding and improving the sealing performance.

[0069] like Figure 1E to Figure 1H As shown, in this embodiment, the tissue defect 996 is a designated hemostasis site of the blood vessel 991, such as a puncture site of the blood vessel 991. The tissue defect 996 has bilateral notches, namely a distal notch 997 and a proximal notch 998. The distal notch 997 is connected to the inner wall of the blood vessel 991, and the proximal notch 998 is connected to the outer wall of the blood vessel 991.

[0070] A puncture channel 993 is formed between the tissue defect 996 and the biological surface 992, and the puncture channel 993 is used for the treatment device to pass through to form an intervention channel or a delivery channel. The distal end of the delivery device 900 is used to load the blocking device 100, and the blocking device 100 is used to reach the tissue defect 996 from the biological surface 992 along the puncture channel 993 and enter the blood vessel 991 under the pushing action of the distal end of the delivery device 900. The distal end of the delivery device 900 is used to release the distal blocking member 101 of the blocking device 100 in the blood vessel 991, so as to facilitate the distal blocking member 101 to block the distal notch 997 of the tissue defect 996.

[0071] The distal direction of the tissue defect 996 may refer to the distal direction of the distal notch 997, i.e., the direction from the distal notch 997 to the central axis of the blood vessel 991, or may refer to the distal direction of the proximal notch 998, i.e., the direction from the proximal notch 998 to the central axis of the blood vessel 991.

[0072] like Figure 1A and Figure 1H As shown, in this embodiment, the distal blocking member 101 includes a first laminated portion 110 and a second laminated portion 130, both of which are used to be released at the distal side of the tissue defect 996 to block the distal gap 997. The first laminated portion 110 and the second laminated portion 130 are stacked and covered in the distal direction of the tissue defect 996, so that the distal gap 997 is blocked by multiple layers at the end of the puncture channel 993, thereby improving the blocking performance of the blocking device 100 on the tissue defect 996.

[0073] The delivery device 900 includes an outer sheath tube 910 and an inner sheath core 930, wherein the outer sheath tube 910 is sleeved on the outer periphery of the inner sheath core 930, and the two can achieve relative movement, such as relative axial movement, circumferential rotation, etc. The outer sheath tube 910 is tubular and has an inner cavity, and the inner sheath core 930 is inserted into the inner cavity of the outer sheath tube 910. The inner sheath core 930 is tubular, and at least one inner cavity is formed inside it for the fixing member 150 to be inserted. In some embodiments, a plurality of channels are formed in the inner sheath core 930 for a plurality of components including the fixing member 150 to be inserted, and different channels are used for inserting different components.

[0074] In this embodiment, the first laminated portion 110 and the second laminated portion 130 are made of different sheets, that is, the first laminated portion 110 and the second laminated portion 130 are separate structures and are both in sheet shape.

[0075] Furthermore, in this embodiment, if Figure 1A to Figure 1B In a natural state (i.e., the blocking device 100 is fully expanded without any external force), the first laminated portion 110 and the second laminated portion 130 have the same structure and are both in the form of flat sheets. Figure 1C and Figure 1DAs shown, in the conveying state (i.e., the occluding device 100 is located in the inner cavity of the conveying device 900, specifically in the inner cavity of the outer sheath tube 910), under the radial compression of the conveying device 900 (specifically, the outer sheath tube 910), the first laminated portion 110 and the second laminated portion 130 are curved, so as to facilitate advancement into the body in a smaller diameter state. Specifically, in the conveying device 900, the first laminated portion 110 and the second laminated portion 130 are both arched, and in other embodiments, the first laminated portion 110 and the second laminated portion 130 are both bent into at least a partial roll shape, that is, the first laminated portion 110 and / or the second laminated portion 130 can be bent into a complete cylinder.

[0076] In some embodiments, at least one of the first stacking portion 110 and the second stacking portion 130 has the same form in the natural state and the conveying state, that is, at least one of the first stacking portion 110 and the second stacking portion 130 does not change in the two states.

[0077] For example, in the two states, the one of the first stacking part 110 and the second stacking part 130 that has the same shape is the first stacking part 110. In one possible implementation, the first stacking part 110 has a smaller area and can be transported at an angle in the transport device. Preferably, in the two states, the first stacking part 110 is arched, specifically in the natural state (such as Figure 1A The surface of the first laminated portion 110 has a baseline, and the position of the baseline can be set on the surface of the first laminated portion 110 as needed. The parts on both sides of the baseline in the first laminated portion 110 gradually extend toward the distal side, so that the first laminated portion 110 bulges (arches) toward the proximal side at the position of the baseline. Preferably, the material of the first laminated portion 110 is harder, so that when the first laminated portion 110 blocks the distal notch of the tissue defect 996, it can fit the inner wall of the blood vessel 991 with an arc shape around the distal notch 997, thereby improving the blocking performance.

[0078] It can be understood that the above technical solution of the first stacking part 110 can be applied to the second stacking part 130 without contradiction.

[0079] In some embodiments, at least one of the first stacked portion 110 and the second stacked portion 130 is a flexible member. In a natural state, the first stacked portion 110 and / or the second stacked portion 130, which are flexible members, are arched. In a transport state, under the action of the radial compression force of the outer sheath tube 910, the degree of bending of the first stacked portion 110 and / or the second stacked portion 130 increases.

[0080] The first laminated part 110 and the second laminated part 130 can be made of at least one of a degradable material and a non-degradable material, that is, the first laminated part 110 can include a degradable material, a non-degradable material, or a degradable material and a non-degradable material. The material used in the first laminated part 110 and the material used in the second laminated part 130 have no mutual constraint relationship, and the first laminated part 110 and the second laminated part 130 can be made of the same material or different materials.

[0081] Furthermore, the first laminated part 110 can be made of at least one of a non-degradable material, a degradable biomaterial, and a degradable polymer material. That is, the first laminated part 110 can be made of at least one of the above three materials. The second laminated part 130 can also be made of at least one of a non-degradable material, a degradable biomaterial, and a degradable polymer material.

[0082] The first stacking part 110 and / or the second stacking part 130 may be made of the following materials:

[0083] Non-degradable materials include, but are not limited to, polypropylene, aromatic polyester, and polytetrafluoroethylene;

[0084] Degradable biomaterials include, but are not limited to, materials such as collagen (e.g., collagen-rich porcine small intestinal submucosa materials), polyhydroxyalkanoate (PHA);

[0085] Degradable polymer materials include, but are not limited to, polyglycolic acid (PGA), polyethylene glycol (PEG), polylactic acid (PLA), polylactic acid-polycaprolactone copolymer (PLCL), polylactic acid-polyglycolic acid copolymer (PLGA), hydrogel, and polyvinyl alcohol (PVA).

[0086] In this embodiment, the first laminated part 110 and the second laminated part 130 are both made of degradable materials, so that after a degradation cycle, the first laminated part 110 and the second laminated part 130 will degrade in the blood vessel and can be completely absorbed, without leaving foreign matter in the blood vessel, and can maintain long-term patency of the blood vessel, reduce the risk of thromboembolism, eliminate long-term complications and adverse effects caused by the permanent retention of the occluding device in the body, and shorten the cycle of taking antithrombotic drugs. In this embodiment, the first laminated part 110 and the second laminated part 130 are made of the same material.

[0087] Further, the first laminated part 110 and / or the second laminated part 130 absorb water and swell, that is, the first laminated part 110 and / or the second laminated part 130 will swell after entering the biological body and contacting the body fluid, thereby increasing the flexibility and elasticity, making it easier to fit and block the peripheral tissue of the distal notch 997, and the blocking and hemostasis effect is better. In some embodiments, the first laminated part 110 absorbs water and swells, and in some embodiments, the second laminated part 130 absorbs water and swells. In this embodiment, both the first laminated part 110 and the second laminated part 130 can absorb water and swell.

[0088] The first laminated part 110 and / or the second laminated part 130 may include at least one of collagen, hydrogel, and polyvinyl alcohol (PVA) to achieve water absorption and swelling. In some embodiments, the first laminated part 110 includes collagen material to ensure that the material is soft, easy to fit the tissue, easy to absorb water and swell, has a good blocking effect, and is degradable. Preferably, the first laminated part 110 and / or the second laminated part 130 are made of a pig small intestine submucosal material rich in collagen, which is biodegradable, expands in volume after absorbing water, and has a relatively soft material.

[0089] Please read further Figure 1A and Figure 1B The first stacked portion 110 is arranged on the distal side of the second stacked portion 130, and the second stacked portion 130 is formed with a through hole 133. The blocking device 100 includes a fixing member 150, and the fixing member 150 is connected between the distal blocking member 101 and the conveying device 900. Specifically, the fixing member 150 is inserted into the through hole 133, one end of the fixing member 150 is connected to the first stacked portion 110, and the other end of the fixing member 150 is connected to the conveying device 900, specifically, connected to the inner sheath core 930.

[0090] like Figure 1E to Figure 1H As shown, during the release process of the occluding device 100, after the distal occluding component 101 is released from the distal end of the conveying device 900 to the distal side of the tissue defect 996, the proximal limit of the second stacked portion 130 is located at the peripheral tissue of the distal notch 997, and the conveying device 900 is used to pull the first stacked portion 110 proximally through the fixing member 150, so that the first stacked portion 110 and the second stacked portion 130 are stacked on each other in the distal direction of the distal notch 997.

[0091] In this embodiment, the first laminated portion 110 and the second laminated portion 130 are both in sheet form. Figure 1B As shown, the second laminated part 130 is provided with a through hole 133 in its central area (the area surrounded by the edge), and the through hole 133 is a through hole that penetrates the second laminated part 130 in the thickness direction. When the occluding device 100 is implanted into a biological body, the through hole 133 penetrates the axial direction of the second laminated part 130. Figure 1BAs shown, the perforation hole 133 is circular. In other embodiments, the perforation hole 133 can be selected into other shapes as needed, such as regular or irregular shapes such as elliptical and strip shapes. The size of the perforation hole 133 needs to match the fixing member 150 so that the fixing member 150 can pass through and ensure that the fixing member 150 can slide smoothly in the perforation hole. At the same time, the perforation hole 133 should be prevented from being too large, so as to reduce the possibility of blood flow through the gap between the perforation hole 133 and the fixing member 150 to form blood flow.

[0092] The fixing member 150 includes a wire. In the present embodiment, the fixing member 150 is in a linear shape and is inserted into the through hole 133 of the second laminated portion 130. The fixing member 150 may be a suture. The fixing member 150 may be a non-degradable suture, which may be a polypropylene suture or the like. The fixing member 150 may also be a degradable suture, such as a collagen suture, a catgut, a glycolic acid suture or other absorbable suture. In other embodiments, the fixing member 150 may also be other components other than the wire body that can pass through the through hole 133. In some embodiments, the fixing member 150 includes other components connected to the suture for locking the end of the suture.

[0093] like Figure 1B As shown, the second laminated part 130 is provided with two penetration holes 133 in the central area. During the assembly process, one end of the fixing member 150 passes through one penetration hole 133 from the proximal side to the distal side, and then passes through another penetration hole 133 from the distal side to the proximal side, which is convenient for simplifying the assembly process. In addition, the second laminated part 130 is provided with two penetration holes 133, which is convenient for the second laminated part 130 to remain stable during the sliding process of the fixing member 150 relative to the penetration hole 133, thereby improving the operability of the release process. It is understandable that the required number of penetration holes can also be flexibly provided on the second laminated part 130 as needed.

[0094] like Figure 1B As shown, in this embodiment, the second stacking portion 130 is rectangular, and the two stacking portions are consistent in shape and size, including relatively long long sides and relatively short wide sides, that is, each stacking portion has different radial dimensions in at least two directions.

[0095] In some embodiments, each stacked portion can be configured as a square, a circle ( Fig. 1I ), ellipse( Figure 1J ), runway shape ( Figure 1K ), similar to an oval ( Figure 1L ), or some irregular shapes, such as Figure 1M As shown. Figure 1LAs shown in the figure, under the condition of ensuring a large enough sealing area, the rounded corners can reduce the scouring effect of blood flow on the laminated part, and the edge of the laminated part is not easy to rise, so the sealing effect is better. Figure 1L as well as Figure 1M As shown, the edges of the stacked parts are all arcs, which can further reduce fluid resistance. The two long sides are longer than the two short sides, avoiding the problem of long-term blood flushing causing the edges of the stacked parts to become ineffective and the effective blocking area to be reduced.

[0096] The direction along or parallel to its long side is its transverse direction, and the direction along or parallel to its wide side is its longitudinal direction. The two through holes 133 provided on the surface of the second laminated part 130 are provided along its transverse direction. In some embodiments, the two through holes 133 provided on the surface of the second laminated part 130 are provided along its longitudinal direction, or along an inclined direction between the transverse direction and the longitudinal direction.

[0097] One end of the fixing member 150 is connected to the first stacking portion 110. The fixing member 150 is fixedly connected to the first stacking portion 110 or movably connected.

[0098] In this embodiment, the fixing member 150 is movably connected to the first laminated part 110. Specifically, the first laminated part 110 is provided with a through hole, and the through hole on the first laminated part 110 can be the same as the through hole 133 on the surface of the second laminated part 130, that is, the technical solution of providing the through hole 133 on the surface of the second laminated part 130 can be applied to the first laminated part 110. Figure 1A As shown, in the present embodiment, the first stacking part 110 is provided with two through holes which penetrate in the thickness direction thereof, and the fixing member 150 passes through the two through holes. During the assembly process, one end of the fixing member 150 passes through a through hole 133 of the second stacking part 130, then passes through a through hole of the first stacking part 110 in the distal direction, then passes through another through hole of the first stacking part 110 in the proximal direction, and then passes through another through hole 133 of the second stacking part 130 in the proximal direction, thereby completing the assembly between the fixing member 150 and the distal blocking member 101.

[0099] In some embodiments, a through hole is provided on the surface of the first laminate portion 110 , and the fixing member 150 can be partially fixed to the first laminate portion 110 by tying a knot at the distal side of the first laminate portion 110 or by providing a locking member at the distal side of the first laminate portion 110 .

[0100] In some embodiments, the proximal surface of the first stack portion 110 is provided with a penetration ring but no penetration hole. The fixing member 150 can pass through the penetration ring to achieve connection with the first stack portion 110, and the fixing member 150 can be fixed to the penetration ring, such as by knotting, bonding, welding, etc.

[0101] In some embodiments, the fixing member 150 is fixedly connected to the first stacking portion 110. For example, a portion of the fixing member 150 can be fixed to the first stacking portion 110 by knotting, sewing, bonding, welding or using other locking members or other existing methods.

[0102] The fixing member 150 is used to fix to the tissue near the distal occluding member 101. In this embodiment, the fixing member 150 is a suture, which is inserted into the inner sheath core 930 of the delivery device 900. The two free ends of the suture are connected to the operating handle of the delivery device (not shown). The operating handle can fix the suture to the tissue near the distal occluding member 101. For example, the fixing member 150 can be fixed to the peripheral tissue of the tissue defect 996 near the distal occluding member 101, that is, fixed to the wall of the blood vessel 991. Please refer to Figure 1H In this embodiment, the fixing member 150 can be fixed to the biological surface 992 proximal to the distal blocking member 101 under the control of the operating handle. Specifically, the fixing member 150 forms a knot 152 on the biological surface 992, thereby being fixed to the biological surface 992. It is understandable that the fixing member 150 can be fixed to the tissue proximal to the distal blocking member 101 by knotting, suturing, additionally providing a locking member that cooperates with it, and the like.

[0103] Second embodiment

[0104] See also Figures 2A to 2M This embodiment provides a blocking system 20, which includes a blocking device 200 and a delivery device 900, wherein the delivery device 900 is used to deliver and release the blocking device 200 to the tissue defect 996. The blocking device 200 provided in this embodiment differs from the blocking device 100 provided in the first embodiment in the following aspects. For the similarities between the blocking system 20 provided in this embodiment and the blocking system 10 provided in the first embodiment, please refer to the first embodiment, which will not be described in detail.

[0105] In this embodiment, the first laminated portion 210 and the second laminated portion 230 are folded from the same sheet of material. Specifically, the sheet of material is the distal blocking member 201, that is, the distal blocking member 201 is a sheet of material, and the distal blocking member 201 is folded to obtain the first laminated portion 210 and the second laminated portion 230, and the first laminated portion 210 and the second laminated portion 230 are used to be stacked in the distal direction of the tissue defect 996.

[0106] It can be understood that the first stacked portion 210 and the second stacked portion 230 are formed by folding the distal blocking member 201. In this embodiment, during the release of the distal blocking member 201, different parts of the distal blocking member 201 are folded with each other to form a multi-layer blocking structure.

[0107] Specifically, the distal blocking member 201 is a sheet of material, and includes a first laminated portion 210 and a second laminated portion 230, wherein the first laminated portion 210 is disposed distally of the second laminated portion 230. During the release of the distal blocking member 201, especially during the process in which the delivery device 900 pulls the first laminated portion 210 proximally through the fixing member 250, the proximal side of the second laminated portion 230 is limited to the peripheral tissue of the distal notch 997 of the tissue defect 996, and the first laminated portion 210 and the second laminated portion 230 are folded with each other. Figure 2B The dotted line in the figure represents the crease formed after the folding process is completed. It is understood that the crease is for illustration and may differ from the actual crease shape and position. The crease divides the distal blocking member 201 into multiple laminated parts, which include a first laminated part 210 and a second laminated part 230. One side of one of the multiple creases is the first laminated part 210, and the other side of the crease is the second laminated part 230. Figure 2B As shown, in the present embodiment, the distal blocking member 201 is folded to obtain a plurality of folds, and correspondingly obtains a plurality of stacked portions divided by the folds. In other embodiments, the distal blocking member 201 may be formed with other numbers of folds, such as one fold, and the fold divides the distal blocking member 201 into a first stacked portion 210 and a second stacked portion 230.

[0108] Further, in this embodiment, during the release process, the distal blocking member 201 is folded with each other under the pulling action of the fixing member 250. Preferably, the first laminated portion 210 and the second laminated portion 230 in the distal blocking member 201 are both provided with penetration holes 203, and the fold is located between different groups of penetration holes 203. The fixing member 250 is used to penetrate the penetration holes 203 and can slide in the penetration holes 203, so as to tighten and fold the distal blocking member 201. In some embodiments, the first laminated portion 210 is provided with a structure such as a penetration ring to achieve connection with the fixing member 250.

[0109] Please combine FIG. 2B to FIG. 2E , see Figure 2H as well as Fig.2I During the process of pulling the fixing member 250, the proximal limit of the second laminated portion 230 is located at the peripheral tissue of the distal notch 997 of the tissue defect 996, and the fixing member 250 drives the first laminated portion 210 to move proximally, and makes the through hole 203 in the first laminated portion 210 gradually approach the through hole 203 in the second laminated portion 230, until the through hole 203 of the first laminated portion 210 and the through hole 203 of the second laminated portion 230 are stacked and aligned in the distal direction of the distal notch 997, penetrate each other, and the surfaces of the first laminated portion 210 and the second laminated portion 230 facing each other are adhered together. At this time, the first laminated portion 210 and the second laminated portion 230 complete the folding process.

[0110] The through holes 203 on the distal blocking member 201 are divided into multiple groups, one group of through holes 203 is arranged in the first stacking portion 210, and one group of through holes 203 is arranged in the second stacking portion 230. It can be understood that Figure 2B As shown in , the distal blocking member 201 can also be provided with other stacked portions, such as the third stacked portion, the fourth stacked portion, etc., which are stacked with the first stacked portion 210 and the second stacked portion 230 and are sealed at the distal side of the tissue defect 996. The adjacent stacked portions are divided by folds. In this embodiment, the first stacked portion 210 is provided at the farthest end of the distal blocking member 201, and the second stacked portion 230 is provided adjacent to the first stacked portion 210. It can be understood that the first stacked portion 210 may not be provided at the distal end of the first stacked portion 210, and the second stacked portion 230 may be provided at intervals from the first stacked portion 210, and other stacked portions may be sandwiched between the two.

[0111] In this embodiment, the number of perforation holes 203 in each group is 2, and the 2 perforation holes 203 in each group are arranged in a direction perpendicular to the axis of the distal blocking member 201. In other embodiments, the number and arrangement of the perforation holes 203 in each group can be selected according to actual needs.

[0112] FIG. 2B to FIG. 2E , showing the connection relationship between the distal blocking member 201 and the fixing member 250. Figure 2B In the figure, the distal blocking member 201 and the fixing member 250 are in a state to be assembled, the distal blocking member 201 is provided with a plurality of penetration holes 203 , and the fixing member has not yet been inserted into the penetration holes 203 . Figure 2C This is a front view of the distal blocking member 201 after the distal blocking member 201 and the fixing member 250 are assembled. Figure 2D This is a rear view of the distal blocking member 201 after the distal blocking member 201 and the fixing member 250 are assembled. Figure 2E FIG. 2 is a side view of the distal blocking member 201 after the distal blocking member 201 and the fixing member 250 are assembled. During the assembly process of the fixing member 250 and the distal blocking member 201, the fixing member 250 passes through the different groups of through holes 203 from the proximal side to the distal side, and then passes through the different groups of through holes 203 from the distal side to the proximal side, thereby completing the assembly. Figure 2E As shown, the fixing member 250 penetrates different penetration holes 203 back and forth on both sides of the distal blocking member 201 .

[0113] definition:

[0114] In the unfolded state, all the laminated parts are not folded along the creases formed after folding, such as Figure 2A and Figure 2B As shown;

[0115] In the fully folded state, all the laminated parts are folded along the creases formed after folding, and the surfaces of adjacent laminated parts facing each other are completely in contact with each other, or the gap between the surfaces of adjacent laminated parts facing each other is small, such as Fig.2I As shown;

[0116] The semi-folded state is a state between the unfolded state and the fully folded state. Figure 3D As shown, that is, adjacent laminated parts are folded at a certain angle along the folded lines, such as 90 degrees or other angles, so that the multiple laminated parts are arranged in a zigzag or wavy shape, and the adjacent laminated parts are not completely in contact with each other, forming a relatively obvious gap. Alternatively, some laminated parts are completely in contact with the surfaces of the adjacent laminated parts facing each other, while other laminated parts are not completely in contact with the surfaces of the adjacent laminated parts facing each other, and a relatively obvious gap is formed.

[0117] In this embodiment, if Figure 2A as well as Figure 2F As shown, in the natural state of the blocking device 200 and in the transport state of the blocking device 200, the distal blocking member 201 does not form any folds, that is, the first laminated portion 210 and the second laminated portion 230 are not folded along the folds formed after folding. That is, in the natural state and in the transport state, the distal blocking member 201 is in an unfolded state. Figure 2H as well as Fig.2I As shown, during the release process of the distal blocking member 201, the folding process of the distal blocking member 201 is realized. Fig.2I As shown, the distal blocking member 201 is in a completely folded state, all the laminated parts are folded along the creases formed after folding, and the surfaces of adjacent laminated parts facing each other are completely fitted together.

[0118] In this embodiment, the distal blocking member 201 is in the shape of a rectangular sheet. Figure 2J to Figure 2M As shown, the distal blocking member 201 can also be in the form of an elliptical sheet ( Figure 2J ), or the structures of the multiple stacked parts in a distal blocking member 201 are consistent, and can all be in a runway shape ( Figure 2K ),hexagon( Figure 2L ), similar to an oval ( Figure 2M ), or other regular or irregular shapes not shown. Figures 2K to 2M As shown, depressions extending toward the axial direction of the distal blocking member 201 are formed between adjacent stacked portions, so as to facilitate folding of adjacent stacked portions with each other.

[0119] In this embodiment, if Figure 2F and Figure 2GAs shown, the distal blocking member 201 is flexible when not absorbing water, and bends into a curved surface under the restraining effect of the outer sheath 910. In some embodiments, the distal blocking member 201 has the same shape in the outer sheath 910 as that outside the outer sheath 910, for example, the distal blocking member 201 is in the shape of a long strip and can be naturally accommodated in the outer sheath 910 without being restrained by the outer sheath 910.

[0120] Third embodiment

[0121] See also FIG. 3A to FIG. 3F In this embodiment, a distal blocking member 301 and a blocking system 30 including the distal blocking member 301 are provided. The distal blocking member 301 is used to be connected to a fixing member 350. The main differences between the distal blocking member 301 and the distal blocking member 201 provided in the second embodiment are as follows. For the similarities between the distal blocking member 301 and the distal blocking member 201, please refer to the second embodiment, which will not be repeated here.

[0122] The distal blocking member 301 is provided with a folding portion 305, which is formed between the first laminated portion 310 and the second laminated portion 330. The folding portion 305 facilitates the folding of the first laminated portion 310 and the second laminated portion 330 in the distal direction of the tissue defect. When the conveying device 900 pulls the first laminated portion 310 proximally through the fixing member 350, the first laminated portion 310 and the second laminated portion 330 are folded relative to each other along the folding portion 305.

[0123] The folding portion 305 facilitates the first stacking portion 310 and the second stacking portion 330 to be folded together. Figure 3A As shown, the folding portion 305 is formed with a crease, that is, the crease of the folding portion 305 is formed during the molding process of the distal blocking member 301, thereby facilitating the first stacking portion 310 and the second stacking portion 330 to fold together along the folding portion 305 during the release process and during pre-installation in the conveying device 900.

[0124] A folding portion 305 is formed between the first stacking portion 310 and the second stacking portion 330, so that the first stacking portion 310 and the second stacking portion 330 can be folded along the predetermined position and trajectory of the folding portion 305. The crease formed after the first stacking portion 310 and the second stacking portion 330 are folded can basically overlap with the folding portion 305, and is relatively regular. The position of the crease is appropriate. After folding, the shapes and sizes of the first stacking portion 310 and the second stacking portion 330 are basically consistent with the preset conditions, so that after the release is completed, the surfaces facing each other between the first stacking portion 310 and the second stacking portion 330 are completely fitted together, and the distal blocking component 301 is in a completely folded state.

[0125] If the distal blocking component 301 is not provided with a folding portion 305, the first stacking portion 310 and the second stacking portion 330 of the distal blocking component 301 are folded during the release process under the influence of the anatomical structure of the tissue defect 996 and the blood flow flushing. The crease position between the first stacking portion 310 and the second stacking portion 330 may not be ideal, and incomplete folding may occur between the two, that is, the gap between the adjacent sides of the first stacking portion 310 and the second stacking portion 330 is large, which may easily lead to poor blocking effect and a high risk of device thrombosis.

[0126] like Figure 3B As shown, in some embodiments, a bending groove is formed in the folding portion 305. That is, the distal blocking member 301 has a groove formed on the surface of the folding portion 305, that is, the sheet-shaped distal blocking member 301 is thinned at the position of the folding portion 305, so as to facilitate guiding the first stacking portion 310 and the second stacking portion 330 to fold at this position. The shape of the bending groove is not limited, and can be as follows: Figure 3B The folding position is shown to be arranged in a straight line along the preset position.

[0127] The folding portion 305 is used to divide different stacked portions. The distal blocking member 301 may adopt multiple folding portions of one structural form, or the distal blocking member 301 may adopt multiple folding portions of different structural forms.

[0128] like Figure 3C As shown, in some embodiments, the folding portion 305 may adopt a bending groove of other structures, for example, a folding portion 305 is provided with a plurality of bending grooves. Figure 3C The folding portion 305 of three structures is shown, which are respectively denoted as the folding portion 305A, the folding portion 305B and the folding portion 305C. The folding portion 305A, the folding portion 305B and the folding portion 305C respectively include a plurality of bending grooves arranged in an array. The bending grooves in the folding portion 305A and the folding portion 305B are rectangular, and the difference is that the bending grooves in the folding portion 305A and the folding portion 305B extend in different directions. The extending direction of the bending groove in the folding portion 305A is along the extending direction of the folding portion 305A. Since the first laminated portion 310 and the second laminated portion 330 are in the axial direction ( Figure 3C The folded portion 305A is folded with each other in the vertical direction (in the vertical direction), therefore, the extension direction of the folded portion 305A is perpendicular to the axial direction of the distal blocking member 301, that is, the extension direction of each bending groove in the folded portion 305A is perpendicular to the axial direction of the distal blocking member 301. The extension direction of each bending groove in the folded portion 305B is not perpendicular to the axial direction of the distal blocking member 301, for example, it can be parallel to the axial direction of the distal blocking member 301. The multiple bending grooves in the folded portion 305C are arranged in an array, each bending groove is elliptical, and its major axis direction (extension direction) is perpendicular to the axial direction of the distal blocking member 301.

[0129] exist Figure 3C In the embodiment shown in which the folding portion includes a plurality of bending grooves, the bending grooves may also be through holes penetrating in the thickness direction of the folding portion 305, namely, bending holes.

[0130] It is understandable that in other embodiments, the bending groove / bending hole can also take the form of other cross-sectional shapes, such as circular, wavy, etc., which are not elaborated here. The number and extension direction of the bending groove / bending hole can also be adjusted as needed.

[0131] In this embodiment, the distal blocking member 301 is a rectangle as an example to illustrate the structure of the folding portion 305. It is understandable that in other embodiments, the distal blocking member 301 may be a rectangle. Figure 2J-2M Or other structural forms not mentioned will not be elaborated here.

[0132] In this embodiment, a folding portion 305 is provided between the first stacking portion 310 and the second stacking portion 330. For example, a folding mark, a bending groove or a bending hole is provided in the folding portion 305. In the conveying state (the distal blocking component 301 is at least partially located in the outer sheath 910) and in the natural state (the blocking device is not subjected to the force of the conveying device and the biological tissue), there are three situations for the relative position relationship between the first stacking portion 310 and the second stacking portion 330.

[0133] In the first case, the distal blocking member 301 is in an unfolded state, that is, the first laminated portion 310 and the second laminated portion 330 are not folded along the folded portion 305. During the molding process, the distal blocking member 301 forms the folded portion 305 before being assembled with the fixing member 350. If the distal blocking member 301 is in a preset shape (a flat surface or a curved surface) before the folded portion 305 is formed, then in the first case, after the folded portion 305 is formed, the distal blocking member 301 still maintains or substantially maintains the preset shape, and the first laminated portion 310 and the second laminated portion 330 are not folded along the folded portion 305, such as Figure 2F In the illustrated embodiment, the angle between the first stacked portion 310 and the second stacked portion 330 is 180°.

[0134] The second situation is that the distal blocking member 301 is in a semi-folded state, and the laminated parts are folded with each other along the folded portion 305, but the surfaces of the laminated parts facing each other are not completely pressed together (an obvious gap is formed). Figure 3D-Figure 3FIn the semi-folded state shown, the distal blocking member 301 is bent into a W shape. In an embodiment where the distal blocking member 301 only has the first laminated portion 310 and the second laminated portion 330 and no other laminated portions, the first laminated portion 310 and the second laminated portion 330 may be V-shaped. In an embodiment where there are more than two laminated portions, the plurality of laminated portions may be folded into a zigzag or wavy shape. In some embodiments, some of the laminated portions in the distal blocking member 301 are completely fitted together, while other laminated portions are not completely fitted together.

[0135] like Figure 3F As shown, in the conveying state, the distal blocking member 301 is in a semi-folded state and is located inside the conveying device 900. In the axial direction of the distal blocking member, the angle between the first laminated portion 310 and the second laminated portion 330 is a, and 0°<a<180°. a=0° is a fully folded state, and a=180° is an unfolded state. To achieve the above-mentioned semi-folded state, the first laminated portion 310 and the second laminated portion 330 can be folded with each other before the release process of the distal blocking member 301 (for example, during the conveying process, the loading process, and the molding process of the distal blocking member 301) to form the folded portion 305, and the first laminated portion 310 and the second laminated portion 330 are kept spaced from each other at one end away from the folded portion 305.

[0136] It can be understood that in the delivery state, the distal blocking member 301 is in a semi-folded state. Figure 3D As shown, the distal blocking member 301 is shaped before the blocking device 300 is loaded into the outer sheath tube 910 to obtain the distal blocking member 301 in a semi-folded state, and the distal blocking member 301 can also be folded during the loading process. In some embodiments, the semi-folded state of the distal blocking member 301 during the transportation process is formed by folding each other during the two processes of the distal blocking member 301 being formed and loaded into the outer sheath tube 910.

[0137] It is understandable that, in the second case, after the distal blocking member 301 is released from the delivery device 900, the folding degree of the distal blocking member 301 gradually increases as the operator gradually tightens the fixing member 350. In some preferred embodiments, by pulling the fixing member 350, the stacked parts can be completely compressed, so that the distal blocking member 301 is in a completely folded state.

[0138] The third situation is that in the conveying state, the distal blocking component 301 is in a completely folded state, and the adjacent stacked parts can be fixed into a stacked structure by solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with anchors of polymer materials, so that the distal blocking component 301 can be formed into a multi-layer stacked structure. Please refer to the subsequent implementation methods for details.

[0139] Fourth embodiment

[0140] See also Figure 4 This embodiment provides a blocking system 40, which includes a blocking device 400 and a conveying device 900. The blocking device 400 includes a distal blocking member 401 and a fixing member 450 connected to each other. The main difference between the distal blocking member 401 provided in this embodiment and the distal blocking member 301 provided in the third embodiment is that the first stacking portion 410 and the second stacking portion 430 in the distal blocking member 401 are folded and fixed to each other into a stacked structure from the same sheet (distal blocking member 401). That is, the first stacking portion 410 and the second stacking portion 430 are fixed to each other and maintain a stacked state.

[0141] In this embodiment, the shape and size of the first stacking portion 410 and the second stacking portion 430 are basically the same. The edge of the first stacking portion 410 can be aligned with the edge of the second stacking portion 430 and then fixed to each other. The fixing method can be solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with polymer anchors.

[0142] The mutually stacked first stacking portion 410 and the second stacking portion 430 are formed by folding and fixing the same sheet material (distal blocking component 401), that is, when the distal blocking component 401 is outside the body, the first stacking portion 410 and the second stacking portion 430 are fixed to each other and maintained in a folded state to realize a stacked structure, and there is no need to achieve mutual folding by pulling the fixing component 450 in the body, which can avoid different stacking states of the distal blocking component 401 during the folding process in the body, and can make the distal blocking component 401 fit the blood vessel wall more closely.

[0143] In some embodiments, the first laminated part 410 and the second laminated part 430 are not in the same shape, and at least a portion of the periphery of the first laminated part 410 is fixedly connected to the second laminated part 430; and / or at least a portion of the periphery of the second laminated part 430 is fixedly connected to the first laminated part 410, thereby achieving mutual fixation of the two laminated parts. The edges of the two laminated parts are fixed together, which facilitates the formation of a flat periphery of the distal blocking member 401, reducing the risk of device thrombosis forming at the periphery of the distal blocking member 401.

[0144] In some modified embodiments, for example, on the basis of the first embodiment, the first stacking portion 410 and the second stacking portion 430 are made of different sheets, and the stacked first stacking portion 410 and the second stacking portion 430 can be fixed in vitro in the above-mentioned manner to achieve stacking and fixed connection with each other, that is, the first stacking portion 410 and the second stacking portion 430 are fixed to each other into a stacking structure with different sheets, thereby improving the sealing performance of the distal blocking component 401.

[0145] Fifth embodiment

[0146] See also FIG. 5A to FIG. 5B This embodiment provides a blocking system 50, which includes a blocking device 500 and a delivery device 900, and the blocking device 500 includes a distal blocking member 501. The main difference between the blocking device 500 and the blocking device 300 is that the distal blocking member 501 includes a folding member 503 and a supporting member 505, the folding member 503 includes a first laminated portion 510 and a second laminated portion 530, the supporting member 505 is disposed at the distal side of the folding member 503, and the hardness of the supporting member 505 is greater than that of the folding member 503.

[0147] In an embodiment, the distal blocking member 501 includes a support member 505 disposed distally of the folding member 503. The folding member 503 includes a first stacking portion 510 and a second stacking portion 530. The folding member 503 may be equivalent to the distal blocking member 401 in the fourth embodiment. The structure of the folding member 503 may refer to the distal blocking member 401 and will not be elaborated here.

[0148] like Figure 5B As shown, the support member 505, the folding member 503 and the fixing member 550 are pre-installed at the distal end of the outer sheath tube 910. When the outer sheath tube 910 passes over the distal notch, the support member 505, the folding member 503 and the fixing member 550 are pushed into the blood vessel. After adjusting the position, the delivery device 900 is moved proximally to the outside of the biological body surface, and the support member 505 is closely attached to the folding member 503, while the proximal side of the folding member 503 is attached to the peripheral tissue of the distal notch of the inner wall of the blood vessel. At this time, the fixing member 550 is in a tensioned state, and then the fixing member 550 is cut off by the delivery device 900, and then the fixing member 550 is fixed to the proximal side of the distal blocking member 501, for example, the fixing member 550 is fixed to the biological epidermis, or to the blood vessel wall, or to the tissue between the biological surface and the blood vessel wall by suturing and knotting in a surgical operation.

[0149] The support member 505 is arranged on the distal side of the folding member 503, and is used to compress the folding member 503 from the distal side to the proximal side to fold it following the fixing member 550. The hardness of the support member 505 is greater than that of the folding member 503, which increases the pressure of the support member 505 on the folding member 503 and the peripheral tissue of the distal notch of the inner wall of the blood vessel, and improves the uniformity of the force applied by the support member 505 to the folding member 503 and the inner wall of the blood vessel. Combined with the locking force of the fixing member 550 when fixed on the surface of the biological body or the blood vessel wall, it can effectively block the tissue gap and achieve the purpose of hemostasis.

[0150] The material of the support member 505 can be, but is not limited to, degradable / non-degradable materials such as polyhydroxyalkanoate (PHA), polylactic acid (PLA), polylactic acid-polycaprolactone copolymer (PLCL), polylactic acid-polyglycolic acid copolymer (PLGA), and polyurethane (PU).

[0151] In this embodiment, the supporting member 505 and the folding member 503 are separate structures.

[0152] In this embodiment, the support member 505 is in the shape of a curved sheet, specifically an arch, so that it can easily fit the shape of the inner wall of the blood vessel and improve the wall adhesion and blocking performance. In this embodiment, the support member 505 is elliptical, and two through holes are provided along the direction of its short axis for the fixing member 550 to pass through.

[0153] The first stacking portion 510 and the second stacking portion 530 are in the shape of rectangular sheets. When the fixing member 550 is tightened, the length direction (the direction parallel to the long side) of the first stacking portion 510 is set to correspond to the long axis direction of the support member 505; similarly, the length direction (the direction parallel to the long side) of the second stacking portion 530 is set to correspond to the long axis direction of the support member 505, so that after being released from the distal notch, the support member 505 can cover and press on the distal side of the first stacking portion 510 to a greater extent, reducing the portion of the edges of multiple stacking portions in the folding member 503 that exceed the periphery of the support member 505, thereby reducing the risk of generating device thrombosis.

[0154] In this embodiment, the folding piece 503 includes multiple stacking parts, such as a first stacking part 510, a second stacking part 530, and other stacking parts. The sizes and shapes of the stacking parts are the same, so that after the folding piece 503 is completely folded, the edge shape is relatively regular, and the differences in the shapes of the multiple stacking parts will not cause obvious stratification of the edges of the folding piece 503 after folding, thereby affecting the normal blood flow rate.

[0155] The coverage of the support member 505 is smaller than that of each laminated portion in the folding member 503. In this embodiment, the support member 505 is arched and can be formed by using an elliptical flat sheet material to fit the shape of the defect opening in the blood vessel. The area of ​​each laminated portion is larger than the support member 505. After the distal blocking member 501 blocks the distal gap, the support member 505 squeezes and fits the folding member 503. The folding member 503 is in a folded state to form a multi-piece laminated structure. The material of the folding member 503 is softer than that of the support member 505. The edge of each laminated portion is exposed outside the periphery of the support member 505, which is conducive to reducing the damage of the periphery of the support member 505 to the tissue defect. In some embodiments, the area of ​​at least one laminated portion is larger than that of the support member 505.

[0156] In this embodiment, each folding portion in the folding member 503 has the same size and shape, and is a rectangle. In other embodiments, the shapes and sizes of the multiple folding portions in the folding member 503 may be different, and each folding portion may be other shapes other than rectangles, such as elliptical, circular, hexagonal or other shapes. The shape of the support member 505 can be set as needed, and can be elliptical, circular, hexagonal or other shapes, and can be consistent with or inconsistent with the shape of the folding portion.

[0157] like Figure 5B As shown, in the conveying state, in the outer sheath 910, the folding member 503 and the supporting member 505 are spaced apart from each other, and after the supporting member 505 is released to the far side of the tissue defect, the folding member 503 is released.

[0158] See also Figure 5C , Figure 5C Shown Figure 5B A modified implementation of the blocking device 500 in the transport state.

[0159] Figure 5C In the conveying state, in the outer sheath tube 910, the folding member 503 and the support member 505 at least partially overlap in the axial direction of the conveying device 900, that is, the folding member 503 and the support member 505 may partially overlap in the axial direction of the conveying device 900, or completely overlap (the support member 505 is arranged in the axial range of the folding member 503, or the folding member 503 is arranged in the axial range of the support member 505). The folding member 503 and the support member 505 at least partially overlap in the axial direction of the conveying device 900, such as Figure 5C As shown, the folding member 503 is covered on at least part of the surface of the support member 505, so as to shorten the length of the fixing member 550 between the two as much as possible. After release, the two will roughly remain in the stacking mode in the outer sheath 910, and the two will be easier to fit each other during the release process. Specifically in this embodiment, before the distal blocking member 501 is loaded into the delivery device 900, the fixing member 550 between the folding member 503 and the support member 505 can be tightened, so that the distance between the folding member 503 and the support member 505 is small. After the distal blocking member 501 is loaded into the delivery device 900, especially in the delivery state, the folding member 503 and the support member 505 are stacked on each other in the axial direction of the outer sheath 910. Correspondingly, the folding member 503 and the support member 505 can also be stacked on each other in the radial direction of the outer sheath 910. The folding member 503 and the support member 505 are close to each other, which reduces the difficulty of the support member 505 fitting and compressing the folding member 503 during the release process.

[0160] If the folding member 503 and the supporting member 505 are spaced apart from each other in the conveying device 900 in the outer sheath 910 , the fixing member 550 therebetween is relatively long, and the distal blocking member 501 is prone to different stacking states during the folding process in the body.

[0161] For example, during the release process, under the action of blood flow, the support member 505 is easy to rotate relative to the folding member 503, and the fixing member 550 between the support member 505 and the folding member 503 is easy to twist, making it difficult to pull the fixing member 550 to slide in the penetration hole of the folding member 503, resulting in the support member 505 being unable to press the folding member 503; or after the support member 505 presses the folding member 503, it is difficult for the support member 505 to press the folding member 503 in a predetermined direction, resulting in a large amount of the edge of the folding member 503 being exposed outside the periphery of the support member 505; or in the process of the folding member 503 being squeezed and folded by the support member 505, the folds formed are irregular, and the adjacent stacked parts cannot be completely fitted, which will lead to an increase in the area of ​​the folding member 503 exposed to the blood flow and a larger endothelialization area, resulting in a higher risk of vascular stenosis and thrombosis.

[0162] In this embodiment, the support member 505 and the folding member 503 are separate structures. In some modified embodiments, such as Figure 5D As shown, the support member 505 and the folding member 503 are fixedly connected to each other or formed in one piece. The folding member 503 and the support member 505, as well as the multiple stacked parts in the folding member 503, can be fixed into an integrated stacked structure by using solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with anchors made of polymer materials, that is, after the occluding device is formed and assembled, the distal occluding member 501 is an integrated structure, the stacked structure of the folding member 503 is fixed, and the abutment form of the support member 505 and the folding member 503 is fixed, so as to avoid the support member 505 gradually abutting against and squeezing the folding member 503 to fold in the body, and avoid the situation that the distal occluding member 501 has different stacking states during the folding process in the body, thereby improving the occlusion success rate.

[0163] In some modified embodiments, the multiple stacked parts in the folding member 503 are fixed into a stacked structure, and the folding member 503 and the supporting member 505 are not fixedly connected to form a stacked integrated structure.

[0164] Sixth Embodiment

[0165] See also FIG. 6A to FIG. 6CIn this embodiment, a blocking system 60 is provided, and the blocking system 60 includes a blocking device 600 and a conveying device 900. The blocking device 600 is different from the blocking device 500 in the fifth embodiment in that the blocking device 600 includes a proximal blocking member 606 disposed proximal to the distal blocking member 601, the proximal blocking member 606 is used to block the proximal opening of the tissue defect, and the fixing member 650 is connected to the proximal blocking member 606.

[0166] Specifically, the proximal blocking member 606 is provided with a through hole for the fixing member 650 to pass through, and the technical solution of the through hole in the distal blocking member 601 can be applied to the proximal blocking member 606 if there is no contradiction.

[0167] like Fig. 6A As shown, in the distal blocking member 601, the folding member 603 and the supporting member 605 are separate structures. It can be understood that, in other embodiments, the folding member 603 and the supporting member 605 can be fixed together or be an integrally formed structure.

[0168] like Figure 6B As shown, in the conveying state, in the conveying device 900 , the folding member 603 and the supporting member 605 at least partially overlap in the axial direction of the conveying device 900 .

[0169] like Fig. 6A and Figure 6B As shown, the delivery device 900 includes an outer sheath 910, an inner sheath core 930, and an intermediate sheath 950 arranged between the outer sheath 910 and the inner sheath core 930. The outer sheath 910, the intermediate sheath 950 and the inner sheath core 930 are stacked in sequence from outside to inside in the radial direction of the delivery device 900.

[0170] In the delivery state, the distal ends of the outer sheath 910, the intermediate sheath 950 and the inner sheath core 930 are arranged in sequence from far to near, the proximal blocking member 606 is accommodated in the inner cavity of the intermediate sheath 950, the distal end of the outer sheath 910 accommodates the distal blocking member 601, the distal end of the intermediate sheath 950 accommodates the proximal blocking member 606, and the distal end of the inner sheath core 930 is located proximal to the proximal blocking member 606. In the delivery state, in the delivery device 900, the distal blocking member 601 is arranged between the distal ends of the outer sheath 910 and the intermediate sheath 950, and the proximal blocking member 606 is located between the distal ends of the intermediate sheath 950 and the distal ends of the inner sheath core 930.

[0171] During the release process, the inner sheath core 930 and the intermediate sheath tube 950 can be controlled to remain stationary by the conveying device 900, and the outer sheath tube 910 can be controlled to move proximally (retract) to release the distal blocking component 601; the conveying device 900 can be used to control the inner sheath core 930 and the intermediate sheath tube 950 to move toward each other to release the proximal blocking component 606, such as by moving (pushing) the inner sheath core 930 distally and fixing the intermediate sheath tube 950 to release the proximal blocking component 606, or by keeping the inner sheath core 930 stationary and moving (retracting) the intermediate sheath tube 950 proximally to release the proximal blocking component 606, or by moving (retracting) the intermediate sheath tube 950 proximally and moving (pushing) the inner sheath core 930 distally at the same time to release the proximal blocking component 606.

[0172] In the delivery state, the distal blocking member 601 and the proximal blocking member 606 are spaced apart from each other in the axial direction of the blocking device 600, thereby ensuring that the fixing member 650 between the distal blocking member 601 and the proximal blocking member 606 is long enough to facilitate the distal side ( Figure 6C After releasing the distal blocking member 601 and completing blocking of the distal gap 997 (on the inner side of the blood vessel 991 in the blood vessel), the operator can release the proximal blocking member 606 as needed to block the proximal gap 998.

[0173] In particular, the delivery device 900 is provided with an intermediate sheath 950. In the delivery state, the proximal blocking component 606 is accommodated in the intermediate sheath 950, so that the distal blocking component 601 and the proximal blocking component 606 can be accurately controlled to be released in steps by controlling the operation of the outer sheath 910, the intermediate sheath 950 and the inner sheath core 930. The blocking device 600 does not need to be developed, and the release process does not require DSA fluoroscopy, thereby realizing blind operation.

[0174] like FIG. 6A to FIG. 6C As shown, the fixing member 650 forms a knot 652 at the distal end of the inner sheath core 930, and the knot 652 is arranged proximal to the proximal blocking member 606. Specifically, the inner sheath core 930 is provided with a plurality of channels penetrating the proximal end and the distal end thereof, and the delivery device 900 includes a push rod 970 for being inserted into the inner sheath core 930, and the distal end of the push rod 970 extends from the distal end of the inner sheath core 930, and the part of the push rod 970 extending from the distal end of the inner sheath core 930 is used to carry and wrap the knot 652, and the knot 652 is arranged around the side wall of the distal end of the push rod 970.

[0175] The fixing member 650 is in a linear shape and has two free ends. The two free ends of the fixing member 650 can be knotted to form a knot 652, which is then sleeved on the distal end of the push rod 970. Both ends of the fixing member 650 are connected to the handles in the conveying device.

[0176] In this embodiment, the knot 652 is a sliding knot. By moving (pulling or loosening) one free end of the fixing member 650 proximally or distally through the conveying device 900, the length of the fixing member 650 distal to the knot 652 can be reduced or increased, that is, the distance between the distal sealing member 601 and the proximal sealing member 606 can be adjusted until the distal sealing member 601 and the proximal sealing member 606 can clamp the defective tissue 996 from both sides to achieve a hemostatic effect.

[0177] The push rod 970 is controlled by the delivery device 900 to move proximally (retract) to the inside of the inner sheath core 930 , and the knot 652 falls off from the distal end of the push rod 970 .

[0178] The other end of the fixing member 650 is pulled proximally by the delivery device 900 to achieve a locking knot, i.e., locking the knot 652, thereby fixing the distance between the proximal blocking member 606 and the distal blocking member 601. The fixing member 650 is used to be fixed to the tissue proximal to the distal blocking member 601. Further, the fixing member 650 is used to be fixed to the tissue proximal to the proximal blocking member 606. Specifically, the delivery device 900 is used to lock the knot 652 proximal to the proximal blocking member 606, i.e., the knot 652 can be used to fix to the proximal tissue of the proximal blocking member 606, such as the blood vessel 991 or the biological surface 992, or the tissue between the blood vessel 991 and the biological surface 992, or to fix to the proximal tissue of the proximal blocking member 606 by other means other than the knot 652 (such as suturing, or using other locking components). After the locking is completed, the fixing member 650 can be cut off at the end of the knot 652 or the biological surface 992 by a wire cutting device to complete the release process.

[0179] In this embodiment, the delivery device 900 is used to control the two free ends of the fixing member 650 and the end of the push rod 970. In a modified embodiment, the two free ends of the fixing member 650 are not fixed to the delivery device 900, and the fixing member 650 may not be pulled by the delivery device 900, but may be pulled by an operator (such as a doctor) or other devices; the end of the push rod 970 may not be fixed to the delivery device 900, but may be directly manually controlled by the operator, or controlled by other devices.

[0180] In this embodiment, the proximal sealing member 606 is in the form of a flat sheet. In some modified embodiments, the proximal sealing member 606 can be in the form of an arch similar to the support member 605 to facilitate fitting the shape of the tissue defect. The shape of the proximal sealing member 606 can be set as needed to be suitable for sealing different tissue defects.

[0181] In some embodiments, the proximal sealing member 606 is made of a flexible material so that the proximal sealing member 606 can better fit the defect peripheral tissue, improve the sealing performance, and reduce damage and stimulation to the tissue. Preferably, the proximal sealing member 606 is more flexible than the support member 605.

[0182] See also Fig.6D , Fig.6D for FIG. 6A to FIG. 6C A modified embodiment of the sixth embodiment shown, Fig.6D In the provided blocking device, multiple components of the distal blocking member 601 are fixed together or formed in one piece, preferably fixed as a stacked structure. Preferably, the folding member 603 and the support member 605, as well as the multiple stacked parts in the folding member 603, can be fixed together by using solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with anchors made of polymer materials, that is, after the blocking device is formed and assembled, it is an integrated structure, preferably fixed as a stacked structure, so that the stacked structure of the folding member 603 is fixed, and the support member 605 and the folding member 603 are fixed in abutting form, so as to avoid the support member 605 gradually abutting against and squeezing the folding member 603 to fold in the body, so as to avoid the distal blocking member 401 from having different stacking states during the folding process in the body, so as to make the distal blocking member 401 more closely fit the blood vessel wall, and improve the blocking success rate.

[0183] In some embodiments, the folding piece 603 and the supporting piece 605 in the distal blocking piece 601 are fixed as a whole, and the multiple stacked parts in the folding piece 603 are not fixed to form a stacked structure; or, the folding piece 603 and the supporting piece 605 in the distal blocking piece 601 are separate structures, and the multiple stacked parts in the folding piece 603 are fixed to form a stacked structure.

[0184] See also Fig. 6E , Fig. 6E for FIG. 6A to FIG. 6C The modified embodiment of the sixth embodiment shown is relative to the sixth embodiment. In this modified embodiment, no support member is provided in the distal blocking member 601, and only a folding member 603 is provided. It can be understood that the multiple folding parts in the folding member 603 can be fixedly connected together in the aforementioned multiple ways and maintain a stacked / folded state.

[0185] Seventh embodiment

[0186] See also Fig. 7AThe seventh embodiment of the present application provides a blocking system 70, which includes a blocking device 700 and a delivery device 900 connected to the blocking device 700. The main difference between the blocking system 70 and the blocking system 60 provided in the sixth embodiment is that the proximal blocking member 706 in the blocking device 700 includes a support member 707 and a folding member 708. For the similarities between the blocking system 70 and the blocking system 60 provided in the sixth embodiment, please refer to the sixth embodiment, which will not be repeated here.

[0187] The support member 707 in the proximal blocking member 706 is consistent with the proximal blocking member 606 in the sixth embodiment. Please refer to the sixth embodiment and no further details will be given here.

[0188] The structure of the folding member 708 can refer to the soft folding member structure in the distal blocking member in other embodiments, such as the distal blocking member 101, the distal blocking member 201, the distal blocking member 301, the distal blocking member 401, the folding member 503, and the folding member 603. In the delivery state, it can maintain any one of the unfolded state, the semi-folded state and the fully folded state, which will not be described in detail here.

[0189] In this embodiment, the structure of the folding member 708 is shown in FIG. Fig. 6A The folding piece 603 in the distal blocking piece 601 includes a plurality of stacked parts. In a natural state, the folding piece 708 can maintain a semi-folded state.

[0190] In this embodiment, both the proximal blocking member 706 and the distal blocking member 701 are provided with a folding member 708 . The material of the folding member 708 is relatively soft and can form a multi-layer flexible multi-layer blocking structure on both sides of the tissue defect, thereby achieving a better blocking effect.

[0191] See also Figure 7B , Figure 7B for Fig. 7A The modified embodiment of the seventh embodiment shown. In this modified embodiment, the support member 707 and the folding member 708 in the distal blocking member 701 are fixed as a whole, and the multiple stacked parts in the folding member 708 are fixed as an integrated stacked structure, that is, the distal blocking member 701 is formed into a stacked structure. Similarly, the support member 707 and the folding member 708 in the proximal blocking member 706 are fixed as a whole, and the multiple stacked parts in the folding member 708 are fixed as an integrated stacked structure, that is, the proximal blocking member 706 is formed into a stacked structure, which prevents the distal blocking member 701 from folding to obtain different stacking states during the release process, and also prevents the proximal blocking member 706 from folding to obtain different stacking states during the release process, so that the blocking device 700 can be more closely attached to the blood vessel wall.

[0192] It should be noted that the specific technical solutions in the above various implementation modes can be applicable to each other.

[0193] Although the present invention has been described with reference to several typical embodiments, it should be understood that the terms used are illustrative and exemplary, rather than restrictive. Since the present invention can be embodied in a variety of forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims, so all changes and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. A blocking system, characterized in that: Used to block tissue defects, comprising a blocking device and a conveying device, wherein the conveying device is used to convey the blocking device and release it to the tissue defect; The delivery device includes an outer sheath tube and an inner sheath core, and the inner sheath core is inserted into the inner cavity of the outer sheath tube; in the delivery state, the blocking device is accommodated in the inner cavity of the outer sheath tube, and the blocking device is arranged at the far side of the far end of the inner sheath core and connected to the inner sheath core; The blocking device includes a distal blocking piece, and the distal blocking piece includes a first stacked portion and a second stacked portion, wherein the first stacked portion and the second stacked portion are used to be stacked in a distal direction of the tissue defect to block the distal gap of the tissue defect.

2. The blocking system according to claim 1, characterized in that: The first laminated part is arranged at the distal side of the second laminated part, the second laminated part is formed with a through hole, the blocking device comprises a fixing part connected to the distal blocking part, the fixing part is inserted into the through hole, one end of the fixing part is connected to the first laminated part, and the other end of the fixing part is connected to the inner sheath core; During the release process of the occluding device, after the distal occluding part is released from the distal end of the conveying device to the distal side of the tissue defect, the proximal limit of the second stacked portion is located at the peripheral tissue of the distal notch, and the conveying device is used to pull the first stacked portion proximally through the fixing member so that the first stacked portion and the second stacked portion are stacked on each other in the distal direction of the tissue defect.

3. The blocking system according to claim 2, characterized in that: The fixing member comprises a wire, The first stacking portion is formed with the through hole, and the fixing member is inserted into the through hole; or A penetration ring is arranged on the surface of the first stacking portion, and the fixing member is penetrated in the penetration ring.

4. The blocking system according to claim 2, characterized in that: The first laminated portion and the second laminated portion are made of different sheet materials.

5. The blocking system according to claim 2, characterized in that: The first laminated portion and the second laminated portion are formed by folding the same sheet material.

6. The blocking system according to claim 5, characterized in that: When the inner sheath core pulls the first laminated portion proximally by the fixing member, the first laminated portion and the second laminated portion are folded with each other.

7. The blocking system according to claim 6, characterized in that: A folding portion is formed between the first laminated portion and the second laminated portion, and the folding portion facilitates folding of the first laminated portion and the second laminated portion in a distal direction of the tissue defect; When the inner sheath core pulls the first laminated portion proximally by the fixing member, the first laminated portion and the second laminated portion are folded together along the folded portion.

8. The blocking system according to claim 7, characterized in that: At least one of a fold, a bending groove, and a bending hole is formed in the folding portion.

9. The blocking device according to any one of claims 5 to 8, characterized in that: In the conveying state, the angle between the first stacking portion and the second stacking portion is a, and 0°<a≤180°.

10. The blocking system according to claim 1, characterized in that: The blocking device comprises a fixing member connected to the distal blocking member, the fixing member passes through the second laminated portion, one end of the fixing member is connected to the first laminated portion, and the other end of the fixing member is connected to the inner sheath core; The first stacked portion and the second stacked portion are formed by folding the same sheet material together and fixing them to form a stacked structure; or, the first stacked portion and the second stacked portion are formed by different sheets material together and fixing them to form a stacked structure.

11. The blocking system according to claim 10, characterized in that: At least a portion of the periphery of the first laminated portion is fixedly connected to the second laminated portion; and / or At least a portion of the periphery of the second laminated portion is fixedly connected to the first laminated portion.

12. The blocking system according to any one of claims 1 to 8, 10 to 11, characterized in that: The first stacking part and the second stacking part are respectively made of at least one of non-degradable materials, degradable biomaterials, and degradable polymer materials.

13. The blocking system according to claim 12, characterized in that: The first laminated portion and / or the second laminated portion swells by absorbing water.

14. The blocking system according to claim 13, characterized in that: The first laminated part and / or the second laminated part includes at least one of collagen, hydrogel, and polyvinyl alcohol (PVA).

15. The blocking system according to any one of claims 1 to 8, 10 to 11, characterized in that: The distal blocking member is arched.

16. The blocking system according to any one of claims 1-8, 10-11, characterized in that: The distal blocking member includes a folding member, the folding member includes the first laminated portion and the second laminated portion, the distal blocking member includes a supporting member disposed distal to the folding member, and the hardness of the supporting member is greater than that of the folding member. The supporting member and the folding member are integrally formed; or The supporting member and the folding member are separate structures; or The supporting member is fixedly connected with the folding member as a whole.

17. The blocking system according to claim 16, characterized in that: In the conveying state, the folding member and the supporting member at least partially overlap in the axial direction of the conveying device.

18. The blocking system according to any one of claims 2-8, 10-11, characterized in that: The fixing member is used to be fixed to the tissue at the proximal side of the distal blocking member; or The blocking device further comprises a proximal blocking piece disposed proximal to the distal blocking piece, the proximal blocking piece being used to block the proximal opening of the tissue defect, the proximal blocking piece being connected to the fixing piece, and the fixing piece being used to be fixed to the tissue proximal to the proximal blocking piece; or The sealing device also includes a proximal sealing piece arranged proximal to the distal sealing piece, the proximal sealing piece is used to seal the proximal opening of the tissue defect, the proximal sealing piece is connected to the fixing piece, the fixing piece includes a knot arranged proximal to the proximal sealing piece, and the conveying device is used to lock the knot proximal to the proximal sealing piece to fix the distance between the proximal sealing piece and the distal sealing piece.

19. The blocking system according to any one of claims 2-8, 10-11, characterized in that: The blocking device further comprises a proximal blocking member disposed proximal to the distal blocking member, the proximal blocking member being used to block the proximal opening of the tissue defect, the proximal blocking member being connected to the fixing member, and the fixing member being used to be fixed to the tissue proximal to the proximal blocking member. In the conveying state, the distal blocking member and the proximal blocking member are spaced apart from each other in the axial direction of the conveying device.

20. The blocking system according to claim 19, characterized in that: The delivery device comprises an intermediate sheath tube disposed between the outer sheath tube and the inner sheath core, In the delivery state, the distal end of the outer sheath tube, the distal end of the intermediate sheath tube and the distal end of the inner sheath core are arranged in sequence from far to near, the distal blocking member is arranged between the distal end of the outer sheath tube and the distal end of the intermediate sheath tube, and the proximal blocking member is accommodated in the inner cavity of the intermediate sheath tube and is located between the distal end of the intermediate sheath tube and the distal end of the inner sheath core. The delivery device controls the outer sheath to move proximally to release the distal blocking member; The conveying device controls the inner sheath core and the intermediate sheath tube to move toward each other to release the proximal blocking member.

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