Plugging device and plugging system
By designing a sealing device with a hardness greater than the fitting part and a mounting part with a flexibility greater than the support part, the problem of poor blood vessel incision sealing in the prior art is solved, and a more effective hemostasis effect and faster Recovery process.
Patent Information
- Application Number
- CN202310786154.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-06-29
- Publication Date
- 2024-12-31
AI Technical Summary
The existing arteriovenous closure devices are difficult to fit completely when blocking the blood vessel incision, resulting in poor hemostasis and long surgery time, which affects the patient's recovery and the intensity of medical care.
A sealing device is designed, including a distal sealing member and a proximal sealing member. The distal sealing member is composed of a support portion with a hardness greater than the fitting portion and a flexible fitting portion with a greater flexibility than the support portion, through the support portion The hardness supports the bonding part to ensure that the bonding part can stably seal the blood vessel defects and realize the effective bonding of the sealing device through pulling the fixing part.
It improves the fitting performance and blocking performance of the sealing device, reduces the risk of bleeding, shortens the hemostasis time, reduces the risk of vascular stenosis and thrombosis, and improves the sealing effect.
Smart Images

Figure CN119214721A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of medical devices, and in particular to a blocking device and a blocking system. Background Art
[0002] In recent years, with the advancement of interventional treatment technology, such as transcatheter heart valve replacement or repair, thoracic aortic aneurysm repair, or cardiac ablation, it is necessary to insert a catheter through an incision in the patient's skin and the underlying tissue to enter the artery or vein for surgery. After the operation, the catheter needs to be removed from the blood vessel, so the blood vessel incision where the catheter is inserted must be closed. Due to the high blood pressure in the artery, conventional methods such as pressing, suturing, and adhesives take a long time to stop bleeding, and are prone to cause unnecessary blood vessel deformation, and it is difficult to achieve a good sealing effect.
[0003] In the 1990s, percutaneous arteriovenous closure devices were introduced. The use of vascular closure devices can quickly achieve hemostasis without compressing the blood vessels or with minimal compression, and is not affected by continuous anticoagulation. The application of arteriovenous occlusion technology is the future development direction of arteriovenous hemostasis, which greatly shortens the time of hemostasis and bed rest. On this basis, it also reduces the patient's pain and the intensity of medical care.
[0004] However, the sealing of arteries and veins requires very high fit between the closure device and the tissue. Current arteriovenous closure devices generally cannot fully fit the vascular incision and have poor hemostasis effects. Summary of the invention
[0005] An embodiment of the present invention provides a sealing device, which is used to seal tissue defects. The sealing device includes a distal sealing piece, which is used to seal the distal gap in the tissue defect. The distal sealing piece includes a supporting portion and a fitting portion, the fitting portion is used to fit the tissue, the supporting portion is used to support the fitting portion, and the hardness of the supporting portion is greater than that of the fitting portion.
[0006] Furthermore, the fitting portion includes a first stacking portion and a second stacking portion, and the supporting portion, the first stacking portion and the second stacking portion are stacked in a distal direction of the tissue defect to block the distal gap of the tissue defect.
[0007] Furthermore, the first stacked portion is arranged on the distal side of the second stacked portion, the second stacked portion is formed with a through hole, and the blocking device includes a fixing member connected to the distal blocking member, the fixing member is inserted into the through hole, one end of the fixing member is connected to the first stacked portion, and the other end of the fixing member is connected to a conveying device; during the release process of the blocking device, the proximal side of the second stacked portion is limited to the peripheral tissue of the distal notch, and the fixing member pulls the supporting portion proximally, so that the supporting portion, the first stacked portion and the second stacked portion are stacked on each other in the distal direction of the tissue defect.
[0008] An embodiment of the present application further provides a closure system, comprising a conveying device and the closure device as described above, wherein the conveying device is used to convey the closure device and release it to the tissue defect.
[0009] An embodiment of the present application also provides a sealing system, including a conveying device and the sealing device described above. During the release process of the sealing device, after the distal sealing member is released from the distal end of the conveying device to the distal side of the tissue defect, the conveying device is used to pull the support portion proximally through the fixing member, so that the support portion, the first stacked portion and the second stacked portion are stacked on each other in the distal direction of the tissue defect.
[0010] An embodiment of the present application also provides a sealing system, including a conveying device and the sealing device as described above, wherein the sealing device also includes a proximal sealing member arranged proximal to the distal sealing member, the proximal sealing member being used to seal the proximal gap of the tissue defect, the proximal sealing member being connected to the fixing member, the fixing member including a knot arranged proximal to the proximal sealing member, and the conveying device being used to lock the knot proximal to the proximal sealing member to fix the distance between the proximal sealing member and the distal sealing member.
[0011] In the blocking device provided in the embodiment of the present application, the support portion of the distal blocking piece has a greater hardness than the fitting portion, and the fitting portion has a greater flexibility than the support portion, which can better conform to the anatomical structure of the tissue defect and improve the fitting performance and flow resistance performance of the distal blocking piece. The support portion is used to support the fitting portion to prevent the fitting portion from deforming too much after fitting the periphery of the tissue defect, thereby ensuring that the fitting portion can stably play a blocking role at the distal gap. BRIEF DESCRIPTION OF THE DRAWINGS
[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are 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 creative work.
[0013] Figure 1 A schematic structural diagram of a blocking system provided in the first embodiment of the present application;
[0014] Figure 2 for Figure 1 A schematic diagram of the structure of a tissue defect blocked by the occlusion system;
[0015] Figure 3 for Figure 1 A schematic diagram of the structure of the provided occluding device for occluding a tissue defect;
[0016] Figure 4 for Figure 1 The structural schematic diagram of the blocking device in the conveying state is shown;
[0017] Figure 5 for Figure 1 The structural schematic diagram of the blocking device in a modified implementation mode in the conveying state is shown;
[0018] Figure 6 A schematic structural diagram of a blocking device provided in a second embodiment of the present application;
[0019] Figure 7 A schematic structural diagram of a blocking device provided in a third embodiment of the present application;
[0020] Figure 8 A schematic structural diagram of a blocking device provided in a fourth embodiment of the present application;
[0021] Fig. 9 for Figure 8 A schematic diagram of the structure of the blocking device after the blocking device is released;
[0022] Fig.10 for Figure 8 A schematic structural diagram of the first stacking portion in a modified embodiment;
[0023] Fig.11 for Figure 8 A schematic structural diagram of the first stacking portion in another modified embodiment;
[0024] Fig.12 A schematic structural diagram of a blocking device provided in a fifth embodiment of the present application;
[0025] Fig.13 A schematic structural diagram of a blocking system in a transport state provided in a fifth embodiment of the present application;
[0026] Fig.14 for Fig.13 The schematic diagram of the structure of the blocking system in the initial stage of the release state;
[0027] Fig.15 for Fig.13 The schematic diagram of the structure of the blocking system in the intermediate stage of the release state;
[0028] Fig.16 for Fig.13 The structural diagram of the blocking device in FIG. 1 when the release is completed;
[0029] Fig.17 A schematic structural diagram of a blocking system provided in a sixth embodiment of the present application;
[0030] Fig.18 for Fig.17 A schematic diagram of the structure of the bonding portion;
[0031] Fig.19 for Fig.18 A schematic structural diagram of the laminating portion in a modified implementation mode;
[0032] Fig. 20 for Fig.17 A schematic structural diagram of the laminating portion in another modified embodiment;
[0033] Fig.21 for Fig.17 A schematic diagram of the structure of the plugging system in the conveying state;
[0034] Fig. 22 for Fig.17 A schematic structural diagram of the blocking system in another angle in the conveying state;
[0035] Fig.23 A schematic structural diagram of a blocking device provided in a seventh embodiment of the present application;
[0036] Fig.24 A schematic structural diagram of a blocking device provided in an eighth embodiment of the present application;
[0037] Fig.25 A schematic structural diagram of a blocking device provided in a ninth embodiment of the present application;
[0038] Fig.26 A schematic structural diagram of a blocking device provided in the tenth embodiment of the present application;
[0039] Fig. 27 A schematic structural diagram of a blocking system in a conveying state provided in a tenth embodiment of the present application;
[0040] Fig.28 for Fig.26 A schematic diagram of the structure of the blocking device after the blocking device is released;
[0041] Fig.29A schematic structural diagram of a blocking device provided in the eleventh embodiment of the present application;
[0042] Fig.30 for Fig.29 Schematic diagram of the structure after the blocking device is released. DETAILED DESCRIPTION
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] 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.
[0049] Definitions:
[0050] 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.
[0051] 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.
[0052] 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.
[0053] Radial: the radial direction of a device or component, which is perpendicular to the axial space.
[0054] 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.
[0055] "Circumferential" together with "axial" and "radial" constitute the three orthogonal directions of a device or component.
[0056] 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.). The following embodiments use the occluding system for occluding 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 embodiments of the present application can also be used to occlude other tissue defects of a biological body mentioned or not mentioned above.
[0057] First embodiment
[0058] See also Figures 1 to 4 This embodiment provides a sealing system for sealing tissue defects, including a conveying device 900 and a sealing device 101A. The conveying device 900 is used to convey the sealing device 101A and release it to the tissue defect 1005. The sealing device 101A includes a distal sealing member, which is used to seal the distal notch 1006 of the tissue defect 1005. The distal sealing member includes a supporting portion 100 and a fitting portion 200. The fitting portion 200 is used to fit on the tissue. The supporting portion 100 is used to support the fitting portion 200. The hardness of the supporting portion 100 is greater than that of the fitting portion 200.
[0059] The sealing system provided in the embodiment of the present application is used to seal the tissue defect 1005. The distal sealing piece of the sealing device 101A can be used to seal the distal gap 1006 of the tissue defect 1005. The delivery device 900 is used to deliver the sealing device 101A and release it at the tissue defect 1005, so as to facilitate the operator to use the distal sealing piece to seal the tissue defect 1005, facilitate operation, and save operation time.
[0060] like Figures 2 to 3 As shown, in this embodiment, the tissue defect 1005 is a blood vessel puncture, and the tissue defect 1005 has bilateral notches, namely a distal notch 1006 and a proximal notch 1007 , wherein the distal notch 1006 is connected to the inner wall of the blood vessel 1002 , and the proximal notch 1007 is connected to the outer wall of the blood vessel.
[0061] A puncture channel 1003 is formed between the tissue defect 1005 and the biological surface 1001, and the puncture channel 1003 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 101A, and the blocking device 101A is used to reach the tissue defect from the biological surface 1001 along the puncture channel 1003 and enter the blood vessel 1002 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 piece of the blocking device 101A in the blood vessel 1002, so as to facilitate the distal blocking piece to block the distal gap 1006 of the tissue defect 1005.
[0062] In the distal plugging member, the support portion 100 has a greater hardness than the fitting portion 200, and the fitting portion 200 has a greater flexibility than the support portion 100, which can better conform to the anatomical structure of the tissue defect 1005 and improve the fitting performance and flow resistance performance of the distal plugging member. The support portion 100 is used to support the fitting portion 200 to prevent the fitting portion 200 from deforming too much after fitting the periphery of the tissue defect 1005, thereby ensuring that the fitting portion can stably play a sealing role at the distal notch 1006.
[0063] Specifically, the support part 100 is disposed at the distal side of the fitting part 200, and after the distal blocking piece is released and blocked at the distal notch 1006, the fitting part 200 is pressed by the support part 100 at the distal notch 1006. The support part 100 and the fitting part 200 are stacked at the distal notch 1006 to form a multi-layer structure for blocking the distal notch 1006. Compared with a single-layer blocking structure, the multi-layer structure formed by the distal blocking piece can prevent excessive gaps between the distal blocking piece and the tissue wall (such as the blood vessel wall), thereby reducing the risk of bleeding and improving the blocking performance.
[0064] Since the hardness of the support portion 100 is greater than that of the fitting portion 200, the support portion protects at least part of the distal surface of the fitting portion from being deformed by blood flow, thereby ensuring the stable shape of the fitting portion 200 in the blood flow, which is beneficial to endothelialization of the device and reduces the risk of vascular stenosis and thrombosis.
[0065] In addition, if Figure 1 As shown, the occluding device 101A includes a fixing member 300, one end of which is connected to the distal occluding member, and the other end is connected to the delivery device 900. After the occluding device 101A is released, the fixing member 300 is used to fix to the tissue near the distal occluding member. The fixing member 300 includes a wire body, and the fixing member 300 is used to pull the distal occluding member, so as to achieve the connection between the delivery device 900 and the occluding device 101A; on the other hand, the fixing member 300 passes through the fitting part 200 to connect the supporting part 100. After the fixing member 300 is fixed to the tissue, under the action of the fixing member 300 pulling the supporting part 100, the supporting part 100 can effectively press the fitting part 200 to fit the periphery of the distal notch 1006, so as to achieve the effect of occluding and stopping bleeding. The hardness of the supporting part 100 is greater than that of the fitting part 200, which is conducive to keeping it at the distal side of the tissue defect 1005 under the pulling action of the fixing member 300. If the supporting part 100 is relatively soft, the fitting part 200 and the supporting part 100 may be pulled to the proximal side of the tissue defect 1005 (outside the wall of the blood vessel 1002) by the pulling action of the fixing part 300, and thus the hemostasis effect cannot be achieved. Similarly, if the supporting part 100 is not provided in the distal occluding component, since the fitting part 200 is relatively soft, the fitting part 200 is also easily pulled to the proximal side of the tissue defect 1005 by the fixing part 300, and the hemostasis effect cannot be achieved.
[0066] like Figure 1 As shown, the fitting portion 200 may be provided with a through hole 202 for the fixing member 300 to pass through, and the shape and number of the through hole 202 may be set as required.
[0067] The supporting part 100 and the fitting part 200 may be made of at least one of non-degradable materials, degradable biomaterials, and degradable polymer materials.
[0068] The supporting part 100 and the fitting part 200 can be made of at least one of a degradable material and a non-degradable material respectively. There is no mutual constraint relationship between the material used in the supporting part 100 and the material used in the fitting part 200. The supporting part 100 and the fitting part 200 can be made of the same material or different materials.
[0069] The types of materials that can be used for the support part and the fitting part are as follows:
[0070] Non-degradable materials include, but are not limited to, polypropylene, aromatic polyester, and polytetrafluoroethylene;
[0071] Degradable biomaterials include, but are not limited to, materials such as collagen (e.g., collagen-rich porcine small intestinal submucosa materials), polyhydroxyalkanoates (PHA);
[0072] 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).
[0073] In this embodiment, the support portion 100 and the fitting portion 200 are both made of degradable materials, so that after a degradation period, the support portion 100 and the fitting portion 200 will degrade in the blood vessel and can be completely absorbed, without leaving any foreign matter in the blood vessel. This can maintain long-term patency of the blood vessels, 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.
[0074] In this embodiment, the support portion 100 and the fitting portion 200 are made of different materials due to their different hardness. The support portion 100 and the fitting portion 200 are separate structures, that is, the support portion 100 and the fitting portion 200 are separate components. In other embodiments, the support portion 100 and the fitting portion 200 can be an integral structure, can be integrally formed, or can be separately formed and then fixedly connected into one.
[0075] Further, the fitting portion 200 absorbs water and swells, that is, the fitting portion 200 will swell after entering the organism and contacting the body fluid, so that the flexibility and elasticity are increased, and it is easier to fit the peripheral tissue of the distal notch 1006, and the hemostasis effect is better. The fitting portion 200 may include at least one of collagen, hydrogel, and polyvinyl alcohol (PVA) to achieve water absorption and swelling. In some embodiments, the fitting portion 200 includes a collagen material to ensure that the material is soft, easy to fit the tissue, easy to absorb water and swell, good blocking effect, and degradable. Preferably, the fitting portion 200 is prepared from a pig small intestine submucosal material rich in collagen, which can be biodegraded, and the volume expands after absorbing water, and the material is relatively soft.
[0076] In this embodiment, the support part 100 is in the form of a sheet, which can be a flat sheet as shown in the figure, or a curved sheet. The end surface of the support part 100 can be circular, elliptical, square, hexagonal, capsule-shaped, or other regular or irregular shapes.
[0077] The fitting portion 200 is relatively soft and has a certain elasticity. In this embodiment, it is irregular in shape and occupies a certain thickness in the axial direction of the occluding device 101A, so that it can better fit the tissue at the distal notch 1006 to block blood flow. In other embodiments, the fitting portion 200 can be in the form of a sheet. It is understood that in some embodiments, the proximal end face and the distal end face of the fitting portion 200 can be respectively circular, elliptical, square, hexagonal, capsule-shaped, teardrop-shaped or other regular or irregular shapes.
[0078] like Figure 3 As shown, after the distal blocking member is released and blocks the distal notch 1006 , the fitting portion 200 is blocked between the supporting portion 100 and the tissue to prevent the supporting portion 100 from damaging the tissue.
[0079] In some embodiments, in a natural state (the occluding device 101A is not subjected to the force applied by the delivery device 900 or the tissue, and is in a naturally expanded state), the radial dimension of the fitting portion 200 is larger than the supporting portion 100, so as to ensure that the fitting portion 200 can be blocked between the supporting portion 100 and the tissue after the occluding device 101A is released. In some embodiments, after the fitting portion 200 enters the biological body and absorbs body fluids, the volume expands, and the flexibility and elasticity are enhanced. Under the pressing action of the supporting portion 100, the radial dimension of the fitting portion 200 is larger than the supporting portion 100, so that the fitting portion 200 can be blocked between the supporting portion 100 and the tissue.
[0080] The fixing member 300 includes a wire. In this embodiment, the fixing member 300 is in a linear shape and is inserted into the through hole 202 of the fitting portion 200. The fixing member 300 can be a suture. The fixing member 300 can be a non-degradable suture, which can be a polypropylene suture or the like. The fixing member 300 can 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 300 can also be other components other than the wire body that can pass through the through hole 202. In some embodiments, the fixing member 300 includes other components connected to the suture for locking the end of the suture.
[0081] The fixing member 300 is used to fix to the tissue near the distal occluding member. In this embodiment, the fixing member 300 is a suture, which is inserted into 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. For example, the fixing member 300 can be fixed to the peripheral tissue of the tissue defect 1005, that is, fixed to the wall of the blood vessel 1002, near the distal occluding member. Please refer to Figure 3 In this embodiment, the fixing member 300 can be fixed to the biological surface 1001 proximal to the distal blocking member under the control of the operating handle. Specifically, the fixing member 300 forms a knot 302 on the biological surface 1001, thereby being fixed to the biological surface 1001. It can be understood that the fixing member 300 can be fixed to the tissue proximal to the distal blocking member by knotting, suturing, additionally providing a locking member that cooperates with it, etc.
[0082] like Figure 1 As shown, the fitting part 200 is provided with a through hole 202. The fitting part 200 is provided with a through hole 202 in its central area (the area surrounded by the edge), and the through hole 202 is a through hole that penetrates the fitting part 200 in the thickness direction. When the occluding device 101A is implanted into the biological body, the through hole 202 penetrates the axial direction of the fitting part 200. Figure 1 As shown, the through hole 202 is circular, and in other embodiments, the through hole 202 can be selected into other shapes as needed, such as regular or irregular shapes such as elliptical and strip shapes. The size of the through hole 202 needs to match the fixing member 300, so that the fixing member 300 can pass through and ensure that the fixing member 300 can slide smoothly in the through hole 202, while also preventing the through hole 202 from being too large, thereby reducing the possibility of blood flow through the gap between the through hole 202 and the fixing member 300 to form blood flow.
[0083] The fixing member 300 passes through the through hole 202 of the fitting portion 200 and is connected to the supporting portion 100. One end of the fixing member 300 is fixedly connected to the supporting portion 100. The fixing member 300 can be fixed to the supporting portion 100 by knotting, suturing, bonding, welding or using other locking members. In other embodiments, the fixing member 300 is movably connected to the supporting portion 100.
[0084] In some embodiments, a penetration ring is disposed on the proximal surface of the support portion 100 , and the fixing member 300 can be fixed to the penetration ring, for example, by knotting, welding, bonding, etc.
[0085] See also Figure 4In the conveying state (the state in which the occluding device 101A is located inside the conveying device 900), the supporting portion 100 and the fitting portion 200 are spaced apart in the conveying device 900, specifically, spaced apart in the axial direction of the conveying device. After the supporting portion 100 is released to the far side of the tissue defect 1005, the fitting portion 200 is released.
[0086] In some variant implementations, see Figure 5 , Figure 5 Shown Figure 4 A modified embodiment of the middle plugging device 101A in the transport state.
[0087] In the conveying state, in the conveying device 900, the support portion 100 and the bonding portion 200 at least partially overlap in the axial direction of the conveying device 900, that is, the support portion 100 and the bonding portion 200 may partially overlap in the axial direction of the conveying device 900, or completely overlap (the support portion 100 is arranged within the axial range of the bonding portion 200, or the bonding portion 200 is arranged within the axial range of the support portion 100). The support portion 100 and the bonding portion 200 at least partially overlap in the axial direction of the conveying device 900. Figure 5 As shown, the bonding portion 200 covers at least a portion of the surface of the supporting portion 100, thereby minimizing the length of the fixing member 300 between the two. After release, the two will roughly remain in a stacked manner within the conveying device 900, and the two will be easier to bond with each other during the release process.
[0088] Specifically in this embodiment, before the distal blocking piece is loaded into the conveying device 900, the fixing piece 300 between the supporting portion 100 and the fitting portion 200 can be tightened so that the distance between the supporting portion 100 and the fitting portion 200 is smaller. After the distal blocking piece is loaded into the conveying device 900, especially in the conveying state, the supporting portion 100 and the fitting portion 200 are at least partially overlapped in the axial direction of the conveying device 900. Accordingly, the supporting portion 100 and the fitting portion 200 can also be stacked on each other in the radial direction of the conveying device 900, and the supporting portion 100 and the fitting portion 200 are close to each other, thereby reducing the difficulty of the supporting portion 100 fitting and compressing the fitting portion 200 during the release process.
[0089] In the conveying device 900, if the supporting portion 100 and the fitting portion 200 are spaced apart from each other, the fixing member 300 therebetween is relatively long, and the distal blocking member is prone to different stacking states during the folding process in the body.
[0090] For example, during the release process, under the scouring effect of the blood flow, the support portion 100 is easy to rotate relative to the fitting portion 200, and the fixing piece 300 between the support portion 100 and the fitting portion 200 is easy to twist, making it difficult to pull the fixing piece 300 to slide in the penetration hole 202 of the fitting portion 200, resulting in the support portion 100 being unable to press the fitting portion 200; or after the support portion 100 presses the fitting portion 200, it is difficult for the support portion 100 to press the fitting portion 200 in a predetermined direction, resulting in a large amount of the edge of the fitting portion 200 being exposed outside the periphery of the support portion 100; these situations will affect the sealing performance of the occluding device 101A, and will also lead to an increase in the area of the fitting portion 200 exposed to the blood flow, a larger endothelialization area, and a higher risk of vascular stenosis and thrombosis.
[0091] Second embodiment
[0092] See also Figure 6 This embodiment provides a blocking device 101B, which is used to block tissue defects. The blocking device 101B includes a support portion 100, a fitting portion 200, and a fixing member 300 that passes through the fitting portion 200 and connects the support portion 100. The blocking device 101B can be used in conjunction with the delivery device 900 provided in the first embodiment to obtain a corresponding blocking system. The delivery device 900 can deliver and release the blocking device 100B. The blocking device 101B in this embodiment and Figure 1 The main difference between the blocking device 101A shown is that the structure of the fitting portion 200 is different. For the similarities between the blocking device 101B in this embodiment and the blocking device 101A provided in the first embodiment, please refer to the first embodiment and will not be repeated here.
[0093] In this embodiment, the fitting portion 200 is in a truncated cone shape, and the fitting portion 200 includes a distal surface 204 facing the support portion 100, a proximal surface 205 facing away from the support portion 100, and a side wall 206 connecting the proximal surface 205 and the distal surface 204. The proximal surface 205 of the fitting portion 200 has a larger area than the distal surface 204, and the side wall 206 is inclined compared to the distal surface 204. After the distal surface 204 fits and blocks the tissue defect 1005, the side wall 206 is inclined relative to the wall of the blood vessel 1002, which is conducive to reducing the resistance of the side wall 206 to blood flow, reducing the scouring effect of blood flow on the fitting portion 200, and reducing the probability of deformation of the fitting portion 200 and formation of thrombus.
[0094] Third embodiment
[0095] See also Figure 7 , Figure 7A schematic diagram of the structure of the blocking device 101C provided in the third embodiment. The blocking device 101C provided in the third embodiment includes a support portion 100, a fitting portion 200, and a fixing member 300 that passes through the fitting portion 200 and connects the support portion 100. The blocking device 101C can be used in conjunction with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system, and the conveying device 900 can convey and release the blocking device 100C. The main difference between the blocking device 100C and the blocking device 100B is that the support portion 100 in the blocking device 100C is arched, and the connection structure of the fixing member 300 and the distal blocking member is different.
[0096] The support portion 100 is arched, specifically in a natural state (such as Figure 7 The support portion 100 has a base line on its surface, and the base line can be arranged on the surface of the support portion 100 as required. The parts on both sides of the base line in the support portion 100 gradually extend distally, so that the support portion 100 bulges (arches) proximally at the base line position, so that when the support portion 100 blocks the distal notch 1006 of the tissue defect 1005, it can adapt to the inner wall of the blood vessel 1002 with an arc-shaped periphery of the distal notch 1006, thereby reducing the distance between the periphery of the support portion 100 and the wall of the blood vessel 1002, increasing the pressing force of the edge of the support portion 100 on the fitting portion 200 and the wall of the blood vessel 1002, and improving the blocking performance.
[0097] In this embodiment, the fitting portion 200 is provided with a plurality of through holes 202, and the support portion 100 is provided with a through hole 102 for the fixing member 300 to pass through. Specifically, the support portion 100 is provided with two through holes 102 that penetrate through the thickness direction thereof. The fixing member 300 passes through the two through holes.
[0098] During the assembly process, one end of the fixing member 300 passes through a through hole 202 of the fitting portion 200, then passes through a through hole 102 of the support portion 100 in the distal direction, then passes through another through hole 202 of the support portion 100 in the proximal direction, and then passes through another through hole 202 of the fitting portion 200 in the proximal direction, thereby completing the assembly between the fixing member 300 and the distal blocking member.
[0099] It should be noted that the two through holes 102 on the support portion 100 are arranged on the baseline of the arched support portion 100, that is, the two through holes 102 are arranged at a position where the support portion 100 protrudes proximally, so that after tightening the fixing member 300, it is beneficial for the part of the fixing member 300 located on the distal side of the support portion 100 (the part between the two through holes 102) to fit against the distal surface of the support portion 100, thereby avoiding the part of the fixing member 300 located on the distal side of the support portion 100 from being suspended in the air and blocking blood flow, thereby reducing the risk of thrombus formation.
[0100] Fourth embodiment
[0101] See also Figures 8 to 9 This embodiment provides a blocking device 101D, which includes a support portion 100, a fitting portion 200, and a fixing member 300 that passes through the fitting portion 200 and connects to the support portion 100. The blocking device 101D can be used in conjunction with the delivery device 900 provided in the first embodiment to obtain a corresponding blocking system, and the delivery device 900 can deliver and release the blocking device 100D. The blocking device 101D in this embodiment and Figure 7 The main difference of the occluding device 100C in the third embodiment is that the fitting portion 200 includes a first laminate portion 210 and a second laminate portion 220, which are laminated in the distal direction of the tissue defect 1005 to occlude the distal notch 1006 of the tissue defect.
[0102] The distal direction of the tissue defect 1005 may refer to the distal direction of the distal notch 1006, i.e., the direction from the distal notch 1006 to the central axis of the blood vessel 1002, or may refer to the distal direction of the proximal notch 1007, i.e., the direction from the proximal notch 1007 to the central axis of the blood vessel 1002.
[0103] The first stacking portion 210 and the second stacking portion 220 are used to be stacked in the distal direction of the tissue defect 1005, so that the first stacking portion 210, the second stacking portion 220 and the supporting portion 100 form a three-layer structure for blocking the distal gap 1006. Compared with the double-layer blocking structure formed by the fitting portion 200 and the supporting portion 100 in the aforementioned embodiment, the number of layers of the more flexible fitting portion 200 is increased, which can better fit the tissue wall (such as the blood vessel wall), thereby reducing the risk of bleeding and improving the blocking performance.
[0104] In this embodiment, the first laminated portion 210 and the second laminated portion 220 are made of different sheets, that is, the first laminated portion 210 and the second laminated portion 220 are separate structures and are both in sheet shape.
[0105] Furthermore, in this embodiment, if Figure 8 As shown, in a natural state (ie, the blocking device 101D is fully expanded without being acted upon by an external force), the first stacked portion 210 and the second stacked portion 220 have the same structure and are both in the form of flat sheets.
[0106] The first stacking part 210 and the second stacking part 220 are relatively soft and have better flexibility than the supporting part 100. Figure 4 or Figure 5) in the inner cavity), under the radial compression of the delivery device 900, the first laminated portion 210 and the second laminated portion 220 can be curved, so as to facilitate advancement into the body with a smaller diameter. Specifically, in the delivery device, the first laminated portion 210 and the second laminated portion 220 can both be arched. In other embodiments, the first laminated portion 210 and the second laminated portion 220 can both be bent into at least a partial roll shape, that is, the first laminated portion 210 and / or the second laminated portion 220 can be bent into a complete cylinder.
[0107] In some embodiments, at least one of the first stacking portion 210 and the second stacking portion 220 has the same form in the natural state and the conveying state, that is, at least one of the first stacking portion 210 and the second stacking portion 220 does not change in the two states.
[0108] like Figure 8 As shown, in this embodiment, the shape and size of the first stacking part 210 and the second stacking part 220 are consistent, so that after the fitting part 200 is completely folded, the edge shape is relatively regular, and the difference in the shapes of the multiple stacking parts will not cause obvious stratification of the edges after the fitting part 200 is folded, thereby affecting the normal blood flow rate.
[0109] In this embodiment, the first stacking portion 210 and the second stacking portion 220 are both rectangular, including relatively long long sides and relatively short wide sides, that is, each stacking portion has different radial dimensions in at least two directions.
[0110] In some embodiments, each stacked portion can be configured in a square, a circle, an ellipse, a racetrack, an ellipse-like shape ( Fig.10 ), or some irregular shapes (such as Fig.11 As shown in Fig.10 As shown, under the condition of ensuring a sufficiently large blocking area, the rounded corners can reduce the scouring effect of blood flow on the first stacking part 210, and the edge of the first stacking part 210 is not easy to be lifted, and the blocking effect is better. Fig.10 as well as Fig.11 As shown, the edges of the first laminated part 210 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 first laminated part 210 to fail and the effective blocking area to decrease. Fig.10 and Fig.11 The modified structure of the first stacking part 210 can also be applied to other stacking parts if there is no contradiction.
[0111] The direction along or parallel to its long side is the transverse direction, and the direction along or parallel to its wide side is the longitudinal direction. The two through holes 202 respectively disposed on the surfaces of the first laminated part 210 and the second laminated part 220 are disposed along the transverse direction. In some embodiments, the two through holes 202 disposed on the surfaces of the first laminated part 210 and the second laminated part 220 are disposed along the longitudinal direction, or along an inclined direction between the transverse direction and the longitudinal direction.
[0112] The fixing member 300 is inserted into the through hole 102 and the through hole 202 . One end of the fixing member 300 is connected to the supporting portion 100 , and the other end of the fixing member 300 is connected to the conveying device 900 .
[0113] During the release process of the occluding device 101D, after the distal occluding part is released from the distal end of the conveying device 900 to the distal side of the tissue defect 1005, the proximal limit of the second stacking part 220 is located at the peripheral tissue of the distal notch 1006, and the conveying device 900 is used to pull the supporting part 100 proximally through the fixing part 300, so that the supporting part 100, the first stacking part 210, and the second stacking part 220 are stacked on each other in the distal direction of the tissue defect 1005.
[0114] It is understandable that in the first to third embodiments in which the fitting portion 200 is a one-piece structure, the delivery device 900 can release the support portion 100 and the fitting portion 200 in the same manner. Specifically, taking the first embodiment as an example, during the release process of the occluding device 101A, after the distal occluding member is released from the distal end of the delivery device 900 to the distal side of the tissue defect 1005, the proximal side of the fitting portion 200 is limited to the peripheral tissue of the distal notch 1006, and the delivery device 900 controls the fixing member 300 to pull the support portion 100 proximally, so that the support portion 100 and the fitting portion 200 are stacked on each other in the distal direction of the tissue defect 1005. In other embodiments, the operator (such as a doctor) can directly pull the fixing member 300 to drive the support portion 100 to move proximally, so that the support portion 100 is attached to the fitting portion 200, and the support portion 100 and the fitting portion 200 are stacked on each other in the distal direction of the tissue defect 1005.
[0115] Fifth embodiment
[0116] See also Figures 12 to 16 The fifth embodiment of the present application provides a blocking device 100E. The blocking device 101E can be used in conjunction with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 100E.
[0117] The blocking device 101E includes a support portion 100, a bonding portion 200, and a fixing member 300 passing through the bonding portion 200 and connected between the support portion 100 and the conveying device 900. The main difference between the blocking device 101E in this embodiment and the blocking device 100D in the fourth embodiment is that the first laminated portion 210 and the second laminated portion 220 in the bonding portion 200 are folded from the same sheet material, that is, the first laminated portion 210 and the second laminated portion 220 are folded from the bonding portion 200 in a sheet shape.
[0118] Specifically, the sheet of material is the laminating portion 200 , that is, the laminating portion 200 is a sheet of material, and the laminating portion 200 is folded to obtain a first laminating portion 210 and a second laminating portion 220 . The supporting portion 100 , the first laminating portion 210 and the second laminating portion 230 are used to be stacked in the distal direction of the tissue defect 1005 .
[0119] It can be understood that the first stacking portion 210 and the second stacking portion 220 are formed by folding the bonding portion 200. In the present embodiment, during the release process of the bonding portion 200, different parts of the bonding portion 200 are folded with each other to form a multi-layer sealing structure.
[0120] Specifically, the fitting part 200 is a sheet of material, and the fitting part 200 includes a first laminated part 210 and a second laminated part 220, and the first laminated part 210 is arranged at the distal side of the second laminated part 220. During the release of the distal blocking member, especially during the process of the fixing member 300 pulling the supporting part 100 proximally, the proximal limit of the second laminated part 220 is located at the peripheral tissue of the distal notch 1006 of the tissue defect 1005, and the support part 100 moves proximally to push the first laminated part 210 to move toward the second laminated part 220, and the first laminated part 210 and the second laminated part 220 are folded with each other, and the support part 100, the first laminated part 210 and the second laminated part 220 are stacked in the distal direction of the tissue defect 1005. Fig.12 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 shape and position of the actual crease. The crease divides the laminating portion 200 into a plurality of laminated portions, the plurality of laminated portions including a first laminated portion 210 and a second laminated portion 220. One side of one of the plurality of creases is the first laminated portion 210, and the other side of the one crease is the second laminated portion 220. Fig.12 As shown, in the present embodiment, the laminating portion 200 is folded to obtain a plurality of creases, and correspondingly obtains a plurality of stacked portions divided by the creases. In other embodiments, the laminating portion 200 may be formed with other numbers of creases, such as one crease, and the crease divides the laminating portion 200 into a first stacked portion 210 and a second stacked portion 220.
[0121] In this embodiment, during the process of the delivery device 900 pulling the support part 100 proximally through the fixing member 300, the support part 100 moves proximally to push the first laminated part 210 to move toward the second laminated part 220 and fold the first laminated part 210 and the second laminated part 220. In a modified embodiment, the fixing member 300 may not be pulled by the delivery device 900, but may be pulled by an operator (such as a doctor) or other devices.
[0122] Further, in this embodiment, during the release process, the fitting part 200 is folded with each other under the pulling action of the fixing member 300. Preferably, the first laminated part 210 and the second laminated part 220 in the fitting part 200 are both provided with a through hole 202. The through holes 202 formed in the same laminated part are a group of through holes 202, and the fold is located between different groups of through holes 202. The fixing member 300 is used to penetrate the through holes 202 and can slide in the through holes 202, so as to tighten and fold the fitting part 200. In some embodiments, the first laminated part 210 is provided with a structure such as a through ring to achieve connection with the fixing member 300.
[0123] like Figures 13 to 16 As shown, in the conveying state, the first laminated portion 210 and the second laminated portion 220 are not folded together along the fold. In the initial stage of the release state, that is, when the fitting portion 200 is released to the far side of the tissue defect and the fixing member 300 is not pulled, the first laminated portion 210 and the second laminated portion 220 are not folded together along the fold. During the release process of the occluding device 101E, in the intermediate stage of the release state, that is, in the process of pulling the fixing member 300, the proximal limit of the second laminated portion 220 is located in the peripheral tissue of the distal notch 1006 of the tissue defect 1005, and the fixing member 300 drives the first laminated portion 210 to move proximally, and makes the perforation hole 202 in the first laminated portion 210 gradually approach the perforation hole 202 in the second laminated portion 220, until the perforation hole 202 of the first laminated portion 210 and the perforation hole 202 of the second laminated portion 220 are stacked and aligned in the distal direction of the distal notch 1006, penetrate each other, and the surfaces of the first laminated portion 210 and the second laminated portion 220 facing each other are adhered together. At this time, the first laminated portion 210 and the second laminated portion 220 complete the folding process.
[0124] The through holes 202 on the distal blocking member are divided into multiple groups, one group of through holes 202 is arranged in the first stacking part 210, and one group of through holes 202 is arranged in the second stacking part 220. It can be understood that Fig.12As shown in , the fitting part 200 can also be provided with other laminated parts, such as the third laminated part, the fourth laminated part, etc., which are used to be laminated with the first laminated part 210 and the second laminated part 220 and block the tissue defect 1005 on the far side, and the adjacent laminated parts are divided by folds. In this embodiment, the first laminated part 210 is arranged at the farthest end of the distal blocking member, and the second laminated part 220 is arranged adjacent to the first laminated part 210. It can be understood that the first laminated part 210 may not be arranged at the far end of the first laminated part 210, and the second laminated part 220 may be arranged at a distance from the first laminated part 210, and other laminated parts may be sandwiched between the two.
[0125] In this embodiment, the number of perforation holes 202 in each group is 2, and the 2 perforation holes 202 in each group are arranged in a direction perpendicular to the axis of the distal blocking member. In other embodiments, the number and arrangement of the perforation holes 202 in each group can be selected according to actual needs.
[0126] definition:
[0127] In the unfolded state, all the laminated parts are not folded along the creases formed after folding, such as Fig.12 and Fig.13 As shown;
[0128] 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.16 As shown;
[0129] The semi-folded state is a state between the unfolded state and the fully folded state. Fig.17 That is, the 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.
[0130] In this embodiment, if Fig.12 as well as Fig.13 As shown, in the natural state of the blocking device 101E and in the conveying state of the blocking device 101E, the bonding portion 200 does not form any folds, that is, the first stacking portion 210 and the second stacking portion 220 are not folded along the folds formed after folding. That is, in the natural state and in the conveying state, the bonding portion 200 is in an unfolded state. Figures 14 to 16 As shown, the blocking device 101E realizes the folding process of the bonding portion 200 during the release process. Fig.16 As shown, the laminating portion 200 is in a completely folded state, all the laminated portions are folded along the creases formed after folding, and the surfaces of adjacent laminated portions facing each other are completely laminating.
[0131] In this embodiment, the fitting part 200 is in the shape of a rectangular sheet. In some other embodiments, the fitting part 200 can also be in the shape of an elliptical sheet, or the structures of multiple stacking parts in one fitting part 200 are consistent, and can all be in the shape of a racetrack, a hexagon, an ellipse, or other regular or irregular shapes. Concavities extending in the axial direction of the fitting part 200 are formed between adjacent stacking parts to facilitate folding of adjacent stacking parts.
[0132] In this embodiment, if Fig.13 As shown, the fitting portion 200 is flexible when not absorbing water, and bends into a curved shape under the restraint of the conveying device 900. In some embodiments, the fitting portion 200 in the conveying device 900 is consistent with the shape outside the conveying device 900, for example, the fitting portion 200 is in the shape of a long strip and can be placed in the conveying device 900 in a natural state without being restrained by the conveying device 900.
[0133] Sixth Embodiment
[0134] See also Figures 17 to 22 The sixth embodiment of the present application provides a blocking system, which includes a blocking device 100F and a conveying device 900. The blocking device 101F includes a support portion 100, a fitting portion 200, and a fixing member 300 passing through the fitting portion 200 and connected between the support portion 100 and the conveying device 900. The main difference between the blocking device 101F in this embodiment and the blocking device 100E in the fifth embodiment is that a folding portion 215 is formed between the first laminated portion 210 and the second laminated portion 220 in the fitting portion 200, and the folding portion 215 facilitates the folding of the first laminated portion 210 and the second laminated portion 220 in the distal direction of the tissue defect 1005. In the process of the fixing member 300 pulling the support portion 100 proximally, the support portion 100 pushes the first laminated portion 210 and the second laminated portion 220 to fold with each other along the folding portion 215. In this embodiment, the delivery device 900 can pull the support portion 100 proximally through the fixing member 300. In a modified embodiment, the fixing member 300 may not be pulled by the delivery device 900, but may be pulled by an operator (such as a doctor) or other devices.
[0135] The folding portion 215 facilitates the first stacking portion 210 and the second stacking portion 220 to be folded together. Fig.18As shown, the folding portion 215 is formed with a crease, that is, the crease of the folding portion 215 is formed during the molding process of the bonding portion 200, so as to facilitate the first stacking portion 210 and the second stacking portion 220 to fold together along the folding portion 215 during the release process and the process of pre-installation in the conveying device 900.
[0136] A folding portion 215 is formed between the first stacking portion 210 and the second stacking portion 220, so that the first stacking portion 210 and the second stacking portion 220 can be folded along the predetermined position and trajectory of the folding portion 215. The crease formed after the first stacking portion 210 and the second stacking portion 220 are folded can basically overlap with the folding portion 215, and is relatively regular. The position of the fold is appropriate. After folding, the shapes and sizes of the first stacking portion 210 and the second stacking portion 220 are basically consistent with the preset conditions, so that after the release is completed, the surfaces facing each other between the first stacking portion 210 and the second stacking portion 220 are completely fitted together, and the distal blocking piece is in a completely folded state.
[0137] If the fitting portion 200 is not provided with the folding portion 215, the first stacking portion 210 and the second stacking portion 220 are folded during the release process of the fitting portion 200 under the influence of the anatomical structure of the tissue defect 1005 and the blood flow flushing. The position of the crease between the first stacking portion 210 and the second stacking portion 220 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 210 and the second stacking portion 220 is large, which may easily lead to poor sealing effect and a high risk of device thrombosis.
[0138] like Fig.19 As shown, in some embodiments, a bending groove is formed in the folding portion 215. That is, the bonding portion 200 forms a groove on the surface of the folding portion 215, that is, the sheet-shaped bonding portion 200 is thinned at the position of the folding portion 215, so as to facilitate guiding the first laminated portion 210 and the second laminated portion 220 to fold at this position. The shape of the bending groove is not limited, and can be as follows Fig.19 The folding position is shown to be arranged in a straight line along the preset position.
[0139] The folding portion 215 is used to divide different stacking portions. The laminating portion 200 may adopt multiple folding portions of one structural form, or the laminating portion 200 may adopt multiple folding portions of different structural forms.
[0140] like Fig. 20 As shown, in some embodiments, the folding portion 215 may adopt a bending groove of other structures, for example, a folding portion 215 is provided with a plurality of bending grooves. Fig. 20The folding portion 215 of three structures is shown, which are respectively denoted as the folding portion 215A, the folding portion 215B and the folding portion 215C. The folding portion 215A, the folding portion 215B and the folding portion 215C respectively include a plurality of bending grooves arranged in an array. The bending grooves in the folding portion 215A and the folding portion 215B are rectangular, and the difference is that the bending grooves in the folding portion 215A and the folding portion 215B extend in different directions. The extending direction of the bending groove in the folding portion 215A is along the extending direction of the folding portion 215A. Since the first laminated portion 210 and the second laminated portion 220 are in the axial direction ( Fig. 20 The folded portions 215A are folded with each other in the vertical direction (in the vertical direction), so the extension direction of the folded portion 215A is perpendicular to the axial direction of the bonding portion 200, that is, the extension direction of each bending groove in the folded portion 215A is perpendicular to the axial direction of the bonding portion 200. The extension direction of each bending groove in the folded portion 215B is not perpendicular to the axial direction of the bonding portion 200, for example, it can be parallel to the axial direction of the bonding portion 200. The multiple bending grooves in the folded portion 215C 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 bonding portion 200.
[0141] exist Fig. 20 In the embodiment shown in the figure where 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 215, namely, bending holes.
[0142] 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.
[0143] In this embodiment, the bonding portion 200 is taken as a rectangle as an example to illustrate the structure of the folding portion 215. It can be understood that in other embodiments, the bonding portion 200 can adopt other structural forms, which will not be described in detail here.
[0144] In this embodiment, a folding portion 215 is provided between the first stacking portion 210 and the second stacking portion 220. For example, a folding mark, a bending groove or a bending hole is provided in the folding portion 215. In the conveying state (the blocking device 100F is at least partially located in the conveying device 900) and in the natural state (the blocking device 101A is not subjected to the force of the conveying device 900 and the biological tissue), the fitting portion 200 may be in three situations.
[0145] In the first case, the laminating portion 200 is in an unfolded state, that is, the first laminated portion 210 and the second laminated portion 220 are not folded along the folded portion 215. During the molding process, the laminating portion 200 forms the folded portion 215 before being assembled with the fixing member 300. If the laminating portion 200 is in a preset shape (flat or curved) before the folded portion 215 is formed, then in the first case, after the folded portion 215 is formed, the laminating portion 200 still maintains or substantially maintains the preset shape, and the first laminated portion 210 and the second laminated portion 220 are not folded along the folded portion 215. Fig.13 In the illustrated embodiment, the angle between the first stacked portion 210 and the second stacked portion 220 is 180°.
[0146] The second situation is that the laminating portion 200 is in a semi-folded state, and the laminated portions are folded toward each other along the folded portion 215, but the surfaces of the laminated portions facing each other are not completely pressed against each other (an obvious gap is formed). Fig.17 and Fig. 22 In the semi-folded state shown, the laminating portion 200 is bent into a W shape. In an embodiment in which the laminating portion 200 only has the first laminated portion 210 and the second laminated portion 220 and no other laminated portions, the first laminated portion 210 and the second laminated portion 220 may be V-shaped. In an embodiment in which 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 laminating portion 200 are completely laminated to each other, while other laminated portions are not completely laminated to each other.
[0147] like Fig.21 and Fig. 22 As shown, in the conveying state, the laminating portion 200 is in a semi-folded state and is located inside the conveying device 900, and the angle between the first laminated portion 210 and the second laminated portion 220 is a, 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 210 and the second laminated portion 220 can be folded with each other before the laminating portion 200 is released (for example, during the conveying process, the loading process, and the molding process of the laminating portion 200) to form a folded portion 215, and the first laminated portion 210 and the second laminated portion 220 are kept spaced apart from each other at one end away from the folded portion 215.
[0148] It is understandable that, in the conveying state, the bonding portion 200 is in a semi-folded state, and the bonding portion 200 can be shaped before the occluding device 100F is loaded into the conveying device 900 to obtain the bonding portion 200 in a semi-folded state, or the bonding portion 200 can be folded during the loading process. In some embodiments, the semi-folded state of the bonding portion 200 during the conveying process is formed by folding each other during the molding process of the bonding portion 200 and the loading process into the conveying device 900.
[0149] It should be noted that, in the conveying state, the extension direction of the folding portion 215 of the fitting portion 200 follows the extension direction of the lumen of the conveying device 900, thereby avoiding the formation of other additional creases in the folding portion 215, simplifying the process flow, and facilitating the fitting portion 200 to fit more smoothly on the tissue surface, reducing the thickness of the occluding device after implantation, and reducing the chance of thrombus formation.
[0150] It is understandable that, in the second case, after the distal blocking member is released from the delivery device 900, the folding degree of the distal blocking member gradually increases as the operator gradually tightens the fixing member 300. In some preferred embodiments, by pulling the fixing member 300, the stacked parts can be completely compressed, so that the distal blocking member is in a completely folded state.
[0151] The third situation is that the bonding part 200 is in a completely folded state, and the adjacent stacking parts can be fixed into a stacking structure by solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with anchors of polymer materials, so that the bonding part 200 can be formed into a multi-layer stacking structure. Please refer to the subsequent implementation methods for details.
[0152] Seventh embodiment
[0153] See also Fig.23 This embodiment provides a blocking device 101G. The blocking device 101G can be used together with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 100G.
[0154] The blocking device 101G includes a support portion 100, a bonding portion 200, and a fixing member 300 that passes through the bonding portion 200 and is connected between the support portion 100 and the conveying device. The main difference between the blocking device 101G in this embodiment and the blocking device 100F in the sixth embodiment is that the first stacking portion 210 and the second stacking portion 220 are folded and fixed to each other as a stacking structure from the same sheet material.
[0155] In this embodiment, the shape and size of the first stacking part 210 and the second stacking part 220 are basically the same. The edge of the first stacking part 210 can be aligned with the edge of the second stacking part 220 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.
[0156] The mutually stacked first stacking portion 210 and the second stacking portion 220 are formed by folding and fixing the same sheet material (fitting portion 200), that is, when the fitting portion 200 is outside the body, the first stacking portion 210 and the second stacking portion 220 are fixed to each other and maintain a folded state to realize a stacked structure, and there is no need to achieve mutual folding by pulling the fixing member 300 in the body, which can avoid different stacking states of the fitting portion 200 during the folding process in the body, and can make the fitting portion 200 fit better with the blood vessel wall.
[0157] In some embodiments, the first laminated part 210 and the second laminated part 220 are not in the same shape, and at least a portion of the periphery of the first laminated part 210 is fixedly connected to the second laminated part 220; and / or at least a portion of the periphery of the second laminated part 220 is fixedly connected to the first laminated part 210, 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.
[0158] In some modified embodiments, for example, based on the fourth embodiment, the first stacking portion 210 and the second stacking portion 220 are made of different sheets, and the stacked first stacking portion 210 and the second stacking portion 220 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 210 and the second stacking portion 220 are fixed to each other into a stacking structure with different sheets, thereby improving the sealing performance of the bonding portion 200.
[0159] Eighth Embodiment
[0160] See also Fig.24 This embodiment provides a blocking device 101H. The blocking device 101H can be used together with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 100H.
[0161] The blocking device 101H includes a support portion 100, a bonding portion 200, and a fixing member 300 passing through the bonding portion 200 and connected between the support portion 100 and the conveying device. The main difference between the blocking device 101H in this embodiment and the blocking device 100G in the seventh embodiment is that the bonding portion 200 and the support portion 100 are fixed to each other in a stacked structure.
[0162] In the above-mentioned embodiment, the supporting part 100 and the fitting part 200 are separate structures. Fig.24 As shown, the support part 100 and the fitting part 200 are fixedly connected as one body, or formed as one body. The fitting part 200 and the support part 100, as well as the multiple stacked parts in the fitting part 200, can be fixed as an integrated stacked structure by using solution bonding, medical glue bonding, or suturing, hot pressing, and fixing with anchor nails of polymer materials, that is, after the occluding device 101H is formed and assembled, the distal occluding member 501 is an integrated structure, the stacked structure of the fitting part 200 is fixed, and the abutment form of the support part 100 and the fitting part 200 is fixed, so as to avoid the support part 100 gradually abutting and squeezing the fitting part 200 to fold in the body, and the fitting part 200 appears in different stacking states during the folding process in the body, thereby improving the occlusion success rate.
[0163] Ninth embodiment
[0164] See also Fig.25 This embodiment provides a blocking device 101I, which can be used in conjunction with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 101I.
[0165] The blocking device 101H includes a support portion 100, a fitting portion 200, and a fixing member 300 that passes through the fitting portion 200 and is connected between the support portion 100 and the conveying device. The main difference between the blocking device 101I in this embodiment and the blocking device 100B in the second embodiment is that the fitting portion 200 and the support portion 100 are an integral structure, and the fitting portion 200 is at least arranged at the periphery and the proximal end of the support portion 100.
[0166] like Fig.25 As shown, the fitting part 200 and the support part 100 are an integral structure, and can be integrally formed or separately formed and then fixedly connected. The support part 100 includes a proximal surface 205, a distal surface 204, and a side wall 206 connecting the proximal surface 205 and the distal surface 204. In order to prevent the edge of the support part 100 from damaging the tissue, the fitting part 200 is connected to the proximal surface 205 and the side wall 206 of the support part.
[0167] In this embodiment, the fitting part 200 and the support part 100 are combined into one body to form a distal blocking piece, the distal blocking piece is in a truncated cone shape, and the support part 100 is in a truncated cone shape. In other embodiments, the support part 100 can be in a cylindrical shape, a drum shape, etc.; the fitting part 200 can be in a rectangular parallelepiped, a cone, an inverted cone, etc.
[0168] Tenth embodiment
[0169] See also Figure 26 to Figure 28 This embodiment provides a blocking device 101J. The blocking device 101J can be used in conjunction with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 100J.
[0170] The blocking device 101J includes a support portion 100, a fitting portion 200, and a fixing member 300 passing through the fitting portion 200 and connected between the support portion 100 and the conveying device 900. The main difference between the blocking device 101J in this embodiment and the blocking device 100G in the seventh embodiment is that the blocking device 101J also includes a proximal blocking member 400 disposed proximal to the distal blocking member, the proximal blocking member 400 is used to block the proximal notch 1007 of the tissue defect 1005, the proximal blocking member 400 is connected to the fixing member 300, and the fixing member 300 is used to be fixed to the tissue proximal to the proximal blocking member 400.
[0171] Specifically, the proximal blocking member 400 is provided with a through hole for the fixing member 300 to pass through, and the fixing member 300 is inserted into the through hole of the proximal blocking member 400. The technical solution of the through hole in the distal blocking member can be applied to the proximal blocking member 400 if there is no contradiction.
[0172] like Fig.26 As shown, in the distal blocking member, the fitting portion 200 and the supporting portion 100 are separate structures. It can be understood that, in other embodiments, the fitting portion 200 and the supporting portion 100 can be fixed together or be an integrally formed structure.
[0173] In the conveying state, in the conveying device 900 , the laminating portion 200 and the supporting portion 100 at least partially overlap in the axial direction of the conveying device 900 .
[0174] The delivery device 900 includes an outer sheath 910 , an inner sheath core 930 , and an intermediate sheath 950 disposed 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 sequentially stacked from outside to inside in the radial direction of the delivery device 900 .
[0175] In the conveying 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 piece 400 is accommodated in the inner cavity of the intermediate sheath 950, the distal end of the outer sheath 910 accommodates the distal blocking piece, the distal end of the intermediate sheath 950 accommodates the proximal blocking piece 400, and the distal end of the inner sheath core 930 is located proximal to the proximal blocking piece 400. In the conveying state, in the conveying device 900, the distal blocking piece is arranged between the distal ends of the outer sheath 910 and the intermediate sheath 950, and the proximal blocking piece 400 is located between the distal ends of the intermediate sheath 950 and the distal ends of the inner sheath core 930.
[0176] 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 member; the inner sheath core 930 and the intermediate sheath tube 950 can be controlled by the conveying device 900 to move toward each other to release the proximal blocking member 400, such as by moving (pushing) the inner sheath core 930 distally and fixing the intermediate sheath tube 950 to release the proximal blocking member 400, or by keeping the inner sheath core 930 stationary and moving (retracting) the intermediate sheath tube 950 proximally to release the proximal blocking member 400, 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 member 400.
[0177] In the conveying state, the distal sealing member (the supporting portion 100 and the fitting portion 200) and the proximal sealing member 400 are spaced apart from each other in the axial direction of the conveying device 900, thereby ensuring that the fixing member 300 between the distal sealing member and the proximal sealing member 400 is long enough to facilitate the release of the distal sealing member at the distal side of the tissue defect 1005 and complete the sealing of the distal gap 1006. After that, the operator can release the proximal sealing member 400 as needed to seal the proximal gap 1007.
[0178] In particular, the delivery device 900 is provided with an intermediate sheath 950. In the delivery state, the proximal blocking component 400 is accommodated in the intermediate sheath 950, so that the distal blocking component and the proximal blocking component 400 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 delivery device 900 does not need to be developed, and the release process does not require DSA fluoroscopy, thereby realizing blind operation.
[0179] like Fig. 27The fixing member 300 forms a knot 302 at the distal end of the inner sheath core 930, and the knot 302 is arranged proximal to the proximal blocking member 400. 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 302, and the knot 302 is arranged around the side wall of the distal end of the push rod 970.
[0180] The fixing member 300 is in a linear shape and has two free ends. The two free ends of the fixing member 300 can be knotted to form a knot 302 and sleeved on the distal end of the push rod 970. Both ends of the fixing member 300 are connected to the handles in the conveying device.
[0181] In this embodiment, the knot 302 is a sliding knot. By moving (pulling or loosening) a free end of the fixing member 300 proximally or distally through the conveying device 900, the length of the fixing member 300 distal to the knot 302 can be reduced or increased, that is, the distance between the distal blocking member and the proximal blocking member 400 is adjusted until the distal blocking member and the proximal blocking member 400 can clamp the tissue defect 1005 from both sides to achieve a hemostatic effect.
[0182] 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 302 falls off from the distal end of the push rod 970 .
[0183] The other end of the fixing member 300 is pulled proximally by the delivery device 900 to achieve a locking knot, ie, a locking knot 302 , thereby fixing the distance between the proximal blocking member 400 and the distal blocking member.
[0184] The fixing member 300 is used to fix to the tissue near the distal occluding member, such as Figure 3 shown.
[0185] Furthermore, the fixing member 300 is used to fix to the tissue on the proximal side of the proximal blocking member 400. Specifically, the delivery device 900 is used to lock the knot 302 on the proximal side of the proximal blocking member 400, that is, the knot 302 can be used to fix to the proximal tissue of the proximal blocking member 400, such as the blood vessel 1002 or the biological surface 1001, or the tissue between the blood vessel 1002 and the biological surface 1001, or other methods other than the knot 302 (such as suturing, or using other locking components) to fix to the proximal tissue of the proximal blocking member 400. After the knot is locked, the fixing member 300 can be cut off at the end of the knot 302 or the biological surface 1001 by the wire cutting device to complete the release process.
[0186] In this embodiment, the delivery device 900 is used to control the two free ends of the fixing member 300 and the end of the push rod 970. In a modified embodiment, the two free ends of the fixing member 300 are not fixed to the delivery device 900, and the fixing member 300 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, but may be directly controlled manually by the operator, or controlled by other devices.
[0187] In this embodiment, the proximal sealing member 400 is in the form of a flat sheet. In some modified embodiments, the proximal sealing member 400 can be set in an arched form similar to the support portion 100 to facilitate fitting the shape of the tissue defect. The shape of the proximal sealing member 400 can be set as needed to be suitable for sealing different tissue defects.
[0188] In some embodiments, the proximal sealing member 400 is made of a flexible material so that the proximal sealing member 400 can better fit the defect peripheral tissue, improve the sealing performance, and reduce damage and stimulation to the tissue. Preferably, the proximal sealing member 400 is more flexible than the support portion 100.
[0189] In some modified implementations, multiple components in the distal occluding member are fixed together or formed in one piece, preferably fixed as a stacked structure. Preferably, the fitting portion 200 and the supporting portion 100, as well as the multiple stacked portions in the fitting portion 200, 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 occluding device is formed and assembled, it is an integrated structure, preferably fixed as a stacked structure, so that the stacked structure of the fitting portion 200 is fixed, and the abutment form of the supporting portion 100 and the fitting portion 200 is fixed, so as to avoid the supporting portion 100 gradually abutting against and squeezing the fitting portion 200 to fold in the body, so as to avoid different stacking states of the distal occluding member during the folding process in the body, so as to make the distal occluding member fit the blood vessel wall better and improve the occlusion success rate.
[0190] In some embodiments, the fitting portion 200 and the supporting portion 100 in the distal blocking member are fixed as a whole, and the multiple stacking portions in the fitting portion 200 are not fixed to form a stacking structure.
[0191] Eleventh Embodiment
[0192] See also Figure 29 to Figure 30 This embodiment provides a blocking device 101K. The blocking device 101K can be used together with the conveying device 900 provided in the first embodiment to obtain a corresponding blocking system. The conveying device 900 can convey and release the blocking device 101K.
[0193] The blocking device 101K includes a support portion 100, a fitting portion 200, a proximal blocking member 400, and a fixing member 300 that passes through the fitting portion 200 and the proximal blocking member 400 and is connected between the support portion 100 and the conveying device. The main difference between the blocking device 101K in this embodiment and the blocking device 100J in the tenth embodiment is that the proximal blocking member 400 in the blocking device 100K includes a support portion 450 and a fitting portion 410.
[0194] The structure of the support portion 450 in the proximal blocking member 400 is consistent with the proximal blocking member 400 in the tenth embodiment. Please refer to the tenth embodiment and will not be described in detail here.
[0195] The structure of the fitting portion 410 may refer to the structure of the fitting portion 200 in any other embodiment of the distal blocking member. In the delivery state, the fitting portion 410 may be kept in any one of an unfolded state, a semi-folded state and a fully folded state, which will not be described in detail here.
[0196] In this embodiment, the structure of the bonding portion 410 is shown in FIG. Fig.26 The laminating portion 200 includes a plurality of laminating portions, and in a natural state, the laminating portion 410 maintains a completely folded state.
[0197] In this embodiment, both the proximal blocking member 400 and the distal blocking member are provided with a fitting portion, the material of the fitting portion is relatively soft, and a multi-layer flexible multi-layer sealing structure can be formed on both sides of the tissue defect, and the sealing effect is better.
[0198] In the modified embodiment, the support portion 100 of the distal plugging member is fixed to the fitting portion 200 as a whole, and the multiple laminated portions in the fitting portion 200 are fixed to form an integrated laminated structure, that is, the distal plugging member is fixedly formed into a laminated structure. Similarly, the support portion 450 and the fitting portion 410 of the proximal plugging member 400 can be fixed to form a whole, and the multiple laminated portions in the fitting portion 410 are fixed to form an integrated laminated structure, that is, the proximal plugging member 400 is fixedly formed into a laminated structure, so as to avoid the distal plugging member from folding to obtain different stacking states during the release process, and also avoid the proximal plugging member 400 from folding to obtain different stacking states during the release process, so as to make the plugging device 101K fit the blood vessel wall better.
[0199] It should be noted that the specific technical solutions in the above various implementation modes can be applicable to each other.
[0200] 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 device, characterized in that: The sealing device is used to seal tissue defects, and includes a distal sealing piece, which is used to seal the distal gap of the tissue defect. The distal sealing piece includes a supporting portion and a fitting portion, the fitting portion is used to fit the tissue, the supporting portion is used to support the fitting portion, and the hardness of the supporting portion is greater than that of the fitting portion.
2. The blocking device according to claim 1, characterized in that: The supporting portion and the fitting portion are separate structures, and the supporting portion is arranged at the far side of the fitting portion.
3. The blocking device according to claim 1, characterized in that: The supporting portion and the fitting portion are an integral structure, and the fitting portion is at least arranged at the periphery and the proximal end of the supporting portion.
4. The blocking device according to claim 3, characterized in that: The support portion includes a proximal surface, a distal surface, and a side surface connecting the proximal surface and the distal surface, and the fitting portion is connected to the proximal surface and the side surface of the support portion.
5. The blocking device according to any one of claims 1 to 4, characterized in that: The supporting portion is arched.
6. The blocking device according to any one of claims 1 to 4, characterized in that: The support portion is made of at least one of a non-degradable material, a degradable biomaterial, and a degradable polymer material; and / or The fitting part is made of at least one of non-degradable material, degradable biomaterial and degradable polymer material.
7. The blocking device according to any one of claims 1 to 4, characterized in that: The contact portion absorbs water and expands.
8. The blocking device according to any one of claims 1 to 4, characterized in that: The fitting portion includes a first stacking portion and a second stacking portion, and the supporting portion, the first stacking portion and the second stacking portion are stacked in a distal direction of the tissue defect to block the distal gap of the tissue defect.
9. The blocking device according to claim 8, 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 conveying device; During the release of the occluding device, the proximal side of the second laminated portion is limited to the peripheral tissue of the distal notch, and the fixing member pulls the supporting portion proximally, so that the supporting portion, the first laminated portion and the second laminated portion are stacked on each other in the distal direction of the tissue defect.
10. The blocking device according to claim 9, characterized in that: The first laminated portion and the second laminated portion are formed by folding the same sheet material.
11. The blocking device according to claim 10, characterized in that: When the fixing member pulls the supporting portion proximally, the first stacked portion and the second stacked portion are folded over each other.
12. The blocking device according to claim 11, 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 fixing member pulls the supporting portion toward the proximal side, the supporting portion pushes the first stacked portion and the second stacked portion to be folded together along the folding portion.
13. The blocking device according to claim 12, characterized in that: At least one of a fold, a bending groove, and a bending hole is formed in the folding portion.
14. The blocking device according to claim 8, characterized in that: The first stacked portion and the second stacked portion are formed by folding and fixing the same sheet material to each other into a stacked structure.
15. The blocking device according to claim 14, characterized in that: The fitting portion and the supporting portion are fixed to each other in a stacked structure.
16. The blocking device according to claim 2, characterized in that: The first stacked portion and the second stacked portion are fixed to each other using different sheets to form a stacked structure.
17. The blocking device according to any one of claims 1 to 4, 8 or 16, 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 member disposed proximal to the distal blocking member, the proximal blocking member being used to block the proximal gap 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; or The blocking device also includes a proximal blocking piece arranged proximal to the distal blocking piece, the proximal blocking piece is used to block the proximal gap of the tissue defect, the proximal blocking piece is connected to the fixing piece, the fixing piece includes a knot arranged proximal to the proximal blocking piece, the knot is used to lock on the proximal side of the proximal blocking piece to fix the distance between the proximal blocking piece and the distal blocking piece.
18. A blocking system, characterized in that: It comprises a conveying device and the occluding device as described in any one of claims 1 to 17, wherein the conveying device is used to convey the occluding device and release it to the tissue defect.
19. A blocking system, characterized in that: It comprises a conveying device and the occluding device as claimed in claim 9. During the release process of the occluding device, after the distal occluding member is released from the distal end of the conveying device to the distal side of the tissue defect, the conveying device is used to pull the supporting portion proximally through the fixing member, so that the supporting portion, the first stacking portion and the second stacking portion are stacked on each other in the distal direction of the tissue defect.
20. A blocking system, characterized in that: It comprises a conveying device and a sealing device as described in any one of claims 1 to 16, wherein the sealing device further comprises a proximal sealing member arranged proximal to the distal sealing member, the proximal sealing member being used to seal the proximal gap of the tissue defect, the proximal sealing member being connected to the fixing member, the fixing member comprising a knot arranged proximal to the proximal sealing member, and the conveying device being used to lock the knot proximal to the proximal sealing member to fix the distance between the proximal sealing member and the distal sealing member.
