Plugging device and plugging system

Abstract

The invention provides a plugging device and a plugging system comprising the plugging device, the plugging device is used for plugging tissue defects, the plugging device comprises a folding part, the folding part is provided with a folding part, the folding part is divided into a first stacking part and a second stacking part by the folding part, and the first stacking part and the second stacking part are arranged on the folding part. The first stacking part and the second stacking part are used for being folded along the folding part and stacked and blocked at the notch of the tissue defect. A folding part is formed between the first laminating part and the second laminating part, so that the first laminating part and the second laminating part can be conveniently folded along the preset position and track of the folding part, a fold formed after the first laminating part and the second laminating part are folded can be basically overlapped with the folding part, the folding part is relatively regular, the position of the fold is proper, and the folding part can be conveniently folded. The shape and the size of the folded first stacking part and the second stacking part are basically consistent with those of a preset condition, and tissue defects can be tightly blocked.

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] In some technical solutions of arteriovenous closure devices, occluding sheets are compressed and stacked at the puncture site in the body to block and stop bleeding. However, during the compression and stacking process of the occluding sheets in the body, they are easily affected by blood flow and the release position, causing the occluding sheets to randomly stack at the puncture site, resulting in poor blocking and hemostasis effects. Summary of the invention

[0005] An embodiment of the present invention provides a sealing device for sealing tissue defects, the sealing device comprising a folding piece, the folding piece forming a folding portion, the folding portion dividing the folding piece into a first stacking portion and a second stacking portion, the first stacking portion and the second stacking portion being used to fold along the folding portion and be stacked and sealed at the gap of the tissue defect.

[0006] The present application also provides an occlusion system, comprising a delivery device and the occlusion device as described above, wherein the delivery device is used to deliver and release the occlusion device to a tissue defect.

[0007] The present application also provides a sealing system, including a conveying device and the sealing device as described above, wherein the sealing device includes a proximal sealing member and a distal sealing member, wherein the proximal sealing member is used to release and seal on the proximal side of the tissue defect, and the distal sealing member is used to release and seal on the distal side of the tissue defect, and in the conveying state, the proximal sealing member and the distal sealing member are spaced apart in the lumen of the conveying device.

[0008] In the embodiment of the present application, a folding portion is formed between the first stacking portion and the second stacking portion, which facilitates the folding of the first stacking portion and the second stacking portion along a predetermined position and trajectory of the folding portion. The crease formed after the first stacking portion and the second stacking portion are folded can basically overlap with the folding portion, is relatively regular, and the position of the fold is appropriate. After folding, the shape and size of the first stacking portion and the second stacking portion are basically consistent with the preset situation, and can achieve a relatively tight sealing of tissue defects. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] 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.

[0010] Figure 1 A schematic structural diagram of a blocking system provided in the first embodiment of the present application;

[0011] Figure 2 for Figure 1 A schematic diagram of the structure of the folding member in FIG.

[0012] Figure 3 for Figure 2 A schematic diagram of the structure of the folding member in a modified implementation mode;

[0013] Figure 4 for Figure 2 A schematic structural diagram of the folding member in another modified embodiment;

[0014] Figure 5 for Figure 1 A schematic diagram of the structure of the plugging system in the conveying state;

[0015] Figure 6 for Figure 1 The occlusion system shown is a schematic diagram of the structure of a tissue defect to be occluded;

[0016] Figure 7 for Figure 1 The schematic diagram of the structure of the blocking system shown is when it is just beginning to be released;

[0017] Figure 8 for Figure 7 A schematic diagram of the structure in which the folding member is folded by pulling the fixing member during the release process of the blocking system;

[0018] Fig. 9 for Figure 7A schematic diagram of the structure of the occluding device occluding the tissue defect after the occluding system is released at the tissue defect;

[0019] Fig.10 for Figure 2 The structure of the first stacked portion shown in FIG. 1 is a schematic diagram of a modified embodiment;

[0020] Fig.11 for Figure 2 A schematic structural diagram of the first stacking portion shown in another modified embodiment;

[0021] Fig.12 A schematic diagram of the structure of the blocking system provided in the second embodiment of the present application;

[0022] Fig.13 for Fig.12 The structural diagram of the blocking device in the conveying state;

[0023] Fig.14 A schematic structural diagram of a blocking system in a delivery state provided in a third embodiment of the present application;

[0024] Fig.15 Fig.14 A schematic diagram of the structure of the occluding device occluding the tissue defect after the occluding system is released at the tissue defect;

[0025] Fig.16 A schematic structural diagram of a blocking device provided in a fourth embodiment of the present application;

[0026] Fig.17 This is a schematic structural diagram of the blocking device provided in the fifth embodiment of the present application. DETAILED DESCRIPTION

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] Definitions:

[0034] 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.

[0035] 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 occlusion system, the delivery device is used to connect the proximal end of the occlusion device from the proximal side; in the occlusion 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.

[0036] 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.

[0037] Radial: the radial direction of a device or component, which is perpendicular to the axial space.

[0038] 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.

[0039] "Circumferential" together with "axial" and "radial" constitute the three orthogonal directions of a device or component.

[0040] The blocking system provided in the embodiment of the present application is used to block tissue defects such as vascular punctures (such as arterial punctures, venous punctures), aortic dissections, heart defects (such as patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, etc.) in a living body. The specific structure of the blocking system is described below by taking the blocking device used to block the vascular puncture of a living body as an example. It can be understood that the blocking system provided in the present application can also be used to block other tissue punctures or tissue defects mentioned or not mentioned above.

[0041] First embodiment

[0042] See also Figures 1 to 9 This embodiment provides a blocking system for blocking a tissue defect 1005 . The blocking system includes a blocking device 101A and a conveying device 900 . The conveying device 900 is used to convey the blocking device 101A and release it to the tissue defect 1005 .

[0043] like Figure 6 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.

[0044] 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 blocking device 101A inside the blood vessel 1002, or inside and outside the blood vessel 1002, so that the blocking device 101A blocks the distal notch 1006 of the tissue defect 1005, or blocks the distal notch 1006 and the proximal notch 1007 of the tissue defect 1005.

[0045] like Figure 1 and Figure 2 As shown, the occluding device 101A includes a folding piece 200, and the folding piece 200 is formed with a folding portion 215. The folding portion 215 divides the folding piece 200 into a first stacking portion 210 and a second stacking portion 220. The first stacking portion 210 and the second stacking portion 220 are used to be folded along the folding portion 215 and stacked to seal the gap of the tissue defect 1005.

[0046] 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, is relatively regular, and the position of the fold is appropriate. After folding, the shape and size of the first stacking portion 210 and the second stacking portion 220 are basically consistent with the preset situation, and can achieve a relatively tight sealing of the tissue defect 1005.

[0047] Please combine Figure 1 as well as Figure 2 See also Fig. 9 A folding portion 215 is formed between the first stacking portion 210 and the second stacking portion 220. After the release is completed, the surfaces of the first stacking portion 210 and the second stacking portion 220 facing each other are completely fitted together, and the folding piece 200 is in a completely folded state.

[0048] like Figure 1 to Figure 2 As shown, the folding member 200 is formed with a plurality of folding portions 215, and any folding portion 215 divides its two sides into two stacked portions. Figure 1The folding piece 200 is formed with four folding parts 215, and the four folding parts 215 are arranged at intervals in a predetermined direction of the folding piece 200, dividing the folding piece 200 into five stacking parts. The figure shows a folding part 215 arranged at the farthest side among the multiple folding parts 215, and the first stacking part 210 and the second stacking part 220 are respectively located on both sides of the folding part 215. In this embodiment, the predetermined direction is the axial direction of the folding piece 200, that is, in the direction between the proximal end and the distal end of the folding piece 200, the multiple folding pieces 200 are arranged at intervals, and the extension directions are parallel and perpendicular to the axial direction of the folding piece 200. In other embodiments, the predetermined direction in which the multiple folding parts 215 are arranged, and the extension direction of each folding part 215 can be flexibly designed as needed. It should be noted that the folding portion 215 described in the present application is a folding portion 215 in the folding piece 200, and is not limited to being a folding portion 215 arranged at the farthest side. Accordingly, one side of the first stacking portion 210 is adjacent to the folding portion 215, and the other side of the folding portion 215 is adjacent to the second stacking portion 220.

[0049] It should be noted that the first laminated portion 210 in this embodiment is the first laminated portion along the direction from the distal side to the proximal side of the folding member 200, and the second laminated portion 220 is the second laminated portion along the direction from the distal side to the proximal side of the folding member 200. In other embodiments, the first laminated portion 210 and the second laminated portion 220 are not limited to being adjacent laminated portions, and other laminated portions may be provided between the two. The first laminated portion 210 is not limited to being provided at the distal side of the second laminated portion 220, and the first laminated portion 210 may be provided at the proximal side of the second laminated portion 220.

[0050] definition:

[0051] The fully folded state refers to a state in which all the laminated parts in the folding member 200 are folded along the folded creases, and the surfaces of adjacent laminated parts facing each other are completely in contact with each other, or the gaps between the surfaces of adjacent laminated parts facing each other are small, such as Fig. 9 shown.

[0052] The folding portion 215 facilitates the first stacking portion 210 and the second stacking portion 220 to be folded together. Figure 1 and Figure 2 As shown, in this embodiment, 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 folding piece 200, thereby facilitating the first stacking portion 210 and the second stacking portion 220 to fold together along the folding portion 215 during the molding process, the release process, and the pre-installation process in the conveying device 900 of the folding piece 200.

[0053] If the folding piece 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 folding piece 200 under the influence of the anatomical structure of the tissue defect 1005 and the blood flow flushing. The crease position 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 surfaces 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.

[0054] like Figure 3 As shown, in some embodiments, a bending groove is formed in the folding portion 215. That is, the folding member 200 has a groove formed on the surface of the folding portion 215, that is, the sheet-shaped folding member 200 is thinned at the position of the folding portion 215, so as to facilitate guiding the first stacking portion 210 and the second stacking portion 220 to fold at this position. The shape of the bending groove is not limited, and can be as follows Figure 3 The folding position is shown to be arranged in a straight line along the preset position.

[0055] The folding portion 215 is used to divide different stacking portions. The folding piece 200 may adopt multiple folding portions of one structural form, and the folding piece 200 may also adopt multiple folding portions 215 of different structural forms.

[0056] like Figure 4 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. Figure 4 The 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 stacking portion 210 and the second stacking portion 220 are in the axial direction ( Figure 4 The folding portions 215A are folded with each other in the vertical direction (in the vertical direction), so the extension direction of the folding portion 215A is perpendicular to the axial direction of the folding member 200, that is, the extension direction of each bending groove in the folding portion 215A is perpendicular to the axial direction of the folding member 200. The extension direction of each bending groove in the folding portion 215B is not perpendicular to the axial direction of the folding member 200, for example, it can be parallel to the axial direction of the folding member 200. The multiple bending grooves in the folding 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 folding member 200.

[0057] exist Figure 4 In the embodiment shown in which the folding portion 215 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.

[0058] 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.

[0059] In this embodiment, the folding piece 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 folding piece 200 can adopt other structural forms, such as an elliptical shape, or other regular or irregular structures.

[0060] like Figure 1 and Figure 2 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 folding piece 200 is completely folded, the edge shape is relatively regular, and the differences in the shapes of the multiple stacking parts will not cause obvious stratification of the edges of the folding piece 200 after folding, thereby affecting the normal blood flow rate.

[0061] 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.

[0062] In some embodiments, each stacked portion can be configured as a square, a circle, an ellipse, a racetrack, an ellipse-like shape ( Fig.10 ), or some irregular shapes (such as Fig.11 ). While ensuring a sufficiently large blocking area, the rounded corners of the stacking part 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 warp, and the blocking effect is better. Fig.10 and 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, which can avoid 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. It can be understood that Fig.10 and Fig.11 The first stacking part 210 is taken as an example to illustrate the variation of the stacking part structure. The specific scheme of the structure of the first stacking part 210 can be applied to other stacking parts.

[0063] 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 101A is at least partially located in the conveying device 900) and the natural state (the blocking device 101A is not subjected to the force of the conveying device 900 and the biological tissue), the folding member 200 may be in three situations.

[0064] In the first case, the folding member 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 folding member 200 forms the folded portion 215 before being assembled with other components (such as the fixing member 300 described below). If the folding member 200 is in a preset shape (a plane or a curved surface) before the folded portion 215 is formed, then in the first case, after the folded portion 215 is formed, the folding member 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. Figure 1 In the illustrated embodiment, in a natural state, the angle between the first stacked portion 210 and the second stacked portion 220 is 180°.

[0065] The second situation is that the folding member 200 is in a semi-folded state, that is, the stacked parts are folded toward each other along the folded portion 215, but the surfaces of the stacked parts facing each other are not completely pressed against each other (an obvious gap is formed). Fig.12 and Fig.13 In the semi-folded state shown, the folding member 200 is bent into a W shape. In an embodiment in which the folding member 200 has only 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. The semi-folded state of the folding member 200 may also refer to that some of the laminated portions in the folding member 200 are completely fitted together, while other laminated portions are not completely fitted together.

[0066] In the conveying state, if the folding member 200 is in a semi-folded state, then in the natural state, the folding member 200 may be in an unfolded state or a semi-folded state. The folding degree of the folding member 200 in the conveying state is greater than or equal to the folding degree in the natural state.

[0067] like Fig.13As shown, in the conveying state, the folding member 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 folding member 200 is released (for example, during the conveying process, the loading process, and the forming process of the folding member 200) to form the folding 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 folding portion 215.

[0068] It is understood that, in the conveying state, the folding member 200 is in a semi-folded state, and the folding member 200 can be shaped before the blocking device 101B is loaded into the conveying device 900 to obtain the semi-folded folding member 200, or the folding member 200 can be folded during the loading process. In some embodiments, the semi-folded state of the folding member 200 during the conveying process is formed by folding each other during the two processes of forming the folding member 200 and loading it into the conveying device 900.

[0069] The delivery device 900 comprises an outer sheath tube 910 and an inner sheath core 930 , and the inner sheath core 930 is passed through the inner cavity of the outer sheath tube 910 ; in the delivery state, the blocking device 101A is accommodated in the inner cavity of the outer sheath tube 910 , and the blocking device 101A is arranged on the distal side of the distal end of the inner sheath core 930 and is connected to the inner sheath core 930 .

[0070] It should be noted that, in the conveying state, the extension direction of the folding portion 215 of the folding piece 200 follows the extension direction of the tubular cavity of the conveying device 900, specifically, the extension direction of the folding portion 215 follows the extension direction of the tubular cavity of the outer sheath tube 910, thereby avoiding the formation of other additional creases in the folding portion 215, simplifying the process flow, and facilitating the folding piece 200 to fit more smoothly to the tissue surface, reducing the thickness of the occluding device after implantation, and reducing the chance of thrombus formation.

[0071] It is understandable that in the second case, after the folding member 200 is released from the conveying device 900, the folding degree of the folding member 200 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 folding member 200 is in a completely folded state.

[0072] The third situation is that the folding piece 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 by suturing, hot pressing, and fixing with anchors of polymer materials, so that the folding piece 200 can be formed into a multi-layer stacking structure. Please refer to the subsequent implementation methods for details.

[0073] The folding member 200 may be made of at least one of a non-degradable material, a degradable biomaterial, and a degradable polymer material.

[0074] The folder 200 may be made of at least one of a degradable material and a non-degradable material.

[0075] The folding member 200 may be made of the following materials:

[0076] Non-degradable materials include, but are not limited to, polypropylene, aromatic polyester, and polytetrafluoroethylene;

[0077] Degradable biomaterials include, but are not limited to, materials such as collagen (e.g., collagen-rich porcine small intestinal submucosa materials);

[0078] 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).

[0079] In this embodiment, the folding part 200 is made of a degradable material, so that after a degradation cycle, the folding part 200 will degrade in the blood vessel and can be completely absorbed, without leaving any foreign matter in the blood vessel. It can maintain long-term patency of the blood vessels, reduce the risk of thromboembolism, eliminate the 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.

[0080] Furthermore, the folding piece 200 absorbs water and swells, that is, the folding piece 200 swells after entering the organism and contacting the body fluid, thereby increasing the flexibility and elasticity, making it easier to fit and block the peripheral tissue of the distal notch 1006, and having a better blocking and hemostasis effect. The folding piece 200 may include at least one of collagen, hydrogel, and polyvinyl alcohol (PVA) to achieve water absorption and swelling. In some embodiments, the folding piece 200 includes collagen material to ensure that the material is soft, easy to fit the tissue, easy to absorb water and swell, has a good blocking effect, and is degradable. Preferably, the folding piece 200 is made of a pig small intestine submucosa material rich in collagen, which is biodegradable, expands in volume after absorbing water, and has a relatively soft material.

[0081] The folding piece 200 is relatively soft and has a certain elasticity. In this embodiment, it is in the shape of a rectangular sheet. In other embodiments, the folding piece 200 can be in other shapes, such as an elliptical sheet, a circular sheet, or other irregular sheet forms, or a blocking structure with a certain thickness. It is understood that in some embodiments, the folding piece 200 can be respectively circular, elliptical, square, hexagonal, capsule-shaped, teardrop-shaped, or other regular or irregular shapes, so that it can be better attached to the tissue at the tissue defect 1005 to block blood flow.

[0082] like Figure 1 As shown, the occluding device 101A includes a fixing member 300, which is connected between the occluding device 101A and the conveying device 900. After the occluding device 101A is released, the fixing member 300 is used to fix to the tissue at the proximal side of the occluding device 101A. The fixing member 300 includes a wire body, and the fixing member 300 is used to pull the occluding device 101A, so as to achieve the connection between the conveying device 900 and the occluding device 101A.

[0083] like Figure 2 As shown, the folding member 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. The fixing member 300 is inserted into the through hole 202 .

[0084] 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 folding member 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.

[0085] The fixing member 300 is used to fix to the tissue at the proximal side of the folding member 200. In this embodiment, the fixing member 300 is a suture, which is inserted into the conveying device 900. Figure 5 and Figure 8 As shown, the fixing member 300 is inserted into the inner sheath core 930 in the delivery device 900, and the two free ends of the suture are connected to the operating handle of the delivery device 900 (not shown), and the operating handle can fix the suture to the tissue near the folding member 200. For example, the fixing member 300 can be fixed to the peripheral tissue of the tissue defect 1005 near the folding member 200, that is, fixed to the wall of the blood vessel 1002. Fig. 9In this embodiment, the fixing member 300 can be fixed to the biological surface 1001 proximal to the folding member 200 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.

[0086] like Figure 1 and Figure 2 As shown, the folding member 200 is provided with a plurality of through holes 202. Specifically, the through holes 202 are provided in the first laminated portion 210 and the second laminated portion 220, and the other laminated portions in the folding member 200 are also provided with through holes 202. In some other embodiments, some of the laminated portions in the folding member 200 are provided with through holes 202, and some of the laminated portions are not provided with through holes 202.

[0087] like Figure 1 to Figure 2 As shown, the laminated part 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 in the thickness direction of the laminated part. When the occluding device 101A is implanted into the biological body, the through hole 202 penetrates the folding part 200 in the axial direction. Figure 2 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.

[0088] The direction along or parallel to the long side of the stack is the transverse direction, and the direction along the width side of the stack is the longitudinal direction. The two through holes 202 are respectively arranged on the surface of the first stack part 210 and the second stack part 220, and the two through holes 202 are arranged along the transverse direction. In some embodiments, the two through holes 202 arranged on the surface of the first stack part 210 and the second stack part 220 are arranged along the longitudinal direction, or along the inclined direction between the transverse direction and the longitudinal direction.

[0089] The fixing member 300 is inserted into the through hole 202. During the assembly process, one end of the fixing member 300 passes through a through hole 202 of the second laminated part 220, then passes through a through hole 102 of the first laminated part 210 in the distal direction, then passes through another through hole 202 of the first laminated part 210 in the proximal direction, and then passes through another through hole 202 of the second laminated part 220 in the proximal direction, thereby completing the assembly between the fixing member 300 and the distal blocking member.

[0090] The end of the fixing member 300 is connected to the conveying device 900. Specifically, the inner sheath core 930 is tubular, the fixing member 300 passes through the lumen of the inner sheath core 930, and the end of the fixing member 300 is fixed in the handle (not shown) of the conveying device 900.

[0091] like Figure 6 As shown, the folding piece 200 can be used to release and seal the distal gap 1006 or the proximal gap 1007 of the tissue defect 1005 .

[0092] In this embodiment, if Figure 1 and Fig. 9 As shown, the folding member 200 is used to release and seal the distal notch 1006 of the tissue defect 1005. Figures 5 to 8 As shown, during the release process of the occluding device 101A, after the folding member 200 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 folding member 200 is located at the peripheral tissue of the tissue defect 1005 and / or the distal end of the conveying device 900, and the conveying device 900 pulls the fixing member 300, so that the first stacking portion 210 and the second stacking portion 220 are folded together along the folding portion 215.

[0093] like Figure 5 As shown, in the conveying state, the first stacking portion 210 and the second stacking portion 220 are not folded together along the folding portion 215. Figure 7 As shown, in the initial stage of the release state, that is, when the folding member 200 is released to the far side of the tissue defect and the fixing member 300 is not pulled, the first stacked portion 210 and the second stacked portion 220 are not folded together along the folded portion 215 .

[0094] During the release process of the folding member 200, in the intermediate stage of the release state, that is, during the process of pulling the fixing member 300, the proximal side of the folding member 200 can abut against the peripheral tissue of the tissue defect 1005, that is, abut against the peripheral tissue of the distal notch 1006. By pulling the fixing member 300, the first laminated portion 210 moves toward the second laminated portion 220 under the drive of the fixing member 300, so that the first laminated portion 210 and the second laminated portion 220 are folded together along the folding portion 215. The first laminated part 210 and the second laminated part 220 are stacked and the through hole 202 in the first laminated part 210 gradually approaches the through hole 202 in the second laminated part 220 until the through hole 202 in the first laminated part 210 and the through hole 202 in the second laminated part 220 are stacked and aligned in the distal direction of the distal notch 1006, penetrate each other, and the surfaces of the first laminated part 210 and the second laminated part 220 facing each other are attached together. At this time, the first laminated part 210 and the second laminated part 220 complete the folding process. In this embodiment, the first laminated part 210 and the second laminated part 220 are stacked on each other in the axial direction of the folding member 200.

[0095] In some embodiments, during the release process of the folding member 200, in the intermediate stage of the release state, that is, during the pulling process of the fixing member 300, the proximal side of the folding member 200 can abut against the distal end of the conveying device 900, and by pulling the fixing member 300, the first stacking portion 210 and the second stacking portion 220 are folded together along the folding portion 215.

[0096] In some embodiments, during the release process of the folding member 200, in the intermediate stage of the release state, that is, during the pulling process of the fixing member 300, the proximal side of the folding member 200 can successively press against the distal end of the conveying device 900 and the peripheral tissue of the distal notch 1006, and by pulling the fixing member 300, the first stacking portion 210 and the second stacking portion 220 are folded together along the folding portion 215.

[0097] like Figures 1 to 9 As shown, the occluding device 101A includes a distal occluding member, which is used to occlude the distal side of the tissue defect 1005. The distal occluding member includes a folding member 200 and a supporting member 100 disposed distal to the folding member 200. The hardness of the supporting member 100 is greater than that of the folding member 200. The supporting member 100 and the folding member 200 are integrally formed, split structures, or fixedly connected. In some modified embodiments, the occluding device 101A includes the folding member 200 but does not include the supporting member 100.

[0098] In the distal blocking member, the support member 100 has a harder hardness than the folding member 200, and the folding member 200 has a greater flexibility than the support member 100. The folding member 200 is disposed on the proximal side of the support member 100 and is used to abut against the tissue defect, and can better conform to the anatomical structure of the tissue defect 1005, thereby improving the fitting performance and flow resistance performance of the distal blocking member. The support member 100 is used to support the folding member 200, so as to prevent the folding member 200 from deforming too much after affixing to the periphery of the tissue defect 1005, thereby ensuring that the folding member 200 can stably play a role in sealing at the distal notch 1006.

[0099] Specifically, the support member 100 is disposed at the distal side of the folding member 200, and after the distal blocking member is released and blocked at the distal notch 1006, the folding member 200 is pressed by the support member 100 at the distal notch 1006. The support member 100 and the folding member 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 member can prevent excessive gaps between the distal blocking member and the tissue wall (such as the blood vessel wall), thereby reducing the risk of bleeding and improving the blocking performance.

[0100] Since the hardness of the support member 100 is greater than that of the folding member 200, the support member 100 protects at least part of the surface of the distal side of the folding member 200 from being deformed by the blood flow, thereby ensuring the stable shape of the folding member 200 in the blood flow, which is beneficial to endothelialization of the device and reduces the risk of vascular stenosis and thrombosis.

[0101] On the other hand, the fixing member 300 passes through the folding member 200 to connect the supporting member 100. After the fixing member 300 is fixed to the tissue, under the action of the fixing member 300 pulling the supporting member 100, the supporting member 100 can effectively press the folding member 200 to fit the periphery of the distal notch 1006, thereby achieving the effect of blocking and stopping bleeding. The hardness of the supporting member 100 is greater than that of the folding member 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 member 100 is relatively soft, under the pulling action of the fixing member 300, the folding member 200 and the supporting member 100 may be pulled to the proximal side of the tissue defect 1005 (outside the wall of the blood vessel 1002), thereby failing to achieve the effect of stopping bleeding. Similarly, if the support member 100 is not provided in the distal blocking member, when the folding member 200 is made of a relatively soft material, the folding member 200 is also relatively easy to be pulled to the proximal side of the tissue defect 1005 by the fixing member 300 and cannot play a role in stopping bleeding.

[0102] The supporting member 100 and the folding member 200 may be made of at least one of non-degradable materials, degradable biomaterials, and degradable polymer materials.

[0103] The support member 100 and the folding member 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 support member 100 and the material used in the folding member 200. The support member 100 and the folding member 200 can be made of the same material or different materials.

[0104] The following materials can be used for the support:

[0105] Non-degradable materials include, but are not limited to, polypropylene, aromatic polyester, and polytetrafluoroethylene;

[0106] Degradable biomaterials include, but are not limited to, polyhydroxyalkanoates (PHAs);

[0107] 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).

[0108] In this embodiment, the support member 100 and the folding member 200 are both made of degradable materials, so that after a degradation cycle, the support member 100 and the folding member 200 will degrade in the blood vessel and can be completely absorbed, without leaving foreign matter in the blood vessel. The blood vessels can be kept unobstructed for a long time, the risk of thromboembolism can be reduced, and the long-term complications and adverse effects caused by the permanent retention of the occluding device in the body can be eliminated, while the cycle of taking antithrombotic drugs can be shortened.

[0109] In this embodiment, the support member 100 and the folding member 200 are made of different materials due to different hardness. The support member 100 and the folding member 200 are split structures, that is, the support member 100 and the folding member 200 are discrete components. In other embodiments, the support member 100 and the folding member 200 can be an integral structure, can be integrally formed, or can be separately formed and then fixedly connected into one.

[0110] In this embodiment, the support member 100 is in the form of a sheet, which may be a curved sheet as shown in the figure, or a flat sheet. The end surface of the support member 100 may be circular, elliptical, square, hexagonal, capsule-shaped, or other regular or irregular shapes.

[0111] Specifically, the support member 100 is arched, specifically in a natural state (such as Figure 1 The support member 100 has a base line on its surface, and the base line can be arranged on the surface of the support member 100 as required. The parts on both sides of the base line in the support member 100 gradually extend distally, so that the support member 100 bulges (arches) proximally at the base line position, so that when the support member 100 blocks the distal notch 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 member 100 and the wall of the blood vessel 1002, increasing the pressing force of the edge of the support member 100 on the folding member 200 and the wall of the blood vessel 1002, and improving the sealing performance.

[0112] In this embodiment, the folding member 200 is provided with a plurality of through holes 202, and the support member 100 is provided with a through hole for the fixing member 300 to pass through. Specifically, the support member 100 is provided with two through holes that run through the thickness direction thereof. The fixing member 300 passes through the two through holes. In the absence of contradiction, the technical solution of the through hole 202 in the folding member 200 can be applied to the through hole of the support member 100.

[0113] During the assembly process, one end of the fixing member 300 passes through the through hole 202 on one side of the folding member 200, then passes through a through hole of the support member 100 in the distal direction, then passes through another through hole 202 of the support member 100 in the proximal direction, and then passes through the through hole 202 on the other side of the folding member 200 in the proximal direction, thereby completing the assembly between the fixing member 300 and the distal blocking member.

[0114] It should be noted that the two through holes on the support member 100 are arranged on the baseline of the arched support member 100, that is, the two through holes 102 are arranged at a position where the support member 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 member 100 (the part between the two through holes) to fit against the distal surface of the support member 100, thereby avoiding the part of the fixing member 300 located on the distal side of the support member 100 from being suspended in the air and blocking the blood flow, thereby reducing the risk of thrombus formation.

[0115] In some embodiments, a penetration ring is disposed on the proximal surface of the support member 100, and the fixing member 300 can be fixed to the penetration ring, for example, by knotting, bonding, welding, etc.

[0116] like Fig. 9 As shown, after the distal blocking member is released and blocked in the distal notch 1006 , the folding member 200 is blocked between the supporting member 100 and the tissue to prevent the supporting member 100 from damaging the tissue.

[0117] In some embodiments, in a natural state (the blocking 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 at least one stacked portion is larger than that of the support member 100, thereby ensuring that after the blocking device 101A is released, the folding member 200 can be blocked between the support member 100 and the tissue. In some embodiments, after the folding member 200 enters the body and absorbs body fluids, the volume expands, and the flexibility and elasticity are enhanced. Under the pressure of the support member 100, the radial dimension of at least one stacked portion is larger than that of the support member 100, thereby ensuring that the folding member 200 can be blocked between the support member 100 and the tissue.

[0118] Second embodiment

[0119] Please participate Figure 12 to Figure 13 The second embodiment of the present application provides a blocking system, the blocking system comprising a blocking device 101B and a conveying device 900, the blocking device 101B is used to block the tissue defect 1005 ( Figure 6 ), the conveying device 900 is used to convey and release the blocking device 101B to the tissue defect. The main difference between the blocking device 101B in this embodiment and the blocking device 101A in the first embodiment is that in the natural state, the folding member 200 is folded along the folding portion 215, and correspondingly, in the conveying state, the folding member 200 is also folded along the folding portion 215.

[0120] like Fig.12 as well as Fig.13 As shown, in the natural state, the folding member 200 is in a semi-folded state. For the specific structural description of the folding member 200 in the semi-folded state, please refer to the previous text and will not be elaborated here.

[0121] like Fig.13 As shown, in this embodiment, in the conveying state, the support member 100 and the folding member 200 are at least partially overlapped in the axial direction of the conveying device 900, or in other words, the support member 100 and the folding member 200 are at least partially stacked in the radial direction of the conveying device 900.

[0122] That is, the support member 100 and the folding member 200 may partially overlap or completely overlap in the axial direction of the conveying device 900 (the support member 100 is arranged within the axial range of the folding member 200, or the folding member 200 is arranged within the axial range of the support member 100). The support member 100 and the folding member 200 at least partially overlap in the axial direction of the conveying device 900, such as Fig.13 As shown, the folding member 200 covers at least part of the surface of the supporting member 100, thereby shortening the length of the fixing member 300 between the two as much as possible. After release, the two will roughly remain in the stacking manner in the conveying device 900, and the two will be easier to fit each other during the release process.

[0123] Specifically in this embodiment, before the blocking device 101B is loaded into the conveying device 900, the fixing member 300 between the support member 100 and the folding member 200 can be tightened to reduce the distance between the support member 100 and the folding member 200. After the blocking device 101B is loaded into the conveying device 900, especially in the conveying state, the support member 100 and the folding member 200 are stacked on each other in the axial direction of the conveying device 900. Correspondingly, the support member 100 and the folding member 200 can also be stacked on each other in the radial direction of the conveying device 900. The support member 100 and the folding member 200 are close to each other, thereby reducing the difficulty of the support member 100 fitting and compressing the folding member 200 during the release process.

[0124] In the conveying device 900 , if the supporting member 100 and the folding member 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.

[0125] For example, during the release process, under the scouring effect of the blood flow, the support member 100 is easy to rotate relative to the folding member 200, and the fixing member 300 between the support member 100 and the folding member 200 is easy to twist, making it difficult to pull the fixing member 300 to slide in the penetration hole 202 of the folding member 200, resulting in the support member 100 being unable to press the folding member 200; or after the support member 100 presses the folding member 200, it is difficult for the support member 100 to press the folding member 200 in a predetermined direction, resulting in a large amount of the edge of the folding member 200 being exposed outside the periphery of the support member 100; these situations will affect the sealing performance of the occluding device 101B, and will also lead to an increase in the area of ​​the folding member 200 exposed to the blood flow, a larger endothelialization area, and a higher risk of vascular stenosis and thrombosis.

[0126] Third embodiment

[0127] Please participate Figure 14 to Figure 15 The third embodiment of the present application provides a blocking system, the blocking system includes a blocking device 101C and a conveying device 900, the blocking device 101C is used to block the tissue defect 1005 ( Figure 6 ), the delivery device 900 is used to deliver and release the blocking device 101C to the tissue defect. The main difference between the blocking device 101C in this embodiment and the blocking device 101B in the second embodiment is that the blocking device 101C includes a distal blocking member and a proximal blocking member, the proximal blocking member is used to block the proximal side of the tissue defect, and the distal blocking member is used to block the distal side of the tissue defect, the distal blocking member includes a supporting member 100, and the proximal blocking member includes a folding member 200, and in a natural state, the folding member 200 is folded along the folding portion 215.

[0128] In this embodiment, the blocking device 101C is used to block both the proximal and distal sides of the tissue defect, thereby improving the blocking capability of the tissue defect 1005. Specifically, a support member 100 is provided in the distal blocking member, which is used to block the tissue defect 1005 ( Figure 6 ), that is, to block the distal gap 1006 ( Figure 6 ); A folding member 200 is provided in the proximal sealing member for sealing the tissue defect 1005 ( Figure 6 ), that is, to block the proximal gap 1007 ( Figure 6 The specific technical solutions of the supporting member 100 and the folding member 200 in the first embodiment and the second embodiment can be applied to this embodiment if there is no contradiction, and will not be described in detail here.

[0129] In the natural state, the folding member 200 is in a semi-folded state, that is, Fig.12 As shown, for the specific structural description of the folding member 200 in the semi-folded state, please refer to the previous text and will not be repeated here.

[0130] In this embodiment, the distal blocking member (support member 100) and the proximal blocking member (folding member 200) are spaced apart in the axial direction of the conveying device 900, thereby ensuring that the distance between the fixing member 300 of the distal blocking member and the proximal blocking member is relatively long. That is, in the conveying state, the distal blocking member and the proximal blocking member are spaced apart in the axial direction of the conveying device 900, thereby ensuring that the fixing member 300 of the distal blocking member and the proximal blocking member is long enough, so that after releasing the distal blocking member at the distal side of the tissue defect 1005 and completing the blocking of the distal gap 1006, the operator can release the proximal blocking member at the proximal side of the tissue defect 1005 as needed to block the proximal gap 1007.

[0131] Preferably, 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 stacked in sequence from outside to inside in the radial direction of the delivery device 900.

[0132] In the conveying state, the distal end of the outer sheath 910, the distal end of the intermediate sheath 950, and the distal end of the inner sheath core 930 are arranged in sequence from far to near, the proximal blocking piece 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, and the distal end of the inner sheath core 930 is located proximal to the proximal blocking piece. In the conveying state, in the conveying device 900, the distal blocking piece is arranged between the distal end of the outer sheath 910 and the distal end of the intermediate sheath 950, and the proximal blocking piece is located between the distal end of the intermediate sheath 950 and the distal end of the inner sheath core 930.

[0133] During the release process, the inner sheath core 930 and the intermediate sheath tube 950 can be controlled to remain stationary by the delivery 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 to move toward each other by the delivery device 900 to release the proximal blocking member. For example, the proximal blocking member can be released by moving (pushing) the inner sheath core 930 distally and fixing the intermediate sheath tube 950, or by keeping the inner sheath core 930 stationary and moving (retracting) the intermediate sheath tube 950 proximally to release the proximal blocking member, or by moving (retracting) the intermediate sheath tube 950 proximally and moving (pushing) the inner sheath core distally at the same time, the proximal blocking member is released.

[0134] 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 can be accurately released in steps by controlling the operation of the outer sheath 910, the intermediate sheath 950 and the inner sheath core 930. The blocking device does not need to be developed, and the release process does not require DSA fluoroscopy, thereby realizing blind operation.

[0135] It should be noted that, in some embodiments, the delivery device 900 is not provided with the intermediate sheath 950 , and the outer sheath 910 and the inner sheath core 930 are used to deliver and release the occluding device.

[0136] Preferably, the fixing member 300 includes a knot 302 disposed proximal to the proximal blocking member. The inner sheath core 930 is provided with a plurality of channels penetrating the proximal end and the distal end thereof. In some embodiments, the delivery device 900 includes a push rod for inserting into the inner sheath core 930, the distal end of the push rod extending from the distal end of the inner sheath core 930, and the portion of the push rod extending from the inner sheath core 930 at the distal end is used to carry and wrap the knot 302, and the knot 302 is disposed around the side wall of the distal end of the push rod.

[0137] 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. Both ends of the fixing member 300 are connected to the handle in the conveying device.

[0138] In this embodiment, the knot 302 is a sliding knot. By moving (pulling or loosening) one 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 sealing member and the proximal sealing member can be adjusted until the distal sealing member and the proximal sealing member can clamp the tissue defect 1005 from both sides, thereby achieving a hemostatic effect.

[0139] The delivery device 900 controls the push rod 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.

[0140] 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 and the distal blocking member.

[0141] The fixing member 300 is used to fix to the tissue near the distal occluding member, such as Fig.15 shown.

[0142] Furthermore, the fixing member 300 is used to fix to the tissue on the proximal side of the proximal blocking member. Specifically, the delivery device 900 is used to lock the knot 302 on the proximal side of the proximal blocking member, that is, the knot 302 can be used to fix to the proximal tissue of the proximal blocking member, 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. 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.

[0143] 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. 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 may not be fixed to the delivery device, but may be directly controlled manually by the operator, or controlled by other devices.

[0144] Fourth embodiment

[0145] See also Fig.16 This embodiment provides a blocking device 101D, which can be used in conjunction with the delivery device 900 provided in other embodiments to form a blocking system. The blocking device 101D in this embodiment includes a support member 100 and a folding member 200. The main difference between the blocking device 101D and the blocking device 101A provided in the first embodiment is that the first stacking portion 210 and the second stacking portion 220 are folded and fixed to each other along the folding portion 215 by the folding member 200 to form a stacking structure.

[0146] 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.

[0147] The mutually stacked first stacking part 210 and the second stacking part 220 are formed by folding and fixing the same sheet material (folding piece 200). That is, when the folding piece 200 is outside the body, the first stacking part 210 and the second stacking part 220 are fixed to each other and maintain a folded state to realize a stacked structure. There is no need to pull the fixing piece 300 in the body to realize mutual folding. This can avoid different stacking states of the folding piece 200 during the folding process in the body, and can make the folding piece 200 fit the blood vessel wall more closely.

[0148] 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, so that the folding member 200 forms a flat periphery, reducing the risk of device thrombosis forming at the periphery of the folding member 200.

[0149] Fifth embodiment

[0150] See also Fig.17In this embodiment, a blocking device 101E is provided, and the blocking device 101E can be used in conjunction with the conveying device provided in other embodiments to form a blocking system. The main difference between the blocking device 101E and the blocking device 101D provided in the fourth embodiment is that the blocking device 101E includes a distal blocking member and a proximal blocking member, and the distal blocking member includes a support member 100 and a folding member 200. Both the support member 100 and the folding member 200 are used to release and block the distal side of the tissue defect, that is, to block the distal gap. Please refer to the aforementioned embodiment for the specific structure of the support member 100 and the folding member 200, which will not be repeated here.

[0151] In this embodiment, the blocking device 101E is provided with a proximal blocking member 400 for blocking the proximal opening of the tissue defect. 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 .

[0152] Specifically, the proximal blocking member 400 is provided with a through hole for the fixing member 300 to pass through, and 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.

[0153] 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 member 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.

[0154] In some embodiments, the folding member 200 can be arranged in the proximal blocking member or the distal blocking member, that is, the proximal blocking member 400 can adopt the folding member 200 as needed, or can further add other blocking components, or the proximal blocking member 400 can adopt the form of stacking multiple components for blocking. Accordingly, the distal blocking member is not limited to adopting the folding member 200, and the structure of the distal blocking member can only include the support member 100, or adopt other structures other than the support member 100. In some embodiments, the folding member 200 can be arranged in the proximal blocking member and the distal blocking member, that is, at least one folding member is arranged in the proximal blocking member, and at least one folding member is also arranged in the distal blocking member.

[0155] 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 member 100.

[0156] In some modified implementations, multiple components in the distal plugging member are fixed together, or formed in one piece, preferably fixed as a stacked structure. Preferably, the folding member 200 and the support member 100, as well as the multiple stacked parts in the folding member 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 distal plugging member is fixed, and the support member 100 and the folding member 200 are fixed in abutting form, so as to avoid the support member 100 gradually abutting against and squeezing the folding member 200 for folding in the body, so as to avoid different stacking states of the distal plugging member in the folding process in the body, so as to make the distal plugging member fit the blood vessel wall more closely, and improve the success rate of occlusion.

[0157] In some embodiments, the folding member 200 in the distal blocking member is fixed to the supporting member 100 as a whole, and the multiple stacked parts in the folding member 200 are not fixed to form a stacked structure.

[0158] In the implementation example where the folding piece 200 is a proximal blocking piece, the multiple stacked parts in the folding piece 200 may also be stacked and fixed together using the aforementioned technical solution, and the folding piece 200 and other blocking structures in the proximal blocking piece may also be fixed together or formed as one piece.

[0159] It should be noted that the specific technical solutions in the above various implementation modes can be applicable to each other.

[0160] 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: Used to block tissue defects, the blocking device includes a folding piece, the folding piece is formed with a folding portion, the folding portion divides the folding piece into a first stacking portion and a second stacking portion, the first stacking portion and the second stacking portion are used to fold along the folding portion and be stacked to block the gap of the tissue defect.

2. The blocking device according to claim 1, characterized in that: At least one of a fold, a bending groove, and a bending hole is formed in the folding portion.

3. The blocking device according to any one of claims 1 to 2, characterized in that: In the conveying state, the angle between the first stacking portion and the second stacking portion is a, and 0°<a≤180°.

4. The blocking device according to claim 3, characterized in that: In the conveying state, the first stacking portion and the second stacking portion are folded with each other, and ends of the first stacking portion and the second stacking portion away from the folding portion are spaced apart from each other.

5. The blocking device according to claim 3, characterized in that: The first stacking part and the second stacking part are both formed with a through hole, and the blocking device includes a fixing member, the fixing member is inserted into the through hole, and an end of the fixing member is connected to the conveying device; During the release process of the occluding device, after the folding member is released from the distal end of the conveying device to the proximal or distal side of the tissue defect, the proximal side of the folding member is limited to the distal end of the conveying device and / or the peripheral tissue of the tissue defect, and the conveying device pulls the fixing member so that the first stacking portion and the second stacking portion are folded along the folding portion.

6. The blocking device according to claim 1 or 2, characterized in that: The first stacking portion and the second stacking portion are folded and fixed to each other along the folding portion by the folding member to form a stacking structure.

7. The blocking device according to claim 6, characterized in that: At least a portion of the periphery of the first laminated portion is fixedly connected to the second laminated portion; and / or At least a portion of the periphery of the second laminated portion is fixedly connected to the first laminated portion.

8. The blocking device according to any one of claims 1 to 2, characterized in that: The first stacking part and the second stacking part are respectively made of at least one of non-degradable materials, degradable biomaterials, and degradable polymer materials.

9. The blocking device according to claim 8, characterized in that: The first laminated portion and / or the second laminated portion swells by absorbing water.

10. The blocking device according to claim 1 or 2, characterized in that: The blocking device comprises a distal blocking piece, the distal blocking piece is used to block the distal side of the tissue defect, the distal blocking piece comprises the folding piece and a support piece arranged distal to the folding piece, the hardness of the support piece is greater than that of the folding piece, the support piece and the folding piece are integrally formed, split structure, or fixedly connected; or The blocking device comprises a proximal blocking piece, which is used to block the proximal side of the tissue defect. The proximal blocking piece comprises the folding piece. The blocking device comprises a distal blocking piece connected to the proximal blocking piece and used to be released at the distal side of the tissue defect.

11. The blocking device according to claim 1 or 2, characterized in that: The occluding device comprises a fixing element, which passes through the folding element and is connected to the conveying device. The fixing element is used to be fixed to the tissue at the proximal side of the folding element.

12. The blocking device according to claim 11, characterized in that: The occluding device includes a proximal occluding member and a distal occluding member, the proximal occluding member is used to seal the proximal side of the tissue defect, and the distal occluding member is used to seal the distal side of the tissue defect, the folding member is arranged on the proximal occluding member and / or the distal occluding member, the fixing member passes through the proximal occluding member and the distal occluding member and is connected to the inner sheath core, the fixing member includes a knot arranged on the proximal side of the proximal occluding member, and during the release process of the occluding device, the conveying device is used to lock the knot to fix the distance between the proximal occluding member and the distal occluding member.

13. A blocking system, characterized in that: It comprises a conveying device and the occluding device according to any one of claims 1 to 12, wherein the conveying device is used to convey and release the occluding device to a tissue defect.

14. The blocking system according to claim 13, characterized in that: The conveying device comprises an outer sheath tube and an inner sheath core, and the inner sheath core is inserted into the inner cavity of the outer sheath tube; in the conveying state, the blocking device is accommodated in the inner cavity of the outer sheath tube, and the blocking device is arranged on the distal side of the distal end of the inner sheath core and connected to the inner sheath core.

15. The blocking system according to claim 13, characterized in that: In the conveying state, the extension direction of the folded portion is arranged along the lumen of the conveying device.

16. A blocking system, characterized in that: It comprises a conveying device and a sealing device as described in any one of claims 1 to 9, wherein the sealing device comprises a proximal sealing member and a distal sealing member, wherein the proximal sealing member is used to release and seal at the proximal side of the tissue defect, and the distal sealing member is used to release and seal at the distal side of the tissue defect, and in a conveying state, the proximal sealing member and the distal sealing member are spaced apart in the lumen of the conveying device.

17. The blocking system according to claim 16, characterized in that: The conveying device comprises an outer sheath tube and an inner sheath core, and the inner sheath core is inserted into the inner cavity of the outer sheath tube; in the conveying state, the blocking device is accommodated in the inner cavity of the outer sheath tube, and the blocking device is arranged on the distal side of the distal end of the inner sheath core and connected to the inner sheath core.

18. The blocking system according to claim 17, characterized in that: The delivery device comprises an intermediate sheath tube disposed between the outer sheath tube and the inner sheath core, In the delivery state, the distal end of the outer sheath tube, the distal end of the intermediate sheath tube and the distal end of the inner sheath core are arranged in sequence from far to near, the distal blocking member is arranged between the distal end of the outer sheath tube and the distal end of the intermediate sheath tube, and the proximal blocking member is accommodated in the inner cavity of the intermediate sheath tube and is located between the distal end of the intermediate sheath tube and the distal end of the inner sheath core. The delivery device controls the outer sheath to move proximally to release the distal blocking member; The conveying device controls the inner sheath core and the intermediate sheath tube to move toward each other to release the proximal blocking member.

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