Closure stent and delivery system

Abstract

The application relates to a blocking stent and a conveying system, wherein the blocking stent comprises a main unit and a blocking unit, the main unit is in a cylindrical shape, the main unit has a proximal end opening and a distal end opening, the blocking unit has a proximal end opening and a distal end plug, the proximal end opening of the blocking unit is connected with the distal end opening of the main unit, and the end opening area of the proximal end opening of the main unit is larger than the end blocking area of the distal end plug of the blocking unit. In the blocking stent and the conveying system, the cylindrical structure is constructed into a conical or conical-like structure on the basis of the basic cylindrical stent structure, the material consumption can be effectively reduced on the basis of guaranteeing the blocking effect, the material consumption reduction can effectively reduce the inflammation and complication initiation probability for the implant which needs to be implanted into the body for a long time and stored in the body, and the postoperative discomfort of the patient is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a closure stent and a delivery system. BACKGROUND

[0002] The coronary artery does not pass through the capillary network, but directly communicates with the heart chamber (Cornary-cameral fistual) or any stage of large blood vessels (systemic circulation or pulmonary circulation), and its pathological and physiological changes are the same, which can be collectively referred to as coronary arteriovernous fistula (CAVF), and is also referred to as coronary artery fistula (CAF).

[0003] The target blood vessel of the coronary artery fistula is relatively large, often accompanied by vascular tortuosity and neoplastic expansion, and the fistula is large. The pathological and physiological manifestations are heart chamber enlargement, heart failure, angina pectoris, arrhythmia, and myocardial infarction. In the tortuous part of the blood vessel, thrombosis may occur, and in the proximal part of the coronary artery, the increased blood flow may induce endothelial injury due to shear stress, leading to coronary atherosclerosis.

[0004] At present, the main methods for treating coronary artery fistula in clinical practice are surgical treatment and percutaneous catheter interventional occlusion. The percutaneous catheter interventional occlusion usually uses a mushroom umbrella type stent for patent ductus arteriosus occlusion. The material is made of nickel-titanium-cobalt alloy wire, and the inner seam has multiple layers of high-density polyester fiber film. After implantation, it will be left in the body for a long time, which can easily cause inflammation and complications. In severe cases, nickel poisoning may occur. Therefore, reducing the volume of the stent and reducing the side effects on the human body have become a problem that needs to be solved in the field. SUMMARY

[0005] Therefore, it is necessary to provide a closure stent and a delivery system in view of the above technical problems.

[0006] The present application provides a closure stent, which comprises:

[0007] A main body unit, which is cylindrical and has a proximal end opening and a distal end opening;

[0008] A closure unit having a proximal end opening and a distal end plug, the proximal end opening of the closure unit being connected to the distal end opening of the main body unit, and the end opening area of the proximal end opening of the main body unit being greater than the end closure area of the distal end plug of the closure unit.

[0009] In one embodiment, the end opening area of the proximal end opening of the main body unit is greater than or equal to the end opening area of the distal end opening of the main body unit; and / or,

[0010] an end opening area of the proximal end opening of the plugging unit is greater than or equal to an end plugging area of the distal end plug of the plugging unit; and / or,

[0011] an end opening area of the distal end opening of the main body unit is greater than or equal to an end opening area of the proximal end opening of the plugging unit.

[0012] In one of the embodiments, at least a part of the section of the main body unit is straight cylinder shaped, or at least a part of the section of the main body unit is tapered cylinder shaped; and / or,

[0013] at least a part of the section of the plugging unit is straight cylinder shaped, or at least a part of the section of the plugging unit is tapered cylinder shaped.

[0014] In one of the embodiments, the main body unit is straight cylinder shaped, or the main body unit is tapered cylinder shaped; or,

[0015] a part of the section of the main body unit located at the proximal end is straight cylinder shaped, and another part of the section of the main body unit located at the distal end is tapered cylinder shaped.

[0016] In one of the embodiments, the plugging unit is straight cylinder shaped, or the plugging unit is tapered cylinder shaped; or,

[0017] a part of the section of the plugging unit located at the proximal end is straight cylinder shaped, and another part of the section of the plugging unit located at the distal end is tapered cylinder shaped.

[0018] In one of the embodiments, the plugging unit is tapered cylinder shaped, and the outer wall surface of the plugging unit is linear or curved from the distal end to the proximal end; or,

[0019] the plugging unit is tapered cylinder shaped, and a plurality of grooves are formed at the distal end of the plugging unit, and the plurality of grooves are distributed circumferentially around the distal end of the plugging unit.

[0020] In one of the embodiments, the plugging stent comprises:

[0021] a shape changing unit connected at the proximal end of the main body unit, the shape changing unit having an expanded state and a contracted state, the shape changing unit being configured to communicate with the proximal end opening of the main body unit in the expanded state, and to plug the proximal end opening of the main body unit in the contracted state.

[0022] In one of the embodiments, the expanded state of the shape changing unit is a helically distributed wire structure.

[0023] In one of the embodiments, the plugging stent comprises:

[0024] The main body additional unit is cylindrical, has a proximal end opening and a distal end opening, the proximal end opening of the main body additional unit is connected with the distal end plug of the plugging unit, and an end opening area of the proximal end opening of the main body additional unit is greater than an end plugging area of the distal end plug of the plugging unit.

[0025] In one of the embodiments, the plugging unit forms the distal end plug of the plugging unit by at least one of welding, hot melting, film covering, binding, knotting or filling.

[0026] The application further provides a delivery system comprising the plugging stent.

[0027] In the plugging stent and the delivery system, the plugging stent is constructed as a conical or conical-like structure on the basis of the substantially cylindrical stent structure, so that the material usage can be effectively reduced on the basis of ensuring the plugging effect, and the reduction of the material usage can effectively reduce the probability of inflammation and complications for the implant which needs to be implanted into the body for a long time and stored in the body. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 A delivery state diagram of the plugging stent provided by one of the embodiments of the application is shown;

[0029] Figure 2 A delivery state diagram of the plugging stent provided by another embodiment of the application is shown;

[0030] Figure 3 A structural diagram of the plugging stent provided by the first embodiment of the application is shown;

[0031] Figure 4 A side view of the plugging stent provided by the first embodiment is shown; Figure 3

[0032] A structural diagram of the plugging stent provided by the second embodiment of the application is shown; Figure 5

[0033] A side view of the plugging stent provided by the second embodiment is shown; Figure 6 Figure 5 A structural diagram of the plugging stent provided by the third embodiment of the application is shown;

[0034] Figure 7 A side view of the plugging stent provided by the third embodiment is shown;

[0035] Figure 8 Figure 7 A side view of the plugging stent provided by the third embodiment is shown;

[0036] ​​Figure 9 A structure diagram of the occlusion stent according to the fourth embodiment of the present application is shown in Fig. 4;

[0037] Figure 10 A structure diagram of the occlusion stent according to the fifth embodiment of the present application is shown in Fig. 5;

[0038] Figure 11 A structure diagram of the occlusion stent according to the sixth embodiment of the present application is shown in Fig. 6;

[0039] Figure 12 A structure diagram of the occlusion stent according to the seventh embodiment of the present application is shown in Fig. 7;

[0040] Figure 13 A structure diagram of the occlusion stent according to the eighth embodiment of the present application is shown in Fig. 8;

[0041] Figure 14 A side view of the occlusion stent according to the eighth embodiment of the present application is shown in Fig. 9; Figure 13

[0042] A structure diagram of the occlusion stent according to the ninth embodiment of the present application is shown in Fig. 10. Figure 15 Reference Signs:

[0043] 100, occlusion stent; 200, delivery device; 300, balloon; 400, pull wire; 500, main body unit; 600, occlusion unit; 700, shape-changing unit; 800, main body additional unit;

[0044] 610, groove.

[0045] DETAILED DESCRIPTION

[0046] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced without some or all of these specific details. In other instances, well-known structures have not been described in detail in order not to unnecessarily obscure the present application.

[0047] ​In the description of the application, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the application.

[0048] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0049] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection", "fixing" and the like should be understood broadly, for example, it can be fixed connection, or detachable connection, or integral; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through intermediate medium, it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0050] In the present application, unless otherwise explicitly specified and limited, the first feature "on" or "under" the second feature can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0051] It is to be understood that when an element as a preamble is referred to as being "on" or "disposed on" another element, it can be directly on the other element or intervening elements can also be present. When an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements can also be present. As used herein the terms "vertical", "horizontal", "up", "down", "left", "right", and the like as well as the like are used for explanation only and not to limit the embodiments.

[0052] Referring to Figure 1 and Figure 2 The present application provides a delivery system, which comprises a balloon 300 and a traction line 400, by which the occlusion stent 100 provided by the present application can be delivered, referring to Figures 3 to 15 The occlusion stent 100 comprises a main unit 500 and an occlusion unit 600, wherein the main unit 500 and the occlusion unit 600 can be integrally formed or connected to each other, and can be made of the same or different materials. The main unit 500 is in a cylindrical shape, which means that it has an axial hollow cavity, and all radial cross sections of the cylindrical shape are closed annular shapes, which can be regular shapes such as a circular ring or a square ring, or irregular shapes, and the radial cross sections formed along the axial direction can be the same or different. For example, according to different cross-sectional shapes, the main unit 500 can be a cylindrical shape, a square cylindrical shape, a straight cylindrical shape, a tapered cylindrical shape, or any other cylindrical shape. Compared with a mesh structure, the cylindrical shape of the occlusion stent 100 only needs one layer of stent material (or one circle of stent material), which can be understood as one layer after the occlusion stent 100 is cut and laid flat. Therefore, the use of the material can be effectively reduced from the perspective of the number of layers of the occlusion stent 100.

[0053] Meanwhile, the main unit 500 has a proximal end opening and a distal end opening, the plugging unit 600 has a proximal end opening and a distal end plug, the proximal end opening of the plugging unit 600 is connected with the distal end opening of the main unit 500, so that the main unit 500 and the plugging unit 600 can be communicated with each other, and the end opening area of the proximal end opening of the main unit 500 is greater than the end plugging area of the distal end plug of the plugging unit 600, so that in the direction from the distal end to the proximal end of the plugging stent 100, the area of the distal end of the plugging stent 100 (i.e. the distal end of the plugging unit 600) is smaller than the area of the proximal end (i.e. the proximal end of the main unit 500), so that the plugging stent 100 as a whole forms a conical or conical-like structure, which has the effect of changing the opening area in the axial direction from the distal end to the proximal end, so that it can be applied to arteriovenous fistula lesions of various sizes for lesion plugging, which not only has wide applicability, but also the conical or conical-like structure of the plugging stent 100 can reduce the amount of material used in the distal end region of the plugging stent 100 due to the smaller area of the distal end of the plugging stent 100.

[0054] The distal end plug is a closure formed at the distal end of the plugging unit 600, and the closure area and closure region of the distal end plug at the distal end of the plugging unit 600 can be selected as required. The distal end plug can form a sealing structure in at least a part of the region of the plugging unit 600, which can close the distal end of the plugging unit 600, thereby achieving the effect of plugging the fistula. The sealing structure can be formed in various forms, for example, welding, hot melting, film covering, binding, knotting, filling can be performed in the opening or hollowed-out region of the plugging unit 600 which needs to be plugged, or the entire plugging unit 600 can be directly made into a solid structure inside, thereby forming the sealing structure in the plugging unit 600, and the sealing effect of the plugging unit 600 is ensured by the sealing structure.

[0055] Therefore, the plugging stent 100 is constructed into a conical or conical-like structure on the basis of the basic cylindrical stent structure, which can effectively reduce the amount of material used while ensuring the plugging effect, i.e. the same plugging effect is achieved with less material. For the implant which needs to be implanted into the body for a long time and saved in the body, the reduction of the amount of material can effectively reduce the probability of inflammation and complications, and reduce the discomfort of the patient after the operation.

[0056] Moreover, the tapered or tapered-like structure of the occlusion stent 100 has good wall adhesion, has low requirements for the size of the lesion, can match various sizes of tubular arteriovenous fistula lumen, and has good fixation effect. After being implanted into the body, the occlusion stent 100 can cause foreign body reaction and stimulate endothelialization. The occlusion stent 100 can be expanded and shaped to support the arteriovenous fistula lumen and occlude the coronary fistula lumen, thereby avoiding various heart and blood vessel diseases such as heart chamber enlargement, heart failure, angina pectoris, arrhythmia, myocardial infarction, and coronary atherosclerosis.

[0057] The tapered or tapered-like structure of the occlusion stent 100 can be specifically formed in various structural forms. On the basis that the opening area of the distal end of the occlusion stent 100 is smaller than that of the proximal end, other sections of the occlusion stent 100 can also be formed in various structural forms according to requirements. For example, the main unit 500 or the occlusion unit 600 can adopt different structural forms according to corresponding functional requirements. In one embodiment, the opening area of the proximal end of the main unit 500 can be greater than or equal to that of the distal end of the main unit 500. Therefore, in the structure of the main unit 500, the main unit 500 can also be formed in a tapered or tapered-like structure, and good wall adhesion can be provided based on the tapered or tapered-like structure. Similarly, the opening area of the proximal end of the occlusion unit 600 can be greater than or equal to that of the distal end of the occlusion unit 600. Therefore, in the structure of the occlusion unit 600, the occlusion unit 600 can also be formed in a tapered or tapered-like structure, and good wall adhesion can be provided based on the tapered or tapered-like structure.

[0058] Specifically, when the opening area of the proximal end of the main unit 500 is greater than that of the distal end of the main unit 500, on the basis that the distal end of the main unit 500 is smaller than the proximal end, other sections of the main unit 500 can also be formed in various structural forms according to requirements. For example, in one embodiment, at least a part of the sections of the main unit 500 is in a tapered cylinder shape. Alternatively, when the opening area of the proximal end of the main unit 500 is equal to that of the distal end of the main unit 500, on the basis that the distal end of the main unit 500 is substantially consistent with the proximal end, other sections of the main unit 500 can also be formed in various structural forms according to requirements. For example, at least a part of the sections of the main unit 500 is in a straight cylinder shape. In one embodiment, the main unit 500 can be in a straight cylinder shape as a whole, or the main unit 500 can be in a tapered cylinder shape as a whole, or a part of the sections of the main unit 500 located at the proximal end is in a straight cylinder shape, and another part of the sections of the main unit 500 located at the distal end is in a tapered cylinder shape, so as to form the main unit 500 in a combination of a straight cylinder shape and a tapered cylinder shape in the axial direction.

[0059] Similarly, when the end opening area of the proximal end opening of the plugging unit 600 is greater than the end plugging area of the distal end plug of the plugging unit 600, on the basis that the distal end of the plugging unit 600 is smaller than the proximal end, the other sections of the plugging unit 600 can also be formed in various different structural forms according to requirements, for example, in one of the embodiments, at least a part of the sections of the plugging unit 600 is a tapered cylinder. Alternatively, when the end opening area of the proximal end opening of the plugging unit 600 is equal to the end plugging area of the distal end plug of the plugging unit 600, on the basis that the distal end of the plugging unit 600 is substantially consistent with the proximal end, the other sections of the plugging unit 600 can also be formed in various different structural forms according to requirements, for example, at least a part of the sections of the plugging unit 600 is a straight cylinder, wherein, in one of the embodiments, the plugging unit 600 can be a straight cylinder as a whole, or the plugging unit 600 can be a tapered cylinder as a whole, or a part of the sections of the plugging unit 600 located at the proximal end is a straight cylinder, and another part of the sections of the plugging unit 600 located at the distal end is a tapered cylinder, so as to form the plugging unit 600 in the combination of the straight cylinder and the tapered cylinder in the axial direction.

[0060] In addition, when the plugging unit 600 is a tapered cylinder as a whole, the tapered cylinder structure of the plugging unit 600 can also have different structural features in the outer contour, for example, in one of the embodiments, the plugging unit 600 is a tapered cylinder as a whole, and on the basis of the structure of the tapered cylinder, the outer wall surface of the plugging unit 600 is linear or curved in the direction from the distal end to the proximal end. The linear type makes the opening area or diameter of the tapered cylinder of the plugging unit 600 gradually and uniformly increase in the direction from the distal end to the proximal end, while the curved type makes the opening area or diameter of the tapered cylinder of the plugging unit 600 gradually increase but not uniformly increase in the direction from the distal end to the proximal end. Alternatively, the plugging unit 600 is a tapered cylinder as a whole, and on the basis of the structure of the tapered cylinder, a plurality of grooves 610 are formed at the distal end of the plugging unit 600, and the plurality of grooves 610 are distributed circumferentially around the distal end of the plugging unit 600.

[0061] Since the main unit 500 and the plugging unit 600 are axially connected, at the position where the main unit 500 is connected with the plugging unit 600, the end opening area of the distal end opening of the main unit 500 can be equal to the end opening area of the proximal end opening of the plugging unit 600, so that the adjacent proximal end opening and distal end opening with the same end opening area can be directly docked and axially communicate the main unit 500 and the plugging unit 600, or the end opening area of the distal end opening of the main unit 500 can be greater than the end opening area of the proximal end opening of the plugging unit 600, at this time, the adjacent proximal end opening and distal end opening with different end opening areas can indirectly form axial communication between the main unit 500 and the plugging unit 600 through the structure of the corresponding material forming a step, wherein the deck between the adjacent proximal end opening and the distal end opening can be perpendicular to the axial direction of the plugging stent 100, or can form a certain angle with the axial direction of the plugging stent 100, which is not limited here.

[0062] In order to clearly illustrate the various structures of the product, the present application will be described in various specific plugging stents 100, for example, referring to Figure 3 and Figure 4 The main unit 500 of the plugging stent 100 can adopt a conical cylinder, which can be hollowed out by metal or absorbable pipe material, and the pipe diameter is preferably Ф2.0-Ф6.0, and the length of the conical body of the main unit 500 can be 3mm-10mm, for example, the length of the conical body of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The plugging unit 600 of the plugging stent 100 can be a 1-4mm pipe solid structure, and the distal plug of the plugging unit 600 is formed by physical welding or hot melting, which is used to plug the lesion position after implantation, and the length of the plugging unit 600 can be 1mm-5mm, for example, the length of the plugging unit 600 is 1mm, 2mm, 3mm, 4mm or 5mm. The plugging stent 100 can be pressed, expanded and fixed after implantation and endothelialization.

[0063] Referring to Figure 5 and Figure 6As shown, the main unit 500 of the occlusion stent 100 can adopt a conical cylinder shape, and can be hollowed out by metal or absorbable tube material. The tube diameter is preferably Ф2.0-Ф6.0, and the length of the cone of the main unit 500 can be 3mm-10mm, for example, the length of the cone of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The occlusion unit 600 of the occlusion stent 100 can be a 1-4mm tube processed into a strip or a wire. This structure is suitable for distal flared occlusion, so that the occlusion stent 100 is more adherent to the wall. The wire-shaped tip position can form the distal plug of the occlusion unit 600 by physical welding, binding, knotting or hot melting. After implantation, it is used for occlusion of the lesion site. The length of the occlusion unit 600 can be 1mm-5mm, for example, the length of the occlusion unit 600 is 1mm, 2mm, 3mm, 4mm or 5mm. The occlusion stent 100 can be pressed, expanded and fixed after implantation and endothelialization.

[0064] Referring to Figure 7 and Figure 8 As shown, the main unit 500 of the occlusion stent 100 can adopt a conical cylinder shape, and can be hollowed out by metal or absorbable tube material. The tube diameter is preferably Ф2.0-Ф6.0, and the length of the cone of the main unit 500 can be 3mm-10mm, for example, the length of the cone of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The occlusion unit 600 of the occlusion stent 100 can be processed by electrospinning process and added with a flow resistance film with a porosity of <0.001mm, which has better occlusion effect. The thickness of the flow resistance film is 200±50μm, which is used for occlusion of the lesion site after implantation. The length of the occlusion unit 600 can be 1mm-5mm, for example, the length of the occlusion unit 600 is 1mm, 2mm, 3mm, 4mm or 5mm. The occlusion stent 100 can be pressed, expanded and fixed after implantation and endothelialization.

[0065] In addition, referring to Figures 9 to 11 As shown, the occlusion unit 600 can also have various structural forms, such as a pointed structure, a flat head structure and a structure formed by a groove 610.

[0066] Referring to Figure 12As shown, the front end of the occlusion stent 100 can adopt a conical cylinder-shaped occlusion unit 600, and the occlusion unit 600 can be composed of a pipe material, a wire material or an electrospun flow resistance film structure, etc. Please refer to the foregoing, the proximal end of the occlusion stent 100 can adopt a structure composed of a combination of a conical cylinder and a straight cylinder, specifically, the distal end of the main unit 500 is conical cylinder-shaped and the proximal end is straight cylinder-shaped. The main unit 500 of the occlusion stent 100 can be composed of a metal or absorbable pipe material, the pipe diameter is preferably Ф2.0-Ф6.0, and the length of the cone of the main unit 500 can be 3mm-10mm, for example, the length of the cone of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The length of the occlusion unit 600 can be 1mm-5mm, for example, the length of the occlusion unit 600 is 1mm, 2mm, 3mm, 4mm or 5mm. The occlusion stent 100 can be pressed, expanded and fixed after implantation and endothelialization.

[0067] Referring to Figure 13 and Figure 14 As shown, the main unit 500 or the occlusion unit 600 of the occlusion stent 100 can adopt a metal or absorbable pipe material, and the main unit 500 and the occlusion unit 600 are both straight cylinder-shaped, wherein the length of the main unit 500 can be 5-10mm, for example, the length of the main unit 500 is 5mm, 6mm, 7mm, 8mm, 9mm or 10mm, and the diameter can be Ф0.5-Ф2, which is used for positioning at the implantation site, and the length of the occlusion unit 600 can be 1-5mm, for example, the length of the occlusion unit 600 is 1mm, 2mm, 3mm, 4mm or 5mm.

[0068] The proximal end of the occlusion stent 100 is connected with a variable unit 700, the length of the variable unit 700 can be 2-10mm, and the variable unit 700 can be processed into a spiral-shaped wire structure by using an absorbable material, and the width of the wire material can be 0.2-1mm in the form of a hypotube, after the occlusion stent 100 is implanted, the wire structure can be pushed into the inside of the main unit 500 by a push tube, which is used for occlusion of the lesion site after implantation.

[0069] Referring to Figure 15As shown, the main body unit 500, occlusion unit 600, and main body auxiliary unit 800 of the occlusion stent 100 can be made of metal or absorbable tubing. The main body auxiliary unit 800, occlusion unit 600, and main body unit 500 are axially connected to form an "I" shape. This structure features flared ends and a constricted middle, making it suitable for lesions with large cavities at both ends and a fistula in the middle. The length of the main body unit 500 can be 5-10 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm, and the diameter can be Ф0.5-Ф2, used for positioning the fistula. The length of the occlusion unit 600 can be 1-5 mm, for example, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm.

[0070] The proximal end of the occlusion stent 100 is connected to a deformable unit 700. The length of the deformable unit 700 can be 2-10mm, and the deformable unit 700 can be processed into filaments by absorbable material to form a spirally distributed filamentous structure. The width of the filaments can be 0.2-1mm, in the form of a hyaluronic acid tube. After the occlusion stent 100 is implanted, the filamentous structure can be pushed into the interior of the main unit 500 through a push tube for occlusion of the lesion site after implantation.

[0071] In one embodiment, the occlusion stent 100 further includes a deformable unit 700 connected to the proximal end of the main body unit 500. The deformable unit 700 has an extended state and a retracted state. The deformable unit 700 is configured to connect to the proximal opening of the main body unit 500 in the extended state and to block the proximal opening of the main body unit 500 in the retracted state. Therefore, when the occlusion stent 100 is implanted into the target position, the deformable unit 700 can be switched from the extended state to the retracted state. For example, the deformable unit 700 can be reshaped to form a clump-like structure that blocks the interior of the main body unit 500, thereby blocking the proximal opening of the main body unit 500.

[0072] The deformable unit 700 can adopt any structural form or material. For example, in one embodiment, the unfolded state of the deformable unit 700 is a spirally distributed filamentous structure. The spiral distribution allows the deformable unit 700 to communicate with the main unit 500 when it is in the unfolded state, forming a roughly cylindrical shape. Moreover, the filamentous structure has the characteristic of being easy to deform, and can be easily inserted into the interior of the main unit 500 after being deformed to the contracted state. For example, the deformable unit 700 can adopt a filamentous structure such as hyaluronic acid fiber, which is not limited here.

[0073] In one of the embodiments, the occlusion stent 100 comprises a main body additional unit 800, which is cylindrical and has a proximal end opening and a distal end opening, the proximal end opening of the main body additional unit 800 is connected with the distal end plug of the occlusion unit 600, the end opening area of the proximal end opening of the main body additional unit 800 is greater than the end occlusion area of the distal end plug of the occlusion unit 600, the main body additional unit 800 can refer to the structural form, material and the like of the main body unit 500, or the main body additional unit 800 can be completely consistent with the main body unit 500 and symmetrical to each other in the axial direction relative to the occlusion unit 600, therefore any technical content of the main body additional unit 800 can refer to the main body unit 500, which will not be repeated here.

[0074] At least one of the main body unit 500, the occlusion unit 600, the variable unit 700 and the main body additional unit 800 of the occlusion stent 100 can adopt a metal material or a non-metal material, such as a nickel-titanium material, a high polymer material or a polyester material, the occlusion stent 100 can be an absorbable material, or a composite material of metal and non-metal, if it is an absorbable material, the absorption time should be less than or equal to 3 years, preferably less than or equal to 1 year, more preferably less than or equal to 6 months. For metal, it can be self-developed, and for non-metal material, it can be developed by inlaying. For example, the main body unit 500 can be a metal frame, a non-metal filament bundle or an electrospun flow resistance film, and the main body unit 500 can be constructed with a corresponding hollow structure according to the needs, and after the main body structure is implanted into the target position by the delivery device 200, it can be expanded by the balloon 300 and form a positioning effect after expansion.

[0075] At least one of the main body unit 500, the occlusion unit 600, the variable unit 700 and the main body additional unit 800 of the occlusion stent 100 has a skeleton wall thickness of ≥200 microns, preferably ≥50 microns, the length of the main body unit 500 is 3-10 mm, and the length of the occlusion unit 600 is 1-5 mm. The occlusion structure can have certain support performance, such as a radial extrusion resistance of the occlusion stent 100 ≥150 Kpa, preferably ≥50 Kpa. The occlusion stent 100 can be laser engraved, injection molded, woven, 3D printed or electrospun, etc., which is not limited here.

[0076] Referring to Figure 1As shown, during the implantation of the occlusion stent 100, the occlusion stent 100 can be first crimped on the matched balloon 300, transported by the delivery device 200 and arrived at the lesion site, expanded by the balloon 300, the pressure value can be determined according to the size of the occlusion stent 100, for example, it can be 7-14 atm, the occlusion stent 100 is released, and the released occlusion stent 100 is positioned through the end opening area of the larger proximal opening of the main unit 500, and at the same time the occlusion stent 100 is occluded by the occlusion unit 600 to occlude the fistula cavity, and the balloon 300 is used to expand and release the occlusion stent 100 after implantation, which is simpler than the release of the self-expanding occlusion device.

[0077] Referring to Figure 2 As shown, if the proximal end of the occlusion stent 100 has a variable unit 700, the wire structure of the variable unit 700 can be connected to the traction wire in the delivery tube, and the balloon 300 is withdrawn from the delivery tube after pressure relief. The traction wire connected to the wire structure of the variable unit 700, the traction wire is pulled back, the spiral length of the wire structure can be determined by the extension length of the traction wire, when the spiral length is left with 5mm, the delivery tube can be pushed 5±2mm in the distal direction, the wire structure is introduced into the inside of the main unit 500 by pushing the traction wire, and the occlusion at the proximal end of the occlusion stent 100 is formed.

[0078] Wherein, the profile of the delivery tube of the delivery device 200 can be less than or equal to 5mm, so the main unit 500 and the occlusion unit 600 of the occlusion stent 100 have the functions of positioning and occlusion respectively, the main unit 500 can be positioned and fixed after expansion, the patterned hollow structure constructed on the main unit 500 can also reduce the amount of implanted material, the occlusion unit 600 can be used to occlude the fistula, the wire structure or electrospinning structure can be engraved on the occlusion unit 600, which can also reduce the amount of implanted material.

[0079] The technical features of the above-mentioned embodiments can be combined arbitrarily, in order to make the description simple, not all possible combinations of the technical features in the above-mentioned embodiments are described, however, as long as the combinations of the technical features do not exist contradictory, it should be considered as the scope of the description.

[0080] The above-mentioned embodiments only express several embodiments of the present application, the description is more specific and detailed, but it cannot be understood as the limitation of the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of variations and improvements can be made, which belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. An occlusion stent, characterized by, The occlusion stent comprises: a main unit, which is cylindrical, has a proximal end opening and a distal end opening; an occlusion unit, which has a proximal end opening and a distal end plug, the distal end plug being a closure formed at the distal end of the occlusion unit; wherein the distal end plug comprises a sealing structure formed at at least a part of the occlusion unit, the sealing structure being used to close the distal end of the occlusion unit; the proximal end opening of the occlusion unit is connected with the distal end opening of the main unit, and the end opening area of the proximal end opening of the main unit is greater than the end plugging area of the distal end plug of the occlusion unit.

2. The occlusion stent of claim 1, wherein, the end opening area of the proximal end opening of the main unit is greater than or equal to the end opening area of the distal end opening of the main unit; and / or, the end opening area of the proximal end opening of the occlusion unit is greater than or equal to the end plugging area of the distal end plug of the occlusion unit; and / or, the end opening area of the distal end opening of the main unit is greater than or equal to the end opening area of the proximal end opening of the occlusion unit.

3. The occlusion stent of claim 2, wherein, at least a part of the main unit is straight cylindrical, or at least a part of the main unit is tapered cylindrical; and / or, at least a part of the occlusion unit is straight cylindrical, or at least a part of the occlusion unit is tapered cylindrical.

4. The occlusion stent of claim 3, wherein, the main unit is straight cylindrical, or the main unit is tapered cylindrical; or, a part of the main unit located at the proximal end is straight cylindrical, and another part of the main unit located at the distal end is tapered cylindrical.

5. The occlusion stent of claim 3, wherein, the occlusion unit is straight cylindrical, or the occlusion unit is tapered cylindrical; or, a part of the occlusion unit located at the proximal end is straight cylindrical, and another part of the occlusion unit located at the distal end is tapered cylindrical.

6. The occlusion stent of claim 5, wherein, the occlusion unit is tapered cylindrical, and the outer wall surface of the occlusion unit is linear or curved in the direction from the distal end to the proximal end; or, the occlusion unit is tapered cylindrical, and a plurality of grooves are opened at the distal end of the occlusion unit, and the plurality of grooves are distributed circumferentially around the distal end of the occlusion unit.

7. The occlusion stent of any one of claims 1-6, wherein, The occlusion stent comprises: a variable unit, which is connected at the proximal end of the main unit, has an expanded state and a contracted state, and is configured to be able to communicate with the proximal end opening of the main unit in the expanded state and to be able to occlude the proximal end opening of the main unit in the contracted state.

8. The occlusion stent of claim 7, wherein, The expanded state of the variable unit is a spiral-shaped distributed filament structure.

9. The occlusion stent of any one of claims 1-6, wherein, The occlusion stent comprises: a main additional unit, which is cylindrical, has a proximal end opening and a distal end opening, and the proximal end opening of the main additional unit is connected with the distal end plug of the occlusion unit, and the end opening area of the proximal end opening of the main additional unit is greater than the end plugging area of the distal end plug of the occlusion unit.

10. The occlusion stent of any one of claims 1-6, wherein, The occlusion unit forms the distal end plug of the occlusion unit by at least one of welding, hot melting, film covering, binding, knotting or filling.

11. A delivery system characterized by, The delivery system comprises the occlusion stent according to any one of claims 1-10.

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