Three-valve deep venous stent

Abstract

The present invention belongs to the field of medical device technology, and specifically relates to a three-flap deep vein stent. A three-flap deep vein stent comprises: an opening and closing section; a covering film arranged on the opening and closing section; a supporting section, a hollow cylindrical structure, the inflow end of which is connected to the outflow end of the opening and closing section; a side leakage skirt, an annular structure with a diameter at the inflow end smaller than that at the outflow end, arranged on the outside of the supporting section; and an artificial leaflet, arranged on the inside of the opening and closing section. The present invention effectively prevents side leakage of blood by combining the design of the supporting section with the addition of a side leakage skirt and opening and closing the side leakage skirt.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a three-flap deep vein stent. Background Art

[0002] Many clinical conditions may require the placement of prosthetic implants to improve venous integrity or venous circulation. For example, conditions such as chronic venous insufficiency (CVI) or venous reflux can cause significant pain, itching, and swelling, which can lead to reduced patient activity and skin ulcers. These conditions can be caused by a number of underlying causes, including congenital weakness or absence of valves or venous walls, venous hypertension, and deep vein thrombosis.

[0003] Traditionally, these clinical conditions have been treated non-invasively, such as with anti-inflammatory or diuretic medications, compression garments, or other non-invasive therapies. More recently, invasive therapies such as the placement of implants such as venous valves are being developed as a way to reverse these debilitating conditions.

[0004] A stent is proposed in a Chinese patent for a venous valve prosthesis (publication number: "CN111991120A"), which utilizes a coating wrapped around the outside of the stent to compress the stent and / or crush and deform the artificial valve leaflets (coating) to pass and block blood flow. This design is not only inefficient, but can also easily cause blood vessel blockage or blood leakage if the blood vessels are severely contracted. Summary of the Invention

[0005] The present invention aims to provide a three-flap deep vein stent to solve the technical problem that existing venous stents easily cause blood vessel blockage or blood leakage.

[0006] A three-flap deep vein stent, comprising:

[0007] an opening and closing section;

[0008] a covering film, arranged on the outside of the opening and closing section;

[0009] an artificial valve leaflet, arranged inside the opening and closing section;

[0010] Also includes:

[0011] a supporting section with a hollow cylindrical structure, the inflow end of which is connected to the outflow end of the opening and closing section;

[0012] A ring-shaped structure with a leaky skirt on one side and a diameter of the inflow end smaller than the diameter of the outflow end is arranged outside the supporting section.

[0013] As a preferred solution, the opening and closing section is a spherical structure with small diameters at the inflow end and the outflow end and a large diameter in the middle.

[0014] As a preferred solution, the opening and closing section includes at least two groups of opening and closing monomers surrounding a spherical structure in a circumferential direction.

[0015] As a preferred embodiment, the opening and closing monomer includes:

[0016] Four curved connecting rods are distributed around the circumference and their ends on the inflow side are connected together;

[0017] The four curved connecting rods are respectively two outer rods and two inner rods, the two inner rods are respectively located between the two outer rods, and the outflow ends of the two adjacent outer rods of two adjacent opening and closing units are connected to each other;

[0018] The outflow end portion of the inner rod and the outflow end connecting portion of the adjacent outer rod are respectively connected to the inflow end of the supporting section.

[0019] As a preferred solution, the curved connecting rod includes:

[0020] an inflow section of a connecting rod, curving outward from an inflow end to an outflow end;

[0021] a connecting rod outflow section, which bends inward from the inflow end to the outflow end, and the inflow end is smoothly transitionally connected to the connecting rod inflow section;

[0022] A connecting rod connecting section extends toward the outflow end to the inflow end of the supporting section, and the inflow end is smoothly transitionally connected to the outflow section of the connecting rod.

[0023] As a preferred solution, the outer side of the opening and closing unit is provided with the covering film, and both side edges of the covering film are sewn to the outer rod of the opening and closing unit.

[0024] As a preferred solution, the edges of both sides of the artificial valve leaflet are sutured to the outer rod of the opening and closing unit, and the artificial valve leaflet and the covering membrane form a pocket structure;

[0025] A plurality of the opening and closing monomers having the pocket structure together form the opening and closing section that allows blood to pass in one direction.

[0026] As a preferred solution, the supporting section adopts a hollow structure, the hollow structure has a plurality of hollow grid frames, and the hollow structure is compressible.

[0027] As a preferred solution, the grid frame is a diamond frame, the support section is surrounded by at least one circle of diamond grid, the diamond grid has a plurality of hollow diamond frames, and the radial crests of the plurality of diamond frames are sequentially connected to form the diamond grid;

[0028] The outflow end connection parts of the adjacent outer rods are connected to the inflow end crests of one corresponding diamond frame, and the outflow end parts of the two inner rods adjacent to the two outer rods are respectively connected to the inflow end crests of the diamond frames on both sides.

[0029] As a preferred solution, the diamond-shaped frame includes:

[0030] A V-shaped frame having two inflow end support rods, wherein the two inflow end support rods are smoothly connected at the inflow end to form an inflow end wave crest;

[0031] An inverted V-shaped frame having two outflow end support rods, wherein the two outflow end support rods are smoothly connected at the outflow end to form an outflow end crest;

[0032] The outflow end portions of the two inflow end support rods are respectively connected to the inflow end portions of the two outflow end support rods to form two radial wave peaks.

[0033] As a preferred solution, the two inflow-end support rods and the two outflow-end support rods are rods with the widest width at both ends and the narrowest width in the middle.

[0034] As a preferred solution, a recess protruding radially outward is provided on the inner wall of the radial wave crest.

[0035] As a preferred solution, the inflow end of the side leakage skirt is sealed and connected to the covering membrane, or forms an integral structure with the covering membrane.

[0036] As a preferred solution, the outflow end of the side leakage skirt is a wavy pleated edge.

[0037] As a preferred solution, the axial length of the three-flap deep vein stent is greater than the radial maximum diameter of the three-flap deep vein stent.

[0038] As a preferred solution, the three-flap deep vein stent further includes:

[0039] A stabilizing section is provided at the outflow end of the supporting section. The stabilizing section adopts the same structure as the opening and closing section and is radially symmetrical with the opening and closing section.

[0040] As a preferred solution, the maximum diameter of the stabilizing section is greater than the maximum diameter of the opening and closing section.

[0041] As a preferred solution, the width of the four curved connecting rods of the stabilizing section is greater than the width of the four curved connecting rods of the opening and closing section.

[0042] As a preferred solution, a plurality of barbs are provided on at least one of the maximum diameter of the stabilizing section or the maximum diameter of the opening and closing section.

[0043] The positive progress of the present invention is that the present invention adopts a three-flap deep vein stent, which has the following advantages:

[0044] 1. The design of the support section is combined with the addition of a side leakage skirt. The opening and closing of the side leakage skirt effectively prevents side leakage of blood.

[0045] 2. The opening and closing section adopts a spherical structure, which can effectively increase the support force of the opening and closing section. The middle part with the largest diameter is used to clamp to the inner wall of the blood vessel, increasing the stability of the stent in the blood vessel.

[0046] 3. In order to achieve better unidirectional blood flow through the opening and closing section, a covering is provided on the outside of each opening and closing unit, and an artificial valve leaflet is provided on the inside of each opening and closing unit to achieve the best unidirectional blood flow effect.

[0047] 4. By designing the specific structure of the support section, the mechanical properties of the bracket during deformation are optimized, especially the design of the notch. During the compression of the support section, the deformation of this position is relatively large. Adding the notch reduces the bending stress at the connection position of the support rod, which can prevent the support rod from breaking during the compression and self-expansion process of the support section of the bracket.

[0048] 5. In order to prevent blood from flowing back from the gap between the stent and the vascular stent and / or the gap between adjacent opening and closing monomers, a side leakage skirt is set at the supporting section. When the pressure of the blood at the outflow end is greater than the pressure at the inflow end, the artificial valve leaflet is closed, and the outflow end of the side leakage skirt opens to the surroundings under the action of blood, closing the gap between the supporting section and the blood vessel. The setting of the side leakage skirt effectively prevents blood from flowing back from the gap between the stent and the blood vessel.

[0049] 6. In order to allow the outflow end of the side leakage skirt to open better and fit the blood vessel wall better, the outflow end of the side leakage skirt is a wavy pleated edge.

[0050] 7. In order to stably maintain the stent in the blood vessel, the present invention also provides a stabilizing section that is symmetrical with the opening and closing section. In order to better fix the stent with the stabilizing section, the maximum diameter of the stabilizing section is the largest diameter in the stent, thereby providing greater supporting force.

[0051] 8. Barbs are provided at the maximum diameter of the stable section or at the maximum diameter of the opening and closing section to better fix the bracket. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] FIG1( a ) is a schematic structural diagram of an embodiment of the present invention;

[0053] FIG1( b ) is a schematic diagram of FIG1( a ) from another angle;

[0054] Figure 1(c) is a front view of Figure 1(a);

[0055] FIG2( a ) is a diagram showing the connection relationship between the opening and closing section and the supporting section in FIG1( a );

[0056] Figure 2(b) is a front view of Figure 2(a);

[0057] Figure 2(c) is a schematic diagram of an expansion of Figure 2(a);

[0058] Figure 2(d) is a compression schematic diagram of Figure 2(c);

[0059] FIG3( a ) is a schematic structural diagram of a side leakage skirt of the present invention;

[0060] FIG3( b ) is a top view of FIG3( a );

[0061] Figure 3(c) is a partial enlarged view of Figure 3(a);

[0062] FIG4( a ) is a schematic structural diagram of another embodiment of the present invention;

[0063] FIG4( b ) is a schematic diagram of FIG4( a ) from another angle;

[0064] FIG4( c ) is a front view of FIG4( a );

[0065] FIG5(a) is a diagram showing the connection relationship between the opening and closing section, the supporting section and the stabilizing section in FIG4(a);

[0066] Figure 5(b) is a front view of Figure 5(a);

[0067] FIG5( c ) is a schematic diagram of an expansion of FIG5( a );

[0068] Figure 5(d) is a compression schematic diagram of Figure 5(c);

[0069] Figure 5(e) is a partial enlarged view of Figure 5(d);

[0070] Figure 6 and Figure 7 This is a schematic diagram of an application of the present invention. DETAILED DESCRIPTION

[0071] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0072] In the present invention, when describing a three-valve deep vein stent, the "inflow end" refers to the direction in which blood normally flows. After the three-valve deep vein stent is implanted, the blood flows into one end of the deep vein stent; accordingly, the "outflow end" refers to the direction in which blood normally flows. After the three-valve deep vein stent is implanted, the blood flows out of one end of the three-valve deep vein stent.

[0073] In the present invention, when describing the three-flap deep vein stent, "axial" refers to the direction between the "inflow end" and the "outflow end." "Radial" refers to the direction perpendicular to the "axial" direction.

[0074] Reference Figure 1(a) to Figure 5(e) A three-valve deep vein stent includes an opening and closing section 100, a supporting section 200, a side leakage skirt 400, a covering 500 and an artificial valve leaflet 600.

[0075] The support section 200 is a hollow cylindrical structure, with its inflow end connected to the outflow end of the opening and closing section 100. The side leakage skirt 400 is an annular structure with a smaller diameter at the inflow end than at the outflow end. The side leakage skirt 400 is located outside the support section 200. The membrane 500 is located outside the opening and closing section 100, while the artificial valve leaflets 600 are located inside the opening and closing section 100.

[0076] Reference Figure 6 , when blood flows from the inflow end through the three-flap deep vein stent of the present invention, it can flow smoothly out of the outflow end. Figure 7 , blood flows from the outflow end through the three-valve deep vein stent of the present invention, but is blocked by the opening and closing section 100, the covering membrane 500, the artificial valve leaflet 600 and other structures, and cannot flow out to the inflow end. In order to prevent blood from flowing back from the gap between the stent and the vascular stent, a side leakage skirt 400 is provided on the supporting section 200. When the pressure at the outflow end of the blood is greater than the pressure at the inflow end, as shown in FIG. Figure 7 As shown in the figure, the outflow end of the side leakage skirt 400 opens to the surroundings under the action of blood, closing the gap between the support section 200 and the blood vessel. The setting of the side leakage skirt 400 effectively prevents blood from flowing back from the gap between the stent and the blood vessel.

[0077] The present invention effectively prevents side leakage of blood by combining the design of the supporting section 200 with the side leakage skirt 400 and opening and closing the side leakage skirt 400.

[0078] In some embodiments, referring to FIG. 2( a ) and FIG. 2 ( b ), the opening and closing section 100 is a spherical structure having small diameters at the inflow end and the outflow end and a large diameter in the middle.

[0079] Through the structural design with small diameters at both ends and a large diameter in the middle, the opening and closing section 100 forms a spherical structure, the middle of which is used to clamp to the inner wall of the blood vessel, which can effectively increase the supporting force of the opening and closing section 100. The spherical structure increases the stability of the entire stent in the blood vessel.

[0080] In some embodiments, referring to FIG. 2( a ) and FIG. 2 ( d ), the opening and closing section 100 includes at least two groups of opening and closing monomers 110 circumferentially surrounding a spherical structure.

[0081] The opening and closing section 100 can be formed by two, three, four or more groups of opening and closing monomers 110. As shown in FIG2(a), three groups of opening and closing monomers 110 are used to form a spherical opening and closing section 100.

[0082] In some embodiments, referring to FIG. 2( b ), the opening and closing unit 110 includes four curved connecting rods 111 distributed circumferentially, with the inflow-side ends of the four curved connecting rods 111 being connected together. The four curved connecting rods 111 are respectively two outer rods 111a and two inner rods 111b. The two inner rods 111b are positioned between the two outer rods 111a. The outflow ends of two adjacent outer rods 111a of two adjacent opening and closing units 110 are connected to each other. The outflow ends of the inner rods 111b and the outflow connection portions of the adjacent outer rods 111a are respectively connected to the inflow end of the support section 200.

[0083] In some embodiments, referring to FIG2( b ), a single curved connecting rod 111 includes a connecting rod inflow section 1111, a connecting rod outflow section 1112, and a connecting rod connecting section 1113 integrally connected from the inflow end to the outflow end. The connecting rod inflow section 1111 bends outward from the inflow end to the outflow end, and the connecting rod outflow section 1112 bends inward from the inflow end to the outflow end. The inflow end of the connecting rod outflow section 1112 is smoothly connected to the outflow end of the connecting rod inflow section 1111. The connecting rod connecting section 1113 extends toward the outflow end to the inflow end of the support section 200, and the inflow end of the connecting rod connecting section 1113 is smoothly connected to the outflow end of the connecting rod outflow section 1112.

[0084] In some embodiments, reference Figure 1(a) to Figure 1(c) A covering film 500 is provided on the outside of each opening and closing unit 110 , and both side edges of the covering film 500 are sewn to the outer rod 111 a of the opening and closing unit 110 .

[0085] In some embodiments, the material of the coating 500 can be made of polymer materials such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene) or animal pericardial biological tissue. The coating 500 covers the outer surface of the opening and closing monomer to prevent blood leakage and achieve a sealing effect.

[0086] In some embodiments, an artificial valve leaflet 600 is disposed on the inner side of each opening / closing unit 110. The two side edges of the artificial valve leaflet 600 are sutured to the outer rod 111a of the opening / closing unit 110. The artificial valve leaflet 600 and the covering 500 form a pocket structure. Multiple opening / closing units 110 with pocket structures together form an opening / closing section 100 that allows for unidirectional blood flow.

[0087] In some embodiments, the material of the artificial valve leaflet 600 can include one or more synthetic materials, engineered biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed / treated tissues, or combinations thereof.

[0088] In some embodiments, the pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissue, or a combination thereof.

[0089] In some embodiments, the supporting section 200 adopts a hollow structure having a plurality of hollow grid frames, and the hollow structure is compressible.

[0090] In some embodiments, referring to Figures 2(c) and 5(c), the opening and closing section 100 and the supporting section 200 are shown in the expanded state. When the opening and closing section 100 and the supporting section 200 are compressed, as shown in Figures 2(d) and 5(d), the opening and closing section 100 and the supporting section 200 are compressed axially, and the radial diameter becomes smaller, so that the compressed stent can be compressed and delivered to the target position in the blood vessel through an external delivery device.

[0091] In some embodiments, reference Figure 2(a) to Figure 2(d) The grid frame is a diamond-shaped frame, and the support section 200 is surrounded by at least one circle of diamond-shaped grid frames. The diamond-shaped grid frame has a plurality of hollow diamond-shaped frames 210, and the radial crests of the plurality of diamond-shaped frames 210 are sequentially connected to form a diamond-shaped grid frame. The outflow end connection portion of the adjacent outer rod 111a is connected to the inflow end crest 211a of one of the corresponding diamond-shaped frames 210, and the outflow end portions of the two inner rods 111b adjacent to the two outer rods 111a are respectively connected to the inflow end crest 211a of the adjacent diamond-shaped frames 210 on both sides. That is, as shown in Figure 2(b), among the three adjacent diamond-shaped frames 210, the inflow end crest 211a of the middle diamond-shaped frame 210 is connected to the outflow end connection portion of the adjacent outer rod 111a, and the inflow end crest 211a of the two diamond-shaped frames 210 on both sides are respectively connected to the outflow end portions of the two inner rods 111b on both sides.

[0092] In some embodiments, referring to FIG. 2( b ), the diamond frame 210 includes a V-shaped frame and an inverted V-shaped frame. The V-shaped frame includes two inflow support rods 211, which are smoothly connected at the inflow end to form an inflow end wave crest 211a. The inverted V-shaped frame includes two outflow support rods 212, which are smoothly connected at the outflow end to form an outflow end wave crest 212a. The outflow end portions of the two inflow support rods 211 are integrally connected to the inflow end portions of the two outflow support rods 212 to form two radial wave crests 213a.

[0093] In some embodiments, the two inflow-end support rods 211 and the two outflow-end support rods 212 are rods with the widest width at both ends and the narrowest width in the middle, so as to optimize the mechanical properties of the stent when it is deformed.

[0094] In some embodiments, referring to FIG5(e), radially outwardly projecting recesses 214 are provided on the inner wall of radial peaks 213a. As shown in FIG2(d) and FIG5(e), during compression of the support segment 200, this location experiences significant deformation. The addition of recesses 214 reduces bending stress at the support rod connection location, thereby preventing the support rod from breaking during compression and self-expansion of the support segment 200.

[0095] In some embodiments, the inflow end of the side leakage skirt 400 is sealed and connected to the covering 500, or the inflow end of the side leakage skirt 400 and the covering 500 are an integral structure. The provision of the side leakage skirt 400 effectively prevents blood from flowing back through the gap between the stent and the blood vessel.

[0096] In some embodiments, reference Figure 3(a) to Figure 3(c) The outflow end of the side leakage skirt 400 is a wavy pleated edge 410. The wavy pleated edge 410 enables the outflow end of the side leakage skirt 400 to be better opened, and the side leakage skirt 400 can better fit the blood vessel wall.

[0097] In some embodiments, the material of the leakage skirt 400 can include one or more synthetic materials, engineered biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed / treated tissues, or combinations thereof.

[0098] In some embodiments, the pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissue, or a combination thereof.

[0099] In some embodiments, referring to FIG1(c), a three-flap deep vein stent having an opening and closing section 100, a supporting section 200, a side leakage skirt 400 and a covering 500 has an axial length H that is greater than its radial maximum diameter D to prevent the three-flap deep vein stent from rolling over in the blood vessel.

[0100] In some embodiments, reference Figures 4(a) to 5(d) The three-valve deep vein stent also includes a stabilizing section 300, which is arranged on the side of the outflow end of the supporting section 200 and connected to the outflow end of the supporting section 200. The stabilizing section 300 adopts the same structure as the opening and closing section 100 and is radially symmetrical with the opening and closing section 100.

[0101] To stably maintain the stent within the blood vessel, the present invention further includes a stabilizing section 300 that is symmetrical to the opening and closing section 100. Because the stabilizing section 300 is used to secure the stent, no covering 500 is provided outside the stabilizing section 300, nor are artificial valve leaflets 600 provided inside the stabilizing section 300.

[0102] In some embodiments, the stabilizing section 300 is a spherical structure with small diameters at the inflow and outflow ends and a large diameter in the middle. The middle portion of the stabilizing section 300 is used to clamp onto the inner wall of the blood vessel, further stably holding the stent in the blood vessel.

[0103] In some embodiments, the stabilizing section 300 includes at least two groups of opening and closing monomers 310 surrounding a spherical structure in a circumferential direction. The number of groups of opening and closing monomers 310 is the same as the number of groups of opening and closing monomers 110 of the opening and closing section 100 and they are symmetrically arranged.

[0104] The stabilizing section 300 can be formed by two, three, four or more groups of opening and closing monomers 310. As shown in FIG5(a), three groups of opening and closing monomers 310 are used to form a spherical stabilizing section 300.

[0105] In some embodiments, the specific structure of the opening and closing monomer 310 is also the same as the opening and closing monomer 110 and is symmetrically arranged. Referring to Figure 5(b), the opening and closing monomer 310 includes four curved connecting rods 311, which are distributed circumferentially, and the ends of the four curved connecting rods 311 on the outflow side are connected together. The four curved connecting rods 311 are respectively two outer rods 311a and two inner rods 311b, and the two inner rods 311b are respectively located between the two outer rods 311a. The ends of the inflow ends of two adjacent outer rods 311a of two adjacent opening and closing monomers 310 are connected to each other. The inflow end ends of the inner rods 311b and the inflow end connecting portions of the adjacent outer rods 311a are respectively connected to the outflow end of the support section 200.

[0106] In some embodiments, referring to FIG5( b ), a single curved connecting rod 311 includes a connecting rod outflow section 3111, a connecting rod inflow section 3112, and a connecting rod connecting section 3113, which are integrally connected from the outflow end to the inflow end. The connecting rod outflow section 3111 bends outward from the outflow end to the inflow end, while the connecting rod inflow section 3112 bends inward from the outflow end to the inflow end. The outflow end of the connecting rod inflow section 3112 is smoothly connected to the inflow end of the connecting rod outflow section 3111. The connecting rod connecting section 3113 extends toward the inflow end to the outflow end of the support section 200, and the outflow end of the connecting rod connecting section 3113 is smoothly connected to the inflow end of the connecting rod inflow section 3112.

[0107] In some embodiments, when the support section 200 is formed by at least one circle of diamond-shaped grids, the inflow end connection portions of adjacent outer rods 311a are connected to the outflow end crests 212a of one of the corresponding diamond-shaped frames 210, and the inflow end portions of the two inner rods 311b adjacent to the two outer rods 311a are respectively connected to the outflow end crests 212a of the adjacent diamond-shaped frames 210 on both sides. That is, as shown in FIG5(b), among the three adjacent diamond-shaped frames 210, the outflow end crest 212a of the middle diamond-shaped frame 210 is connected to the inflow end connection portion of the adjacent outer rod 311a, and the outflow end crests 212a of the two diamond-shaped frames 210 on both sides are respectively connected to the inflow end portions of the two inner rods 311b on both sides.

[0108] In some embodiments, the maximum diameter of the stabilizing section 300 is greater than the maximum diameter of the opening and closing section 100. To better fix the stabilizing section 300 to the stent, the maximum diameter of the stabilizing section 300 is the largest in the stent, thereby providing greater support.

[0109] In some embodiments, the width of the four curved links 311 of the stabilizing section 300 is greater than the width of the four curved links 111 of the opening and closing section 100 , so as to provide a better fixing bracket for the stabilizing section 300 and thus provide greater supporting force.

[0110] In some embodiments, for better fixation, a plurality of barbs (not shown) are provided at the maximum diameter of the stabilizing section 300 for fixing the three-flap deep vein stent of the present invention.

[0111] In some embodiments, in order to make the stent more stably fixed in the blood vessel, a plurality of barbs (not shown) are also provided at the maximum diameter of the opening and closing section 100 for fixing the three-flap deep vein stent of the present invention.

[0112] In some embodiments, the opening and closing section 100 and the supporting section 200, or the opening and closing section 100, the supporting section 200 and the stabilizing section 300 of the three-flap deep vein stent can be constructed as a single integral piece, or constructed as independent pieces and connected together, for example, by welding, fusion, bonding or mechanical attachment.

[0113] In some embodiments, the opening and closing section 100 and the supporting section 200, or the opening and closing section 100, the supporting section 200 and the stabilizing section 300 of the three-flap deep vein stent can be made of materials commonly known for stents, such as, but not limited to, stainless steel, Nitinol (nickel-titanium shape memory alloy), (cobalt-chromium-nickel alloys), some biocompatible plastics, and combinations thereof.

[0114] In some embodiments, the tri-valve deep vein stent may be a self-expanding stent or may be a balloon-expandable stent.

[0115] In some embodiments, reference Figure 6 and Figure 7 The three-flap deep vein stent in Figure 4(a) is placed in the target position of the blood vessel 700, and the maximum diameter of the opening and closing section 100 and the maximum diameter of the stable section 300 of the three-flap deep vein stent are respectively clamped to the inner wall of the blood vessel to support the entire three-flap deep vein stent.

[0116] like Figure 6 As shown in the figure, blood can flow smoothly from the inflow end through the three-flap deep vein stent to the outflow end. Figure 7 As shown in , when blood flows from the outflow end through the three-valve deep vein stent, the pressure at the outflow end is greater than the pressure at the inflow end. Due to the one-way flow effect of the covering 500 of the opening and closing section 100 and the artificial valve leaflet 600, the artificial valve leaflet is closed at this time to prevent blood from flowing out. The outflow end of the side leakage skirt 400 opens to the surroundings under the action of blood, closing the gap between the supporting section 200 and the blood vessel 700, effectively preventing blood from flowing back from the gap between the three-valve deep vein stent and the blood vessel 700.

[0117] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A three-flap deep vein stent, comprising: An opening and closing section, comprising at least two groups of opening and closing monomers surrounding a spherical structure; a covering film, arranged on the outside of the opening and closing section, and the covering film is arranged on the outside of the opening and closing unit; an artificial valve leaflet, disposed inside the opening and closing section, wherein the artificial valve leaflet and the covering membrane form a pocket structure, and a plurality of the opening and closing units having the pocket structure together form an opening and closing section that allows blood to flow in a unidirectional manner; It is characterized by further comprising: a supporting section with a hollow cylindrical structure, the inflow end of which is connected to the outflow end of the opening and closing section; A ring-shaped structure with a leaky skirt on one side and a diameter of the inflow end smaller than the diameter of the outflow end is arranged outside the supporting section.

2. The three-flap deep vein stent according to claim 1, characterized in that: The opening and closing section is a spherical structure with small diameters at the inflow end and the outflow end and a large diameter in the middle.

3. The three-flap deep vein stent according to claim 1, characterized in that: The opening and closing monomer comprises: Four curved connecting rods are distributed around the circumference and their ends on the inflow side are connected together; The four curved connecting rods are respectively two outer rods and two inner rods, the two inner rods are respectively located between the two outer rods, and the outflow ends of the two adjacent outer rods of two adjacent opening and closing units are connected to each other; The outflow end portion of the inner rod and the outflow end connecting portion of the adjacent outer rod are respectively connected to the inflow end of the supporting section.

4. The three-flap deep vein stent according to claim 3, characterized in that: The curved connecting rod includes: an inflow section of a connecting rod, curving outward from an inflow end to an outflow end; a connecting rod outflow section, which bends inward from the inflow end to the outflow end, and the inflow end is smoothly transitionally connected to the connecting rod inflow section; A connecting rod connecting section extends toward the outflow end to the inflow end of the supporting section, and the inflow end is smoothly transitionally connected to the outflow section of the connecting rod.

5. The three-flap deep vein stent according to claim 3, characterized in that: The two side edges of the covering film are sewn to the outer rod of the opening and closing unit.

6. The three-flap deep vein stent according to claim 5, characterized in that: The edges of both sides of the artificial valve leaflet are sutured to the outer rod of the opening and closing unit.

7. The three-flap deep vein stent according to claim 3, characterized in that: The supporting section adopts a hollow structure, the hollow structure has a plurality of hollow grid frames, and the hollow structure is compressible.

8. The three-flap deep vein stent according to claim 7, characterized in that: The grid frame is a diamond-shaped frame, and the support section is surrounded by at least one circle of diamond-shaped grids. The diamond-shaped grid has a plurality of hollow diamond-shaped frames, and radial crests of a plurality of the diamond-shaped frames are sequentially connected to form the diamond-shaped grid. The outflow end connection parts of the adjacent outer rods are connected to the inflow end crests of one corresponding diamond frame, and the outflow end parts of the two inner rods adjacent to the two outer rods are respectively connected to the inflow end crests of the diamond frames on both sides.

9. The three-flap deep vein stent according to claim 8, characterized in that: The diamond-shaped frame includes: A V-shaped frame having two inflow end support rods, wherein the two inflow end support rods are smoothly connected at the inflow end to form an inflow end wave crest; An inverted V-shaped frame having two outflow end support rods, wherein the two outflow end support rods are smoothly connected at the outflow end to form an outflow end crest; The outflow end portions of the two inflow end support rods are respectively connected to the inflow end portions of the two outflow end support rods to form two radial wave peaks.

10. The three-flap deep vein stent according to claim 9, characterized in that: The two inflow end support rods and the two outflow end support rods are rods with the widest width at both ends and the narrowest width in the middle.

11. The three-flap deep vein stent according to claim 9, characterized in that: A recess protruding radially outward is provided on the inner wall of the radial wave crest.

12. The three-flap deep vein stent according to claim 1, characterized in that: The inflow end of the side leakage skirt is sealed and connected to the covering membrane, or forms an integral structure with the covering membrane.

13. The three-flap deep vein stent according to claim 1, characterized in that: The outflow end of the side leakage skirt is a wavy pleated edge.

14. The three-flap deep vein stent according to claim 1, characterized in that: The axial length of the three-flap deep vein stent is greater than the radial maximum diameter of the three-flap deep vein stent.

15. The three-flap deep vein stent according to any one of claims 1 to 14, characterized in that: The three-flap deep vein stent further includes: A stabilizing section is provided at the outflow end of the supporting section. The stabilizing section adopts the same structure as the opening and closing section and is radially symmetrical with the opening and closing section.

16. The three-flap deep vein stent according to claim 15, characterized in that: The maximum diameter of the stabilizing section is greater than the maximum diameter of the opening and closing section.

17. The three-flap deep vein stent according to claim 15, characterized in that: The width of the four curved connecting rods of the stabilizing section is greater than the width of the four curved connecting rods of the opening and closing section.

18. The three-flap deep vein stent according to claim 15, characterized in that: A plurality of barbs are provided on at least one of the maximum diameter position of the stabilizing section or the maximum diameter position of the opening and closing section.

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