Vein valve

Abstract

The invention provides a venous valve. The venous valve comprises a valve frame and at least two valve leaflets, the valve frame comprises an annular supporting body, at least two valve feet and a combination layer. All the petal feet are connected in sequence to form an annular structure; the annular supporting body surrounds the periphery of the bottom of the annular structure and extends downwards from the periphery to form the annular supporting body; a plurality of suture holes are formed in the outer side face of the annular supporting body. All the suture holes are evenly formed in the circumferential direction of the annular supporting body. The outer surface of the valve frame is coated with a bonding layer; the number of the valve leaflets is the same as that of the valve feet, all the valve leaflets are arranged in the annular structure, the valve leaflets are made of polyurethane materials, and all the valve leaflets are connected with the bonding layer; a fiber layer is arranged on the outer surface of the valve leaflet; and a sewing film is arranged in the hole wall of each sewing hole. After the vein valve is implanted, lifelong anticoagulation is not needed, and the valve leaflet can have better anti-fatigue and anticoagulation performance and the like; the binding layer can enhance the binding force between the valve frame and the valve leaflet; the fiber layer can enhance the mechanical performance of the valve leaflet.

Description

Technical Field

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

[0003] Among them, venous hypertension caused by valvular disease is an important pathogenesis of varicose veins in the lower extremities. There are venous valves on the walls of the veins, especially in the veins of the lower extremities, which are more numerous and well-developed. They can prevent blood from flowing back and allow blood to flow toward the heart. In clinical diagnosis, the valve loses its normal one-way "valve" function, causing blood to flow back, which in turn causes increased pressure in some veins and gradually forms varicose veins.

[0004] Existing great saphenous vein stripping surgery or elastic bandage pressure therapy can effectively relieve the symptoms of chronic venous insufficiency, but studies have shown that the recurrence rate is high and the ulcer healing rate is low. Only by fundamentally repairing the function of the venous valve and changing the pathological state of venous blood reflux can the recurrence rate after treatment of chronic venous insufficiency be reduced and the ulcer healing rate be improved. Therefore, there are still a large number of patients who need deep vein valve reconstruction surgery to obtain better clinical efficacy.

[0005] Therefore, how to design a venous valve with strong mechanical properties, good fatigue resistance, no need for lifelong anticoagulation, and good anti-calcification performance is a problem that technical personnel in this field need to solve. Summary of the invention

[0006] In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a venous valve with strong mechanical properties, good fatigue resistance, no need for lifelong anticoagulation, and good anti-calcification performance.

[0007] In order to solve the above technical problems, the present invention provides a venous valve, comprising: a valve frame and at least two leaflets;

[0008] The valve frame includes an annular support body, at least two valve feet and a bonding layer; all the valve feet are connected in sequence to form an annular structure; surrounding the periphery of the bottom of the annular structure and extending downward therefrom, the annular support body is formed; the annular structure is coaxially arranged with the annular support body; a plurality of suture holes are arranged on the outer surface of the annular support body; all the suture holes are evenly arranged along the circumference of the annular support body; the outer surface of the valve frame is covered with the bonding layer;

[0009] The number of the leaflets is the same as the number of the petal feet, all the leaflets are arranged inside the annular structure, the leaflets are made of polyurethane material, and all the leaflets are connected to the combining layer; the outer surface of the leaflet is provided with a fiber layer; and a suture membrane is provided in the hole wall of each suture hole.

[0010] Preferably, all of the sewing films are integrally formed with the bonding layer.

[0011] Preferably, the fiber layer is made of polyurethane, polypropylene, polyethylene or nylon.

[0012] Preferably, the valve frame is made of polyetheretherketone, polyurethane, stainless steel alloy or nickel-titanium alloy.

[0013] Preferably, each of the leaflets has a fixed edge and a free edge, and the fixed edge of the leaflet is connected to the bonding layer; the free edge of each leaflet has an arc-shaped redundant portion; the free edges of two adjacent leaflets can fit together; when the free edges of all the leaflets are in a state of fitting together, the venous valve is in a closed state.

[0014] Furthermore, when the free edges of all the leaflets are in a mutually attached state, all the free edges converge to a central vertex;

[0015] When the central vertex is higher than the vertex of the petal foot, the angle between the horizontal plane passing through the vertex of the petal foot and the free edge of any one of the leaflets is 0 to 10°;

[0016] When the central apex is lower than the apex of the flap foot, the angle between the horizontal plane passing through the apex of the flap foot and any free edge of the leaflet is 0 to 30°.

[0017] Preferably, when the flap foot is in the expanded state, the bottom width of the flap foot is 6.28 mm to 20.94 mm.

[0018] Preferably, before the leaflet is formed, a bonding layer is first formed closely on the leaflet frame by a spraying or dipping process; then the leaflet is integrally formed on the bonding layer by at least one spraying or dipping process, and after the leaflet is formed, a fiber layer is formed on the surface of the leaflet by melt blowing or electrospinning.

[0019] As described above, the venous valve of the present invention has the following beneficial effects:

[0020] In the venous valve of the present invention, an annular support body is arranged at the lower part of the annular structure of the valve frame, so that the valve frame can be installed in the vein of the lower limb; the leaflets of the venous valve are made of polyurethane material, so that the venous valve does not need lifelong anticoagulation after implantation, the leaflets can have better anti-fatigue, anti-coagulation and other properties, and the flexibility of the leaflets is improved; since the polyurethane material has good anti-calcification properties, this can reduce the risk of calcification of the leaflets after implantation; the bonding layer can enhance the bonding force between the valve frame and the leaflets, and the surface of the valve frame is wrapped with the bonding layer, which can prevent the material of the valve frame from directly contacting human blood; after the leaflets are formed, a fiber layer is formed on the surface of the leaflets, and the fiber layer can enhance the mechanical properties of the leaflets and prevent the occurrence of failure modes such as cracks and crack extension caused by stress concentration in the leaflets. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the three-dimensional structure of the venous valve of Example 1 when it is in an unclosed state.

[0022] Figure 2 Shown is a schematic diagram of the three-dimensional structure of the valve frame of the venous valve of Example 1.

[0023] Figure 3 Shown is a schematic diagram of the three-dimensional structure of the leaflets of the venous valve of Example 1.

[0024] Figure 4 Shown is a schematic cross-sectional structure diagram of the venous valve of Example 1.

[0025] Figure 5 It is a schematic diagram of the side structure of the venous valve of Example 1 when it is in a closed state.

[0026] Figure 6 It is a schematic diagram of the three-dimensional structure of the venous valve of Example 2 when it is in a closed state.

[0027] Description of Figure Numbers

[0028] 100 Petal Rack

[0029] 110 Ring support

[0030] 120 Petal Foot

[0031] 130 Bonding layer

[0032] 140 Suture hole

[0033] 141 Suture film

[0034] 200 Leaflets

[0035] 210 Fixed edge

[0036] 220 Free Edge

[0037] 221 Arc Redundancy

[0038] W1 bottom width of the flap DETAILED DESCRIPTION

[0039] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0040] Please refer to the attached drawings. It should be noted that the structures, proportions, sizes, etc. illustrated in the attached drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0041] like Figures 1 to 5 As shown, the venous valve of this embodiment includes: a valve frame 100 and at least two leaflets 200;

[0042] The valve frame 100 includes an annular support body 110, at least two valve feet 120 and a bonding layer 130; all the valve feet 120 are connected in sequence to form an annular structure; the annular support body 110 is formed by surrounding the periphery of the bottom of the annular structure and extending downward therefrom; the annular structure is coaxially arranged with the annular support body 110; a plurality of suture holes 140 are arranged on the outer surface of the annular support body 110; all the suture holes 140 are evenly arranged along the circumference of the annular support body 110; the outer surface of the valve frame 100 is covered with a bonding layer 130;

[0043] The number of the leaflets 200 is the same as the number of the petal feet 120. All the leaflets 200 are arranged inside the annular structure. The leaflets 200 are made of polyurethane material. All the leaflets 200 are connected to the bonding layer 130. The outer surface of the leaflets 200 is provided with a fiber layer. The hole wall of each suture hole 140 is provided with a suture membrane 141. Each leaflet 200 is a one-layer or multi-layer structure, and each leaflet 200 is an arc-shaped structure. The leaflets 200 are formed by imitating the leaflet 200 structure of the human body valve.

[0044] In the venous valve of the present invention, an annular support body 110 is arranged at the lower part of the annular structure of the valve frame 100, so that the valve frame 100 can be installed in the vein of the lower limb; the leaflets 200 of the venous valve are made of polyurethane material, so that the venous valve does not need lifelong anticoagulation after implantation, and the leaflets 200 can have better anti-fatigue, anti-coagulation and other properties, and the flexibility of the leaflets 200 is improved; since the polyurethane material has good anti-calcification performance, this can reduce the risk of calcification of the leaflets 200 after implantation; the bonding layer 130 can enhance the bonding force between the valve frame 100 and the leaflets 200, and the surface of the valve frame 100 is wrapped with the bonding layer 130, which can prevent the material of the valve frame 100 from directly contacting human blood; after the leaflets 200 are formed, a fiber layer is formed on the surface of the leaflets 200, and the fiber layer can enhance the mechanical properties of the leaflets 200, and prevent the occurrence of failure modes such as cracks and crack extension caused by stress concentration in the leaflets 200.

[0045] In this embodiment, the central axis of the suture hole 140 is perpendicular to the central axis of the annular support body 110. The suture hole 140 is radially opened at the bottom end of the valve frame 100, and the suture hole 140 is for the suture needle to pass through.

[0046] All suture films 141 are integrally formed with the bonding layer 130. The material of the suture films 141 is the same as that of the bonding layer 130. This structure makes it possible to have no gaps at the suture holes 140, so that blood will not flow into the gaps, reducing the risk of leakage caused by the suture holes 140 and reducing the risk of hemolytic reaction.

[0047] The fiber layer is made of polyurethane, polypropylene, polyethylene or nylon. The fiber layer is made of thermoplastic polymer material, so that the mechanical properties of the leaflet 200 are enhanced.

[0048] The valve frame 100 is made of polyetheretherketone, polyurethane, stainless steel alloy or nickel-titanium alloy. The material of the valve frame 100 is a material with good biocompatibility and is suitable for implantation in the human body.

[0049] Each leaflet 200 has a fixed edge 210 and a free edge 220, and the fixed edge 210 of the leaflet 200 is connected to the bonding layer 130; the free edge 220 of each leaflet 200 has an arc-shaped redundant portion 221; the free edges 220 of two adjacent leaflets 200 can fit together; when the free edges 220 of all leaflets 200 are in a state of fitting together, the venous valve is in a closed state.

[0050] The free edge 220 of the leaflet 200 has an arc-shaped redundant portion 221, so that when all the leaflets 200 are closed, the width of the closed apposition edge of the leaflets 200 is increased, and the central leakage of the venous valve is reduced; when all the leaflets 200 are opened, the transvalvular pressure difference of the venous valve is reduced and the opening area is increased, so that the leaflets 200 can be opened under a smaller pressure. Under the action of blood flow, the leaflets 200 can be fully opened and fully closed; when the leaflets 200 are closed under pressure, the leaflets 200 can be fully closed, and the blood flow will not pass through the middle of the leaflets 200.

[0051] Each leaflet 200 has two arc-shaped redundant portions 221 . When the venous valve is in a closed state, all the leaflets 200 are closed, and the arc-shaped redundant portions 221 of two adjacent leaflets 200 fit together.

[0052] When the free edges 220 of all the leaflets 200 are in a mutually attached state, all the free edges 220 converge to a central vertex;

[0053] When the central vertex is higher than the vertex of the petal foot 120 , the angle between the horizontal plane passing through the vertex of the petal foot 120 and the free edge 220 of any leaflet 200 is 0 to 10°;

[0054] When the central vertex is lower than the vertex of the flap foot 120 , the angle between the horizontal plane passing through the vertex of the flap foot 120 and the free edge 220 of any flap 200 is 0 to 30°.

[0055] This structure makes the height of the central apex of the venous valve of this embodiment higher than the central apex of other existing venous valve products, so that the overall deformation of the leaflets 200 of the venous valve is reduced, thereby enhancing the fatigue resistance of the leaflets 200 and increasing the upper limit of the service life of the venous valve.

[0056] In this embodiment, the central vertex is lower than the vertex of the flap foot 120, and the angle A between the horizontal plane passing through the vertex of the flap foot 120 and the free edge 220 of any leaflet 200 is 5°.

[0057] When the flap foot 120 is in the expanded state, the bottom width W1 of the flap foot 120 is 6.28mm to 20.94mm. The flap foot 120 is triangular. The width of the flap foot 120 of this embodiment is increased compared to the width of the flap foot 120 of the existing venous valve. By increasing the width of the flap foot 120, the bonding force between the leaflet 200 and the valve frame 100 is increased, reducing the risk of valve failure caused by the leaflet 200 falling off. The flap foot 120 and the flange structure in the valve frame 100 are integrally machined or injection molded, without the need for additional assembly, reducing the risk of separation of the sewing ring assembly and the flap foot 120. In this embodiment, the bottom width W1 of the flap foot 120 is 8.37mm.

[0058] Before the leaflet 200 is formed, a bonding layer 130 is first formed by spraying or dipping on the valve frame 100 to enhance the bonding force between the valve frame 100 and the leaflet 200; the leaflet 200 is then formed integrally on the bonding layer 130 by one or more spraying or dipping processes. After the leaflet 200 is formed, a fiber layer is formed on the surface of the leaflet 200 by melt-blowing or electrostatic spinning. The fiber layer can enhance the mechanical properties of the leaflet 200 and prevent the occurrence of failure modes such as cracks and crack extension caused by stress concentration in the leaflet 200. The bonding layer 130 is made of polyurethane material, and the bonding layer 130 is made of the same material as the leaflet 200, so that the bonding layer 130 and the leaflet 200 can be formed integrally. Since the material of the suture membrane 141 is the same as that of the bonding layer 130, the suture membrane 141 and the leaflet 200 are also formed integrally.

[0059] The bonding layer 130 is a coating on the surface of the valve frame 100, and the bonding layer 130 is polyurethane; the material of the leaflet 200 is polyurethane, and the bonding layer 130 and the leaflet 200 are made of the same material; this can improve the anti-coagulation function, reduce the risk of thrombosis, and make the venous valve have good biocompatibility without the need for lifelong anticoagulation.

[0060] In this embodiment, the number of the leaflets 200 is three, and the venous valve is a trileaflet valve.

[0061] Example 2

[0062] like Figure 6 As shown, in this embodiment, the number of the leaflets 200 is two, and the venous valve is a bicuspid valve.

[0063] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0064] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A venous valve, characterized in that: include: A valve frame (100) and at least two valve leaflets (200); The flap frame (100) comprises an annular support body (110), at least two flap feet (120) and a bonding layer (130); all the flap feet (120) are connected in sequence to form an annular structure; The annular support body (110) is formed around the periphery of the bottom of the annular structure and extends downward therefrom; the annular structure is coaxially arranged with the annular support body (110); a plurality of suture holes (140) are arranged on the outer surface of the annular support body (110); all the suture holes (140) are evenly arranged along the circumference of the annular support body (110); the outer surface of the valve frame (100) is covered with the bonding layer (130); The number of the leaflets (200) is the same as the number of the leaflets (120), all the leaflets (200) are arranged inside the annular structure, the leaflets (200) are made of polyurethane material, and all the leaflets (200) are connected to the connecting layer (130); the outer surface of the leaflet (200) is provided with a fiber layer; and a suture membrane (141) is provided in the hole wall of each suture hole (140).

2. The venous valve according to claim 1, characterized in that: All of the sewing films (141) are integrally formed with the bonding layer (130).

3. The venous valve according to claim 1, characterized in that: The fiber layer is made of polyurethane, polypropylene, polyethylene or nylon.

4. The venous valve according to claim 1, characterized in that: The valve frame (100) is made of polyetheretherketone, polyurethane, stainless steel alloy or nickel-titanium alloy material.

5. The venous valve according to claim 1, characterized in that: Each of the leaflets (200) has a fixed edge (210) and a free edge (220), and the fixed edge (210) of the leaflet (200) is connected to the bonding layer (130); the free edge (220) of each leaflet (200) has an arc-shaped redundant portion (221); the free edges (220) of two adjacent leaflets (200) can fit together; when the free edges (220) of all the leaflets (200) are in a state of fitting together, the venous valve is in a closed state.

6. The venous valve according to claim 5, characterized in that: When the free edges (220) of all the leaflets (200) are in a mutually attached state, all the free edges (220) converge to a central vertex; When the central vertex is higher than the vertex of the flap foot (120), the angle between the horizontal plane passing through the vertex of the flap foot (120) and the free edge (220) of any one of the flaps (200) is 0 to 10°; When the central vertex is lower than the vertex of the flap foot (120), the angle between the horizontal plane passing through the vertex of the flap foot (120) and the free edge (220) of any one of the leaflets (200) is 0 to 30 degrees.

7. The venous valve according to claim 1, characterized in that: When the flap foot (120) is in an expanded state, the bottom width of the flap foot (120) is 6.28 mm to 20.94 mm.

8. The venous valve according to claim 1, characterized in that: Before the leaflet (200) is formed, a bonding layer (130) is first formed closely on the leaflet frame (100) by a spraying or dipping process; then, the leaflet (200) is integrally formed on the bonding layer (130) by at least one spraying or dipping process. After the leaflet (200) is formed, a fiber layer is formed on the surface of the leaflet (200) by melt-blowing or electrostatic spinning.

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