Prosthetic valve

Abstract

The invention provides an artificial valve. The artificial valve comprises a valve frame, at least two valve leaflets and a suture ring assembly. The valve frame comprises valve feet, a flange structure and a combination layer, and at least two valve feet are installed on the inner side face of the flange structure; all the petal feet are connected in sequence to form an annular structure; a plurality of suture holes are formed in the top surface of the flange structure; the outer surface of the valve frame is coated with the bonding layer; all the valve leaflets are arranged in the annular structure and are connected with the bonding layer; a fiber layer is arranged on the outer surface of the valve leaflet; the valve leaflet is made of a polyurethane material; the suture ring assembly wraps the outer side face of the flange structure. The valve leaflet of the artificial valve can have better fatigue resistance, anticoagulation and the like, and the risk of calcification of the valve leaflet after implantation can be reduced. The binding layer can enhance the binding force between the valve frame and the valve leaflet; a fiber layer is formed on the surface of the valve leaflet and can enhance the mechanical performance of the valve leaflet.

Description

Technical Field

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

[0002] The number of patients with heart valve disease is very large, and there is a great need for treatment. Among heart disease patients, valvular disease is a disease with a high incidence rate.

[0003] Essentially, valvular disease is an elderly disease. As residents age, the prevalence of valvular disease gradually increases, and it is expected that the number of patients with valvular disease will gradually increase in the future.

[0004] For patients with severe valvular heart disease, replacing an artificial heart valve is the most effective treatment. According to the materials used to make the valve, artificial heart valves can be divided into mechanical valves and biological valves. At present, artificial heart valves are mainly biological valves and mechanical valves, with the clinical application ratio of biological valves being 45% and that of mechanical valves being 55%. Mechanical valves are made of pyrolytic carbon, and biological valves are made of biological tissues of pigs, cows, etc. Mechanical valves are designed to have a longer service life, generally more than 50 years, but are more prone to related complications, and require lifelong anticoagulant medication and coagulation function testing, which greatly affects the patient's quality of life. The service life of biological valves is shorter than that of mechanical valves, but anticoagulants only need to be taken 3 to 6 months after surgery. Since the service life of biological valves is only 10 to 15 years, it is difficult to meet the needs of the increasingly younger patients with valvular disease. Some patients even experience valve tissue calcification shortly after valve replacement, causing valve failure.

[0005] How to design an artificial 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 an artificial 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 an artificial valve, comprising: a valve frame, at least two valve leaflets and a sewing ring assembly;

[0008] The flap frame comprises flap feet, a flange structure and a bonding layer, at least two flap feet are installed on the inner side of the flange structure; all the flap feet are connected in sequence to form a ring structure; a plurality of suture holes are arranged on the top surface of the flange structure; the outer surface of the flap 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, and all the leaflets are connected to the bonding layer; the outer surface of the leaflet is provided with a fiber layer; the leaflet is made of polyurethane material;

[0010] The sewing ring assembly is wrapped around the outer side of the flange structure.

[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, the sewing ring assembly is a double-layer structure; the outer layer structure of the sewing ring assembly is a non-woven fabric layer or a polyester fabric layer; the inner layer structure of the sewing ring assembly is a non-woven fabric layer, and the inner layer structure of the sewing ring assembly is wrapped on the outer side of the flange structure.

[0014] Preferably, the sewing ring assembly is a single-layer structure, and the single-layer structure is a non-woven fabric layer.

[0015] 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 artificial valve is in a closed state.

[0016] Furthermore, when the free edges of all the leaflets are in a mutually attached state, all the free edges converge to a central vertex;

[0017] 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°;

[0018] 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°.

[0019] Preferably, when the flap foot is in the expanded state, the bottom width of the flap foot is 17.8 mm to 34.6 mm.

[0020] 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.

[0021] As described above, the artificial valve of the present invention has the following beneficial effects:

[0022] The leaflets of the artificial valve of the present invention are made of polyurethane material, so that the artificial 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 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 to 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

[0023] Figure 1 It is a schematic diagram of the three-dimensional structure of the artificial valve of Example 1 when it is in an unclosed state.

[0024] Figure 2 Shown is a schematic diagram of the three-dimensional structure of the valve frame of the artificial valve of Example 1.

[0025] Figure 3 Shown is a schematic diagram of the three-dimensional structure of the leaflets of the artificial valve of Example 1.

[0026] Figure 4 Shown is a schematic diagram of the cross-sectional structure of the leaflets of the artificial valve of Example 1.

[0027] Figure 5 Display as Figure 4 Schematic diagram of the enlarged structure at A.

[0028] Figure 6 It is a schematic diagram of the three-dimensional structure of the artificial valve of Example 1 when it is in a closed state.

[0029] Figure 7 Shown is a schematic diagram of the three-dimensional structure of the artificial valve of Example 2.

[0030] Figure 8 Shown is a schematic side view of the structure of the artificial valve of Example 2.

[0031] Fig. 9 Shown is a schematic diagram of the three-dimensional structure of the artificial valve of Example 3.

[0032] Fig.10 Shown is a schematic diagram of the three-dimensional structure of the artificial valve of Example 4.

[0033] Description of Figure Numbers

[0034] 100 Petal Rack

[0035] 110 Petal Foot

[0036] 120 Flange structure

[0037] 121 Suture hole

[0038] 130 Bonding layer

[0039] 200 Leaflets

[0040] 210 Fixed edge

[0041] 220 Free Edge

[0042] 221 Arc Redundancy

[0043] 300 Suture Ring Assembly

[0044] 310 Outer structure

[0045] 320 Inner structure

[0046] W1 bottom width of the flap DETAILED DESCRIPTION

[0047] 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.

[0048] 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.

[0049] like Figures 1 to 6 As shown, the artificial valve of this embodiment includes: a valve frame 100, at least two valve leaflets 200 and a sewing ring assembly 300;

[0050] The valve frame 100 includes a valve foot 110, a flange structure 120 and a bonding layer 130. At least two valve feet 110 are installed on the inner side of the flange structure 120. All the valve feet 110 are connected in sequence to form a ring structure. A plurality of suture holes 121 are provided on the top surface of the flange structure 120. The outer surface of the valve frame 100 is covered with a bonding layer 130.

[0051] The number of the leaflets 200 is the same as the number of the petal feet 110. All the leaflets 200 are arranged inside the annular structure, and all the leaflets 200 are connected to the bonding layer 130. The outer surface of the leaflet 200 is provided with a fiber layer. The leaflet 200 is made of polyurethane material. Each leaflet 200 is a one-layer or multi-layer structure, and each leaflet 200 is an arc-shaped structure. The leaflet 200 is formed by imitating the leaflet structure of the human valve.

[0052] The sewing ring assembly 300 is wrapped around the outer side of the flange structure 120 .

[0053] The leaflets 200 of the artificial valve of the present invention are made of polyurethane material, so that the artificial valve does not need lifelong anticoagulation after implantation, 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 anti-calcification properties, 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.

[0054] 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.

[0055] 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.

[0056] The sewing ring assembly 300 is a double-layer structure; the outer layer structure 310 of the sewing ring assembly 300 is a non-woven fabric layer or a polyester fabric layer; the inner layer structure 320 of the sewing ring assembly 300 is a non-woven fabric layer, and the inner layer structure 320 of the sewing ring assembly 300 is wrapped on the outer side of the flange structure 120. The outer layer structure 310 is arranged outside the inner layer structure 320. Alternatively, the sewing ring assembly 300 is a single-layer structure, and the single-layer structure is a non-woven fabric layer. In this embodiment, the sewing ring assembly 300 is a double-layer structure. The polyester fabric layer has greater pulling force, tension, and load-bearing capacity, and can avoid damage, shedding, and other adverse events such as thrombosis during implantation. There are fine meshes in the non-woven fabric layer and the polyester fabric layer, which is more conducive to the growth of human tissue and allows the native valve ring to be combined and fixed with the sewing ring assembly 300 as soon as possible.

[0057] The sewing ring assembly 300 is sewn to the flange structure 120 by means of sutures, or the sewing ring assembly 300 is bonded to the flange structure 120 by means of glue, so that the sewing ring assembly 300 and the flange structure 120 can be stably connected together.

[0058] All suture holes 121 are evenly arranged along the circumference of the flange structure 120. The structure of the suture holes 121 facilitates the combination and fixation of the native valve ring and the suture ring assembly 300. The axial direction of each suture hole 121 is parallel to the axial direction of the annular structure.

[0059] 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 the leaflets 200 are in a state of fitting together, the artificial valve is in a closed state.

[0060] 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 artificial valve is reduced; when all the leaflets 200 are opened, the pressure difference across the artificial 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.

[0061] Each leaflet 200 has two arc-shaped redundant portions 221 . When the artificial 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.

[0062] 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;

[0063] When the central vertex is higher than the vertex of the petal foot 110 , the angle between the horizontal plane passing through the vertex of the petal foot 110 and the free edge 220 of any leaflet 200 is 0 to 10°;

[0064] When the central vertex is lower than the vertex of the flap foot 110 , an angle B between a horizontal plane passing through the vertex of the flap foot 110 and a free edge 220 of any leaflet 200 is in a range of 0 to 30°.

[0065] This structure makes the height of the central apex of the artificial valve of this embodiment higher than the central apex of other existing artificial valve products, so that the overall deformation of the leaflets 200 of the artificial valve is reduced, thereby enhancing the fatigue resistance of the leaflets 200 and increasing the upper limit of the service life of the artificial valve.

[0066] In this embodiment, the central vertex is lower than the vertex of the petal foot 110, and the angle B between the horizontal plane passing through the vertex of the petal foot 110 and the free edge 220 of any leaflet 200 is 5°.

[0067] When the flap foot 110 is in the expanded state, the bottom width W1 of the flap foot 110 is 17.8 mm to 34.6 mm. The flap foot 110 is triangular. The width of the flap foot 110 of this embodiment is increased compared to the width of the flap foot of the existing artificial valve. By increasing the width of the flap foot 110, 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 110 and the flange structure 120 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 300 and the flap foot 110. In this embodiment, the bottom width of the flap foot 110 is 24 mm.

[0068] 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 integrally formed 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 leaflet 200 from failure modes such as cracks and crack extension caused by stress concentration. 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 integrally formed.

[0069] In this embodiment, the number of leaflets 200 is three, the flange structure 120 is wavy, and the artificial valve is a trileaflet aortic valve.

[0070] Example 2

[0071] like Figures 7 and 8 As shown, in this embodiment, the number of leaflets 200 is two, the flange structure inside the sewing ring assembly 300 is wavy, and the artificial valve is a bicuspid aortic valve.

[0072] Example 3

[0073] like Fig. 9 As shown, in this embodiment, the number of leaflets 200 is three, the flange structure inside the sewing ring assembly 300 is in a circular ring shape, and the artificial valve is a tri-leaflet mitral valve.

[0074] Example 4

[0075] like Fig.10 As shown, in this embodiment, the number of leaflets 200 is two, the flange structure inside the sewing ring assembly 300 is in a circular ring shape, and the artificial valve is a bicuspid mitral valve.

[0076] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0077] 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. An artificial valve, characterized in that: include: A valve frame (100), at least two valve leaflets (200), and a sewing ring assembly (300); The flap frame (100) comprises flap feet (110), a flange structure (120) and a bonding layer (130); at least two flap feet (110) are installed on the inner side surface of the flange structure (120); all the flap feet (110) are connected in sequence to form a ring structure; a plurality of suture holes (121) are provided on the top surface of the flange structure (120); and the outer surface of the flap frame (100) is covered with the bonding layer (130); The number of the leaflets (200) is the same as the number of the petal feet (110); all the leaflets (200) are arranged inside the annular structure; all the leaflets (200) are connected to the bonding layer (130); a fiber layer is arranged on the outer surface of the leaflet (200); and the leaflet (200) is made of polyurethane material; The sewing ring assembly (300) is wrapped around the outer side surface of the flange structure (120).

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

3. The artificial 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.

4. The artificial valve according to claim 1, characterized in that: The sewing ring assembly (300) is a double-layer structure; the outer layer structure (310) of the sewing ring assembly (300) is a non-woven fabric layer or a polyester fabric layer; the inner layer structure (320) of the sewing ring assembly (300) is a non-woven fabric layer, and the inner layer structure (320) of the sewing ring assembly (300) is wrapped on the outer side of the flange structure (120).

5. The artificial valve according to claim 1, characterized in that: The sewing ring assembly (300) has a single-layer structure, which is a non-woven fabric layer.

6. The artificial 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 artificial valve is in a closed state.

7. The artificial valve according to claim 6, 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 (110), the angle between the horizontal plane passing through the vertex of the flap foot (110) 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 (110), the angle between the horizontal plane passing through the vertex of the flap foot (110) and the free edge (220) of any one of the leaflets (200) is 0 to 30 degrees.

8. The artificial valve according to claim 1, characterized in that: When the flap foot (110) is in an expanded state, the bottom width of the flap foot (110) is 17.8 mm to 34.6 mm.

9. The artificial 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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