Suture-free valve

Abstract

The utility model provides a suture-free valve. The suture-free valve comprises a valve frame, at least two valve leaflets, a supporting frame assembly and a suture ring. The valve frame comprises valve feet, a flange structure and a bonding layer, and the flange structure is provided with at least two valve feet; all the petal feet are connected in sequence to form an annular structure; the surface of the valve frame is coated with the bonding layer; all the valve leaflets are connected with the bonding layer; a fiber layer is arranged on the surface of the valve leaflet; the valve leaflet is made of a polyurethane material; the supporting frame assembly comprises a sewing frame and a grid frame, the top of the grid frame is connected with the sewing frame, and the sewing frame is of an annular structure; the outer side face of the supporting frame assembly is coated with skirt cloth. The suturing ring is arranged between the suturing frame and the flange structure, and the suturing frame, the suturing ring and the flange structure are connected in series. The suture-free valve provided by the utility model is anti-fatigue, anti-calcification and anti-coagulation, and has good mechanical property and biocompatibility.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a sutureless valve. Background Technology

[0002] The number of people suffering from valvular heart disease is very large, with a significant need for treatment. Valvular disease is a relatively common condition among heart disease patients. In my country, there were 36.3 million people with valvular heart disease in 2019, and this number is projected to increase to 40.2 million by 2025. Essentially, valvular disease is a disease of the elderly; its prevalence gradually increases with the age of the population. It is expected that with the further aging of my country's population, the number of people with valvular heart disease will continue to rise.

[0003] Sutureless bioprosthetic valves integrate endovascular stent and transcatheter valve technology, representing a new generation of valve products. Sutureless bioprosthetic valves offer significant advantages. Compared to surgical active valve replacement, they feature smaller incisions, faster implantation, lower complication rates, less demanding surgical procedures, and higher safety. Compared to transcatheter active valve replacement, sutureless bioprosthetic valves allow for the removal of calcified autologous aortic valves, significantly improving valve durability and reducing complications caused by thromboembolism.

[0004] Depending on the type, sutureless bioprosthetic valves can be divided into self-expanding and rapid implantation types. Due to limitations in technology and research and development, the number of sutureless bioprosthetic valves currently available worldwide is extremely small, and they are mainly used for aortic valve replacement or transcatheter aortic valve replacement.

[0005] In recent years, with advancements in medical technology, transcatheter aortic valve replacement (TAVR) has gradually replaced surgical aortic valve replacement (SAV) as the mainstream technique for treating valvular heart disease. The new generation of sutureless bioprosthetic valves is expected to fill the gap between TVR and traditional surgical aortic valve replacement, offering vast market potential. Currently, the global sutureless bioprosthetic valve market is still in its early stages of development, with relatively few products available worldwide. Compared to the European and American markets, research on sutureless bioprosthetic valves in my country started later, and current market demand mainly relies on imports. However, under the major trend of domestic substitution, domestic companies are actively expanding into this market.

[0006] Designing a sutureless valve that is fatigue-resistant, calcification-resistant, anticoagulant, and possesses good mechanical properties and biocompatibility is a problem that needs to be solved by those skilled in the art. Utility Model Content

[0007] In view of the shortcomings of the prior art described above, the technical problem solved by this utility model is to provide a sutureless valve that is anti-fatigue, anti-calcification, anti-coagulation, and has good mechanical properties and biocompatibility.

[0008] To achieve the above and other related objectives, this utility model provides a sutureless valve, comprising: a valve frame, at least two leaflets, a support frame assembly, and a suture ring;

[0009] The valve frame includes valve feet, a flange structure, and a bonding layer. At least two valve feet are installed on the inner side of the flange structure. All the valve feet are connected in sequence to form a ring structure. The surface of the valve frame is covered with the bonding layer.

[0010] The number of leaflets is the same as the number of leaf feet, all of the leaflets are disposed inside the annular structure, and all of the leaflets are connected to the bonding layer; the leaflets are made of polyurethane material;

[0011] The support frame assembly includes a sewing frame and a mesh frame. The top of the mesh frame is connected to the sewing frame. The sewing frame has a ring-shaped structure and is arranged along the circumference of the mesh frame. The sewing frame is located below the flange structure. The outer surface of the support frame assembly is covered with a skirt fabric made of polyurethane, polyethylene terephthalate, or polytetrafluoroethylene.

[0012] The suture ring is disposed between the suture frame and the flange structure, and the suture frame, the suture ring, and the flange structure are connected in series.

[0013] Preferably, the top surface of the suture frame is provided with a plurality of suture through holes, all of which are evenly arranged along the circumference of the suture frame; the top surface of the flange structure is provided with a plurality of flange suture through holes, all of which are evenly arranged along the circumference of the flange structure; the suture through holes correspond one-to-one with the flange suture through holes; the suture thread passes sequentially through the flange suture through holes, the suture ring, and the suture through holes, connecting the suture frame, the suture ring, and the flange structure in series.

[0014] Preferably, the surface of the leaflet is provided with a fibrous layer.

[0015] Furthermore, the fiber layer is made of polyurethane, polypropylene, polyethylene, or nylon.

[0016] Preferably, the petiole frame is made of polyetheretherketone, polyurethane, stainless steel alloy, or nickel-titanium alloy.

[0017] Preferably, the suture ring has a single-layer structure, which is a non-woven fabric layer.

[0018] Preferably, the suture ring has a double-layer structure; the outer layer of the suture ring is a polyester fabric layer; and the inner layer of the suture ring is a non-woven fabric layer.

[0019] Preferably, each leaflet has a fixed edge and a free edge, the fixed edge of the leaflet being connected to the bonding layer; each leaflet has an arc-shaped redundant portion on its free edge; the free edges of two adjacent leaflets can be fitted together; when all the free edges of the leaflets are in a fitted state, the sutureless valve is in a closed state.

[0020] Preferably, the flange structure is integrally formed with the petal foot.

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

[0022] In this sutureless valve, the leaflets are made of polyurethane, which improves their flexibility and provides better fatigue resistance. Polyurethane is a polymer material with anti-calcification properties, reducing the risk of leaflet calcification after implantation. The bonding layer enhances the bond between the valve frame and the leaflets, and the bonding layer covering the valve frame surface prevents the valve frame material from directly contacting human blood, thus avoiding lifelong anticoagulation in patients. This invention is a sutureless valve that is fatigue-resistant, anti-calcification, anticoagulant, and possesses good mechanical properties and biocompatibility. Attached Figure Description

[0023] Figure 1 The diagram shown is a three-dimensional structural schematic of the sutureless valve in this embodiment.

[0024] Figure 2 The diagram shown is a three-dimensional structural schematic of the valve frame of the sutureless valve in this embodiment.

[0025] Figure 3 The diagram shown is a three-dimensional structural schematic of the three leaflets of the sutureless valve in this embodiment.

[0026] Figure 4 The diagram shown is a top view of the sutureless valve in this embodiment.

[0027] Figure 5 The diagram shown is a three-dimensional structural schematic of the suture ring of the sutureless valve in this embodiment.

[0028] Figure 6 The diagram shows the internal structure of the suture ring located below the valve frame of the sutureless valve in this embodiment.

[0029] Figure 7 Displayed as Figure 6 An enlarged structural diagram of point A.

[0030] Figure 8 The diagram shows a three-dimensional structural diagram of the connection between the suture frame and the mesh frame of the support frame assembly for the sutureless valve in this embodiment.

[0031] Figure 9 The diagram shown is a side view of the support frame assembly for the sutureless valve in this embodiment.

[0032] Figure 10 The diagram shown is a schematic representation of the internal structure of the sutureless valve in this embodiment.

[0033] Explanation of icon numbers

[0034] 100-petal frame

[0035] 110 petals

[0036] 120 Flange Structure

[0037] 121 Flange seam through hole

[0038] 130 bonding layer

[0039] 200 petals

[0040] 210 Fiber layer

[0041] 201 Fixed edge

[0042] 202 Free Edge

[0043] 203 Arc-shaped Redundancy Section

[0044] 300 support frame assembly

[0045] 310 Sewing Frame

[0046] 311 Suture section suture through hole

[0047] 320 grid frame

[0048] 330 skirt fabric

[0049] 400 suture ring

[0050] 410 Outer Structure

[0051] 420 Inner Structure Detailed Implementation

[0052] The following specific embodiments illustrate the implementation of this utility model. Those skilled in the art can easily understand other advantages and effects of this utility model from the content disclosed in this specification.

[0053] Please refer to the accompanying drawings. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are merely for illustrative purposes to aid those skilled in the art and are not intended to limit the scope of this invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of this invention, should still fall within the scope of the technical content disclosed in this invention. Furthermore, the terms such as "upper," "lower," "left," "right," "middle," and "one" used in this specification are merely for clarity and are not intended to limit the scope of this invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of this invention.

[0054] like Figures 1 to 10 As shown, the sutureless valve of this embodiment includes: a valve frame 100, at least two leaflets 200, a support frame assembly 300, and a suture ring 400;

[0055] The valve frame 100 includes valve feet 110, flange structure 120 and bonding layer 130. At least two valve feet 110 are installed on the inner side of the flange structure 120. All valve feet 110 are connected in sequence to form a ring structure. Multiple suture holes are provided on the top surface of the flange structure 120. The surface of the valve frame 100 is covered with bonding layer 130. The material of bonding layer 130 is polyurethane.

[0056] The number of leaflets 200 is the same as the number of leaf feet 110. All leaflets 200 are located inside the annular structure and are connected to the bonding layer 130. The leaflets 200 are made of polyurethane material. In this embodiment, the leaflets 200 are one or more arc-shaped structures formed in imitation of the structure of human leaflets 200.

[0057] The support frame assembly 300 includes a sewing frame 310 and a mesh frame 320. The top of the mesh frame 320 is connected to the sewing frame 310. The sewing frame 310 has a ring structure and is arranged along the circumference of the mesh frame 320. The sewing frame 310 is located below the flange structure 120. The outer surface of the support frame assembly 300 is covered with a skirt fabric 330, which is made of polyurethane, polyethylene terephthalate, or polytetrafluoroethylene.

[0058] The suture ring 400 is disposed between the suture frame 310 and the flange structure 120, and the suture frame 310, the suture ring 400 and the flange structure 120 are connected in series.

[0059] In the sutureless valve, the leaflet 200 is made of polyurethane, which improves its flexibility and elasticity, reduces overall deformation, and enhances its fatigue resistance. Polyurethane is a polymer material with anti-calcification properties, reducing the risk of calcification of the leaflet 200 after implantation. The bonding layer 130, formed by spraying or dipping onto the valve frame 100, strengthens the bond between the valve frame 100 and the leaflet 200. Furthermore, the bonding layer 130 covering the surface of the valve frame 100 prevents the valve frame material from directly contacting human blood, thus avoiding lifelong anticoagulation in patients. After molding, the leaflet 200 is bonded to the valve frame using melt-blowing or electrospinning methods. A fiber layer 210 is formed on the surface of the 200. In this embodiment, the skirt 330 is made of polyurethane material. Compared with the skirt 330 made of polyester fabric, the polyurethane material is softer and denser without mesh, which makes the expanded support frame assembly 300 have better anti-valvular leakage performance. At the same time, the polyurethane material has good biocompatibility, which promotes the endothelialization of the skirt 330 with the cells of the native tissue. The skirt 330 covering the surface of the support frame assembly 300 can prevent the material of the support frame assembly 300 from directly contacting human blood, thereby avoiding lifelong anticoagulation for patients. This embodiment is a sutureless valve that is anti-fatigue, anti-calcification, anticoagulant, and has good mechanical properties, biocompatibility and biological stability.

[0060] In this embodiment, the skirt fabric 330 is formed by uniformly attaching one or more layers of film to the outer surface of the support frame assembly 300 through processes such as spraying, dipping, or bonding. There are three leaflets 200. The bonding layer (130) is made of polyurethane material.

[0061] The top surface of the suture frame 310 is provided with multiple suture through holes 311, all of which are evenly arranged along the circumference of the suture frame 310; the top surface of the flange structure 120 is provided with multiple flange suture through holes 121, all of which are evenly arranged along the circumference of the flange structure 120; the suture through holes 311 and the flange suture through holes 121 correspond one-to-one; the suture thread passes through the flange suture through holes 121, the suture ring 400 and the suture through holes 311 in sequence, connecting the suture frame 310, the suture ring 400 and the flange structure 120 in series, thus directly fixing the suture frame 310, the suture ring 400 and the flange structure 120 together, which can reduce the risk of the support frame assembly 300 separating from the valve frame 100.

[0062] The surface of the leaflet 200 is provided with a fiber layer 210; the fiber layer 210 can enhance the mechanical properties of the leaflet 200 and prevent the occurrence of failure modes such as cracks and crack propagation caused by stress concentration.

[0063] The fiber layer 210 is made of polyurethane, polypropylene, polyethylene, or nylon. The use of thermoplastic polymers in the fiber layer 210 enhances the mechanical properties of the leaflet 200.

[0064] The valve holder 100 is made of polyetheretherketone, polyurethane, stainless steel alloy, or nickel-titanium alloy. The material of the valve holder 100 gives it good biocompatibility.

[0065] According to a preferred embodiment of this utility model, the stitching ring 400 has a single-layer structure, which is a non-woven fabric layer. The non-woven fabric layer is easy to process and manufacture. The single-layer structure is not shown in the figure.

[0066] According to another preferred embodiment of the present invention, the suture ring 400 has a double-layer structure; the outer layer 410 of the suture ring 400 is a polyester fabric layer; and the inner layer 420 of the suture ring 400 is a non-woven fabric layer. The polyester fabric layer has greater tensile strength, tension, and load-bearing capacity, which can avoid adverse events such as thrombosis caused by damage or shedding during implantation.

[0067] Each leaflet 200 has a fixed edge 201 and a free edge 202. The fixed edge 201 of the leaflet 200 is connected to the conjoint layer 130. Each free edge 202 of the leaflet 200 has an arc-shaped redundant portion 203. The free edges 202 of two adjacent leaflets 200 can fit together. When all the free edges 202 of the leaflets 200 are in a state of mutual contact, the sutureless valve is in a closed state. When all the free edges 202 of the leaflets 200 are in a state of mutual contact, all the free edges 202 converge to a central vertex.

[0068] The leaflet 200 has an arc-shaped redundant portion 203 on its free edge 202, which increases the width of the closure margin of the leaflet 200 when all leaflets 200 are closed, reducing the central leakage of the sutureless valve; when all leaflets 200 are open, it reduces the transvalvular pressure gradient of the sutureless valve and increases the opening area, allowing the leaflet 200 to open under less pressure. Under the action of blood flow, the leaflet 200 reaches complete opening and complete closing; when the leaflet 200 is closed by pressure, it can achieve complete closure, and blood flow will not pass through the middle of the leaflet 200.

[0069] Before the leaflet 200 is formed, a bonding layer 130 is formed on the leaflet frame 100 by spraying or dip coating. Then, the leaflet 200 is integrally formed on the bonding layer 130 by at least one spraying or dip coating process. After the leaflet 200 is formed, a fiber layer 210 is formed on the surface of the leaflet 200 by meltblowing or electrospinning.

[0070] The flange structure 120 and the petal foot 110 are integrally formed. In this embodiment, the flange structure 120 and the petal foot 110 are integrally formed by machining or injection molding, without the need for separate assembly, reducing the risk of separation between the stitching ring 400 and the petal foot 110.

[0071] The above embodiments are merely illustrative of the principles and effects of this utility model and are not intended to limit the scope of this utility model. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this utility model. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this utility model should still be covered by the claims of this utility model.

Claims

1. A sutureless valve, characterized in that, include: Valve frame (100), at least two leaflets (200), support frame assembly (300), and suture ring (400); 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. The surface of the valve frame (100) is covered with the bonding layer (130). The number of leaflets (200) is the same as the number of leaf feet (110), all of the leaflets (200) are disposed inside the annular structure, and all of the leaflets (200) are connected to the bonding layer (130); the leaflets (200) are made of polyurethane material; The support frame assembly (300) includes a sewing frame (310) and a mesh frame (320). The top of the mesh frame (320) is connected to the sewing frame (310). The sewing frame (310) has a ring-shaped structure and is arranged along the circumference of the mesh frame (320). The sewing frame (310) is located below the flange structure (120). The outer surface of the support frame assembly (300) is covered with a skirt fabric (330). The skirt fabric (330) is made of polyurethane, polyethylene terephthalate, or polytetrafluoroethylene. The suture ring (400) is disposed between the suture frame (310) and the flange structure (120), and the suture frame (310), the suture ring (400) and the flange structure (120) are connected in series.

2. The sutureless valve according to claim 1, characterized in that: The top surface of the sewing frame (310) is provided with a plurality of sewing through holes (311), and all the sewing through holes (311) are evenly arranged along the circumference of the sewing frame (310); the top surface of the flange structure (120) is provided with a plurality of flange sewing through holes (121), and all the flange sewing through holes (121) are evenly arranged along the circumference of the flange structure (120); the sewing through holes (311) correspond one-to-one with the flange sewing through holes (121); the suture thread passes through the flange sewing through holes (121), the suture ring (400) and the sewing through holes (311) in sequence, connecting the sewing frame (310), the suture ring (400) and the flange structure (120) in series.

3. The sutureless valve according to claim 1, characterized in that: The surface of the leaflet (200) is provided with a fiber layer (210).

4. The sutureless valve according to claim 3, characterized in that: The fiber layer (210) is made of polyurethane, polypropylene, polyethylene or nylon.

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

6. The sutureless valve according to claim 1, characterized in that: The suture ring (400) has a single-layer structure, which is a non-woven fabric layer.

7. The sutureless valve according to claim 1, characterized in that: The stitching ring (400) has a double-layer structure; the outer layer (410) of the stitching ring (400) is a polyester fabric layer; and the inner layer (420) of the stitching ring (400) is a non-woven fabric layer.

8. The sutureless valve according to claim 1, characterized in that: Each leaflet (200) has a fixed edge (201) and a free edge (202). The fixed edge (201) of the leaflet (200) is connected to the bonding layer (130). Each free edge (202) of the leaflet (200) has an arc-shaped redundant portion (203). The free edges (202) of two adjacent leaflets (200) can fit together. When all the free edges (202) of the leaflets (200) are in a state of mutual fit, the sutureless valve is in a closed state.

9. The sutureless valve according to claim 1, characterized in that: The flange structure (120) and the petal foot (110) are integrally formed.

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