Ball expansion valve

Abstract

The utility model provides a ball expansion valve. The ball expansion valve comprises a valve frame, a skirt cloth assembly and at least two valve leaflets. The valve frame is a cylindrical support; the surface of the valve frame is coated with a polyurethane film layer; the skirt cloth assembly comprises inner skirt cloth and outer skirt cloth, the inner skirt cloth is arranged on the inner circumferential surface of the valve frame, and the outer skirt cloth is arranged on the outer circumferential surface of the valve frame; the inner skirt cloth and the outer skirt cloth are made of polyurethane, polyethylene terephthalate or polytetrafluoroethylene materials; all the valve leaflets are arranged in the valve frame; the valve leaflet is made of a polyurethane material; and the inner skirt cloth is connected with the valve leaflet. The utility model provides the ball-expanded valve which is resistant to fatigue, calcification, blood coagulation and perivalvular leakage, and has good mechanical property and biocompatibility.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field, especially a kind of ball dilatation valve. BACKGROUND

[0002] The number of patients with heart valve disease is very large, and there is a large treatment demand. Among heart disease patients, valve disease is a disease with high incidence. According to Frost & Sullivan data, there were about 209 million patients worldwide with heart valve disease in 2018, causing about 2.6 million deaths per year. It is estimated that there were 1930 and 2600 million people worldwide with aortic stenosis or aortic regurgitation in 2018.

[0003] In China, there were 3630 million patients with heart valve disease in 2019, and it is predicted that the number will increase to 4020 million people in 2025. Essentially, valve disease is an old disease, and as the age of residents increases, the prevalence of valve disease gradually increases. It is predicted that the number of patients with valve disease will also gradually increase in the future as China's population continues to age.

[0004] The incidence of heart valve disease increases with age, but traditional surgical aortic valve replacement surgery is traumatic and prone to perioperative complications, and cannot be applied to all high-risk patients. Since the first report of transcatheter aortic valve replacement, transcatheter aortic valve replacement technology has developed rapidly and become the preferred treatment for patients with aortic valve stenosis. At the same time, with the iteration of instruments and the supplement of clinical evidence-based medicine, the indications for transcatheter aortic valve replacement have expanded from extremely high-risk and high-risk patients to low-risk patients. According to the different valve expansion methods, the valves in transcatheter aortic valve replacement are mainly divided into self-expanding valves and balloon-expandable valves. Currently, both types of valves have been approved by the U.S. Food and Drug Administration and the European Union for use in low-risk surgical patients. In China, the number of transcatheter aortic valve replacement cases has exceeded 7000, but the valve systems used in China are mainly self-expanding valves, and the use and research of balloon-expandable valves are very limited.

[0005] Domestic balloon-expandable valve devices are still in the initial and exploratory stage in China. The transcatheter aortic valve replacement valves that have been marketed in China all use the single technical route of self-expanding valves, and no domestic balloon-expandable valves have been marketed. According to research, balloon-expandable valves have the characteristics of low paravalvular leakage rate, low vascular complication rate and low mortality rate. In addition to being used for aortic valve stenosis, balloon-expandable valves also play a good clinical value and technical advantage in bioprosthetic valve failure valve-in-valve surgery and ring-in-valve surgery.

[0006] However, the service life of the biological ball-expanding valve is only 10-15 years, which is difficult to meet the needs of the current more and more young patients with valvular disease, and even some patients face the problems of valve dysfunction, calcification, high immunogenicity and thrombosis risk after valve replacement, causing valve failure.

[0007] Therefore, how to design a valve with anti-fatigue, anti-calcification, anti-coagulation, anti-perivalvular leakage, and good mechanical properties and biocompatibility is a problem to be solved by those skilled in the art. Utility model content

[0008] In view of the above-mentioned disadvantages of the prior art, the technical problem to be solved by the utility model is to provide a ball-expanding valve with anti-fatigue, anti-calcification, anti-coagulation, anti-perivalvular leakage, and good mechanical properties and biocompatibility.

[0009] To achieve the above-mentioned objects and other related objects, the utility model provides a ball-expanding valve, which comprises a valve frame, a skirt assembly and at least two valve leaves.

[0010] The valve frame is a cylindrical support, and the surface of the valve frame is coated with a polyurethane film layer.

[0011] The skirt assembly comprises an inner skirt and an outer skirt, the inner skirt is arranged on the inner circumferential surface of the valve frame, and the outer skirt is arranged on the outer circumferential surface of the valve frame; the inner skirt and the outer skirt are made of polyurethane, polyethylene terephthalate or polytetrafluoroethylene material.

[0012] All the valve leaves are arranged inside the valve frame; the valve leaves are made of polyurethane material; the inner skirt is connected with the valve leaves.

[0013] Preferably, the number of valve leaves is 3; the valve frame is provided with three leaf connecting rods; the width of each leaf connecting rod is 0.4mm-1mm; the number of valve leaves is equal to the number of leaf connecting rods, and the valve leaves are connected with the corresponding leaf connecting rods.

[0014] Preferably, the two ends of the valve frame are the far end and the near end respectively; the valve frame comprises a large-mesh frame body and a small-mesh frame body connected in sequence, the size of the mesh hole of the large-mesh frame body is larger than that of the small-mesh frame body; compared with the large-mesh frame body, the small-mesh frame body is closer to the near end of the valve frame, and the large-mesh frame body is closer to the far end of the valve frame; the inner skirt is arranged on the inner circumferential surface of the small-mesh frame body.

[0015] Further, the middle part of the length direction of the small-mesh frame body to the near end of the valve frame is an outer skirt mounting section of the valve frame, and the outer skirt is arranged on the outer circumferential surface of the outer skirt mounting section.

[0016] Preferably, the frame is made of cobalt-chromium alloy, stainless steel alloy, or nickel-titanium alloy.

[0017] Preferably, the surface of the leaflet is provided with a fiber layer.

[0018] Further, the fiber layer is made of polyurethane, polypropylene, polyethylene, or nylon material.

[0019] Preferably, each leaflet has a fixed edge and a free edge, the fixed edge of the leaflet is connected with the inner skirt, the free edge of each leaflet has an arc-shaped redundant part, the free edges of two adjacent leaflets can be attached to each other, and when the free edges of all the leaflets are in the state of being attached to each other, the ball-expanding valve is in a closed state.

[0020] As described above, the ball-expanding valve has the following beneficial effects:

[0021] In the ball-expanding valve, the leaflet is made of polyurethane material, which can improve the flexibility of the leaflet, and the polyurethane leaflet has better fatigue resistance; polyurethane is a high molecular material, has anti-calcification performance, and can reduce the risk of calcification of the leaflet after implantation; the frame surface is coated with a polyurethane film layer, which can prevent the material of the frame from directly contacting the human blood, thereby avoiding lifelong anticoagulation of the patient; the inner skirt and the leaflet are both soft high molecular materials, so that the leaflet will not be damaged during balloon expansion, and the ball-expanding valve provides greater possibility for recovery and secondary release; the material of the outer skirt is soft and dense without mesh holes, so that the ball-expanding valve has better paravalvular leakage resistance after balloon expansion; the ball-expanding valve of the utility model has good mechanical properties and biocompatibility, and is resistant to fatigue, calcification, blood coagulation, and paravalvular leakage. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 Fig. 1 shows a perspective structural schematic diagram of the ball-expanding valve of the embodiment.

[0023] Figure 2 Fig. 2 shows a perspective structural schematic diagram of the frame of the ball-expanding valve of the embodiment.

[0024] Figure 3 Fig. 3 shows a perspective structural schematic diagram of three leaflets of the ball-expanding valve of the embodiment.

[0025] Figure 4 Fig. 4 shows a top view structural schematic diagram of the ball-expanding valve of the embodiment.

[0026] Figure 5 Fig. 5 shows an enlarged structural schematic diagram of A in Fig. 4. Figure 4

[0027] ​Figure 6 Fig. 4 shows a structure schematic diagram of an inner skirt cloth arranged on a frame of a ball-expanding valve according to the embodiment.

[0028] Figure 7 Fig. 5 shows a structure schematic diagram of an outer skirt cloth of a ball-expanding valve according to the embodiment.

[0029] Figure 8 Fig. 6 shows a structure schematic diagram of an internal three-dimensional structure of a ball-expanding valve according to the embodiment.

[0030] Figure 9 Fig. 7 shows a structure schematic diagram of an enlarged view of B in Fig. 6. Figure 8

[0031] BRIEF DESCRIPTION OF DRAWINGS

[0032] 100 frame

[0033] 110 leaf connecting rod

[0034] 111 connecting area

[0035] 101 large mesh frame body

[0036] 102 small mesh frame body

[0037] 1021 middle part of the length direction of the small mesh frame body

[0038] 103 proximal end

[0039] 200 valve leaf

[0040] 210 fiber layer

[0041] 201 fixed edge

[0042] 202 free edge

[0043] 203 arc-shaped redundant part

[0044] 310 inner skirt cloth

[0045] 320 outer skirt cloth DETAILED DESCRIPTION

[0046] The advantages and effects of the present application can be easily understood by those skilled in the art from the content disclosed in the specification.

[0047] ​Please refer to the drawings. It should be understood that the structures, proportions, sizes and the like shown in the drawings attached to the present specification are only used to cooperate with the content disclosed in the specification, to be understood and read by those skilled in the art, and are not used to limit the implementation of the present application. The conditions, so it has no technical significance, any modification of the structure, change of the proportion relationship or adjustment of the size, without affecting the effect and purpose of the present application, should still fall within the scope of the technical content disclosed by the present application. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" in the present specification are only for the convenience of clear description, and are not used to limit the scope of the present application. The change or adjustment of the relative relationship is also considered as the scope of the present application without changing the technical content.

[0048] In the following description, the proximal end of the frame 100 refers to the end of the balloon dilatation valve close to the apex of the heart, and the distal end of the frame 100 refers to the end of the balloon dilatation valve away from the apex of the heart.

[0049] As shown in Figures 1 to 9 The balloon dilatation valve of the present embodiment comprises a frame 100, a skirt assembly and at least two leaflets 200; in the present embodiment, the number of leaflets 200 is three;

[0050] The frame 100 is a cylindrical stent, and the surface of the frame 100 is covered with a polyurethane film layer;

[0051] The skirt assembly comprises an inner skirt 310 and an outer skirt 320, the inner skirt 310 is arranged on the inner circumferential surface of the frame 100, and the outer skirt 320 is arranged on the outer circumferential surface of the frame 100; the inner skirt 310 and the outer skirt 320 are made of polyurethane, polyethylene terephthalate or polytetrafluoroethylene material;

[0052] All the leaflets 200 are arranged inside the frame 100; the leaflets 200 are made of polyurethane material; the inner skirt 310 is connected with the leaflets 200. In the present embodiment, the leaflets 200 are one or more layers of arc surface structures imitating the structure of human leaflets.

[0053] In the ball-expanding valve, the valve leaflet 200 is made of polyurethane material, which can improve the flexibility of the valve leaflet 200, and the polyurethane valve leaflet 200 has better fatigue resistance; polyurethane is a high polymer material, which has anti-calcification performance and can reduce the risk of calcification of the valve leaflet 200 after implantation; the surface of the valve frame 100 is coated with a polyurethane film layer, which can prevent the material of the valve frame 100 from directly contacting the human blood, thereby avoiding lifelong anticoagulation of the patient; the inner skirt 310 and the valve leaflet 200 are both soft high polymer materials, so that the valve leaflet 200 will not be damaged during balloon expansion, and the ball-expanding valve provides greater possibility for recovery and secondary release; the outer skirt 320 of the polyurethane is made of polyester cloth material compared with the existing skirt, and the material of the outer skirt 320 is soft and dense without mesh holes, so that the ball-expanding valve has better paravalvular leakage resistance after balloon expansion; the ball-expanding valve has good mechanical properties and biocompatibility.

[0054] Compared with the valve leaflet 200 made of biological material, the polyurethane material gives the valve leaflet 200 greater toughness and elasticity, and can achieve greater over-expansion than the biological valve without affecting the fatigue performance of the valve, while avoiding the rupture of the human native annulus and achieving the best anchoring.

[0055] The number of valve leaflets 200 is three; the valve frame 100 has three leaflet connecting rods 110; the width of each leaflet connecting rod 110 is 0.4mm-1mm; the number of valve leaflets 200 is equal to the number of leaflet connecting rods 110, and the valve leaflet 200 is connected with the corresponding leaflet connecting rod 110.

[0056] Compared with the existing biological ball-expanding valve, the ball-expanding valve of the embodiment cancels the suture hole structure, so that the width of the leaflet connecting rod 110 is uniform, the width of the leaflet connecting rod 110 is in the range of 0.4mm-1mm, thereby increasing the uniformity and support force of the valve frame 100, reducing the compression diameter, and making the instrument more easily pass through the blood vessels of the patient with narrow access. The combination force of the valve leaflet 200 and the valve frame 100 is increased, and the risk of separation of the valve leaflet 200 from the connecting area 111 is reduced. The connecting area 111 is the area where each leaflet connecting rod 110 is connected with the corresponding valve leaflet 200. Compared with the sutured valve leaflet of the existing biological ball-expanding valve, which is sutured inside the valve frame, the connecting area 111 of the ball-expanding valve of the embodiment does not need to extend to the axis like the sutured area of the existing biological ball-expanding valve, so that the ball-expanding valve of the embodiment can increase the opening area and reduce the transvalvular pressure difference. In the embodiment, the width of the leaflet connecting rod 110 is 0.6mm. The upper part of the valve leaflet 200 is connected with the corresponding leaflet connecting rod 110, and the lower part of the valve leaflet 200 is connected with the inner skirt 310.

[0057] The two ends of the frame 100 are a distal end and a proximal end 103; the frame 100 comprises a large mesh frame body 101 and a small mesh frame body 102 connected in sequence, the size of the mesh hole of the large mesh frame body 101 is larger than that of the small mesh frame body 102; compared with the small mesh frame body 102, the large mesh frame body 101 is closer to the distal end of the frame 100, and the small mesh frame body 102 is closer to the proximal end of the frame 100; the inner skirt cloth 310 is arranged on the inner circumferential surface of the small mesh frame body 102. The inner skirt cloth 310 can fix the proximal end 103 of the frame 100, and the inner skirt cloth 310 is a structure of one or more layers of films uniformly attached on the inner circumferential surface of the small mesh frame body 102, which provides greater possibility for the recovery and secondary release of the balloon-expandable valve. The mesh hole of the large mesh frame body 101 needs to be unobstructed for human body structure, and there is a coronary artery at the large mesh frame body 101, so that if the large mesh frame body 101 is blocked, complications will be caused.

[0058] The middle part 1021 of the small mesh frame body 102 in the length direction to the proximal end 103 of the frame 100 is an outer skirt mounting section of the frame 100, and the outer skirt cloth 320 is arranged on the outer circumferential surface of the outer skirt mounting section. The outer skirt cloth 320 plays a role of preventing leakage.

[0059] The frame 100 is made of cobalt-chromium alloy, stainless steel alloy or nickel-titanium alloy. The material of the frame 100 makes the frame 100 have good biocompatibility.

[0060] The surface of the leaflet 200 is provided with a fiber layer 210. The fiber layer 210 is formed on the surface of the leaflet 200, which can enhance the mechanical properties of the leaflet 200 and prevent the occurrence of failure modes such as cracks and crack propagation of the leaflet 200 due to stress concentration.

[0061] The fiber layer 210 is made of polyurethane, polypropylene, polyethylene or nylon material. The fiber layer 210 adopts thermoplastic polymer material, so that the mechanical properties of the leaflet 200 are enhanced.

[0062] Each leaflet 200 has a fixed edge 201 and a free edge 202, the fixed edge 201 of the leaflet 200 is connected with the inner skirt cloth 310; each leaflet 200 has an arc-shaped redundant part 203 on the free edge 202; the free edges 202 of the adjacent two leaflets 200 can be attached to each other; when the free edges 202 of all the leaflets 200 are in the state of being attached to each other, the balloon-expandable valve is in a closed state. When the free edges 202 of all the leaflets 200 are in the state of being attached to each other, all the free edges 202 converge to a central vertex.

[0063] The arc-shaped redundant part 203 is arranged on the free edge 202 of the leaflet 200, so that when all the leaflets 200 are closed, the width of the coaptation edge of the leaflets 200 is increased, and the central leakage of the ball-expansion valve is reduced; when all the leaflets 200 are opened, the trans-valve pressure difference of the ball-expansion valve is reduced, and the opening area is increased, so that the leaflets 200 can be opened under the action of smaller pressure. Under the action of blood flow, the leaflets 200 reach full opening and full closing; when the leaflets 200 are closed under pressure, the leaflets 200 can reach full closing, and blood flow cannot pass through the middle of the leaflets 200.

[0064] Before the leaflets 200 are formed, the inner skirt cloth 310 is arranged on the inner circumferential surface of the small mesh frame body 102 of the frame 100 through a spraying, dipping or bonding process, the inner skirt cloth 310 is a one-layer or multi-layer film structure; the outer skirt cloth 320 is connected with the frame 100, and the outer skirt cloth 320 is wrapped on the outer circumferential surface of the outer skirt mounting section of the frame 100; then the leaflets 200 are integrally formed on the inner skirt cloth 310 through one or more spraying or dipping processes, and the fiber layer 210 is formed on the surface of the leaflets 200 through melt blowing or electrospinning after the leaflets 200 are formed.

[0065] The progress of the high polymer material opens up a new field for overcoming the main defects of the biological valve, and the ball-expansion valve provided by the application has the advantages of small trauma and low risk of the biological ball-expansion valve, does not need long-term anticoagulant therapy, and has excellent durability.

[0066] The above examples only exemplarily illustrate the principle and effect of the application, and are not used to limit the application. Any person skilled in the art can modify or change the above examples without departing from the spirit and scope of the application. Therefore, all equivalent modifications or changes completed by those skilled in the art without departing from the spirit and technical thought of the application should be covered by the claims of the application.

Claims

1. A ball-expanding valve, characterized by, The application relates to a valve frame, which comprises a valve frame (100), a skirt assembly and at least two valve leaves (200). The valve frame (100) is a cylindrical support, and the surface of the valve frame (100) is coated with a polyurethane film layer. The skirt assembly comprises an inner skirt (310) and an outer skirt (320), the inner skirt (310) is arranged on the inner circumferential surface of the valve frame (100), and the outer skirt (320) is arranged on the outer circumferential surface of the valve frame (100); the inner skirt (310) and the outer skirt (320) are made of polyurethane, polyethylene terephthalate or polytetrafluoroethylene material. All the valve leaves (200) are arranged inside the valve frame (100); the valve leaves (200) are made of polyurethane material; and the inner skirt (310) is connected with the valve leaves (200). The number of the valve leaves (200) is three; the valve frame (100) is provided with three leaf connecting rods (110); the width of each leaf connecting rod (110) is 0.4mm-1mm; the number of the valve leaves (200) is equal to the number of the leaf connecting rods (110), and the valve leaves (200) are connected with the corresponding leaf connecting rods (110).

2. The ball-expanding valve of claim 1, wherein: The two ends of the valve frame (100) are a distal end and a proximal end (103) respectively; the valve frame (100) comprises a large-mesh frame body (101) and a small-mesh frame body (102) which are connected in sequence; the size of the mesh holes of the large-mesh frame body (101) is larger than that of the small-mesh frame body (102); compared with the large-mesh frame body (101), the small-mesh frame body (102) is closer to the proximal end (103) of the valve frame (100), and the large-mesh frame body (101) is closer to the distal end of the valve frame (100); and the inner skirt (310) is arranged on the inner circumferential surface of the small-mesh frame body (102).

3. The ball-expanding valve of claim 2, wherein: The middle part of the length direction of the small-mesh frame body (102) to the proximal end (103) of the valve frame (100) is an outer skirt mounting section of the valve frame (100), and the outer skirt (320) is arranged on the outer circumferential surface of the outer skirt mounting section.

4. The ball-expanding valve of claim 3, wherein: The valve frame (100) is made of cobalt-chromium alloy, stainless steel alloy or nickel-titanium alloy.

5. The ball-expanding valve of claim 1, wherein: The surface of the valve leaf (200) is provided with a fiber layer (210).

6. The ball-expanding valve of claim 1, wherein: The fiber layer (210) is made of polyurethane, polypropylene, polyethylene or nylon material.

7. The ball-expanding valve of claim 6, wherein: Each valve leaf (200) has a fixed edge (201) and a free edge (202), the fixed edge (201) of the valve leaf (200) is connected with the inner skirt (310); the free edge (202) of each valve leaf (200) is provided with an arc-shaped redundant part (203); the free edges (202) of two adjacent valve leaves (200) can be mutually adhered; when the free edges (202) of all the valve leaves (200) are in the mutually adhered state, the ball-expanding valve is in a closed state.

8. The ball-expanding valve of claim 1, wherein: ​

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