Valve stents and valve prostheses for surgical operation

Abstract

This application relates to the field of medical device technology and provides a surgical valve holder and valve prosthesis. The surgical valve holder comprises a base portion and a support portion extending from the base portion for connecting to an artificial valve leaflet. The support portion, or both the base and the support portion, are provided with a coating region, and the coating region is provided with a coating reinforcement portion extending inwardly in the thickness direction of the support portion. The technical solution of this application can improve the flexibility and durability of the valve prosthesis.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a valve frame and valve prosthesis for surgical operations. Background Art

[0002] Replacing a diseased heart valve with an artificial heart valve prosthesis through traditional surgery is an important treatment for valvular heart disease. This procedure provides excellent exposure to the heart and major blood vessels, facilitating surgical access. It is particularly suitable for patients with multiple valves, complex lesions, and those requiring multiple or complex intraoperative procedures. Existing surgical valve prostheses generally consist of two components: a support and anchoring structure, known as the valve frame; and the movable elements, known as the leaflets, that open and close to allow blood flow and prevent backflow. The leaflets are typically made of biogenic materials, including bovine or porcine pericardium. However, biogenic materials are prone to calcification and damage, leading to leaflet calcification, decay, or fatigue failure, reducing the durability of the valve prosthesis. Furthermore, leaflets made of biogenic materials are typically sutured to the valve frame. As the heart beats, the leaflets constantly shift and shift under the pressure of blood. Over time, stress and friction can cause tearing and damage at the sutures, also reducing the durability of the valve prosthesis.

[0003] Compared with traditional biological leaflets, polymer leaflets have the advantages of excellent durability, low cost and industrial production, and are currently a hot topic of research. However, polymer leaflets are coated on the valve frame, so the long-term stability of valve prostheses remains to be verified. Summary of the Invention

[0004] The technical problem to be solved by the present application is to provide a surgical valve frame and valve prosthesis suitable for use with valve leaflets made of polymer synthetic materials, and to be able to help improve the durability of the valve prosthesis made of valve leaflets made of polymer synthetic materials.

[0005] In a first aspect, the present application provides a valve frame for surgical operations, comprising: a base and a support portion extending from the base for connecting an artificial valve leaflet, a coating area being provided on the support portion or the base and the support portion, and the coating area being provided with a coating reinforcement portion extending inwardly in the thickness direction of the support portion.

[0006] In the process of implementing the above technical solution, the valve frame includes a base and a support portion extending from the base, the support portion is used to connect the artificial valve leaflet, and a coating area is provided on the support portion, or a coating area is provided on the base and the support portion, and a coating reinforcement portion extending inward along the thickness direction of the support portion is provided in the coating area, thereby increasing the bonding area between the valve frame and the polymer film and improving the connection force between the valve frame and the polymer film. Since the artificial valve leaflet made of polymer synthetic material is connected to the valve frame through the polymer film covering the valve frame, the coating reinforcement portion improves the connection force between the polymer film and the valve frame, so the artificial valve leaflet made of polymer synthetic material can be better connected to the valve frame, thereby improving the durability of the artificial valve leaflet.

[0007] In addition, the coating reinforcement portion extends inward in the thickness direction of the support portion, thinning the local wall thickness of the valve frame. While meeting the structural strength of the valve frame, the valve frame is easier to deform than a planar structure, thereby improving the circumferential flexibility of the valve frame, alleviating stress concentration on the artificial valve leaflets when closing, reducing fatigue damage to the artificial valve leaflets, and increasing the service life of the valve prosthesis.

[0008] As an embodiment, the coating reinforcement portion extends on the support portion to form a closed area, or the coating reinforcement portion extends on the base portion and the support portion to form a closed area.

[0009] In the process of implementing the above technical solution, the coating reinforcement part is a closed area formed on the support part, which reduces the wall thickness of the valve frame while meeting the structural strength, improves the flexibility of the valve frame, and can alleviate the problem of durable failure of the valve prosthesis caused by high stress concentration of the artificial valve leaflet; of course, the coating reinforcement part can also extend on the base and the support part to form a closed area.

[0010] As an embodiment, the closed area enclosed by the coating reinforcement portion penetrates in the thickness direction of the support portion.

[0011] In the process of implementing the above technical solution, the coating reinforcement part is set through, so that part of the support part is in the shape of a through hole, which reduces the weight of the valve frame and changes the local thickness of the support part. While meeting the overall structural strength of the valve frame, it also improves the flexibility of the valve frame. In the process of the artificial valve hanging angle position swinging in and out with the pulsating flow of the human body, the accumulated potential energy of the artificial valve leaflet can be converted into kinetic energy for release, alleviating the problem of damage to the stress concentration position of the artificial valve due to fatigue durability.

[0012] As an embodiment, the closed area surrounded by the coating reinforcement portion forms a bottom wall.

[0013] During the implementation of the above technical solution, the closed area surrounded by the coating reinforcement part forms a bottom wall, thereby thinning the local thickness of the support part and reducing the weight of the valve frame. While meeting the overall structural strength of the valve frame, the valve frame is easier to deform, thereby improving the flexibility of the valve frame. In the process of the artificial valve hanging angle position swinging in and out with the pulsating flow of the human body, the accumulated potential energy of the artificial valve leaflet can be converted into kinetic energy for release, thereby alleviating the problem of damage to the stress concentration position of the artificial valve due to fatigue durability.

[0014] As an embodiment, the bottom wall is provided with a coating reinforcement pattern.

[0015] In the process of implementing the above technical solution, the coating reinforcement lines can increase the structural strength of the coating reinforcement part, thereby increasing the overall structural strength of the valve frame; and at the same time increase the connection force between the valve frame and the polymer film.

[0016] As an embodiment, the coating reinforcement portion is provided with steps or patterns.

[0017] In the process of implementing the above technical solution, the steps or patterns can increase the structural strength of the coating reinforcement part, thereby increasing the structural strength of the valve frame as a whole; and at the same time increase the connection force between the valve frame and the polymer film.

[0018] As an embodiment, the base is provided with a plurality of holes penetrating the base along the circumferential direction.

[0019] In the process of implementing the above technical solution, the base is easily deformed, which improves the flexibility of the valve frame around the ring. At the same time, it is also convenient to connect the valve frame and the artificial valve ring by suturing.

[0020] As an embodiment, the base is provided with at least one connection portion for increasing the contact area with the artificial valve ring, and the radial dimension of the connection portion is the same as the radial dimension of the base.

[0021] In the process of implementing the above technical solution, by setting a connecting part, the contact part between the valve frame and the artificial valve ring becomes thicker in the height direction, and the connecting part and the base can increase the contact area with the artificial valve ring, thereby improving the stability of the valve prosthesis and extending the service life of the valve prosthesis.

[0022] As an embodiment, the surgical valve frame also includes a connecting segment, the radial dimension of the first end of the connecting segment is smaller than the radial dimension of the base, the first end of the connecting segment is connected to the base, and a groove for clamping with the artificial valve ring is formed therebetween.

[0023] In the process of implementing the above technical solution, the local radial dimension of the connecting segment is smaller than the radial dimension of the base, and the first end of the connecting segment is connected to the base, and a groove for engaging with the artificial valve ring is formed between the two, which facilitates the connection between the artificial valve ring and the valve frame. In addition, it also improves the stability between the artificial valve ring and the valve frame.

[0024] As an embodiment, the surface of the valve frame is covered with a polymer film.

[0025] During the implementation of the above technical solution, a polymer film is formed on the outer surface and the inner surface of the valve frame, and the polymer film facilitates a better connection between the valve frame and the artificial valve leaflet.

[0026] In a second aspect, the present application provides a surgical valve prosthesis, comprising the surgical valve frame provided in the first aspect; an artificial valve leaflet made of a polymer synthetic material, connected to a support portion or a polymer membrane on the support portion.

[0027] In the process of implementing the above technical solution, the artificial valve leaflet adopts a polymer synthetic material, which can better combine the artificial valve leaflet with the polymer membrane to improve the durability of the artificial valve leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0029] Figure 1 A schematic structural diagram of a valve support for surgical operation provided in an embodiment of the present application;

[0030] Figure 2 A schematic structural diagram of a valve prosthesis for surgical operation provided in an embodiment of the present application;

[0031] Figure 3 A schematic structural diagram of a valve support for surgical operation provided by another embodiment of the present application;

[0032] Figure 4 A schematic structural diagram of a valve support for surgical operation provided in yet another embodiment of the present application;

[0033] Figure 5 Schematic diagram of the structure of a valve frame for surgical operation provided by a different embodiment of the present application.

[0034] Icon: 1-base; 11-hole; 2-support part; 31-membrane reinforcement part; 33-bottom wall; 4-connecting part; 5-artificial valve leaflet; 6-connecting segment; 61-groove. DETAILED DESCRIPTION

[0035] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings in the embodiments of the present application.

[0036] It should be noted that similar reference numerals and letters represent similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings. At the same time, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and should not be understood as indicating or implying relative importance.

[0037] like Figure 2 As shown, in the first aspect, the embodiment of the present application provides a valve frame for surgical operation. The valve frame serves as the main supporting structure of the valve prosthesis and provides a stable supporting force for the artificial valve leaflets 5. The valve prosthesis is implanted at the designated position and realizes the pulsation function at the expected position. When the valve prosthesis is closed, the artificial valve leaflets 5 will be subjected to a certain pressure given by the blood in the body. The stress concentration in the hanging angle area of ​​the artificial valve leaflets 5 is the largest. At this time, the artificial valve leaflets 5 transfer this part of the load to the valve frame connected to it; because the valve frame in the embodiment of the present application is flexible, the pressure transmitted by the artificial valve leaflets 5 can be stored as potential energy and released in the form of kinetic energy at an appropriate time. Such an action will relieve the stress concentration of the artificial valve leaflets 5 when closing, thereby delaying the maximum stress concentration position of the artificial valve leaflets 5 due to fatigue damage, and increasing the fatigue durability of the valve prosthesis.

[0038] like Figure 1 and 2 As shown, the valve frame includes a base 1 and a support portion 2 extending from the base 1, the support portion 2 is used to connect the artificial valve leaflet 5, and a coating area is provided on the support portion 2, the coating area is used to coat a polymer film, and a coating reinforcement portion 31 extending inward along the thickness direction of the support portion 2 is provided in the coating area. The coating reinforcement portion 31 increases the bonding area between the valve frame and the polymer film, and improves the connection force between the valve frame and the polymer film. Since the artificial valve leaflet 5 made of polymer synthetic material is connected to the valve frame through the polymer film covering the valve frame, the coating reinforcement portion 31 improves the connection force between the polymer film and the valve frame, so the artificial valve leaflet 5 made of polymer synthetic material can be better connected to the valve frame, thereby also improving the durability of the valve prosthesis.

[0039] At the same time, the coating reinforcement portion 31 is a concave structure, which reduces the weight of the valve frame as a whole and makes the local wall thickness of the valve frame thinner. Compared with the planar structure, the thinned area of ​​the valve frame in the embodiment of the present application is more easily deformed, and the flexibility of the valve frame is improved, which relieves the stress concentration of the artificial valve leaflet 5 when closing, relieves the damage of the artificial valve leaflet 5 due to fatigue, and improves the service life of the valve prosthesis.

[0040] Optionally, the base 1 and the support portion 2 are integrally formed to improve the structural strength of the valve frame.

[0041] Optionally, the valve frame can be made of PEK. The valve frame can be made of medical-grade PEEK, which has good support and flexibility, ensuring that a lower valve frame height can be designed during preparation while still achieving sufficient structural strength.

[0042] Of course, as another embodiment, a coating area may be provided on the base 1 and the support 2 , that is, a portion of the coating area is provided on the base 1 and another portion of the coating area is provided on the support 2 .

[0043] Optionally, the petal frame is formed by surrounding a support portion 2 of a tapered sheet material, wherein the thickness of the support portion 2 gradually decreases from bottom to top.

[0044] Optionally, there are three support portions 2, which are evenly spaced. The three support portions 2 are evenly distributed on the annular base 1 of the petal frame, that is, the angle between the line connecting two adjacent support portions 2 and the center of the petal frame is 120°.

[0045] like Figure 1 and 3 As shown, as an embodiment, the closed area formed by the extension of the coating reinforcement portion 31 on the support portion 2 enables the valve frame to have flexibility while meeting the structural strength requirements, and can alleviate the problem of durable failure of the valve prosthesis caused by high stress concentration of the artificial valve leaflet 5.

[0046] Of course, the coating reinforcement portion 31 can also extend on the base 1 and the support portion 2 to form a closed area, which can also make the valve frame flexible while meeting the structural strength requirements, and can alleviate the problem of durable failure of the valve prosthesis caused by high stress concentration of the artificial valve leaflet 5.

[0047] Optionally, the closed area formed by the coating reinforcement portion 31 may be a triangle, a circle, or other closed shapes.

[0048] like Figure 3 As shown, as an embodiment, the closed area surrounded by the coating reinforcement part 31 passes through the thickness direction of the support part 2, so that the support part 2 is partially in the shape of a through hole, which reduces the weight of the valve frame and changes the local thickness of the support part 2. While meeting the overall structural strength of the valve frame, the valve frame is also made flexible. In the process of the artificial valve hanging angle position swinging in and out with the pulsating flow of the human body, the accumulated potential energy of the artificial valve leaflet 5 can be converted into kinetic energy for release, thereby alleviating the problem of damage to the artificial valve stress concentration position caused by fatigue durability.

[0049] like Figure 1As shown, as an embodiment, the closed area surrounded by the coating reinforcement part 31 forms a bottom wall 33, thereby thinning the local thickness of the support part 2 and reducing the weight of the valve frame. While meeting the overall structural strength of the valve frame, the valve frame is also made flexible. In the process of the artificial valve hanging angle position swinging in and out with the pulsating flow of the human body, the accumulated potential energy of the artificial valve leaflet 5 can be converted into kinetic energy for release, thereby alleviating the problem of damage to the stress concentration position of the artificial valve due to fatigue durability.

[0050] As an embodiment, a coating reinforcement pattern (not shown in the figure) is provided on the bottom wall 33. On the one hand, it can increase the structural strength of the coating reinforcement portion 31, thereby increasing the overall structural strength of the valve frame; on the other hand, it can also increase the bonding area between the valve frame and the polymer film, increase the connection force between the valve frame and the polymer film, and also improve the durability of the valve prosthesis.

[0051] Optionally, the reinforcement lines may be in the form of convex ribs; or in the form of radially recessed grooves along the bottom wall 33 .

[0052] like Figure 1 and 3 As shown, as an embodiment, steps or patterns are provided on the coating reinforcement portion 31, so as to increase the structural strength of the coating reinforcement portion 31, thereby increasing the structural strength of the valve frame as a whole; on the other hand, it can also increase the bonding area between the valve frame and the polymer film, increase the connection force between the valve frame and the polymer film, and also improve the durability of the valve prosthesis.

[0053] like Figure 1 and 3 As shown, as an embodiment, the base 1 is provided with a plurality of holes 11 penetrating the base 1 along the circumferential direction, so that the valve frame can have flexibility around the circumference, and at the same time, it is convenient to connect the valve frame and the artificial valve ring by suturing.

[0054] like Figure 4 As shown, as an embodiment, at least one connection portion 4 for increasing the contact area with the artificial valve ring is provided on the base 1, and the radial dimension of the connection portion 4 is the same as the radial dimension of the base 1. By providing the connection portion 4, the contact portion between the valve frame and the artificial valve ring is thickened in the height direction. The connection portion 4 and the base 1 can increase the contact area with the artificial valve ring, thereby improving the stability of the valve prosthesis and extending the service life of the valve prosthesis.

[0055] Optionally, one or more connecting parts 4 may be provided.

[0056] Optionally, the connecting portion 4 is also provided with a through hole communicating with the hole 11 on the base 1 .

[0057] like Figure 5As shown, as an embodiment, the valve frame also includes a connecting segment 6, the radial dimension of the first end of the connecting segment 6 is smaller than the radial dimension of the base 1, and the radial dimension of the second end is larger than the radial dimension of the first end, that is, the local radial dimension of the connecting segment 6 is smaller than the radial dimension of the base 1, and the first end of the connecting segment 6 is connected to the base 1, and a groove 61 for engaging with the artificial valve ring is formed therebetween, which facilitates the connection between the artificial valve ring and the valve frame, and also improves the stability between the artificial valve ring and the valve frame.

[0058] As an embodiment, the surface of the valve frame is covered with a polymer film.

[0059] After the valve frame is formed, before the artificial valve leaflets 5 are formed on the valve frame, the outer and inner surfaces of the valve frame are coated with a polymer film in advance. Usually, the valve frame is placed in a molten polymer layer material. After cooling, a polymer film is formed on the outer and inner surfaces of the valve frame. The polymer film facilitates better connection between the valve frame and the artificial valve leaflets 5.

[0060] Optionally, the artificial valve ring has an annular structure and has multiple arc-shaped protrusions, which is suitable for matching with the aortic valve.

[0061] In the second aspect, an embodiment of the present application provides a surgical valve prosthesis, comprising the surgical valve frame provided in the first aspect, and an artificial valve leaflet 5 made of a polymer synthetic material, which can be connected to the support part 2, and of course, can also be connected to the polymer membrane on the support part 2.

[0062] The artificial valve leaflet 5 made of polymer synthetic materials has better durability than biological valve leaflets.

[0063] Optionally, the polymer film material on the surface of the valve frame can be the same as the material of the leaflets, because the valve frame and the artificial leaflets 5 are heterogeneous materials, and the polymer film made of the same material as the artificial leaflets 5 improves the stability and consistency of the artificial leaflets 5 on the valve frame.

[0064] Optionally, the thickness of the artificial valve leaflet 5 is uniform, and the thickness of the artificial valve leaflet 5 can be controlled within 0.09 mm to 0.15 mm.

[0065] Optionally, the artificial valve leaflet 5 can be made of TPU composite material (Thermoplastic polyurethanes). The artificial valve leaflet 5 made of TPU composite material has the same structural design, overall quality, tissue at each position and thickness. The artificial valve leaflet 5 with uniform thickness can have a larger flow opening area when in the open position, further reducing the transvalvular pressure difference. Not only that, the artificial valve leaflet 5 made of TPU composite material can reduce valve calcification problems in multiple tests, thereby improving the service life of the surgically implanted artificial valve.

[0066] Of course, the artificial valve leaflet 5 can also be made of SEBS styrene-ethylene-butylene-styrene block copolymer or SPU silane-modified polyurethane.

[0067] The above description is merely an embodiment of the present application and is not intended to limit the scope of protection of the present application. For those skilled in the art, various modifications and variations of the present application are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

[0068] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

[0069] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

Claims

1. A valve support for surgical operation, characterized in that: include: A base and a support portion extending from the base for connecting to an artificial valve leaflet, the valve frame being a tapered sheet material support portion arranged around the base, and the surface of the valve frame being covered with a polymer film; A coating area is provided on the support portion or the base portion and the support portion, and the coating area is provided with a coating reinforcement portion extending inwardly in the thickness direction of the support portion; The coating reinforcement portion is a closed area extended on the support portion or the coating reinforcement portion is a closed area extended on the base and the support portion, and the closed area is a recessed structure, thereby increasing the bonding area between the valve frame and the polymer film, and at the same time making the local wall thickness of the valve frame thinner; the artificial valve leaflet made of polymer synthetic material is connected to the valve frame through the polymer film, and the coating reinforcement portion is used to improve the connection force between the polymer film and the valve frame.

2. The surgical valve holder according to claim 1, wherein: The closed area surrounded by the coating reinforcement portion passes through the support portion in the thickness direction.

3. The surgical valve holder according to claim 1, wherein: The closed area surrounded by the coating reinforcement portion forms a bottom wall.

4. The surgical valve holder according to claim 3, wherein: The bottom wall is provided with a coating reinforcement pattern.

5. The surgical valve holder according to any one of claims 1 to 4, characterized in that: The coating reinforcement portion is provided with steps or patterns.

6. The valve holder for surgical operation according to any one of claims 1 to 4, characterized in that: The base is provided with a plurality of holes penetrating the base along the circumferential direction.

7. The surgical valve holder according to claim 6, wherein: The base is provided with at least one connecting portion for increasing the contact area with the artificial valve ring, and the radial dimension of the connecting portion is the same as the radial dimension of the base.

8. The surgical valve holder according to claim 6, wherein: The surgical valve frame also includes a connecting segment, the radial dimension of the first end of the connecting segment is smaller than the radial dimension of the base, the first end of the connecting segment is connected to the base, and a groove for engaging with an artificial valve ring is formed therebetween.

9. A valve prosthesis for surgical operation, characterized in that: A valve support for surgical operation according to any one of claims 1 to 8; The artificial valve leaflet made of polymer synthetic material is connected to the polymer membrane on the support part.

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