Surgical valve frame and surgical valve prosthesis

Abstract

The present application relates to the technical field of medical instruments, and provides a surgical valve frame and a surgical valve prosthesis. The surgical valve frame comprises: a base portion and support portions extending from the base portion and used for connecting prosthetic valve leaflets, wherein the support portions or the base portion and the support portions are each provided with a coating area, and the coating area is provided with a coating reinforcement section that extends inward in the thickness direction of the corresponding support portion. By means of the technical solution of the present application, the flexibility and durability of the valve prosthesis can be improved.

Description

Surgical valve stents and valve prostheses

[0001] Cross-references to related applications

[0002] This application claims priority to Chinese Patent Application No. 202410801425.6, filed on June 20, 2024, entitled "Surgical Valve Frame and Valve Prosthesis", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical device technology, and more specifically, to valve stents and valve prostheses for surgical procedures. Background Technology

[0004] Replacing the original diseased valve with an artificial heart valve prosthesis through traditional surgery is one of the important methods for treating valvular heart disease. This procedure allows for good exposure of the heart and major blood vessels, facilitating surgical manipulation, and is particularly suitable for patients with multiple valves, complex lesions, or those requiring multiple surgical procedures or complex operations during surgery. Current surgical valve prostheses generally consist of two parts: a support structure called the valve frame, which provides support and fixation; and a moving unit called the valve leaflet, which enables opening and closing, allowing blood flow and preventing backflow. The valve leaflet is usually made of bio-based materials, including bovine or porcine pericardium. However, bio-based materials are prone to calcification and damage, leading to leaflet calcification, decay, or fatigue failure, reducing the durability of the valve prosthesis. Furthermore, valve leaflets made of bio-based materials are typically sutured to the valve frame. With each heartbeat, the leaflets constantly change position under the pressure of blood flow. Over time, stress and friction can cause tearing and damage at the suture sites, similarly reducing the durability of the valve prosthesis.

[0005] Compared with traditional bioprosthetic valve leaflets, polymeric valve leaflets have the advantages of excellent durability, low cost and industrial production capability, making them a current research hotspot. However, since polymeric valve leaflets are coated on the valve frame, the long-term stability of valve prostheses needs to be verified.

[0006] Summary of the Invention

[0007] The technical problem to be solved by this application is to provide a surgical valve frame and valve prosthesis suitable for use with polymer synthetic material valve leaflets, and to improve the durability of the valve prosthesis with polymer synthetic material valve leaflets.

[0008] An embodiment of this application provides a surgical valve frame, comprising: a base and a support extending from the base for connecting an artificial valve leaflet, wherein the support or the base and the support are provided with a covering area, and the covering area is provided with a covering reinforcement extending inward in the thickness direction of the support.

[0009] In the implementation of the above technical solution, the valve frame includes a base and a support extending from the base. The support is used to connect the artificial valve leaflet. A film-coated area is provided on the support, or a film-coated area is provided on both the base and the support. A film-coated reinforcement extending inward along the thickness direction of the support is provided in the film-coated area, thereby increasing the bonding area between the valve frame and the polymer membrane and improving the connection force between the valve frame and the polymer membrane. Since the artificial valve leaflet of polymer synthetic material is connected to the valve frame through the polymer membrane covering the valve frame, the film-coated reinforcement improves the connection force between the polymer membrane and the valve frame. Therefore, the artificial valve leaflet of polymer synthetic material can be better connected to the valve frame, thereby improving the durability of the artificial valve leaflet.

[0010] In addition, the membrane reinforcement extends inward in the thickness direction of the support, making the local wall thickness of the valve frame thinner. While meeting the structural strength requirements of the valve frame, it makes the valve frame more deformable than a planar structure, improving the circumferential flexibility of the valve frame, alleviating stress concentration of the artificial leaflet when it closes, reducing fatigue damage to the artificial leaflet, and improving the service life of the valve prosthesis.

[0011] As an optional implementation, the coating reinforcement extends on the support to form a closed area, or the coating reinforcement extends on both the base and the support to form a closed area.

[0012] In the implementation of the above technical solution, the membrane reinforcement is a closed area formed on the support, which reduces the wall thickness of the valve frame and improves the flexibility of the valve frame while meeting the structural strength requirements. This can alleviate the problem of valve prosthesis durability failure caused by high stress concentration in artificial valve leaflets. Of course, the membrane reinforcement can also be extended on the base and support to form a closed area.

[0013] As an optional implementation, the closed area enclosed by the film reinforcement portion penetrates through the thickness direction of the support portion.

[0014] In the implementation of the above technical solution, the membrane reinforcement is installed through the entire structure, making the part of the support part a through hole, reducing the weight of the valve frame and changing 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. When the artificial valve hangs at the corner position, it swings inward and outward with the pulsation of the human body, which can convert the accumulated potential energy of the artificial valve leaflet into kinetic energy release, and alleviate the problem of damage to the artificial valve at the stress concentration point caused by fatigue and durability.

[0015] As an optional implementation, the closed area enclosed by the coating reinforcement forms a bottom wall.

[0016] In the process of implementing the above technical solution, the closed area enclosed by the membrane reinforcement forms the bottom wall, thereby reducing the local thickness of the support 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, improving the flexibility of the valve frame. At the artificial valve hanging corner, it will swing inward and outward with the pulsation of the human body, which can convert the accumulated potential energy of the artificial valve leaflet into kinetic energy release, and alleviate the problem of damage to the artificial valve at the stress concentration point caused by fatigue and durability.

[0017] As an optional implementation, the bottom wall is provided with a coating-reinforced texture.

[0018] In the process of implementing the above technical solution, the coating reinforcement texture can increase the structural strength of the coating reinforcement part, thereby increasing the overall structural strength of the valve frame; at the same time, it increases the connection force between the valve frame and the polymer membrane.

[0019] As an optional implementation, the coating reinforcement portion is provided with steps or patterns.

[0020] In the process of implementing the above technical solution, the steps or patterns can increase the structural strength of the coating reinforcement, thereby increasing the overall structural strength of the petiole frame; at the same time, they can increase the connection between the petiole frame and the polymer membrane.

[0021] As an optional implementation, the base is provided with a plurality of holes penetrating the base in the circumferential direction.

[0022] In the process of implementing the above technical solution, the base is made easy to deform, which improves the flexibility of the valve frame circumference. At the same time, it also facilitates the connection between the valve frame and the artificial valve ring by suturing.

[0023] As an optional implementation, the base is provided with at least one connecting portion for increasing the contact area with the artificial valve annulus, and the radial dimension of the connecting portion is the same as the radial dimension of the base.

[0024] In the implementation of the above technical solution, by setting a connecting part, the contact part between the valve frame and the artificial valve annulus becomes thicker in the height direction. The connecting part and the base can increase the contact area with the artificial valve annulus, thereby improving the stability of the valve prosthesis and extending the service life of the valve prosthesis.

[0025] As an optional implementation, the surgical valve frame further includes a connecting segment, the first end of which has a radial dimension smaller than that of the base, the first end of which is connected to the base, and a groove is formed between them for engaging with an artificial valve annulus.

[0026] In the implementation of the above technical solution, the local radial dimension 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 is formed between the two for engaging with the artificial valve ring, 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.

[0027] As an optional implementation, the surface of the valve frame is coated with a polymer film.

[0028] In the process of implementing the above technical solution, a polymer membrane is formed on the outer and inner surfaces of the valve frame, which facilitates better connection between the valve frame and the artificial leaflet.

[0029] As an optional implementation, the petiole frame is made of PEEK material.

[0030] As an optional implementation, the base and the support are integrally formed.

[0031] As an optional implementation, the thickness of the support gradually decreases from bottom to top.

[0032] As an optional implementation, the number of support portions is three, and they are arranged at equal intervals.

[0033] As an optional implementation, the closed area formed by the coating reinforcement is triangular or circular.

[0034] As an alternative implementation, the reinforcing texture is in the form of raised ribs or in the form of grooves that are radially recessed along the bottom wall.

[0035] As an optional implementation, the number of support portions is three, and they are arranged at equal intervals.

[0036] As an optional implementation, the connecting part is provided with a through hole that communicates with the hole on the base.

[0037] As an optional implementation, the artificial valve annulus has a ring structure and multiple arc-shaped protrusions, which is suitable for fitting the aortic valve.

[0038] Furthermore, this application also provides a surgical valve prosthesis, including the surgical valve frame provided in the aforementioned embodiments; and an artificial valve leaflet made of polymeric synthetic material, connected to a support portion or a polymeric membrane on the support portion.

[0039] In the implementation of the above embodiments, the artificial leaflets are made of polymer synthetic materials, which enables the artificial leaflets to better combine with the polymer membrane, thereby improving the durability of the artificial leaflets. Attached Figure Description

[0040] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0041] Figure 1 is a schematic diagram of the structure of the surgical valve stent provided in an embodiment of this application;

[0042] Figure 2 is a schematic diagram of the structure of the surgical valve prosthesis provided in the embodiment of this application;

[0043] Figure 3 is a schematic diagram of the structure of a surgical valve stent provided in another embodiment of this application;

[0044] Figure 4 is a schematic diagram of the structure of a surgical valve stent provided in another embodiment of this application;

[0045] Figure 5 is a structural schematic diagram of a surgical flap provided in a different embodiment of this application.

[0046] Icons: 1-Base; 11-Hole; 2-Support; 31-Covering reinforcement; 33-Bottom wall; 4-Connector; 5-Artificial leaflet; 6-Connecting segment; 61-Groove. Detailed Implementation

[0047] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0048] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0049] As shown in Figure 2, this embodiment of the application provides a surgical valve frame. The valve frame, as the main support structure of the valve prosthesis, provides stable support for the artificial valve leaflet 5. The valve prosthesis is implanted into the designated position and achieves pulsation function at the expected location. When the valve prosthesis closes, the artificial valve leaflet 5 bears a certain pressure from the blood in the body. The stress concentration is greatest in the hanging corner area of ​​the artificial valve leaflet 5. At this time, the artificial valve leaflet 5 transfers this load to the valve frame connected to it. Because the valve frame in this embodiment of the application is flexible, it can store the pressure transmitted by the artificial valve leaflet 5 as potential energy and release it as kinetic energy at an appropriate time. This action alleviates the stress concentration of the artificial valve leaflet 5 when it closes, thereby delaying fatigue damage at the location of maximum stress concentration and increasing the fatigue durability life of the valve prosthesis.

[0050] As shown in Figures 1 and 2, the valve frame includes a base 1 and a support 2 extending from the base 1. The support 2 is used to connect the artificial valve leaflet 5. The support 2 is provided with a coating area for coating a polymer membrane. The coating area is provided with a coating reinforcement 31 extending inward along the thickness direction of the support 2. The coating reinforcement 31 increases the bonding area between the valve frame and the polymer membrane, and improves the connection force between the valve frame and the polymer membrane. Since the artificial valve leaflet 5 made of polymer synthetic material is connected to the valve frame through the polymer membrane covering the valve frame, the coating reinforcement 31 improves the connection force between the polymer membrane and the valve frame. Therefore, the artificial valve leaflet 5 made of polymer synthetic material can be better connected to the valve frame, thereby improving the durability of the valve prosthesis.

[0051] Meanwhile, the membrane reinforcement 31 has a concave structure, which reduces the weight of the entire valve frame and makes the local wall thickness of the valve frame thinner. Compared with the planar structure, the thinned area of ​​the valve frame in this embodiment is easier to deform, which also improves the flexibility of the valve frame, relieves the stress concentration of the artificial leaflet 5 when it is closed, relieves the artificial leaflet 5 from fatigue damage, and improves the service life of the valve prosthesis.

[0052] Optionally, the base 1 and the support 2 are integrally formed to improve the structural strength of the petiole frame.

[0053] Optionally, the valve frame can be made of PEEK material. The valve frame can be made of medical-grade PEEK material, which has good support and flexibility, ensuring that sufficient structural strength can be achieved even when the valve frame height is designed during fabrication.

[0054] Of course, as another implementation, a coating area can also be provided on the base 1 and the support 2, that is, a part of the coating area is provided on the base 1 and another part of the coating area is provided on the support 2.

[0055] Optionally, the petal frame is formed by a support portion 2 of tapered sheet material, wherein the thickness of the support portion 2 gradually decreases from bottom to top.

[0056] Optionally, the number of support parts 2 is three, and they are evenly spaced. The three support parts 2 are evenly distributed on the annular base 1 of the petiole frame, that is, the included angle between the lines connecting two adjacent support parts 2 to the center of the petiole frame is 120°.

[0057] As shown in Figures 1 and 3, in one embodiment, the membrane reinforcement 31 extends into a closed area on the support 2, so that the valve frame has flexibility while meeting the structural strength requirements, which can alleviate the problem of valve prosthesis durability failure caused by high stress concentration of artificial leaflet 5.

[0058] Of course, the membrane reinforcement 31 can also extend to form a closed area on the base 1 and the support 2, which can also make the valve frame flexible while meeting the structural strength requirements, and can alleviate the problem of valve prosthesis durability failure caused by high stress concentration of artificial valve leaflet 5.

[0059] Optionally, the closed area formed by the coating reinforcement 31 can be triangular, circular, or other closed shapes.

[0060] As shown in Figure 3, in one embodiment, the closed area enclosed by the membrane reinforcement 31 penetrates through the thickness direction of the support 2, thereby making a part of the support 2 a through hole, reducing the weight of the valve frame, and also changing the local thickness of the support 2. While satisfying the overall structural strength of the valve frame, it also makes the valve frame flexible. At the artificial valve hanging corner position, it will swing inward and outward with the pulsation of the human body, which can convert the potential energy accumulated by the artificial valve leaflet 5 into kinetic energy release, and alleviate the problem of damage to the artificial valve stress concentration position caused by fatigue and durability.

[0061] As shown in Figure 1, in one embodiment, the closed area enclosed by the membrane reinforcement 31 forms the bottom wall 33, thereby reducing the local thickness of the support 2 and reducing the weight of the valve frame. While satisfying the overall structural strength of the valve frame, it also makes the valve frame flexible. At the artificial valve hanging corner, it will swing inward and outward with the pulsation of the human body, which can convert the accumulated potential energy of the artificial valve leaflet 5 into kinetic energy release, and alleviate the problem of damage to the artificial valve stress concentration position caused by fatigue and durability.

[0062] As one implementation, the bottom wall 33 is provided with a membrane reinforcement texture (not shown in the figure). On the one hand, it can increase the structural strength of the membrane reinforcement part 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 membrane, increase the connection force between the valve frame and the polymer membrane, and also improve the durability of the valve prosthesis.

[0063] Optionally, the reinforcing texture can be in the form of raised ribs; or it can be in the form of grooves that are radially recessed along the bottom wall 33.

[0064] As shown in Figures 1 and 3, in one embodiment, the membrane reinforcement 31 is provided with steps or patterns, which can increase the structural strength of the membrane reinforcement 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 membrane, increase the connection force between the valve frame and the polymer membrane, and also improve the durability of the valve prosthesis.

[0065] As shown in Figures 1 and 3, in one embodiment, the base 1 is provided with a plurality of holes 11 penetrating the base 1 in the circumferential direction, so that the circumference of the valve frame can be flexible, and at the same time, it is convenient to connect the valve frame and the artificial valve ring by stitching.

[0066] As shown in Figure 4, in one embodiment, the base 1 is provided with at least one connecting part 4 for increasing the contact area with the artificial valve annulus. The radial dimension of the connecting part 4 is the same as the radial dimension of the base 1. By providing the connecting part 4, the contact area between the valve frame and the artificial valve annulus becomes thicker in the height direction. The connecting part 4 and the base 1 can increase the contact area with the artificial valve annulus, thereby improving the stability of the valve prosthesis and extending the service life of the valve prosthesis.

[0067] Optionally, one or more connecting parts 4 may be provided.

[0068] Optionally, the connecting part 4 is also provided with a through hole that communicates with the hole 11 on the base part 1.

[0069] As shown in Figure 5, in one 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. The first end of the connecting segment 6 is connected to the base 1, and a groove 61 for engaging with the artificial valve annulus is formed between the two, which facilitates the connection between the artificial valve annulus and the valve frame. In addition, it also improves the stability between the artificial valve annulus and the valve frame.

[0070] In one implementation, the surface of the valve frame is covered with a polymer film.

[0071] After the petiole frame is formed, before the artificial petiole 5 is formed on the petiole frame, a polymer film is pre-coated on the outer and inner surfaces of the petiole frame. Usually, the petiole frame is placed in a molten polymer layer material, and after cooling, a polymer film is formed on the outer and inner surfaces of the petiole frame. The polymer film facilitates better connection between the petiole frame and the artificial petiole 5.

[0072] Optionally, the artificial valve annulus has a ring structure and multiple arc-shaped protrusions, making it suitable for fitting the aortic valve.

[0073] Furthermore, this application provides a surgical valve prosthesis, including the surgical valve frame provided in the aforementioned embodiments, and an artificial valve leaflet 5 made of polymer synthetic material, which can be connected to the support portion 2, or of course, can also be connected to the polymer membrane on the support portion 2.

[0074] Artificial leaflets made of polymer synthetic materials have better durability than biological leaflets.

[0075] Optionally, the polymer membrane material on the surface of the petiole frame can be the same as the material of the petiole leaf, because the petiole frame and the artificial petiole leaf 5 are heterogeneous materials, and the polymer membrane of the same material as the artificial petiole leaf 5 improves the stability and consistency of the artificial petiole leaf 5 on the petiole frame.

[0076] Optionally, the thickness of the artificial leaflet 5 is uniform, and the thickness of the artificial leaflet 5 can be controlled within 0.09mm to 0.15mm.

[0077] Optionally, the artificial leaflet 5 can be made of TPU composite material (Thermoplastic polyurethanes). The artificial leaflet 5 made of TPU composite material has the same structural design, overall weight, tissue and thickness at all locations. The artificial leaflet 5 with uniform thickness can have a larger flow area when in the open position, further reducing the transvalvular pressure gradient. Moreover, the artificial leaflet 5 made of TPU composite material can reduce valve calcification problems in multiple tests, thereby improving the service life of surgically implanted artificial valves.

[0078] Of course, artificial leaflets 5 can also be made of SEBS styrene-ethylene-butene-styrene block copolymer or SPU silane-modified polyurethane.

[0079] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0080] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0081] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. Industrial applicability

[0082] This application provides a surgical valve frame and valve prosthesis that enable the artificial valve leaflets to better integrate with the polymer membrane, thereby improving the durability of the artificial valve leaflets.

[0083] Furthermore, it is understood that the surgical valve frame and valve prosthesis of this application are reproducible and can be widely used in the field of medical devices.

Claims

1. A surgical valve holder, characterized in that, include: The base and a support extending from the base for connecting the artificial leaflet, the support or the base and the support having a coating area, the coating area having a coating reinforcement extending inward in the thickness direction of the support.

2. The surgical flap holder according to claim 1, characterized in that, The coating reinforcement extends on the support to form a closed area, or the coating reinforcement extends on both the base and the support to form a closed area.

3. The surgical flap holder according to claim 2, characterized in that, The closed area enclosed by the film-reinforced portion penetrates through the thickness direction of the support portion.

4. The surgical flap holder according to claim 2, characterized in that, The closed area enclosed by the coating reinforcement forms the bottom wall.

5. The surgical flap holder according to claim 4, characterized in that, The bottom wall is provided with a coating-reinforced texture.

6. The surgical flap according to any one of claims 2 to 5, characterized in that, The coating reinforcement section is provided with steps or patterns.

7. The surgical flap according to any one of claims 1 to 5, characterized in that, The base has multiple holes penetrating it along its circumference.

8. The surgical flap holder according to claim 7, characterized in that, The base is provided with at least one connecting part for increasing the contact area with the artificial valve annulus, and the radial dimension of the connecting part is the same as the radial dimension of the base.

9. The surgical flap holder according to claim 7, characterized in that, The surgical valve holder further includes a connecting segment, the first end of which has a radial dimension smaller than that of the base, and the first end of the connecting segment is connected to the base, forming a groove between them for engaging with an artificial valve annulus.

10. The surgical flap according to any one of claims 1 to 5, characterized in that, The surface of the valve frame is covered with a polymer film.

11. The surgical flap according to any one of claims 1 to 10, characterized in that, The petal frame is made of PEEK material.

12. The surgical flap according to any one of claims 1 to 11, characterized in that, The base and the support are integrally formed.

13. The surgical flap according to any one of claims 1 to 12, characterized in that, The thickness of the support gradually decreases from bottom to top.

14. The surgical flap according to any one of claims 1 to 13, characterized in that, The number of support parts is three, and they are evenly spaced.

15. The surgical flap according to any one of claims 2 to 14, characterized in that, The closed area formed by the coating reinforcement is triangular or circular.

16. The surgical flap holder according to claim 5, characterized in that, The reinforcing texture is in the form of raised ribs or grooves that are radially recessed along the bottom wall.

17. The surgical flap according to any one of claims 1 to 13, characterized in that, The number of support parts is three, and they are evenly spaced.

18. The surgical flap holder according to claim 8, characterized in that, The connecting part is provided with a through hole that communicates with the hole on the base.

19. The surgical flap according to any one of claims 1 to 13, characterized in that, The artificial valve annulus has a ring structure and multiple arc-shaped protrusions, making it suitable for fitting the aortic valve.

20. A surgical valve prosthesis, characterized in that, Includes the surgical valve frame as described in any one of claims 1 to 19; Artificial petals made of polymeric synthetic materials are connected to a support or a polymeric membrane on the support.

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