Composite material valve leaflet

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to a composite material valve leaflet. The utility model provides a composite material valve leaflet. The composite material valve leaflet comprises a first high polymer layer, a reinforcing layer and a second high polymer layer which are sequentially stacked. The composite material valve leaflet is provided with the reinforcing layer, the valve root strength of the composite material valve leaflet can be improved, the composite material valve leaflet is not prone to avulsion at the tissue suturing edge, and the function of replacing a human body valve leaflet switch to control blood flow passing is achieved; besides, the first high polymer layer and the second high polymer layer arranged on the composite material valve leaflet have excellent softness and activity, can well simulate the function of the valve leaflet of a human body, are strong in tissue inertia, reduce the rejection reaction of tissues, improve the durability and the using effect of the composite material valve leaflet, and prolong the service life of the composite material valve leaflet.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a composite material leaflet. Background Technology

[0002] Currently, aortic valve repair materials for infants and children mainly use fresh autologous pericardium or glutaraldehyde-treated autologous pericardial tissue. However, autologous pericardial material has disadvantages as aortic valve repair material, including inconsistent thickness, relatively weak strength, and a high long-term calcification rate. Furthermore, pericardial tissue-based aortic valve repair surgery is prone to infective endocarditis. In addition, some children undergoing secondary aortic valve repair may face the predicament of having no suitable repair material due to pericardial absence or severe pericardial adhesions. Therefore, there is an urgent need for an alternative tissue material to autologous pericardium.

[0003] Existing technologies typically use polymeric materials (such as expanded polytetrafluoroethylene, ePTFE) as tissue engineering materials. These materials are inexpensive, easy to manufacture, and compared to autologous pericardium, they are thinner, more flexible, have better mobility, and are more tissue inert, making them less prone to calcification and infective endocarditis after implantation. However, artificial valve leaflets made of polymeric materials in existing technologies are prone to tearing at the tissue suture edges. Utility Model Content

[0004] The purpose of this invention is to provide a composite material valve leaflet. The composite material valve leaflet provided by this invention is provided with a reinforcing layer, which improves the strength of the valve root and makes it less likely to tear off at the tissue suture edge.

[0005] To achieve the above objectives, this utility model provides the following technical solution:

[0006] This invention provides a composite material leaflet, which includes a first polymer layer, a reinforcing layer, and a second polymer layer stacked sequentially.

[0007] Preferably, the materials of the first polymer layer and the second polymer layer independently comprise expanded polytetrafluoroethylene.

[0008] Preferably, the reinforcing layer is made of biomaterials; the tear resistance of the biomaterials is greater than that of the first polymer layer; and the tear resistance of the biomaterials is greater than that of the second polymer layer.

[0009] Preferably, the biological material includes bovine pericardium and / or porcine pericardium.

[0010] Preferably, the thickness of the composite material leaflet gradually decreases from the leaflet root to the leaflet tip.

[0011] Preferably, the sides of the reinforcing layer that are in contact with the first polymer layer and the second polymer layer are both rough surfaces.

[0012] This invention provides a composite material valve leaflet, comprising a first polymer layer, a reinforcing layer, and a second polymer layer stacked sequentially. The reinforcing layer enhances the leaflet's root strength, preventing tearing at tissue suture edges and effectively replacing the function of a human valve in controlling blood flow. Furthermore, the first and second polymer layers possess excellent softness and mobility, effectively mimicking the function of a human valve. Their strong tissue inertness reduces tissue rejection, improving the durability and effectiveness of the composite valve and extending its service life.

[0013] Moreover, the composite material leaflet provided by this invention has a gradually decreasing thickness from the root to the tip, thus more closely resembling the structure of the human valve itself and ensuring the integrity of the composite material leaflet's function. At the same time, this invention also limits the sides where the reinforcing layer is bonded to the first polymer layer and the second polymer layer to rough surfaces, which increases the friction on the sides and thus improves the firmness of the composite material leaflet. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 A schematic diagram of the axial side of the composite material leaflet provided in Example 1;

[0016] Figure 2 A schematic diagram of the root section of the composite material leaflet provided in Example 1;

[0017] Figure 3 A cross-sectional schematic diagram of the composite material leaflet provided in Example 1;

[0018] Figure 4 This is a schematic diagram of the stitching of the composite material leaflet provided in Example 1;

[0019] Figures 1-4 In the diagram, 1 is the valve tip, 2 is the valve root, 3 is the first polymer layer, 4 is the reinforcing layer, and 5 is the second polymer layer. Detailed Implementation

[0020] This invention provides a composite material leaflet, which includes a first polymer layer, a reinforcing layer, and a second polymer layer stacked sequentially.

[0021] In this utility model, all materials used are commercially available products well known to those skilled in the art.

[0022] In this invention, the material of the first polymer layer preferably includes expanded polytetrafluoroethylene (ePTFE); the material of the second polymer layer preferably includes ePTFE. This invention uses ePTFE as both the first and second polymer layers, ensuring the strong and ductile bond between the first and second polymer layers and the reinforcing layer, improving the smoothness and anticoagulation effect of the leaflet surface, and enhancing the durability of the composite leaflet. ePTFE has excellent softness and mobility, effectively mimicking the function of the body's own leaflets. Furthermore, its strong tissue inertness reduces tissue rejection, improves the performance of the composite leaflet, extends its service life, and effectively replaces the function of the patient's damaged leaflets.

[0023] In this invention, the reinforcing layer is preferably made of biomaterials; the tear resistance of the biomaterials is preferably greater than that of the first polymer layer; the tear resistance of the biomaterials is preferably greater than that of the second polymer layer; the biomaterials preferably include bovine pericardium and / or porcine pericardium, more preferably bovine pericardium. This invention uses bovine pericardium as the reinforcing layer, ensuring the stability of the valve root and avoiding root tearing caused by repeated opening and closing of the composite valve leaflet; this invention provides a multi-layer (three-layer) structure for the root portion of the composite valve leaflet, which facilitates suturing the valve root to the valve annulus, ensuring a firm fit between the valve root and the valve annulus, avoiding complications such as paravalvular leakage after composite valve surgery, and improving medical quality.

[0024] In this invention, the thickness of the composite material leaflet preferably gradually decreases from the root to the tip. The composite material leaflet provided by this invention has a thickness transition between the root and tip, making the composite material leaflet closer to the structure of the human valve itself, thus ensuring the integrity of the composite material leaflet's function.

[0025] In this invention, the side surface where the reinforcing layer adheres to the first polymer layer and the second polymer layer is preferably a rough surface, which increases the friction of the side surface and thus improves the firmness of the composite material leaflet. In this invention, the rough surface is preferably obtained through rough grinding.

[0026] In this invention, the first polymer layer, the reinforcing layer, and the second polymer layer preferably all meet the aseptic requirements.

[0027] In this invention, after the damaged leaflet is removed, it is preferable to use sutures to suture the root of the composite leaflet to the original leaflet ring. The composite leaflet can be adjusted according to the actual size of the original leaflet ring and the damaged leaflet to achieve the functional state of the original leaflet.

[0028] To further illustrate this utility model, the composite material leaflets provided by this utility model will be described in detail below with reference to the accompanying drawings and embodiments, but these should not be construed as limiting the scope of protection of this utility model.

[0029] Example 1

[0030] exist Figures 1-4 In the diagram, 1 is the valve tip, 2 is the valve root, 3 is the first polymer layer, 4 is the reinforcing layer, and 5 is the second polymer layer.

[0031] Figure 1 This is an axial view of the composite material leaflet provided in this embodiment; Figure 2 This is a schematic diagram of the root section of the composite material leaflet provided in this embodiment; Figure 3 This is a cross-sectional schematic diagram of the composite material leaflet provided in this embodiment.

[0032] The composite material leaflet provided in this embodiment includes a first polymer layer 3, a reinforcing layer 4, and a second polymer layer 5 stacked sequentially. The first polymer layer 3 and the second polymer layer 5 are both made of expanded polytetrafluoroethylene, and the reinforcing layer 4 is made of ox pericardium. The thickness of the composite material leaflet gradually decreases from the root 2 to the tip 1. The sides of the reinforcing layer 4 that are attached to the first polymer layer 3 and the second polymer layer 5 are roughened by coarse grinding.

[0033] Figure 4 This is a schematic diagram of the stitching of the composite material leaflet provided in this embodiment.

[0034] When suturing the composite material leaflet provided in this embodiment, after removing the damaged leaflet, the root of the composite material leaflet is sutured to the original valve annulus using suture thread.

[0035] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, not all embodiments. Other embodiments can be obtained based on the present embodiments without creative intent, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A composite material leaflet, characterized in that, The composite material leaflet comprises a first polymer layer, a reinforcing layer, and a second polymer layer stacked sequentially. The reinforcing layer is made of biomaterials; the tear resistance of the biomaterials is greater than that of the first polymer layer; the tear resistance of the biomaterials is greater than that of the second polymer layer; The thickness of the composite material leaflet gradually decreases from the root to the tip of the leaflet; The first polymer layer and the second polymer layer are independently made of expanded polytetrafluoroethylene; The biological material includes bovine pericardium and / or porcine pericardium.

2. The composite material leaflet according to claim 1, characterized in that, The sides of the reinforcing layer that are in contact with the first polymer layer and the second polymer layer are both rough surfaces.

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