Heart valve prosthesis and preparation method thereof

Abstract

The invention discloses an artificial heart valve prosthesis and a preparation method. The prosthetic heart valve prosthesis comprises: a stent; the plurality of artificial valve leaflets are assembled on the bracket; each artificial valve leaflet comprises a valve leaflet closing area, a valve leaflet commissure area and a valve leaflet middle area; the strength of the valve leaflet commissure area is greater than the strength of the valve leaflet closure area and the strength of the valve leaflet middle area; the elongation rate of the valve leaflet closing area and the elongation rate of the valve leaflet middle area are both larger than the elongation rate of the valve leaflet commissure area; therefore, the mechanical property of the artificial valve is enhanced, the service life of the artificial valve is prolonged, and meanwhile, a patient is helped to better recover normal valve functions.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an artificial heart valve prosthesis and a preparation method thereof. BACKGROUND

[0002] The heart contains four heart chambers, the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The atrium and ventricle form an inflow end of the ventricle, the left ventricle and the aorta form an outflow end of the left ventricle, and the right ventricle and the pulmonary artery form an outflow end of the right ventricle. There are valves with "one-way valve" function at the inflow end and outflow end of the chamber, which ensure the normal flow of blood in the heart chamber. When the valve is problematic, the cardiac hemodynamics changes and the heart function is abnormal, which is called valvular heart disease. With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly, and research shows that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, the traditional surgical treatment is still the preferred treatment for patients with severe valvular disease, but for the elderly, patients with multiple organ diseases, patients with a history of thoracotomy, and patients with poor cardiac function, the risk of traditional surgical treatment is high, and the mortality rate is high. Part of the patients do not even have the opportunity to operate. The replacement / repair of the transcatheter valve has the advantages of no need for thoracotomy, small trauma, and rapid recovery of the patient, and has received extensive attention from experts and scholars. However, the durability of the artificial valve is poor, which directly affects the service life of the valve.

[0003] It should be noted that the information disclosed in the background section of the present application is intended to deepen the understanding of the general background of the present application, and should not be regarded as acknowledging or implying in any form that the information constitutes prior art known to those skilled in the art. SUMMARY

[0004] The purpose of the present application is to provide an artificial heart valve prosthesis and a preparation method, which can enhance the mechanical properties of the artificial valve leaflet and improve the service life of the artificial valve.

[0005] To achieve the above-mentioned purpose, the present application provides an artificial heart valve prosthesis, which comprises:

[0006] a stent; and

[0007] a plurality of artificial valve leaflets assembled on the stent;

[0008] Each of the artificial valve leaflets comprises a valve leaflet closing area, a valve leaflet commissure area, and a valve leaflet middle area; the strength of the valve leaflet commissure area is greater than the strength of the valve leaflet closing area and the strength of the valve leaflet middle area; the elongation rate of the valve leaflet closing area and the elongation rate of the valve leaflet middle area are both greater than the elongation rate of the valve leaflet commissure area.

[0009] Optionally, each of the artificial valve leaflets is a whole braided structure; the braiding density of the commissure area of the valve leaflet is greater than the braiding density of the closing area of the valve leaflet and the braiding density of the middle area of the valve leaflet; the braiding aperture of the commissure area of the valve leaflet is smaller than the braiding aperture of the closing area of the valve leaflet and the braiding aperture of the middle area of the valve leaflet.

[0010] Optionally, the braiding density of the closing area of the valve leaflet is greater than the braiding density of the middle area of the valve leaflet, and the braiding aperture of the closing area of the valve leaflet is smaller than the braiding aperture of the middle area of the valve leaflet.

[0011] Optionally, the braiding aperture of the commissure area of the valve leaflet is ≤20μm, the braiding aperture of the closing area of the valve leaflet is >20um and ≤90um, and the braiding aperture of the middle area of the valve leaflet is >90um and ≤160um.

[0012] Optionally, the braiding angle of the commissure area of the valve leaflet is 75°-105°.

[0013] Optionally, the braiding angle of the commissure area of the valve leaflet is 90°.

[0014] Optionally, the braiding angle of the closing area of the valve leaflet is 30°-60° or 120°-150°, and / or the braiding angle of the middle area of the valve leaflet is 30°-60° or 120°-150°.

[0015] Optionally, the braiding angle of the closing area of the valve leaflet is 45° or 135°, and / or the braiding angle of the middle area of the valve leaflet is 45° or 135°.

[0016] Optionally, the artificial valve leaflet is a pre-folded structure and forms at least one folding line on the central axis.

[0017] Optionally, the folding line is a plurality of folding lines, one of the folding lines is located on the central axis, and the remaining plurality of folding lines is symmetrically arranged about the central axis.

[0018] Optionally, the folding line is 3-7.

[0019] Optionally, the stent comprises a stent mesh and a stent arcuate rod; the stent arcuate rod is recessed towards the inflow direction of the stent, so that the stent is arranged as an open area along the outflow direction thereof; the stent arcuate rod is arranged in correspondence with the artificial valve leaflet, and the valve leaflet fixing edge of each artificial valve leaflet is connected with the corresponding stent arcuate rod.

[0020] Optionally, the artificial heart valve prosthesis further comprises:

[0021] A skirt arranged on the inner side of the stent and connected with the stent, and the skirt is bulged inward to form a plurality of independent bulges.

[0022] Based on the same inventive concept, the application further provides a preparation method of the artificial heart valve prosthesis, which comprises:

[0023] Manufacturing the artificial valve leaflets, and making the strength of the commissure area of the artificial valve leaflets greater than the strength of the valve closing area and the strength of the middle area of the valve leaflets, and making the elongation of the valve closing area and the elongation of the middle area of the valve leaflets both greater than the elongation of the commissure area of the valve leaflets;

[0024] Assembling a plurality of the artificial valve leaflets on the stent.

[0025] Optionally, the artificial valve leaflets are manufactured by a weaving process, and the weaving density of the commissure area of the valve leaflets is greater than the weaving density of the valve closing area and the weaving density of the middle area of the valve leaflets, and the weaving aperture of the commissure area of the valve leaflets is smaller than the weaving aperture of the valve closing area and the weaving aperture of the middle area of the valve leaflets.

[0026] Optionally, the artificial valve leaflets manufactured by the weaving process further comprise:

[0027] Weaving at a weaving angle of 75°-105° to form the commissure area of the valve leaflets;

[0028] Weaving at a weaving angle of 30°-60° or 120°-150° to form the valve closing area and the middle area of the valve leaflets.

[0029] Optionally, before assembling the artificial valve leaflets, the method further comprises:

[0030] Pre-folding the woven artificial valve leaflets to form at least one folding line on the artificial valve leaflets.

[0031] Optionally, the folding line is a plurality of folding lines, one of which is located on the central axis, and the rest of the folding lines are symmetrically arranged about the central axis.

[0032] Optionally, the assembling of the woven artificial valve leaflets on the stent comprises:

[0033] Connecting the valve fixing edge of each artificial valve leaflet with the corresponding stent arc rod on the stent, and the stent arc rod is recessed towards the inflow direction of the stent, so that the stent is arranged as an open area along the outflow direction of the stent.

[0034] Optionally, the preparation method further comprises:

[0035] The skirt is arranged on the inner side of the stent and connected with the stent, and the skirt is bulged inward to form a plurality of independent bulges.

[0036] Compared with the prior art, the artificial heart valve prosthesis and the preparation method provided by the application have at least the following beneficial effects:

[0037] In the application, the different strengths and elongations of the commissure region, the closed region and the middle region of the artificial valve leaflet make the commissure region of the artificial valve leaflet able to withstand greater tension, thereby not easily abraded and broken during the opening and closing of the artificial valve leaflet, while the closed region and the middle region of the artificial valve leaflet can provide better elongation, thereby increasing the effective orifice area and blood flow while improving the durability, thereby not only enhancing the mechanical properties of the artificial valve and prolonging the service life of the artificial valve, but also helping the patient to better recover the normal valve function.

[0038] In further improvements, by means of the pre-folding of the artificial valve leaflet, the circular arc rod of the stent and / or the inward bulging of the skirt, the space regions of the compressed valve prosthesis can be reasonably distributed, thereby effectively reducing the size of the compressed valve prosthesis, reducing the damage to the blood vessel during the intervention of the valve prosthesis and increasing the safety of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0039] Those skilled in the art will understand that the provided drawings are for better understanding of the application and do not constitute any limitation on the scope of the application. Among them:

[0040] Figure 1 is a structural schematic diagram of an artificial heart valve prosthesis provided according to an embodiment of the application;

[0041] Figure 2 is a schematic diagram of a plurality of artificial valve leaflets provided according to an embodiment of the application, which are tightly closed in a sealing abutting manner in a closed state;

[0042] Figure 3 is a region schematic diagram of an artificial valve leaflet according to the stress conditions of different parts provided according to an embodiment of the application;

[0043] Figure 4 is a schematic diagram of the weaving angle between two weaving wires intersecting with each other on an artificial valve leaflet provided according to an embodiment of the application;

[0044] Figure 5 is a weaving structure schematic diagram of a commissure region of a valve leaflet provided according to an embodiment of the application;

[0045] Figure 6 is a weaving structure schematic diagram of a closed region of a valve leaflet provided according to an embodiment of the application;

[0046] Figure 7 is a schematic diagram of the effect of the artificial valve leaflet in use according to an embodiment of the present application;

[0047] Figure 8 is a schematic diagram of the structure of the artificial valve leaflet pre-folded once according to an embodiment of the present application;

[0048] Figure 9 is a schematic diagram of the structure of the artificial valve leaflet pre-folded three times according to an embodiment of the present application;

[0049] Figure 10 is a schematic diagram of the structure of the artificial valve leaflet pre-folded five times according to an embodiment of the present application;

[0050] Figure 11 is a schematic diagram of the structure of the artificial heart valve prosthesis using the pre-folded artificial valve leaflet according to an embodiment of the present application;

[0051] Figure 12 is a schematic diagram of the structure of the artificial heart valve prosthesis using the skirt and the skirt being inwardly bulged according to an embodiment of the present application;

[0052] Figure 13 is a schematic diagram of the overall structure of the artificial heart valve prosthesis according to an embodiment of the present application; wherein the arrow indicates the pressing direction. DETAILED DESCRIPTION

[0053] In order to make the content of the present application more clear and easy to understand, the present application is further described below in conjunction with the accompanying drawings of the specification. Of course, the present application is not limited to the specific embodiments provided below, and general substitutions well known to those skilled in the art are also covered within the protection scope of the present application.

[0054] The terms used in the present application are only for the purpose of describing specific embodiments, and are not intended to limit the present application. The singular forms "a", "an" and "the" used in the present application are also intended to include the plural forms, unless the context clearly indicates otherwise. It should be understood that "one" or "a" and the like similar words do not represent a quantity limitation, but represent the existence of at least one; "multiple" represents a quantity of two or more. The terms "include" or "contain" and the like mean that the elements or objects appearing before "include" or "contain" cover the elements or objects listed after "include" or "contain" and their equivalents, and do not exclude other elements or objects. Secondly, the present application is described in detail by using schematic diagrams, but these schematic diagrams are only for the convenience of describing the examples of the present application, and should not be taken as a limitation of the present application.

[0055] "Circumferential" direction corresponds to the circumferential direction of the artificial heart valve prosthesis; "radial" direction corresponds to the diameter direction of the artificial heart valve prosthesis; "axial" direction corresponds to the central axis direction of the artificial heart valve prosthesis; the terms "inflow" and "outflow" are defined relative to the position of the artificial heart valve prosthesis after implantation in the body relative to the native annulus, in the normal direction of blood flow, "inflow" is the end of the blood flow into the artificial heart valve prosthesis, and "outflow" is the end of the blood flow out of the artificial heart valve prosthesis. "Inner side" in the present application refers to the side close to the central axis of the artificial heart valve prosthesis, and "outer side" refers to the side away from the central axis of the artificial heart valve prosthesis.

[0056] The core idea of the present application is to provide an artificial heart valve prosthesis to solve the problem of poor durability of artificial valve. The present application can set different strength and elongation for artificial valve leaflets according to the stress condition of different parts of artificial valve leaflets, thereby enhancing the mechanical properties of artificial valve leaflets and improving the service life of artificial valve.

[0057] It should be noted that the artificial heart valve prosthesis provided by the present application can be applied to any one of the mitral valve, tricuspid valve, aortic valve and pulmonary valve.

[0058] The following is described with reference to the accompanying drawings. The following is described by way of example for application to the tricuspid valve, but those skilled in the art will be able to modify the following description to apply to the mitral valve, aortic valve and pulmonary valve with appropriate modifications in detail.

[0059] Figure 1 is a structural schematic diagram of an artificial heart valve prosthesis 100. As shown in Figure 1 The artificial heart valve prosthesis 100 includes artificial valve leaflets 110 and a stent 120. The stent 120 is in the form of a tubular structure as a whole. The stent 120 can provide several functions for the heart valve prosthesis 100, including serving as the main structure of the valve, bearing the internal artificial valve leaflets 110, connecting structure (hanging ears or fixing ears) with the delivery system, etc. The stent 120 can be woven or cut. Alternatively, the stent 110 is made of a biocompatible metal frame or a laser-cut solid metal tube made of materials such as nickel-titanium, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, or other biocompatible metals known to those skilled in the art, preferably nickel-titanium material. The stent 110 can also be made of a material that can be elastically or plastically deformed, such as a balloon-expandable material.

[0060] The plurality of artificial valve leaflets 110 are assembled on the stent 120 and can dynamically switch between the open and closed states; in the closed state, the plurality of artificial valve leaflets 110 are tightly or met in a sealing abutment manner.

[0061] In some application scenarios, the artificial heart valve prosthesis 100 further comprises a skirt 130, which can be at least one of an inner skirt and an outer skirt, without limitation. The skirt 130 is connected with the stent 120. The skirt 130 can be knitted, woven, or braided polyester fabric, or can be made of polyurethane, polyamide, or other high molecular polymers, without limitation on the specific material.

[0062] Further, to solve the problem of poor durability of the artificial valve, the inventors have found, after research and analysis, that the artificial valve leaflet 110 is mainly divided into three parts according to different stresses in actual use, i.e., a valve leaflet closing area 111, a valve leaflet commissure area 112, and a valve leaflet middle area 113; among them, the valve leaflet commissure area 112 is the area with the largest stress, followed by the valve leaflet closing area 111, and the valve leaflet middle area 113 has the smallest stress. Please refer to Figure 2 and Figure 3 for more details.

[0063] The valve leaflet closing area 111 refers to the part where multiple artificial valve leaflets 110 need to be sealed and abutted; the valve leaflet commissure area 112 (also referred to as a leaflet lobe) refers to the part where the artificial valve leaflet 110 is attached to the stent 110; and the valve leaflet middle area 113 refers to the part of the artificial valve leaflet 110 other than the valve leaflet closing area 111 and the valve leaflet commissure area 112.

[0064] Based on the above research, as shown in Figure 13 , in the artificial heart valve prosthesis 100, different strengths and elongations are set according to the stress conditions of different areas of the artificial valve leaflet 110, so that the valve leaflet commissure area 112 can withstand greater tension, and thus is not easily worn and broken during the opening and closing of the artificial valve leaflet 110. At the same time, the valve leaflet closing area 111 and the valve leaflet middle area 113 can provide better elongation, which not only improves the durability, but also increases the effective valve orifice area and blood flow. In this way, not only the mechanical properties of the artificial valve are enhanced, and the service life of the artificial valve is improved, but also the patient's normal valve function can be better restored.

[0065] Specifically, to realize the above idea, the strength of the commissure region 112 is greater than the strength of the coaptation region 111 and the strength of the middle region 113, and the elongation of the coaptation region 111 and the elongation of the middle region 113 are both greater than the elongation of the commissure region 112. Further, the strength of the coaptation region 111 is greater than the strength of the middle region 113. Further, the elongation of the coaptation region 111 is less than the elongation of the middle region 113. Herein, the strength can be material strength and structural strength, which refers to the ability of the structure or material itself to resist fracture and excessive deformation when subjected to external force, especially tensile strength; the elongation refers to the degree to which the material and structure can be stretched, defined as the ratio of the elongation of the sample after tensile fracture to the original length of the sample.

[0066] The above differences in strength and elongation can be realized by materials or by structures. For example, the commissure region 112 can use a material with higher strength, and the coaptation region 111 and the middle region 113 can use a material with relatively high elongation. It should be noted that the specific material of the artificial valve leaflet 110 is not limited in the present application, and in practice, the artificial valve leaflet 110 can be formed of any suitable material or combination of materials.

[0067] In a preferred embodiment provided by the present application, the artificial valve leaflet 110 is made by a weaving process, so that each piece of the artificial valve leaflet 110 is a whole woven structure. In this way, different weaving forms such as different weaving densities, weaving porosities, and weaving wire thicknesses can be conveniently set according to the stress conditions of different parts of the artificial valve leaflet 110, so that the strength of the commissure region 112 is greater than the strength of the coaptation region 111 and the strength of the middle region 113, and the elongation of the coaptation region 111 and the elongation of the middle region 113 are both greater than the elongation of the commissure region 112. The weaving process can better meet the requirements of the artificial valve leaflet 110 for strength and elongation, and at the same time, it is beneficial to reduce the manufacturing difficulty and manufacturing cost of the artificial valve leaflet 110.

[0068] Preferably, the weaving density of the leaflet merging region 112 is greater than the weaving density of the leaflet closing region 111 and the weaving density of the leaflet middle region 113. Correspondingly, the weaving porosity of the leaflet merging region 112 is smaller than the weaving porosity of the leaflet closing region 111 and the weaving porosity of the leaflet middle region 113. It should be understood that the weaving density refers to the number of braided threads per unit area, i.e., the number of braided threads per unit length. Generally, the higher the weaving density, the more braided threads per unit area, and correspondingly, the smaller the size of the weaving porosity (also called the mesh size). It is understandable that, with the same amount of warp and weft yarns, a higher weaving density results in a stronger and more robust structure. In other words, a higher weaving density means the braided threads are more tightly interwoven, resulting in a more robust structure and increased structural strength. Conversely, a sparser weaving density results in looser interweaving and better elongation performance.

[0069] In practice, artificial leaflets 110 with different weaving patterns can be obtained by segmented weaving or integral weaving. This application does not limit this, as long as the weaving of the leaflet fusion region 112 is the densest and the weaving of other regions is relatively loose. More preferably, the weaving density of the leaflet closure region 111 is second only to that of the leaflet fusion region 112, and the weaving density of the leaflet middle region 113 is the smallest and the weaving is the loosest. In other words, the weaving porosity of the leaflet fusion region 112 is the smallest, the weaving porosity of the leaflet closure region 111 is second only to that of the leaflet fusion region 112, and the weaving porosity of the leaflet middle region 113 is the largest.

[0070] Optionally, the weaving pores in the leaflet fusion region 112 are ≤20μm, the weaving pores in the leaflet closure region 111 are >20μm and ≤90μm, and the weaving pores in the leaflet middle region 113 are >90μm and ≤160μm. These weaving pores enable the strength and elongation of each region to be in a better state, ultimately ensuring the durability of the valve and enhancing the service life of the artificial leaflet.

[0071] like Figure 4 As shown, the two intersecting braided filaments (A and B) on the artificial petal leaf 110 form an angle, which is the braiding angle α. The braiding angle α is the angle between the warp thread A and the weft thread B. Since the braiding angle α can also affect the strength, elasticity, and other properties of the braided structure, it is necessary to reasonably set the braiding angle α of each region when braiding the artificial petal leaf 110 to make the mechanical properties of the artificial petal leaf 110 better.

[0072] Thus, after extensive research and analysis, the inventors concluded that when the weaving angle α of the leaflet fusion region 112 is 75°-105°, especially a weaving angle α of 90°, the performance is superior; this angle ensures that the leaflet fusion region 112 possesses both high strength and good elasticity. For example, Figure 5In some embodiments, the weaving angle a of the commissure region 112 is 90°, which can provide stronger tensile force and increase the durability of the artificial leaflet 110.

[0073] After a large number of research and analysis, it is also concluded that when the weaving angle a of the closed region 111 of the leaflet is 30°-60° or 120°-150°, the closed region 111 of the leaflet can provide better elongation rate while taking into account the strength. Figure 6 In the preferred embodiments described in the middle, the weaving angle a of the closed region 111 of the leaflet is 45°, or the supplementary angle 135° of 45°, and the elongation rate of these angles is better.

[0074] Similar to the closed region 111 of the leaflet, when the weaving angle a of the middle region 113 of the leaflet is 30°-60° or 120°-150°, the middle region 113 of the leaflet can provide better elongation rate while taking into account the strength. More suitably, the weaving angle a of the middle region 113 of the leaflet is 45° or 135°, and the effect is better.

[0075] Further, as Figure 7 shown, by increasing the elongation rate of at least one of the closed region 111 and the middle region 113 of the leaflet, the artificial leaflet 110 has better elasticity during the opening of the valve, thereby increasing the effective orifice area and increasing the blood flow (the arrow indicates the direction of blood flow). It should be understood that when the artificial leaflet 110 is in the open state, the blood flow enters the valve from the inflow tract and then flows out of the valve from the outflow tract.

[0076] The artificial leaflet 110 can be made of any suitable woven material, for example, collagen such as catgut, and can also be a high molecular material such as polypropylene (PP), polyethylene (PE), or other biocompatible polymers or combinations of polymers.

[0077] Further, the overall size of the existing artificial valve prosthesis after being loaded and squeezed is large, which causes a large trauma to the blood vessels during the intervention. In this regard, the inventors have further researched and analyzed that the reason why the size after being squeezed is large is that the artificial leaflet 110 is folded in an unreasonable manner.

[0078] According to some embodiments described in Figure 8 to Figure 10 , before assembling the artificial leaflet 110, the woven artificial leaflet 110 is first pre-folded to form at least one folding line 110A on the axis of the artificial leaflet 110 (see Figure 8 ). In this way, the space regions of each part of the artificial heart valve prosthesis 100 after being squeezed can be reasonably distributed, the size of the valve prosthesis after being squeezed can be effectively reduced, the damage to the blood vessels during the intervention of the valve prosthesis can be reduced, and the safety of the operation can be increased.

[0079] In fact, the number of the folding lines 110A can be 1, 3, 5, etc. odd number, and the number of the folding lines 110A is preferably 3-7. Figure 8 In the described example, the folding line 110A is one and located at the central axis of the artificial valve leaflet 110; for example, Figure 9 In the described example, the folding line 110A is three, one of which is located at the central axis of the artificial valve leaflet 110, and the other two are symmetrically arranged about the central axis; or, Figure 10 In the described example, the folding line 110A is five, one of which is located at the central axis of the artificial valve leaflet 110, and the other four are symmetrically arranged about the central axis. Therefore, when the folding line 110A is multiple, one folding line 110A is located on the central axis of the artificial valve leaflet 110, and the remaining multiple folding lines 110A are symmetrically arranged about the central axis.

[0080] In fact, the folding line 110A is preferably multiple, so that the artificial valve leaflet 110 can be folded multiple times along the central axis at each folding line 110A when crimping, which is more conducive to reducing the size of the valve prosthesis after crimping. It should be noted that the artificial valve leaflet 110 can be pre-folded by a mold or heat treatment, and then assembled on the stent 120.

[0081] Further, for the problem of the larger size after crimping, on the other hand, it is because of the interference between the stent 120 and the artificial valve leaflet 110.

[0082] According to Figure 11 According to some embodiments described, the stent 120 includes a stent grid 121 and a stent arc rod 122; the stent grid 121 can have various suitable shapes, including but not limited to square, rectangular, or diamond, etc.; the stent arc rod 122 is overall arc-shaped and can be obtained by laser cutting; the stent arc rod 122 is recessed towards the inflow direction of the stent 120, so that the stent 120 is arranged as an open area along the outflow direction. The stent arc rod 122 is used to fix the artificial valve leaflet 110, specifically, the stent arc rod 122 is matched and arranged corresponding to the artificial valve leaflet 110, and the valve leaflet fixing edge of each artificial valve leaflet 110 is connected (usually sutured) with the corresponding stent arc rod 122. In this way, the interference between the stent 120 and the artificial valve leaflet 110 during the crimping of the valve prosthesis can be avoided, not only reducing the damage to the artificial valve leaflet 110 during the crimping of the valve prosthesis, but also optimizing the space allocation, reducing the size of the valve prosthesis after crimping, and reducing the damage to the blood vessel caused by implantation.

[0083] In another aspect, Figure 12In some of the described embodiments, the skirt 130 is positioned inside the stent 120 and connected to it, with the skirt 130 bulging inward to form multiple independent bulges 131. This avoids interference between the stent 120 and the artificial leaflet 110 and the skirt 130 during valve prosthesis compression, thereby reducing damage to the artificial leaflet 130 during compression. It also optimizes space allocation, reducing the size of the valve prosthesis after compression and minimizing vascular damage during implantation. In practice, the inward bulging of the skirt 130 can be achieved through suturing, pre-shaping, or other processes; there are no special requirements for this.

[0084] It should be understood that if the skirt 130 does not bulge, it will easily occupy the gap between the support rods during the pressing process, resulting in an increase in the pressing size. Therefore, after the skirt 130 bulges inward, it is less likely to occupy the gap between the support rods during subsequent pressing, which is beneficial for the support 120 to be compressed to a smaller size. The inward bulging of the skirt 130 refers to protruding in the direction of the central axis C of the support 120, but it is not a continuous, solid protrusion, but rather a series of small bulges 131. The size of the bulges 131 can be the same or different, and the edge of each bulge 131 is attached to the support 120.

[0085] Figure 13 This is a three-dimensional structural diagram of the artificial heart valve prosthesis 100 in a preferred embodiment of this application. Figure 13 As shown, the artificial heart valve prosthesis 100 includes an artificial valve leaflet 110, a stent 120, and a skirt 130; the skirt 130 is disposed inside the stent 120; the stent 120 fixes the artificial valve leaflet 110 through a stent arc rod 122. It should be understood that the artificial valve leaflet 110, the stent 120, and the skirt 130 can be assembled together by processes such as suturing, spraying, or dipping; this application does not specifically limit the assembly method.

[0086] In actual use, the valve prosthesis needs to be crimped and inserted into the delivery system. During this process, the artificial heart valve prosthesis 100 is crimped in the direction indicated by the arrow. At this time, the artificial leaflet 110 is folded along multiple fold lines 110A, and the stent 120 is arranged as an open area along the outflow direction on the stent arc rod 122 to avoid the stent 120 and the artificial leaflet 110 from overlapping, thus reducing the size of the valve prosthesis after crimping. At the same time, the skirt 130 bulges inward, which can also prevent the stent 120 and the skirt 130 from overlapping, thus reducing the size of the valve prosthesis after crimping. Ultimately, the overall crimped size of the prosthesis 100 is small, the damage to blood vessels during implantation is small, and the safety is good.

[0087] Finally, based on the same inventive concept, this application also provides a method for preparing an artificial heart valve prosthesis, comprising:

[0088] Artificial leaflets 110 are fabricated, and the strength of the leaflet commissural region 112 in the artificial leaflet 110 is greater than the strength of the leaflet closure region 111 and the strength of the leaflet mid-region 113. At the same time, the elongation rate of the leaflet closure region 111 and the elongation rate of the leaflet mid-region 113 are both greater than the elongation rate of the leaflet commissural region 112. Then, multiple artificial leaflets 110 are assembled on a stent 120 to obtain an artificial heart valve prosthesis 100.

[0089] Preferably, the artificial leaflets 110 are manufactured by a weaving process, and the weaving density of the leaflet connecting region 112 in the artificial leaflet 110 is greater than the weaving density of its leaflet closing region 111 and the weaving density of its leaflet middle region 113, and the weaving gap of the leaflet connecting region 112 is smaller than the weaving gap of the leaflet closing region 111 and the weaving gap of its leaflet middle region 113; then the woven artificial leaflets 110 are assembled on the support 120.

[0090] Optionally, the process of creating artificial petals using a weaving technique further includes:

[0091] The weaving is performed at a weaving angle of 75°-105° to form the leaflet junction area 112;

[0092] The woven material is woven at an angle of 30°-60° or 120°-150° to form the closed area 111 of the leaflet and the middle area 113 of the leaflet.

[0093] Optionally, prior to assembling the artificial leaflet 110, the following also includes:

[0094] The woven artificial leaflet 110 is pre-folded to form at least one fold line 110A located on its central axis.

[0095] Optionally, assembling the woven multiple artificial leaflets 110 onto the support 120 includes:

[0096] Connect the fixed edge of each artificial leaflet 110 to the corresponding arc rod 122 on the support 120.

[0097] Optionally, the preparation method further includes:

[0098] The skirt 130 is arranged inside the support 120 and connected to the support 120, and the skirt 130 bulges inward to form multiple independent bulges 131.

[0099] It should be noted that since the method for preparing the artificial heart valve prosthesis provided in this application and the artificial heart valve prosthesis provided in this application belong to the same inventive concept, the method for preparing the artificial heart valve prosthesis provided in this application has at least all the beneficial effects of the artificial heart valve prosthesis provided in this application. For details, please refer to the relevant descriptions of the beneficial effects of the artificial heart valve prosthesis provided in this application above. Therefore, the beneficial effects of the method for preparing the artificial heart valve prosthesis provided in this application will not be elaborated here.

[0100] Compared with existing technologies, the artificial heart valve prosthesis and its preparation method provided in this application have at least the following advantages:

[0101] First, different regions of the artificial leaflet 110 use different strengths and elongation rates, which can enhance the mechanical properties of the leaflet and improve the service life of the valve.

[0102] Secondly, by pre-folding the artificial valve leaflet 110, opening the stent's arc rod, and inwardly oriented the skirt 130, the size of the valve prosthesis after compression can be effectively reduced, thus minimizing damage to blood vessels during valve prosthesis intervention.

[0103] In summary, the artificial heart valve prosthesis 100 provided in this application has good durability, and its size after compression is small, resulting in less damage to blood vessels and higher surgical safety.

[0104] It should be noted that those skilled in the art can make various improvements and additions without departing from the scope of this application, and these improvements and additions should also be considered within the protection scope of this application. Any modifications, alterations, and variations made by those skilled in the art without departing from the spirit and scope of this application, based on the disclosed technical content, are equivalent embodiments of this application; furthermore, any modifications, alterations, and variations made to the above embodiments based on the essential technology of this application still fall within the scope of the technical solution of this application.

Claims

1. An artificial heart valve prosthesis, characterized in that, include: support; as well as, Multiple artificial leaflets are assembled on the support. Each of the artificial leaflets includes a leaflet closure region, a leaflet fusion region, and a leaflet middle region; the strength of the leaflet fusion region is greater than the strength of the leaflet closure region and the strength of the leaflet middle region; the elongation rate of the leaflet closure region and the elongation rate of the leaflet middle region are both greater than the elongation rate of the leaflet fusion region.

2. The artificial heart valve prosthesis as described in claim 1, characterized in that, Each of the artificial leaflets is a woven structure; the weaving density of the leaflet fusion region is greater than the weaving density of the leaflet closure region and the weaving density of the leaflet middle region; the weaving porosity of the leaflet fusion region is smaller than the weaving porosity of the leaflet closure region and the weaving porosity of the leaflet middle region.

3. The artificial heart valve prosthesis as described in claim 2, characterized in that, The weaving density of the closed area of ​​the leaflet is greater than that of the middle area of ​​the leaflet, and the weaving porosity of the closed area of ​​the leaflet is smaller than that of the middle area of ​​the leaflet.

4. The artificial heart valve prosthesis as described in claim 2 or 3, characterized in that, The weaving pore size of the leaflet junction area is ≤20μm, the weaving pore size of the leaflet closure area is >20μm and ≤90μm, and the weaving pore size of the middle area of ​​the leaflet is >90μm and ≤160μm.

5. The artificial heart valve prosthesis as described in claim 2, characterized in that, The weaving angle of the leaflet junction area is 75°-105°.

6. The artificial heart valve prosthesis as described in claim 5, characterized in that, The weaving angle of the leaflet junction area is 90°.

7. The artificial heart valve prosthesis as described in claim 2, characterized in that, The weaving angle of the closed area of ​​the leaflet is 30°-60° or 120°-150°, and / or the weaving angle of the middle area of ​​the leaflet is 30°-60° or 120°-150°.

8. The artificial heart valve prosthesis as described in claim 7, characterized in that, The weaving angle of the closed area of ​​the leaflet is 45° or 135°, and / or the weaving angle of the middle area of ​​the leaflet is 45° or 135°.

9. The artificial heart valve prosthesis as described in claim 1 or 2, characterized in that, The artificial leaflet is a pre-folded structure and forms at least one fold line located on its central axis.

10. The artificial heart valve prosthesis as described in claim 9, characterized in that, There are multiple fold lines, one of which is located on the central axis, and the other multiple fold lines are symmetrically arranged about the central axis.

11. The artificial heart valve prosthesis as described in claim 10, characterized in that, The number of fold lines is 3-7.

12. The artificial heart valve prosthesis as described in claim 1 or 2, characterized in that, The support includes a support grid and a support arc rod; the support arc rod is recessed in the direction of the inflow channel of the support, so that the support is arranged as an open area along its outflow channel; the support arc rod is matched and correspondingly arranged with the artificial petiole, and the fixed edge of each artificial petiole is connected to the corresponding support arc rod.

13. The artificial heart valve prosthesis as described in claim 1 or 2, characterized in that, Also includes: The skirt is arranged inside the bracket and connected to the bracket, and the skirt bulges inward to form multiple independent bulges.

14. A method for preparing an artificial heart valve prosthesis, characterized in that, include: Artificial leaflets are fabricated such that the strength of the leaflet junction region of the artificial leaflet is greater than the strength of its leaflet closure region and the strength of its leaflet middle region, and the elongation rate of the leaflet closure region and the elongation rate of the leaflet middle region are both greater than the elongation rate of the leaflet junction region. Multiple artificial leaflets are assembled onto a scaffold.

15. The method for preparing an artificial heart valve prosthesis as described in claim 14, characterized in that, The artificial petals are made by a weaving process, wherein the weaving density of the petal fusion region is greater than the weaving density of the petal closure region and the weaving density of the petal middle region, and the weaving porosity of the petal fusion region is smaller than the weaving porosity of the petal closure region and the weaving porosity of the petal middle region.

16. The method for preparing an artificial heart valve prosthesis as described in claim 15, characterized in that, The fabrication of the artificial petals using a weaving process also includes: The woven section is formed by weaving at an angle of 75°-105° to create the leaflet junction area. The woven area is woven at an angle of 30°-60° or 120°-150° to form the closed area of ​​the leaflet and the middle area of ​​the leaflet.

17. The method for preparing an artificial heart valve prosthesis as described in claim 14, characterized in that, Before assembling the artificial leaflet, the procedure also includes: The woven artificial petal leaflet is pre-folded to form at least one fold line on its central axis.

18. The method for preparing an artificial heart valve prosthesis as described in claim 17, characterized in that, There are multiple fold lines, one of which is located on the central axis, and the remaining fold lines are symmetrically arranged about the central axis.

19. The method for preparing an artificial heart valve prosthesis as described in claim 14, characterized in that, The step of assembling the woven artificial leaflets onto the scaffold includes: The fixed edge of each artificial petal is connected to the corresponding arc rod on the support, and the arc rod is recessed in the direction of the inflow channel of the support, so that the support is arranged as an open area along its outflow channel.

20. The method for preparing an artificial heart valve prosthesis as described in claim 14, characterized in that, Also includes: The skirt is arranged inside the bracket and connected to the bracket, and the skirt bulges inward to form multiple independent bulges.

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