Heart valve molding components

Abstract

The present invention discloses a heart valve molding component, which includes: a main base, three leaflet forming areas, and three leaflet partitions. The main base has a leaflet end for forming the leaflets, and the three leaflet forming areas are circumferentially spaced at the leaflet end of the main base. Each leaflet partition is formed between two adjacent leaflet forming areas. The leaflet partition has a central side close to the central axis of the main base and a peripheral side close to the peripheral wall of the main base. The width of the central side of the leaflet partition is not less than the width of the peripheral side of the leaflet partition. This increases the distance between the middle parts of the two adjacent leaflets, prevents the middle parts of the two adjacent leaflets from prematurely combining and supporting each other, and allows for better closure between the two adjacent leaflets, reducing leaflet regurgitation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a heart valve molding component. Background Art

[0002] Heart valves are the basic structure of the heart, and severe valvular diseases can lead to death. Heart valves refer to the valves between the atria and ventricles or between the ventricles and arteries. Their main function is to prevent blood from flowing back and ensure that blood flows from the atria to the ventricles (or from the ventricles to the aorta / pulmonary artery). There are four types of heart valves based on their shape and position: the mitral valve between the left ventricle and the left atrium, the tricuspid valve between the right ventricle and the right atrium, the aortic valve between the left ventricle and the aorta, and the pulmonary valve between the right ventricle and the pulmonary artery. Heart valves may fail to close due to congenital or acquired inflammation, resulting in reflux, valvular stenosis and other diseases.

[0003] For patients with severe valvular heart disease, replacing an artificial heart valve is the most effective treatment. Compared with mechanical valves, biological valves can be compressed and delivered through a catheter, and do not require lifelong anticoagulation after implantation. As an artificial heart valve, the biological valve's internal leaflets serve as components that replace the native leaflets for opening and closing, and its importance is self-evident.

[0004] The production process of biological valves requires cutting and suturing of the leaflets and suture membranes. In particular, the suturing of the leaflets requires very high precision skills and a long learning cycle for suturing employees. Qualified valve suturing employees need to undergo at least 3 months of training. Moreover, the suturing of the leaflets has very strict requirements on process design. If the needle spacing is too large or too small, it will directly affect the number of times the valve can be operated. Manual knotting is inevitable in the suturing process, and loose knots can also cause abnormal operation of the leaflets or even valve failure. Compared with the operation of manually suturing leaflets, the demand for one-piece valve manufacturing is becoming increasingly strong. The one-piece valve manufacturing method can achieve high-precision, high-quality, and large-scale applications, reduce costs, and eliminate the uncontrollability of manual suturing.

[0005] The structure of the molded components of an integrated heart valve is related to the performance of the valve, such as blood regurgitation and valve reliability. However, the existing artificial valve leaflets formed by the surface of revolution directly formed by the following function formula (I) and function formula (II) have a structure in which the middle distance between two adjacent leaflets 10 is too close, such as Figure 1A and Figure 1B As shown, when the artificial leaflet 10 is closed, the middle parts of the adjacent leaflets 10 will prematurely combine and support each other, resulting in the two ends of the adjacent leaflets not being firmly closed, which is prone to regurgitation. Therefore, it is necessary to improve it.

[0006]

[0007]

[0008] R is the radius of the main base, α is the inclination angle of the conic surface, and x, y, z are the x-axis, y-axis, and z-axis of the three-dimensional coordinate system. Summary of the Invention

[0009] In view of the technical problem in the prior art that the distance between the middle parts of two adjacent leaflets of an artificial valve leaflet formed by a revolution curved surface is too close and regurgitation is easily caused, the purpose of the present invention is to provide a heart valve molding component.

[0010] The heart valve molding component of the present invention comprises:

[0011] a main base having petal ends forming leaflets;

[0012] three leaflet forming areas, the three leaflet forming areas being circumferentially spaced apart and arranged at the leaflet end of the main body;

[0013] There are three petal partitions, each of which is formed between two adjacent leaflet forming areas. The petal partition has a central side close to the central axis of the main base and a peripheral side close to the peripheral wall surface of the main base. The width of the central side of the petal partition is not less than the width of the peripheral side of the petal partition.

[0014] In a preferred embodiment of the present invention, the leaflet forming area has a revolution curved surface, and the width of the petal partition gradually increases from the circumference to the center, so that the revolution curved surface of the leaflet forming area is divided into:

[0015] a revolution curved surface adjustment surface, the revolution curved surface adjustment surface being located in a section of the leaflet forming area close to the leaflet end of the main base;

[0016] The non-adjustment surface of the curved surface of revolution is located in a section of the leaflet forming area away from the leaflet end of the main base, and the adjustment surface of the curved surface of revolution is transitionally connected to the non-adjustment surface of the curved surface of revolution.

[0017] In a preferred embodiment of the present invention, the rotational curved surface adjustment surface and the rotational curved surface non-adjustment surface are smoothly transitionally connected.

[0018] In a preferred embodiment of the present invention, based on the axial direction of the main substrate, the axial height of the revolution curved surface adjustment surface does not exceed 1 / 3 of the axial height of the revolution curved surface.

[0019] In a preferred embodiment of the present invention, the difference between the width of the central side of the petal partition and the width of the peripheral side of the petal partition is between 0 mm and 1 mm.

[0020] In a preferred embodiment of the present invention, the revolution curved surface intersects with the peripheral wall surface of the main base at an angle.

[0021] In a preferred embodiment of the present invention, the central sides of the three petal partitions converge at the axis of the main base.

[0022] In a preferred embodiment of the present invention, the main substrate is a cylinder.

[0023] In a preferred embodiment of the present invention, the circumferential width of the petal partition is 1 mm to 8 mm, preferably 1.5 mm to 7.5 mm, and more preferably 2 mm to 7 mm.

[0024] In a preferred embodiment of the present invention, the revolution surface is a surface formed by the intersection of a cylinder and a conical surface with an inclination angle.

[0025] In a preferred embodiment of the present invention, the inclination angle α of the conical surface is 1° to 5°, preferably 2° to 4°, and more preferably 3°.

[0026] In a preferred embodiment of the present invention, the three leaflet forming areas are distributed around the central axis of the main base at an angle of 100° to 140°, preferably 110° to 130°, and more preferably 120°.

[0027] In a preferred embodiment of the present invention, the ratio of the height of the main substrate to the diameter of the main substrate is not less than 1 / 10.

[0028] In a preferred embodiment of the present invention, a through hole is provided on the side wall of the main substrate. Preferably, the diameter of the through hole is 0.5 mm-1 mm.

[0029] In a preferred embodiment of the present invention, the main body has a non-petal end, which is symmetrically arranged with the petal end, and a fixing component is provided at the central axis of the non-petal end of the main body.

[0030] In a preferred embodiment of the present invention, the fixing member is a core column with a fixing hole or a fixing core shaft.

[0031] In a preferred embodiment of the present invention, the core column or the fixed core shaft is connected to the inner side wall of the main base through a fixed plate.

[0032] In a preferred embodiment of the present invention, the peripheral wall surface of the main substrate is coated with a wax layer.

[0033] The positive progress effect of the present invention is:

[0034] 1) The heart valve molding component of the present invention restructures the width of the disc partition between adjacent leaflets, ensuring that the central width of the disc partition is no less than the circumferential width of the disc partition. This prevents premature joint support between the middle portions of adjacent leaflets, allowing for better closure between the leaflets and reducing leaflet regurgitation. Specifically, the disc partition gradually increases in width from the circumferential side to the central side, creating a curved surface of revolution at the leaflet end near the main base in the leaflet formation area. This facilitates smooth leaflet opening and reduces transvalvular pressure differentials.

[0035] 2) The heart valve molding component of the present invention provides a wax layer on the peripheral wall surface of the main body, which can be quickly melted and detached by heating. This avoids the need for traditional artificial valve leaflets to be torn or repeatedly dragged from the heart valve molding component to separate them. Tearing and dragging can cause deformation of the artificial valve leaflets, thereby affecting the performance of the artificial valve leaflets. At the same time, to ensure that the wax layer can better adhere to the surface of the heart valve molding component, the surface of the heart valve molding component is provided with through holes, through which the wax layer can pass, so that the wax layer forms a rivet-like shape at the through holes and adheres to the surface of the heart valve molding component, preventing the wax layer from falling off. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1A Schematic diagram of an artificial valve leaflet formed by the surface of revolution formed by function formula (I) and function formula (II) in the prior art;

[0037] Figure 1B Schematic diagram of the artificial valve leaflet closed when formed by the revolution surface of the function formula (I) and the function formula (II) in the prior art;

[0038] Figure 2 Schematic diagram of the structure of the heart valve molding component 20 of the present invention;

[0039] Figure 3 This is a schematic structural diagram of a three-petal partition 23 of the present invention;

[0040] Figure 4 is a side view of a heart valve molding component 20 of the present invention;

[0041] Figure 5 Schematic diagram of the structure of a heart valve molding component 20 provided with a through hole 213 of the present invention;

[0042] Figure 6 is a partial cross-sectional view of a heart valve molding component 20 of the present invention;

[0043] Figure 7A FIG. 2 is another schematic structural diagram of the heart valve molding component 20 of the present invention from another perspective;

[0044] Figure 7BFIG. 1 is a schematic three-dimensional structural diagram of a heart valve molding component 20 according to another example of the present invention.

[0045] Description of reference numerals:

[0046] 10. Artificial valve leaflet formed by formula, 20. Heart valve molding component, 21. Main base, 21a. Valve end, 21b. Non-valve end, 212. Peripheral wall surface, 213. Through hole, 214. Wax layer, 215. Fixing component, 215a. Fixing hole, 2151. Core column, 2152. Fixed core shaft, 22. Three leaflet forming areas, 221. Rotational curved surface, 222. Rotational curved surface adjustment surface, 223. Rotational curved surface non-adjustment surface, 23. Petal partition, 231. Center side, 232. Peripheral side. DETAILED DESCRIPTION

[0047] The following describes the embodiments of the present invention through specific examples. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different viewpoints and applications without departing from the spirit of the present invention.

[0048] like Figure 2 As shown, the heart valve molding component 20 of the present invention includes: a main substrate 21 for spinning, three leaflet forming areas 22 for forming artificial valve leaflets, and three leaflet partitions 23 for separating the three artificial valve leaflets. The main substrate 21 is formed by removing one end of a cylinder (details will be described later). One end of the main substrate 21 is used to form the three artificial valve leaflets, that is, the removed end, and therefore, this end is also called the leaflet-forming end 21a. Three leaflet forming areas 22 are circumferentially spaced apart at the leaflet end 21a. Since the leaflet forming areas 22 are used to spin artificial valve leaflets that are close to the shape of native leaflets, it is preferable that the shape of the leaflet forming areas 22 is consistent with the shape of the native leaflets in the human heart. One feasible implementation method is to use the surface rotation formula in the prior art to remove the leaflet forming areas 22 formed by the cylindrical leaflet end 21a. After using the surface rotation formula in the prior art to eliminate the petal end 21a of the cylinder to form the leaflet forming area 22, a petal partition 23 is also generated between the two adjacent leaflet forming areas 22 on the main substrate 21. Each petal partition 23 has a central side 231 close to the central axis of the main substrate 21 and a peripheral side 232 close to the peripheral wall surface 212 of the main substrate 21. The function of the petal partition 23 is to allow the leaf edges of the two adjacent artificial leaflets formed by spinning to be combined and supported. Therefore, the shape and width of the petal partition 23 also determine the consistency of the time sequence of the combination of the leaf edges of the two adjacent artificial leaflets at different positions. Therefore, in this example, if Figure 3As shown, the width Q of the central side 231 of the petal partition 23 is set to be no less than the width K of the circumferential side 232 of the petal partition 23. In this example, the heart valve molding component 20 reconstructs the width of the central side 231 of the petal partition 23 between two adjacent leaflets, so that the width Q of the central side 231 of the petal partition 23 is no less than the width K of the circumferential side 232 of the petal partition 23. This prevents the middle portions of the two adjacent leaflets from prematurely joining and supporting each other, allowing for better closure between the two adjacent leaflets and reducing leaflet regurgitation. In particular, the width of the petal partition 23 is gradually increased from the circumferential side 232 to the central side 231, so that the leaflet end 21a of the leaflet forming area near the main base 21 forms a rotational curved adjustment surface, which facilitates smooth opening and closing of the leaflets and reduces the trans-petal pressure difference.

[0049] like Figure 1A As shown, the human aortic valve is composed of three semilunar valves, which are supported by the chordae tendineae of the mastoid muscles. According to the bionics principle, the leaflet forming area of ​​the heart valve molding component 20 in the prior art has three rotational surfaces, which are directly formed by the function and The artificial valve leaflet 10 formed by the rotational curved surface is as follows Figure 1A and Figure 1B As shown. The three leaflets are distributed around the central axis at 100° to 140°, preferably 110° to 130°, and more preferably 120°. However, in terms of the distribution structure of the rotational curved surface formed in this way, the distance between the middle parts of two adjacent artificial leaflets 10 is the shortest, as shown in FIG. Figure 1B As shown, when the artificial valve leaflets 10 close, the middle portions of the two adjacent leaflets 10 will prematurely join and support each other, resulting in a loose closure at both ends of the adjacent leaflets 10 and a high risk of regurgitation. Furthermore, after the middle portions of the two adjacent leaflets 10 join, blood can cause the leaflets to fold back, leading to stress concentration and shortening the lifespan of the artificial valve leaflets 10. Furthermore, once folded back, platelet deposition and thrombosis are likely to occur at the folded portion.

[0050] Therefore, in view of the above problems in the prior art, in this example, a heart valve molding component 20 with the following structure is designed. Figure 3As shown, the three petal partitions 23 are integrally formed and the central sides 231 of the three petal partitions 23 converge at the axis on the side of the petal end 21a of the main base 21. The three petal partitions 23 are distributed around the central axis on the side of the petal end 21a of the main base 21 at 100° to 140°, preferably 110° to 130°, and more preferably 120°. In this example, the width K of the petal partition 23 is gradually increased from the circumferential side 232 to the width Q of the central side 231, but the difference between the width Q of the central side 231 of the petal partition 23 and the width K of the circumferential side 232 of the petal partition 23 is satisfied to be between 0mm and 1mm, thereby optimizing (for example: increasing relative to the smaller middle distance directly formed by the function) the middle distance between the two adjacent leaflets, ensuring that the adjacent leaflets can be better closed and reducing leaflet regurgitation. The width K of the circumferential side 232 of the petal partition 23 is 1mm to 8mm, preferably 1.5mm to 7.5mm, and more preferably 2mm to 7mm, for example 3mm, 4mm, 5mm, 6mm, because an excessively large width K of the circumferential side 232 will cause incomplete closure of the leaflets, resulting in mid-valve leakage; and an excessively small width K of the circumferential side 232 will cause the overlapping area of ​​the middle part of the leaflets to be too large, and may even cause the leaflets to bend back, resulting in stress concentration, significantly affecting the life of the leaflets, and once the leaflets are bent back, platelet deposition and thrombus formation are also prone to occur at the bent part.

[0051] According to the above design method of "gradually increasing the width K of the petal partition 23 from the peripheral side 232 to the width Q of the central side 231, but satisfying that the difference between the width Q of the central side 231 of the petal partition 23 and the width K of the peripheral side 232 of the petal partition 23 is between 0mm and 1mm", a rotational curved surface is formed as follows, Figure 4As shown, the revolved surface 221 intersects obliquely with the peripheral wall surface 212 on the side of the petal end 21a of the main base 21. In this example, the revolved surface 221 is a curved surface formed by the intersection of a cylinder and a conical surface having an inclination angle α of 1° to 5°, preferably 2° to 4°, and more preferably 3°. At the same time, the revolved surface 221 is distributed around the central axis of the main base 21 at 100° to 140°, preferably 110° to 130°, and more preferably 120°. Due to the widening of the width Q of the central side 231 of the petal partition 23, that is, the width K of the petal partition 23 gradually increases from the width Q of the peripheral side 232 to the width Q of the central side 231, the revolved surface 221 of the leaflet forming area 22 is divided into: a revolved surface adjustment surface 222 and a revolved surface non-adjustment surface 223. The rotational adjustment surface 222 is located in a section of the leaflet forming region 22 near the leaflet end 21a of the main body 21, while the rotational non-adjustment surface 223 is located in a section of the leaflet forming region 22 away from the leaflet end 21a of the main body 21. Specifically, the rotational adjustment surface 222 is a curved surface formed by adjusting the width of the center side 231 of the leaflet partition 23 of the heart valve molding component 20, while the rotational non-adjustment surface 223 is identical to the rotational surface 221 directly formed by function formula (I) and function formula (II). A smooth transition is formed between the rotational adjustment surface 222 and the rotational non-adjustment surface 223 to prevent any impact on the opening and closing of the leaflets. Taking the axial direction of the main base 21 as a reference, the axial height of the rotational curved surface adjustment surface 222 does not exceed 1 / 3 of the axial height H1 of the rotational curved surface 221, that is, at least 2 / 3 of the axial height H1 of the rotational curved surface 221 is the rotational curved surface non-adjustment surface 223, which is conducive to the smooth opening and closing of the leaflet and reduces the trans-petal pressure difference.

[0052] The heart valve molding component 20 designed by the above-mentioned design method is then spun to form an artificial valve leaflet to make an artificial heart valve. The experiment of evaluating the performance of the artificial heart valve is carried out using the Pulse Duplicator of the Canadian Vivitro Laboratory (for example, composed of equipment such as the model number ViVitroSuperPump pulsating pump-10647, ViVitro model heart-SD2001-1 or flow meter-FS0992). The Pulse Duplicator can simulate the operating environment of the valve in the natural heart and reproduce the state of the artificial heart valve after implantation in the human body as realistically as possible. The performance of the artificial heart valve is evaluated by measuring the hemodynamic-related parameters. The valve performance is evaluated by measuring the hemodynamic-related parameters; the test parameters under different physiological and pathological conditions provided in "YY / T 1449.3-2016 Cardiovascular Implants Artificial Heart Valves Part 3: Transcatheter Implantable Artificial Heart Valves" are used for testing:

[0053] The initial experimental conditions were: a heart rate of 70 / min, a systolic period of 35%, a cardiac output of 5 L / min, a mean aortic pressure of 100 mmHg, an R value of 15 mm, and a K value of 5 mm. The prosthetic valve was adjusted by widening the central side 231 of the valve partition 23 to a width Q of 5.5 mm. The following data were obtained:

[0054]

[0055]

[0056] From the above data, it can be concluded that after widening the width Q of the central side 231 of the petal partition 23, the total regurgitant volume of the artificial valve leaflet is significantly reduced, which is about half of the artificial valve leaflet body before adjustment, and the trans-valvular pressure difference and the effective opening area have no obvious changes, that is, the rotational curved surface adjustment surface 222 obtained after widening the central side 231 of the petal partition 23 has no obvious effect on the opening and closing of the valve leaflet, and still maintains good opening and closing performance.

[0057] Continue as Figure 2 and Figure 4 As shown, the main body 21 of the heart valve molding component 20 has a non-valve end 21b, which is symmetrically arranged with the valve end 21a. That is, the valve end 21a is arranged at one end of the cylindrical main body 21, and the non-valve end 21b is arranged at the other end of the cylindrical main body 21. The non-valve end 21b of the main body 21 is cylindrical, and the valve end 21a of the main body 21 has three leaflet forming areas 22 arranged circumferentially. The radius R of the main body is determined by the diameter of the native leaflet or valve ring at the desired implantation location, such as the aortic valve ring. For example, the R value is 10mm to 16mm, forming a function formula of the revolution surface 221: The variable R value ensures that the three leaflet-forming areas 22 of the heart valve molding component 20 can adapt to valve diameters of different specifications while maintaining essentially consistent structural parameters, thereby ensuring that the leaflets in the molded leaflet-forming areas 22 have essentially consistent performance. The ratio of the height H2 of the cylinder at the non-leaflet end 21b of the main body 21 to the diameter D of the main body 21 is no less than 1 / 10. This is because the larger the diameter D of the leaflets in the leaflet-forming area 22, the greater the opening and closing amplitude of the leaflets, which in turn affects the opening and closing performance of the leaflets. Therefore, the height H2 of the cylinder at the non-leaflet end 21b of the main body 21 is limited to prevent the main body 21 from being too short, resulting in insecure fixation of the leaflets. It should be noted that the leaflets of the molded artificial valve leaflets are fixed by the non-leaflet end 21b of the main body 21. Exceptionally, when the leaflets of the molded artificial valve leaflets are fixed directly by the leaflet edges, the main body can be omitted, and the same heart valve molding component 20 can be made without the main body 21.

[0058] Conventionally, the friction between the artificial valve leaflets and the molding member 20 is reduced by applying silicone oil or spraying Teflon on the outer surface of the molding member 20, so that the artificial valve can be easily removed from the molding member 20. In actual operation, although the above-mentioned setting effectively increases the smoothness of the surface of the molding member 20, the artificial valve leaflets still need to be dragged and torn to be removed. For this reason, Figure 6 As shown, a wax layer 214 is provided on the surface of the heart valve molding component 20. The thickness of the wax layer 214 is 0.1 mm to 1 mm, for example, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, etc. The wax layer 214 can be made of, for example, medical wax. Figure 5 As shown, the heart valve molding component 20 is hollow. To better adhere the wax layer to the surface of the heart valve molding component 20, a through hole 213 is provided on the side wall 212 of the main base 21. Preferably, the diameter of the through hole 213 is 0.5 mm to 1 mm. The inner side of the wax layer 214 can penetrate the through hole 213 on the side wall 212 of the main base 21. The wax layer 214 can also be formed on the inner side of the through hole 213, so that the wax layer 214 can form a rivet-like adhesion to the surface of the heart valve molding component 20 at the through hole 213, preventing the wax layer 214 from falling off. In this example, compared with traditional methods such as applying silicone oil or spraying Teflon, the wax layer 214 on the surface of the heart valve molding component 20 of the present application has a certain thickness, and the temperature of the heart valve molding component 20 during spinning is room temperature. Therefore, during the spinning process, the wax layer 214 on the surface of the heart valve molding component 20 is solid. After the artificial valve leaflet body on the molding component 20 is processed, the wax layer 214 with a certain thickness is melted by heating. At this time, the external contour size of the heart valve molding component 20 is reduced relative to the size of the artificial valve leaflet body after processing. At this time, the heart valve molding component 20 is very easy to remove from the artificial valve leaflet body, avoiding the traditional artificial valve leaflet body needing to be torn from the heart valve molding component 20, or dragged and separated from the heart valve molding component 20 multiple times, because tearing and dragging will cause deformation of the artificial valve leaflet body, thereby affecting the performance of the artificial valve leaflet body, and even direct tearing damage to the artificial valve leaflet body during the separation process will reduce the product yield. Now, the wax layer 214 on the surface of the heart valve molding component 20 can be melted, so that the artificial valve leaflets can be directly separated from the heart valve molding component 20, avoiding the artificial valve leaflets from being damaged by tearing force during the process of separating from the heart valve molding component 20.

[0059] like Figure 7A and Figure 7BAs shown, there is a fixing component 215 at the central axis of the non-valve end 21b of the main base 21, wherein the fixing component 215 is a core column 2151 or a fixed core shaft 2152 with a fixing hole 215a, and the core column 2151 or the fixed core shaft 2152 is connected to the inner wall of the main base 21 through a fixing plate 215b, and is used for fixed installation of the heart valve molding component 20.

[0060] In conjunction with the accompanying drawings, the method of use of the present invention is as follows: when the heart valve molding component 20 is working, it is installed on the driving component to perform axial rotation of the heart valve molding component 20. At this time, a spinning pump (device) is installed at a suitable position away from the heart valve molding component 20. The spinning fluid is continuously, quantitatively and evenly squeezed out from the capillaries of the spinneret or spinneret by the spinning pump (or metering pump) to form a liquid stream to form fibers, which are then attached to the surface of the heart valve molding component 20 under the action of air or electric field. After a certain period of spinning, a uniform spinning layer is formed on the surface of the heart valve molding component 20. Then, by pressurizing, fixing, drying, demolding and cutting, the desired artificial valve leaflet body can be obtained.

[0061] The present invention has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. A heart valve molding component, characterized in that The heart valve molding component comprises: a main base having petal ends forming leaflets; three leaflet forming areas, the three leaflet forming areas being circumferentially spaced apart and arranged at the leaflet end of the main body; three petal partitions, each petal partition being formed between two adjacent leaflet forming areas, the petal partition having a central side close to the central axis of the main base and a peripheral side close to the peripheral wall surface of the main base, and a width of the central side of the petal partition being not less than a width of the peripheral side of the petal partition; The leaflet forming area has a revolution curved surface, and the width of the petal partition gradually increases from the circumferential side to the central side, so that the revolution curved surface of the leaflet forming area is divided into: a revolution curved surface adjustment surface, the revolution curved surface adjustment surface being located in a section of the leaflet forming area close to the leaflet end of the main base; a non-adjustment surface of a curved surface of revolution, the non-adjustment surface of the curved surface of revolution being located in a region of the leaflet forming area away from the leaflet end of the main body, the adjustment surface of the curved surface of revolution being transitionally connected to the non-adjustment surface of the curved surface of revolution; The rotational curved surface adjustment surface and the rotational curved surface non-adjustment surface are smoothly transitionally connected; The non-adjusted surface of the revolution surface is formed by the function formula (I) and the function formula (II) …Formula (I) …Formula (II) R is the radius of the main base, α is the inclination angle of the conic surface, and x, y, z are the x-axis, y-axis, and z-axis of the three-dimensional coordinate system.

2. The heart valve molding component according to claim 1, characterized in that Taking the axial direction of the main substrate as a reference, the axial height of the revolution curved surface adjustment surface does not exceed 1 / 3 of the axial height of the revolution curved surface.

3. The heart valve molding component according to claim 1, wherein The difference between the width of the central side of the petal partition and the width of the peripheral side of the petal partition is between 0 mm and 1 mm.

4. The heart valve molding component according to claim 1, wherein The revolution curved surface intersects obliquely with the peripheral wall surface of the main base.

5. The heart valve molding component according to claim 1, wherein The central sides of the three petal partitions converge at the axis of the main base.

6. The heart valve molding component according to claim 1, wherein The circumferential width of the petal partition is 1 mm to 8 mm.

7. The heart valve molding component according to claim 6, characterized in that The circumferential width of the petal partition is 1.5 mm to 7.5 mm.

8. The heart valve molding component according to claim 7, characterized in that The circumferential width of the petal partition is 2 mm to 7 mm.

9. The heart valve molding component according to claim 1, wherein The revolution curved surface is a curved surface formed by the intersection of a cylinder and a conical surface with an inclination angle, and the inclination angle α of the conical surface is 1° to 5°.

10. The heart valve molding component according to claim 9, characterized in that The inclination angle α of the conical surface is 2°~4°.

11. The heart valve molding component according to claim 10, wherein The inclination angle α of the conical surface is 3°.

12. The heart valve molding component according to claim 1, wherein The three leaflet forming areas are distributed at an angle of 100° to 140° around the central axis of the main base.

13. The heart valve molding component according to claim 12, characterized in that The three leaflet forming areas are distributed at an angle of 110° to 130° around the central axis of the main base.

14. The heart valve molding component according to claim 13, characterized in that The three leaflet forming areas are distributed at 120° around the central axis of the main base.

15. The heart valve molding component according to claim 1, characterized in that The ratio of the height of the main matrix to the diameter of the main matrix is ​​not less than 1 / 10.

16. The heart valve molding component according to any one of claims 1 to 15, characterized in that The peripheral wall surface of the main substrate is coated with a wax layer.

17. The heart valve molding component according to claim 16, characterized in that The side wall surface of the main base is provided with a through hole.

18. The heart valve molding component according to claim 17, characterized in that The through hole has a diameter of 0.5 mm to 1 mm.

19. The heart valve molding component according to claim 1, wherein The main base has a non-petal end, which is symmetrically arranged with the petal end. A fixing component is provided at the central axis of the non-petal end of the main base.

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