Heart valve forming member

Abstract

The invention discloses a heart valve forming component. The heart valve forming component comprises a main base body, three valve leaflet forming areas and three valve separating partitions. The main base body is provided with a valve end forming valve leaflets, the three valve leaflet forming areas are arranged at the valve end of the main base body in the circumferential direction at intervals, each valve separating partition is formed between every two adjacent valve leaflet forming areas, and each valve separating partition is provided with a center side close to the center axis of the main base body and a circumferential side close to the circumferential wall face of the main base body. The width of the center side of the sectioning partition is not smaller than the width of the peripheral side of the sectioning partition. Therefore, the distance between the middle portions of the two adjacent valve leaflets is increased, the middle portions of the two adjacent valve leaflets are prevented from being combined and supported too early, the two adjacent valve leaflets can be better closed, and valve leaflet backflow is reduced.

Description

Technical Field

[0001] The 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 opening and closing 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 distance 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 manual suturing of leaflets, the demand for one-piece valve manufacturing is becoming more and more urgent. 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 molding component of the integrated heart valve is related to the performance of the valve, such as blood regurgitation, valve reliability, etc., and the existing artificial valve leaflets formed by the revolution surface directly formed by the following function formula (I) and function formula (II) are structurally too close to each other in the middle of the two adjacent leaflets 10. 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, resulting in loose closure of the two ends of the adjacent leaflets, 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 body having petal ends forming petals;

[0012] three leaflet forming areas, the three leaflet forming areas being circumferentially spaced 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, and the petal partition has a central side close to the central axis of the main substrate and a peripheral side close to the peripheral wall surface of the main substrate, and 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 circumferential side to the central side, so that the revolution curved surface of the leaflet forming area is divided into:

[0015] A revolved curved surface adjustment surface, the revolved curved surface adjustment surface is located in a section of the leaflet forming area close to the leaflet end of the main substrate;

[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 substrate, and the adjustment surface of the curved surface of revolution is transitionally connected with 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 substrate 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 substrate 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 matrix to the diameter of the main matrix is ​​not less than 1 / 10.

[0028] In a preferred embodiment of the present invention, a through hole is provided on the side wall surface 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 substrate has a non-flap end, the non-flap end is symmetrically arranged with the flap end, and a fixing component is provided at the central axis of the non-flap end of the main substrate.

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

[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 and progressive effects of the present invention are:

[0034] 1) The heart valve molding component of the present invention reconstructs the width of the petal partition between two adjacent leaflets so that the width of the center side of the petal partition is not less than the width of the circumferential side of the petal partition, thereby preventing the middle of the two adjacent leaflets from being supported prematurely, so that the two adjacent leaflets can be better closed and the leaflet regurgitation can be reduced. In particular, the width of the petal partition is gradually increased from the circumferential side to the center side, so that the petal end close to the main base on the leaflet forming area forms a revolved curved adjustment surface, which is conducive to the smooth opening of the leaflet and reduces the pressure difference across the leaflet.

[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 fallen off by heating, thereby avoiding the need for the traditional artificial valve leaflet to be torn or dragged multiple times from the heart valve molding component to separate from the heart valve molding component, which will cause the deformation of the artificial valve leaflet and further affect the performance of the artificial valve leaflet. At the same time, in order to better adhere the wax layer to the surface of the heart valve molding component, the surface of the heart valve molding component is provided with through holes, and the wax layer can penetrate the through holes, so that the wax layer forms a rivet shape at the through holes and adheres to the surface of the heart valve molding component to prevent the wax layer from falling off. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0038] Figure 2 is a schematic structural diagram of a heart valve molding component 20 of the present invention;

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

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

[0041] Figure 5 2 is a schematic structural diagram 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] Fig. 7A Another perspective structural diagram of the heart valve molding component 20 of the present invention;

[0044] Figure 7BFIG. 2 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 leaflets 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, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways 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 leaflets, and three leaflet partitions 23 for separating the three artificial leaflets. The main substrate 21 is a shape formed by eliminating one end of a cylinder (see below for details). One end of the main substrate 21 is used to form three artificial leaflets, that is, the eliminated end, so this end is also called the leaflet end 21a for forming the leaflets. There are three leaflet forming areas 22 arranged at circumferential intervals at the leaflet end 21a. Since the leaflet forming area 22 is used for spinning to form an artificial leaflet close to the shape of the original leaflet, it is better that the shape of the leaflet forming area 22 is consistent with the shape of the original leaflet in the human heart. A feasible implementation scheme is to use the surface rotation formula in the prior art to eliminate the leaflet forming area 22 formed by the leaflet end 21a of the cylinder. 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 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 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 combination time of the leaf edges of 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 not less than the width K of the peripheral 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 not less than the width K of the peripheral side 232 of the petal partition 23, thereby preventing the middle of the two adjacent leaflets from being supported prematurely, so that the two adjacent leaflets can be better closed and the leaflet regurgitation can be reduced. In particular, the width of the petal partition 23 is gradually increased from the peripheral side 232 to the central side 231, so that the petal end 21a on the leaflet forming area close to the main base 21 forms a rotational curved adjustment surface, which is conducive to the 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 mastoid tendon chordae. According to the bionics principle, the leaflet forming area of ​​the heart valve molding component 20 in the prior art has three revolution 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 leaflet 10 is closed, the middle parts of the two adjacent leaflets 10 will be combined and supported too early, resulting in the two ends of the adjacent leaflets 10 not being firmly closed, and reflux is likely to occur. Even after the middle parts of the two adjacent leaflets 10 are combined, the leaflets will be folded under the action of blood, resulting in stress concentration, affecting the life of the artificial valve leaflet 10, and once folding occurs, platelet deposition is likely to occur at the folding site, resulting in thrombus formation.

[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 substrate 21. The three petal partitions 23 are distributed around the central axis on the side of the petal end 21a of the main substrate 21 at 100° to 140°, preferably 110° to 130°, and more preferably 120°. In this example, the width K of the petal partition 23 from the circumferential side 232 to the width Q of the central side 231 is gradually increased, 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 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 valve leaflets, resulting in mid-valve leakage; while an excessively small width K of the circumferential side 232 will cause an excessively large overlapping area of ​​closure in the middle of the valve leaflets, and may even cause the valve leaflets to fold back, resulting in stress concentration, significantly affecting the life of the valve leaflets, and once the valve leaflets fold back, platelet deposition and thrombus formation are likely to occur at the folded 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 0 mm and 1 mm", a rotational curved surface of the following manner is formed, such as Figure 4As shown, the revolved surface 221 intersects obliquely with the peripheral wall surface 212 on one side of the petal end 21a of the main substrate 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 substrate 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 from the peripheral side 232 to the width Q of the central side 231 is gradually increased, resulting in the revolved surface 221 of the leaflet forming area 22 being divided into: a revolved surface adjustment surface 222 and a revolved surface non-adjustment surface 223. The revolved curved surface adjustment surface 222 is located in a section of the leaflet forming area 22 close to the valve end 21a of the main substrate 21, and the revolved curved surface non-adjustment surface 223 is located in a section of the leaflet forming area 22 away from the valve end 21a of the main substrate 21, that is, the revolved curved surface adjustment surface 222 is a curved surface formed after adjusting the width of the central side 231 of the valve partition 23 of the heart valve molding component 20, and the revolved curved surface non-adjustment surface 223 is the same as the revolved curved surface 221 directly formed by the function formula (I) and the function formula (II). The revolved curved surface adjustment surface 222 and the revolved curved surface non-adjustment surface 223 are smoothly transitionally connected to prevent the opening and closing of the leaflets from being affected. Taking the axial direction of the main substrate 21 as a reference, the axial height of the revolved curved surface adjustment surface 222 does not exceed 1 / 3 of the axial height H1 of the revolved curved surface 221, that is, at least 2 / 3 of the axial height H1 of the revolved curved surface 221 is the revolved curved surface non-adjustment surface 223, which is conducive to the smooth opening and closing of the leaflets 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 artificial heart valves is carried out using the Pulse Duplicator of the Canadian Vivitro Laboratory (for example, composed of equipment such as the model ViVitroSuperPump pulsating pump-10647, ViVitro model heart-SD2001-1 or flowmeter-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; refer to 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" for testing:

[0053] The initial conditions of the experiment were: test heart rate 70 / min, systolic period 35%, cardiac output 5L / min, mean aortic pressure 100mmHg, R 15mm, K 5mm. The artificial valve was adjusted, i.e. the width of the center side 231 of the valve partition 23 was widened, and the width Q of the center side 231 after widening was 5.5mm. 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 regurgitation volume of the artificial valve leaflet is significantly reduced, which is about half of the artificial valve leaflet body before adjustment, and there is no obvious change in the trans-valvular pressure difference and the effective opening area, 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, and the non-valve end 21b 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 a cylinder, and the valve end 21a of the main body 21 is three leaflet forming areas 22 arranged circumferentially at intervals. The radius R of the main body is determined according to the diameter of the native leaflet or valve ring of the desired implantation position, such as the aortic valve ring. For example, the R value is 10mm to 16mm, and the function formula of the revolution surface 221 is formed: The variable R value is in the , which ensures that the three leaflet forming areas 22 of the heart valve molding component 20 can adapt to valve diameters of different specifications and maintain basically consistent structural parameters, thereby ensuring that the leaflets of the molded leaflet forming area 22 have basically consistent performance. The ratio of the height H2 of the cylinder at the non-leaf end 21b of the main substrate 21 to the diameter D of the main substrate 21 is not less than 1 / 10. This is because the larger the diameter D of the leaflets in the leaflet forming area 22, the larger the opening and closing amplitude of the leaflets will be, which in turn affects the opening and closing performance of the leaflets. Therefore, the height H2 of the cylinder at the non-leaf end 21b of the main substrate 21 is limited to prevent the main substrate 21 from being too short, resulting in the leaflets being unreliably fixed. It should be noted here that the leaflets of the molded artificial valve leaflet body at this time are fixed by the non-leaf end 21b of the main substrate 21. Exceptionally, when the leaflets of the molded artificial valve leaflet body are fixed directly by the leaflet edge, the main body can be omitted, and the same heart valve molding component 20 can remove the main substrate 21.

[0058] Conventionally, the friction between the artificial valve leaflet and the molding component 20 is usually reduced by applying silicone oil or spraying Teflon on the outer surface of the molding component 20, so that the artificial valve can be easily removed from the molding component 20. In actual operation, although the above arrangement effectively increases the smoothness of the surface of the molding component 20, the artificial valve leaflet still needs to be removed by dragging and tearing. 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 at this time. In order to better attach the wax layer to the surface of the heart valve molding component 20, a through hole 213 is provided on the side wall surface 212 of the main substrate 21. Preferably, the diameter of the through hole 213 is 0.5mm-1mm. The inner side of the wax layer 214 can penetrate the through hole 213 on the side wall surface 212 of the main substrate 21, and the wax layer 214 can also be formed on the inner side of the through hole 213, so that the wax layer 214 can be attached to the surface of the heart valve molding component 20 in a rivet shape at the through hole 213, thereby 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 be removed from the artificial valve leaflet body, avoiding the need for traditional artificial valve leaflets to be torn from the heart valve molding component 20, or dragged multiple times to separate from the heart valve molding component 20, 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, thereby avoiding the artificial valve leaflets being damaged by tearing force during the separation process of the heart valve molding component 20.

[0059] like Fig. 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 capillary holes of the spinneret or spinneret by a spinning pump (or a 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 an 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, the desired artificial valve leaflet body can be obtained by pressurizing, fixing, drying, demolding and cutting.

[0061] The present invention is described in detail above in conjunction with the embodiments of the accompanying drawings. A person skilled in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not be construed as limiting the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. A heart valve molding component, characterized in that The heart valve molding component comprises: a main body having petal ends forming petals; three leaflet forming areas, the three leaflet forming areas being circumferentially spaced and arranged at the leaflet end of the main body; There are three petal partitions, each of which is formed between two adjacent leaflet forming areas, and the petal partition has a central side close to the central axis of the main substrate and a peripheral side close to the peripheral wall surface of the main substrate, and the width of the central side of the petal partition is not less than the width of the peripheral side of the petal partition.

2. The heart valve molding component according to claim 1, characterized in that: The leaflet forming area has a revolved curved surface, and the width of the petal partition gradually increases from the peripheral side to the central side, so that the revolved curved surface of the leaflet forming area is divided into: A revolved curved surface adjustment surface, the revolved curved surface adjustment surface is located in a section of the leaflet forming area close to the leaflet end of the main substrate; 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 substrate, and the adjustment surface of the curved surface of revolution is transitionally connected with the non-adjustment surface of the curved surface of revolution.

3. The heart valve molding component according to claim 2, characterized in that The revolution curved surface adjustment surface and the revolution curved surface non-adjustment surface are smoothly transitionally connected.

4. The heart valve molding component according to claim 2, 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.

5. The heart valve molding component according to claim 2, characterized in that: The difference between the width of the center side of the petal partition and the width of the peripheral side of the petal partition is between 0 mm and 1 mm.

6. The heart valve molding component according to claim 2, characterized in that: The revolution curved surface intersects with the peripheral wall surface of the main base body at an angle.

7. The heart valve molding component according to claim 2, characterized in that: The central sides of the three petal partitions converge at the axis of the main base.

8. The heart valve molding component according to claim 2, characterized in that: The main matrix is ​​a cylinder.

9. The heart valve molding component according to claim 2, characterized in that 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.

10. The heart valve molding component according to claim 2, characterized in that The revolved curved surface is a curved surface formed by the intersection of a cylinder and a conical curved surface with an inclination angle, and the inclination angle α of the conical curved surface is 1° to 5°, preferably 2° to 4°, and more preferably 3°.

11. The heart valve molding component according to claim 1, characterized in that The three leaflet forming areas are distributed around the central axis of the main substrate at an angle of 100° to 140°, preferably 110° to 130°, and more preferably 120°.

12. 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.

13. The heart valve molding component according to any one of claims 1 to 13, characterized in that The peripheral wall surface of the main substrate is coated with a wax layer.

14. The heart valve molding component according to claim 13, characterized in that The side wall surface of the main substrate is provided with a through hole, and preferably, the diameter of the through hole is 0.5mm-1mm.

15. The heart valve molding component according to claim 1, characterized in that The main substrate has a non-flap end, which is symmetrically arranged with the flap end, and a fixing component is arranged at the central axis of the non-flap end of the main substrate.

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