Heart valve prosthesis and forming method thereof

Abstract

The invention provides a heart valve prosthesis and a forming method thereof. The heart valve prosthesis comprises a valve frame, an artificial valve leaflet and a joint mechanism, the valve frame is of a hollow columnar structure, a joint hole is formed in the valve frame, and the joint hole extends in the radial direction of the valve frame in a penetrating mode. The number of the artificial valve leaflets is multiple, and the artificial valve leaflets are arranged on the inner side of the valve frame and are sequentially arranged in the circumferential direction of the valve frame. The joint mechanism comprises a first joint part and a second joint part, the first joint part covers at least part of the outer surface of the valve frame, and the second joint part penetrates through the joint hole; the first joint part, the second joint part and the artificial valve leaflet are integrally formed by adopting a high polymer material, such as an injection molding mode. The artificial heart valve prosthesis has good anticoagulation performance and durability, and the artificial valve leaflet is firmly connected with the valve frame.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an artificial heart valve prosthesis and a molding method thereof. Background Art

[0002] Heart valve disease has become one of the major diseases that endanger human life and health. For severe heart valve disease, artificial heart valve prostheses can be used to replace the decaying autologous valves for treatment. Traditional artificial heart valve prostheses can be divided into mechanical valves and biological valves according to the materials of the artificial valve leaflets. The artificial valve leaflets of mechanical valves are supported by rigid materials such as metal and pyrolytic carbon. They have good durability and can generally be used for life, but mechanical valves have poor biocompatibility and patients need to take anticoagulant drugs for a long time. The material of the artificial valve leaflets of biological valves is generally animal-derived materials, such as pig pericardium, bovine pericardium or pig valves. They have good biocompatibility and generally do not cause coagulation problems, but they are prone to calcification in the body, resulting in low durability.

[0003] Based on the above problems, medical device manufacturers are committed to developing an artificial heart valve prosthesis with good durability and biocompatibility. The artificial valve leaflets of this type of artificial heart valve prosthesis are made of polymer materials, but the common problems of this type of artificial heart valve prosthesis are that the connection between the artificial valve leaflets and the valve frame is not firm or the artificial valve leaflets are easily deformed during use, resulting in abnormal function. Summary of the invention

[0004] The object of the present invention is to provide an artificial heart valve prosthesis and a molding method thereof, aiming to improve the connection firmness between the artificial valve leaflets and the valve frame of the artificial heart valve prosthesis and to improve the morphological stability of the artificial valve leaflets during use.

[0005] To achieve the above-mentioned objectives, the present invention provides an artificial heart valve prosthesis, comprising a valve frame, an artificial valve leaflet and a coupling mechanism; the valve frame is a hollow columnar structure, and a coupling hole is provided on the valve frame, and the coupling hole extends radially through the valve frame; there are multiple artificial valve leaflets, and the artificial valve leaflets are arranged on the inner side of the valve frame and arranged in sequence along the circumference of the valve frame; the coupling mechanism comprises a first coupling portion and a second coupling portion, the first coupling portion covers at least part of the outer surface of the valve frame, and the number of the second coupling portions is penetrated at the coupling hole; the first coupling portion, the second coupling portion, and the artificial valve leaflet are integrally formed using a polymer material.

[0006] Optionally, the valve frame includes a base and a plurality of column peaks, the column peaks are connected to a side of the base close to the outflow end of the artificial heart valve prosthesis, and the plurality of column peaks are arranged at intervals along the circumference of the base, and an artificial valve leaflet is provided between two adjacent column peaks; a plurality of the coupling holes are provided on the base and / or the column peaks, the plurality of the coupling holes located on the base are arranged at intervals along the circumference of the valve frame, the plurality of the coupling holes located on the same column peak are arranged at intervals along the axial direction of the valve frame or are arranged along the circumference of the valve frame, and a second coupling portion is passed through each of the coupling holes.

[0007] Optionally, the number of the engagement holes located on the column peak is less than the number of the engagement holes located on the base.

[0008] Optionally, on the outer side surface of the base, the total area of ​​the plurality of engagement holes provided on the base is less than 1 / 2 of the area of ​​the outer side surface of the base.

[0009] Optionally, the polymer material includes any one of medical polyurethane, medical polytetrafluoroethylene, and styrene-isobutylene-styrene triblock copolymer; and / or,

[0010] The material of the valve frame includes any one of medical polyetheretherketone, medical stainless steel, nickel-titanium alloy or titanium alloy.

[0011] Optionally, the medical polyurethane includes medical silicon-containing polyurethane or medical polycarbonate-containing polyurethane.

[0012] Optionally, the thickness of the artificial valve leaflet is 0.2 mm to 0.35 mm.

[0013] Optionally, the artificial heart valve prosthesis further comprises a sewing ring, which is connected to the valve frame and comprises a ring body and a suture hole arranged on the ring body.

[0014] Optionally, the sewing ring and the valve frame are formed separately and connected to each other, or the sewing ring, the artificial valve leaflet and the joint are formed integrally.

[0015] Optionally, the artificial heart valve prosthesis further comprises a wrapping cloth, and the wrapping cloth wraps the sewing ring.

[0016] To achieve the above object, the present invention also provides a molding method of an artificial heart valve prosthesis, which is used to prepare the artificial heart valve prosthesis as described above, and the molding method comprises the following steps:

[0017] providing the valve frame;

[0018] Placing the valve frame in a mold and fixing it on an injection molding machine;

[0019] heating the valve frame at a temperature lower than the melting temperature of the polymer material; and

[0020] The molten polymer material is injected into the mold by an injection molding machine, and the polymer material is cooled and solidified to form the artificial valve leaflet and the joint mechanism.

[0021] Optionally, the injection pressure during injection molding is 110 MPa to 130 MPa, the injection speed is 30 mm / s to 50 mm / s, and the injection time is less than 1 s.

[0022] Optionally, the thickness of the mold cavity of the mold for accommodating the polymer material is 0.35 mm to 0.4 mm.

[0023] Compared with the prior art, the artificial heart valve prosthesis and the molding method thereof of the present invention have the following advantages:

[0024] The aforementioned artificial heart valve prosthesis includes a valve frame, an artificial valve leaflet and a coupling mechanism; the valve frame is a hollow columnar structure, and a coupling hole is provided on the valve frame, and the coupling hole extends radially through the valve frame; the number of the artificial valve leaflets is multiple, and the artificial valve leaflets are arranged on the inner side of the valve frame and arranged in sequence along the circumference of the valve frame; the coupling mechanism includes a first coupling part and a second coupling part, the first coupling part covers at least part of the outer surface of the valve frame, and the second coupling part is penetrated at the coupling hole; the first coupling part, the second coupling part, and the artificial valve leaflet are integrally formed with a polymer material. The artificial valve leaflet is connected to the valve frame by the coupling mechanism, which, on the one hand, avoids stress concentration at the junction of the valve frame and the artificial valve leaflet, and on the other hand, avoids excessive pulling and deformation caused by excessive force when the artificial valve leaflet is closed, which is conducive to maintaining the shape of the artificial valve leaflet, and then maintaining the performance of the artificial heart valve prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0026] Figure 1 is a schematic structural diagram of an artificial heart valve prosthesis provided according to an embodiment of the present invention;

[0027] Figure 2 is a schematic structural diagram of an artificial heart valve prosthesis provided according to an embodiment of the present invention, wherein the wrapping cloth is not shown;

[0028] Figure 3 is a schematic structural diagram of a valve frame of an artificial heart valve prosthesis provided according to an embodiment of the present invention;

[0029] Figure 4is a schematic structural diagram of a valve frame of an artificial heart valve prosthesis provided according to another embodiment of the present invention;

[0030] Figure 5 is a schematic structural diagram of a valve frame of an artificial heart valve prosthesis provided according to another embodiment of the present invention;

[0031] Figure 6 is a schematic structural diagram of an artificial heart valve prosthesis provided according to another embodiment of the present invention;

[0032] Figure 7 FIG. 4 is a top view of a valve frame of an artificial heart valve prosthesis provided according to an embodiment of the present invention.

[0033] [Description of reference numerals is as follows]:

[0034] 10-artificial heart valve prosthesis, 11-inflow end, 12-outflow end, 100-valve frame, 110-base, 120-column peak, 101-joining hole, 101a-first joining hole, 101b-second joining hole, 200-artificial valve leaflet, 310-first joining part, 400-suture ring, 410-ring body, 411-suture hole, 500-wrapping cloth. DETAILED DESCRIPTION

[0035] The following is an explanation of the embodiments of the present invention by 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. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0036] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0037] As used in this specification, the singular forms "one", "an", and "the" include plural objects, and the plural form "a plurality" includes two or more objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0038] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0039] Please refer to Figures 1 to 5The artificial heart valve prosthesis 10 provided in the embodiment of the present invention includes a valve frame 100, an artificial valve leaflet 200 and a joint mechanism (not marked in the figure). The valve frame 100 is a hollow columnar structure, and a joint hole 101 is provided on the valve frame 100, and the joint hole 101 extends radially through the valve frame 100. There are multiple artificial valve leaflets 200, and multiple artificial valve leaflets 200 are arranged on the inner side of the valve frame 100 and arranged in sequence along the circumference of the valve frame 100. The joint mechanism includes a first joint part 310 and a second joint part (not shown in the figure). The first joint part 310 covers at least part of the outer surface of the valve frame 100, preferably including the entire outer surface of the valve frame 100. The second joint part is penetrated at the joint hole 101. The first joint part 310, the second joint part, and the artificial valve leaflet 200 are integrally formed using a polymer material. The outer surface of the valve frame 100 refers to the surface of the valve frame 100 away from its axis. It should be noted that the “plurality” mentioned here and in the following text refers to two or more, for example, two, three or more.

[0040] The use of the polymer material to manufacture the artificial valve leaflet 200 makes it possible for the artificial heart valve prosthesis to have both good durability and good anticoagulant effect. The artificial valve leaflet 200 is connected to the valve frame 100 through the coupling mechanism, so that the valve frame 100 and the coupling mechanism jointly bear the stress generated when the artificial valve leaflet 200 is opened and closed, avoiding the situation where the valve frame 100 is subjected to stress concentration at the coupling portion between it and the artificial valve leaflet 200 and thus causing fracture failure, and also avoiding the artificial valve leaflet 200 being subjected to excessive pulling force when closed and causing fatigue deformation, which is beneficial to maintaining the shape of the artificial valve leaflet 200 and extending the service life. Usually, the number of the second coupling parts is multiple, the number of the coupling holes 101 is also multiple, and each of the coupling holes 101 is penetrated by a second coupling part.

[0041] Next, the detailed configuration of the artificial heart valve prosthesis 10 is introduced.

[0042] The artificial heart valve prosthesis 10 has a relative inflow end 11 and an outflow end 12. When the artificial heart valve prosthesis 10 is implanted in the body to replace the native valve leaflet, after the artificial heart valve prosthesis 10 is opened, blood flows into the artificial heart valve prosthesis 10 from the inflow end 11 and flows out of the artificial heart valve prosthesis 10 from the outflow end 12.

[0043] Optionally, please refer to Figures 3 to 5, the valve frame 100 includes a base 110 and a plurality of column peaks 120, each of the column peaks 120 is connected to a side of the base 110 close to the outflow end 12, and the plurality of column peaks 120 are arranged at intervals along the circumference of the base 110. Preferably, the base 110 and the column peaks 120 are both provided with the engagement holes 101. For ease of description, the engagement holes 101 provided on the base 110 are referred to herein as first engagement holes 101a, and the engagement holes 101 provided on the column peaks 120 are referred to herein as second engagement holes 101b. In some implementations, the base 110 is provided with a plurality of the first engagement holes 101a, and the plurality of the first engagement holes 101a are arranged at intervals along the circumference of the base 110. In some implementations, the column peak 120 is provided with a plurality of the second engagement holes 101b, and the second engagement holes 101b located on the same column peak 120 are arranged at intervals along the circumference of the valve frame 100 (eg, Figure 3 ), or a plurality of the second engagement holes 101b located on the same column peak 120 are arranged at intervals along the axial direction of the valve frame 100 (as shown in Figure 4 and Figure 5 ). Among them, Figure 3 The design of the second engagement hole 101b shown can reduce stress concentration on the column peak 120 during the opening and closing process of the artificial valve leaflet, and also make the column peak 120 have a certain degree of flexibility. In an alternative implementation, each column peak may be provided with only one second engagement hole (not shown in the figure), or one second engagement hole may be provided on a part of the column peaks, and a plurality of second engagement holes may be provided on another part of the column peaks (not shown in the figure).

[0044] The embodiment of the present invention does not particularly limit the size of the first engaging hole 101a and the second engaging hole 101b. In some implementations, when viewed from the outer surface of the valve frame 100, the area of ​​the second engaging hole 101b is larger than the area of ​​the first engaging hole 101a (e.g., Figure 3 In some other implementations, the area of ​​the second engaging hole 101b is smaller than the area of ​​the first engaging hole 101a (as shown in FIG. Figure 4 and Figure 5 In some other implementations, the area of ​​the second engagement hole 101b is equal to the area of ​​the second engagement hole 101a. The arrangement is specifically based on the size of the column peak 120 in the circumferential direction of the valve frame 100. Usually, the number of the second engagement holes 101b is less than the number of the first engagement holes 101a.

[0045] Preferably, the total area of ​​the plurality of first engagement holes 101a is less than 1 / 2 of the area of ​​the outer surface of the base 110 when viewed from the outer surface of the base 110. In this way, the base 110 can have sufficient strength to ensure that when the artificial heart valve prosthesis 10 is implanted in the body to replace the native valve, the base 110 will not be squeezed and deformed during the cardiac cycle. In addition, in general, the more the number of the first engagement holes 101a, the more conducive it is to improve the uniformity of the distribution of the force between the artificial valve leaflet 200 and the valve frame 100.

[0046] Those skilled in the art should understand that the valve frame 100 is made of rigid material, and the optional rigid material includes but is not limited to medical polyetheretherketone, medical stainless steel, nickel titanium alloy, titanium alloy, etc. The thickness of the valve frame 100 is determined according to actual conditions, and is usually 0.8 mm to 1 mm.

[0047] Each of the artificial valve leaflets 200 is arranged between two adjacent column peaks 120. The polymer materials used to manufacture the artificial valve leaflets 200 and the bonding mechanism include but are not limited to medical polyurethane, medical polytetrafluoroethylene, and styrene-isobutylene-styrene triblock copolymer. Medical polyurethane is preferred, and medical silicon-containing polyurethane or medical polycarbonate-containing polyurethane is more preferred. These two types of polyurethanes have excellent biocompatibility and chemical stability, which can make the artificial valve leaflet 200 have good anti-coagulation ability and good durability.

[0048] The first joint portion 310, all the second joint portions and all the artificial leaflets 200 can be integrally formed by injection molding. Moreover, when the polymer material is medical polyurethane, the thickness of the artificial leaflet 200 is preferably 0.2 mm to 0.35 mm. The artificial leaflet 200 of this thickness can have a better opening and closing shape in a fluid mechanics environment, and can effectively reduce regurgitation when the artificial heart valve prosthesis 10 is implanted in the body to replace the native leaflet. The thickness of the artificial leaflet 200 made of other polymer materials is designed according to factors such as material properties.

[0049] Also, please refer back to Figure 2 The artificial heart valve prosthesis 10 further comprises a sewing ring 400, which is connected to the valve frame 100 and is used to be sutured and connected with the native valve ring when the artificial heart valve prosthesis 10 is implanted in the body. Therefore, the sewing ring 400 comprises a ring body 410 and a plurality of suture holes 411 arranged on the ring body 410, and the plurality of suture holes 411 are arranged at intervals along the circumference of the ring body 410. During implantation, the suture thread used to suture the sewing ring 400 and the native valve ring passes through at least part of the suture holes 411.

[0050] The shape of the sewing ring 400 is determined according to the implantation site of the artificial heart valve prosthesis 10. For example, when the artificial heart valve prosthesis 10 is implanted at the intersection of the left atrium and the left ventricle to replace the native mitral valve, the sewing ring 400 is configured in a horseshoe shape (e.g., Figure 1 and Figure 2 As another example, when the artificial heart valve prosthesis 10 is implanted at the intersection of the left ventricle and the aorta to replace the native aortic valve, the sewing ring 400 is constructed in a circular ring shape (as shown in FIG. Figure 6 to fit the native aortic valve annulus.

[0051] In addition, in some implementations, the sewing ring 400 can be formed separately and then connected to the valve frame 100 in any suitable manner, such as by sewing. In this case, the material of the sewing ring 400 can be the same as or different from the material of the artificial valve leaflet 200 and the engaging mechanism. When the material of the sewing ring 400 is different from the material of the artificial valve leaflet 200 and the engaging mechanism, the material of the sewing ring 400 is, for example, medical silicone.

[0052] In other implementations, the sewing ring 400 may be integrally formed with the artificial valve 200 and the coupling mechanism, so that the material of the sewing ring 400 is the same as that of the artificial valve 200 and the coupling mechanism.

[0053] Furthermore, if Figure 1 As shown, the artificial heart valve prosthesis 10 further includes a wrapping cloth 500, and the wrapping cloth 500 wraps the sewing ring 400. The provision of the wrapping cloth 500 can promote endothelialization between the artificial heart valve prosthesis 10 and the native valve ring. The material of the wrapping cloth 500 is, for example, PET woven cloth.

[0054] Next, the molding method of the artificial heart valve prosthesis 10 is introduced. The molding method specifically comprises the following steps:

[0055] Step S10: prepare the valve frame 100 by any appropriate method.

[0056] Step S20: placing the petal frame 100 on the mold and fixing it to the injection molding machine. Figure 7 As shown, the valve frame 100 includes a plurality of connection holes 102, and the connection holes 102 extend through the axial direction of the valve frame 100. The number of the connection holes 102 is, for example, three, and each of the connection holes 102 can be a threaded hole, so that the valve frame 100 can be threadedly connected to the injection molding machine through the connection holes 102 and screws to prevent the valve frame 100 from shifting during the injection molding process.

[0057] Step S30, preheating the valve frame 100. The preheating temperature is determined according to the type of the polymer material, and is generally slightly lower than the melting temperature of the polymer material. By preheating the valve frame 100, demolding can be avoided during the injection molding process.

[0058] Step S40, injecting the molten polymer material into the mold using an injection molding machine. Optionally, the injection pressure during injection molding is 110MPa-130Mpa, the injection speed is 30mm / s-50mm / s, and the injection time is less than 1s. If the injection speed is too low and the injection time is too long, the mold cavity of the mold will not be completely filled, but the polymer material at the bottom will begin to solidify, affecting the quality of the injection molded product.

[0059] Step S50, cooling and solidifying the polymer material to at least form the artificial valve leaflet 200 and the joining mechanism.

[0060] It should be understood that if the sewing ring 400 is formed integrally with the artificial valve leaflet 200 and the coupling mechanism, then after the step S50 is completed, the sewing ring 400 is also formed at the same time.

[0061] In addition, the thickness of the mold cavity for accommodating the polymer material is 0.35mm to 0.4mm, preferably 0.36mm. The reason for this design is that if the thickness is too large, the gap between two adjacent artificial leaflets 200 formed by injection molding will be too large when they are closed, which actually means that the artificial leaflets 200 are not completely closed, which will produce central reflux. If the thickness is too small, it will seriously affect the injection molding accuracy, making it difficult to mold the artificial leaflets 200, and the strength of the artificial leaflets 200 obtained by injection molding will be greatly reduced, making it difficult to meet the use requirements.

[0062] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. An artificial heart valve prosthesis, characterized in that: It includes a valve frame, an artificial valve leaflet and a coupling mechanism; the valve frame is a hollow columnar structure, and a coupling hole is provided on the valve frame, and the coupling hole extends radially through the valve frame; there are multiple artificial valve leaflets, and the artificial valve leaflets are arranged on the inner side of the valve frame and arranged in sequence along the circumference of the valve frame; the coupling mechanism includes a first coupling part and a second coupling part, the first coupling part covers at least part of the outer surface of the valve frame, and the second coupling part is passed through the coupling hole; the first coupling part, the second coupling part, and the artificial valve leaflet are integrally formed using a polymer material.

2. The artificial heart valve prosthesis according to claim 1, characterized in that: The valve frame includes a base and a plurality of column peaks, wherein the column peaks are connected to a side of the base close to the outflow end of the artificial heart valve prosthesis, and the plurality of column peaks are arranged at intervals along the circumference of the base, and an artificial valve leaflet is arranged between two adjacent column peaks; a plurality of coupling holes are provided on the base and / or the column peaks, and the plurality of coupling holes located on the base are arranged at intervals along the circumference of the valve frame, and the plurality of coupling holes located on the same column peak are arranged at intervals along the axial direction of the valve frame or arranged along the circumference of the valve frame, and a second coupling portion is passed through each of the coupling holes.

3. The artificial heart valve prosthesis according to claim 2, characterized in that: The number of the engagement holes located on the column peak is less than the number of the engagement holes located on the base.

4. The artificial heart valve prosthesis according to claim 2, characterized in that: On the outer side surface of the base, a total area of ​​the plurality of engagement holes provided on the base is smaller than 1 / 2 of an area of ​​the outer side surface of the base.

5. The artificial heart valve prosthesis according to claim 1, characterized in that: The polymer material includes any one of medical polyurethane, medical polytetrafluoroethylene, and styrene-isobutylene-styrene triblock copolymer; and / or, The material of the valve frame includes any one of medical polyetheretherketone, medical stainless steel, nickel-titanium alloy or titanium alloy.

6. The artificial heart valve prosthesis according to claim 5, characterized in that: The medical polyurethane includes medical silicon-containing polyurethane or medical polycarbonate-containing polyurethane.

7. The artificial heart valve prosthesis according to claim 6, characterized in that: The thickness of the artificial valve leaflet is 0.2 mm to 0.35 mm.

8. The artificial heart valve prosthesis according to claim 1, characterized in that: The artificial heart valve prosthesis also includes a sewing ring, which is connected to the valve frame and includes a ring body and a sewing hole arranged on the ring body.

9. The artificial heart valve prosthesis according to claim 8, characterized in that: The sewing ring and the valve frame are formed separately and connected to each other, or the sewing ring, the artificial valve leaflet and the joint are formed in one piece.

10. The artificial heart valve prosthesis according to claim 9, characterized in that: The artificial heart valve prosthesis further comprises a wrapping cloth, which wraps the sewing ring.

11. A method for molding an artificial heart valve prosthesis, for preparing the artificial heart valve prosthesis according to any one of claims 1 to 10, characterized in that: The molding method comprises the following steps: providing the valve frame; Placing the valve frame in a mold and fixing it on an injection molding machine; heating the valve frame at a temperature lower than the melting temperature of the polymer material; and The molten polymer material is injected into the mold by an injection molding machine, and the polymer material is cooled and solidified to form the artificial valve leaflet and the joint mechanism.

12. The method for forming an artificial heart valve prosthesis according to claim 11, characterized in that: The injection pressure during injection molding is 110MPa-130Mpa, the injection speed is 30mm / s-50mm / s, and the injection time is less than 1s.

13. The method for forming an artificial heart valve prosthesis according to claim 11, characterized in that: The thickness of the mold cavity of the mold for accommodating the polymer material is 0.35 mm to 0.4 mm.

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