Heart valve stent, heart valve prosthesis and method of manufacturing thereof

Abstract

The embodiment of the application provides a heart valve stent, a heart valve prosthesis and a preparation method thereof, and belongs to the technical field of medical devices. The heart valve stent comprises a first valve frame and a second valve frame. The first valve frame comprises a first valve frame body and a plurality of first valve corners. The first valve frame body defines a flow channel for blood circulation. The plurality of first valve corners are distributed along the circumference of the first valve frame body and are located on the same side of the first valve frame body in the axial direction. The second valve frame comprises a plurality of second valve corners for connecting valve leaflets. The plurality of second valve corners have the same extension direction in the axial direction as the first valve corners and correspond to the first valve corners in the circumferential direction. The second valve frame is arranged on the radially inner side of the first valve frame. The second valve frame and the first valve frame are connected after being shaped, and the second valve corners are connected with the corresponding first valve corners. The heart valve stent is beneficial to reducing the difficulty of covering the membrane, improving the covering effect of the heart valve stent, and prolonging the service life of the heart valve stent.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a heart valve stent, a heart valve prosthesis, and a method for preparing the same. Background Technology

[0002] Heart valves are located between the atria and ventricles, and between the ventricles and aorta, acting as one-way valves to help blood flow in one direction. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased, such as narrowing or insufficiency, blood flow will be affected, leading to abnormal heart function and ultimately heart failure.

[0003] Currently, when valves become diseased, valve replacement surgery is the most common treatment, replacing them with artificial mechanical valves or bioprosthetic valves. However, most existing polymeric surgical valve frames are one-piece molded stents, manufactured using machining processes and used as the frame support for the valve. The lining process involves first processing the frame material with a special technique, then fabricating a lining that fits the frame and valve leaflets, making the lining process quite complex. Because the frame is a single, complex structure, and the polymeric material lining process is special, the overall lining of the frame is difficult to complete, the lining effect is hard to control, and the probability of lining defects is high, affecting the lifespan of the heart valve and increasing the risk of patients needing valve replacement again. Summary of the Invention

[0004] This application provides a heart valve stent, a heart valve prosthesis, and a method for preparing the same, which helps reduce the difficulty of laparotomy, improves the laparotomy effect of the heart valve stent, and thus extends the service life of the heart valve stent.

[0005] In a first aspect, embodiments of this application provide a heart valve stent, which includes a first valve frame and a second valve frame. The first valve frame includes a first valve frame body and a plurality of first valve angles. The first valve frame body defines a flow channel for blood flow. The plurality of first valve angles are distributed circumferentially along the first valve frame body and are located on the same side of the first valve frame body in the axial direction. The second valve frame includes a plurality of second valve angles for connecting valve leaflets. The plurality of second valve angles extend in the same direction in the axial direction as the first valve angles and correspond to the first valve angles in the circumferential direction. The second valve frame is disposed on the radial inner side of the first valve frame. The second valve frame and the first valve frame are respectively formed and connected, and the second valve angles are connected to the corresponding first valve angles.

[0006] In this solution, the heart valve stent adopts a split stent structure, comprising a first valve frame and a second valve frame. The second valve frame is located radially inside the first valve frame. During the manufacturing process of the heart valve stent, the first and second valve frames can be formed separately, and then assembled together. Compared to a monolithic frame, the structure of a single first and second valve frame is simpler, and the forming effect of the first and second valve frames is easier to control. Furthermore, during the coating process, compared to the monolithic frame in existing technologies, only the second valve frame needs to be coated, eliminating the need for batch coating of the entire heart valve stent, thus simplifying the coating steps. Additionally, the second valve frame includes multiple second valve angles, further simplifying its overall structure and reducing the probability of air bubbles or incomplete coating during the coating process. This increases the yield of the dip-coated valve, reduces the difficulty of the coating process, improves the coating effect of the heart valve stent, and consequently extends the service life of the heart valve stent. In this design, the second petal angle is connected to the first petal angle, which can increase the strength of the second petal angle and help reduce the risk of cracks or breakage of the second petal angle caused by petal movement.

[0007] In some embodiments, the second petal angle and the first petal angle correspond one-to-one along the radial direction of the first petal frame.

[0008] In the above technical solution, the positions of the first valve angle and the second valve angle are aligned one-to-one in the radial direction of the first valve stent, and the first valve angle and the second valve angle are respectively set to overlap each other, so that the force and force transmission of the heart valve stent are more uniform and the overall structure of the heart valve stent is better.

[0009] In some embodiments, a first connecting hole is provided on the first petal corner, and a second connecting hole is provided on the second petal corner. The first connecting hole and the second connecting hole are used for threading through to connect the second petal frame to the first petal frame.

[0010] In the above technical solution, a first connecting hole is provided on the first petal corner, and a second connecting hole is provided on the second petal corner. The first and second petal corners are connected by threading a piece through them, thereby achieving a fixed connection between the first and second petal frames. The connection method is simple. Moreover, the connection method using threaded sewing is reversible. Even if the connection between the first and second petal frames is not good, the thread can be removed and reconnected, making it easier to ensure the connection effect between the first and second petal frames.

[0011] In some embodiments, there are multiple first connecting holes, and the number and position of the second connecting holes correspond one-to-one with the number and position of the first connecting holes; at least one wire passes through multiple first connecting holes and second connecting holes to connect the second petal frame to the first petal frame.

[0012] In the above technical solution, by setting multiple first and second connecting holes in a one-to-one correspondence, and having the wires pass through the first and second connecting holes, multiple connection points are created between the first and second petal frames, resulting in higher connection stability between the first and second petal frames. Furthermore, the force transmission between the first and second petal frames is more uniform, reducing the probability of local instability between them.

[0013] In some embodiments, the first petal frame protrudes radially inward to form a first protrusion, the first protrusion being used to position the second petal frame so that the second petal frame can be embedded in the first petal frame.

[0014] In the above technical solution, the first protrusion on the inner surface of the first petal frame serves as a pre-positioning feature for the second petal frame. After the second petal frame is embedded in the first petal frame, the multiple first connecting holes on the first petal frame align with the second connecting holes on the second petal frame, reducing the difficulty of threading the wires. Furthermore, the first protrusion provides support and limitation for the second petal frame, making it less likely for the second petal frame to detach from the first petal frame, thus increasing the connection stability between the first and second petal frames.

[0015] In some embodiments, the first protrusion includes a body and a first flange. The body protrudes radially inward from the inner side of the first petal corner, and the outline of the body at the first petal corner is adapted to the outline of the second petal corner on the side of the body of the first petal corner. The body is used to support the second petal corner. The first flange is disposed around the periphery of the body, and there is a gap between the first flange and the inner side of the first petal corner along the radial direction of the first petal corner, so as to form a slot for the second petal corner to be inserted between the first flange and the first petal corner.

[0016] In the above technical solution, the first protrusion includes a body and a first flange. The body protrudes from the inner side of the first petal corner, and the contour of the body at the first petal corner matches the contour of the second petal frame on the side closest to the body of the first petal frame. After the second petal frame is installed on the first petal frame, the body can provide support, limitation, and pre-positioning for the second petal frame. The first connecting hole and the second connecting hole can automatically align, reducing the installation difficulty of the second petal frame. Furthermore, a slot is formed between the first flange and the first petal corner for the second petal frame to be inserted. The slot allows the second petal frame to be inserted, that is, the inner sides of the first flange and the first petal corner are respectively clamped on the radial sides of the second petal frame. The first flange and the first petal corner can limit the radial sides of the second petal frame. In the radial direction of the first petal frame, the second petal frame will not have relative displacement with the first petal frame, and the installation stability and integrity of the second petal frame on the first petal frame are stronger.

[0017] In some embodiments, the inner and outer sides of the second petal frame are provided with a polymer coating layer.

[0018] In the above technical solution, a diaphragm layer is provided on the inner and outer sides of the second valve stent. The diaphragm layer serves to isolate the second valve stent from blood, and also makes the anticoagulation ability of the heart valve stent better and the hydrodynamics closer to the original valve.

[0019] In some embodiments, the first valve body protrudes radially outward to form a second protrusion, and the second protrusion has a plurality of suture holes for connection with heart tissue.

[0020] In the above technical solution, a second protrusion is formed by protruding outward on the first valve body. The second protrusion is provided with multiple suture holes, and sutures can be used to pass through the suture holes to suture and fix the heart valve stent to human tissue.

[0021] In some embodiments, the first petal angle includes two first connecting rods. The two first connecting rods belonging to the same first petal angle are connected at the end away from the flow channel to form a first petal peak. The first petal peaks of multiple first petal angles are arranged circumferentially. The two first connecting rods belonging to two adjacent first petal angles meet at a first node at the end near the first petal frame body. The first node is connected to the first petal frame body. A first hole is formed between the two first connecting rods belonging to the same first petal angle and the first petal frame body.

[0022] In the above technical solution, since the heart valve stent has a double-layer structure, the double-layer structure can easily lead to increased rigidity and affect flexibility. By forming a first hole between the two first connecting rods at the same first valve angle and the first valve body, it is equivalent to forming multiple hollow structures in the circumferential direction of the first valve, giving the first valve a certain degree of flexibility. During the contraction of the heart valve stent, the potential energy of the heart valve stent can be released through the deformation of the first hole itself, reducing the risk of stress concentration at the valve angle during use and extending the service life of the heart valve stent.

[0023] In some embodiments, the second petal angle includes two second connecting rods. The two second connecting rods belonging to the same second petal angle are connected at the end away from the flow channel to form a second petal peak. The second petal peaks of multiple second petal angles are arranged circumferentially. The two second connecting rods belonging to two adjacent second petal angles meet at the end near the flow channel at a second node. The two second connecting rods belonging to the same second petal angle form a second hole by surrounding the first petal frame body.

[0024] In the above technical solution, a second hole is formed on the second valve stent, which is equivalent to multiple hollow structures forming on the circumference of the second valve stent. The second hole also makes the second valve stent have a certain degree of flexibility. During the contraction of the heart valve stent, under the action of the first hole and the second hole, the potential energy of the heart valve stent can be released through the deformation of the first hole and the second hole, which reduces the risk of stress concentration at the valve angle position during the use of the heart valve stent and extends the service life of the heart valve stent.

[0025] In some embodiments, a skirt is provided around the outer periphery of the first petal frame.

[0026] In the above technical solution, by providing a skirt around the outer periphery of the first valve stent, on the one hand, the skirt can cover the outer periphery of the first valve stent, preventing the polymer or metal materials of the heart valve stent itself from being directly exposed to the blood, thus avoiding adverse phenomena such as blood clotting. On the other hand, the skirt can ensure the sealing of the outer periphery of the heart valve stent, preventing blood leakage or seepage from the heart valve prosthesis.

[0027] Secondly, embodiments of this application provide a heart valve prosthesis, which includes a leaflet and the aforementioned heart valve stent, with the leaflet located on a second stent.

[0028] In the above technical solution, the heart valve stent includes a first valve frame and a second valve frame. During the coating process, the valve leaflets are installed on the second valve frame, requiring only the second valve frame to undergo the coating process, thus simplifying the heart valve stent coating steps. Furthermore, the overall structure of the second valve frame is simpler, reducing the probability of air bubbles or incomplete coating during the coating process, thereby increasing the yield of the dip-coated valve, reducing the difficulty of the coating process, improving the coating effect of the heart valve stent, and correspondingly extending the service life of the heart valve stent.

[0029] In some embodiments, the heart valve prosthesis includes a skirt that surrounds the outer periphery of the first valve frame.

[0030] In the above technical solution, the skirt can wrap around the outer periphery of the first valve stent, preventing the polymer or metal materials of the heart valve stent itself from being directly exposed to the blood, thus avoiding adverse phenomena such as blood clotting. The skirt can ensure the sealing of the outer periphery of the heart valve stent, preventing blood leakage or seepage from the heart valve prosthesis.

[0031] Thirdly, embodiments of this application provide a method for preparing a heart valve prosthesis. The method is used to prepare the aforementioned heart valve prosthesis and includes the following steps: processing and molding to obtain a first valve frame and a second valve frame respectively; coating the molded second valve frame with a polymer film; impregnating the coated second valve frame with a polymer material to generate valve leaflets; and connecting the second valve frame with the generated valve leaflets to the first valve frame.

[0032] By employing a split-type valve stent, the first and second valve stents can be formed separately. During the lamination process, only the second valve stent needs to be laminated with a polymer membrane, eliminating the need to laminate the entire heart valve stent, thus simplifying the lamination procedure. After lamination, the second valve stent undergoes a dip-coating process to generate leaflets. Finally, the leaflet-bearing second valve stent is connected to the first valve stent to obtain the heart valve prosthesis. Compared to the monolithic frame in existing technologies, this simplifies the lamination process, requiring only lamination of the second valve stent, and ensures a more effective lamination result.

[0033] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0034] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0035] Figure 1 This is a schematic diagram of the structure of the heart valve stent provided in some embodiments of this application;

[0036] Figure 2 This is a front view of a cardiac valve stent provided in some embodiments of this application;

[0037] Figure 3 This is a schematic diagram of the structure of the first valve frame in a heart valve stent provided in some embodiments of this application;

[0038] Figure 4 for Figure 3 Enlarged diagram of A in the middle;

[0039] Figure 5 This is a front view of the first valve frame in a heart valve stent provided in some embodiments of this application;

[0040] Figure 6 This is a schematic diagram of the structure of the second valve frame in a cardiac valve stent provided in some embodiments of this application;

[0041] Figure 7 This is a front view of the second valve frame in a heart valve stent provided in some embodiments of this application.

[0042] Icons: 100-Heart valve stent; 10-First valve stent; 11-First valve stent body; 12-First valve angle; 121-First connecting hole; 1211-First sub-connecting hole; 1212-Second sub-connecting hole; 122-First connecting rod; 123-First valve peak; 124-First node; 125-First hole; 14-First protrusion; 141-Body; 142-First flange; 143-Slot; 15-Second protrusion; 151-Suture hole; 20-Second valve stent; 21-Second valve angle; 211-Second connecting hole; 212-Second connecting rod; 213-Second valve peak; 214-Second node; 215-Second hole. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0044] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0045] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0046] In the description of the embodiments of this application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on this application. In addition, the terms "first," "second," "third," etc. are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0047] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up" and "connected" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0048] Example

[0049] This application provides a cardiac valve stent; please refer to... Figures 1 to 7 The heart valve stent 100 includes a first valve frame 10 and a second valve frame 20. The first valve frame 10 includes a first valve frame body 11 and a plurality of first valve angles 12. The first valve frame body 11 defines a flow channel for blood flow. The plurality of first valve angles 12 are distributed circumferentially along the first valve frame body 11 and are located on the same side of the first valve frame body 11 in the axial direction. The second valve frame 20 includes a plurality of second valve angles 21 for connecting the valve leaflets. The plurality of second valve angles 21 extend in the same direction in the axial direction as the first valve angles 12 and correspond to the first valve angles 12 in the circumferential direction. The second valve frame 20 is disposed on the radial inner side of the first valve frame 10. The second valve frame 20 and the first valve frame 10 are respectively formed and connected, and the second valve angles 21 are connected to the corresponding first valve angles 12.

[0050] In this design, the heart valve stent 100 adopts a split stent structure, comprising a first valve frame 10 and a second valve frame 20. The second valve frame 20 is located radially inside the first valve frame 10. During the manufacturing of the heart valve stent 100, the first valve frame 10 and the second valve frame 20 can be formed separately, and then assembled and connected. Compared to an integral frame, the structure of a single first valve frame 10 and the second valve frame 20 is simpler, and the forming effect of the first valve frame 10 and the second valve frame 20 is easier to control. Furthermore, during the coating process, compared to the integral frame in the prior art, only the second valve frame 20 needs to be coated, instead of coating the entire heart valve stent in batches, simplifying the coating steps of the heart valve stent 100. Furthermore, the second valve frame 20 includes multiple second valve corners 21, resulting in a simpler overall structure. This reduces the probability of air bubbles or incomplete coating during the coating process, thereby increasing the yield of the dip-coated valve, reducing the difficulty of the coating process, improving the coating effect of the heart valve stent 100, and correspondingly extending the service life of the heart valve stent 100. In this design, the second valve corner 21 is connected to the first valve corner 12, which increases the strength of the second valve corner 21 and helps reduce the risk of cracks or breakage of the second valve corner 21 due to leaflet movement.

[0051] The first petal frame 10 and the second petal frame 20 can be made of the same or different materials. The materials of the first petal frame 10 and the second petal frame 20 can be nickel-titanium, cobalt-chromium, or polymer materials, etc. The first petal frame 10 and the second petal frame 20 can be connected in various ways. For example, the first petal frame 10 and the second petal frame 20 can be connected by snap-fit, adhesive, injection molding, welding, or sewing.

[0052] The number of second lobes 21 can be three, four, or five, etc. In this embodiment, there are three second lobes 21, which are evenly distributed around the circumference of the second lobe frame 20. Of course, the number and position of the first lobes 12 correspond one-to-one with the number and position of the second lobes 21. That is, if there are three second lobes 21, then there are also three first lobes 12, and the positions and numbers of the first lobes 12 and the second lobes 21 correspond one-to-one.

[0053] It should be noted that the existing monolithic frame structure is complex. Due to its small included angle and complex bending angle, the monolithic frame is prone to air bubbles, incomplete coverage, or other coverage abnormalities during the endovascular coating process, resulting in a high failure rate and affecting the lifespan of the artificial heart valve. When air bubbles or incomplete coverage occur during the coating process, gaps appear in the coating. These gaps can lead to crack propagation, causing the entire coating to peel off, detach, tear, or even cause the entire valve to fail, thus affecting the lifespan of the heart valve.

[0054] In some embodiments, please refer to Figure 1 and Figure 2 Along the radial direction of the first valve frame 10, the second valve angle 21 and the first valve angle 12 correspond one-to-one. In the radial direction of the first valve frame 10, the positions of the first valve angle 12 and the second valve angle 21 correspond one-to-one, and the first valve angle 12 and the second valve angle 21 are respectively arranged to overlap each other, so that the force and force transmission of the heart valve stent 100 are more uniform, and the overall structure of the heart valve stent 100 is better.

[0055] In some embodiments, please refer to Figure 1The first petal corner 12 is provided with a first connecting hole 121, and the second petal corner 21 is correspondingly provided with a second connecting hole 211. The first connecting hole 121 and the second connecting hole 211 are used for threading to connect the second petal frame 20 to the first petal frame 10. The first connecting hole 121 is provided on the first petal corner 12, and the second connecting hole 211 is provided on the second petal corner 21. The first petal corner 12 and the second petal corner 21 are connected by threading, thereby achieving a fixed connection between the first petal frame 10 and the second petal frame 20. The connection method using threaded sewing is reversible. Even if the connection between the first petal frame 10 and the second petal frame 20 is not good, the thread can be removed and reconnected, making it easier to ensure the connection effect between the first petal frame 10 and the second petal frame 20.

[0056] The thread can be a suture thread. A first connecting hole 121 is provided through the first petal corner 12, and a second connecting hole 211 is provided through the second petal corner 21. For the first petal corner 12, the number of first connecting holes 121 can be one or more, and for the second petal corner 21, the number of second connecting holes 211 can be one or more. The number of first connecting holes 121 and second connecting holes 211 can be determined according to the actual situation.

[0057] In some embodiments, please refer to Figure 1 There are multiple first connecting holes 121, and the number and position of second connecting holes 211 correspond one-to-one with the number and position of the first connecting holes 121. At least one wire passes through multiple first connecting holes 121 and second connecting holes 211 to connect the second petal frame 20 to the first petal frame 10. By setting multiple first connecting holes 121 and second connecting holes 211 in a one-to-one correspondence, and by having wires pass through the first connecting holes 121 and second connecting holes 211, there are multiple connection points between the first petal frame 10 and the second petal frame 20, resulting in higher connection stability between the first petal frame 10 and the second petal frame 20. Furthermore, the force transmission between the first petal frame 10 and the second petal frame 20 is more uniform, reducing the probability of local instability between the first petal frame 10 and the second petal frame 20.

[0058] Of course, the first petal frame 10 and the second petal frame 20 can be connected by a single thread that passes through multiple first connecting holes 121 and second connecting holes 211 in sequence, or by multiple threads that pass through multiple first connecting holes 121 and second connecting holes 211 to sew the first petal frame 10 and the second petal frame 20 together.

[0059] In some embodiments, please refer to Figure 3 , Figure 4 and Figure 5The first petal frame 10 has a first protrusion 14 that protrudes radially inward. The first protrusion 14 is used to position the second petal frame 20 so that the second petal frame 20 can be embedded in the first petal frame 10. Through the provision of the first protrusion 14 on the inner surface of the first petal frame 10, the first protrusion 14 can pre-position the second petal frame 20. After the second petal frame 20 is embedded in the first petal frame 10, the multiple first connecting holes 121 on the first petal frame 10 are aligned with the second connecting holes 211 on the second petal frame 20, reducing the difficulty of threading the wires. Furthermore, the first protrusion 14 can provide support and limit the second petal frame 20, making it less likely for the second petal frame 20 to detach from the first petal frame 10, thus increasing the connection stability between the first petal frame 10 and the second petal frame 20.

[0060] like Figure 3 As shown, the first protrusion 14 refers to the protruding structure that protrudes from the inner surface of the first petal frame 10. The first protrusion 14 can provide positioning and limiting functions for the second petal frame 20.

[0061] In some embodiments, please combine Figures 3 to 5 The first protrusion 14 includes a body 141 and a first flange 142. The body 141 protrudes inward along the radial direction of the first petal frame 10 and is formed on the inner side of the first petal corner 12. The outline of the body 141 at the first petal corner 12 is adapted to the outline of the second petal frame 20 on the side close to the body 11 of the first petal frame. The body 141 is used to support the second petal frame 20. The first flange 142 is arranged around the periphery of the body 141. Along the radial direction of the first petal frame 10, there is a gap between the first flange 142 and the inner side of the first petal corner 12 to form a slot 143 for the second petal frame 20 to be inserted between the first flange 142 and the first petal corner 12.

[0062] The first protrusion 14 includes a body 141 and a first flange 142. The body 141 protrudes from the inner side of the first petal corner 12, and the outline of the body 141 at the first petal corner 12 matches the outline of the second petal frame 20 on the side close to the body of the first petal frame 11. After the second petal frame 20 is installed on the first petal frame 10, the body 141 can provide support, limit and pre-position for the second petal frame 20. The first connecting hole 121 and the second connecting hole 211 can be automatically aligned, reducing the installation difficulty of the second petal frame 20. Furthermore, a slot 143 is formed between the first flange 142 and the first petal corner 12 for the second petal frame 20 to be embedded. The slot 143 allows the second petal frame 20 to be embedded and inserted. That is, the inner surfaces of the first flange 142 and the first petal corner 12 are respectively clamped on the radial sides of the second petal frame 20. The first flange 142 and the first petal corner 12 can limit the radial sides of the second petal frame 20. In the radial direction of the first petal frame 10, the second petal frame 20 will not have relative displacement with the first petal frame 10. The installation stability and integrity of the second petal frame 20 on the first petal frame 10 are stronger.

[0063] The thickness of the slot 143 can be adapted to the thickness of the second petal frame 20. The first protrusion 14 and the first petal frame 10 can be integrally formed.

[0064] It should be noted that, please refer to... Figure 3 and Figure 4 A first connecting hole 121 on the first petal frame 10, corresponding to the position of the first protrusion 14, can penetrate through the first petal corner 12 and the first flange 142 of the first protrusion 14. That is, the first connecting hole 121 may include a first sub-connecting hole 1211 and a second sub-connecting hole 1212. The first sub-connecting hole 1211 is opened on the first petal corner 12, and the second sub-connecting hole 1212 is opened on the first flange 142. The first sub-connecting hole 1211 and the second sub-connecting hole 1212 together constitute the first connecting hole 121. When the second petal frame 20 is engaged on the first petal frame 10, the first sub-connecting hole 1211, the second connecting hole 1211, and the second connecting hole 1212 are aligned with each other.

[0065] In some embodiments, a polymer coating layer (not shown in the figure) is provided on the inner and outer sides of the second valve stent 20. The coating layer on the inner and outer sides of the second valve stent 20 serves to isolate the second valve stent 20 from blood, and the coating layer also makes the anticoagulant performance of the heart valve stent 100 better and the hydrodynamics closer to that of the original valve.

[0066] The covering layer refers to a thin film of polymer material applied to the inner and outer sides of the second petal frame 20 using a dip-coating process.

[0067] In some embodiments, please refer to Figure 1 and Figure 2 The first valve body 11 protrudes outward along its radial direction to form a second protrusion 15, and the second protrusion 15 is provided with a plurality of suture holes 151 for connecting with heart tissue. By forming the second protrusion 15 on the first valve body 11 and providing a plurality of suture holes 151 on the second protrusion 15, sutures can be passed through the suture holes 151 to suture and fix the heart valve stent 100 to human tissue.

[0068] The suture hole 151 is provided through the second protrusion 15 along the axial direction of the first flap 10. Multiple suture holes 151 are equally spaced along the circumference of the second protrusion 15. The number of multiple suture holes 151 can be determined according to the actual situation.

[0069] In some embodiments, please refer to Figure 3 , Figure 4 and Figure 5The first valve angle 12 includes two first connecting rods 122. The two first connecting rods 122 belonging to the same first valve angle 12 are connected at the end away from the flow channel to form a first valve peak 123. The first valve peaks 123 of multiple first valve angles 12 are arranged circumferentially. The two first connecting rods 122 belonging to two adjacent first valve angles 12 converge at the end near the first valve frame body 11 to a first node 124. The first node 124 is connected to the first valve frame body 11. A first hole 125 is formed between the two first connecting rods 122 belonging to the same first valve angle 12 and the first valve frame body 11. Since the heart valve stent 100 has a double-layer structure, the double-layer structure can easily lead to an increase in the rigidity of the heart valve stent 100, and its flexibility is affected to a certain extent. By forming a first hole 125 between the two first connecting rods 122 at the same first valve angle 12 and the first valve frame body 11, it is equivalent to forming multiple hollow structures in the circumferential direction of the first valve frame 10, which makes the first valve frame 10 have a certain degree of flexibility. During the contraction of the heart valve stent 100, the potential energy of the heart valve stent 100 can be released through the deformation of the first hole 125 itself, which reduces the risk of stress concentration at the valve angle position during the use of the heart valve stent 100 and extends the service life of the heart valve stent 100.

[0070] In some embodiments, please refer to Figure 6 and Figure 7 The second petal angle 21 includes two second connecting rods 212. The two second connecting rods 212 belonging to the same second petal angle 21 are connected at the end away from the flow channel to form a second petal peak 213. The second petal peaks 213 of multiple second petal angles 21 are arranged at intervals along the circumference. The two second connecting rods 212 belonging to two adjacent second petal angles 21 converge at the end near the flow channel at a second node 214. The two second connecting rods 212 belonging to the same second petal angle 21 form a second hole 215 between themselves and the first petal frame body 11. The second valve frame 20 has a corresponding second hole 215, which is equivalent to having multiple hollow structures in the circumferential direction of the second valve frame 20. The second hole 215 also makes the second valve frame 20 have a certain degree of flexibility. During the contraction of the heart valve stent 100, under the action of the first hole 125 and the second hole 215, the potential energy of the heart valve stent 100 can be released through the deformation of the first hole 125 and the second hole 215, which reduces the risk of stress concentration at the valve angle position during the use of the heart valve stent 100 and extends the service life of the heart valve stent 100.

[0071] The shape and area of ​​the first hole 125 and the second hole 215 may be equal or unequal. In this embodiment, the first hole 125 and the second hole 215 are triangular in shape. Of course, the shape of the first hole 125 and the second hole 215 may also be square or circular, etc. The shape of the first hole 125 and the second hole 215 is not limited here.

[0072] The first connecting rod 122 can be an arc-shaped rod, with a rounded transition between two first connecting rods 122 belonging to two adjacent first valve angles 12; and / or, the second connecting rod 212 can be an arc-shaped rod, with a rounded transition between two second connecting rods 212 belonging to two adjacent second valve angles 21. By using arc-shaped rods for the first connecting rod 122 and the second connecting rod 212, the generation of sharp angles is reduced compared to straight rods, thereby reducing the risk of the heart valve stent 100 scratching heart tissue.

[0073] In some embodiments, a skirt (not shown) is provided around the outer periphery of the first valve stent 10. By providing a skirt around the outer periphery of the first valve stent 10, on the one hand, the skirt can cover the outer periphery of the first valve stent 10, preventing the polymer or metal materials of the heart valve stent 100 from being directly exposed to the blood, thus avoiding adverse phenomena such as blood clotting. On the other hand, the skirt can ensure the sealing of the outer periphery of the heart valve stent 100, preventing blood leakage or seepage from the heart valve prosthesis.

[0074] This application provides a heart valve prosthesis, which includes a leaflet and the aforementioned heart valve stent 100, with the leaflet located on a second valve stent 20.

[0075] The heart valve stent 100 includes a first valve frame 10 and a second valve frame 20. During the coating process, the valve leaflets are installed on the second valve frame 20, requiring only the second valve frame 20 to undergo the coating process, thus simplifying the coating steps of the heart valve stent 100. Furthermore, the overall structure of the second valve frame 20 is simpler, reducing the probability of air bubbles or incomplete coating during the coating process, thereby increasing the yield of the dip-coated valve, reducing the difficulty of the coating process, improving the coating effect of the heart valve stent 100, and correspondingly extending the service life of the heart valve stent 100.

[0076] In some embodiments, the heart valve prosthesis includes a skirt that surrounds the outer periphery of the first valve stent 10. The skirt covers the outer periphery of the first valve stent 10, preventing the polymer or metal materials of the heart valve stent 100 from being directly exposed to the blood, thus avoiding adverse phenomena such as blood clotting. The skirt ensures the sealing of the outer periphery of the heart valve stent 100, preventing blood leakage or seepage from the heart valve prosthesis.

[0077] This application provides a method for preparing a heart valve prosthesis. The method includes the following steps: processing and molding a first valve frame 10 and a second valve frame 20; coating the molded second valve frame 20 with a polymer film; impregnating the coated second valve frame 20 with a polymer material to generate leaflets; and connecting the second valve frame 20 with the generated leaflets to the first valve frame 10.

[0078] By employing a split-type valve stent, the first valve stent 10 and the second valve stent 20 can be formed separately. During the lamination process, only the second valve stent 20 needs to be laminated with a polymer film, instead of the entire heart valve stent, simplifying the lamination steps of the heart valve stent 100. After lamination, the second valve stent 20 undergoes a dip-coating process to generate leaflets. Finally, the leaflet-bearing second valve stent 20 is connected to the first valve stent 10 to obtain the heart valve prosthesis. Compared to the monolithic frame in existing technologies, this simplifies the lamination process, requiring only lamination of the second valve stent 20, and ensures a more effective lamination result.

[0079] After the first valve frame 10 no longer needs to be covered, the attachment edge of the leaflet can be increased by sewing, welding or bonding, which strengthens the strength of the leaflet at the fatigue point and extends the service life of the heart valve prosthesis.

[0080] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0081] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A cardiac valve stent, characterized in that, include: The first valve frame includes a first valve frame body and a plurality of first valve angles. The first valve frame body defines a flow channel for blood flow. The plurality of first valve angles are distributed circumferentially along the first valve frame body and are located on the same side of the first valve frame body in the axial direction. The second petal frame includes a plurality of second petal angles for connecting petal leaflets. The plurality of second petal angles extend in the same axial direction as the first petal angle and correspond to the first petal angle in the circumferential direction. The second petal frame is disposed on the radial inner side of the first petal frame, and the second petal frame and the first petal frame are connected after being formed respectively, and the second petal angle is connected to the corresponding first petal angle; The first petal frame protrudes radially inward to form a first protrusion, which is used to position the second petal frame so that the second petal frame can be embedded in the first petal frame; The first protrusion includes a body and a first flange. The body protrudes radially inward along the first petal frame and is formed on the inner side of the first petal corner. The body is used to support the second petal frame. Along the radial direction of the first petal frame, there is a gap between the inner surface of the first flange and the first petal corner to form a slot for the second petal frame to be fitted between the first flange and the first petal corner.

2. The cardiac valve stent according to claim 1, characterized in that, Along the radial direction of the first petal frame, the second petal angle corresponds one-to-one with the first petal angle.

3. The cardiac valve stent according to claim 1, characterized in that, The first petal corner is provided with a first connecting hole, and the second petal corner is provided with a corresponding second connecting hole. The first connecting hole and the second connecting hole are used for threading to connect the second petal frame to the first petal frame.

4. The cardiac valve stent according to claim 3, characterized in that, There are multiple first connecting holes, and the number and position of the second connecting holes correspond one-to-one with the number and position of the first connecting holes; At least one of the wires passes through a plurality of the first connection holes and the second connection holes to connect the second petal frame to the first petal frame.

5. The cardiac valve stent according to claim 1, characterized in that, The outline of the body at the first petal angle is adapted to the outline of the second petal frame on the side close to the body of the first petal frame; The first flange is provided around the outer perimeter of the body.

6. The cardiac valve stent according to claim 1, characterized in that, The inner and outer sides of the second petal frame are covered with a polymer coating layer.

7. The cardiac valve stent according to claim 1, characterized in that, The first valve body protrudes outward along its radial direction to form a second protrusion, and the second protrusion is provided with a plurality of suture holes for connecting with heart tissue.

8. The cardiac valve stent according to claim 1, characterized in that, The first petal angle includes two first connecting rods. The two first connecting rods belonging to the same first petal angle are connected at the end away from the flow channel to form a first petal peak. The first petal peaks of multiple first petal angles are arranged circumferentially. The two first connecting rods, which belong to two adjacent first petal corners, meet at a first node at one end near the first petal frame body, and the first node is connected to the first petal frame body; The two first connecting rods belonging to the same first petal angle form a first hole by enclosing the first petal frame body.

9. The cardiac valve stent according to claim 7, characterized in that, The second lobe angle includes two second connecting rods. The two second connecting rods belonging to the same second lobe angle are connected at the end away from the flow channel to form a second lobe peak. The second lobe peaks of multiple second lobe angles are arranged at circumferential intervals. The two second connecting rods, which belong to two adjacent second lobe corners, meet at a second node at one end near the flow channel; The two second connecting rods belonging to the same second petal angle form a second hole by surrounding the first petal frame body.

10. The cardiac valve stent according to claim 1, characterized in that, The outer periphery of the first petal frame is surrounded by a skirt.

11. A heart valve prosthesis, characterized in that, It includes leaflets and a cardiac valve stent according to any one of claims 1-9, wherein the leaflets are located on the second valve stent.

12. The heart valve prosthesis according to claim 11, characterized in that, The heart valve prosthesis includes: The skirt fabric is wrapped around the outer periphery of the first petal frame.

13. A method for preparing a heart valve prosthesis, used to prepare the heart valve prosthesis according to claim 11 or 12, characterized in that, Includes the following steps: The first petal frame and the second petal frame are processed and shaped separately; the shaped second petal frame is coated with a polymer film, and the coated second petal frame is dipped in a polymer material to generate petal leaflets; the second petal frame with generated petal leaflets is connected to the first petal frame.

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