Heart valve stent, heart valve prosthesis and preparation method thereof

Abstract

The embodiment of the invention provides a heart valve stent, a heart valve prosthesis and a preparation method of the heart valve stent and the heart valve prosthesis, and belongs to the technical field of medical instruments. The heart valve stent comprises a first valve stent body and a second valve stent body, the first valve stent body comprises a first valve stent body and a plurality of first valve angles, the first valve stent body defines a flow channel for blood circulation, and the first valve angles are distributed in the circumferential direction of the first valve stent body at intervals and located on the same side of the first valve stent body in the axial direction; the second valve frame comprises a plurality of second valve angles used for being connected with the valve leaflet, the extending direction of the second valve angles in the axial direction is the same as that of the first valve angles, and the second valve angles correspond to the first valve angles in the circumferential direction. The second valve frame is arranged on the radial inner side of the first valve frame, the second valve frame and the first valve frame are connected after being formed, and the second valve angle is connected with the corresponding first valve angle. The heart valve stent is favorable for reducing the film covering difficulty and improving the film covering effect of the heart valve stent, so that the service life of the heart valve stent is prolonged.

Description

Technical Field

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

[0002] Heart valves grow between the atria and ventricles, and between the ventricles and aortas, and act 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 becoming narrow or incompletely closed, it will affect the flow of blood, causing abnormal heart function and eventually leading to heart failure.

[0003] At present, when the valve is diseased, valve replacement is often used for treatment, that is, artificial mechanical valve or biological valve is replaced. However, most of the existing polymer surgical valve frames are one-piece molded stents, and their structures are manufactured by machining and used as the frame support part of the valve. The coating part is first processed by a special process for the frame material, and then a coating suitable for the frame and leaflet part is made. The coating process is relatively cumbersome. However, since the frame is an integral frame with a relatively complex structure and a special polymer material coating process, the overall coating of the frame is difficult, the coating effect is difficult to control, and the probability of coating defects is relatively high, which affects the service life of the heart valve and increases the risk of patients replacing the valve again. Summary of the invention

[0004] The embodiments of the present application provide a heart valve stent, a heart valve prosthesis and a preparation method thereof, which are helpful in reducing the difficulty of coating, and improving the coating effect of the heart valve stent, thereby extending the service life of the heart valve stent.

[0005] In a first aspect, an embodiment of the present application provides a heart valve stent, which comprises a first valve frame and a second valve frame, wherein the first valve frame comprises a first valve frame body and a plurality of first valve angles, the first valve frame body defines a flow channel for blood circulation, the plurality of first valve angles are distributed at intervals along the circumference of the first valve frame body and are axially located on the same side of the first valve frame body; the second valve frame comprises a plurality of second valve angles for connecting leaflets, the plurality of second valve angles have the same axial extension direction as the first valve angles, and correspond to the first valve angles in the circumferential direction; wherein the second valve frame is arranged 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 is a split stent structure, the heart valve stent includes a first valve frame and a second valve frame, the second valve frame is arranged on the radial inner side of the first valve frame, when the heart valve stent is processed and manufactured, the first valve frame and the second valve frame can be formed separately, and then the first valve frame and the second valve frame are assembled and connected. Compared with the integral frame, the structure of the single first valve frame and the second valve frame is simpler, and the molding effect of the first valve frame and the second valve frame is easier to control. And when performing the coating process, compared with the integral frame in the prior art, only the second valve frame needs to be coated, and the entire heart valve stent does not need to be coated in batches, which simplifies the coating steps of the heart valve stent. In addition, the second valve frame includes multiple second valve angles, and the overall structure of the second valve frame is simpler, which reduces the probability of bubbles or incomplete coating during the coating process, thereby increasing the yield of the dip-coated valve, reducing the difficulty of the covering process, improving the coating effect of the heart valve stent, and correspondingly extending the service life of the heart valve stent. The second petal angle in this solution 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 in the second petal angle due to leaflet movement.

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

[0008] In the above technical solution, in the radial direction of the first petal frame, the positions of the first petal angle and the second petal angle correspond one to one, and the first petal angle and the second petal angle are respectively overlapped with each other, so that the force and force transmission of the heart valve stent are more uniform, and the integrity of the heart valve stent structure is better.

[0009] In some embodiments, a first connection hole is provided at the first petal angle, and a second connection hole is correspondingly provided at the second petal angle. The first connection hole and the second connection hole are used for passing a wire to connect the second petal frame with the first petal frame.

[0010] In the above technical solution, a first connection hole is provided on the first petal corner, and a second connection hole is provided on the second petal corner. The first petal corner and the second petal corner are connected by threading a thread piece, so that the first petal frame and the second petal frame are connected and fixed, and the connection method is simple. Moreover, the connection method by threading and sewing is reversible. Even if the connection effect between the first petal frame and the second petal frame is not good, the thread piece can be removed and reconnected, and the connection effect of the first petal frame and the second petal frame is more easily guaranteed.

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

[0012] In the above technical solution, the number of the first connection hole and the second connection hole is set to be multiple and arranged one by one, and the wire member passes through the first connection hole and the second connection hole, so that there are multiple connection points between the first petal frame and the second petal frame, so that the connection stability of the first petal frame and the second petal frame is higher. In addition, the force transmission between the first petal frame and the second petal frame is more uniform, which reduces the probability of local instability between the first petal frame and the second petal frame.

[0013] In some embodiments, the first petal frame protrudes radially inward to form a first protrusion, and the first protrusion is 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, by setting the first convex part on the inner surface of the first petal frame, the first convex part can play the function of pre-positioning the second petal frame. After the second petal frame is embedded in the first petal frame, the multiple first connection holes on the first petal frame are aligned with the second connection holes on the second petal frame, which reduces the difficulty of threading the wire. In addition, the first convex part can provide support and limit functions for the second petal frame, and the second petal frame is not easy to fall off from the first petal frame, so that the connection stability between the first petal frame and the second petal frame is higher.

[0015] In some embodiments, the first protrusion includes a main body and a first flange, the main body protrudes radially inward along the first petal frame to form an inner side surface of the first petal corner, and the contour of the main body at the first petal corner is adapted to the contour of the second petal frame close to the side of the first petal frame main body, and the main body is used to support the second petal frame; the first flange is arranged around the outer periphery of the main body, and along the radial direction of the first petal frame, there is a spacing between the first flange and the inner side surface of the first petal corner to form a slot between the first flange and the first petal corner for the second petal frame to be embedded.

[0016] In the above technical solution, the first convex part includes a body and a first flange, the body protrudes from the inner side of the first petal angle, and the contour of the body at the first petal angle is adapted to the contour of the second petal frame close to the first petal frame body. After the second petal frame is installed on the first petal frame, the body can support, limit and pre-position the second petal frame, and the first connecting hole and the second connecting hole can be automatically aligned, which reduces the installation difficulty of the second petal frame. In addition, a slot for the second petal frame to be embedded is formed between the first flange and the first petal angle, and the slot can be embedded and inserted into the second petal frame, that is, the first flange and the inner side of the first petal angle are respectively clamped on both sides of the radial direction of the second petal frame, and the first flange and the first petal angle 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 be relatively displaced 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, a coating layer made of a polymer material is disposed on the inner and outer sides of the second petal frame.

[0018] In the above technical solution, a coating layer is provided on the inner and outer sides of the second valve frame, which serves to isolate the second valve frame from blood. The coating layer also makes the anticoagulant ability of the heart valve stent better and the fluid dynamics closer to the native valve.

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

[0020] In the above technical solution, the second convex portion is formed by bulging outward on the first valve frame body, and a plurality of suture holes are provided on the second convex portion. Suture threads can be passed through the suture holes to suture and fix the heart valve stent to the human tissue.

[0021] In some embodiments, the first lobe angle includes two first connecting rods, and the two first connecting rods belonging to the same first lobe angle are connected at an end away from the flow channel to form a first lobe peak, and the first lobe peaks of multiple first lobe angles are arranged at circumferential intervals; the two first connecting rods belonging to two adjacent first lobe angles converge at a first node at an end close to the first lobe frame body, and the first node is connected to the first lobe frame body; a first hole is formed between the two first connecting rods belonging to the same first lobe angle and the first lobe frame body.

[0022] In the above technical solution, since the heart valve stent is a double-layer structure, the double-layer structure easily increases the rigidity of the heart valve stent, and the flexibility is affected to a certain extent. A first hole is formed by enclosing the structure between the two first connecting rods of the same first petal angle and the first petal frame body, which is equivalent to forming multiple hollow structures in the circumferential direction of the first petal frame, so that the first petal frame as a whole has a certain 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, which reduces the risk of stress concentration at the petal angle position of the heart valve stent during use, and prolongs the service life of the heart valve stent.

[0023] In some embodiments, the second lobe angle includes two second connecting rods, and the two second connecting rods belonging to the same second lobe angle are connected at an end away from the flow channel to form a second lobe peak, and the second lobe peaks of multiple second lobe angles are arranged at circumferential intervals; the two second connecting rods belonging to two adjacent second lobe angles converge at a second node at an end close to the flow channel; the two second connecting rods belonging to the same second lobe angle are enclosed with the first lobe frame body to form a second hole.

[0024] In the above technical solution, a second hole is correspondingly formed on the second valve frame, which is equivalent to forming multiple hollow structures on the circumference of the second valve frame. The second hole also makes the second valve frame as a whole have a certain 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, thereby reducing the risk of stress concentration at the valve angle position of the heart valve stent during use and extending 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 cloth around the outer circumference of the first valve frame, on the one hand, the skirt cloth can wrap the outer circumference of the first valve frame to prevent the polymer material or metal material of the heart valve stent itself from being directly exposed to the blood, causing adverse phenomena such as blood coagulation. On the other hand, the skirt cloth can ensure the sealing of the outer circumference of the heart valve stent to prevent the heart valve prosthesis from leaking blood sideways or seeping.

[0027] In a second aspect, an embodiment of the present application provides a heart valve prosthesis, which includes a valve leaflet and the aforementioned heart valve support, wherein the valve leaflet is located on a second valve support.

[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 mounted on the second valve frame, and only the second valve frame needs to be coated, which simplifies the coating steps of the heart valve stent. In addition, the overall structure of the second valve frame is simpler, which reduces the probability of 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 disposed around the outer circumference of the first valve frame.

[0030] In the above technical solution, the skirt cloth can wrap the outer peripheral side of the first valve frame to prevent the polymer material or metal material of the heart valve stent itself from being directly exposed to the blood, causing adverse phenomena such as blood coagulation. The skirt cloth can ensure the sealing of the outer peripheral side of the heart valve stent to prevent the heart valve prosthesis from leaking blood sideways or leaking.

[0031] In a third aspect, an embodiment of the present application provides a method for preparing a heart valve prosthesis, the method for preparing the aforementioned heart valve prosthesis, the method comprising the following steps: separately processing and molding to obtain a first valve frame and a second valve frame; polymer coating the molded second valve frame, and dip-coating the coated second valve frame with a polymer material to generate leaflets; and connecting the second valve frame after generating the leaflets to the first valve frame.

[0032] By adopting a split valve stent, the first valve frame and the second valve frame can be formed separately, and then during the coating process, only the second valve frame needs to be coated with a polymer, and the entire heart valve stent does not need to be coated, which simplifies the coating steps of the heart valve stent. After the coating is completed, the second valve frame uses a dip coating process to generate the valve leaflets, and finally the second valve frame with the valve leaflets is connected to the first valve frame to obtain a heart valve prosthesis. Compared with the integral frame in the prior art, the coating steps are simplified, and only the second valve frame needs to be coated, and the coating effect is easier to ensure.

[0033] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

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

[0036] Figure 2 A front view of a heart valve stent provided in some embodiments of the present application;

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

[0038] Figure 4 for Figure 3 A is an enlarged schematic diagram;

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

[0040] Figure 6 This is a schematic structural diagram of a second valve frame in a heart valve frame provided in some embodiments of the present application;

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

[0042] Icon: 100-heart valve support; 10-first valve frame; 11-first valve frame 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 convex part; 141-body; 142-first flange; 143-slot; 15-second convex part; 151-suture hole; 20-second valve frame; 21-second valve angle; 211-second connecting hole; 212-second connecting rod; 213-second valve peak; 214-second node; 215-second hole. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0044] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0045] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0046] In the description of the embodiments of the present 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 the application is usually placed when in use, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply 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 a limitation on the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0047] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0048] Example

[0049] The present application embodiment provides a heart 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 circulation. The plurality of first valve angles 12 are distributed at intervals along the circumference of the first valve frame body 11 and are axially located on the same side of the first valve frame body 11; the second valve frame 20 includes a plurality of second valve angles 21 for connecting the leaflets. The axial extension direction of the plurality of second valve angles 21 is the same as that of the first valve angles 12, and corresponds to the first valve angles 12 in the circumferential direction; wherein the second valve frame 20 is arranged on the radial inner side of the first valve frame 10, and the second valve frame 20 and the first valve frame 10 are respectively molded and connected, and the second valve angles 21 are connected to the corresponding first valve angles 12.

[0050] In this solution, the heart valve stent 100 is a split stent structure, and the heart valve stent 100 includes a first valve frame 10 and a second valve frame 20, and the second valve frame 20 is arranged on the radial inner side of the first valve frame 10. When the heart valve stent 100 is processed and manufactured, the first valve frame 10 and the second valve frame 20 can be formed separately, and then the first valve frame 10 and the second valve frame 20 are assembled and connected. Compared with the integral frame, the structure of the single first valve frame 10 and the second valve frame 20 is simpler, and the molding effect of the first valve frame 10 and the second valve frame 20 is easier to control. And when performing the coating process, compared with the integral frame in the prior art, only the second valve frame 20 needs to be coated, and the entire heart valve stent does not need to be coated in batches, which simplifies the coating steps of the heart valve stent 100. Furthermore, the second flap frame 20 includes a plurality of second flap angles 21, and the overall structure of the second flap frame 20 is simpler, which reduces the probability of 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. The second flap angle 21 in this solution is connected to the first flap angle 12, which can increase the strength of the second flap angle 21, which is conducive to reducing the risk of cracks or fractures in the second flap angle 21 caused by leaflet activity.

[0051] The materials of the first petal frame 10 and the second petal frame 20 may be the same or different. The materials of the first petal frame 10 and the second petal frame 20 may be nickel-titanium, cobalt-chromium or polymer materials. The first petal frame 10 and the second petal frame 20 may be connected in a variety of ways. For example, the first petal frame 10 and the second petal frame 20 may be connected by snap connection, bonding, injection molding, welding or sewing.

[0052] The number of the second petal angles 21 may be three, four, or five, etc. In the present embodiment, the number of the second petal angles 21 is three, and the three second petal angles 21 are evenly spaced in the circumferential direction of the second petal frame 20. Of course, the number and position of the first petal angles 12 correspond to the number and position of the second petal angles 21 one by one, that is, when the number of the second petal angles 21 is three, the number of the first petal angles 12 is also three, and the positions and numbers of the first petal angles 12 and the second petal angles 21 correspond one by one.

[0053] It should be noted that the integral frame structure in the prior art is complex. Due to the small angle and complex bending angle of the integral frame, bubbles, incomplete coating or other coating abnormalities are easily generated during the coating process, and the coating defect rate is high, which affects the service life of the artificial heart valve. When bubbles or incomplete coating appear during the coating process, gaps appear in the coating, and the gaps will cause cracks to expand, resulting in the peeling, shedding, and tearing of the entire coating, and even causing the entire valve to fail, affecting the service life of the heart valve.

[0054] In some embodiments, please refer to Figure 1 and Figure 2 , along the radial direction of the first petal frame 10, the second petal angle 21 corresponds to the first petal angle 12. In the radial direction of the first petal frame 10, the positions of the first petal angle 12 and the second petal angle 21 correspond to each other, and the first petal angle 12 and the second petal angle 21 are respectively overlapped with each other, so that the force received and transmitted by the heart valve stent 100 is more uniform, and the integrity of the structure of the heart valve stent 100 is better.

[0055] In some embodiments, please refer to Figure 1, the first petal angle 12 is provided with a first connection hole 121, and the second petal angle 21 is correspondingly provided with a second connection hole 211, and the first connection hole 121 and the second connection hole 211 are used for threading to connect the second petal frame 20 with the first petal frame 10. The first petal angle 12 is provided with a first connection hole 121, and the second petal angle 21 is provided with a second connection hole 211, and the first petal angle 12 and the second petal angle 21 are connected by threading, so that the first petal frame 10 and the second petal frame 20 are connected and fixed, and the connection method is simple. Moreover, the connection method of threading and sewing is reversible, even if the connection effect between the first petal frame 10 and the second petal frame 20 is not good, the thread can be removed and reconnected, and the connection effect of the first petal frame 10 and the second petal frame 20 is more easily guaranteed.

[0056] The thread piece may be a suture thread, the first connection hole 121 is set through the first petal angle 12, and the second connection hole 211 is set through the second petal angle 21. For the first petal angle 12, the number of the first connection hole 121 may be one or more, and for the second petal angle 21, the number of the second connection hole 211 may be one or more, and the number of the first connection hole 121 and the second connection hole 211 may be determined according to actual conditions.

[0057] In some embodiments, please refer to Figure 1 , the number of the first connection holes 121 is multiple, and the number and position of the second connection holes 211 correspond to the number and position of the first connection holes 121 one by one; at least one wire member passes through the multiple first connection holes 121 and the second connection holes 211 to connect the second petal frame 20 to the first petal frame 10. By setting the number of the first connection holes 121 and the second connection holes 211 to be multiple and arranged one by one, the wire member passes through the first connection holes 121 and the second connection holes 211, so that there are multiple connection points between the first petal frame 10 and the second petal frame 20, so that the connection stability of the first petal frame 10 and the second petal frame 20 is higher. And the force transmission between the first petal frame 10 and the second petal frame 20 is more uniform, which reduces 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 passing through a plurality of first connecting holes 121 and a second connecting hole 211 in sequence, or by a plurality of threads passing through a plurality of first connecting holes 121 and a second connecting hole 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 protrudes radially inward to form a first convex portion 14, which 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. By setting the first convex portion 14 on the inner surface of the first petal frame 10, the first convex portion 14 can play a pre-positioning function for the second petal frame 20. After the second petal frame 20 is embedded in the first petal frame 10, the multiple first connection holes 121 on the first petal frame 10 are aligned with the second connection holes 211 on the second petal frame 20, which reduces the difficulty of threading the wire. In addition, the first convex portion 14 can provide support and limit functions for the second petal frame 20, and the second petal frame 20 is not easy to fall off from the first petal frame 10, so that the connection stability between the first petal frame 10 and the second petal frame 20 is higher.

[0060] like Figure 3 As shown, the first protrusion 14 refers to a protruding structure protruding from the inner surface of the first petal frame 10 , and 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 main body 141 and a first flange 142. The main 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 contour of the main body 141 at the first petal corner 12 is adapted to the contour of the second petal frame 20 on the side close to the first petal frame main body 11. The main body 141 is used to carry the second petal frame 20. The first flange 142 is arranged around the outer periphery of the main body 141, and along the radial direction of the first petal frame 10, there is a spacing between the first flange 142 and the inner side of the first petal corner 12 to form a slot 143 between the first flange 142 and the first petal corner 12 for embedding the second petal frame 20.

[0062] The first protrusion 14 includes a main body 141 and a first flange 142. The main body 141 protrudes from the inner side of the first petal angle 12, and the contour of the main body 141 at the first petal angle 12 is adapted to the contour of the second petal frame 20 close to the side of the first petal frame body 11. After the second petal frame 20 is installed on the first petal frame 10, the main body 141 can support, limit and pre-position the second petal frame 20, and the first connecting hole 121 and the second connecting hole 211 can be automatically aligned, reducing the difficulty of installing the second petal frame 20. In addition, a slot 143 for embedding the second petal frame 20 is formed between the first flange 142 and the first petal angle 12, and the slot 143 can be used for the second petal frame 20 to be embedded and inserted, that is, the inner side surfaces of the first flange 142 and the first petal angle 12 are respectively clamped on the radial sides of the second petal frame 20, and the first flange 142 and the first petal angle 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 be relatively displaced with the first petal frame 10, and 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 may be adapted to the thickness of the second petal frame 20. The first protrusion 14 and the first petal frame 10 may be integrally formed.

[0064] It should be noted that please combine Figure 3 and Figure 4 , the first connection hole 121 corresponding to the position of the first convex portion 14 on the first petal frame 10 can be set through the first petal angle 12 and the first flange 142 of the first convex portion 14, that is, the first connection hole 121 can include a first sub-connection hole 1211 and a second sub-connection hole 1212, the first sub-connection hole 1211 is opened on the first petal angle 12, the second sub-connection hole 1212 is opened on the first flange 142, and the first sub-connection hole 1211 and the second sub-connection hole 1212 together constitute the first connection hole 121. When the second petal frame 20 is clamped on the first petal frame 10, the first sub-connection hole 1211, the second connection hole 211 and the second sub-connection hole 1212 are aligned with each other.

[0065] In some embodiments, a coating layer of polymer material (not shown) is disposed on the inner and outer sides of the second valve frame 20. The coating layer is disposed on the inner and outer sides of the second valve frame 20, and the coating layer serves to isolate the second valve frame 20 from blood, and the coating layer also makes the anticoagulant ability of the heart valve stent 100 better, and the fluid dynamics are closer to the native valve.

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

[0067] In some embodiments, please refer to Figure 1 and Figure 2 The first valve frame body 11 protrudes outwardly along its radial direction to form a second convex portion 15, and the second convex portion 15 is provided with a plurality of suture holes 151 for connecting with heart tissue. By protruding outwardly on the first valve frame body 11 to form the second convex portion 15, and the second convex portion 15 is provided with a plurality of suture holes 151, suture threads can be used to penetrate the suture holes 151 to suture and fix the heart valve stent 100 to the human tissue.

[0068] The suture holes 151 are arranged along the axial direction of the first petal frame 10 and penetrate the second convex portion 15 . The plurality of suture holes 151 are evenly spaced along the circumference of the second convex portion 15 . The number of the plurality of suture holes 151 can be determined according to actual conditions.

[0069] In some embodiments, please refer to Figure 3 , Figure 4 and Figure 5The first lobe angle 12 includes two first connecting rods 122. The two first connecting rods 122 belonging to the same first lobe angle 12 are connected at one end away from the flow channel to form a first lobe peak 123. The first lobe peaks 123 of the plurality of first lobe angles 12 are arranged at intervals along the circumferential direction; the two first connecting rods 122 belonging to two adjacent first lobe angles 12 meet at a first node 124 at one end close to the first lobe frame body 11, and the first node 124 is connected to the first lobe frame body 11; the two first connecting rods 122 belonging to the same first lobe angle 12 and the first lobe frame body 11 enclose a first hole 125 to form. Since the heart valve stent 100 is a double-layer structure, the double-layer structure easily increases the rigidity of the heart valve stent 100, and the flexibility is affected to a certain extent. A first hole 125 is formed by an enclosed structure between two first connecting rods 122 of the same first petal angle 12 and the first petal frame body 11, which is equivalent to forming a plurality of hollow structures in the circumferential direction of the first petal frame 10, so that the first petal frame 10 as a whole has a certain 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, thereby reducing the risk of stress concentration at the petal angle position of the heart valve stent 100 during use and extending the service life of the heart valve stent 100.

[0070] In some embodiments, please refer to Figure 6 and Figure 7 The second lobe angle 21 includes two second connecting rods 212. The two second connecting rods 212 belonging to the same second lobe angle 21 are connected at an end away from the flow channel to form a second lobe peak 213. The second lobe peaks 213 of multiple second lobe angles 21 are arranged at intervals along the circumferential direction; the two second connecting rods 212 belonging to two adjacent second lobe angles 21 converge at a second node 214 at an end close to the flow channel; the two second connecting rods 212 belonging to the same second lobe angle 21 are surrounded by the first lobe frame body 11 to form a second hole 215. A second hole 215 is correspondingly formed on the second valve frame 20, which is equivalent to forming a plurality of hollow structures on the circumference of the second valve frame 20. The second hole 215 also makes the second valve frame 20 as a whole have a certain 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, thereby reducing the risk of stress concentration at the valve angle position of the heart valve stent 100 during use and extending the service life of the heart valve stent 100.

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

[0072] The first connecting rod 122 may be an arc-shaped rod, and the two first connecting rods 122 belonging to two adjacent first petal angles 12 have an arc transition; and / or the second connecting rod 212 may be an arc-shaped rod, and the two second connecting rods 212 belonging to two adjacent second petal angles 21 have an arc transition. By using the first connecting rod 122 and the second connecting rod 212 as arc-shaped rods, the arc-shaped rods reduce the generation of sharp corners compared to straight rods, thereby reducing the risk of the heart valve stent 100 scratching heart tissue.

[0073] In some embodiments, a skirt cloth (not shown) is provided around the outer circumference of the first valve frame 10. By providing a skirt cloth around the outer circumference of the first valve frame 10, on the one hand, the skirt cloth can wrap the outer circumference of the first valve frame 10 to prevent the polymer material or metal material of the heart valve stent 100 from being directly exposed to the blood, causing adverse phenomena such as blood coagulation. On the other hand, the skirt cloth can ensure the sealing of the outer circumference of the heart valve stent 100 to prevent blood leakage or seepage from the heart valve prosthesis.

[0074] The embodiment of the present application provides a heart valve prosthesis, which includes a valve leaflet and the aforementioned heart valve support 100 , wherein the valve leaflet is located on a second valve support 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 mounted on the second valve frame 20, and only the coating process needs to be performed on the second valve frame 20, which simplifies the coating steps of the heart valve stent 100. In addition, the overall structure of the second valve frame 20 is simpler, which reduces the probability of 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 cloth, which is arranged around the outer peripheral side of the first valve frame 10. The skirt cloth can wrap the outer peripheral side of the first valve frame 10 to prevent the polymer material or metal material of the heart valve stent 100 from being directly exposed to the blood, causing adverse phenomena such as blood coagulation. The skirt cloth can ensure the sealing of the outer peripheral side of the heart valve stent 100 to prevent the heart valve prosthesis from leaking blood or seepage.

[0077] The embodiment of the present application provides a method for preparing a heart valve prosthesis, and the preparation method is used to prepare the aforementioned heart valve prosthesis, and the preparation method includes the following steps: separately processing and molding to obtain a first valve frame 10 and a second valve frame 20; polymer coating the molded second valve frame 20, and dip-coating the coated second valve frame 20 with a polymer material to generate leaflets; and connecting the second valve frame 20 after generating the leaflets to the first valve frame 10.

[0078] By adopting a split valve stent, the first valve frame 10 and the second valve frame 20 can be formed separately, and then during the coating process, only the second valve frame 20 needs to be coated with a polymer, and the entire heart valve stent does not need to be coated, which simplifies the coating steps of the heart valve stent 100. After the coating, the second valve frame 20 uses a dip coating process to generate the leaflets, and finally the second valve frame 20 with the leaflets is connected to the first valve frame 10 to obtain a heart valve prosthesis. Compared with the integral frame in the prior art, the coating steps are simplified, and only the second valve frame 20 needs to be coated, and the coating effect is easier to ensure.

[0079] After the first valve frame 10 does not need to be covered with a film, the leaflet attachment edge can be increased by sewing, welding or bonding, thereby reinforcing the strength of the leaflet fatigue point and extending the service life of the heart valve prosthesis.

[0080] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0081] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A heart valve stent, characterized in that: include: A first valve frame, comprising a first valve frame body and a plurality of first valve corners, wherein the first valve frame body defines a flow channel for blood circulation, and the plurality of first valve corners are distributed at intervals 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; A second petal frame includes a plurality of second petal angles for connecting the petals, wherein 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 arranged on the radial inner side of the first petal frame, the second petal frame and the first petal frame are respectively formed and connected, and the second petal angle is connected to the corresponding first petal angle.

2. The heart valve stent according to claim 1, characterized in that: Along the radial direction of the first lobe frame, the second lobe angle corresponds to the first lobe angle one by one.

3. The heart valve stent according to claim 1, characterized in that: The first petal angle is provided with a first connection hole, and the second petal angle is correspondingly provided with a second connection hole. The first connection hole and the second connection hole are used for passing a wire to connect the second petal frame with the first petal frame.

4. The heart valve stent according to claim 3, characterized in that: There are multiple first connection holes, and the number and positions of the second connection holes correspond one-to-one to the number and positions of the first connection holes; At least one of the wire members passes through the first connection holes and the second connection holes to connect the second flap frame with the first flap frame.

5. The heart valve stent according to claim 1, characterized in that: The first petal frame protrudes radially inward to form a first convex portion, and the first convex portion is used to position the second petal frame so that the second petal frame can be embedded in the first petal frame.

6. The heart valve stent according to claim 5, characterized in that: The first convex portion includes a body and a first flange, the body protrudes inwardly along the radial direction of the first petal frame and is formed on the inner side of the first petal angle, and the contour of the body at the first petal angle is adapted to the contour of the second petal frame close to the first petal frame body side, and the body is used to carry the second petal frame; The first flange is arranged around the periphery of the main body, and along the radial direction of the first petal frame, there is a distance between the first flange and the inner side surface of the first petal angle, so as to form a slot for the second petal frame to be embedded between the first flange and the first petal angle.

7. The heart valve stent according to claim 1, characterized in that: The inner and outer sides of the second petal frame are provided with a coating layer made of a polymer material.

8. The heart valve stent according to claim 1, characterized in that: The first valve frame body protrudes outwardly along its radial direction to form a second convex portion, and the second convex portion is provided with a plurality of suture holes for connecting with heart tissue.

9. The heart valve stent according to claim 1, characterized in that: The first lobe angle includes two first connecting rods, and the two first connecting rods belonging to the same first lobe angle are connected at one end away from the flow channel to form a first lobe peak, and the first lobe peaks of the plurality of first lobe angles are arranged at intervals along the circumferential direction; Two first connecting rods belonging to two adjacent first petal angles meet at a first node at one end close to the first petal frame body, and 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 lobe angle and the first lobe frame body.

10. The heart valve stent according to claim 9, characterized in that: The second lobe angle includes two second connecting rods, and the two second connecting rods belonging to the same second lobe angle are connected at an end away from the flow channel to form a second lobe peak, and the second lobe peaks of the plurality of second lobe angles are arranged at intervals along the circumferential direction; Two second connecting rods belonging to two adjacent second lobe corners meet at a second node at one end close to the flow channel; The two second connecting rods belonging to the same second petal angle and the first petal frame body form a second hole.

11. The heart valve stent according to claim 1, characterized in that: A skirt is provided around the outer periphery of the first petal frame.

12. A heart valve prosthesis, characterized in that: It comprises a leaflet and a heart valve support according to any one of claims 1-11, wherein the leaflet is located on the second valve support.

13. The heart valve prosthesis according to claim 12, characterized in that: The heart valve prosthesis comprises: The skirt cloth is arranged around the outer peripheral side of the first petal frame.

14. A method for preparing a heart valve prosthesis, for preparing the heart valve prosthesis according to claim 12 or 13, characterized in that: The following steps are involved: The first petal frame and the second petal frame are respectively processed and formed; the formed second petal frame is coated with a polymer film, and the coated second petal frame is dipped in a polymer material to form a leaflet; and the second petal frame after the leaflet is formed is connected to the first petal frame.

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