Valve stents, artificial heart valves, molding dies, and valve stent fabrication methods

Abstract

This invention relates to a valve stent, an artificial heart valve, a molding die, and a method for manufacturing a valve stent. The valve stent includes a valve seat, a valve annulus, and a first covering member. The valve seat includes an annular first base and a first valve foot disposed on the first base. The valve annulus is an annular component. The first covering member is an integral flexible material used to cover the surfaces of the valve seat and the valve annulus. The first covering member includes a first covering area, a second covering area, a third covering area, and a fourth covering area connected in sequence. The first covering area covers the outer side of the first base, the second covering area covers the first valve foot, the third covering area covers the inner side of the first base, and the fourth covering area covers the valve annulus and helps to move the valve annulus onto the outside of the first base. The above-mentioned valve stent is simple to manufacture and can improve production efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve stent, an artificial heart valve, a molding die, and a method for manufacturing the valve stent. Background Technology

[0002] Heart valves are the valves between the atria and ventricles or between the ventricles and arteries. Their main function is to prevent backflow of blood, ensuring that blood flows from the atria to the ventricles or from the ventricles to the aorta / pulmonary artery. Based on their shape and location, there are four types of heart valves: the mitral valve (between the left ventricle and left atrium), the tricuspid valve (between the right ventricle and right atrium), the aortic valve (between the left ventricle and aorta), and the pulmonary valve (between the right ventricle and pulmonary artery). Heart valves can develop diseases such as insufficiency (regurgitation) and valvular stenosis due to congenital or acquired inflammation, affecting the patient's quality of life and, in severe cases, endangering life.

[0003] Artificial heart valves are implantable organs that replace natural heart valves, allowing blood to flow in one direction and functioning like natural heart valves. When heart valve disease is severe and valve function cannot be restored or improved through valve separation or repair surgery, artificial heart valve replacement surgery is necessary.

[0004] Currently, the most commonly used heart valves in clinical practice include mechanical valves and bioprosthetic valves. Mechanical valves are made of advanced metal composite materials. Compared to bioprosthetic valves, these valves are more durable; however, patients who receive mechanical valve implantation need lifelong anticoagulation therapy and regular checks of coagulation parameters to prevent embolism or bleeding. Excessive use of anticoagulants can increase the risk of bleeding. Furthermore, if a mechanical valve fails to function or becomes lodged, it can cause significant harm to the patient, even death.

[0005] Compared to mechanical valves, bioprosthetic valves have significant advantages; patients receiving bioprosthetic valve implantation do not need to take anticoagulants. Bioprosthetic valves include allogeneic valves, autologous valves, and xenogeneic bioprosthetic valves. Allogeneic valves are made from complete allogeneic materials obtained from volunteers or cadavers, or from materials obtained from volunteers; autologous valves are made from materials obtained from the patient; and xenogeneic bioprosthetic valves are made from materials obtained from pigs, horses, or cattle. The design and construction of xenogeneic bioprosthetic valves primarily involves using pericardial tissue obtained from pigs, horses, or cattle to create leaflets, which are then sewn together in pairs onto a valve frame. The valve frame is then sewn onto the valve seat, and finally, it is fitted into the valve annulus. The Carpentier-Edwards Perimount™ bovine pericardial valve suture uses this process. Traditional artificial heart valves are mostly handmade, requiring extensive training for personnel and resulting in lengthy production times and low efficiency. Summary of the Invention

[0006] Therefore, it is necessary to provide a valve stent, an artificial heart valve, a molding die, and a valve stent manufacturing method to address the issues of reducing the fabrication time of artificial heart valves and improving production efficiency.

[0007] This application provides a valve stent, comprising: a valve seat, the valve seat including an annular first base and a first valve foot disposed on the first base; a valve annulus, the valve annulus being an annular component; and a first covering member, which is an integral flexible material for covering the surfaces of the valve seat and the valve annulus; the first covering member includes a first covering area, a second covering area, a third covering area, and a fourth covering area connected in sequence; the second covering area is used to cover the first valve foot; one of the outer side surface and the inner side surface of the first base is covered by the first covering area, and the other is covered by the third covering area; the fourth covering area covers the valve annulus and is used to drive the valve annulus to be sleeved outside the first base.

[0008] In some embodiments, the first covering is a flexible tubular member with openings at both ends. The first covering includes a covering body and a first end and a second end disposed at both ends of the covering body. The covering body between the first end and the second end includes a first covering area, a second covering area, a third covering area, and a fourth covering area arranged sequentially.

[0009] In some embodiments, the first end is sewn to the outer side of the first base by a first suture, and the fourth covering area and / or the second end is sewn to the outer side of the first base by a second suture.

[0010] In some embodiments, the first suture coincides with or is parallel to the second suture.

[0011] In some embodiments, both the first suture and the second suture are arranged on the bottom edge of the first base and covered by the petal ring.

[0012] In some embodiments, the first end is bonded to the bottom edge of the first base, and the fourth covering area and / or the second end is bonded to the outer side of the first base.

[0013] In some embodiments, the valve seat includes at least two first valve feet, each first valve foot being circumferentially spaced along the first base, and the second covering area having receiving spaces that respectively match each first valve foot, with the first valve feet being received in the receiving spaces one-to-one.

[0014] Another aspect of the present invention provides an artificial heart valve, comprising: a valve stent as described in any of the foregoing embodiments; a valve frame, the valve frame being received within a space enclosed by the first valve foot via connection to the first cover member of the valve stent; and a leaflet, the leaflet being disposed on the valve frame.

[0015] In some embodiments, the valve frame is covered with a second covering, the second covering is sewn to the first covering, and the leaflet is sewn to the second covering.

[0016] In another aspect, the present invention provides a molding die for molding the first covering member of the valve stent described in any of the foregoing embodiments. The molding die includes: a first mold, the outer contour shape of which is the same as the outer contour shape of the valve seat, the first mold including a second base having an annular hollow portion and a second valve foot disposed on the second base; and a second mold, the second mold being a tubular structure, the second mold being sleeved on the second valve foot, and a space for clamping a second covering area being formed between the second mold and the second valve foot.

[0017] In another aspect, the present invention provides a method for manufacturing a valve stent, used to manufacture the valve stent described in any of the foregoing embodiments using a molding die, comprising the following steps: providing a flexible tubular member with openings at both ends as a first covering member, the first covering member having a first end and a second end; folding the first covering member so that the first end and the second end are respectively arranged on the outer and inner sides of the first die, and the second valve foot is covered with a covering body; fitting the second die onto the second valve foot covered with the covering body; heating the first covering member, the first die, and the second die as a whole, and then cooling and shaping the first covering member, so that the covering body between the second die and the second valve foot is formed. Second covering area; remove the first mold and the second mold; cover the first petal foot of the petal seat with the second covering area, the first end is placed outside the first base, the covering body between the first end and the second covering area forms a first covering area, the second end is placed inside the first base, the covering body extending from the second end relative to the bottom edge of the first base forms a fourth covering area, the covering body between the second covering area and the fourth covering area forms a third covering area, the first covering area and the third covering area are respectively used to cover the outer side and inner side of the first base; roll up the fourth covering area to cover the petal ring and drive the petal ring to be sleeved outside the first base; fix the first covering part to the first base.

[0018] In some embodiments, the step of folding the first covering so that the first end and the second end are respectively arranged on the outside and inside of the first mold specifically includes: passing the second end through the inside of the annular hollow portion through the second base, so that the first end is arranged on the side of the first mold away from the second base, and so that the first covering forms a folded portion on the side near the first end that extends beyond the top of the second petal by at least a predetermined length h; folding the first end outward by a predetermined length h, so that the folded portion covers the outer contour of the first mold; the length of the first mold is D, and the h exceeds the D by 1 mm to 3 mm.

[0019] In some embodiments, the step of fixing the first covering to the first base specifically includes: first clamping the folded portion with a clamping member, then sewing the fourth covering area and / or the second end to the outer side of the first base with a second suture, and then sewing the first end to the inner side of the valve ring with a first suture.

[0020] In some embodiments, the step of fixing the first covering to the first base specifically includes: first sewing the first end to the bottom edge of the first base with a first suture, and then sewing the fourth covering area and / or the second end to the inner side of the valve ring with a second suture.

[0021] In some embodiments, the first suture coincides with or is parallel to the second suture, and the first suture and the second suture are the same suture.

[0022] In some embodiments, the step of heating the first covering, the first mold, and the second mold as a whole specifically includes: placing the first covering, the first mold, and the second mold as a whole into a heat medium, wherein the temperature of the heat medium is 90°C to 100°C, and the heat setting time is 10 min to 15 min.

[0023] In some embodiments, the step of cooling and shaping the first covering part includes: immersing the first covering part, the first mold, and the second mold as a whole in a coolant, wherein the temperature of the coolant is 0°C to 4°C, and the cooling time is 10 min to 15 min.

[0024] Beneficial effects:

[0025] The aforementioned valve stent, artificial heart valve, molding die, and manufacturing method pre-form a first covering component of an integral flexible material into a second covering area for covering the first valve foot. By covering the first valve foot with the pre-formed first covering component, the first covering area can cover the outer side of the first base. Then, the fourth covering area is flipped over to cover the outside of the valve annulus, thereby causing the third covering area to be driven by the fourth covering area to cover the inner side of the first base. Finally, by fixing the first covering component to the first base, such as by sewing it to the first base, the valve seat and valve annulus can be stably connected without the need for cutting the first covering component. Furthermore, the integrally formed first covering component greatly reduces the edges that need to be fixed, simplifies the sewing or bonding lines, reduces the manufacturing difficulty, and improves production efficiency. Attached Figure Description

[0026] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the structure of the first covering component in one embodiment before final shaping;

[0029] Figure 2 This is a schematic diagram of the valve seat structure according to one embodiment;

[0030] Figure 3 This is a diagram showing the mating relationship between the first covering member and the valve seat in one embodiment;

[0031] Figure 4 This is a schematic diagram of the structure of a valve stent according to one embodiment;

[0032] Figure 5 This is a schematic diagram of the structure of the first mold in one embodiment;

[0033] Figure 6 This is a schematic diagram of the structure of the second mold in one embodiment;

[0034] Figure 7 This is a schematic diagram illustrating the process of inserting a first covering component into a first mold, according to one embodiment.

[0035] Figure 8 This is a schematic diagram of a second mold fitting into the second petal of a first mold that is covered by a first covering element, according to one embodiment.

[0036] Figure 9 This is a schematic diagram of the structure of an artificial heart valve according to one embodiment.

[0037] Explanation of reference numerals in the attached figures:

[0038] 10. Petal seat; 11. First base; 12. First petal foot; 20. First covering; 21. First end; 22. Second end; 23. First covering area; 24. Second covering area; 25. Third covering area; 26. Fourth covering area; 30. Petal ring; 40. First mold; 41. Second base; 42. Second petal foot; 43. Annular hollow part; 50. Second mold; 60. Petal frame; 70. Petal leaf. Detailed Implementation

[0039] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0040] See Figures 1 to 4 This application provides a valve stent in one embodiment, which provides support for the valve frame and leaflets of an artificial heart valve. Specifically, the valve stent includes a valve seat 10, a valve annulus 30, and a first covering member 20. The valve seat 10 supports the valve frame and leaflets of the artificial heart valve. See [link to previous document]. Figure 2 The valve seat 10 includes an annular first base 11 and a first valve foot 12 disposed on the first base 11. Preferably, the first base 11 is a hollow annulus. The valve ring 30 is an annular component, which is sleeved on the outside of the first base 11. The valve ring 30 is used to connect human tissue so as to install and fix the artificial heart valve in the human body.

[0041] The first covering 20 is an integral flexible material used to cover the surfaces of the valve seat 10 and the valve annulus 30. The first covering 20 includes a first covering area, a second covering area, a third covering area, and a fourth covering area connected in sequence. The second covering area covers the first valve foot 12. One of the outer side and the inner side of the first base 11 is covered by the first covering area, and the other is covered by the third covering area. The fourth covering area covers the valve annulus 30 and is used to move the valve annulus to be sleeved outside the first base. (See also...) Figure 1 as well as Figure 4The first covering 20 is an integral flexible material used to cover the surfaces of the valve seat 10 and the valve annulus 30. The first covering 20 includes a covering body and a first end 21 and a second end 22 disposed at both ends of the covering body. The covering body between the first end 21 and the second end 22 includes a first covering area 23, a second covering area 24, a third covering area 25, and a fourth covering area 26 arranged sequentially. The second covering area 24 is pre-formed to accommodate the first valve foot 12, and the shape of the accommodating space matches the outer contour shape of the first valve foot 12. The first covering area 23 covers the outer side of the first base 11, the second covering area 24 covers the first valve foot 12, the third covering area 25 covers the inner side of the first base 11, and the fourth covering area 26 covers the valve annulus 30 and is used to drive the valve annulus 30 to be sleeved on the outside of the first base 11.

[0042] Preferably, in this embodiment, the first covering 20 is a flexible tubular member with openings at both ends, so that the first covering 20 is easy to process or easy to manufacture.

[0043] In traditional artificial heart valves, the process of covering the valve seat 10 with knitted fabric is quite cumbersome, typically involving two steps: first, a cutting step, where the knitted fabric is cut into a suitable shape according to the outer contour of the valve seat 10; and second, a sewing step, where the cut knitted fabric is inserted into the valve seat 10, and then the free edges of the cut knitted fabric are sewn together to ensure a proper fit. However, after cutting, there are numerous free edges of the knitted fabric that need to be sewn, resulting in complex sewing lines, a cumbersome sewing process, high production costs, and low production efficiency.

[0044] In some embodiments of the valve stent of this application, a first covering 20 of integral flexible material is pre-shaped into a second covering area 24 for covering the first valve foot 12. By covering the first valve foot 12 with the shaped first covering 20, the first covering area 23 can cover the outer side of the first base 11. Then, the fourth covering area 26 is flipped outward to cover the outside of the valve annulus 30, so that the third covering area 25 is driven by the fourth covering area 26 to cover the inner side of the first base 11. Finally, by fixing the first end 21 and the second end 22 of the first covering 20 to the first base 11, for example by sewing them to the first base 11, the valve seat 10 and the valve annulus 30 can be stably connected without cutting the first covering 20. Furthermore, the integrally formed first covering 20 greatly reduces the edges that need to be fixed. Only the first end 21 and the second end 22 need to be sewn or glued to fix them, which simplifies the sewing or bonding process, reduces the manufacturing difficulty, and improves production efficiency.

[0045] Preferably, the first covering 20 is a fabric, such as a knitted fabric. More preferably, the material of the first covering 20 can be polyester, spandex, or a blend of both. Since the first covering 20 covers the valve seat 10 and the valve annulus 30, the artificial heart valve can be fixed to the human tissue by sewing the valve frame to the second covering area 24 covering the first valve foot 12, and then by sewing the fourth covering area 26 covering the valve annulus 30 to the human tissue. It is worth noting that in another embodiment, the material of the first covering 20 can also be other elastic materials, such as polyethylene terephthalate (PET).

[0046] Preferably, in this embodiment, both the first end 21 and the second end 22 are fixed to the first base 11 by sewing. Specifically, the first end 21 is sewn to the outer side of the first base 11 by a first suture. Preferably, after the first covering area 23 covers the outer side of the first base 11, the first end 21 extends 1mm to 3mm beyond the bottom edge of the first base 11 before sewing, thereby providing space for subsequent sewing edges, ensuring sewing strength while reducing the thickness and area of ​​the sewing edges. Specifically, by folding the portion of the first covering 20 that extends beyond the bottom edge of the first base 11, and then sewing the first end 21 and the other parts of the first covering 20 together by the first suture, the first suture is near the bottom edge of the first base. The bottom edge of the first base 11 refers to the end of the first base 11 away from the first petal foot 12. Preferably, the sewing method of the first end 21 includes, but is not limited to, purse-string sewing, mattress sewing, or straight sewing.

[0047] The second end 22 is sewn to the outer side of the first base 11 via a second suture. Specifically, after the second end 22 passes through the bottom edge of the first base 11, it is turned outward so that the fourth covering area 26 covers the valve ring 30 and then sewn to the outer side of the first base 11. It is worth noting that in another embodiment, the fourth covering area 26 can also be directly sewn to the outer side of the first base 11 via the second suture. Similarly, the sewing methods for the fourth covering area 26 and the second end 22 include, but are not limited to, purse-string suture, mattress suture, or straight suture.

[0048] Furthermore, the suture stitches of the first suture and the second suture coincide or are parallel. Preferably, when the suture stitches of the first end 21 coincide or are parallel to the suture stitches of the second end 22, the first end 21 and the second end 22 can be sutured simultaneously using the same suture, thereby further simplifying the suturing process and saving suturing time.

[0049] Preferably, the sutures of the first suture and the second suture are both located at the bottom edge of the first base 11 and covered by the valve ring 30, thereby avoiding exposure of the first suture and the second suture, thus minimizing the formation of thrombi near the first suture and the sutures of the second suture.

[0050] Of course, it is worth noting that in other embodiments, the first end 21 may also be bonded to the bottom edge of the first base 11, and the fourth covering area 26 and / or the second end 22 may also be bonded to the outer side of the first base 11.

[0051] Preferably, the valve seat 10 includes at least two first valve feet 12, each first valve foot 12 being spaced apart circumferentially along the first base 11. For example, in this embodiment, the valve seat 10 includes three first valve feet 121. The three first valve feet 12 are spaced apart circumferentially along the first base 11, and the valve frame and leaflets of the artificial heart valve are installed within the space formed by the three valve feet. Correspondingly, the second covering region 24 has receiving spaces that respectively match each first valve foot 121. The first valve feet 12 are received in the receiving spaces one-to-one, thereby ensuring that the second covering region 24 can fit each first valve foot 12.

[0052] See Figures 5 to 8 In another aspect, this application also provides a molding die for molding the first covering 20 of any of the above embodiments. Specifically, one embodiment of the molding die includes a first die 40 and a second die 50, wherein, see... Figure 5 The outer contour shape of the first mold 40 is the same as that of the petal seat 10. The first mold 40 includes a second base 41 with an annular hollow portion 43 and second petal feet 42 disposed on the second base 41. Understandably, the second base 41 is a hollow annulus corresponding to the first base 11, and three second petal feet 42 are provided, each corresponding to one of the three first petal feet 12. See also... Figure 6 as well as Figure 8 The second mold 50 is a tubular structure. The second mold 50 is used to fit onto the second petal 42, and a space is formed between the second mold 50 and the second petal 42 for clamping the second covering area 24. Thus, the second mold 50 can provide external pressure to the first covering member 20 covering the second petal 42, so that the first covering member 20 fits the second petal 42 for shaping. This allows the portion of the first covering member 20 covering the second petal 42 to form a second covering area 24 with a matching receiving space for the first petal.

[0053] Preferably, the end face of the second petal 42 away from the second base 41 is an arc surface, so as to avoid scratching the first covering 20.

[0054] The aforementioned molding die, through the cooperation of the first die 40 and the second die 50, enables the first covering part 2 to pre-shape the second covering area 24 for covering the first petal foot 12. By covering the first petal foot 12 with the shaped first covering part 20, the first covering area 23 can cover the outer side of the first base 11. Then, the fourth covering area 26 is flipped outward to cover the petal ring 30, so that the third covering area 25 is driven by the fourth covering area 26 to cover the inner side of the first base 11. Finally, by fixing the first end 21 and the second end 22 of the first covering part 20 to the first base 11, for example by sewing them to the first base 11, the petal seat 10 and the petal ring 30 can be firmly connected without cutting the first covering part 20. Furthermore, the one-piece molding of the first covering part 20 greatly reduces the edges that need to be sewn. Only the first end 21 and the second end 22 need to be sewn or glued, which simplifies the sewing or bonding process, reduces the manufacturing difficulty, and improves production efficiency.

[0055] Furthermore, this application also provides a method for manufacturing a valve stent using the above-described molding die to produce any of the aforementioned embodiments, comprising the following steps:

[0056] S110: A flexible tubular member with openings at both ends is provided as a first covering member 20. The first covering member 20 has a first end 21 and a second end 22. The first covering member 20 is folded so that the first end 21 and the second end 22 are respectively arranged on the outer side and the inner side of the first mold 40, and the second petal 42 is covered by the first covering member 20. Specifically, the cylinder formed by extending from the generatrix of the annular hollow portion 43 to both ends is defined as the outer side of the cylinder, which is the outer side of the first mold 40, and the inner side of the cylinder is the inner side of the first mold.

[0057] S120: The second mold 50 is fitted onto the second petal 42 covered by the first covering part 20;

[0058] S130: The first covering part 20, the first mold 40 and the second mold 50 are heated as a whole, and then cooled and shaped. The first covering part 20 is formed by the second mold 50 and the second petal 42. The first covering part 20 forms the second covering area 24.

[0059] S140: Remove the first mold 40 and the second mold 50;

[0060] S150: The second covering area 24 covers the first petal foot 12 of the petal seat 10. The first end 21 is placed on the outside of the first base 11. The first covering member 20 between the first end 21 and the second covering area 24 forms the first covering area 23. The second end 22 is placed on the inside of the first base 11. The first covering member 20 extending from the bottom edge of the first base 11 relative to the second end 22 forms the fourth covering area 26. The first covering member between the second covering area 24 and the fourth covering area 26 forms the third covering area 25. The first covering area 23 and the third covering area 25 are used to cover the outside and inside of the first base 11, respectively. The fourth covering area 26 is rolled up to cover the petal ring 30 and drive the petal ring 30 to be sleeved on the outside of the first base 11.

[0061] S160: Secure the first covering 20 to the first base 11.

[0062] Furthermore, in one embodiment, step S110 further includes the following steps:

[0063] S111: The second end 22 is passed through the second base 41 by the annular hollow part 43, so that the first end 21 is arranged on the side of the first mold 40 away from the second base 41, and the first covering 20 forms a folded part on the side near the first end 21 that extends beyond the top of the second petal 42 by at least a predetermined length h.

[0064] S112: Flip the first end 21 outward by a preset length h so that the folded part covers the outer contour of the first mold 40;

[0065] The length of the first mold 40 is D, which refers to the vertical distance from the bottom edge of the first mold 40 to the top of the second petal 42. Preferably, the preset length h exceeds the length D of the first mold 40 by 1mm to 3mm, thereby providing space for subsequent sewing, ensuring sewing strength while reducing sewing thickness and area.

[0066] In one embodiment, the step of securing the first cover 20 to the first base 11 includes the following steps:

[0067] S161a: First, clamp the folded part with the clamping member, then sew the fourth covering area 26 and / or the second end 22 to the outer side of the first base 11 with the second suture, and then sew the first end 21 to the inner side of the valve ring 30 with the first suture, so that the first end 21 and the second end 22 are connected and fixed to the first base 11.

[0068] In another embodiment, the step of securing the first cover 20 to the first base 11 may also include:

[0069] S161b: First, the first end portion 21 is sewn to the bottom edge of the first base 11 using a first suture. Preferably, the first end portion 21 and other parts of the first covering 20, such as the first covering area 26, are sewn together using the first suture, such that the first suture is near the bottom edge of the first base 11. Then, the fourth covering area 26 and / or the second end portion 22 are sewn to the inside of the valve annulus 30 using a second suture.

[0070] Furthermore, the stitches of the first suture and the second suture coincide or are parallel. When the stitches of the first end 21 coincide or are parallel to the stitches of the second end 22, the first end 21 and the second end 22 can be sutured to the first base 11 simultaneously using the same suture, thereby further simplifying the suturing process and saving suturing time.

[0071] Furthermore, the step of heating the first covering 20, the first mold 40, and the second mold 50 as a whole includes:

[0072] S131: The first covering part 20, the first mold 40, and the second mold 50 are placed as a whole into a heat medium, wherein the temperature of the heat medium is 90℃~100℃, and the heat setting time is 10min~15min. The heat medium includes, but is not limited to, hot water.

[0073] Furthermore, the step of cooling and shaping the first covering part 20 includes:

[0074] The first covering component 20, the first mold 40, and the second mold 50 are placed as a whole into a coolant, wherein the temperature of the coolant is 0℃ to 4℃ and the cooling time is 10 min to 15 min. The cooling medium includes, but is not limited to, cold water.

[0075] The above-described valve stent manufacturing method uses a first mold 40 and a second mold 50 to pre-shape a first covering part 20 of one-piece flexible material into a second covering area 24 for covering the first valve foot 12. By covering the first valve foot 12 with the pre-shaped first covering part 20, the first covering area 23 can cover the outer side of the first base 11. Then, the fourth covering area 26 is flipped outward to cover the outside of the valve annulus 30, so that the third covering area 25 is driven by the fourth covering area 26 to cover the inner side of the first base 11. Finally, by fixing the first end 21 and the second end 22 of the first covering part 20 to the first base 11, for example by sewing them to the first base 11, the valve seat 10 and the valve annulus 30 can be stably connected without cutting the first covering part 20. Furthermore, the one-piece molding of the first covering part 20 greatly reduces the edges that need to be fixed. Only the first end 21 and the second end 22 need to be sewn or glued to fix them, which simplifies the sewing or bonding process, reduces the manufacturing difficulty, and improves production efficiency.

[0076] This application also provides an artificial heart valve, specifically, see [link to relevant documentation]. Figure 9 , Figure 9 The diagram illustrates the structure of an artificial heart valve according to one embodiment. It should be noted that... Figure 9 To facilitate observation of the structure of the artificial heart valve, the first covering member 20 has been concealed. One embodiment of the artificial heart valve includes a valve support, a valve frame 60, and valve leaflets 70, wherein the valve frame 60 is housed within the space enclosed by the first valve foot 12 via connection to the first covering member 20 of the valve support. The valve leaflets 70 are disposed on the valve frame 60. Preferably, the valve frame 60 is covered by a second covering member, which is sutured to the first covering member 20, and the valve leaflets 70 are sutured to the second covering member. Further, multiple valve leaflets 70 are provided, and these multiple valve leaflets 70 are used to prevent blood backflow.

[0077] The valve stent of the aforementioned artificial heart valve places the valve seat 10 into the pre-shaped first covering 20, thereby eliminating the need to cut the first covering 20. Furthermore, the integrally formed first covering 20 greatly reduces the edges that need to be sutured. Only the first end 21 and the second end 22 need to be sutured or bonded for fixation, which simplifies the suture line, reduces the manufacturing difficulty, and improves production efficiency.

[0078] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0079] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

[0080] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do 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, they should not be construed as limitations on this invention.

[0081] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0082] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0083] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0084] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

Claims

1. A method for manufacturing a valve stent, characterized in that, The valve stent includes: The petal seat includes an annular first base and a first petal foot disposed on the first base; Lobe ring; and, The first covering is an integral flexible material used to cover the surfaces of the valve seat and the valve annulus; the first covering includes a first covering area, a second covering area, a third covering area, and a fourth covering area connected in sequence; the second covering area is used to cover the first valve foot; one of the outer side surface and the inner side surface of the first base is covered by the first covering area, and the other is covered by the third covering area; the fourth covering area covers the valve annulus and is used to drive the valve annulus to be sleeved outside the first base; wherein, the second covering area is pre-formed by a molding die to accommodate a receiving space for the first valve foot, and the shape of the receiving space matches the outer contour shape of the first valve foot. A molding die for molding the first covering of the valve stent, the molding die comprising: A first mold, the outer contour shape of which is the same as the outer contour shape of the petal seat, the first mold including a second base having an annular hollow portion and a second petal foot disposed on the second base; and... The second mold is a tubular structure and is used to be fitted onto the second petal foot, and a space for clamping the second covering area is formed between the second mold and the second petal foot. The method for manufacturing the valve stent includes the following steps: A flexible tubular member with openings at both ends is provided as a first covering member. The first covering member has a first end and a second end. The first covering member is folded so that the first end and the second end are respectively arranged on the outside and inside of the first mold, and the second petal is covered with the covering body. The second mold is fitted onto the second petal foot that covers the encapsulated body; The first covering part, the first mold and the second mold are heated as a whole, and then cooled and shaped. The first covering part is then cooled and shaped so that the covering body between the second mold and the second petal forms a second covering area. Dismantle the first mold and the second mold; The second covering area covers the first petal foot of the petal seat. The first end is placed on the outside of the first base. The covering body between the first end and the second covering area forms a first covering area. The second end is placed on the inside of the first base. The covering body extending from the second end relative to the bottom edge of the first base forms a fourth covering area. The covering body between the second covering area and the fourth covering area forms a third covering area. The first covering area and the third covering area are used to cover the outer side and the inner side of the first base, respectively. The fourth covering area is rolled up to cover the petal ring and cause the petal ring to be sleeved outside the first base; Secure the first covering to the first base.

2. The method for manufacturing a valve stent according to claim 1, characterized in that, The step of folding the first covering so that the first end and the second end are respectively arranged on the outside and inside of the first mold specifically includes: The second end passes through the inside of the annular hollow portion through the second base, so that the first end is arranged on the side of the first mold away from the second base, and the first covering part forms a folded portion on the side near the first end that extends beyond the top of the second petal by at least a predetermined length h. Fold the first end outward by a predetermined length h so that the folded part covers the outer contour of the first mold; The length of the first mold is D, and the h exceeds D by 1mm to 3mm.

3. The manufacturing method according to claim 2, characterized in that, The step of fixing the first covering to the first base specifically includes: First, the folded portion is clamped by a clamping member, then the fourth covering area and / or the second end is sewn to the outer side of the first base by a second suture, and then the first end is sewn to the inner side of the valve ring by a first suture.

4. The manufacturing method according to claim 1, characterized in that, The step of fixing the first covering to the first base specifically includes: First, the first end is sewn to the bottom edge of the first base with a first suture, and then the fourth covering area and / or the second end is sewn to the inside of the valve ring with a second suture.

5. The manufacturing method according to claim 3 or 4, characterized in that, The first suture coincides with or is parallel to the second suture, and the first suture and the second suture are the same suture.

6. The manufacturing method according to claim 1, characterized in that, The step of heating the first covering component, the first mold, and the second mold as a whole specifically includes: The first covering, the first mold, and the second mold are placed together in a heat medium, wherein the temperature of the heat medium is 90℃~100℃ and the heat setting time is 10min~15min.

7. The manufacturing method according to claim 1, characterized in that, The step of cooling and shaping the first covering part includes: The first covering, the first mold, and the second mold are placed in a coolant, wherein the temperature of the coolant is 0°C to 4°C and the cooling time is 10 min to 15 min.

8. A molding die for molding the first covering of the valve stent according to any one of claims 1-7, characterized in that, The molding die includes: A first mold, the outer contour shape of which is the same as the outer contour shape of the petal seat, the first mold including a second base having an annular hollow portion and a second petal foot disposed on the second base; and... The second mold is a tubular structure and is used to fit onto the second petal foot, with a space between the second mold and the second petal foot for clamping the second covering area.

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