A heart valve assembly and method of making the same

Abstract

In order to solve the problems of the artificial heart valve being easy to age and difficult to connect the valve leaflet material to the stent in the prior art, the present application provides a heart valve assembly, an artificial valve device and a preparation method of the heart valve assembly. The heart valve assembly comprises a skirt part comprising a tubular structure, at least two leaflet bodies arranged on the inner wall of the skirt part, and a plurality of integrated anchor rings arranged on the outer part of the skirt part. One end of the integrated anchor ring is fixedly arranged on the outer part of the skirt part, and the other end is a free end. The skirt part, the leaflet body and the integrated anchor ring constitute an integrated valve structure. The technical scheme of the present application has the following advantages: the heart valve assembly of the present application simplifies the assembly process by significantly reducing the need for precise suturing of the valve assembly to the stent. It is also possible to reduce the uncertainty of the current suturing technology.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a heart valve assembly and its preparation method. Background Technology

[0002] There are currently three types of heart valves: 1) mechanical valves, 2) biological valves, and 3) synthetic polymer valves.

[0003] Mechanical heart valves consist of one or more valves mounted on an eccentric axis and then secured to a safety seat in the heart muscle. These mechanical valves are highly reliable, but they are prone to causing blood flow disturbances and increasing the risk of thrombosis. Therefore, implanted mechanical valves require patients to take anticoagulants for life. Furthermore, because the valve components of a mechanical valve cannot be fully compressed into the catheter, it cannot be delivered to the implantation site via minimally invasive catheterization. Consequently, mechanical valves require highly invasive intracardiac implantation surgery, making them unsuitable for many elderly patients due to pre-existing complications.

[0004] Bioprosthetic valves are valve prostheses made from human organ tissue (allogeneic grafts) or animal-derived tissue (autografts). Because these bioprosthetic valves generally integrate well with the heart and offer the added benefit of supporting catheter delivery, they overcome the aforementioned drawbacks of mechanical valves and are increasingly used. However, since bioprosthetic valves are composed of organic tissue, they are prone to natural aging and degeneration. To prevent this, these bioprosthetic tissues typically undergo extensive chemical treatments to ensure biocompatibility and prevent surface calcification. Furthermore, these bioprosthetic tissues need to be mounted in a specific location for effective fixation within the heart, and this location may also create unfavorable flow conditions within the bioprosthetic valve.

[0005] Synthetic polymer valves, which are prosthetic valves made entirely of synthetic materials, typically polyurethane or silicone, effectively overcome problems associated with material fatigue while maintaining natural blood flow. However, these synthetic polymer valves are at risk of rupture in bending areas over time due to cyclic stress. Recent advancements in 3D printing technology have further increased attempts in this field, utilizing various printable polymers to replicate the shape of natural heart valves with increasing precision. However, to date, these valves have achieved little success clinically or commercially due to limitations in product design and structural materials. Based on cyclic stress, attempts have been made to create "all-textile" heart prostheses using weaving techniques, but existing all-textile heart prostheses still suffer from problems such as excessive fatigue in bending areas leading to prosthesis failure or inadequate material and shape requirements.

[0006] Another challenge in current heart valve technology is the difficulty in attaching valve leaflet material to the stent, which is typically done manually. This method requires highly trained and skilled technicians to connect the various components of the heart valve (leaflets, suture rings, accessory valve sealing rings, etc.) to the stent or frame. This process inherently involves uncertainty due to the varying skill levels of the sewing technicians and the inherent subjectivity of the assembly process. Summary of the Invention

[0007] Therefore, in order to solve the problems of easy aging of existing artificial heart valves and difficulty in connecting the valve leaflet material to the stent, the present invention provides a heart valve assembly, an artificial valve device, and a method for preparing a heart valve assembly.

[0008] A heart valve assembly includes: a skirt portion having a tubular structure, at least two leaflets disposed on the inner wall of the skirt portion, and a plurality of integrated anchoring rings disposed on the outer side of the skirt portion; one end of each integrated anchoring ring is fixedly disposed on the outer side of the skirt portion, and the other end is a free end; the skirt portion, the leaflets, and the integrated anchoring rings constitute an integral valve structure.

[0009] Furthermore, one end of the integrated anchoring ring is disposed at the edge of the skirt portion, or at any position in the width direction outside the skirt portion, or at the interlacing area of ​​the skirt portion and the leaflet.

[0010] Furthermore, the skirt portion, integrated anchoring ring, and leaflets may be made of the same or different materials; the materials are biocompatible polymers; the biocompatible polymers are UHMWPE (ultra-high molecular weight polyethylene), PET (polyethylene terephthalate), PEEK (polyether ether ketone), TPU (thermoplastic polyurethane elastomer rubber), PGA (polyglycolic acid), PLGA (polylactic acid-glycolic acid copolymer), PLA (polylactic acid), PLLA's (poly-L-lactide), PDO (polydioxanone), PHA's (polyhydroxyalkanoates), and PGSU (polyglycerol sebacate polyurethane). Preferably, the skirt portion, integrated anchoring ring, and leaflets are all made of ultra-high molecular weight polyethylene.

[0011] Furthermore, the length of the integrated anchoring ring is from 2 mm to 50 mm.

[0012] The distance between the upper and lower sides of the skirt is 1mm-50mm.

[0013] The heart valve assembly also includes a paravalve sealing ring, a skirt portion, leaflets, an integrated anchoring ring, and a paravalve sealing ring, forming an integrated valve structure.

[0014] Furthermore, the skirt body, integrated anchoring ring, leaflet, and sidelobe sealing ring may be made of the same or different materials;

[0015] Furthermore, the skirt portion is cylindrical or similar in shape.

[0016] An artificial valve device includes the aforementioned heart valve assembly, and further includes a stent mounted on the heart valve assembly.

[0017] A method for fabricating a heart valve assembly involves forming a fabric using a shuttle narrow-width electronic jacquard loom; the fabric consists of three fabric layers, the first fabric layer forming a skirt portion, the second fabric layer forming a leaflet, and the third fabric layer forming a loop, i.e., an integrated anchoring ring; these layers are seamlessly interwoven together along the length of the fabric at predetermined positions.

[0018] The method for forming the second fabric layer is as follows: at a point along the width direction of the first fabric layer, the second fabric layer is completely woven into the first fabric layer using any of the known weaving patterns, and the two fabric layers are seamlessly connected.

[0019] Furthermore, the shuttle-operated narrow-width electronic jacquard loom is MEGEBA SSLMV (German).

[0020] Furthermore, the method for forming the second fabric layer is as follows: at a certain point along the width direction of the first fabric layer, the second fabric layer is completely woven into the first fabric layer using one of many known weaving patterns, with a seamless connection between the two fabric layers; the known weaving pattern can be a double-layer plain weave orthogonal weave pattern.

[0021] Furthermore, the specific method for forming the integrated anchoring ring is as follows: the weft yarn extends laterally a certain distance from the intersection point with the selvage of the first fabric layer, the distance being 2mm to 50mm; at a predetermined point, the weft yarn will interweave with a highly taut single warp yarn to form an integrated anchoring ring; the laterally refers to the width direction of the first fabric layer.

[0022] Furthermore, the weft yarn extends laterally a certain distance of 2mm from the intersection point with the selvage of the first fabric layer.

[0023] The aforementioned integrated valve structure is manufactured using a textile process.

[0024] Furthermore, the two longitudinal ends (along the length of the first fabric layer) of the first fabric layer can be connected by any sewing method; the sewing method includes sewing, ultrasonic welding, thermal bonding, etc., and the component is formed into a cylindrical shape or a shape similar to a cylinder;

[0025] The highly taut single warp yarn is called a tuft; the function of the tuft is to assist in forming an integrated anchoring ring; when fixing the heart valve to the stent, the tuft is used to manipulate each anchoring ring to a predetermined anchoring position on the stent frame, simplifying the connection process.

[0026] Furthermore, the stent is a surgical heart valve stent, a self-expanding catheter-delivered heart valve stent, or a balloon-expandable catheter-delivered heart valve stent.

[0027] Furthermore, the yarn fineness of the second to fourth fabric layers is 5-100 denier.

[0028] The technical solution of the present invention has the following advantages:

[0029] 1. The heart valve component of this invention simplifies the assembly process by significantly reducing the need for precise suturing to connect the valve component to the stent. It may also reduce the uncertainty of current suturing techniques.

[0030] 2. The heart valve assembly and its preparation method of the present invention promote the application of synthetic materials in surgical and transcatheter heart valves.

[0031] 3. Using the heart valve component of the present invention can improve the lifespan of heart valves using animal-derived tissues.

[0032] 4. Seamlessly integrating the anchoring ring to the outside of the skirt section will help simplify the assembly process and reduce the total time required to manufacture the valve, thereby potentially reducing the total cost of manufacturing the device.

[0033] 5. The heart valve component of the present invention enables the stent to be placed more quickly and assembled onto the skirt and leaflet components more rapidly, thereby achieving greater precision and repeatability and reducing the need for trained assembly technicians.

[0034] 6. The heart valve component of the present invention can accommodate any number and geometry of blades, which can be optimized for ideal flow dynamics when using a variety of combined materials.

[0035] 7. The improved preparation method of the present invention can be used to prepare bio-textile materials required in other medical device fields besides heart valves. Attached Figure Description

[0036] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0037] Figure 1 This is a schematic diagram of the heart valve assembly structure in Example 1;

[0038] Figure 2 A cross-sectional view of a three-layer fabric structure with integrated anchoring rings;

[0039] Figure 3 This is a schematic diagram of the integrated anchoring ring formed by the yarn gathering. The main purpose is to show how the anchoring ring is formed. 9 represents multiple fabric layers, which can be the first fabric and / or the second fabric layer and / or the fourth fabric layer. No distinction is made between the specific fabric layers.

[0040] Figure 4 It consists of a 3-layer fabric including an integrated anchoring ring;

[0041] Figure 5 for Figure 4 The cross-section of the three-layer fabric, including the integrated anchoring ring, is shown in Figure 8; Figure 8 represents the interlacing area of ​​the three-layer fabric.

[0042] Figure 6 It consists of 3 layers of fabric (with integrated anchoring rings), with the first fabric layer matching the profile of the support; 11 is the cutting area of ​​the first fabric layer;

[0043] Figure 7 The fabric is composed of four fabric layers as in Example 2 (in Figure 6 Based on the existing structure, a paravalve sealing ring is integrated, and the first fabric layer matches the shape of the stent; reference numeral 12 in the attached figure is the paravalve sealing ring.

[0044] Figure 8 for Figure 7 The cross-section of the fabric; 8 represents the interlacing area of ​​the four fabric layers;

[0045] Figure 9 This is a typical surgical heart valve component in existing technology;

[0046] Figure 10 A schematic diagram of the artificial valve device in Example 3; some parts are not labeled in this diagram to illustrate that the heart valve assembly is assembled with the stent as a whole.

[0047] Figure 11 Figure 10 Enlarged view of part A;

[0048] Figure 12 The bracket is shown in Example 3; the circle is not a structure on the bracket, but is added to more clearly show the predetermined anchor point; reference numeral 14 indicates the predetermined anchor point;

[0049] The "well" shape in the above figures represents textiles;

[0050] Explanation of reference numerals in the attached figures:

[0051] 1. Skirt section; 2. Leaflet; 3. Integrated anchoring ring; 4. Connection point; 5. Gathering thread; 6. Weft yarn; 7. Warp yarn; 8. Interlacing area of ​​two or more fabric layers; 9. Multi-layer fabric; 10. Connection area between leaflet and skirt section; 11. Cutting area; 12. Side lobe sealing ring; 13. Support; 14. Pre-set anchoring point. Detailed Implementation

[0052] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0053] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., 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 the invention and for 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 the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0054] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0055] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0056] Example 1: A cardiac valve assembly

[0057] A heart valve assembly, such as Figure 1 As shown, it includes a skirt portion 1 with a tubular structure, and at least two leaflets 2 connected to the inner wall of the skirt portion 1; a plurality of integrated anchoring rings 3 disposed on the outside of the skirt portion 1; the skirt portion 1, the leaflets 2 and the integrated anchoring rings 3 constitute an integrated valve structure.

[0058] The skirt portion 1 has woven edges on its upper and lower sides; the leaf-shaped body 2 has an interlaced side and a free side on opposite sides, respectively. The interlaced side is fixed between the two woven edges of the skirt portion 1 by a weaving method, and the free side is a woven edge. The integrated anchoring ring 3 has an interlaced side and a free side on opposite sides, respectively. The interlaced side is fixed between the two woven edges on the outside of the skirt portion 1 by a weaving method.

[0059] In this embodiment, the number of leaflets 2 is set to 3.

[0060] The skirt portion 1 provides a secure anchoring point for the valve leaflet, preventing perivalvular cardiac tissue from growing into the valve and interfering with leaflet function, while also preventing paravalvular leakage.

[0061] The function of the integrated anchoring ring 3 is to anchor the valve assembly to the stent.

[0062] In this embodiment, the skirt part 1, the leaflet 2, and the integrated anchoring ring 3 are all made of the biocompatible polymer UHMWPE.

[0063] The method for preparing the heart valve assembly (refer to) Figure 1-6 )for:

[0064] 1) The fabric is formed using a shuttle narrow-width electronic jacquard loom (MEGEBA SSLMV). The fabric consists of three layers: a base layer (first fabric layer) forms the skirt portion 1, a second fabric layer forms the leaf-like parts 2, and a third fabric layer forms the rings of the support anchoring elements, i.e., anchoring rings 3. These layers are seamlessly interwoven together along the length of the fabric at predetermined locations.

[0065] The synthesized leaflets 2 are connected to the fabric base layer (first fabric layer). During the formation of the first fabric layer, the weft yarns pass through the two edges of the first fabric layer without being cut, forming a selvage.

[0066] The width of the first fabric layer is 1mm-50mm, depending on the length of the connection point forming the skirt (the length of the connection area between the leaflet 2 and the first fabric layer); the fineness of the yarn used in the first fabric layer is 5-100 denier, depending on the required thickness and density of the first fabric layer. In this embodiment, the width of the first fabric layer is 50mm, and the fineness of the yarn used in the first fabric layer is 100 denier.

[0067] 2) At a point along the width direction of the first fabric layer, one of many known weaving patterns is used. In this embodiment, a double plain weave orthogonal weaving pattern is used to completely weave the second fabric layer into the first fabric layer, with a seamless connection between the two fabric layers.

[0068] The second fabric layer will form synthetic leaflets 2 (valve leaflets), which are formed by the interlacing of warp and weft yarns.

[0069] At certain points along the length of the first fabric layer, the second fabric layer is integrally connected to the first fabric layer, forming attachment points. These points can be changed during the weaving process to create any number of geometric patterns, thereby achieving optimal valve leaflet performance. In this embodiment, the pattern is linear, see... Figure 4 and Figure 6 .

[0070] The shapes of the first and second fabric layers in this embodiment are shown below. Figure 4 That is, the first fabric layer is rectangular; as an alternative embodiment, the first fabric layer can be modified by cutting it into a specific shape that matches the shape of the support, see Figure 6 Meanwhile, the modified skirt part 1 can still be joined with the leaflet 2.

[0071] 3) A third fabric layer is structurally added to the first and second fabric layers. This third fabric layer consists of integrated anchoring loops 3 formed using weft yarns. These weft loops can interweave with the first and second fabric layers along one selvage of the first fabric layer, or they can interweave with the first fabric layer along one selvage of the first fabric layer. They can also be staggered at different points along the width of the first fabric layer. These weft yarns extend laterally (in this context, laterally refers to the width direction of the first fabric layer) from the intersections with the first and / or second fabric layers to a predetermined length, and these loops can be anchored to anchoring points on the support surface.

[0072] In this embodiment, the specific method for forming the integrated anchoring ring 3 is as follows: the weft yarn extends laterally a certain distance (2mm) from the interlacing point with the selvage of the first fabric layer. At a predetermined point, the weft yarn interlaces with a highly taut single warp yarn, thus forming an integrated anchoring ring; the highly taut single warp yarn is referred to as the yarn gather 5, see... Figure 2 and Figure 3 Repeating the above steps can form multiple integrated anchoring rings. The material of the anchoring wire can be fiber, yarn, or steel wire; in this embodiment, it is fiber.

[0073] As an alternative implementation, the distance from the weft yarn extending laterally from the interlacing point with the selvage of the first fabric layer is 2 mm to 50 mm.

[0074] A single yarn 5 will intersect the weft at a fixed point along the length of the first fabric layer. These yarns 5 will be used to assist in forming an integrated anchoring ring, the length of which will ultimately be determined by the anchoring point position on the corresponding stent, i.e., the final position where the artificial valve is attached to the stent.

[0075] The interfaces between the first, second, and third fabric layers (anchoring rings) form a seamless, integrated valve assembly that can then be quickly and repeatably anchored to the stent frame.

[0076] 4) After weaving the required number of valves, leaflets, and anchoring rings, remove the woven structure from the loom while maintaining sufficient tension on the yarn 5 to ensure that the integrated anchoring rings 3 are supported and held. The two longitudinal (along the length of the first fabric layer) ends of the first fabric layer can be connected by any sewing method, such as... Figure 1 At the connection point 4, the stitching method includes suturing, ultrasonic welding, thermal bonding, etc., and the component is formed into a cylindrical shape or a similar cylindrical shape, such as... Figure 1 .

[0077] Example 2

[0078] The difference from Embodiment 1 is that the heart valve assembly also includes a paravalve sealing ring 12, which, together with the skirt portion 1, the leaflet body 2, and the integrated anchoring ring 3, forms an integrated valve structure (see...). Figure 7 and Figure 8 The fabric is formed using a shuttle-operated narrow-width electronic jacquard loom. The fabric consists of four layers: a base layer (first fabric layer) forming the skirt portion 1; a second fabric layer forming the leaflets 2; a third fabric layer consisting of rings-anchoring rings 3 forming support anchoring elements; and a fourth layer forming a sewing ring / or side-leaf sealing ring 12, having an interlacing side and a free side, as shown below. Figure 7 As shown, in this embodiment, along the interlacing area of ​​the first and second fabric layers, one of many known weaving patterns is used. This embodiment uses a double-layer plain weave orthogonal weave pattern to completely weave the interlacing side of the fourth fabric layer into the interlacing area, with seamless connections between the four fabric layers. The fourth fabric layer is square in shape. These layers are seamlessly interlaced together along the length of the fabric at predetermined locations. The function of the accessory valve sealing ring 12 is to make compressive contact with the biological tissue surrounding the valve prosthesis to ensure that no paravalvular leakage occurs during implant positioning and throughout its lifespan. It can also promote tissue growth into the accessory valve sealing ring 12, which will further reduce the possibility of leakage and increase the anchoring stability of the valve over time.

[0079] This embodiment modifies the first fabric layer by cutting it into a specific shape that matches the shape of the support frame. Figure 7 Meanwhile, the modified skirt part 1 can still be joined with the leaflet 2.

[0080] Example 3

[0081] An artificial valve device includes a heart valve assembly prepared according to Example 1 or Example 2, and a stent 13 mounted on the heart valve assembly. The stent is a surgical heart valve stent (for open-heart surgery), a self-expanding catheter-delivered heart valve stent (for minimally invasive surgery / TAVR), or a balloon-expanded catheter-delivered heart valve stent (for minimally invasive surgery / TAVR). After the heart valve assembly in this embodiment is prepared, it can be processed using any post-processing techniques such as thermoforming, embedding molding, ultrasonic welding, solvent treatment, and boiling (cleaning with solvent) to construct the final geometry. After construction, it can be fixed to the stent. The method of fixing the stent to the heart valve assembly depends on the geometry of the stent and the structure of the heart valve assembly. The fixation between the heart valve assembly and the stent is achieved through an anchoring ring (see...). Figures 10-12 In this embodiment, the method of fixing the stent 13 to the heart valve assembly is to hang the free end of the anchoring ring to the predetermined anchoring point 14 of the stent; and to manipulate each integrated anchoring ring to the predetermined anchoring position on the stent frame using the hub 5, and then remove the hub 5, which simplifies the connection process.

[0082] The heart valve assembly provided in this invention makes it easier to align and position the stent, thereby enabling more accurate, simpler, and less subjective installation.

[0083] Once the heart valve components are anchored to the stent, the method for securing the stent to other components will depend on the stent's shape, intended application (i.e., aortic valve, mitral valve, etc.), and surgical method (i.e., transcatheter delivery, open-heart surgery, etc.). Various methods can be used to secure the remaining valve components, including but not limited to sutures, welding, selective placement of adhesives, and designing "pockets" in the skirt section to reinforce anchorage with the stent.

[0084] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A heart valve assembly, characterized in that, include: It includes a tubular skirt section, at least two leaflets disposed on the inner wall of the skirt section, and several integrated anchoring rings disposed on the outer side of the skirt section; one end of each integrated anchoring ring is fixedly disposed on the outer side of the skirt section, and the other end is a free end; the skirt section, the leaflets, and the integrated anchoring rings constitute an integrated valve structure. The skirt body has woven edges on both the top and bottom sides; the opposite sides of the leaf-shaped body are an interlaced side and a free side, respectively. The interlaced side is fixed between the two woven edges of the skirt body by a weaving method, and the free side is a woven edge; the opposite sides of the integrated anchoring ring are an interlaced side and a free side, respectively. The interlaced side is fixed between the two woven edges on the outside of the skirt body by a weaving method. The function of the integrated anchoring ring is to anchor the valve assembly to the stent.

2. The heart valve assembly according to claim 1, characterized in that... One end of the integrated anchoring ring is disposed at the edge of the skirt portion, or at any position in the width direction outside the skirt portion, or at the interlacing area of ​​the skirt portion and the leaflet.

3. The cardiac valve assembly according to claim 1 or 2, characterized in that... The skirt body, integrated anchoring ring, and leaflets may be made of the same or different materials; the material is a biocompatible polymer.

4. The cardiac valve assembly according to claim 3, characterized in that... The biocompatible polymer is one or more of the following: ultra-high molecular weight polyethylene, polyethylene terephthalate, polyetheretherketone, thermoplastic polyurethane elastomer rubber, polyglycolic acid, polylactic acid-glycolic acid copolymer, polylactic acid, poly-L-lactide, polydioxanone, polyhydroxyalkanoate, and polyglycerol sebacate polyurethane.

5. The cardiac valve assembly according to claim 1 or 2, characterized in that... The skirt, integrated anchoring ring, and leaflets are all made of ultra-high molecular weight polyethylene.

6. The cardiac valve assembly according to claim 1 or 2, characterized in that... The length of the integrated anchoring ring is 2mm to 50mm.

7. The cardiac valve assembly according to claim 1 or 2, characterized in that... The distance between the upper and lower sides of the skirt is 1mm-50mm.

8. The heart valve assembly according to claim 1 or 2, further comprising a paravalve sealing ring, the skirt portion, the leaflet body, the integrated anchoring ring, and the paravalve sealing ring forming an integral valve structure.

9. A method for preparing a cardiac valve assembly as described in any one of claims 1-8, characterized in that, The fabric is formed by using a shuttle narrow-width electronic jacquard loom; the fabric consists of three fabric layers, the first fabric layer forming the skirt part, the second fabric layer forming the leaf-like parts, and the third fabric layer forming the loop, i.e., the integrated anchoring ring; these layers are seamlessly interwoven together along the length of the fabric at predetermined positions.

10. The method for preparing the heart valve assembly according to claim 9, characterized in that, The method for forming the second fabric layer is as follows: at a point along the width direction of the first fabric layer, the second fabric layer is completely woven into the first fabric layer using any of the known weaving patterns, and the two fabric layers are seamlessly connected.

11. The method for preparing a heart valve assembly according to claim 9 or 10, characterized in that, The specific method for forming the integrated anchoring ring is as follows: the weft yarn extends laterally a certain distance from the interlacing point with the selvage of the first fabric layer, the distance being 2mm to 50mm; at a predetermined point, the weft yarn will interlace with a highly taut single warp yarn to form an integrated anchoring ring; the laterally refers to the width direction of the first fabric layer.

12. The method for preparing the heart valve assembly according to claim 11, characterized in that, The weft yarn extends laterally a certain distance of 2 mm from the point where it intersects with the selvage of the first fabric layer.

13. An artificial valve device, characterized in that, The heart valve assembly includes the heart valve assembly according to any one of claims 1-8 or the heart valve assembly prepared by the preparation method according to any one of claims 9-12, and further includes a stent mounted on the heart valve assembly.

Images