Valve frame and heart valve prosthesis

By designing the smooth connection of the valve frame and the joint of the wide solid part, the problem of uneven shape of the valve during compression and expansion is solved, and the stability and functional uniformity of the valve are achieved.

CN223350391UActive Publication Date: 2025-09-19HANGZHOU VALGEN MEDTECH CO LTD
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Patent Information

Application Number
CN202422669698.8
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-11-01
Publication Date
2025-09-19
Estimated Expiration
2034-11-01

AI Technical Summary

Technical Problem

During the compression or expansion process of existing aortic valve replacement products, the grid opening connection parts of the valve frame are easily broken due to uneven force, resulting in uneven shape and affecting the stability and function of the valve.

Method used

A valve frame is designed, including an inflow row grid, an outflow row grid and an intermediate row grid. The opposite ends of the struts are connected by a joint portion. The joint portion has a smooth shape and a solid portion with a width greater than twice the width of the struts, ensuring that the shape remains uniform during radial compression and expansion, thereby reducing stress concentration.

Benefits of technology

Through the smoothly connected joint part and wide solid part, the valve frame has a uniform shape during the conversion process, reducing the risk of fracture and improving the stability and functional consistency of the valve.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model relates to a valve frame and an artificial heart valve. The valve frame can be switched between a radial compression structure and a radial expansion structure; each of an inflow row grid, an outflow row grid and a middle row grid of the valve frame comprises two rows of wave rods which are oppositely arranged and connected with each other, each row of wave rods comprises a plurality of supporting rods, and the opposite ends of every two adjacent supporting rods are connected at a joint part; each joint part comprises a solid part and a vacant part radially penetrating through the solid part, the opposite ends of the two adjacent supporting rods are smoothly connected with the solid part on the two sides of the vacant part, the vacant part is also in a smooth shape, and an opening of the vacant part corresponding to the wave crest of the wave rod faces the wave trough in the axial direction; the opening of the vacant part corresponding to the wave trough of the wave rod faces the wave crest in the axial direction; the joint part is used for helping each grid to uniformly deform in the structure conversion process of the valve frame; the width of the solid part is larger than or equal to the sum of two times of the width of the supporting rod and the width of the vacant part. The heart valve prosthesis comprises the valve frame, a covering film and at least two artificial valve leaflets capable of being opened and closed oppositely.
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Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to a valve frame and an artificial heart valve. Background Art

[0002] Aortic valve disease is a common heart disease, including aortic stenosis, aortic regurgitation (also known as aortic regurgitation), etc. In recent years, transcatheter aortic valve replacement has become an effective treatment for severe aortic stenosis.

[0003] Current aortic valve replacement products, known as prosthetic aortic valves, typically consist of a metal frame (also known as a valve frame), a skirt sewn to the frame, and prosthetic valve leaflets secured to the frame and / or skirt. The frame primarily utilizes a skeletal design with multiple mesh openings, allowing it to be compressed into a low profile for delivery and expanded over the site of a diseased native aortic valve.

[0004] Under existing technical conditions, aortic valve replacement products still have some defects. The most prominent of these is that during the compression or expansion process of the valve frame, the connection parts of the struts that surround the grid openings may break due to uneven force, or the shapes of the grids and the entire valve frame after contraction and expansion may become uneven. Summary of the Invention

[0005] In view of this, the present invention aims to provide a valve holder and an artificial heart valve that can solve the above problems or at least alleviate the above problems to a certain extent.

[0006] On the one hand, the utility model provides a valve frame, which is roughly annular and can be converted between a radially compressed structure and a radially expanded structure; the valve frame includes a row of inflow row grids, a row of outflow row grids, and at least one row of intermediate row grids, the intermediate row grids being located between the inflow row grids and the outflow row grids; the inflow row grids, the outflow row grids, and the intermediate row grids each include two rows of wave rods that are opposite to and connected to each other, each row of the wave rods includes a plurality of struts, and the opposite ends of two adjacent struts are connected at a joint portion; the joint portion includes a solid portion and a vacant portion that radially passes through the solid portion, the opposite ends of two adjacent struts are smoothly connected to the solid portion on both sides of the vacant portion, the vacant portion also having a smooth shape, the opening of the vacant portion corresponding to the wave crest of the wave rod is axially oriented towards the wave trough, and the opening of the vacant portion corresponding to the wave trough of the wave rod is axially oriented towards the wave crest; the joint portion is used to help each of the grids deform uniformly during the structural conversion process of the valve frame; the width of the solid portion is greater than or equal to the sum of twice the width of the strut and the width of the vacant portion.

[0007] On the other hand, the present invention also provides an artificial heart valve, comprising the valve frame, a membrane and at least two artificial leaflets that can open and close relative to each other; the membrane is arranged on the radial inner side of the valve frame and is connected to at least the support rods of the middle row grid by sutures; the artificial leaflets are connected to the membrane by sutures.

[0008] The valve frame and artificial heart valve provided by the present invention are arranged such that the opposite ends of the two adjacent struts are smoothly connected to the solid part on both sides of the vacant part of the joint part, the vacant part also has a smooth shape, and the width of the solid part is also arranged to be greater than or equal to the sum of 2 times the width of the strut and the width of the vacant part. When the valve frame is converted between the radial compression structure and the radial expansion structure, the joint part basically does not deform and maintains its shape, which can reduce or eliminate the stress concentration on the opposite ends of the two adjacent struts, and help each of the grids to deform evenly during the structural conversion process of the valve frame, thereby making the shape of the entire valve frame uniform. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 This is a schematic diagram of the three-dimensional structure of an artificial heart valve according to an embodiment of the present invention;

[0010] Figure 2 yes Figure 1 A schematic exploded perspective view of an artificial heart valve;

[0011] Figure 3 yes Figure 2 Schematic diagram of the main view of the middle petal frame;

[0012] Figure 4 yes Figure 3 Schematic diagram of partial plane expansion of the middle petal frame;

[0013] Figure 5 yes Figure 4 A magnified schematic diagram of point A in the middle;

[0014] Figure 6 yes Figure 4 A magnified schematic diagram of point B in the middle;

[0015] Figure 7 yes Figure 4 The enlarged schematic diagram of point C in the middle;

[0016] Figure 8 yes Figure 4 The enlarged schematic diagram of point D in the middle;

[0017] Figure 9 yes Figure 3 A three-dimensional schematic diagram of the valve frame in a radially compressed configuration;

[0018] Figure 10 yes Figure 2 Schematic diagram of the plane expansion of the middle covering film;

[0019] Figure 11 yes Figure 2 Schematic diagram of the plane expansion of the artificial valve leaflet;

[0020] Figure 12 It is a planar schematic diagram of the artificial valve leaflet and the covering membrane being fixed by sutures in a flat-seam manner;

[0021] Figure 13 It is a three-dimensional schematic diagram of the artificial valve leaflet and the covering membrane, as well as the edges of both sides of the covering membrane being fixed by sutures in a flat-seam manner;

[0022] Figure 14 is a schematic diagram showing that the flap is connected to the struts of the valve frame by sutures in a winding suture manner;

[0023] Figure 15 It is a three-dimensional schematic diagram of the artificial valve leaflets opening relatively in the valve frame;

[0024] Figure 16 It is a three-dimensional schematic diagram of the relative closure of the artificial valve leaflets in the valve frame;

[0025] Figure 17 This is a schematic diagram of the artificial heart valve of the present invention being used to replace the native aortic valve;

[0026] Figure 18 This is a schematic diagram of the artificial heart valve of the present invention being used to replace the native mitral valve;

[0027] Figure 19 This is a schematic diagram of the artificial heart valve of the present invention being used to replace the native tricuspid valve. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. In addition, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.

[0029] First of all, it should be noted that in this article, "proximal end" refers to the end of the device or component closest to the operator, and "distal end" refers to the end of the device or component away from the operator. According to the direction of blood flow in the heart, "inflow end" refers to the end located upstream of the blood, and "outflow end" refers to the end located downstream of the blood. "Axial" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential" refers to the direction surrounding the axial direction.

[0030] It is worth noting that the above-mentioned terms indicating orientation or positional relationship are only for the purpose of facilitating the description of the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limiting the present invention.

[0031] It is also worth noting that the valve frame and artificial heart valve in the present invention have a compressed structure suitable for delivery, and also have an expanded structure in a free state or after deployment. Unless otherwise specified, the structural description below is made under the expanded structure.

[0032] See also Figure 1 and Figure 2 The present invention provides an artificial heart valve 100, which is particularly suitable for replacing a diseased native aortic valve. Of course, in other embodiments, the artificial heart valve 100 can also be used to replace other native heart valves. The artificial heart valve 100 includes a valve frame 10, a membrane 30 and at least two artificial valve leaflets 50. The membrane 30 is connected to the valve frame 10 on the radial inner side of the valve frame 10, and the artificial valve leaflets 50 are connected to the membrane 30 and the valve frame 10. When the artificial valve leaflets 50 are relatively open, the artificial valve 100 allows antegrade blood flow (such as from the left ventricle to the aorta) to pass through, and when the artificial valve leaflets 50 are relatively closed, the retrograde blood flow is inhibited.

[0033] The valve frame 10 is generally annular and includes a plurality of grids, which can be converted between a radially compressed structure and a radially expanded structure. Specifically, the valve frame 10 can be made of any suitable plastic expandable material (e.g., stainless steel, cobalt-chromium alloy) or self-expanding material (e.g., nickel-titanium alloy) through a laser cutting process. When the valve frame 10 is made of a plastic expandable material, the valve frame 10 and the entire artificial heart valve 100 can be crimped into a radially compressed structure on a delivery catheter using a crimping tool; after the artificial heart valve 100 is delivered to a predetermined position, it is expanded by an inflatable balloon, so that the valve frame 10 is converted to an expanded structure. When the valve frame 10 is made of self-expanding material, the valve frame 10 and the entire artificial heart valve 100 can be creased into a radially compressed structure on the delivery catheter by a crimping tool and the compressed structure can be maintained by a sheath tube sleeved on the artificial heart valve 100; after the artificial heart valve 100 is delivered to a predetermined position, the artificial heart valve 100 can be pushed out of the sheath tube, and the valve frame 10 and the entire artificial heart valve 100 automatically expand to their functional size.

[0034] Combined diagram Figures 1 to 4 The valve frame 10 includes a row of outflow row grids 111, a row of inflow row grids 115, and at least one row of intermediate row grids 113. The inflow row grids 115 define the inflow end 119 of the valve frame 10 (i.e., the end receiving antegrade blood flow), the outflow row grids 111 define the outflow end 117 of the valve frame 10 (i.e., the end axially opposite to the inflow end), and the intermediate row grids 113 are located between the inflow row grids 115 and the outflow row grids 111. In some embodiments, two rows of intermediate row grids 113 may be provided between the inflow row grids 115 and the outflow row grids 111, hereinafter referred to as the first row of intermediate row grids and the second row of intermediate row grids.

[0035] Specifically, according to Figure 3 and Figure 4 In order from top to bottom:

[0036] The outflow grid 111 is a hexagonal grid formed by a first row of wave rods 12, a second row of wave rods 13 opposite to the first row of wave rods 12, and a plurality of first axial vertical rods 123 correspondingly connecting the troughs G of the first row of wave rods 12 and the peaks F of the second row of wave rods 13.

[0037] The first middle row grid 113 is a quadrilateral or diamond grid formed by connecting the second row of wave rods 13 and the third row of wave rods 14 opposite to the second row of wave rods 13, wherein the troughs G of the second row of wave rods 13 are connected one-to-one with the peaks F of the third row of wave rods 14.

[0038] The second middle row grid 113 is a quadrilateral or diamond grid formed by connecting the third row of wave rods 14 and the fourth row of wave rods 15 opposite to the third row of wave rods 14, wherein the troughs G of the third row of wave rods 14 are connected one-to-one with the peaks F of the fourth row of wave rods 15.

[0039] The row of inflow grids 115 is a hexagonal grid formed by the fourth row of wave rods 15, the fifth row of wave rods 16 opposite to the fourth row of wave rods 15, and a plurality of second axial vertical rods 156 correspondingly connecting the troughs G of the fourth row of wave rods 15 and the peaks F of the fifth row of wave rods 16.

[0040] The first row of corrugated rods 12, the second row of corrugated rods 13, the third row of corrugated rods 14, the fourth row of corrugated rods 15, and the fifth row of corrugated rods 16 each include a plurality of end-to-end connected support rods Z. The opposing ends of two adjacent support rods Z are connected at a joint portion 17 and form an angle (preferably an obtuse angle). One of two circumferentially adjacent joint portions 17 forms a crest F of the corresponding corrugated rod 12, 13, 14, 15, 16, while the other forms a trough G of the corresponding corrugated rod 12, 13, 14, 15, 16. Since each row of corrugated rods 12, 13, 14, 15, 16 is cut and manufactured through the same laser cutting process, the width and length of each support rod Z are substantially consistent.

[0041] Please refer to Figures 3 to 8 Each joint portion 17 includes a solid portion 171 and a recessed portion 173 radially extending through the solid portion 171. The opposing ends of two adjacent rods Z are smoothly connected to the solid portion 171 on either side of the recessed portion 173, and the recessed portion 173 also has a smooth rounded shape. Specifically, the opposing ends of two adjacent rods Z are smoothly connected to the solid portion 171 on either side of the recessed portion 173, preferably with a rounded transition. The rounded shape of the recessed portion 173 can be a "U" shape, an inverted "U" shape, a semicircle, an arc, or the like. The opening of the vacancy 173 at the wave crest F corresponding to the wave rod 12, 13, 14, 15, 16 is axially oriented toward the wave trough G. As an example, the rounded shape of the vacancy 173 is an inverted "U" shape; the opening of the vacancy 173 at the wave trough G corresponding to the wave rod 12, 13, 14, 15, 16 is axially oriented toward the wave crest F. As an example, the rounded shape of the vacancy is a "U" shape.

[0042] Compared with the joint portion 17 at the crest F of the first row of wave rods 12 that only connects two adjacent rods Z, the joint portion 17 at the trough G of the second row of wave rods 13 that only connects two adjacent rods Z, the joint portion 17 at the crest F of the third row of wave rods 14 that only connects two adjacent rods Z, the joint portion 17 at the trough G of the third row of wave rods 14 that only connects two adjacent rods Z, the joint portion 17 at the crest F of the fourth row of wave rods 15 that only connects two adjacent rods Z, and the joint portion 17 at the trough G of the fifth row of wave rods 16 that only connects two adjacent rods Z, the first In addition to connecting the two adjacent support rods Z, the joint portion 17 at the wave trough G of the row wave rod 12 is also connected to one end of the first axial vertical rod 123; in addition to connecting the two adjacent support rods Z, the joint portion 17 at the wave crest F of the second row wave rod 13 is also connected to the other end of the first axial vertical rod 123; in addition to connecting the two adjacent support rods Z, the joint portion 17 at the wave trough G of the fourth row wave rod 15 is also connected to one end of the second axial vertical rod 156; and the joint portion 17 at the wave crest F of the fifth row wave rod 16 is also connected to the other end of the second axial vertical rod 156.

[0043] Compared to other joint portions 17, the joint portion 17 connecting the first axial vertical rod 123 or the second axial vertical rod 156 further includes an extension portion 175 extending from the solid portion 171 toward the first axial vertical rod 123 or the second axial vertical rod 156. The width of the extension portion 175 gradually decreases from the solid portion 171 toward the first axial vertical rod 123 or the second axial vertical rod 156, allowing the joint portion 17 to smoothly transition to the first axial vertical rod 123 or the second axial vertical rod 156. Specifically, the extension portion 175 of the joint portion 17 located at the wave trough G extends downward until it smoothly transitions to the first axial vertical rod 123 or the second axial vertical rod 156, and the extension portion 175 of the joint portion 17 located at the wave crest F extends upward until it smoothly transitions to the first axial vertical rod 123 or the second axial vertical rod 156.

[0044] It is worth noting that Figures 5 to 8 As shown, in each joint portion 17, the width W1 of the solid portion 171, the width W2 of the vacant portion 173, and the width W3 of the support rod Z satisfy the following relationship:

[0045] W1≥2W3+W2

[0046] That is, the width W1 of the solid portion 171 is greater than or equal to the sum of twice the width W3 of the support rod Z and the width W2 of the vacant portion 173 .

[0047] contrast Figure 3 and Figure 9 , combined with the graph Figures 4 to 8In the technical solution described above, the opposite ends of the two adjacent struts Z are smoothly connected to the solid part 171 on both sides of the vacant part 173 of the joint part 17. The vacant part 173 also has a smooth shape, and the width W1 of the solid part 171 is greater than or equal to the sum of 2 times the width W3 of the strut Z and the width W2 of the vacant part 173, thereby ensuring the structural stability of the joint part 17. When the valve frame 10 is converted between the radial compression structure and the radial expansion structure, based on the existence of the space of the vacant part 173, the joint part 17 can basically not deform and maintain its shape. If the position where the strut Z is smoothly connected to the solid part 171 is deformed, the stress concentration on the opposite ends of the two adjacent struts Z can be reduced or eliminated, thereby helping each grid 111, 113, and 115 to deform evenly during the structural conversion process of the valve frame 10, thereby making the shape of the entire valve frame 10 uniform.

[0048] More specifically:

[0049] The width W3 of the struts Z ranges from 0.3 mm to 0.6 mm, the width W2 of the recesses 173 ranges from 0.1 mm to 1 mm, and the width W1 of the solid portion 171 is at least 0.7 mm. The width W2 of the recesses 173 must be larger than the diameter of the laser cutter spot while also taking into account the diameter of the entire valve stent 10 in the compressed configuration to facilitate transcatheter delivery.

[0050] The height H1 of the solid portion 171 is set to be greater than the sum of the width W3 of the support rod Z and the height H2 of the vacant portion 173, that is, H1 ≥ W3 + H2. The height of the solid portion 171 outside the vacant portion 173 (i.e., H1-H2) is preferably in the range of 0.3 mm to 1 mm to increase the strength of the entire joint portion 17. The height H2 of the vacant portion 173 is set to no more than 2 mm, which provides sufficient space to protect the vacant portion 173 from deformation of the opposite ends of the support rods Z located on both sides of the vacant portion 173, thereby reducing the overall height of the entire joint portion 17.

[0051] The extension portion 175 smoothly transitions to connect the axial vertical rods 123 and 156 in the form of a rounded transition or a slanted transition, so as to improve the connection strength between the corresponding joint portion 17 and the first axial vertical rod 123 or the second axial vertical rod 156, ensure the stability of the first axial vertical rod 123 or the second axial vertical rod 156, and also help the uniform deformation of each hexagonal grid 111, 115 during the structural conversion process of the petal frame 10.

[0052] The width W4 of the first axial vertical rod 123 or the second axial vertical rod 156 is greater than or equal to the width W2 of the vacant portion 173 , that is, W4 ≥ W2. Preferably, the size range of W4 is 0.3 mm-1 mm to ensure the strength and stability of the first axial vertical rod 123 or the second axial vertical rod 156 itself.

[0053] Combine Figures 1 to 4 and Figure 8 As shown, among the multiple first axial vertical rods 123, the widths of three circumferentially spaced first axial vertical rods 123 are larger than those of other first axial vertical rods 123. The three first axial vertical rods 123 are respectively used to connect the lugs 53 of adjacent artificial leaflets 50. Due to the increase in width, the area for the lugs 53 to wrap around and contact is increased, thereby improving the connection stability.

[0054] Combine Figure 1 、 Figure 2 and Figure 10 The coating 30 is at least provided on the radial inner side of the valve frame 10, and is used to block the blood flow through the grid covered by the coating 30, helping to form a seal between the artificial heart valve 100 and the native valve ring. In order to prevent the blockage of the coronary artery orifice, the coating 30 covers the other grids 113 and 115 except the outflow row grid 111, that is, the outflow row grid 111 is not covered by the coating. The material of the coating 30 can be, but is not limited to, polymer materials such as polyethylene terephthalate (PET). The coating 30 is generally in the shape of a long strip in the flattened state, and its outflow end edge 31 is set in a wavy shape to correspond to the various struts Z that wrap the second row wave rod 13 and are sutured and connected by sutures 70.

[0055] like Figure 11 As shown, there are three artificial leaflets 50, which can be formed from animal pericardial tissue (such as bovine pericardium, porcine pericardium) or suitable biocompatible synthetic materials. Each artificial leaflet 50 includes a leaflet body 51 and lugs 53 extending from both sides of the leaflet body 51. The leaflet body 51 has a matching edge 511 (or free edge) located on the outflow side of the lug 53, and a fan-shaped fixed edge 513 located on the inflow side of the lug 53. The lugs 53 of adjacent leaflets 50 can be connected together to form a lug joint 55. The lug joint 55 is first wrapped around the first axial vertical rod 123 with increased width, and then sutures 70 are used to sew or tie around the lug joint 55 to form a connection between the valve frame 10 and the lug joint 55.

[0056] See also Figure 12 and Figure 13The fixed edge 513 of the artificial valve leaflet 50 is fixed to the membrane 30 by suture 70, and the left and right side edges 33 and 35 of the membrane 30 are sutured and fixed by suture 70 to form a cylindrical shape. Then, the combination of the artificial valve leaflet 50 and the membrane 30 is connected to the valve frame 10 by suture 70.

[0057] Specifically, the fixed edge 513 of the artificial valve leaflet 50 is fixed to the covering 30 by means of a flat stitch using sutures 70, and the left and right edges 33 and 35 of the covering 30 are also fixed by means of a flat stitch using sutures 70. A flat stitch is a stitch in which the suture 70 extends in a straight line between the needle entry point and the needle exit point and lies flat against the surface of the component being stitched. The flat stitching between the artificial valve leaflet 50 and the covering 30, as well as the flat stitching between the edges 33 and 35 on both sides of the covering 30, helps reduce the amount of suture 70 used and the radial space occupied by the suture 70, effectively reducing the radial dimensions of the artificial heart valve 100 in the radially compressed configuration, facilitating transcatheter delivery.

[0058] See also Figure 14 , combined Figure 1 and Figure 3 The coating 30 is connected to at least the struts Z of the middle row of grids 113, i.e., the struts Z of the second row of rods 13, the struts Z of the third row of rods 14, and the struts Z of the fourth row of rods 15, by means of sutures 70 in a winding stitch manner. It is understood that the coating 30 can also be connected to the fifth row of rods 16 by means of sutures 70 in a winding stitch manner. A winding stitch is a stitch that forms a coil or turn 72 around the strut Z between the needle exit and needle entry points. During the transition of the valve frame 10 between the radially compressed configuration and the radially expanded configuration, the coating 30 will expand and contract axially and circumferentially relative to the struts Z. The winding stitch allows relative sliding between the coil or turn 72 and the struts Z, thereby preventing the coating 30 from tearing. Preferably, at least two turns 72 are wound around each strut Z, and the distance between two adjacent turns 72 does not exceed 2 mm to ensure the reliability of the connection between the coating 30 and the struts Z.

[0059] See also Figure 15 and Figure 16During the opening and closing of the artificial valve leaflet 50, all parts of the artificial valve leaflet 50, including the lug 53 and the abutting edge 511, are no higher than the position of the trough G of the wave bar forming the free end of the outflow row grid 111, that is, the position of the trough G of the first row of wave bars 12. On the one hand, the valve frame 10 can completely isolate the artificial valve leaflet 50 from the native tissue surrounding the implantation location of the artificial heart valve 100, preventing the native tissue from interfering with the normal opening and closing of the artificial valve leaflet 50. On the other hand, a gap X exists between the abutting edge 511 of the artificial valve leaflet 50 and the free end of the outflow row grid 111. The axial height of this gap X is at least equal to the axial height of the strut Z of the first row of wave bars 12. This gap X allows a coronary catheter to pass through it, presetting conditions for possible subsequent coronary treatment.

[0060] See also Figure 17 The artificial heart valve 100 provided by the present invention can be used alone to replace the diseased native aortic valve AV, and the outflow grid 111 is located above the direction shown in the figure.

[0061] See also Figure 18 The artificial heart valve 100 provided by the present invention can be used with a docking device 200, such as an anchoring ring, a spiral anchoring coil, an anchoring frame, etc., to replace the diseased native mitral valve MV, and the outflow grid 111 is located below the direction shown in the figure.

[0062] See also Figure 19 The artificial heart valve 100 provided by the present invention can be used with a docking device 200, such as an anchoring ring, a spiral anchoring coil, an anchoring frame, etc., to replace the diseased native tricuspid valve TV, and the outflow grid 111 is also located below the direction shown in the figure.

[0063] The above description is only a preferred specific implementation method of the present invention. The protection scope of the present invention is not limited to the embodiments listed above. Any simple change or equivalent replacement of the technical solution that can be obviously obtained by any technician familiar with this technical field within the technical scope disclosed in the present invention falls within the protection scope of the present invention.

Claims

1. A valve frame, generally annular in shape, capable of switching between a radially compressed configuration and a radially expanded configuration; the valve frame comprising a row of inflow grids, a row of outflow grids, and at least one row of intermediate grids, the intermediate grids being located between the inflow grids and the outflow grids, characterized in that: The inflow row grid, the outflow row grid and the middle row grid all include two rows of wave rods that are opposite to each other and connected, and each row of the wave rods includes a plurality of support rods, and the opposite ends of two adjacent support rods are connected at a joint part; the joint part includes a solid part and a vacant part that radially passes through the solid part, and the opposite ends of two adjacent support rods are smoothly connected to the solid part on both sides of the vacant part, and the vacant part also has a smooth shape, and the opening of the vacant part corresponding to the crest of the wave rod is axially facing the trough, and the opening of the vacant part corresponding to the trough of the wave rod is axially facing the crest; the width of the solid part is greater than or equal to the sum of twice the width of the support rod and the width of the vacant part; the joint part is used to help each of the grids to deform evenly during the structural transformation of the valve frame.

2. The valve frame according to claim 1, wherein: The width of the support rod ranges from 0.3 mm to 0.6 mm, and the width of the gap ranges from 0.1 mm to 1 mm.

3. The valve frame according to claim 1, wherein: The height of the solid portion is greater than the sum of the width of the support rod and the height of the vacant portion.

4. The valve frame according to claim 3, wherein: The height of the gap does not exceed 2 mm.

5. The valve frame according to any one of claims 1 to 4, characterized in that: The inflow row grid and the outflow row grid further include a plurality of axial vertical rods, respectively, and each of the two ends of the axial vertical rod is connected to a joint portion, so that the inflow row grid and the outflow row grid are both hexagonal; the joint portion also includes an extension portion extending from the solid portion toward the axial vertical rod, and the width of the extension portion gradually decreases from the solid portion toward the axial vertical rod, so that the joint portion smoothly transitions to connect with the axial vertical rod.

6. The valve frame according to claim 5, wherein: The transition connection is in the form of a rounded corner transition or a slanted line transition.

7. The valve frame according to claim 5, wherein: The width of the axial vertical rod is greater than the width of the gap.

8. An artificial heart valve, characterized in that: The valve frame comprises the valve frame according to any one of claims 1 to 7, a covering, and at least two artificial valve leaflets that can open and close relative to each other; The covering membrane is arranged on the radial inner side of the valve frame and is connected to at least the struts of the middle row of grids by sutures; The artificial valve leaflet is connected to the membrane by sutures.

9. The artificial heart valve according to claim 8, wherein The edges of both sides of the covering are fixed by suturing with sutures in a flat seam manner, thereby forming a cylindrical shape.

10. The artificial heart valve according to claim 8, wherein The artificial valve leaflet and the covering membrane are fixed by suturing in a flat-seam manner using sutures.

11. The artificial heart valve according to claim 8, wherein The coating is connected to the support rods by sutures in a winding stitching manner, and at least two turns of wire are wound around each support rod, and the distance between two adjacent turns of wire does not exceed 2 mm.

12. The artificial heart valve according to any one of claims 8 to 11, characterized in that: The outflow row grid is not covered by the membrane, and during the opening and closing of the artificial valve leaflet, each part of the artificial valve leaflet is no higher than the position of the trough of the wave rod constituting the free end of the outflow row grid.