Prosthetic heart valve

Abstract

The present disclosure discloses a prosthetic heart valve (110A, 311) comprising a support frame (110, 210) having a distal end (117), a proximal end (118), and three rows of adjacently placed hexagonal cells (211A, 211B, or 211C) between the distal end (117) and the proximal end (118). The three rows include an upper row (111), a middle row (112) and a lower row (113). The lower row (113) is positioned toward a distal end (117) of the support frame (110, 210). The support frame (110, 210) includes an expanded state and a curled state. Each hexagonal unit (211A, 211B or 211C) has a plurality of straight strut members (b, b1, b2, c, d) and a plurality of V-shaped strut members (a) having two arms. The upper row (111) occupies 50-55% of the total length (L) of the support frame (110, 210). In the curled state, high-density regions corresponding to the V-shaped strut members (a) and low-density regions corresponding to the straight strut members (b, b1, b2, c, d) are alternately formed along the length (L) of the support frames (110, 210).

Description

Technical Field

[0001] This disclosure relates to an artificial heart valve. More specifically, the present invention relates to a percutaneously implantable artificial heart valve. Background Art

[0002] The human heart is a hollow organ with four chambers, separated by their respective valves (aortic valve, pulmonary valve, tricuspid valve, and mitral valve). The valves of the human heart can be affected by a variety of diseases that lead to cardiac dysfunction, resulting in serious cardiovascular damage or death. Diseased heart valves may be narrowed and / or dysfunctional. Narrowed valves cannot open sufficiently to allow adequate blood flow. Dysfunctional valves cannot close completely, causing more blood to flow back than a normally functioning valve.

[0003] Recently, a percutaneous catheter insertion technique has been developed for the introduction and implantation of artificial heart valves using a flexible catheter. In this technique, the artificial valve is mounted by curling it at the distal end of a flexible catheter. The catheter is introduced into the patient's blood vessel (such as the femoral or carotid artery) and advanced through the vessel until the curled valve reaches the implantation site. This allows the valve to expand to its functional size at the location of a defective natural valve.

[0004] Despite advanced catheter insertion techniques, interventional cardiologists often find it difficult to accurately place and implant artificial heart valves into the natural valve rings. Because the implantation process relies heavily on the visibility of the artificial heart valve via fluoroscopy, poor visibility during implantation makes it challenging for interventional cardiologists to determine the valve's position relative to the natural valve rings.

[0005] Therefore, there is a need for an artificial heart valve that provides good visibility under fluorescence fluoroscopy, so that interventional cardiologists can accurately place and implant the artificial heart valve into the natural valve ring. SUMMARY OF THE INVENTION

[0006] This invention discloses an artificial valve comprising a support frame having a distal end, a proximal end, and three rows of hexagonal units adjacent to each other between the distal and proximal ends. These three rows include an upper row, a middle row, and a lower row. The lower row faces the distal end of the support frame. The support frame includes an unfolded state and a rolled-up state. Each hexagonal unit has multiple straight strut members and multiple V-shaped strut members with two arms. The upper row occupies 50-55% of the total length of the support frame. In the rolled-up state, along the length of the support frame, high-density regions corresponding to the V-shaped strut members alternate with low-density regions corresponding to the straight strut members.

[0007] The foregoing and other features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] A better understanding of the above overview and the following detailed description of illustrative embodiments can be obtained by reading in conjunction with the accompanying drawings. Exemplary constructions of this disclosure are shown in the drawings for illustrative purposes. However, this disclosure is not limited to the specific methods and means disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not drawn to scale. Where permissible, similar elements are represented by the same numerals.

[0009] In the following figures and description, the terms "frame," "support," "frame structure," "scaffolding structure," "supporting frame," or "scaffolding" refer to the metal frame of the present invention. These terms are used interchangeably but have the same meaning. The term "valve" or "artificial valve" refers to the artificial valve of the present invention assembled using a frame structure and other components such as leaflets, skirts, etc., of animal tissue. These terms are also used interchangeably. The term "natural valve" refers to the natural valves in the human heart.

[0010] Figure 1 This is a perspective view of the support frame according to an embodiment of the present disclosure.

[0011] Figure 1A According to embodiments of this disclosure Figure 1 Front view of the supporting frame.

[0012] Figure 1B Artificial valves according to embodiments of the present disclosure are depicted.

[0013] Figure 2 According to one embodiment of the present invention, when the cylindrical frame is vertically cut along its length L and flattened in a plane, Figure 1 and 1A A partial view of the battery's supporting frame.

[0014] Figure 3 According to embodiments of this disclosure, when rolled up on the balloon of the delivery system, Figure 1B A schematic diagram of an artificial valve. DETAILED DESCRIPTION

[0015] Throughout this specification, references to "an embodiment," "embodiment," or similar language mean that certain specific features, structures, or characteristics described in connection with that embodiment are included in at least one embodiment. Therefore, the phrases "in one embodiment," "in a particular embodiment," and similar language appearing throughout this specification may, but do not necessarily, refer to the same embodiment, but rather to "one or more, but not all, embodiments," unless otherwise expressly stated.

[0016] The terms “including,” “comprising,” “having,” and other similar words mean “including, but not limited to,” unless otherwise expressly stated. Unless otherwise expressly stated, the list of enumerated items does not imply that any or all items are mutually exclusive and / or mutually inclusive. Unless otherwise expressly stated, the terms “a,” “an,” and “the” also mean “one or more.”

[0017] While exemplary embodiments of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the specific order disclosed. For example, the operations described in order may be rearranged or performed simultaneously in certain circumstances. Furthermore, the description and disclosure provided in connection with a particular embodiment are not limited to that embodiment and can be applied to any embodiment disclosed herein. Additionally, for simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, methods, and apparatus can be used in conjunction with other systems, methods, and apparatuses.

[0018] Furthermore, the features, advantages, and characteristics described in the embodiments can be combined in any suitable manner. Those skilled in the art will recognize that these embodiments can be practiced without one or more specific features or advantages of a particular embodiment. In other instances, additional features and advantages that may not be present in all embodiments may be recognized in certain embodiments. These features and advantages of the embodiments will become more apparent from the following description and the appended claims, or may be learned by practicing the embodiments set forth below.

[0019] The disclosed embodiments of the radially expandable and compressible support frame, which is modified from multiple leaflets made of animal tissue, can be used for any artificial valve, such as an artificial aortic heart valve. Artificial valves with embodiments having the support frame offer numerous advantages, which will be described in further detail later.

[0020] The terms “up,” “middle,” “down,” “vertical,” and “horizontal” refer to the specific way an item or component is displayed in a diagram, rather than to its absolute direction or location.

[0021] This invention discloses a balloon-expandable artificial heart valve (or artificial valve) that can be implanted into the narrowed aortic orifice via catheter insertion technology.

[0022] A representative embodiment of this disclosure provides an artificial valve having an expandable and contractile flexible support frame, multiple leaflets (preferably three leaflets) formed of animal tissue, and an annular skirt made of fabric attached to the frame. Each leaflet has a rectangular portion at one end and a semi-circular portion (scalloped) at the other end, and has two connection nodes for connecting the leaflet to a connecting post. The scalloped portion is secured to the lower part of the frame and the skirt by stitching.

[0023] The support frame design facilitates precise positioning and deployment of the prosthetic valve during implantation under fluoroscopic guidance. Furthermore, the length of the support frame limits its protrusion at the LVOT to a maximum of 4 mm, preferably approximately 3.3-3.5 mm, after precise implantation. This eliminates any possibility of myocardial interference carrying electrical signals or interference with the normal function of the anterior mitral valve leaflet. The overall length of the support frame ensures patency of the coronary ostia by maximal openings in the upper row of the support frame, extending into the ascending aorta after precise implantation. The support frame design also makes the prosthetic valve mechanically stronger, allowing for a reduction in strut thickness to 350 micrometers without compromising the mechanical strength (radial strength and fatigue resistance) of the support frame.

[0024] Figure 1 and 1A This is an embodiment of the support frame 110 of an exemplary embodiment of an artificial valve. Figure 1 This is a perspective view of the supporting frame 110. Figure 1A It depicts the view when viewed from direction a. Figure 1 The figure shows a front view of the support frame 110. As shown, the support frame 110 is a cylindrical scaffolding structure with a diameter of D and a length of l. The support frame 110 has a distal end 117 and a proximal end 118. Furthermore, three rows of hexagonal units are arranged between the distal end 117 and the proximal end 118, namely, the upper row 111, the middle row 112, and the lower row 113. The hexagonal units in a single row have the same cross-sectional area; for example, the hexagonal units in the upper row 111 have the same cross-sectional area. However, the cross-sectional areas of the hexagonal units in different rows can be the same or different; for example, the cross-sectional area of ​​the units in the upper row 111 can be the same or different from the cross-sectional area of ​​the hexagonal units in the middle row 112 or the lower row 113. In one embodiment, the area of ​​the hexagonal units in the same row is different from the area of ​​the hexagonal units in one or more remaining rows.

[0025] The support frame 110 may include a plurality of connecting posts 114, the function of which is to connect one or more leaflets to the support frame 110. For example... Figure 1A As shown, there are three connecting posts 114 located on the upper row 111, which are set at 120 degrees relative to each other.

[0026] Figure 1B Depicting the use Figure 1-1A An artificial valve 110A with a diameter D and a length L is constructed from a supporting frame 110. (As shown...) Figure 1BAs depicted, there are three connecting posts 114 in the upper row 111, positioned at 120° to each other. Connecting nodes of corresponding leaflets are attached to each connecting post 114. The connecting nodes of two leaflets are sewn to the connecting posts 114 of the support frame 110. The fan-shaped portions 115 of the leaflets are connected to the middle row 112 and the lower row 113 by sewing to the unit posts and skirt 116. Furthermore, the skirt 116 is attached to the support frame 110, covering the middle row 112 and the lower row 113.

[0027] Blood enters from the distal end 117 (inflow / lower end) of the prosthetic valve 110A and exits through the proximal end 118 (outflow / upper end). Therefore, after implantation of the prosthetic valve 110A, the lower end 117 faces the left ventricle and the upper end 118 faces the ascending aorta.

[0028] Figure 2 It depicts the cylindrical portion of the support frame 110 along its length L (passing through) Figure 1A The XX shown is vertically cut and flattened. Figure 1-1A A partial basic view of the support frame 110. This basic support frame corresponds to a portion of the support frame 110 and is located within... Figure 2 Depicted as 210. The support frame 210 includes multiple repeating support members a, b, b1, b2, c, and d, which are interconnected to form a support of hexagonal units. These hexagonal units are interconnected to create a honeycomb-like support frame 110. Figure 1-1A In one embodiment, the support frame 110 has three rows of hexagonal units, namely the upper row 111, the middle row 112 and the lower row 113, which respectively include hexagonal units 211A, 211B and 211C.

[0029] The support frame 210 has two ends, namely 212 and 213. The artificial valve 110A is constructed and implanted in such a way that blood flows in through end 212 and flows out from end 213. Therefore, end 212 of the support frame 210 is the "inflow end" (corresponding to...). Figure 1 The distal end 117 in / 1A / 1B), and the end 213 is the "outflow end" (corresponding to the end 117 in / 1A / 1B). Figure 1 (Proximal 118 in / 1A / 1B). After the artificial valve 110A is implanted through the natural aortic valve annulus, blood will enter the artificial valve 110A from distal 212 and exit the artificial valve 110A from distal 213. Therefore, distal 212 will face the left ventricle and distal 213 will face the ascending aorta.

[0030] like Figure 2As shown, each hexagonal unit 211A, 211B, or 211C has six sides corresponding to the six support members a, b, b1, b2, c, and d. The sides of hexagonal units 211A, 211B, or 211C are shared with the sides of adjacent hexagonal units 211A, 211B, or 211C. Figure 2 As shown, the strut member "A" of each hexagonal unit 211A, 211B, or 211C includes two arms forming a V-shape at an angle α. When the support frame 110 / 210 is in its fully deployed state, the angle α between the two arms of the V-shaped strut member "A" in each hexagonal unit 211A, 211B, or 211C can be from 120° to 135° (preferably 125° to 130°). The angle α between the two arms of the V-shaped strut member "A" can be different for different sizes (diameters) of the artificial valve 110A.

[0031] The strut members b, b1, b2, c, and d of hexagonal units 211A, 211B, or 211C are straight strut members and connect two pairs of V-shaped strut members "a". In one embodiment, the straight strut members b, b1, and b2 are of the same length. The straight strut members c and d may be of the same or different lengths. In one embodiment, the straight strut members b, b1, and b2 are longer than the straight strut members c and d. These features make the cross-sectional area of ​​hexagonal unit 211A larger than that of hexagonal units 211B and 211C. The thickness of the plurality of straight strut members b, b1, b2, c, d, and the plurality of V-shaped strut members "a" is 350 micrometers.

[0032] Although support members b, b1, b2, c, and d are described as straight support members, they may be replaced by one or more curved support members, angled support members, curved support members, etc. This also falls within the scope of the teachings of this disclosure.

[0033] In one embodiment, the hexagonal units 211A in the upper row 111 have support members 'a' and 'b'. The structure of the hexagonal unit 211A has two pairs of V-shaped support members 'a' and two straight support members 'b'. The hexagonal units 211A are interconnected to form the upper row 111 of the hexagonal units 211A. Two adjacent units 211A share a common straight support member 'b'. Each straight support member serving as a connecting column 215 consists of straight support members b1 and b2, instead of a single straight support member 'b'.

[0034] Straight strut members b1 and b2 form rectangular openings in the upper row 111 for connecting columns 215, where the attachment nodes of the leaflets are fixed. In one embodiment, there are three pairs of such straight strut members b1 / b2 in the support frame 110, positioned at 120° to each other, forming three connecting columns 215. Each connecting column 215 has a rectangular opening formed by the straight strut members b1 and b2. Methods known in the prior art for attaching leaflets to such connecting columns 215 are available.

[0035] Similarly, in one embodiment, the hexagonal units 211B of the middle row 112 have support members 'a' and 'c'. The structure of the hexagonal unit 211B has two pairs of V-shaped support members 'a' and two straight support members 'c'. The hexagonal units 211B are interconnected to form the middle row 112. Two adjacent hexagonal units 211B share a common straight support member 'c'.

[0036] Similarly, the hexagonal unit 211C in the lower row 113 has support members 'a' and 'd'. The structure of the hexagonal unit 211C has two pairs of V-shaped support members 'a' and two straight support members 'd'. The hexagonal units 211C are interconnected to form the lower row 113. Two adjacent hexagonal units 211C share a common straight support member 'd'.

[0037] The interconnection points of all support members a, b, b1, b2, c, and d are circular. For example, in one embodiment, two V-shaped support members "a" intersect to form a U-shape, as shown below. Figure 2 As shown by the "e" in the text. From Figure 2 As can be clearly seen, all the connection points are U-shaped. This U-shape helps to disperse excessive stress concentration at these intersections.

[0038] The total length of the support frame 110 is L. In one embodiment, the upper row 111, made of hexagonal units 211A, occupies approximately 50%-55% of the total length of the support frame 110, preferably 52%-53%. The middle row 112 and the lower row 113, made of hexagonal units 211B and 211C, together occupy the remaining length of the support frame 110. Therefore, the cross-sectional area of ​​hexagonal unit 211A is larger than the cross-sectional area of ​​hexagonal units 211B or 211C.

[0039] The honeycomb structure of the support frame 110 makes the frame structure mechanically stronger, which allows for a reduction in strut thickness, i.e., its radial strength and fatigue resistance, without compromising the mechanical strength of the support frame 110. The lower strut thickness results in a reduced profile of the artificial valve 110A when coiled onto the balloon of the delivery catheter. This lower profile facilitates the manipulation of the coiled artificial valve 110A through the patient's vascular system to its target location in the aorta. In one embodiment, the support frame 110 is made of a metallic alloy, such as a cobalt-chromium-molybdenum alloy, such as MP35N or alloy L605. When made of alloy MP35N, the strut member thickness of the support frame 110 in one embodiment is 350 micrometers. The support frame 110 has a radial strength of at least 100 Newtons, preferably in the range of 150-200 Newtons. The support frame 110 successfully passed a durability test of 600 million cycles under the conditions specified in ISO 5840.

[0040] like Figure 2 As shown, hexagonal units 211B and 211C are located in the lower half of the support frame 210, i.e., towards the inflow end 212 (upstream of blood flow) of the artificial valve 110A, and positioned towards the left ventricle. The inflow end 212 of the artificial valve 110A is subjected to higher mechanical forces than the outflow end 213 of the artificial valve 110A. In one embodiment, hexagonal units 211B and 211C have a smaller cross-sectional area than hexagonal unit 211A. This results in a more compact structure for hexagonal units 211B and 211C than for hexagonal unit 211A, which gives the lower portion of the artificial valve 110A higher radial strength to withstand the higher mechanical forces at the inflow end 212.

[0041] In one embodiment of the invention, when the artificial valve 110A is precisely implanted, the protrusion of the artificial valve 110A at the LVOT is limited to a maximum of 4 mm, preferably about 3.3-3.5 mm. This eliminates any interference with the myocardium carrying electrical signals and the possibility of interfering with the normal function of the anterior mitral valve leaflet.

[0042] When the support frame 110 (and the artificial valve 110A) is in its expanded state, the total length L of the artificial valve 110A is lower, varying from 17 mm to 29 mm (for artificial valve 110A with a diameter D varying from 20 mm to 32 mm). The shorter length of the artificial valve 110A helps to eliminate blockages at the coronary ostium.

[0043] When the support frame 110 (and the artificial valve 110A) contracts from its expanded state to its coiled state, the length L of the artificial valve 110A increases and its diameter D decreases. In an exemplary embodiment, the length L of the artificial valve 110A in its coiled state increases by 21% to 24%. In another exemplary embodiment, the length L of the artificial valve 110A in its coiled state increases by 18% to 22%. In one exemplary embodiment, the diameter D of the artificial valve 110A in its coiled state decreases from 20 mm to 7 mm (for an artificial valve 110A with a nominal volume diameter of 20 mm), i.e., a reduction of more than 2.8 times. In another exemplary embodiment, the diameter D of the artificial valve 110A in its coiled state decreases from 32 mm to 7.8 mm (for an artificial valve 110A with a standard volume diameter of 32 mm), i.e., a reduction of more than 4.1 times.

[0044] During precise implantation of the artificial valve 110A, the hexagonal unit 211A is typically positioned above the natural valve, i.e., at the location of the coronary ostium. As mentioned above, the length L of the support frame 110 is relatively small, ensuring that the artificial valve 110A does not obstruct the coronary ostium. Furthermore, the hexagonal unit 211A has a larger cross-sectional area, i.e., a larger opening area. Figure 2 (Shaded area 214 in the image). This further ensures that blood flow to the coronary artery ostium is not blocked.

[0045] It is crucial to precisely implant the artificial valve 110A in the optimal location to ensure best performance. Ideally, the leaflet (tip) of the artificial valve 110A should be positioned where the tip of the natural valve would be. This is typically achieved by the operator's judgment under fluorescence imaging during implantation. The structure of the support frame 110 of the artificial valve 110A of this invention guides the operator to precisely position the artificial valve 110A during implantation (described below).

[0046] The artificial valve 110A is designed to be installed on the delivery system catheter by coiling it around the balloon of the delivery catheter.

[0047] Figure 3 An artificial valve 311 is schematically shown after being rolled up on the balloon 312 of the delivery system.

[0048] In one embodiment, the coiled artificial valve 311 exhibits alternating "dark bands" and "bright bands," as seen under fluorescence imaging. The number of "dark bands" and "bright bands" exhibited by the artificial valve 311 depends on the number of rows of hexagonal units 211A, 211B, and 211C present in the support frame 110 of the artificial valve 311.

[0049] In an exemplary embodiment, such as Figure 3As shown, the support frame 110 has three rows of hexagonal units 211A, 211B, and 211C, and the support frame 110 will exhibit four "dark bands" and three "bright bands". The area visible near the distal balloon marker 313 is the first dark band 316. The order of the areas is: first dark band 316 - first bright band 317 - second dark band 318 - second bright band 319 - third dark band 320 - third bright band 321 - fourth dark band 322. Figure 3 As shown, distal and proximal balloon markers 313 and 314 are located beyond the length of the coiled artificial valve 311 (i.e., beyond the first dark band 316 and the fourth dark band 322).

[0050] When the support frame 110 is rolled up to its rolled-up state (or curled state), the angle A between the two arms of the V-shaped strut member 'A' decreases to angle B (not shown). As angle A decreases to angle b, one or more high-density regions are formed. The arms of the V-shaped strut member 'A' move closer to each other (or cluster together), thereby increasing the material density of the support frame 110 where the V-shaped strut member 'A' is located, thus forming high-density regions. When the support frame 110 is rolled up, the clustering of the V-shaped strut member 'a' and the combined high density of the material of the support frame 110 are observed as "dark bands" under fluorescence fluoroscopy.

[0051] Due to the aggregation of the arms of the V-shaped strut member 'a', when the support frame 110 curls to its curled state (or curled condition), each straight strut member b, b1, b2, c and d approaches the adjacent straight strut member b, b1, b2, c and d.

[0052] After the support frame 110 is curled into its curled state, one or more low-density (material) regions are formed by straight strut members b, b1, b2, c, and d. The straight strut members b, b1, b2, c, and d aggregate together to increase the material density of the support frame 110. However, due to the relatively small number of straight strut members 'b', 'c', and 'd' (because each of the straight strut members 'b', 'c', and 'd' is shared by adjacent hexagonal units 211A, 211B, and 211C, respectively), the increase in material density of the support frame 110 caused by the straight strut members 'b', 'c', and 'd' is relatively smaller than the increase in material density of the support frame 110 caused by the V-shaped strut member 'a'. Therefore, the V-shaped strut member 'a' generates one or more high-density (material) regions of the support frame 110, while the straight strut members b, b1, b2, c, and d generate one or more low-density (material) regions of the support frame 110.

[0053] Therefore, under fluorescent light, due to the aggregation of the straight support components b, b1, b2, c, and d, the material density of the support frame 110 is relatively low, thus forming a "light band".

[0054] Furthermore, the material used to construct the support frame 110 facilitates the visualization of dark and bright bands. When the curled artificial valve 311 is observed under fluorescence fluoroscopy, the lowest V-shaped strut member "a" (in...) Figure 2 The middle label is marked as 1) as the first dark band 316 ( Figure 3 (As can be seen.) Figure 2 The straight support member in the lower row 113 marked as 2 in the middle is in Figure 3 It is visible as the first light band 317. Similarly, it is marked as 3 ( Figure 2 The V-shaped support component "a" in Figure 3 The second dark band 318 is visible. Thus, the support members marked 4, 5, 6, and 7 are visible as the second bright band 319, the third dark band 320, the third bright band 321, and the fourth dark band 322, respectively. In an embodiment of the invention, the support frame 110 is made of a cobalt-chromium-molybdenum alloy, such as MP35N or alloy L605.

[0055] The exemplary embodiments of the artificial valves 110A and 311 described above have support frames 110 and 210, which have three rows of hexagonal units 211A, 211B, or 211C. The artificial valves 110A and 311 can be precisely placed under fluorescence fluoroscopy by using the aortic ring aorta as a reference to locate the bright / dark bands.

[0056] Similarly, the teachings can be applied to frames for artificial valves with more than three rows of units. For example, a frame with four rows of hexagonal units will present five dark bands and four light bands. Similarly, a frame with five rows of hexagonal units will present six dark bands and five light bands. In either case, precise positioning of the coiled valve can be achieved by locating a specific light band or a specific dark band relative to the aortic annulus plane using it as a reference. In individual cases, the aortic annulus plane may be aligned with the edge of the band, or the band may be divided in two, depending on the number of rows in the frame and the size of each row. Those skilled in the art can calculate the number and size of the units and determine the criteria for precise valve positioning relative to the anatomical features of the natural valve annulus using the same principles as for any frame structure.

[0057] The teachings of this invention can also be applied to artificial valve frames made of non-hexagonal cells, provided that when the valve is located at the orifice of the human aorta, the frame structure should show alternating bright and dark bands under fluorescence fluoroscopy.

[0058] Given that the principles of the disclosed invention can be applied to many possible embodiments, it should be recognized that the embodiments shown are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims.

[0059] The scope of this invention is limited only by the appended patent claims. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on the specific application using the teachings of this invention.

Claims

1. An artificial heart valve (110A, 311), comprising: A support frame (110, 210) having a distal end (117), a proximal end (118), and three rows of hexagonal units (211A, 211B or 211C) adjacently placed between the distal end (117) and the proximal end (118), the three rows comprising an upper row (111), a middle row (112) and a lower row (113), wherein the lower row (113) is placed toward the distal end (117) of the support frame (110, 210); in, Each hexagonal unit (211A, 211B or 211C) has A plurality of straight support members (b, b1, b2, c, d), and A plurality of V-shaped strut members (a) having two arms; wherein the upper row (111) occupies 50-55% of the total length (L) of the support frame (110, 210); In which, in the curled state, high-density areas corresponding to V-shaped pillar members (a) and low-density areas corresponding to straight pillar members (b, b1, b2, c, d) are formed alternately along the length (L) of the support frame (110, 210).

2. The artificial heart valve (110A, 311) according to claim 1, characterized in that: The cross-sectional area of ​​the hexagonal units (211A) of the upper row (111) is different from the cross-sectional area of ​​the hexagonal units (211B, 211C) of the middle or lower rows (112, 113).

3. The artificial heart valve (110A, 311) according to claim 1, characterized in that: In each hexagonal unit (211A, 211B, 211C), an angle A between two arms of the V-shaped pillar member (A) is in the range of 120° to 135°.

4. An artificial heart valve (110A, 311) according to claim 1, wherein the length (L) of the support frame (110, 210) varies between 17 mm and 29 mm.

5. The artificial heart valve (110A, 311) according to claim 1, wherein the diameter (D) of the support frame (110, 210) varies between 20 mm and 32 mm.

6. An artificial heart valve (110A, 311) according to claim 1, wherein the thickness of the plurality of straight strut members (b, b1, b2, c, d) and the plurality of V-shaped strut members (a) is 350 microns.

7. The artificial heart valve (110A, 311) according to claim 1, characterized in that: The support frame (110, 210) is made of cobalt-chromium-molybdenum alloy.

8. An artificial heart valve (110A, 311) according to claim 1, wherein the support frame (110, 210) includes a plurality of engagment posts (114) to attach one or more leaflets to the support frame (110, 210).

9. The artificial heart valve (110A, 311) according to claim 1, wherein: A skirt (116) is attached to the support frame (110, 210), covering the middle row (112) and the lower row (113).

10. An artificial heart valve (110A, 311) according to claim 1, wherein when the support frame (110, 210) contracts from its expanded state to its curled state, the length (L) of the support frame (110, 210) increases and the diameter D of the support frame (110, 210) decreases.

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