TAVI deployment accuracy - improved stent frame

Abstract

An artificial heart valve may include a balloon-expandable frame extending between an inlet end and an outlet end, a plurality of artificial valve leaflets mounted within the frame, and an inner skirt positioned between the plurality of artificial valve leaflets and the frame. The frame may include a first row of rhomboid cells at the inlet end of the frame, a second row of rhomboid cells, and a row of outlet cells positioned at the outlet end of the frame. Each cell in the row of outlet cells does not have to be rhomboid, and in the expanded state of the frame, each cell in the row of outlet cells may have a larger area than each cell in the first and second rows of rhomboid cells combined. Each outlet cell may be defined at least partially by a commissure attachment shape, and each outlet cell may lack symmetry.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 579,378, filed on August 29, 2023. The disclosure of this application is incorporated herein by reference in its entirety.

Background Art

[0002] Cardiac valve diseases, particularly those of the aortic and mitral valves, are significant health problems in the United States. One option for treating cardiac valve diseases is valve replacement. Artificial heart valves, including collapsible / expandable heart valves intended for surgical heart valves and transcatheter aortic valve replacement or implantation ( "TAVR" or "TAVI") or transcatheter mitral valve replacement ( "TMVR"), are known in the patent literature. For example, surgical or mechanical heart valves can be sutured to a patient's native annulus during open - heart surgery. Collapsible / expandable heart valves can be delivered into a patient's body via a tubular delivery device such as a catheter, trocar, laparoscopic instrument, etc., to avoid more invasive procedures such as full sternotomy, open - heart surgery, etc. As used herein, reference to a "collapsible / expandable" heart valve includes not only a heart valve that is formed in a small cross - section so as to be capable of being delivered into a patient's body through a tubular delivery device in a minimally invasive procedure and then expanded to an operative state when placed in place, but also a heart valve that is first folded into a small cross - section after construction and delivered into a patient's body and then expanded to an operative size when placed in place within the annulus.

[0003] Foldable / expandable artificial heart valves generally take the form of a one-way valve structure (often referred to as a valve assembly) mounted on / inside an expandable stent (the terms “stent” and “frame” are used synonymously herein). Generally, these foldable / expandable heart valves include self-expanding or balloon-expanding stents, which are often made from nitinol or another shape-memory metal or metal alloy (in the case of self-expanding stents), or steel or cobalt-chromium (in the case of balloon-expanding stents). Existing foldable / expandable TAVR devices are known to use different stent layout configurations, including linear longitudinal struts connected by a “V-shaped section” as shown in U.S. Patent No. 8,454,685, or a rhomboid cell layout as shown in U.S. Patent No. 9,326,856. Both of these patents are incorporated herein by reference. A one-way valve assembly mounted on / inside a stent includes one or more valve leaflets and may also include a cuff or skirt. The cuff can be positioned on the inner surface of the stent, i.e., the luminal surface, the outer surface of the stent, i.e., the abluminal surface, and / or both surfaces. The cuff helps ensure that blood does not simply flow around the valve leaflets when the valve or valve assembly is not optimally seated within the valve annulus. A cuff or portion of a cuff positioned on the outer surface of the stent may help prevent leakage that flows around the outside of the valve (this leakage is known as paravalvular regurgitation, or "PV" regurgitation).

[0004] A balloon-expandable valve is typically delivered to the natural valve annulus in a folded (or "crimped") state on the deflated balloon of a balloon catheter, with or without an outer sheath. Once the crimped prosthetic valve is positioned within the annulus of the natural valve to be replaced, the balloon is inflated, transitioning the balloon-expandable valve from a folded or crimped state to an expanded or deployed state. At this point, the prosthetic valve tends to retain its expanded shape. Typically, once the folded prosthetic valve is determined to be in the desired position relative to the natural annulus (for example, using fluoroscopic visualization), a fluid such as saline (usually a liquid, but sometimes a gas) is injected into the balloon catheter via a syringe (manually, automatically, or semi-automatically), thereby filling the balloon and initiating expansion, thus expanding the outer sheath of the prosthetic valve within the natural annulus.

[0005] When deploying an artificial heart valve within the natural heart annulus, the precision of deployment is generally a crucial indicator of the valve's success. For example, in aortic valve replacement, the position of the artificial valve relative to the aortic annulus and the extent to which it extends into the left ventricular outflow tract ("LVOT") can affect the valve's performance attributes, such as hemodynamics, PV regurgitation, and the need to implant a pacemaker along with the valve. Therefore, to optimize the performance attributes of the artificial heart valve, it is desirable to improve the precision with which the artificial heart valve can be positioned within the natural annulus. [Overview of the project]

[0006] According to one aspect of the present disclosure, an artificial heart valve includes a balloon-expandable frame extending between an inlet end and an outlet end, a plurality of artificial valve leaflets mounted within the frame, and an inner skirt positioned between the plurality of artificial valve leaflets and the frame. The frame may include a first row of rhomboid cells at the inlet end of the frame, a second row of rhomboid cells, and a row of outlet cells positioned at the outlet end of the frame. Each cell in the row of outlet cells does not have to be rhomboid, and in the expanded state of the frame, each cell in the row of outlet cells may define an internal area larger than the internal area defined by each cell in the first and second rows of rhomboid cells. Each cell in the row of outlet cells may be defined at least partially by a commissure attachment feature, and each cell in the row of outlet cells may lack symmetry. The frame may include a third row of rhomboid cells positioned between the first row of rhomboid cells and the second row of rhomboid cells. The first and second rows of the rhombic cells may each contain 12 cells, and the outflow cell row may contain 6 cells. The frame may include an inflow section containing the rhombic cells of the first and second rows, and an outflow section containing the outflow cell row, thereby requiring more force to extend the inflow section than the outflow section. The crossover mounting section may include a plurality of crossover mounting sections, each having a rectangular or triangular shape, each of which can be attached to one cell in the rhombic cells of the second row, and can define portions of two cells in the outflow cell row. The one cell in the rhombic cells of the second row may include two struts that form an outflow apex, which are connected to the inflow end of the corresponding crossover mounting section.Each cell in the outflow cell row can be defined by (i) a portion of one of a plurality of joint attachment shapes, (ii) struts at the outflow ends of multiple cells in the rhombic cell of the second row, and (iii) a plurality of connecting struts extending between the outflow end of one of the multiple cells in the rhombic cell of the second row and the one of the plurality of joint attachment shapes. The plurality of connecting struts may include a first connecting strut extending in the outflow direction away from the one of the multiple cells in the rhombic cell of the second row, a second connecting strut extending in the direction back from the first connecting strut toward the rhombic cell of the second row, and a third connecting strut extending from the second connecting strut toward and connecting to the one of the plurality of joint attachment shapes. The third connecting strut may be coupled to the outflow end of the one of the plurality of joint attachment shapes. The first connecting strut may have a width greater than the width of the second connecting strut.

[0007] In another aspect of the present disclosure, an artificial heart valve may include a balloon-expandable frame extending between an inlet and an outlet end, and a plurality of artificial valve leaflets mounted within the frame. The frame may include a first row of kite-shaped cells and a second row of kite-shaped cells positioned in the outlet direction relative to the first row of kite-shaped cells. Each cell in the first row may be defined by two inlet struts and two outlet struts, and each cell in the second row of kite-shaped cells may be defined by two inlet struts and two outlet struts, where the two outlet struts in the first row are the same as the two inlet struts in the second row. The two inlet struts of each cell in the first row may be wider than the two outlet struts of each cell in the first row, or the two outlet struts of each cell in the second row. The two outflow struts of each cell in the first column may be wider than the two outflow struts of each cell in the second column. The two inflow struts of each cell in the first column may be thicker than the two outflow struts of each cell in the first column or the two outflow struts of each cell in the second column. The two outflow struts of each cell in the first column may be thicker than the two outflow struts of each cell in the second column. The two inflow struts of each cell in the first column may form a first angle with respect to each other, and the two outflow struts of each cell in the first column may form a second angle with respect to each other, and the first angle is greater than the second angle. The two inflow struts of each cell in the second column can form a third angle with respect to each other, and the two outflow struts of each cell in the second column can form a fourth angle with respect to each other, the third angle being greater than the fourth angle, and the first angle being greater than the third angle.

[0008] According to another aspect of this disclosure, a method for implanting an artificial heart valve may include advancing the distal end of a delivery device to the natural aortic valve while the balloon is crimped onto the balloon at the distal end of the delivery device while the balloon is deflated. Under fluoroscopy, while the balloon is deflated, it may be confirmed that the inlet end of the artificial heart valve frame is aligned with the desired target site. After confirmation, the balloon can be inflated by passing an inflation medium through it, thereby expanding the artificial heart valve within the natural aortic valve. After expanding the artificial heart valve, the inlet end of the frame may be positioned at the desired target site. Between confirming and expanding the artificial heart valve, the delivery device cannot move in parallel with respect to the natural aortic valve. While expanding the artificial heart valve, the frame of the artificial heart valve may be shortened axially. While expanding the artificial heart valve, the outlet end of the frame may move in parallel with respect to the target site, while the inlet end of the frame does not move in parallel with respect to the target site. When the balloon inflates and expands the artificial heart valve, the friction between the balloon and the inlet end of the artificial heart valve may be greater than the friction between the balloon and the outlet end of the artificial heart valve. [Brief explanation of the drawing]

[0009] [Figure 1A] This is a perspective view of an artificial heart valve stent according to one embodiment of the present disclosure. [Figure 1B] Figure 1A is a schematic front view of a section of the stent. [Figure 1C] Figure 1A is a schematic front view of a section of a stent representing an alternative embodiment of the artificial heart valve. [Figure 1D] Figure 1C is a front view of the stent section in its folded state. [Figure 1E] Figure 1C is a front view of the stent section in its expanded state. [Figure 1F] This is a side view of a portion of the stent in the folded state according to the embodiment of Figure 1C. [Figure 1G] This is a side view of a portion of the stent in an expanded state according to the embodiment of Figure 1C. [Figure 1H] This is a plan view of the stent according to the embodiment of Figure 1C when it has been cut open and laid flat. [Figure 1I] Figure 1C is a front view of the artificial heart valve including the stent. [Figure 1J] Figure 1C is a side view of the artificial heart valve including the stent. [Figure 1K] This figure shows the stent with an additional outer cuff added, compared to the diagram in Figure 1H. [Figure 2A] This figure shows an artificial heart valve crimped onto a balloon of a delivery device. [Figure 2B] This is a schematic diagram of the balloon after it has been inflated (Figure 2A). [Figure 3A] This figure shows a stent in its folded state, positioned near the target deployment site. [Figure 3B] This is a diagram showing the stent after expansion (Figure 3A). [Figure 4A] This is a schematic front view of a section of an artificial heart valve stent. [Figure 4B] This figure shows the stent in its folded state, positioned near the target deployment site. [Figure 4C] This is a diagram showing the stent after expansion (Figure 4B). [Figure 5] This is a very schematic front view of a section of an artificial heart valve stent. [Figure 6] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 7] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 8A] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 8B] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 8C]It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 9] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 10] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 11] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 12] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 13] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 14] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 15A] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 15B] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 16] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 17] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 18] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 19] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 20] It is a schematic front view of a section of a frame that is an alternative version of the frame portion shown in FIG. 4A. [Figure 21] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 22] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 23] This is a schematic front view of a section of the frame, which is an alternative version of the frame shown in Figure 4A. [Figure 24A] This is an enlarged view of the shape for attaching the connecting part according to another aspect of the present disclosure. [Figure 24B] This is an enlarged view of the shape for attaching the connecting part according to another aspect of the present disclosure. [Figure 25] This is an enlarged view of the shape for attaching the connecting part according to a further aspect of the present disclosure. [Figure 26] This is a schematic front view of a section of the frame, which is a further alternative version of the frame shown in Figure 4A. [Figure 27] This is a schematic front view of a section of the frame, which is a further alternative version of the frame shown in Figure 4A. [Figure 28] This is a schematic front view of a section of the frame, which is a further alternative version of the frame shown in Figure 4A. [Figure 29] This is a schematic front view of a section of the frame, which is a further alternative version of the frame shown in Figure 4A. [Figure 30] This is a schematic front view of a section of the frame, which is a further alternative version of the frame shown in Figure 4A. [Modes for carrying out the invention]

[0010] Where used herein, the term “inflow end,” when used in relation to an artificial heart valve, refers to the end of the artificial valve from which blood first flows when the artificial valve is implanted in its intended position and orientation. Conversely, the term “outflow end,” when used in relation to an artificial heart valve, refers to the end of the artificial valve from which blood flows when the artificial valve is implanted in its intended position and orientation. Thus, in the case of an artificial aortic valve, the inflow end is the end closer to the left ventricle, and the outflow end is the end closer to the aorta. The intended position and orientation are used for convenience in describing the valve disclosed herein, but it should be noted that the use of the valve is not limited to this intended position and orientation and can be deployed in any type of lumen or passage. For example, while an artificial heart valve is described herein as an artificial aortic valve, the same or similar structure and features can be employed in other heart valves such as pulmonary valves, mitral valves, or tricuspid valves. Furthermore, where used in relation to a delivery device or system, the term “proximal,” when used in relation to a delivery device or system, refers to the direction relatively close to the user when the device or system is used as intended. On the other hand, the term “distal” refers to a direction relatively far from the user of the device. In other words, the tip of the delivery device or delivery system is positioned distal to its rear end when the delivery device or delivery system is used as intended. As used herein, the terms “substantially,” “generally,” “approximately,” and “about” are intended to mean that the range of the terms thereby modified includes a small deviation from the absolute value. As used herein, a stent can be in an “expanded state” and a “folded state,” which refer to the relative radial size of the stent.

[0011] Figure 1A shows a perspective view of a stent 100 of an artificial heart valve according to one embodiment of the present disclosure. The stent 100 may include a frame extending axially between an inlet end 101 and an outlet end 103. The stent 100 comprises three substantially symmetrical sections, each section extending approximately 120 degrees of the circumference of the stent 100. The stent 100 includes three longitudinal struts 110a, 110b, and 110c extending axially substantially parallel to the direction of blood flow through the stent. This axis may also be referred to as the longitudinal central axis. Each longitudinal strut 110a, 110b, and 110c may extend substantially along the entire axial length between the inlet end 101 and the outlet end 103 of the stent 100, and may be positioned between two sections and shared by two sections. In other words, each section is defined by the portion of the stent 100 located between two longitudinal struts. Therefore, each longitudinal strut 110a, 110b, and 110c is also separated by approximately 120 degrees along the circumference of the stent 100. It should be understood that when the stent 100 is used in an artificial heart valve having three leaflets, the stent may include three sections as shown. However, in other embodiments, when the artificial heart valve has two leaflets, the stent may include only two sections.

[0012] Figure 1B shows a schematic diagram of stent section 107 of stent 100. Stent section 107 is described in more detail herein, representing all three sections. The stent section 107 shown in Figure 1B includes a first longitudinal strut 110a and a second longitudinal strut 110b. The first longitudinal strut 110a extends axially between the first inlet node 102a and the first outer node 135a. The second longitudinal strut 110b extends axially between the second inlet node 102b and the second outer node 135b. As shown, the longitudinal struts 110a and 110b can extend substantially along the entire axial length of stent 100. In some embodiments, stent 100 can be formed as a single unit, for example, by laser cutting the stent from a tube. The term "node" can refer to the location where two or more struts of stent 100 intersect each other. A pair of continuous inverted V-shaped sections extend between the inflow nodes 102a and 102b, including a first inflow inverted V-shaped section 120a and a second inflow inverted V-shaped section 120b, which are joined together at the inflow node 105. The first inflow inverted V-shaped section 120a includes a first outer lower strut 122a extending between the first inflow node 102a and the first central node 125a. The first inflow inverted V-shaped section 120a further includes a first inner lower strut 124a extending between the first central node 125a and the inflow node 105. The second inflow inverted V-shaped section 120b includes a second inner lower strut 124b extending between the inflow node 105 and the second central node 125b. The second inlet inverted V-shaped section 120b further includes a second outer lower strut 122b extending between the second central node 125b and the second inlet node 102b. Although described as inverted V-shaped sections, these structures can also be described as half-cells, each half-cell being a semi-rhomboid cell with the open portion of the half-cell at the inlet end 101 of the stent 100.

[0013] The stent section 107 further includes a first central strut 130a extending between a first central node 125a and an upper node 145. The stent section 107 also includes a second central strut 130b extending between a second central node 125b and an upper node 145. The first central strut 130a, the second central strut 130b, the first inner lower strut 124a, and the second inner lower strut 124b form a rhomboid cell 128. The stent section 107 includes a first outer upper strut 140a extending between a first outer node 135a and a first outflow node 104a. The stent section 107 further includes a second outer upper strut 140b extending between a second outer node 135b and a second outflow node 104b. The stent section 107 includes a first inner upper strut 142a extending between the first outflow node 104a and the upper node 145. The stent section 107 further includes a second inner upper strut 142b extending between the upper node 145 and the second outflow node 104b. The stent section 107 includes an outflow inverted V-shaped section 114 extending between the first outflow node 104a and the second outflow node 104b. The first longitudinal strut 110a, the first outer upper strut 140a, the first inner upper strut 142a, the first central strut 130a, and the first outer lower strut 122a form a first generally kite-shaped cell 133a. The second longitudinal strut 110b, the second outer upper strut 140b, the second inner upper strut 142b, the second central strut 130b, and the second outer lower strut 122b form a second generally kite-shaped cell 133b. The first kite-shaped cell 133a and the second kite-shaped cell 133b are symmetrical and face each other in the stent section 107. Although the term "kite-shaped" has been used above, it should be understood that such a shape is not limited to the strict geometric definition of a kite. The outflow inverted V-shaped section 114, the first inner upper strut 142a, and the second inner upper strut 142b form an upper cell 134. The upper cell 134 is generally kite-shaped and axially aligned with the rhombic cell 128 in the stent section 107.Although shown as separate struts, it should be understood that the various struts described herein may be part of a single, integrated structure as described above. However, in other embodiments, the stent 100 does not need to be formed as an integrated structure, and therefore the struts may be a combination of different structures (or parts of different structures).

[0014] Figure 1C shows a schematic diagram of a stent section 207 according to an alternative embodiment of the present disclosure. Unless otherwise specified, similar reference numerals refer to similar elements of the stent 100 described above, but with 200-series numerals. The stent section 207 is substantially similar to the stent section 107 and includes inlet nodes 202a, 202b, longitudinal struts 210a, 210b, a first inlet inverted V-shaped section 220a and a second inlet inverted V-shaped section 220b, and outlet nodes 204a, 204b. The structure of the stent section 207 differs from that of the stent section 107 in that it does not include an outlet inverted V-shaped section. The object of one embodiment having the structure of the stent section 207 shown in Figure 1C is to reduce the force required to expand the outlet end 203 of the stent 200 compared to the stent 100, and to promote uniform expansion to the inlet end 201. The outflow nodes 204a and 204b are connected by a well-oriented V-shape formed by a first inner upper strut 242a, upper node 245, and second inner upper strut 242b. In other words, the struts 242a and 242b can form a semi-rhomboid cell 234, the open end of which faces the outflow end 203. The semi-rhomboid cell 234 is axially aligned with the rhomboid cell 228. Adding the outflow inverted V-shape connected between the outflow nodes 204a and 204b contributes to the addition of material, thereby increasing resistance to changes in the stent shape and requiring additional force to expand the stent. By removing material from the outflow end 203, resistance to expansion at the outflow end 203 is reduced, which can promote uniform expansion of the inflow end 201 and the outflow end 203. In other words, the inlet end 201 of the stent 200 does not include a continuous circumferential structure, but rather has a nearly or completely open half-cell with the open portion of the half-cell facing toward the inlet end 201, while most of the outlet end 203 includes a substantially continuous circumferential structure via struts corresponding to struts 140a and 140b. All other conditions being equal, a substantially continuous circumferential structure may require greater force to expand than a similar but open structure.Therefore, the inlet end 101 of the stent 100 may require a greater force for radial expansion compared to the outlet end 103. By omitting the inverted V-shaped portion 114 and constructing a stent 200, the force required to expand the outlet end 203 of the stent 200 can be reduced to a size closer to that of the inlet end 201.

[0015] Figure 1D shows a front view of stent section 207 in its folded state, and Figure 1E shows a front view of stent section 207 in its extended state. In Figures 1D and 1E, the stent 200 is shown with an opaque tube that penetrates the interior of the stent; however, this is merely to aid in the explanation of the stent, and it should be understood that stent section 207 may represent a crimped balloon. As mentioned above, the stent consists of three symmetrical sections, each section spanning approximately 120 degrees of the circumference of the stent. Stent section 207, shown in Figures 1D and 1E, is defined by the region between the longitudinal struts 210a and 210b. Stent section 207 represents all three sections of the stent. Stent section 207 has an arcuate structure, and when the three sections are connected, they form a single complete cylindrical shape. Figures 1F and 1G show a side view of part of the stent. In other words, the diagrams of stent 200 in Figures 1F and 1G are rotated by approximately 60 degrees compared to the diagrams in Figures 1D and 1E. The diagrams of the stent shown in Figures 1F and 1G are centered on the longitudinal strut 210b, with approximately half of two adjacent stent sections 207a and 207b shown on each side of the longitudinal strut 210b. The sections 207a and 207b surrounding the longitudinal strut 210b are mirror images of each other. Figure 1F shows the stent sections 207a and 207b in the folded state, and Figure 1G shows the stent sections 207a and 207b in the expanded state.

[0016] Figure 1H shows a plan view of stent 200, which includes three stent sections 207a, 207b, and 207c, when it is cut longitudinally and laid flat. As shown in the figure, sections 207a, 207b, and 207c are symmetrical to each other, and adjacent sections share a common longitudinal strut. As mentioned above, although stent 200 is shown in a plan view, each section 207a, 207b, and 207c has an arc shape spanning 120 degrees, forming a complete cylinder. Figure 1H further shows valve leaflets 250a, 250b, and 250c coupled to stent 200. However, it should be understood that only the connection between valve leaflets 250a-250c is shown in Figure 1H. In other words, each valve leaflet 250a-250c typically has a free edge, which adheres tightly to each other to prevent backflow of blood through the stent 200, and also moves radially outward toward the inner surface of the stent to allow antegrade flow of blood through the stent. These free edges are not shown in Figure 1H. Instead, the attachment edges of the valve leaflets 250a-250c are shown as dashed lines in Figure 1H. Attachment can be carried out by any preferred method, but it is preferable that the attachment edges be sutured to the stent 200 and / or to a cuff or skirt interposed between the stent and the valve leaflets 250a-250c. Each of the three valve leaflets 250a, 250b, and 250c extends approximately 120 degrees from end to end around the stent 200, and each leaflet has a belly that can extend toward the radial center of the stent 200 when the leaflets are in close contact with each other. Each leaflet extends between the upper nodes of adjacent sections. The first leaflet 250a extends from the first upper node 245a of the first stent section 207a to the second upper node 245b of the second stent section 207b. The second leaflet 250b extends from the second upper node 245b to the third upper node 245c of the third stent section 207c. The third leaflet 250c extends from the third upper node 245c to the first upper node 245a. Therefore, each upper node is connected to the first end of the first valve leaflet and the second end of the second valve leaflet.In the illustrated embodiment, each end of each leaflet is joined to its respective node by suture. However, any joining means can be used to attach the leaflets to the stent. It is further assumed that the stent may include any number of sections and / or leaflets. For example, the stent may include two sections, each extending over 180 degrees of the circumference of the stent. Furthermore, the stent may include two leaflets to mimic a bicuspid valve. It should be noted that each leaflet may include a tab or other structure (not shown) at the junction between the free edge and the attachment edge of the leaflet, and each tab of each leaflet may be joined to a tab of an adjacent leaflet to form a commissure. In the illustrated embodiment, the leaflet commissure is shown to be attached to a node where the struts intersect. However, in other embodiments, the stent 200 may have a commissure attachment shape incorporated into the stent to facilitate such attachment. For example, the commissure attachment portion can be formed on the stent 200 at nodes 245a to 245c, and the commissure attachment portion includes one or more holes to facilitate suturing the valve leaflet commissure to the stent. Furthermore, the valve leaflets 250a to 250c can be formed from a biomaterial such as the pericardium of an animal, or alternatively, from a synthetic material such as a polymer containing plastic, cloth, and / or ultra-high molecular weight polyethylene (UHMWPE).

[0017] Figures 1I and 1J show an artificial heart valve 206 comprising a stent 200, a cuff 260 attached to the stent 200 (e.g., by suture), and valve leaflets 250a, 250b, 250c attached to the stent 200 and / or the cuff 260 (e.g., by suture). The artificial heart valve 206 is intended for use in the replacement of the aortic valve, but the same or similar structure can be used for artificial valves for the replacement of other heart valves. The cuff 260 is located on the luminal or inner surface of the stent 200, although the cuff may be located on the non-luminal or outer surface of the stent, alternatively or additionally. The cuff 260 may have an inlet end that is substantially located along the inlet end 201 of the stent 200. Figure 1I shows a front view of the valve 206, showing a cuff 260 and a stent portion 207 between longitudinal struts 210a, 210b, including the outlines of two valve leaflets 250a, 250b sutured to the cuff 260. Various methods can be used to suture the valve leaflets to the cuff, and to suture the valve leaflets and / or the cuff to the stent, many of which are described in U.S. Patent No. 9,326,856, which is incorporated herein by reference. In the illustrated embodiment, the upper edge (or outflow edge) of the cuff 260 is sutured to a first central node 225a, upper node 245, and a second central node 225b, and extends along the first central strut 230a and the second central strut 230b. The upper edge (or outflow edge) of the cuff 260 extends substantially continuously between the second central node of one section and the first central node of the adjacent section. The cuff 260 extends between the upper node 245 and the inflow end 201. Thus, the cuff 260 covers the cells of the stent portion 207 formed by the strut between the upper node 245 and the inflow end 201, including the rhomboid cells 228. Figure 1J shows a side view of the stent 200 including the cuff 260 and the outline of the valve leaflet 250b. In other words, the diagram of the valve 206 in Figure 1J is rotated by approximately 60 degrees compared to the diagram in Figure 1I. The diagram shown in Figure 1J is centered on the longitudinal strut 210b, with approximately half of two adjacent stent sections 207a and 207b shown on each side of the longitudinal strut 210b.Sections 207a and 207b surrounding the longitudinal strut 210b are mirror images of each other. As described above, the cuff can be positioned on the inner or luminal surface of the stent, the outer or non-luminal surface of the stent, and / or both. The cuff ensures that blood does not simply flow around the valve leaflets if the valve or valve assembly is not optimally fitted within the annulus. A cuff or portion of a cuff positioned on the outer surface of the stent can help minimize or eliminate leakage that flows around the outside of the valve (this leakage is known as paravalvular regurgitation, or "PV" regurgitation). In the embodiments shown in Figures 1I and 1J, the cuff 260 covers only about half of the axial range of the stent 200, leaving about half of the stent uncovered by the cuff. This configuration requires less cuff material compared to a cuff that covers more or all of the stent 200. The reduced amount of cuff material allows the artificial heart valve 206 to be crimped to have a smaller external shape when folded. The cuff is expected to cover any size of the surface area of ​​the cylinder formed by the stent. For example, the upper edge of the cuff can extend straight along the circumference of any cross-section of the cylinder formed by the stent. The cuff 260 can be formed from any suitable material, including biomaterials such as animal pericardium or synthetic materials such as UHMWPE.

[0018] As described above, Figures 1I and 1J show a cuff 260 positioned on the inner surface of the stent 200. Figure 1K shows an example of an additional outer cuff 270. It should be understood that the outer cuff 270 can take a different shape from that shown in Figure 1K. The outer cuff 270 shown in Figure 1K may be provided without the inner cuff 260, but is preferably provided in addition to the inner cuff 260. The outer cuff 270 can be formed integrally with the inner cuff 260 and folded back over the inlet edge of the stent (e.g., wrapping around the edge), or it can be provided as a separate component from the inner cuff 260. The outer cuff 270 can be formed from any of the materials described herein in relation to the inner cuff 260. In the illustrated embodiment, the outer cuff 270 comprises an inlet edge 272 and an outlet edge 274. If the inner cuff 260 and the outer cuff 270 are formed separately, the inlet edge 272 can be joined to the inlet end of the stent 200 and / or the inlet edge of the inner cuff 260, for example, by suturing, ultrasonic welding, or any other preferred attachment method. The joining of the inlet edge 272 of the outer cuff 270 and the stent 200 and / or the inner cuff 260 preferably results in a seal between the inner cuff 260 and the outer cuff 270 at the inlet end of the artificial heart valve, preventing blood from passing over the inlet edges of the inner cuff 260 and the outer cuff 270 even if blood flows back into the space between the inner cuff 260 and the outer cuff 270. The outlet edge 274 can be joined to the strut of the stent 200 and / or the inner cuff 260 at a selected position on the circumference of the stent 200, for example, by suturing. In this configuration, openings can be formed between the inner cuff 260 and the outer cuff 270 in the circumferential direction between adjacent connection points. As a result, blood tends to flow back into the space between the inner cuff 260 and the outer cuff 270 through these openings, but it cannot pass beyond the inflow edge of the cuff. When blood flows into the space between the inner cuff 260 and the outer cuff 270, the outer cuff 270 expands outward, which can further improve the sealing between the outer cuff 270 and the innate valve annulus against which the outer cuff 270 is pressed.The outer cuff 270 can be provided as a continuous cylindrical member or as a strip that encloses the outer circumference of the stent 200, and its side edges, which may be parallel or non-parallel to the longitudinal central axis of the artificial heart valve, are attached to each other so that the outer cuff 270 encloses the entire circumference of the stent 200.

[0019] Stents can be formed from biocompatible materials including metals and metal alloys, such as cobalt-chromium (or cobalt-chromium) or stainless steel, but in some embodiments, stents can be formed from shape memory materials such as nitinol. In some embodiments, stents can be formed from cobalt-chromium with the addition of metals or metal alloys such as nickel and / or molybdenum. Thus, stents are configured to fold by crimping to a smaller diameter and / or expand by being pushed out by, for example, the expansion of a balloon within the stent, and the stent substantially maintains its modified shape in a stationary state. When crimped and folded radially, stents can elongate (to some extent) axially, reducing their external shape in any given cross-section. Stents can also be shortened (to some extent) axially when expanded radially.

[0020] Artificial heart valves can be delivered via any suitable transvascular route, for example, transapical or transfemoral. Generally, transapical delivery involves using a relatively rigid catheter to puncture the apex of the left ventricle through the patient's chest, and therefore causes a relatively higher degree of trauma compared to transfemoral delivery. In transfemoral delivery, the delivery device housing the valve is inserted through the femoral artery and advanced against the flow of blood into the left ventricle. In either delivery method, the valve can first be folded onto an inflatable balloon while the inflatable balloon is deflated. The balloon can be coupled to or positioned within the delivery system, allowing the valve to be transported through the body and within the heart to reach the aortic valve. Here, the valve is positioned on the balloon (and, in some cases, under the outer sheath). Upon reaching the aortic valve or its vicinity, the surgeon or operator of the delivery system can position the artificial valve within the natural annulus as desired while the artificial valve is folded onto the balloon. Once the desired alignment is achieved, the prosthetic valve can be exposed by retracting (or advancing) the outer sheath, if one is provided. The prosthetic valve can then be expanded radially by inflating the balloon, in which case at least a portion of the prosthetic valve is shortened axially.

[0021] Referring to Figure 2A, an example of an artificial heart valve PHV, which may include a stent similar to stent 100 or 200, is shown crimped onto the balloon 380 of the balloon catheter 390 while the balloon 380 is deflated. It should be understood that the handle used for manipulation and / or deployment, and other components of the delivery device such as a syringe for inflating the balloon 380, are omitted from Figures 2A and 2B. The artificial heart valve PHV can be delivered intravascularly, for example, through the femoral artery, around the aortic arch, and to the natural aortic annulus, while remaining in the crimped state shown in Figure 2A. Once the desired position is achieved, the balloon 380 can be inflated by pushing fluid into the balloon catheter 390, as shown in Figure 2B. Although the artificial heart valve PHV is omitted in Figure 2B, it should be understood that when the balloon 380 is inflated, the balloon 380 forces the artificial heart valve PHV to expand within the natural aortic annulus (however, it should be understood that other heart valves can also be replaced using the concepts described herein). In the illustrated example, fluid flows from a syringe (not shown) through the lumen of the balloon catheter 390 to one or more ports 385 located inside the balloon 380 and into the balloon 380. In the specific example shown in Figure 2B, the first port 385 may be one or more holes in the side wall of the balloon catheter 390, and the second port 385 may be the distal open end of the balloon catheter 390 which can terminate within the internal space of the balloon 380.

[0022] One of the potential problems with most expandable heart valves is that, typically, as the valve expands radially within the original annulus during deployment, it simultaneously shortens axially. This is usually true for both self-expanding and balloon-expanding valves. This axial shortening can be problematic because the axial position of a particular valve element relative to the original annulus before expansion is often not the same as the axial position of the valve element relative to the original annulus after expansion. In other words, even if the heart valve has a specific alignment shown under visualization (e.g., fluoroscopy) immediately before deployment, at least some axial displacement of its relative alignment usually occurs during deployment, and if such displacement is not minimized or compensated for, the resulting position of the deployed heart valve may be suboptimal.

[0023] An example of the axial misalignment described above is shown in Figures 3A and 3B. Figure 3A shows an artificial heart valve stent folded on a balloon inside a patient's body, and this figure is a fluoroscopic (e.g., X-ray) image in which only the metal stent 400 of the valve is easily visible. When deploying an artificial heart valve, it is usually important that the inlet end of the artificial heart valve has a desired alignment with respect to the original valve annulus being deployed. In Figures 3A and 3B, the desired target position of the inlet end 410 of the artificial heart valve is indicated by the target line 430. The positioning of the outlet end 420 relative to the original valve annulus is usually less important (but not unimportant) than the alignment of the inlet end 410. In Figure 3A, the stent 400 is still folded on the balloon, and the inlet end 410 is precisely aligned with the target line 430. However, as deployment occurs, the stent 400 expands radially and shortens axially, so that after deployment, the inlet end 410 of the stent 400 is separated from the target line 430 by a distance D1. In other words, because axial shortening occurs and this axial shortening is (1) not minimized and / or (2) not separately compensated for, the initial relative position of the stent 400 to the anatomical structure (during folding) was not a reliable indicator of the final position of the stent 400 to the anatomical structure (during expansion). One way to compensate for this change in positioning is to advance the inlet end 410 of the stent 400 beyond the target line 430 before deployment, and expect that the compensated distance will equal the axial displacement of the inlet end 410 so that the stent 400 settles into the desired position after deployment. However, this may not be a particularly reliable method and can lead to inconsistent results. It is preferable that the artificial heart valve itself and / or the delivery device have features that result in more precise placement of the artificial heart valve during deployment and minimize the need for subjective positioning compensation at the start of deployment.

[0024] Figure 4A illustrates a stent 500 used as part of a balloon-expandable prosthesis valve, which may be substantially similar to the prosthesis valve 206, except for a specific configuration of the stent 500. As with Figure 1B, it should be understood that Figure 4A illustrates only one section of the stent 500 when laid flat. In other words, the section of the stent 500 in Figure 4A may represent approximately one-third of the complete stent 500, especially when the stent 500 is used in combination with a three-lobed prosthesis valve. In the illustrated embodiment, the stent 500 is a balloon-expandable stent and may be formed from cobalt-chromium, which may (but not required) include additional materials such as nickel and / or molybdenum. As will be described in more detail below, the stent 500 may include features that control the shortening and / or stability of the stent 500 during expansion, thereby providing at least some stent elements of the stent 500 as a more predictable indicator of the final implantation position after shortening.

[0025] Generally, the stent 500 includes a stent geometry that tends to stabilize the inlet end of the stent 500 and / or increase the retention force of the inlet end of the stent 500 on the balloon 380, and that makes it easier to shorten the stent (during radial expansion) at the outlet end of the stent 500. Referring to Figure 4A, the stent 500 may include an inlet section 510 and an outlet section 520. In the illustrated embodiment, the inlet section 510 may include multiple rows of generally diamond-shaped cells. For example, the inlet section 510 may include diamond-shaped cells 512 in the outermost inlet row, diamond-shaped cells 514 in an adjacent intermediate row, and diamond-shaped cells 516 in the outermost outlet row. In this configuration, each cell in the intermediate row cell 514 includes two struts shared with the adjacent cell in the outermost inlet row cell 512 and two struts shared with the adjacent cell in the outermost outlet row cell 516. Although the term “outflow end” is used in relation to cell 516 of the third column, it should be understood that additional stent structures, which will be described in more detail below, are still provided in the outflow direction relative to cell 516 of the outflow end column. The inflow apex of each cell in cell 512 of the first column may include a hole 513 formed therein, which can receive a suture or similar shaped portion that can assist in connecting other elements such as an internal cuff, external cuff, and / or artificial valve leaflets to the stent 500. However, as with all other frame embodiments described herein, holes similar to hole 513 may be optionally included or omitted at the inflow apex of cells in the inflow end column. In the illustrated embodiment, assuming that the stent 500 is used with a 3-leaflet valve, and therefore the section shown in Figure 4A represents one-third of the stent, each column of cells 512, 514, and 516 contains 12 individual cells. However, this number of cells can be changed, as will be described in more detail below. In one particular example, the inflow section 510 may contain only two columns of cells, all of which are diamond-shaped.In another specific example, the inflow section 510 may include one or two rows of diamond-shaped cells and one row of hexagonal cells, where the row of hexagonal cells is located in the inflow-side outermost row of the inflow section 510, the outflow-side outermost row of the inflow section 510, or (if the inflow section 510 has three rows) in the middle row of the inflow section 510.

[0026] Continuing to refer to Figure 4A, the outflow section 520 of the stent 500 may include larger cells 522 having shapes other than regular polygons. For example, the lower part of a larger cell 522 may be defined by two upper struts of cell 516 and one upper strut each of two adjacent cells 516. In other words, the lower end of each larger cell 522 may be formed by a group of four consecutive upper struts of three circumferentially adjacent cells 516. The upper part of a larger cell 522 may be defined by three connecting struts 522a, 522b, and 522c. The first connecting strut 522a may be connected to the upper part or outflow apex of cell 516 and may extend diagonally upward toward the commissure attachment feature (CAF) 540. A second connecting strut 522b may extend diagonally downward from the end of the first connecting strut 522a toward the cell 516 of the outermost row on the outflow side. A third connecting strut 522c may again extend upward from the end of the second connecting strut 522b and connect directly to the CAF 540. If a larger cell 522 has sides, the first side is defined by a portion of the CAF 540, and the second side is defined by the connection between the first connecting strut 522a and the corresponding upper strut of the cell 516 attached to the first connecting strut 522a.

[0027] The CAF540 can generally function as an attachment site for the leaflet commissure (e.g., where two artificial leaflets meet) to be coupled to the stent 500. In the illustrated example, the CAF540 is roughly rectangular, with its axial length being longer than its circumferential length. The CAF540 also defines an open rectangular space inside. The struts forming the CAF540 may be generally smooth on the surface defining the open rectangular space, but some or all of the struts may have one or more suture notches on the opposite surface. For example, in the illustrated example, the CAF540 includes two lateral struts (on the long sides of the rectangle) and one upper (or outflow) strut, all of which include alternating projections and notches on their outward-facing surfaces. These projections and notches can help maintain the position of one or more sutures that wrap around these struts. These sutures can directly connect the artificial valve leaflets to the frame 500 and / or directly connect an intermediate sheet material (e.g., cloth or tissue) to the CAF 540, with the artificial valve leaflets directly connected to the intermediate sheet material. In some embodiments, the tabs or ends of the artificial valve leaflets can be pulled out through the openings in the CAF 540, while in other embodiments, the artificial valve leaflets can be largely or completely retained within the inner diameter of the frame 500. It should be understood that balloon-expanding frames, including all other embodiments described herein, are typically formed from a very rigid metal or metal alloy, particularly compared to self-expanding valves. At least partly due to this rigidity, the artificial valve leaflets can be sutured to the frame in the CAF 540 or otherwise directly connected, but it is preferable that most or all of the remaining portion of the artificial valve leaflets is not directly attached to the frame 500, but rather directly attached to the inner skirt, which in turn is directly connected to the frame 500. Furthermore, it should be understood that other shapes and configurations of the CAF 540 may be appropriate. Various other embodiments of the frame are provided below, but it should be understood that features of one frame embodiment can be combined with features of other frame embodiments, as will be described in more detail below.

[0028] In the embodiments described above, the stent 500 includes three rows of rhomboid cells 512, 514, and 516 and a single row of larger cells 522. In a three-leaflet embodiment of an artificial heart valve incorporating the stent 500, each row of rhomboid cells 512, 514, and 516 contains 12 cells, while the row of larger cells contains 6 larger cells 522. As can be seen, when the stent 500 is expanded, the area defined by each of the individual cells 512, 514, and 516 is significantly smaller than the area defined by each of the larger cells 522. Also, there are significantly more structures (e.g., struts) forming each row of individual cells 512, 514, and 516 than structures forming the row of larger cells 522.

[0029] As a consequence of the above-described configuration, the inlet section 510 has a higher cell density than the outlet section 520. In other words, the total number of cells, as well as the number of cells per row, is greater in the inlet section 510 compared to the outlet section 520. The above-described configuration of the stent 500 may also result in the inlet section 510 being generally more rigid than the outlet section 520, and / or requiring more radial force to expand the inlet section 510 compared to the outlet section 520, even though the stent 500 may be formed from the same metal or metal alloy throughout.

[0030] In addition to cell density, the width and / or thickness of the struts forming the cells of the inlet section 510 and outlet section 520 can be changed to adjust the radial force required to expand the stent frame 500. As used herein, the “width” of a strut refers to the circumferential direction of the stent 500, while the “thickness” of a strut refers to the depth dimension from the radial outer surface to the radial inner surface (which may also be referred to as the “wall thickness” of the stent). For example, the “width” of a strut can generally refer to the lateral dimension of the strut as seen in Figure 4A, while the “thickness” of a strut can generally refer to the dimension in the plane of the paper in the diagram of Figure 4A. Increasing the thickness of a strut (all other conditions being equal) usually increases the radial force required to expand the area of ​​increased thickness, and similarly, increasing the width of a strut (all other conditions being equal) increases the radial force required to expand the area of ​​increased width. For example, in the embodiment of frame 500 in Figure 4A, all cells 512, 514, and 516 in the column of the inflow section 510 have approximately the same strut width, which is larger than most or all of the struts forming the larger cell 522 in the outflow section 520. For example, as shown in Figure 4A, the connecting strut 522 may have a width approximately equal to or slightly smaller than the width of the struts forming cells 512, 514, and 516 in the column, while the connecting struts 522b and 522c may have a width even smaller than the width of the connecting strut 522a. In some embodiments, each connecting strut 522a, 522b, and 522c may have a constant width, but in other embodiments, the connecting struts may have a tapered width, for example, having a relatively large width near the connection point of the connecting strut 522a to cell 516 in the outflow column, and the width of the connecting strut 522a narrows as it moves away from the connection point.It should be understood that the width and thickness of the struts may be modified in ways other than those explicitly shown and described, in order to further adjust the amount of radial force required to expand the inlet section 510 and the amount of radial force required to expand the outlet section 520.

[0031] Figures 4B and 4C illustrate one of the advantages of varying the amount of radial force required to expand the stent 500 at different positions along the axial direction of the stent 500. Figure 4B illustrates the stent 500 of an artificial heart valve folded on a balloon inside a patient's body, and this figure is a fluoroscopic (e.g., X-ray) image in which only the metal stent 500 of the valve is easily visible. Similar to Figures 3A and 3B, in Figures 4B and 4C, the desired target position of the inlet edge of the inlet section 510 of the artificial heart valve is indicated by the target line 530. In Figure 4B, the stent 500 is still folded on the balloon, and the inlet edge of the inlet section 510 is precisely aligned with the target line 530. As deployment occurs (and the balloon inflates), the stent 500 expands radially and shortens axially. However, unlike the situations in Figures 3A and 3B, the stent 500 in Figures 4B and 4C expands so that, after deployment, the inlet edge of the inlet section 510 of the stent 500 is still precisely (or nearly precisely) aligned with the target line 530. This result is achievable because, as the balloon expands, the outlet section 520 of the stent shortens significantly more easily than the inlet section 510, at least in part, due to the difference in radial forces required to expand the different stent sections. In other words, the inlet edge of the inlet section 510 of the stent 500 can be used before expansion or deployment as a reliable visual indicator of where the inlet edge of the inlet section 510 of the stent 500 will be positioned after expansion or deployment. This reduces or eliminates the need to separately compensate for axial shortening by advancing the stent 500 "beyond" the target line 530 before deployment in an attempt to achieve the correct final positioning of the inlet end of the stent 500 at the target line 530 after deployment. This eliminates significant guesswork from the deployment procedure and generally improves the accuracy of the final axial positioning of the stent relative to the original valve annulus after deployment.

[0032] While Figure 4A shows only one example of a section of the frame 500, it should be understood that other components of the artificial heart valve incorporating the frame 500 may be similar to or identical to those described in relation to the artificial heart valve 206. For example, the artificial valve leaflets, inner cuff, and / or outer cuff may be similar to those illustrated and described in relation to the artificial heart valve 206 and can be used with the frame 500 to fabricate the artificial heart valve. Also, while one particular embodiment of the frame 500 is shown, it should be understood that certain modifications may be made, such as increasing or decreasing the total number of rows of cells (e.g., in the inflow section 510) and / or increasing or decreasing the number of cells per row (e.g., in the inflow section 510). Generally, increasing the number of rows or the number of cells per row may increase the rigidity of that region of the frame (or require more force to expand that section), and vice versa, all other conditions being equal. It should also be understood that the embodiment shown in Figure 4A may offer additional advantages not entirely related to changes in force. For example, relatively large cells 522 in the outflow section 522 can be left uncovered by the inner or outer cuff, thereby leaving the interior of these large cells 522 open. After deployment, the large open spaces of the cells 522 can help ensure sufficient blood flow to the coronary arteries and facilitate subsequent interventions in the coronary arteries. For example, if it is necessary to place a stent in the coronary artery after an artificial heart valve incorporating a frame 500 has been implanted, the catheter housing such a coronary stent can pass relatively easily through the internal space of the cells 522 to reach the coronary artery. This is even more true if the artificial heart valve incorporating a stent 500 is implanted such that each of the three CAFs 540 is aligned with the innate commissure of the innate heart valve. In some embodiments, at implantation, the coronary orifice can be roughly aligned beyond the outflow end of the frame 500, for example, near the valley between two adjacent connecting struts 522a.

[0033] Similar to other stents described herein, the stent 500 can be formed by laser cutting a continuous tube of a desired metal or metal alloy so that the stent 500 is formed as a single, integral component; however, the stent 500 may also be formed using other methods, including forming the stent 500 as multiple parts and joining them together.

[0034] While the stent 500 in Figure 4A is described as having certain features to provide varying radial forces along the axial range of the stent, including generally larger (i.e., "macro") designs such as varying cell density, other smaller (i.e., "micro") designs can also be implemented to achieve varying radial forces. For example, Figure 5 shows a very schematic drawing of stent 600 (or a part thereof, similar to stent 500 in Figure 4A), which includes certain features for adjusting the radial forces required to expand stent 600 using balloons or other expansion members. It should be understood that certain features, such as the shape for connecting parts, are not shown in Figure 5, and that Figure 5 does not represent the entire circumferential or axial range of stent 600. Rather, Figure 5 is intended to show how certain "micro" design variations can be implemented to adjust radial forces, including design features that can be implemented in stent 500 or other stent designs.

[0035] Referring to Figure 5, this shows a portion of the stent 600 in a flattened state, with only two complete rows of cells shown, including the inlet side row cells 612 and the intermediate row cells 614. However, it should be understood that additional rows of cells can be provided to create a complete stent 600, and, as with stent 500, the portion of stent 600 shown in Figure 5 may represent only a portion (e.g., just one-third) of the entire circumferential length of stent 600. Figure 5 more clearly shows that the inlet cells 612 may contain struts with varying widths. For example, each inlet cell 612 may contain two proximal struts 612a, each having a width greater than the width of the two distal struts 612b of cell 612. Each distal strut 612b of each inlet cell 612 may also form the proximal strut of each intermediate cell 614. Each intermediate cell 614 may contain two distal struts 614b, each having a width less than the width of the strut 612b. In this configuration, the three rows of struts 612a, 612b, and 614b forming the two rows of cells 612 and 614 have a width that decreases in the direction from inlet to outlet. In other words, the decrease in strut width provides a reduction in the radial force required to expand the stent 600 in the direction from the inlet end to the outlet end. Although not shown in Figure 5, the thickness of the struts 612a, 612b, and 614b can be provided as a thickness that decreases in the direction from inlet to outlet. The decreasing thickness can be brought about in any preferred way. For example, the stent 600 may be laser-cut from a tube having a single wall thickness, and after cutting, strut 612b may be machined down to a thickness smaller than strut 612a, strut 614b may be machined down to a thickness smaller than strut 612b, and so on. By including such a decrease in strut thickness in the direction from inlet to outlet, it is possible to similarly provide a reduction in the radial force required to expand the stent 600 in the direction from the inlet end to the outlet end.

[0036] The angles between the struts forming the cells can also be manipulated to affect the amount of force required to extend different sections of the stent 600. For example, the three rows of rhombic cells 512, 514, and 516 of the stent 500 in Figure 4A are all substantially identical in shape to each other, with the two bottom struts of each cell being substantially mirror images of the two upper struts of each cell. However, this is not the case for the stent 600 in Figure 5. For example, the two struts 612a in each cell 612 are not mirror images of the other two struts 612b in each cell 612. Rather, each strut 612a has the same circumferential range as each strut 612b, but each of the two struts 612a has a significantly smaller axial range than the two struts 612b. As a result, when frame 600 is in its extended state, the two bottom struts 612a form an angle α1 that is larger than the angle α2 formed between the two top struts 612b, forming a kite-shaped cell 612. Similarly, referring to cell 614, each strut 612b has the same circumferential range as each strut 614b, but each pair of struts 612b has a significantly smaller axial range than the two struts 614b. As a result, when frame 600 is in its extended state, the two bottom struts 612b of cell 614 form an angle α3 that is larger than the angle α4 formed between the two top struts 614b, forming a kite-shaped cell 614. As another consequence of this configuration, the edges of cell 612 form an angle β1 that is smaller than the angle β2 formed by the edges of cell 614.

[0037] In the simplest case, a rhombic cell with a smaller opening angle (e.g., α4) will shorten less during expansion compared to a rhombic cell with a larger opening angle (e.g., α1). Overall, the type of design shown in Figure 5 results in a smaller overall displacement (e.g., distance D1 shown in Figure 3B). An angle α1 is more open, and therefore results in further shortening during expansion. All other conditions being equal, a strut cell with a larger opening angle (e.g., α1) will have greater radial strength than one with a smaller opening angle (e.g., α4). This is because the strut with a larger opening angle is more inclined circumferentially in the expansion configuration. Thus, the combination of opening angle and strut width can affect both the radial force and shortening of the rhombic cell. Next, the ratio of radial forces across different struts in the axial direction can affect how the valve frame 600 expands during balloon expansion. The balloon itself also has factors that cause it to open in different ways, depending on its design. As a result, the interaction between the balloon and the axial force on the valve frame can be designed to achieve the desired motion, and the goal is generally to achieve little to no axial movement at the inlet end of the frame 600 during expansion. One or more of these “micro” design features can be utilized, including those used on the frame 500, to help achieve the result shown in Figures 4B and 4C, in which the inlet end of the stent does not move (or moves significantly) axially between the folded state (Figure 4B) and the expanded state (Figure 4C).

[0038] While the above disclosures are generally directed towards using “macro” or “micro” design features of the prosthetic heart valve stent to help achieve desired shortening so that the inlet end of the prosthetic heart valve does not deviate significantly axially during expansion, other features, including the interaction between the prosthetic heart valve and the balloon it is crimped into, can be used to help achieve similar results. For example, the outer surface of the balloon 380 can be treated to increase and / or decrease friction. For example, it may be desirable for the portion of the balloon 380 that will be in contact with the inner surface of the prosthetic heart valve at the inlet end to have relatively high friction, and / or for the portion of the balloon 380 that will be in contact with the inner surface of the prosthetic heart valve at the outlet end to have relatively low friction. Lower friction between the outlet end of the prosthetic heart valve and the balloon may facilitate shortening of the stent cell during expansion (requiring axial movement relative to the balloon). Low-friction surfaces can be formed on the balloon by smoothing the surface, using low-friction material on that section of the balloon, and / or including a low-friction coating on that section of the balloon. On the other hand, greater friction between the inlet end of the artificial heart valve and the balloon can make it more difficult for the cell to shorten during expansion. High-friction surfaces can be fabricated on the balloon by roughening the surface, using high-friction materials (as co-extrusion or an additional layer), coating, plasma treatment, or other surface modifications for that section of the balloon. Similarly, the inner diameter of the artificial heart valve can be treated to produce a desired amount of friction with the balloon by adjusting the chemical treatment of the tissue or modifying the surface of the stent frame. The balloon / artificial heart valve assembly can be treated with chemical or thermal processes after crimping to improve adhesion, either alternatively or additionally.

[0039] Figure 4A shows one example of a portion of the frame 500 suitable for use with a balloon-expandable artificial heart valve, but various additional frames may be similarly suitable. Various alternative embodiments compared to frame 500 are described in the following disclosure. It should be understood that features of a frame embodiment can be combined with features of other frame embodiments as appropriate, even if such combinations are not explicitly shown. For example, the outflow portion of one frame embodiment can be combined with the inflow portion of another frame embodiment, and similarly, the CAF of any embodiment can be substituted with the CAF of any other embodiment. Furthermore, the “micro” design variations illustrated and described in relation to Figure 5 can be applied to other frame embodiments described below.

[0040] Figure 6 shows a portion of an example frame 700 used in a balloon-expandable artificial heart valve (e.g., an artificial aortic valve), cut lengthwise and flattened. Similar to frame 500, frame 700 represents only one-third of the entire frame (when three artificial valve leaflets are used with frame 700), and the entire frame consists of a total of three repeating patterns of the portion shown in Figure 6, forming a continuous cylindrical or tubular member. Similar to frame 500, the artificial heart valve incorporating frame 700 can be formed from a plastically expandable material (e.g., stainless steel or cobalt-chromium), for example, by laser cutting from a tube. Artificial valve leaflets and inner and / or outer sealing skirts or cuffs are not shown but can be used with frame 700 to form the artificial heart valve, similar to those described in relation to frame 500. The information in this paragraph applies to the remaining frame portions shown in Figures 7 to 25 and is therefore not repeated for each embodiment for brevity.

[0041] As shown in Figure 6, the frame 700 may include an inlet section 710 and an outlet section 720. In the illustrated embodiment, the inlet section 710 may include multiple rows of generally diamond-shaped and / or kite-shaped cells. For example, the inlet section 710 may include diamond-shaped cells 712 in the inlet-side outermost row, diamond-shaped cells 714 in the adjacent intermediate row, and diamond-shaped or kite-shaped cells 716 in the outlet-side outermost row. In this configuration, each cell in the intermediate row cell 714 includes two struts shared with the adjacent cell in the inlet-side outermost row cell 712 and two struts shared with the adjacent cell in the outlet-side outermost row cell 716. The term “outlet-side outermost” is used in relation to the cells 716 of the third row, but it should be understood that additional frame structures, which will be described in more detail below, are further provided in the outlet direction relative to the cells 716 of the outlet-side outermost row. The inlet apex of each cell in the first column of cell 712 may have a hole or eyelet (similar to eyelet 513) formed inside it, but in other embodiments, including the illustrated embodiment, the hole or eyelet may be omitted. The inlet section 710 may be functionally similar to the inlet section 510 of frame 500, but several differences may be provided (in addition to the omission of the inlet eyelet). For example, cells 712 and 714 may all have an opening angle α5 that is greater than the opening angles of cells 512 and 514. In the illustrated embodiment, the opening angle α5 may be about 130 degrees to about 150 degrees, including about 140 degrees. In the illustrated embodiment, cells 712 and 714 may be symmetrical with respect to the strut angles that form the cells. Cell 716 may have an outlet apex formed by struts that form an opening angle α6 that is smaller than the opening angle α5. For example, the opening angle α6 may be about 80 degrees to about 100 degrees, including about 90 degrees.Opening angles other than those explicitly described above can be provided, and a general goal is that by providing an opening angle α5 that is larger than α6 (and thus providing struts that extend more circumferentially at opening angle α5 compared to opening angle α6), cells 712 and 714 can provide greater radial force than cell 716, thereby aiding in better fixation. Furthermore, in the illustrated embodiment, the four struts forming each cell 712 have a greater width than each of the four struts forming each cell 716, thereby allowing cell 712 to have higher rigidity than cell 716. As used herein, the term opening angle generally refers to the angle between two struts of a cell when the frame is expanded to typical operating conditions (e.g., a desired size expected to be used when implanted in a natural aortic valve).

[0042] Another difference between frame 700 and frame 500 is the CAF740. Each CAF740 can be formed integrally with the rest of frame 700 and can generally define a longitudinal bar with one or more eyelets for receiving sutures inside. In the illustrated embodiment, each CAF740 includes three eyelets in a single row, but it may also be preferable to have other numbers of eyelets in different configurations (e.g., a 2x2 grid). Each CAF740 can extend axially from one of the outflow vertices of cells 716 in the outflow-side outermost row of the inflow section 710.

[0043] Continuing to refer to Figure 6, the outflow section 720 of the stent 700 may include larger cells 722 having shapes other than regular polygons. For example, the lower part of a larger cell 722 may be defined by two upper struts of cell 716 and one upper strut each of two adjacent cells 716. In other words, the lower end of each larger cell 722 may be formed by a group of four consecutive upper struts of three circumferentially adjacent cells 716. The top of a larger cell 722 may be defined by two connecting struts 722a, 722b. The first connecting strut 722a may be connected to the top or outflow apex of cell 716 and extend diagonally upward toward the CAF 740. The second connecting strut 722b may extend diagonally downward from the end of the first connecting strut 722a and connect directly to the CAF 740 at the top or outflow side of the CAF 740. If the larger cell 722 has sides, the first side is defined by a portion of the CAF 740, and the second side is defined by the connection between the first connecting strut 722a and the corresponding upper strut of cell 716 attached to the first connecting strut 722a. Also, as described in relation to the connecting struts 522a-522c in the illustrated embodiment, the first connecting strut 722a is provided with a greater width than the second connecting strut 722b. Similar to frame 500, the configuration illustrated and described in relation to frame 700 results in an outflow section 720 having lower rigidity than the inflow section 710. Furthermore, although many differences are described between frame 700 and frame 500, there are still many similarities, and it should be understood that the relevant parts of the description of the function of frame 500 apply substantially similarly to the function of frame 700.

[0044] Figure 7 shows a portion of frame 800, including alternative features compared to frame 700. For brevity, only the differences are described here, and therefore, items not described should be understood to be the same or similar to the corresponding elements of frame 700 (or frame 500). Similar to frame 700, frame 800 includes an inlet section 810 with three rows of cells, but the outermost inlet row has a rhomboid or kite shape with a relatively small opening angle α7 (which can be, for example, about 90 to about 110 degrees, including about 100 degrees). The intermediate row 814 and the outlet row 816 may both be similar or identical to each other and have a general rhomboid shape with an opening angle α8 (which can be about 120 to about 140 degrees, including about 130 degrees). Similar to frame 700, the struts forming cell 812 may be wider than the struts forming cell 816. The outflow section 820 may be substantially the same as the outflow section 720, including the general shape of the cell 822 and CAF 840. The first connecting strut 822a and the second connecting strut 822b may have a similar shape to the struts 722a and 722b, but in the illustrated embodiment, the connecting struts 822a and 822b have a width substantially the same as the struts forming the cell 812, and the stiffness of the connecting struts 822a and 822b is the same as the stiffness of the struts forming the cell 812. It should be understood that certain features of frames 700 and 800 may be combined to form frames not shown, such as combining the inflow sections 710 and 810 with the outflow sections 720 and 820 of the other frame.

[0045] Figures 8A to 8C show some different versions of frames 900a to 900c, which are generally similar to frames 700 and 800. Therefore, only the differences will be described below, and any features not described should be understood to be similar to or identical to the corresponding features of frames 700 and 800. Each of frames 900a to 900c includes inlet sections 910a to 910c and outlet sections 920a to 920c. The inlet sections 910a to 910c of each frame 900a to 900c may include two rows of cells, including inlet side rows 912a to 912c and outlet side rows 916a to 916c. Each of the cells in the inlet sections 910a to 910c may be generally rhombic, but some cells may have axial runners of different lengths to vary the shape of a particular cell. For example, cell 916a has an axial runner of zero or near-zero length, while cell 912a has an axial runner of greater length, thereby making cell 912a roughly hexagonal. Frame 900c has the opposite configuration compared to frame 900a, with cell 912c having an axial runner of zero or near-zero length, and cell 916c having a runner of greater length, thereby making cell 916c roughly hexagonal. On the other hand, frame 900b has an intermediate configuration in which cells 912b and 916c are substantially identical, each having an axial runner that is longer than the runners of cells 912a and 916c, but shorter than the runners of cells 912c and 916a. In some embodiments, the inlet sections 910a to 910c can all have the same axial length as each other, thereby making the entire frame 900a to 900c have the same axial length as each other. This may be particularly true when the outflow sections 920a to 920c are identical to each other, as shown in Figures 8A to 8C. The outflow sections 920a to 920c include larger cells 922a to 922c, along with CAF 940a to 940c, which are partially formed by first connecting struts 922a1, 922b1, 922c1 and second connecting struts 922a2, 922b2, and 922c2.In the illustrated embodiment, the outflow sections 920a to 920c are the same as or identical to the outflow section 820, but in other embodiments, they may be the same as or identical to any other outflow section described herein.

[0046] Figure 9 shows a portion of another example of frame 1000, which is substantially similar to frame 500, except for certain differences described herein. Features not described in relation to frame 1000 should be understood to be similar to or identical to those of frame 500. Similar to frame 500, frame 1000 includes an inlet section having three rows of cells, including an inlet cell 1012, an intermediate cell 1014, and an outlet cell 1016. These cells may all be identical to each other and may be substantially rhomboid in shape. However, compared to cells 512, 514, and 516, cells 1012, 1014, and 1016 have slightly elongated axial runners (it should be understood that axial runners do not contribute to any axial shortening of the frame during expansion). Also, the inlet apex of cell 1012 omits any holes or eyelets similar to those of eyelet 513. Outlet section 1020 is substantially similar to outlet section 520, except for two main differences. The larger cell 1022 has a shape that is generally similar to that of cell 522, but instead of three connecting struts 522a-522c, it contains only two connecting struts 1022a and 1022c. Also, the CAF1040 is substantially identical to the CAF540, but the connecting strut 1022c is connected to the CAF1040 near its bottom (or inflow) side, meaning that the CAF1040 is not supported by the connecting strut 1022c over a greater axial length. This configuration may allow the CAF1040 to deflect more inward during use (for example, during ventricular diastole when the prosthetic valve leaflets are closed and pressure is being applied to the prosthetic valve in an outflow-to-inflow direction).

[0047] Figure 10 shows a portion of another example of frame 1100, which has features common to frames 500 and 1000, with the exception of certain differences described herein. Features not described in relation to frame 1100 should be understood to be similar to or identical to those of frames 500 and / or 1000. Similar to frame 500, frame 1000 includes an inlet section, but with two rows of cells (instead of three), namely inlet cells 1112 and outlet cells 1116. Both inlet cells 1112 and outlet cells 1116 may be roughly diamond-shaped cells with no axial runners (or at least no axial runners of any significant length). Cell 1112 may have inlet struts that are wider than the outlet struts shared with cell 1116, and cell 1116 may have outlet struts that are thinner than the inlet struts shared with cell 1112. This configuration allows the struts forming cells 1112 and 1116 to have decreasing rigidity in the direction from inflow to outflow. Furthermore, cell 1112 can have an opening angle α9 (which can be between approximately 80 and 100 degrees, including 90 degrees) that is smaller than the opening angle α10 (which can be between approximately 60 and 80 degrees, including 70 degrees) of cell 1116. This configuration allows cell 1112 to have increased radial strength compared to cell 1116. The outflow section 1120 may be identical to the outflow section 1020 and includes cell 1122, which is partially formed by two connecting struts 1122a and 1122c, with the connecting struts 1122c connected to the CAF 1140 near the bottom or inflow side of the CAF 1140.

[0048] Figure 11 shows a portion of another example of frame 1200, which has features common to frame 1100, with the exception of certain differences described herein. Features not described in relation to frame 1200 should be understood to be similar to or identical to those of frame 1100. Similar to frame 1100, frame 1200 includes an inlet section having two rows of cells, including inlet cell 1212 and outlet cell 1216. However, unlike cells 1112 and 1116, cells 1212 and 1216 each include an axial runner of considerable length such that cells 1212 and 1216 are roughly hexagonal. Similar to inlet section 1110, the struts of inlet section 1210 are widest in the inlet strut of cell 1212, of intermediate width in the strut shared between cells 1212 and 1216, and may be thinner in the outlet strut of cell 1216. The outflow section 1220 may be substantially similar to the outflow section 1120, including a large cell 1222 partially formed by two connecting struts 1222a, 1222c. However, the connecting strut 1222c is shown to connect to the axial midpoint of the CAF 1240, which may provide further stability to the CAF 1240 compared to the configuration of the frame 1100.

[0049] Figure 12 shows a portion of another example of frame 1300, which has features common to frame 1100, with the exception of certain differences described herein. Features not described in relation to frame 1300 should be understood to be similar to or identical to those of frame 1100. Similar to frame 1100, frame 1300 includes an inlet section having two rows of cells, including inlet cells 1312 and outlet cells 1316. Both cells 1312 and 1316 may be generally rhomboid, have similar or identical opening angles, and have uniform strut widths. Inlet section 1310 is similar to inlet section 510 in that the inlet struts of inlet cells 1312 include eyelets 1313 at the inlet apex to assist in suture material (e.g., inner and / or outer skirt / cuff material and / or valve leaflet material) to frame 1300. Outflow section 1320 may be substantially similar to outflow section 820 in that it includes a large cell 1322 partially formed by the two connecting struts 1322a, 1322c, with the first connecting strut 1322a being wider than the second connecting strut 1322c, and the second connecting strut 1322c being connected near the top of CAF 1340. However, unlike the other CAFs described and illustrated above, CAF 1340 has a substantially rectangular body with small eyelets arranged in a 2x2 configuration and a single elongated eyelet below the 2x2 arrangement of small eyelets. As with the other embodiments described herein, connecting the second connecting strut 1322c to the top of CAF 1340 can provide CAF 1340 with more stability compared to connections at the midpoint or bottom of CAF.

[0050] Figure 13 shows a portion of another example of frame 1400, which has features common to frame 1200, with the exception of certain differences described herein. Features not described in relation to frame 1400 should be understood to be similar to or identical to those of frame 1200. Similar to frame 1200, frame 1400 includes an inlet section 1410 having two rows of cells, including inlet cell 1412 and outlet cell 1416. However, unlike cells 1212 and 1216, cells 1412 and 1416 are shown having struts that are equal in width to each other. Outlet section 1420 may be substantially similar to outlet section 1220, including a large cell 1422 partially formed by two connecting struts 1422a and 1422c. However, although the connecting strut 1422c is shown to connect to the axial midpoint of CAF 1440, CAF 1440 has a different configuration from CAF 1240. CAF1440 is formed in a rod shape that extends generally axially (similar to CAF840), and is shown having a single row of four eyelets, although each CAF1440 may contain more or fewer eyelets in a single row or in a different arrangement. The inlet apex of cell 1412 may include a notch 1413 that can serve a similar purpose to the eyelet 513. In other words, the suture can wrap around the notch 1413 to help secure the position of the suture relative to the frame 1400. The outlet end of CAF1440 may include a similar notch to help secure the suture.

[0051] Figure 14 shows a portion of another example of frame 1500, which is identical to frame 1400 except for CAF1540. Therefore, all other features of frame 1500 will not be described. CAF1540 is connected to a second connecting strut 1522c near the axial midpoint of CAF1540, while CAF1540 has configurations not shown or described above. For example, each CAF1540 may be roughly rectangular and include two horizontal or circumferential struts defining the top and bottom of CAF1540, and four axial struts or posts connecting the horizontal struts. The ends of the horizontal struts are joined to each other by a pair of axial posts, defining a roughly rectangular shape. Two additional axial struts or posts may connect the horizontal struts at positions inward from the outermost posts. This configuration creates three axially elongated openings in CAF1540. In some embodiments, the tabs or lateral edges of two adjacent artificial valve leaflets can be joined together and extended through the central opening of the CAF1540, and the tabs or lateral edges can then be placed substantially flat with respect to the outer surface of the CAF1540. However, it should be understood that other specific configurations for attaching the artificial valve leaflet commissure to the CAF1540 may be preferred.

[0052] Figure 15A shows a portion of another example of frame 1600, which has features common to frame 1200, with the exception of certain differences described herein. Features not described in relation to frame 1600 should be understood to be similar to or identical to those of frame 1200. Similar to frame 1200, frame 1600 includes an inlet section 1610 having two rows of cells, including inlet cell 1612 and outlet cell 1616. However, unlike cells 1212 and 1216, cells 1612 and 1616 are shown with struts having equal widths to each other. Also, similar to frame 500, the inlet apex of cell 1612 includes an eyelet 1613. The outlet section 1620 may be substantially similar to the outlet section 1220, including a large cell 1622 partially formed by two connecting struts 1622a and 1622c. However, although the connecting strut 1622c is shown to connect to the axial midpoint of the CAF1640, the CAF1640 has a different configuration from the CAF1240. The CAF1640 has a roughly hexagonal shape, comprising two axial struts (each connected to the connecting strut 1622c) and two pairs of struts, each forming a vertex that connects the two axial struts (one inlet strut vertex and one outlet strut vertex). This configuration allows the CAF1640 to be foldable. In other words, when the artificial heart valve incorporating the frame 1600 is crimped to a smaller size (e.g., on a delivery device for transcatheter delivery), the axial struts of the CAF1640 can move closer to each other as the two strut vertices become more acute. The foldability of the CAF1640 allows for a smaller overall crimp diameter of the artificial heart valve incorporating the frame 1600, thus enabling better access to the patient. When frame 1600 expands (for example by balloon inflation), CAF1640 expands again, providing a large open space for the attachment and flexing of "soft" components (e.g., cloth and / or tissue cuffs and / or artificial valve leaflets) that are attached directly or indirectly to CAF1640.

[0053] Figure 15B shows a portion of the outflow section 1620' of frame 1600', which has a single modification compared to frame 1600 and therefore only the modification is described, as the rest of frame 1600' is identical to frame 1600. Frame 1600' includes a large cell 1622' partially formed by two connecting struts 1622a', 1622c', and a second connecting strut 1622c' is also connected near the axial midpoint of CAF1640', however the configuration of connecting struts 1622a', 1622c' differs from the configuration of connecting struts 1622a, 1622c. The difference is best illustrated by comparing the dashed line 1642 in Figure 15A with the dashed line 1642' in Figure 15B. When frame 1600 is in the expanded state, the joints of connecting struts 1622a and 1622c are at approximately the same axial height (or circumferentially aligned) as the outflow apex of CAF 1640. On the other hand, in Figure 15B, when frame 1600' is in the expanded state, the joints of connecting struts 1622a' and 1622c' are axially lower (in the inflow direction) than the outflow apex of CAF 1640'. By lowering connecting strut 1622c' (compared to connecting strut 1622c) so that connecting strut 1622c' is more horizontally or circumferentially oriented (compared to connecting strut 1622), connecting strut 1622c' can better "pull" CAF 1640' to open or expand when expanding the artificial heart valve incorporating frame 1600'.

[0054] Figure 16 shows a portion of another example of frame 1700, which has features common to frame 1300, with the exception of certain differences described herein. Features not described in relation to frame 1700 should be understood to be similar to or identical to those of frame 1300. Similar to frame 1300, frame 1700 includes an inlet section 1710 having two rows of cells, including inlet cells 1712 and outlet cells 1716, all of which may be formed by struts of similar or identical width. All inlet cells 1712 may be roughly diamond-shaped, similar to or identical to each other cell in the same row, and the inlet vertices of some or all inlet cells 1712 may include eyelets 1713 similar to eyelets 513. The cells 1716 in the outlet side row may also be roughly diamond-shaped, although selected cells in the outlet side row may be formed as enlarged cells 1717. In the illustrated embodiment, one expansion cell 1717 is provided for each CAF 1740 in the row of outflow cells 1716 (for example, a total of three expansion cells 1717 and a total of three CAF 1740 in the case of a three-lobed prosthesis valve). The CAF 1740 may be substantially similar to or identical to the CAF 1340, but in the illustrated embodiment, instead of the CAF 1340 being located above the outflow apex of the cell 1316, the bottom (or inflow side) of the CAF 1740 is connected to two struts that form the outflow end of the expansion cell 1717. In other words, the outflow end of the expansion cell 1717 does not need to be the apex; rather, the two outflow struts of the expansion cell 1717 may transition directly to the two lateral edges of the CAF 1740. In addition to including the elongated cell 1717, the main difference between the frame 1700 and the frame 1300 is the expansion cell 1722. Each enlarged cell 1722 in the outflow section 1720 may be partially formed by three connecting struts 1722a to 1722c. In the illustrated embodiment, the first connecting strut 1722a is connected to an axial runner 1723 extending in the outflow direction from a selected cell 1716 in the outflow side row. The first connecting strut 1722a may be short and angled toward the inflow side of the frame 1700.The second connecting strut 1722b can extend for most of the distance between the axial runner 1723 and the CAF 1740. In the illustrated example, the second connecting strut 1722b is curved (for example, having the shape of a part of a circle) with the convex side of the curve generally facing the outflow direction and the concave side of the curve generally facing the inflow direction. The two ends of the curved second connecting strut 1722b can be connected to the ends of the first connecting strut 1722a and the third connecting strut 1722c. The third connecting strut 1722c can extend upward or in the outflow direction and can be connected at or near the top (or outflow end) of the CAF 1740. By using an arched strut design (primarily referring to the second connecting strut 1722b), stress can be distributed more uniformly over the length of the arched strut during folding and expanding of the frame 1700 compared to a design with only straight connecting struts. This elastic energy can help minimize crimp strain and can also be used to assist in centering the CAF1740 by flexing and repelling each other on the extended frame 1700.

[0055] Figure 17 shows a portion of frame 1800 of another example, which shares features with frames 1600 and 1600', with the exception of certain differences described herein. Features not described in relation to frame 1800 should be understood to be similar to or identical to those of frames 1600 or 1600'. The outflow section 1820 of frame 1800 is identical to the outflow section 1620' of frame 1600, including the shape of the large cell 1822 and the position of the connecting struts relative to the CAF 1840 (see dashed line 1842). However, the inflow section 1810 differs from any of the inflow sections described above. In particular, the inflow section 1810 includes inflow cells 1812 and outflow cells 1816. The inflow cells 1812 are generally perfectly circular in shape, and each adjacent circular cell 1812 is connected by short horizontal connecting struts (shown in Figure 17, but not separately referenced). In the illustrated embodiment, four circular inlet cells 1812 are provided for each section of the frame 1800 (for example, a total of 12 circular inlet cells 1812 in a three-lobed artificial heart valve). Outlet cells 1816 may be formed as partially rhomboid cells. For example, the outlet end of each outlet cell 1816 may be formed as a rhomboid cell, along with an elongated axial runner extending from the outlet strut apex of each cell 1816. The elongated axial runner may be directly connected to the apex (or outlet end) of one of the circular inlet cells 1812. This frame design, including an alternating cell structure with semi-rhomboid cells 1816 and fully circular cells 1812, can be particularly suitable for maintaining uniformity of shape during folding and expanding while controlling the recoil of the stent frame using distributed stress / strain on the arc(s) of the cell(s) 1812.

[0056] Figure 18 shows a portion of another example of frame 1900, which has features common to frame 13, except for certain differences described herein. Features not described in relation to frame 1900 should be understood to be similar to or identical to those of frame 1300. The difference between the inlet section 1910 of frame 1900 and all other embodiments disclosed above is that the inlet section 1910 is formed from a single row of cells 1912, which can be significantly larger than the inlet cells of other embodiments described herein. For example, as shown in Figure 18, the cells 1912 may be roughly rhomboid and may contain only three cells per CAF 1940 (e.g., a total of 12 cells 1912 for one embodiment with three artificial valve leaflets). Despite the inlet section 1910 containing only a single row of cells 1912, the axial height of the inlet section 1910 may be similar to the axial height of other inlet sections described herein. In the illustrated embodiment, the inflow apex of cell 1912 includes an eyelet 1913 similar to that of eyelet 513. Due to the larger size of cell 1912, none of the cells 1912 have an outflow apex that is not directly connected to a strut of cell 1922 or CAF 1940. The outflow section 1920 may be substantially similar to the outflow section 1320, including the fact that the outflow section 1920 may include a larger cell 1922 partially formed by connecting struts 1922a, 1922b. Each connecting strut 1922a may be directly connected to an outflow apex of one of the larger inflow cells 1912, and each connecting strut 1922b may be connected to the apex or outflow side of CAF 1940, which may be similar to or identical to CAF 1340. The larger design of cell 1912 may help improve coronary artery access. For example, after implantation of an artificial heart valve incorporating frame 1900, it is desirable to avoid the structure of the artificial heart valve obstructing future access to the coronary arteries. Due to the design of frame 1900, the large cell 1922 has a larger open area compared to the other large cells described herein.For example, comparing a large cell 1922 to a large cell 1322, we find that the large cell 1922 has a larger area because there is a greater circumferential spacing between the outflow apex of adjacent inflow cells 1912 (compared to the spacing between cells 1316). If one of the large cells 1922 aligns with a coronary artery after implantation, it may be easier to pass a device (e.g., an interventional catheter) through the large cell 1922 into the coronary artery, for example, to place a coronary stent. The "soft" components of the artificial heart valve incorporating the frame 1900 (e.g., inner or outer cloth or tissue cuffs, or cloth or tissue prosthetic valve leaflets) can be attached to the large inflow cells 1912 with different desired tensions to produce different results. For example, these soft components may be attached tightly to create a taut cloth (or tissue) or more loosely to create a loose cloth (or tissue) connection. In some cases, the attachment may be tighter or looser depending on the particular cell. For example, the inner cuff may be tightly coupled to cells 1912 that are not directly axially aligned with CAF1940, but loosely coupled to cells 1912 that are directly axially aligned with CAF1940. This configuration allows for a looser mounting area, which can create extra flexibility for leaflet attachment, thus helping to reduce the stress directly applied to the tissue leaflet connection.

[0057] Figure 19 shows a portion of another example of frame 2000, which has features common to frame 1300, with the exception of certain differences described herein. Features not described in relation to frame 2000 should be understood to be similar to or identical to those of frame 1300. Similar to frame 1300, frame 2000 includes an inflow section 2010 having two rows of cells, including inflow cells 2012 and outflow cells 2016, which may all be formed by struts of similar or identical width. Inflow cells 2012 and outflow cells 2016 may all be roughly diamond-shaped and similar to or identical to each other cell in the same row, and the inflow vertices of some or all inflow cells 2012 may include eyelets 2013 similar to eyelets 513. The outflow section 2020 may include CAF2040, which is similar to or identical to CAF1340. The main difference between frame 1300 and frame 2000 is the configuration of the large cell 2022 in the outflow section 2020. In particular, in the embodiment shown in Figure 19, four connecting struts 2022a to 2022d are arranged in a zigzag pattern between circumferentially adjacent CAF 2040s, and the connecting struts 2022a to 2022d are not directly connected to the cell 2016. For example, the first connecting strut 2022a can be directly attached, for example, to the top or near the outflow end of the CAF 2040. The first connecting strut 2022a can be connected to the second connecting strut 2022b, and the connection point forms a vertex pointing in the outflow direction. The second connecting strut 2022b can be connected to the third connecting strut 2022c, and the connection point forms a vertex pointing in the inflow direction. The third connecting strut 2022c can be connected to the fourth connecting strut 2022d, and the connection point forms a vertex pointing in the outflow direction. Finally, the fourth connecting strut 2022d can be directly attached to one of the CAF2040s, for example, near its top or outflow end. With this configuration, the connecting struts 2022a to 2022d are separated from most of the structure of the frame 2000, except for the CAF2040.This configuration can help provide relatively uniform folding and expansion of the large cell 2022 while simultaneously functioning as a thin upper or outflow ring of the frame 2000. Its function as a thin outflow ring can help control (e.g., minimize) the degree of flare at the outflow end of the frame 2000 when the prosthetic valve is expanded, and at the same time, it can help ensure that the natural aortic valve leaflets are not pushed back and interfere with the operation of the prosthetic valve incorporating the frame 2000.

[0058] Figure 20 shows a portion of frame 2100 in another example. Frame 2100 illustrates a little more than one-third of the entire frame 2100 (assuming frame 2100 is used with a 3-lobed artificial heart valve). Frame 2100 may include an inlet section 2110 and an outlet section 2120. The inlet section 2110 may have cells 2112 in the inlet-side outermost row, but the cells 2112 are not continuous across the circumference of the row. For example, Figure 20 illustrates that cells 2112 in the inlet-side outermost row may include a pair of rhomboid cells on both sides of the CAF 2140 circumferentially and gaps formed by larger cells 2112 between each pair of adjacent cells 2112. In the 3-lobed embodiment, frame 2100 may include a total of 6 inlet-side outermost cells 2112. The inlet section 2110 may also include cells 2116 in the outlet-side row. Similar to cell 2112, cell 2116 is not continuously distributed along the circumference of the frame. Rather, a single rhomboid cell is positioned directly beneath each CAF 2140 and is formed by a strut that forms part of a pair of inflow cells 2112.

[0059] One inlet cell 2112 of a pair of inlet cells can be connected to an inlet cell 2112 of an adjacent pair of inlet cells by two struts 2115 that form a "V" shape with a vertex pointing in the direction of inflow. In the illustrated embodiment, the struts 2115 have a width greater than the width of the struts forming cells 2112 and 2116. The outflow section 2120 may include a very large cell 2122 that is not limited to the outflow section 2120. In the illustrated example, each adjacent pair of CAF 2140 is connected by two connecting struts 2122a, 2122b. Each connecting strut 2122a, 2122b has a first end that connects to the CAF 2140 near its apex or outflow edge, and opposite ends that connect to each other. In the illustrated example, the connection between the connecting struts 2122a, 2122b forms a vertex pointing towards the inflow end of the frame 2100. In some embodiments, including the illustrated embodiment, the connecting struts may flare out toward the outflow end of the frame 2100 near their connection points to form a prominent "V" apex, which may have a apex angle similar to that formed by strut 2115. In this configuration, the very large cell 2122 is bounded at the outflow end by connecting struts 2122a, 2122b, at the side edge by CAF 2140, and by the struts and strut 2115 of cells 2116, 2112. The design shown in Figure 20 can provide very little shortening during the expansion of the frame 2100. The connecting struts 2122a and 2122b provide support to the outflow end of the frame 2100 (including providing support to the CAF 2140), but when the frame is folded, the V-shaped connection between the connecting struts 2122a and 2122b can shift downward in the D direction and eventually nest into the folded V-shaped strut 2115. Other features of the frame 2100, including the method and materials for forming the frame 2100 and the features of the artificial heart valve incorporating the frame 2100, may be the same as or identical to other embodiments described herein.

[0060] Figure 21 shows a portion of frame 2200 in another example. Frame 2200 illustrates a little more than one-third of the entire frame 2200 (assuming frame 2200 is used with a three-lobed artificial heart valve). Frame 2200 may include an inlet section 2210 and an outlet section 2220. Inlet section 2210 may have a cell 2212 in the inlet-side outermost column and a cell 2214 in an adjacent intermediate column. In the illustrated embodiment, cells 2212 and 2214 are all substantially diamond-shaped and provided in a complete column (e.g., nine consecutive diamond-shaped cells in each column). Inlet cell 2112 may include an inlet vertex defining an eyelet 2213 which may be similar to eyelet 513. Inlet section 2210 may also include a cell 2216 in the outlet-side outermost column, which may also be substantially diamond-shaped, but cell 2216 is not consecutive around the circumference of the column. For example, Figure 21 illustrates that the cell 2216 in the outermost row on the outflow side may contain a single diamond-shaped cell 2216 directly below each CAF 2240 (which may be similar to or identical to CAF 1340). In the three-leaflet embodiment, the frame 2200 may contain a total of three outermost outflow cells 2216.

[0061] In the illustrated example, four connecting struts 2222a to 2222d are arranged in a zigzag pattern between circumferentially adjacent CAF2240s. For example, the first connecting strut 2222a can be directly attached, for example, near the top or outlet end of a CAF2240. The first connecting strut 2222a can be connected to the second connecting strut 2222b, and the connection point forms a vertex pointing in the inflow direction. The second connecting strut 2222b can be connected to the third connecting strut 2222c, and the connection point forms a vertex pointing in the outflow direction. The third connecting strut 2222c can be connected to the fourth connecting strut 2222d, and the connection point forms a vertex pointing in the inflow direction. Finally, the fourth connecting strut 2222d can be directly attached, for example, near the top or outlet end of one of the CAF2240s. At the connection between the second connecting strut 2222b and the third connecting strut 2222c, an axial connecting strut 2223 can be connected to bridge the connection between the struts 2222b and 2222c and one of the outflow vertices of the intermediate cell 2214. In the illustrated embodiment, each axial connecting strut 2223 is positioned midway between each adjacent pair of CAF 2240. Similar to frame 2100, when frame 2300 is folded, the inflow-oriented vertices between struts 2222a and 2222b and between struts 2222c and 2222d move downward in direction D, substantially nesting within or between the struts of the cell in the inflow section 2210.

[0062] The embodiment shown in Figure 21 is another design that helps minimize shortening, similar to frame 2100. Here again, the top row of large cells 2222 in the outflow section 2220 is designed to move or shift downward toward the inflow section 2210 when folded, thus shortening in the middle of the frame structure and not increasing the overall length. Other features of frame 2200, including the method and materials for forming frame 2200, and the features of the artificial heart valve incorporating frame 2200, may be the same as or identical to other embodiments described herein.

[0063] Figure 22 shows a portion of frame 2300 in another example. Figure 22 illustrates nearly two-thirds of the entire frame 2300 (assuming frame 2300 is used with a three-lobed artificial heart valve). Frame 2300 may include an inlet section 2310 and an outlet section 2320. The inlet section 2310 may have cells 2312 in the inlet-side outermost row and cells 2316 in the adjacent outlet-side row. In the illustrated embodiment, cells 2312 and 2316 are all substantially rhomboid, but are not provided in complete rows. Rather, in the illustrated embodiment, two rhomboid inlet-side rows 2312 are provided in pairs on both circumferential sides of each CAF 2340 (which may be similar to or identical to CAF 1340), resulting in a total of six cells 2312 for a three-lobed valve. In the illustrated embodiment, the outflow cells 2316 are located directly below each CAF 2340, resulting in a total of three diamond-shaped cells 2316 for a three-lobed valve. Elongated cells 2317 can be provided between each pair of adjacent inflow cells 2312. The elongated cells 2317 can be diamond-shaped or kite-shaped, and each single elongated cell 2317 extends the entire axial distance of the inflow section 2310. In the illustrated embodiment, the inflow apex of the inflow cells 2312 and elongated cells 2317 may include eyelets 2213 similar to or identical to eyelets 513.

[0064] In the illustrated example, four connecting struts 2322a to 2322d are arranged in a zigzag pattern between circumferentially adjacent CAF2340. For example, the first connecting strut 2322a can be directly attached, for example, near the top or outlet end of a CAF2340. The first connecting strut 2322a can be connected to the second connecting strut 2322b, and the connection point forms a vertex pointing in the outlet direction. The second connecting strut 2322b can be connected to the third connecting strut 2322c, and the connection point forms a vertex pointing in the inflow direction. The third connecting strut 2322c can be connected to the fourth connecting strut 2322d, and the connection point forms a vertex pointing in the outlet direction. Finally, the fourth connecting strut 2322d can be directly attached, for example, near the top or outlet end of one of the CAF2340. The connection between the second connecting strut 2322b and the third connecting strut 2322c can also serve as a connection to the outflow apex of the elongated cell 2317.

[0065] The embodiment shown in Figure 22 has an asymmetrical cell design in which tall and short cell rows are arranged alternately, the number of rows alternates, and the strut length alternates, creating an overall connecting system that forms an open space for coronary artery access and also forms a structure for attaching the valve leaflets to the stent frame. Other features of the frame 2300, including the method and materials for forming the frame 2300 and the features of the artificial heart valve incorporating the frame 2300, may be the same as or identical to other embodiments described herein.

[0066] Figure 23 shows a portion of frame 2400 in another example, and Figure 23 shows slightly more than one-third of the entire frame 2400 (assuming the frame is used with three artificial valve leaflets). Frame 2400 may include an inlet section 2410 and an outlet section 2420. The inlet section 2410 may have cells 2412 in the inlet-side outermost column, cells 2414 in the adjacent middle column, and cells 2416 in the outlet-side column. In the illustrated embodiment, cells 2412, 2414, and 2416 are all substantially diamond-shaped. Columns 2412 and 2414 may be provided as complete columns of identical cells, while column 2416 may include elongated cells 2417 (which may be diamond-shaped or kite-shaped) alternating with the diamond-shaped cells 2416. The elongated outflow cells 2417 are located directly below each CAF 2440 and directly below the connection points of the connecting struts 2422b and 2422c (described in more detail below), resulting in a total of six rhombic cells 2416 and six elongated outflow cells 2417 in a three-leaflet valve. Each elongated cell 2417 can extend toward the outflow end over an axial distance greater than the axial range of the rhombic cell 2416. In the illustrated embodiment, the inflow apex of the inflow cell 2412 may include a notch 2413, which may be similar to or identical to the notch 1413.

[0067] In the illustrated example, four connecting struts 2422a to 2422d are arranged in a zigzag pattern between circumferentially adjacent CAF2440s. For example, the first connecting strut 2422a can be directly attached, for example, near the axial midpoint of a CAF2440. The first connecting strut 2422a can be connected to the second connecting strut 2422b, and the connection point forms a vertex pointing in the outflow direction. The second connecting strut 2422b can be connected to the third connecting strut 2422c, and the connection point forms a vertex pointing in the inflow direction. The third connecting strut 2422c can be connected to the fourth connecting strut 2422d, and the connection point forms a vertex pointing in the outflow direction. Finally, the fourth connecting strut 2422d can be directly attached, for example, near the axial midpoint of one of the CAF2440s. The connection between the second connecting strut 2422b and the third connecting strut 2422c can also serve as a connection to the outflow apex of the elongated cell 2417.

[0068] One of the advantages of the frame 2400 design is that it is designed to have the maximum possible space for coronary artery access. In particular, this can be achieved, at least in part, by the combination of the design structure of the frame's outflow region, which consists of large, elongated cells 2417 and alternating smaller cells 2416.

[0069] Figure 24A shows a portion of frame 2500 in another example. Frame 2500 may be similar to or identical to frames 1200, 1400, 1500, or 1600, with the exception of CAF 2540. In the limited portion of frame 2500 shown in Figure 24A, connecting struts 2522a, 2522c are shown that at least partially form the outflow cell 2516 and the large cell 2522. The remaining portion of frame 2500, with the exception of CAF 2540 which will be described in more detail below, may have any of the features of frames 1200, 1400, 1500, or 1600 (or other frames described herein).

[0070] Figure 24B shows an enlarged view of one of the CAF2540s, illustrating additional features relating to the connection of the artificial valve leaflets to the CAF2540. In the illustrated embodiment, the CAF2540 is integrally formed with the rest of the frame, with the bottom end (or inlet end) of the CAF2540 attached to the outlet apex of the outlet cell 2516, and the lateral edges connected to the connecting strut 2522c at or near the axial midpoint of the CAF2540. Each CAF2540 may have a generally triangular or trapezoidal outer boundary. In other words, the CAF2540 may have a bottom or inlet edge or inlet portion that can be called a relatively long straight base, and an apex or outlet edge or outlet portion that can be called a relatively short straight apex. The base and apex may be joined by two angled lateral portions extending at non-parallel angles to each other. In addition to this outer triangular or trapezoidal shape, a generally triangular projection 2542 may extend from the base toward the top of the CAF2540 without actually contacting the top of the CAF2540. One or more eyelets may be formed on the triangular projection 2542. In the illustrated embodiment, three eyelets are provided in a single row (decreasing in size from bottom to top), but it should be understood that more or fewer eyelets (including no eyelets) may be provided in the same or different arrangements and in the same or different sizes. The above-described configuration of the CAF2540 forms a generally "A" or inverted "V" shaped slot 2544 within the CAF2540.

[0071] Continuing to refer to Figure 24B, two leaflet tabs 2580 (e.g., lateral edges or extensions of two adjacent artificial leaflets joined together to form an artificial commissure) are positioned in and / or through angled slots 2544, so that the leaflet tabs extend along an angle nonparallel to the longitudinal central axis of the frame 2500. To assist in securing the leaflet tabs 2580 to the CAF 2540, one or more sutures S can be passed through eyelets in the triangular projections 2542, through the leaflet tabs 2580 (and / or around them), and wrapped around the sides of the CAF 2540. One advantage of the CAF 2540 design is that it is designed for angled leaflet attachment. When attaching artificial leaflets to an artificial heart valve (e.g., the frame and / or fabric / tissue members on the frame), it is generally important to minimize stress on the artificial leaflets (and thus leaflet fatigue). The angled valve leaflet embodiments illustrated and described in relation to Figures 24A and 24B may allow for careful adjustment of the angle of the valve leaflet mounting itself, and thereby adjustment of the amount of stress / fatigue that the artificial valve leaflet may experience during normal operation.

[0072] Figure 25 shows a portion of frame 2600 in another example. Frame 2600 may be similar to or identical to frames 1200, 1400, 1500, or 1600, with the exception of CAF 2640. In the limited portion of frame 2600 shown in Figure 25, connecting struts 2622a, 2622c are shown that form at least partially the outflow cell 2616 and the larger cell 2622. The remaining portion of frame 2600, with the exception of CAF 2640 which will be described in more detail below, may have any of the features of frames 1200, 1400, 1500, or 1600 (or other frames described herein).

[0073] In the illustrated embodiment, the CAF2640 is integrally formed with the rest of the frame, with the bottom end (or inlet end) of the CAF2640 attached to the outlet apex of the outlet cell 2616, and the side edges connected to the connecting strut 2622c at or near the axial midpoint of the CAF2640. Each CAF2640 may have a generally triangular or trapezoidal outer boundary. In other words, the CAF2640 may have a relatively long, straight bottom or inlet edge or inlet portion that can be called a base, and a relatively short, straight or curved apex or outlet edge or outlet portion that can be called an outlet. The base and apex may be joined by two angled lateral portions extending at non-parallel angles to each other. One or more openings or eyelets may be formed in the CAF2640. In the illustrated embodiment, an elongated central opening is provided, which extends for most of the axial height of the CAF2640 and can accommodate a valve leaflet tab therein. Two angled openings may be provided on either side of an elongated central opening, and the angled openings may be configured to receive sutures or valve leaflet tabs therein to assist in the attachment of valve leaflets and / or cuffs to the frame 2600. In this embodiment, the tapered design of the CAF2640 may help to allow for a smaller folded outer shape of the frame 2600.

[0074] The frames shown in Figures 4A and 6-25 include various combinations of components and features shown in specific examples. However, it should be understood that the features of these frames can be mixed and adapted as needed. For example, the inflow sections of any of these frames may be interchangeable to reach specific combinations not actually shown. Similarly, the outflow sections of any of these frames may be interchangeable to reach specific combinations not actually shown. Furthermore, a specific CAF shown may be interchangeable with other CAFs shown herein. Other specific features of the frames may be modified as needed, even if not specifically shown. For example, the number and configuration of connecting struts in the outflow section of any of these frames may be replaced with those of other frames shown herein. The location of the CAF (e.g., top, middle, or bottom) to which the connecting struts(s) are attached may be changed as desired in any of these frames. The connecting struts may all have the same width as one another, or they may be provided with different widths, including widths that decrease in the direction toward the CAF. While adjacent connecting struts are shown in embodiments where a certain angle is formed between them when extended, it should be understood that other angles may be provided instead, including those seen in other embodiments of the frame herein. The number of cells per row in the inlet section, the number of rows in the inlet section, and the specific shape of the cells in the inlet section may be adjusted. For example, an inlet section of any of the frames disclosed herein may be interchangeable with an inlet section of any of the other frames disclosed herein. As described in relation to Figure 5, any of the frames disclosed herein may include strut widths that are substantially the same or have a gradient, including, for example, struts that are relatively wider closer to the inlet end of the frame and generally narrower in the direction toward the outlet end of the frame.Furthermore, as described in relation to Figure 5, any of the frames disclosed herein may include the same or, as desired, different opening angles. In addition, any of the frames may be provided with eyelets at the inlet apex of the inlet cell, or with notches instead of eyelets, or neither eyelets nor notches, or with other features that serve the same purpose as eyelets or notches. Briefly, the various embodiments of frames described herein are provided in specific embodiments, each having individual features that can offer particular advantages, and those skilled in the art should understand that different features of different embodiments can be combined (including in ways not expressly shown herein) to achieve a frame that includes the advantages of each individual feature incorporated into the frame.

[0075] Furthermore, in all embodiments disclosed herein, when an artificial heart valve incorporating a particular frame described herein is in an expanded state, the frame may be substantially cylindrical or have a substantially constant outer diameter, and without the kind of pronounced flare seen in self-expanding valves. Furthermore, all large outflow cells (e.g., 522, 722, 822, etc.) are shown as lacking axial struts, with the exception of frames 1700 and 2200. In this context, the CAFs forming part of the large outflow cells should be understood as not being axial struts. In all large outflow cells described herein (e.g., 522, 722, 822, etc.), the outflow cells (and / or the open spaces defined by the outflow cells) lack symmetry (both left-right and up-down symmetry). In particular, in embodiments lacking axial struts forming large outflow cells (e.g., 522, 722, 822, etc.), the outflow edges of the frames may include relatively deep valleys, especially in the region between adjacent CAFs. These deep valleys can be intentionally created and generally configured to be positioned below (e.g., upstream) the coronary artery during implantation, allowing for a higher level of coronary artery access after the procedure.

[0076] As described above, various features of the different frame examples illustrated and described herein can be combined to achieve the desired result. One particular example is shown in Figure 26, which shows a portion of frame 2700, which combines features similar to those of frame 1400 in Figure 13 and features similar to those of frame 2400 in Figure 23. In this example, Figure 26 shows approximately one-third of frame 2700 (assuming the frame is used with three prosthetic valve leaflets). As with the other examples described herein, when frame 2700 is used with an artificial heart valve having three prosthetic valve leaflets, the portion of frame 2700 shown in Figure 26 will be repeated approximately three times in a generally circular or annular shape. Frame 2700 may include an inflow section 2710 and an outflow section 2720. The inflow section 2710 may have cells 2712 in the inflow-side outermost column, cells 2714 in the adjacent middle column, and cells 2716 in the outflow-side column. In the illustrated embodiment, cells 2712, 2714, and 2716 are all substantially rhomboid. Rows 2712 and 2714 may be provided as complete rows of the same cell, while row 2716 may include elongated cells 2717 (which may be rhomboid or kite-shaped) alternating with the rhomboid cells 2716. The elongated outflow cells 2717 are located directly below each CAF 2740 (which may be the same as or identical to CAF 1440) and directly below the connections of the connecting struts 2722b and 2722c (described in more detail below), resulting in a total of six rhomboid cells 2716 and six elongated outflow cells 2717 when the frame 2700 is used as part of a three-leaflet valve. Each elongated cell 2717 may extend toward the outflow end over an axial distance greater than the axial range of the rhomboid cells 2716. In the illustrated embodiment, the inflow apex of the inflow cell 2712 may include an eyelet 2713, which may be the same as or identical to the eyelet 513.

[0077] In the illustrated example, four connecting struts 2722a to 2722d are arranged in a zigzag pattern between circumferentially adjacent CAF2740s. For example, the first connecting strut 2722a can be directly attached to the CAF2740, for example, near its axial midpoint. The first connecting strut 2722a can be connected to the second connecting strut 2722b, and the connection point forms a vertex pointing in the outflow direction. The second connecting strut 2722b can be connected to the third connecting strut 2722c, and the connection point forms a vertex pointing in the inflow direction. The third connecting strut 2722c can be connected to the fourth connecting strut 2722d, and the connection point forms a vertex pointing in the outflow direction. Finally, the fourth connecting strut 2722d can be directly attached, for example, to the axial midpoint of one of the CAF2740s or near thereto. The connection between the second connecting strut 2722b and the third connecting strut 2722c can also serve as a connection to the outflow apex of the elongated cell 2717.

[0078] One of the advantages of the frame 2700 design may be that, like the frame 2400, it is designed to have maximum space for coronary artery access. In particular, this may be achieved, at least in part, by the combination of the design structure of the large, elongated cell 2717 in the outflow region of the frame and the alternating smaller cell 2716. Another advantage of the frame 2700 design is that the relatively narrow angle formed by the two outflow struts in the elongated cell 2717 (compared to the relatively wide angle formed by the two outflow struts in the adjacent cell 2716) may help allow the CAF2740 to deflect during use of the prosthetic valve. In other words, when the prosthetic leaflets (attached to the CAF2740) close to prevent regurgitation through the prosthetic valve incorporating the frame 2700, the force of the prosthetic leaflets resisting regurgitation may cause the CAF2740 to deflect slightly inward. This deflection may be desirable because it helps reduce the stress on the prosthetic valve leaflets, which can be particularly important in balloon-expandable prosthetic heart valves, for example, when the frame 2700 is formed of stainless steel or cobalt-chromium material, because these materials are usually very rigid (and rigid materials may not readily dampen the forces and / or stresses / strains applied to the prosthetic valve leaflets). Furthermore, although the frame 2700 is shown having an inlet section 2710 with three rows of cells (rows of 2712, 2714, and alternating rows of cells 2716 / 2717), in some examples the inlet section 2710 may have only two rows of cells. For example, if the artificial heart valve incorporating frame 2700 is offered in different sizes (e.g., to consider patients with different sized annulus), the larger size may have three rows of cells in the inflow section 2710 as shown in Figure 26, while the smaller size may omit one of the inflow-side cell rows, such as the row of cell 2714, to accommodate smaller innate anatomical structures.As with other embodiments described herein, the artificial heart valve incorporating frame 2700 may include an inner skirt and / or an outer skirt, which may be similar to or different from the inner skirt / cuff 260 and outer skirt / cuff 270.

[0079] Figure 27 shows a little more than one-third of another frame 2800 (assuming the frame is used with three prosthetic leaflets). Since frame 2800 can be identical to frame 2700 with certain exceptions, only the exceptions are described here, and other features not described should be understood to be identical to those described in relation to frame 2700 in Figure 26. For example, like frame 2700, frame 2800 may include an inlet section 2810 and an outlet section 2820, with the inlet section 2810 having three rows of cells 2812, 2814, and 2816 (with cell 2817 alternating with cell 2816). Cells 2812 and 2814 may be substantially identical to cells 2712 and 2714, except that cell 2812 is shown having a notch 2813 instead of an eyelet 2713. Other key differences include the fact that cells 2816 and 2817 may be substantially identical to each other, and cell 2817 may be only slightly more elongated in the outflow direction compared to cell 2816, but if so, it is minimal. Otherwise, the outflow section 2820, which includes cell 2822 and four connecting struts 2822a-2822d connecting pairs of circumferentially adjacent CAF 2840s, is largely the same as that in frame 2700. However, because cells 2816 and 2817 are identical (or nearly identical) in shape, the fact that cell 2817 is not more elongated compared to cell 2717 may result in a smaller open space in the hybrid cell 2822 and a smaller coronary artery access volume.

[0080] Figure 28 shows a little more than one-third of another frame 2900 (assuming the frame is used with three artificial valve leaflets). Since frame 2900 can be identical to frame 2700 with certain exceptions, only the exceptions are described here, and other features not described should be understood to be identical to those described in relation to frame 2700 in Figure 26. For example, like frame 2700, frame 2900 may include an inlet section 2910 and an outlet section 2920. However, the inlet section 2910 is shown having two rows of cells, including a diamond-shaped cell 2912 in the inlet side row (which includes a notch 2913 at the inlet apex instead of an eyelet) and one row of enlarged outlet cells 2916, 2917. Each outflow cell 2916, 2917 may be axially longer than all inflow cells 2912, and may include, for example, two inflow struts forming a vertex pointing to the inflow end, two outflow struts forming a vertex pointing to the outflow end, and two axial struts connecting the inflow struts and pairs of outflow struts. With this configuration, the axial range of the inflow section 2910 may be roughly the same as the axial range of the inflow section 2710 of frame 2700, whereas the inflow section 2710 is shown having three rows of cells, while the inflow section 2910 is shown having two rows of cells. Outflow cells 2916 and 2917 may be substantially identical in shape to each other, but in some examples, outflow cell 2917 may be (but not required) slightly axially elongated in the outflow direction compared to outflow cell 2916. Otherwise, the outflow section 2920, which includes cell 2922 and four connecting struts 2922a-2922d that connect the circumferentially adjacent pairs of CAF 2940, is largely the same as that in frame 2700. However, because cells 2916 and 2917 are identical (or nearly identical) in shape, this configuration may result in a smaller open space for the hybrid cell 2922 and potentially less coronary artery access.

[0081] Figure 29 shows a little more than one-third of another frame 3000 (assuming the frame is used with three artificial valve leaflets). Since frame 3000 can be identical to frame 2900 with certain exceptions, only the exceptions are described here, and other features not described should be understood to be identical to those described in relation to frame 2900 in Figure 28. For example, like frame 2900, frame 3000 may include an inlet section 3010 with two rows of cells and an outlet section 3020 with one row of cells. For example, the inlet section 3010 may include a diamond-shaped cell 3012 in the inlet side row (which includes a notch 3013 at the inlet apex) and a single row of enlarged outlet cells 3016, 3017. Each outflow cell 3016, 3017 may be axially longer than all inflow cells 3012, and may include, for example, two inflow struts forming a vertex pointing to the inflow end, two outflow struts forming a vertex pointing to the outflow end, and two axial struts connecting the inflow struts and pairs of outflow struts. With this configuration, the axial range of the inflow section 3010 may be roughly the same as the axial range of the inflow section 2710 of the frame 2700, whereas the inflow section 2710 is shown having three rows of cells, while the inflow section 3010 is shown having two rows of cells. Outflow cells 3016 and 3017 may be substantially identical in shape to each other, but in some examples, outflow cell 3017 may be (but not required) slightly axially elongated in the outflow direction compared to outflow cell 3016. The main differences between frame 2900 and frame 3000 are that the rhomboid inlet cell 3012 may be slightly more axially compressed compared to the inlet cell 2912, and the axial struts of the outlet cells 3016 and 3017 may be longer than the axial struts of the outlet cells 2916 and 2917. This configuration allows the inlet and outlet strut pairs of the outlet cells 3016 and 3017 to form a larger opening angle compared to the corresponding struts of cells 2916 and 2917.Otherwise, the outflow section 3020, which includes cell 3022 and four connecting struts 3022a to 3022d connecting adjacent pairs of CAF 3040 in each circumferential direction, is generally the same as that in frame 2900, except that hybrid cell 3022 may have an even smaller open area compared to hybrid cell 2922.

[0082] Figure 30 shows a little more than one-third of another frame 3100 (assuming the frame is used with three artificial valve leaflets). Since frame 3100 can be broadly similar to frames 2900 and 3000 with certain exceptions, only the exceptions are described here, and other features not described should be understood to be identical to those described in relation to frames 2900 or 3000 in Figure 28 or Figure 29. For example, like frame 3000, frame 3100 may include an inlet section 3110 with two rows of cells and an outlet section 3120 with one row of cells. For example, the inlet section 3110 may include cell 3112 of the inlet-side cell row (which includes a notch 3113 at the inlet apex). The inlet cell 3112 may include a pair of struts forming an apex pointing in the inlet direction, a pair of struts forming an apex pointing in the outlet direction, and a pair of axial struts connecting the two pairs of struts. In this configuration, cell 3112 is longer in the axial direction compared to cell 3012, forming a hexagonal shape rather than a rhombus. Cells 3116 and 3117 in the outflow side row may be substantially rhombus or kite-shaped. In this configuration, the axial range of the inflow section 3110 may be roughly the same as the axial range of the inflow section 2710 of frame 2700, although the inflow section 2710 is shown having three rows of cells, while the inflow section 3110 is shown having two rows of cells. Outflow cells 3116 and 3117 may be substantially identical in shape to each other, but in some examples, outflow cell 3117 may be (but not required) slightly more axially elongated in the outflow direction compared to outflow cell 3116. The outflow section 3120 includes four connecting struts 3122a to 3122d that connect cell 3122 and each circumferentially adjacent pair of CAF 3140, and is generally the same as that in frame 3000, except that hybrid cell 3122 may have a slightly larger open area compared to hybrid cell 3022 (for example, similar to the amount of open space in hybrid cell 2922).

[0083] Although the present invention has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present invention. Therefore, it should be understood that numerous modifications can be made to the exemplary embodiments, and that other configurations can be devised without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. It is an artificial heart valve, A balloon-expandable frame extending between the inlet end and the outlet end, Multiple artificial valve leaflets are mounted within the frame, An inner skirt positioned between the plurality of artificial valve leaflets and the frame Equipped with, The frame includes a first row of diamond-shaped cells at the inlet end of the frame, a second row of diamond-shaped cells, and a row of outlet cells positioned at the outlet end of the frame. Each cell in the row of outflow cells is not diamond-shaped, and in the expanded state of the frame, each cell in the row of outflow cells defines an internal area larger than the internal area defined by each of the diamond-shaped cells in the first row and the second row. An artificial heart valve in which each cell in the row of outflow cells is defined at least partially by a commissure attachment shape, and each cell in the row of outflow cells lacks symmetry.

2. The artificial heart valve according to claim 1, wherein the frame includes a third row of rhomboid cells positioned between the first row of rhomboid cells and the second row of rhomboid cells.

3. The artificial heart valve according to claim 1, wherein the diamond-shaped cells in the first row and the diamond-shaped cells in the second row each contain 12 cells, and the outflow cell row contains 6 cells.

4. The artificial heart valve according to claim 1, wherein the frame comprises an inlet section including a first row of rhomboid cells and a second row of rhomboid cells, and an outlet section including a row of outlet cells, thereby requiring more force to extend the inlet section than the outlet section.

5. The artificial heart valve according to claim 1, wherein the commissure attachment shaped portion includes a plurality of commissure attachment shaped portions, each having a rectangular or triangular shape, and each of the commissure attachment shaped portions is attached to one cell in the rhombic cell of the second row and defines a portion of two cells in the row of outflow cells.

6. The artificial heart valve according to claim 5, wherein one of the rhomboid cells in the second row includes two struts that form an outflow apex which is coupled to the inflow end of the corresponding commissure mounting shape.

7. The artificial heart valve according to claim 5, wherein each cell in the row of outflow cells is defined by (i) a portion of one of the plurality of commissure attachment shapes, (ii) struts at the outflow ends of a plurality of cells in the rhomboid cells of the second row, and (iii) a plurality of connecting struts extending between the outflow end of one of the plurality of cells in the rhomboid cells of the second row and one of the plurality of commissure attachment shapes.

8. The artificial heart valve according to claim 7, wherein the plurality of connecting struts include a first connecting strut extending in the outflow direction away from one of the plurality of cells in the rhombic cells of the second row, a second connecting strut extending in the direction back from the first connecting strut toward the rhombic cells of the second row, and a third connecting strut extending from the second connecting strut toward one of the plurality of commissure attachment shapes and connecting thereto.

9. The artificial heart valve according to claim 8, wherein the third connecting strut is coupled to one of the plurality of commissure attachment shaped portions.

10. The artificial heart valve according to claim 8, wherein the first connecting strut has a width greater than the width of the second connecting strut.

11. It is an artificial heart valve, A balloon-expandable frame extending between the inlet end and the outlet end, Multiple artificial valve leaflets attached within the frame Equipped with, The frame includes a first row of kite-shaped cells and a second row of kite-shaped cells positioned in the outflow direction relative to the first row of kite-shaped cells. An artificial heart valve in which each cell in the first row is defined by two inlet struts and two outlet struts, and each kite-shaped cell in the second row is defined by two inlet struts and two outlet struts, and the two outlet struts in the first row are the same as the two inlet struts in the second row.

12. The artificial heart valve according to claim 11, wherein the two inflow struts of each cell in the first row are wider than the two outflow struts of each cell in the first row, or the two outflow struts of each cell in the second row.

13. The artificial heart valve according to claim 12, wherein the two outflow struts of each cell in the first row are wider than the two outflow struts of each cell in the second row.

14. The artificial heart valve according to claim 11, wherein the two inflow struts of each cell in the first row are thicker than the two outflow struts of each cell in the first row, or the two outflow struts of each cell in the second row.

15. The artificial heart valve according to claim 14, wherein the two outflow struts of each cell in the first row are thicker than the two outflow struts of each cell in the second row.

16. The artificial heart valve according to claim 11, wherein the two inflow struts of each cell in the first row form a first angle with respect to each other, and the two outflow struts of each cell in the first row form a second angle with respect to each other, the first angle being greater than the second angle.

17. The artificial heart valve according to claim 16, wherein the two inflow struts of each cell in the second row form a third angle with respect to each other, and the two outflow struts of each cell in the second row form a fourth angle with respect to each other, the third angle being greater than the fourth angle, and the first angle being greater than the third angle.

18. A method for implanting an artificial heart valve, While the balloon is in a deflated state, the distal end of the delivery device is advanced to the natural aortic valve, with the artificial heart valve crimped onto the balloon at the distal end of the delivery device. Under fluoroscopy, while the balloon is in the deflated state, confirm that the inlet end of the artificial heart valve frame is aligned with the desired target site, After confirmation, the balloon is inflated by passing an inflation medium through it, and the artificial heart valve is expanded within the original aortic valve. Includes, A method wherein, after the artificial heart valve has been expanded, the inlet end of the frame is positioned at the desired target site, and the delivery device does not move in parallel with respect to the natural aortic valve between checking and expanding the artificial heart valve.

19. The method according to claim 18, wherein the frame of the artificial heart valve is shortened in the axial direction while the artificial heart valve is being expanded.

20. The method according to claim 19, wherein, while the artificial heart valve is being expanded, the outflow end of the frame moves parallel to the target site, while the inflow end of the frame does not move parallel to the target site.

21. The method according to claim 18, wherein, when the balloon inflates and expands the artificial heart valve, the friction between the balloon and the inlet end of the artificial heart valve is greater than the friction between the balloon and the outlet end of the artificial heart valve.

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