Prosthetic heart valve

Abstract

The name of the invention is a prosthetic heart valve. The prosthetic heart valve can include a radially collapsible and expandable annular frame having a plurality of struts defining openings. The prosthetic heart valve can further include a plurality of leaflets that regulate the flow of blood through the frame. The prosthetic heart valve can also include a sealing member mounted on the frame and having an inner layer and an outer layer. At least the outer layer is mounted on the outer side of the frame, and the inner layer covers at least the openings in the frame between adjacent cusp portions of adjacent leaflets, and the inner layer does not cover one or more openings in the frame at locations facing the outflow surface of the leaflets to permit retrograde blood flow through the one or more uncovered openings in the frame and into the space between the outer layer and the frame.

Description

[0001] This application is a divisional application of the original application with the filing date of August 1, 2017, the application number of 2017800473933, and the invention title of "Prosthetic Heart Valves". TECHNICAL FIELD

[0002] The present disclosure relates to embodiments of prosthetic heart valves. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and eventually require replacement of the native valve with a prosthetic valve. There are many known prosthetic valves and many known methods of implanting these prosthetic valves into the human body.

[0004] Various surgical techniques can be used to replace or repair diseased or damaged valves. Due to stenosis and other heart valve diseases, thousands of patients undergo surgical procedures each year in which a defective native heart valve is replaced with a prosthetic valve. Another less aggressive method for treating a defective valve is through repair or reconstruction, which is typically used for minimally calcified valves. The problem with surgical therapy is that it poses significant risk to these chronically ill patients with high morbidity and mortality associated with surgical repair.

[0005] Surgical implantation of a prosthetic valve typically requires a thoracotomy when replacing a native valve, during which the heart is stopped and the patient is placed on cardiopulmonary bypass (a so-called "heart-lung machine"). In one common surgical procedure, the diseased native valve leaflets are excised and the prosthetic valve is sewn to the surrounding tissue at the valve annulus. Due to the trauma associated with this procedure and the duration of extracorporeal blood circulation that accompanies it, some patients do not survive the procedure or die shortly after the procedure. It is well known that the patient's risk increases as the amount of time required for extracorporeal circulation increases. Due to these risks, a large number of patients with defective native valves are considered inoperable because they are too weak to withstand the procedure. It is estimated that over 50% of subjects over 80 years of age with valvular stenosis cannot undergo a valve replacement procedure.

[0006] Due to the drawbacks associated with conventional open-heart surgery, percutaneous and minimally invasive surgical approaches are gaining significant interest. In one technique, a prosthetic valve is configured to be implanted via catheterization in a less invasive procedure. For example, U.S. Patent Nos. 5,411,522 and 6,730,118 describe a collapsible, transcatheter heart valve that can be introduced percutaneously on a catheter in a compressed state and expanded at the desired location by balloon expansion or by utilizing a self-expanding frame or stent.

[0007] An important design parameter for transcatheter heart valves is the diameter of the folded or crimped profile. The diameter of the crimped profile is important because it directly impacts the ability of the physician to advance the transcatheter heart valve through the femoral artery or vein. More specifically, a smaller profile allows for enhanced safety to treat a broader patient population. Another important design parameter is to control paravalvular leakage that can occur for a period of time after initial implantation. SUMMARY

[0008] In one representative embodiment, a prosthetic heart valve includes an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame includes a plurality of struts defining openings. The prosthetic heart valve can further include a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame, wherein each leaflet includes an inflow surface, an outflow surface, and a tip edge that is fixed relative to the frame. The prosthetic heart valve can also include a sealing member mounted on the frame and including an inner layer and an outer layer. At least the outer layer is mounted on an outer side of the frame, and the inner layer covers at least the openings in the frame between adjacent tip portions of adjacent leaflets, and the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood flow through the one or more uncovered openings in the frame and into a space between the outer layer and the frame.

[0009] In some embodiments, the tip edge portions of the leaflets have curved scalloped shapes, and the inner layer of the sealing member includes a plurality of triangular portions mounted on the frame at locations between adjacent tip edge portions of adjacent leaflets.

[0010] In some embodiments, the inner layer does not cover any openings in the frame at locations facing the outflow surfaces of the leaflets.

[0011] In some embodiments, the inner layer is mounted on an outer surface of the frame.

[0012] In some embodiments, the inner layer is mounted on an inner surface of the frame.

[0013] In some embodiments, the outer layer is shaped such that, when the frame is in the radially expanded configuration, the outer layer extends radially away from the frame.

[0014] In some embodiments, the outer layer includes a shaped fabric.

[0015] In some embodiments, the outer layer includes: a tapered lower wall section extending outwardly from the frame in a direction from the inlet end to the outlet end; a tapered upper wall section extending outwardly from the frame in a direction from the outlet end to the inlet end; and a central wall section extending between the tapered lower wall section and the tapered upper wall section.

[0016] In some embodiments, the tip edge portion of each leaflet is secured relative to the frame by a connecting sleeve connected to and disposed between the frame and the tip edge portion of the leaflet, wherein each connecting sleeve is sutured to a strut of the frame extending diagonally from the inlet end to the outlet end of the frame.

[0017] In some embodiments, wherein each connecting sleeve includes two layers of material sutured to the tip edge portion of the leaflet and to the strut of the frame.

[0018] In some embodiments, each leaflet includes opposing upper tabs on opposite sides of the leaflet and a plurality of opposing lower tabs on opposite sides of the leaflet below the upper tabs, wherein each upper tab pairs with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures, and wherein each lower tab is folded to form at least one folded layer along the tip edge portion of the respective leaflet.

[0019] In some embodiments, each leaflet is unattached to the frame at a location between the upper tabs and the lower tabs.

[0020] In some embodiments, each leaflet is formed with a gap between the upper tabs and the lower tabs on each side of the leaflet.

[0021] In some embodiments, at least one reinforcing chord extends along the tip edge portion of each leaflet and below each commissure.

[0022] In another representative embodiment, a prosthetic heart valve includes: an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The prosthetic heart valve can also include a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame. Each leaflet can include: opposing upper tabs on opposite sides of the leaflet; opposing lower tabs on opposite sides of the leaflet below the upper tabs; a tip edge portion extending between the lower tabs, the tip edge portion being secured relative to the frame, wherein each upper tab pairs with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures that are secured relative to the frame, and wherein each lower tab is folded to form at least one folded layer along the tip edge portion of the respective leaflet.

[0023] In some embodiments, the opposing side edges of the leaflets are unattached to the frame between the upper tabs and the lower tabs.

[0024] In some embodiments, the opposing side edges of the leaflets are formed with gaps between the upper tabs and the lower tabs at which the side edges are unattached to the frame.

[0025] In some embodiments, the prosthetic heart valve can include a sealing member mounted on the frame and including an inner layer and an outer layer, wherein at least the outer layer is mounted on the outer side of the frame, and the inner layer covers at least the openings in the frame between adjacent cusp edge portions of adjacent leaflets, and the inner layer has uncovered regions at locations facing the outflow surface of the leaflets to permit retrograde blood flow through the openings in the frame and into the space between the outer layer and the frame.

[0026] In some embodiments, the reinforcing chord extends along and is secured to at least one folded layer of each cusp edge portion of each leaflet and each lower tab.

[0027] In another representative embodiment, a prosthetic heart valve includes an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The prosthetic heart valve can further include a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame. Each leaflet can include opposing tabs on opposing sides of the leaflet and a cusp edge portion between the tabs that is secured relative to the frame, wherein each tab pairs with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are secured relative to the frame, and wherein each leaflet has opposing edges between the tabs and the cusp edge portion that are unattached to the frame, allowing blood to flow between the frame and the unattached edges.

[0028] In some embodiments, the unattached edges are spaced radially inwardly from the frame.

[0029] In some embodiments, the tabs of each leaflet include upper tabs that pair with adjacent upper tabs of adjacent leaflets to form commissures, and each leaflet further includes opposing lower tabs below the upper tabs on opposing sides of the leaflets, the lower tabs being spaced from the upper tabs by the unattached edges, wherein the lower tabs are folded against the cusp edge portion of the leaflet.

[0030] In some embodiments, the reinforcing chord extends along and is secured to the cusp edge portion of each leaflet and through the space below each commissure.

[0031] In some embodiments, each unattached edge of a leaflet is engageable with an adjacent unattached edge of an adjacent leaflet in the case of retrograde blood flow and disengageable from the adjacent unattached edge in the case of antegrade blood flow.

[0032] In another representative embodiment, a prosthetic heart valve includes an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The prosthetic heart valve can further include a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame, wherein each leaflet includes opposing tabs on opposing sides of the leaflet and a cusp edge portion between the tabs, wherein each tab is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures connected to the frame. The cusp edge portion of each leaflet can be connected to the frame by a connecting sleeve connected to and disposed between the frame and the cusp edge portion of the leaflet, wherein each connecting sleeve is sewn to a strut of the frame extending diagonally from the inflow end to the outflow end of the frame.

[0033] In some embodiments, the cusp edge portion of each leaflet is folded toward the outflow end of the frame.

[0034] In some embodiments, each connecting sleeve is sewn to the cusp edge portion of a leaflet and the frame.

[0035] In some embodiments, a reinforcing chord is secured to each cusp edge portion opposite the respective connecting sleeve, the reinforcing chord defining a bending axis for the respective leaflet.

[0036] In some embodiments, each connecting sleeve prevents the cusp edge portion of the respective leaflet from contacting an inner surface of the frame.

[0037] In some embodiments, the cusp edge portion is not supported by any metal component within the frame.

[0038] In some embodiments, each connecting sleeve includes two layers of material sewn to the cusp edge portion of a leaflet and the frame.

[0039] In some embodiments, each connecting sleeve supports the cusp edge portion of a leaflet at a location radially inwardly spaced from an inner surface of the frame.

[0040] In another representative embodiment, a prosthetic heart valve includes an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame includes a plurality of struts defining openings. The prosthetic heart valve can include a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame, wherein each leaflet includes: an inflow surface; an outflow surface; an opposing upper tab on an opposing side of the leaflet; an opposing lower tab on the opposing side of the leaflet below the upper tab; a tip edge portion extending between the lower tabs. Each upper tab can mate with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each lower tab can be folded to form at least one folded layer along the tip edge portion of the respective leaflet. The tip edge portion of each leaflet can be connected to the frame by a connecting sleeve connected to and disposed between the frame and the tip edge portion of the leaflet, wherein each connecting sleeve is sewn to a strut of the frame extending diagonally from the inflow end to the outflow end of the frame. Each leaflet can have opposing edges between the upper tab and the lower tab that are unattached to the frame, wherein the unattached edges are spaced radially inwardly from the frame, allowing blood to flow between the frame and the unattached edges. The prosthetic heart valve can further include a sealing member mounted on the frame and including an inner layer and an outer layer. At least the outer layer is mounted on an outer side of the frame, and the inner layer covers at least the openings in the frame between adjacent tip portions of adjacent leaflets, and the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood flow through the one or more uncovered openings in the frame and into a space between the outer layer and the frame. BRIEF DESCRIPTION OF DRAWINGS

[0041] FIGS. 1A-1B is a perspective view of a prosthetic heart according to one embodiment.

[0042] FIG. 1C is FIGS. 1A-1B an enlarged perspective view of an area below one of the commissures of the prosthetic heart valve.

[0043] FIG. 2 is FIGS. 1A-1C a side elevational view of a sealing member of the prosthetic heart valve.

[0044] FIG. 3 is FIGS. 1A-1C a perspective cross-sectional view of the sealing member of

[0045] FIG. 4 is FIGS. 1A-1C a cross-sectional view of the prosthetic heart valve showing flow of retrograde blood through the valve.

[0046] FIG. 5 is a magnified perspective view showing a portion of the interior of a prosthetic heart valve. FIGS. 1A-1C

[0047] FIG. 6 shows a fabric strip that can be used to form a sealing member, such as the sealing member of FIG. 3

[0048] FIGS. 7A-7B is a perspective view of an exemplary tubular body that can be used to form a sealing member of a prosthetic heart valve.

[0049] FIG. 8 is a perspective view of a partially assembled prosthetic heart valve according to one embodiment, showing attachment of the leaflets using a connection sleeve.

[0050] FIG. 9 is a plan view of a leaflet and connection sleeve used in the prosthetic heart valve of FIG. 8

[0051] FIG. 10 , 10A , 11A, and 1 IB are different views showing attachment of the connection sleeve of FIG. 9 to the leaflets.

[0052] FIG. 12 , 12A , and 12B are different views showing connection of the connection sleeve of FIG. 9 to the frame of the prosthetic valve of FIG. 8

[0053] FIG. 13A is a perspective view of a frame of a prosthetic heart valve according to one embodiment and a leaflet mounted within the frame.

[0054] FIG. 13B is a magnified view of a portion of the frame of FIG. 13A and one of the leaflets.

[0055] FIG. 14 is a plan view of a leaflet that can be used in a prosthetic heart valve according to one embodiment.

[0056] FIG. 15A , 15B , 15C, 15D, 16, 17, 18, 19, 20, 21, 22, and 23 show various ways in which a tip edge portion of a leaflet can be connected to a frame of a prosthetic heart valve using a connection sleeve.

[0057] FIG. 24 ​​​​is a magnified perspective view of the interior of a prosthetic heart valve showing another way of connecting the tip edge portion of the leaflets to the frame of the valve.

[0058] FIG. 25A 、 25B , 26, 27, 28, 29, 30, 31, and 32 show alternative ways of connecting the tip edge portion of the leaflets to the frame of a prosthetic heart valve with or without a connecting sleeve.

[0059] FIG. 33 is a plan view of a leaflet that can be used in a prosthetic heart valve according to one embodiment.

[0060] FIG. 34 、 35 , and 36 show half of a commissure formed using leaflets of the type shown in FIG. 33 according to one embodiment.

[0061] FIG. 37 is a cross-sectional view of a commissure formed by two leaflets of the type shown in FIG. 33 according to one embodiment.

[0062] FIG. 38 is a cross-sectional view of a commissure formed by two leaflets of the type shown in FIG. 33 according to another embodiment.

[0063] FIG. 39 is a plan view of a leaflet that can be used in a prosthetic heart valve according to another embodiment.

[0064] FIG. 40 is a plan view of a leaflet that can be used in a prosthetic heart valve according to another embodiment.

[0065] FIG. 41 、 42 , 43, 44, and 45 show a commissure formed by two leaflets of the type shown in FIG. 40 according to one embodiment.

[0066] FIG. 46 is a cross-sectional view of a commissure formed by two leaflets of the type shown in FIG. 40 according to one embodiment.

[0067] FIG. 47 is a cross-sectional view of a commissure formed by two leaflets of the type shown in FIG. 33 according to another embodiment.

[0068] FIG. 48 is a cross-sectional view of a commissure formed by two leaflets of the type shown in FIG. 40 according to another embodiment.

[0069] FIG. 49 is a plan view of a leaflet that can be used in a prosthetic heart valve according to another embodiment.

[0070] FIGS. 50-51 is a cross-sectional view of two embodiments of a commissure formed by two leaflets of the type shown. FIG. 49

[0071] FIG. 52 , 53 , 54, and 55 are different views showing the attachment of a commissure of FIG. 50 or 51 to a prosthetic heart valve using a commissure attachment member.

[0072] FIG. 56 is a cross-sectional view of another embodiment of a commissure formed by two leaflets of the type shown. FIG. 33

[0073] FIG. 57 and 58 are a side elevation view and a perspective view, respectively, of a prosthetic heart valve according to another embodiment.

[0074] FIG. 59 is a plan view showing a sealing member of FIGS. 57-58 a prosthetic heart valve in a flat configuration.

[0075] FIG. 60 and 61 are a perspective view and a cross-sectional view, respectively, of a prosthetic heart valve according to another embodiment.

[0076] FIG. 62 , 63 , and 64 show the mounting of a sealing member of FIGS. 60-61 a prosthetic heart valve on a frame of the valve.

[0077] FIG. 65 and 66 are perspective views of a prosthetic heart valve according to another embodiment.

[0078] FIG. 67 is a perspective view of a portion of FIGS. 65-66 a prosthetic heart valve.

[0079] FIG. 68 is a perspective view of a sealing member of FIGS. 65-66 a prosthetic heart valve.

[0080] FIG. 69 is a cross-sectional view showing the attachment of a tip edge portion of a leaflet to a connecting sleeve according to another embodiment.

[0081] FIG. 70 ​​This is a plan view showing an embodiment of a connecting sleeve for connecting the tip edge portion of a leaflet to a frame in a flat configuration.

[0082] FIG. 71 yes FIGS. 65-66 Side elevation view of the frame of an artificial heart valve.

[0083] FIG. 72 The installation of a valve assembly according to one embodiment is shown. FIG. 71 Within the framework.

[0084] FIG. 73 yes FIG. 72 A magnified view of the frame and part of the valve assembly.

[0085] FIG. 74 yes FIGS. 65-66 A perspective view of the leaflets of an artificial heart valve.

[0086] FIG. 75A It is shown in a flat configuration FIG. 74 A plan view of the small leaf.

[0087] FIG. 75B yes FIG. 74 Xiaoye and FIG. 70 A plan view of the connecting sleeve positioned along the tip edge of the leaflet.

[0088] FIG. 76 A plan view of an embodiment of the connecting attachment member is shown in a flat configuration.

[0089] FIG. 77 and 78 They are FIGS. 65-66 A perspective view and a cross-sectional view of one of the sutures of an artificial heart valve.

[0090] FIG. 79 and 80 These are, respectively, a perspective view and a top view of an artificial heart valve according to another embodiment.

[0091] FIG. 81 and 82 These are, respectively, a perspective view and a top view of an artificial heart valve according to another embodiment.

[0092] FIG. 83 and 84 This is a perspective view of an artificial heart valve according to another embodiment.

[0093] FIG. 85 and 86 They are FIGS. 83-84 Side and top views of one of the sutures of an artificial valve. Detailed Implementation

[0094] The present disclosure relates to implantable prosthetic devices, and in particular to embodiments of implantable prosthetic valves and methods for manufacturing such devices. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves (aortic, mitral, pulmonary, and tricuspid). Further, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve. The prosthetic valve can also include other types of implantable valves in other body lumens outside the heart, or implantable valves in the heart at locations other than the native valves, for example, transatrial or transventricular septal valves.

[0095] The disclosed prosthetic heart valve is particularly well suited for implantation in a native aortic valve. In the context of a prosthetic aortic valve, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, in the orientation shown in the figures, the lower end of the prosthetic valve is its inflow end, and the upper end of the prosthetic valve is its outflow end. It will be appreciated, however, that the prosthetic valve can be implanted in the opposite orientation. For example, for implantation at the mitral position, the upper end of the prosthetic valve is the inflow end, and the lower end of the valve is the outflow end.

[0096] FIG. 1A is a perspective view of a prosthetic heart valve 10 according to one embodiment. The illustrated valve is adapted for implantation in a native aortic valve annulus, but in other embodiments it can be adapted for implantation in other native valve annuli of the heart. The valve 10 can have three main components: a stent or frame 12; a valve structure 14; and a sealing member 16. FIG. 1B A perspective view of the prosthetic valve 10 is shown in transparent lines for illustrative purposes, with its components located on the outside of the frame 12 (including the sealing member 16).

[0097] Valve structure 14 can include three leaflets 20 that collectively form a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other embodiments, a greater or lesser number of leaflets (e.g., one or more leaflets 20) can be present. The lower edge of valve structure 14 desirably has a wavy, curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves the durability of the valve. Moreover, by virtue of this scalloped shape, creases and corrugations at the belly (central region) of each leaflet that can cause those regions to calcify early can be eliminated or at least minimized. The scalloped shape also reduces the amount of tissue material used to form the leaflet structure, thereby allowing a smaller, more uniform profile of coiling at the inflow end of the valve. Leaflets 20 can be formed from pericardial tissue (e.g., bovine or porcine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118.

[0098] Each leaflet 20 can be coupled to frame 12 along its inflow edge 30 (lower edge in the figures, also referred to as the "tip edge") and at commissures 32 of valve structure 14 where adjacent portions of two leaflets join one another, as described further below.

[0099] Frame 12 can be made from any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as known in the art. When composed of a plastically-expandable material, frame 12 (and thus prosthetic valve 10) can be coiled into a radially compressed state on a delivery catheter and then expanded within the patient by an inflatable balloon or any suitable expansion mechanism. When composed of a self-expanding material, frame 12 (and thus prosthetic valve 10) can be coiled into a radially compressed state and restrained in that compressed state by insertion into a sheath of a delivery catheter or equivalent mechanism. Once in the body, the prosthetic valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0100] Suitable plastically-expandable materials that can be used to form frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular embodiments, frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N TM (SPS Technologies trade name), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that the use of MP35N to form frame 12 provides superior structural results over stainless steel. In particular, when MP35N is used as a frame material, less material is needed to achieve the same or better performance in terms of radial force and crush resistance, fatigue resistance, and corrosion resistance. Moreover, because less material is needed, the crimped profile of the frame can be reduced, thereby providing a smaller profile valve assembly for percutaneous delivery to a treatment site in the body.

[0101] In the illustrated embodiment, frame 12 includes a plurality of circumferentially extending angled struts 22 that define a plurality of cells or openings 24 of the frame. As shown, frame 12 can have a cylindrical or substantially cylindrical shape with a constant diameter from an inflow end 26 to an outflow end 28 of the frame, or the diameter of the frame can vary along the height of the frame, as disclosed in U.S. Pub. No. 2012 / 0239142.

[0102] In the illustrated embodiment, sealing member 16 is mounted on the outside of frame 12 and is used to create a seal against surrounding tissue (e.g., native leaflets and / or the native annulus) to prevent or at least minimize paravalvular leakage. Sealing member 16 can include an inner layer 34 (which can be in contact with the outer surface of frame 12) and an outer layer 36. Sealing member 16 can be connected to frame 12 using suitable techniques or mechanisms. For example, sealing member 16 can be sewn to frame 12 via a sewing portion 38 that can extend around struts 22 and through inner layer 34. In alternative embodiments, inner layer 34 can be mounted on the inner surface of frame 12, while outer layer 36 is on the outside of the frame.

[0103] Outer layer 36 can be configured or shaped to extend radially outward from inner layer 34 and frame 12 when prosthetic valve 10 is deployed. As best shown in FIG. 3 When the prosthetic valve is fully inflated outside the human body, outer layer 36 can inflate away from inner layer 34 to create a space 40 between the two layers. This, therefore, allows outer layer 36 to inflate into contact with surrounding tissue when implanted in the body.

[0104] In the illustrated embodiment, the outer layer 36 includes a tapered lower wall section 36a extending outwardly from the frame in a direction from the inlet end to the outlet end, a tapered upper wall section 36b extending outwardly from the frame in a direction from the outlet end to the inlet end, and a central wall section 36c extending between the tapered lower wall section and the tapered upper wall section. The central wall section 36c can extend parallel to the longitudinal axis of the prosthetic valve, as shown. In alternative embodiments, the upper and lower wall sections can extend perpendicularly relative to the longitudinal axis of the prosthetic valve. In alternative embodiments, the outer layer 36 can be formed by connecting separate fabric components (e.g., separate pieces of material for each wall section 36a, 36b, 36c) together (e.g., by stitching) to form an unshaped three-dimensional structure.

[0105] The inner layer 34 is desirably formed to have at least one aperture or opening, and more desirably a plurality of apertures or openings 42. FIG. 5 As best shown in FIG. 4 , retrograde blood (indicated by arrows 44) can flow along the outside of the leaflets 20 through the openings 24 of the frame, through the openings 42 in the inner layer 34, and into the space 40 between the inner layer 34 and the outer layer 36 to facilitate inflation of the sealing member 16 and create a seal against the surrounding tissue. In some embodiments, the outer layer 36 can be formed to have a plurality of apertures or openings that can allow blood to flow into the sealing member at least during valve deployment.

[0106] In the illustrated embodiment, the inner layer 34 is formed to have one or more openings 42 along the portion of the inner layer facing the outflow surface 70 of the leaflets (the area of the frame between the commissures) to allow retrograde blood to flow through the frame at these locations. The portion of the inner layer 34 covering the area of the frame between the tip edge portions of the leaflets completely covers the openings in the frame at these locations, thereby preventing antegrade blood from flowing through the frame at these locations. In alternative embodiments, the inner layer can have a portion covering the area of the frame between the tip edge portions of the frame and have a cutout section along the portion of the frame facing the outflow surface of the leaflets (see sealing members 702, 802, described below).

[0107] As shown in FIG. 5 , the openings 42 can be centered at the junctions 50 where the frame struts 22 intersect, which inhibits the material of the inner layer 34 surrounding the openings from protruding inwardly through the frame and contacting the leaflets.

[0108] The sealing member 16 can be formed from a fabric or non-fabric material, such as PET, PTFE, ePTFE, polyurethane, silicone, polyester, silk screen, natural tissue (e.g., pericardium), and / or other suitable material configured to limit and / or prevent blood flow therethrough. In some embodiments, the sealing member can be formed from a generally flat strip, folded longitudinally to form inner and outer layers, and then formed into a tube, for example, by welding or stitching the ends together. In other embodiments, the sealing member 16 can be formed by weaving, knitting, or braiding the sealing member into a tubular shape. The bulge in the outer layer 36 can be formed, for example, by forming the material into the desired configuration (e.g., as shown in FIGS. 1 and 2). The shaping of the outer layer can make the outer layer self-expandable or cause radial expansion of the outer layer. Additionally or alternatively, the outer layer 36 can be self-expandable by inclusion of Nitinol wire in the outer layer. FIGS. 1A-1C

[0109] In alternative embodiments, the inner layer 34 does not have any openings 42, but can be formed from a porous material that allows blood to flow through the inner layer. For example, in some embodiments, the inner layer 34 can be formed from a relatively more porous material than the outer layer 36. In further alternative embodiments, the outer layer 36 need not be configured to extend away from the outer surface of the frame, but can have a shape that conforms to the outer surface of the frame. For example, the outer layer 36 can be generally tubular so as to correspond to the shape of the frame 12. In some embodiments, the outer layer can be formed from a fabric having a pile layer (e.g., a fleece fabric) having fibers or yarns that form loops or cut piles that help achieve a seal with surrounding tissue. Sealing members formed from such fabrics are further described in U.S. Application No. 62 / 513,348, filed May 31, 2017.

[0110] FIG. 6 A fabric strip that can be used to form a sealing member 16 according to one embodiment is shown. As shown, the fabric strip can include a central section 52 and first and second longitudinal edge portions 54, 56 extending along opposite sides of the central section 52. The central section 52 can include three sets of one or more openings 42 (e.g., three openings in each set in the illustrated embodiment). The openings 42 are positioned to correspond to the location of the commissures 50 under the commissures of a prosthetic valve. The first and second longitudinal edge portions 54, 56 can be folded over the central section 52 and secured to each other, for example, by stitching, to form the sealing member. The longitudinal edge portions 54, 56 collectively form the outer layer 36, while the central section 52 forms the inner layer 34.

[0111] FIG. 7A 7B ​​is a perspective view of an exemplary tubular body that can be used to form the sealing member 16. Referring to 7A, the tubular body 80 can include an upper portion 82 and a lower portion 84. The upper portion 82 can include a radially expanded portion 86. The tubular body 80 can be formed, for example, by three-dimensional weaving, knitting, or braiding. The lower portion 84 can be folded or inverted into the upper portion 82 to form a sealing member having an outer layer formed by the upper portion 82 and an inner layer formed by the lower portion 84.

[0112] Referring to FIG. 7B , the tubular body 90 can include a cylindrical central portion 92, a flared upper portion 94, and a flared lower portion 96. The tubular body 90 can be formed, for example, by three-dimensional weaving, knitting, or braiding. The flared upper portion 94 can be folded or inverted into the flared lower portion 96 to form two layers of a sealing member.

[0113] FIGS. 8-13B Techniques for mounting the inflow edges 30 of the leaflets 20 to the frame 12 are demonstrated in accordance with one embodiment. In the demonstrated embodiment, a connecting sleeve 100 is secured to the lower edge portion 102 (also referred to as the tip edge portion) of each leaflet. As best shown in FIG. 9 , each connecting sleeve 100 can include an elongated, generally rectangular object 104 that is formed to have a plurality of tabs 106a, 106b formed along opposite longitudinal edges of the object 104. The connecting sleeve 100 can include any suitable synthetic material (e.g., PET) or natural tissue.

[0114] Referring to FIG. 10 and 10A , to secure the connecting sleeve 100 to the leaflet 20, the object 104 is folded along a central longitudinal crease bisecting the object to form folded portions 110a, 110b, which are then placed on opposite sides of the lower edge portion 102 of the leaflet 20 such that the tabs 106a are adjacent the outer surface of the leaflet and the tabs 106b are adjacent the inner surface of the leaflet. Stitching can then be used to form stitches 108 that extend through the opposite folded portions 110a, 110b of the object 104 and the lower edge portion 102 of the leaflet and extend longitudinally along the length of the lower edge portion 102. FIG. 11A A flattened view of the leaflet 20 is shown with the connecting sleeve 100 folded around the lower edge portion 102 of the leaflet. FIG. 11B A flattened view of the leaflet 20 is shown after the connecting sleeve 100 has been secured to the leaflet by the stitches 108.

[0115] Referring to FIG. 12 , 12Aand 12B, each pair of leaflets 106a, 106b being folded away from the respective strut 22 of the frame and secured in place by sutures 112 that extend through the leaflets 106a, 106b along the suture lines outside the frame 12. As best shown in FIG. 12B The connecting sleeve 100 mounts the leaflet to the frame 12 such that the lower edge portion 102 extends radially inwardly at an angle of about 90 degrees relative to the frame 12. This effectively moves the bend axis of the lower edge portion 102 inwardly away from the inner surface of the frame and toward the center of the frame.

[0116] As best shown in FIG. 8 Each of the connecting sleeves 100 is secured to the frame along a diagonal line 116 that extends along the curved surface of the frame, defined by the row of diagonal extending struts 22 that extend from the inflow end of the frame toward the outflow end. In this way, the lower edge portion 102 of each leaflet is also positioned along a respective diagonal line 116 defined by the corresponding row of diagonal extending struts 22. This advantageously reduces tension in the leaflets 20 as well as the formation of wrinkles.

[0117] Attachment along the diagonal lines 116 also helps to reduce the crimped profile of the prosthetic valve when it is radially compressed into its delivery configuration. In particular, the struts in the circumferentially extending row of struts of the frame move or bend toward one another during crimping, while the struts positioned along the diagonal lines 116 substantially maintain their alignment relative to one another along the diagonal lines 116 during crimping. In this way, the connecting sleeves 100, which are typically formed of non-stretchable material, do not inhibit the movement or deformation of the struts relative to one another. Also, since the tip edge portions of the leaflets move with the connecting sleeves during crimping, stretching of the leaflets along the tip edge portions is prevented or at least minimized.

[0118] FIG. 13A is a perspective view of the frame 12 and the leaflets 20 supported therein in their installed configuration, with the connecting sleeves 100 removed for purposes of illustration. FIG. 13B is an enlarged partial cross-sectional view of the frame and leaflets. As can be seen, the lower edge portions 102 of the leaflets extend perpendicularly or anti-parallel relative to the frame, creating a gap G between the inner surface of the frame and the bend axis 114 of the leaflets 20. Advantageously, this helps to prevent or at least minimize contact of the outer surfaces of the leaflets with the frame and other relatively abrasive components as the leaflets open during a valve procedure, thereby inhibiting undesired wear to the leaflets from contact with the frame. The enlarged spacing between the leaflets and the frame can also promote washing of the leaflets by blood at the bend axis of the leaflets.

[0119] Further, with known prosthetic valves, care must be taken to prevent the leaflets from extending through the open openings of the frame during crimping to prevent damage to the leaflets. For example, known crimping devices for prosthetic valves can include components or accessories that press the leaflets away from the frame or shield the leaflets from extending through the frame openings during crimping. In contrast, the connecting sleeve 100 assists in maintaining at least the inflow portion of the leaflets spaced apart from the inner surface of the frame during crimping of the prosthetic valve to reduce the need for such specially designed crimping accessories.

[0120] In addition, the connecting sleeve 100 (and other connecting sleeves described herein) can facilitate assembly of the prosthetic valve compared to known assembly techniques. For example, the leaflets or sleeve can be assembled while the leaflets are in a flat configuration before forming the tubular (annular) configuration valve structure 14. The sleeve can be sewn to the leaflets using automated or semi-automated techniques. Also, once the valve structure is placed within the frame, the lower edge portion 102 of the leaflet can be secured to the frame by stitching that is entirely external to the frame 12. This can significantly reduce assembly time as the assembler does not have to thread a needle to form the stitches 112 inside and outside the openings 24 of the frame.

[0121] As further shown in FIGS. 13A-13B Each leaflet 20 includes opposing tabs 60, as further shown in FIGS. 13A-13B The prosthetic valve shown in

[0122] The tab layer 60a can have a sloped edge 62 that extends radially inward from a location on the frame to a coaptation edge 64 of the leaflet. The sloped edge 62 also extends in the axial direction from the location on the frame to the coaptation edge 64. This places the center (halfway between adjacent commissures) of the coaptation edge 64 lower than the area of attachment of the commissures and tabs 60 to the frame. In other words, the commissures are located at a different height along the frame than the center of the coaptation edge 64. This configuration is advantageous because of a more even distribution of stress applied along the tabs 60 during valve cycling. In some embodiments, at least when the leaflet is in the closed position, the entire coaptation edge 64 of the leaflet is lower than the location where the commissures are attached to the frame.

[0123] During valve cycling, the leaflets can articulate at the innermost edge 66 of the tabbing 60a, which helps to keep the leaflets away from the frame during normal operation of the prosthetic valve. This is particularly advantageous in situations where the prosthetic valve does not fully expand to its normal size when implanted in a patient. Thus, the prosthetic valve can be implanted with a wider range of patient annulus sizes. Under relatively greater forces, such as when the prosthetic valve is radially compressed to facilitate delivery, the leaflets can flare away from each other at the frame to reduce stress on the leaflets.

[0124] The commissures and coaptation edges of the leaflets are typically relatively large volume portions of the leaflets and can inhibit full radial compression of the prosthetic valve if they are at the same height along the frame. FIGS. 13A-13B Another advantage of the tabbing 60 of the commissures shown in FIGS. 15A-15D is that the commissures and coaptation edges are separated from each other in the axial direction when the prosthetic valve is radially compressed to facilitate delivery into a patient's body. Separating these portions of the leaflets reduces the overall crimping profile of the prosthetic valve.

[0125] FIG. 14 and 15A FIG. 15D shows an alternative technique for mounting the lower edge portion 102 of the leaflet to the frame 12 using a connecting sleeve 100. As shown in FIG. 15D, a slit 120 can be formed along the lowermost section of the edge portion 102 to facilitate folding of the edge portion during the assembly process. FIG. 14 FIGS. 15A-15D FIGS. 15E-15G show a step-by-step process for attaching the connecting sleeve 100 to the leaflet 20 and then mounting the sleeve to the frame.

[0126] Referring first to FIG. 15A, the connecting sleeve 100 is folded to form a first sleeve layer 124 and a second sleeve layer 126, and the folded sleeve is placed along the upper surface of the leaflet 20. The edge portion 102 of the leaflet is then wrapped over the folded edge of the connecting sleeve 100 to form first and second leaflet layers 128, 130 sandwiching the first and second sleeve layers 124, 126. These layers can then be secured to each other by sutures 132 that extend through all four layers and longitudinally along the length of the edge portion 102 of the leaflet. The advantage of folding the edge portion 102 of the leaflet is that the leaflet can better resist the pulling of the sutures 132 therethrough.

[0127] Referring to FIG. 15B, the second sleeve layer 126 of the sleeve can then be folded around the two first and second leaflet layers 128, 130 so as to form a third sleeve layer 134 adjacent the second leaflet layer 130 and a fourth sleeve layer 136 adjacent the first leaflet layer 128. FIG. 15B FIG. 15C ​​The first sleeve layer 124 can then be folded back onto the third sleeve layer 134 to form the fifth sleeve layer 138. The fourth sleeve layer 136 can be folded back onto itself to form the sixth sleeve layer 140. All six sleeve layers and the two leaflet layers can be secured together by stitches 142 that extend through all eight layers and longitudinally along the length of the edge portion 102 of the leaflet. Furthermore, the fifth sleeve layer 138 and the sixth sleeve layer 140 can be secured together by stitches 144 at locations radially outwardly spaced from the leaflet 20, respectively, that extend through the two layers and longitudinally along the length of the connecting sleeve 100.

[0128] The leaflet and sleeve assembly can then be fixed to the frame 12. For example... FIG. 15D As shown, for example, the fifth sleeve layer 138 and the sixth sleeve layer 140 can be placed below the frame's supports 22 and secured to the frame using, for example, stitching 146, which extends around these supports and passes through the fifth sleeve layer 138 and the sixth sleeve layer 140. Alternatively, instead of stitching 146 or otherwise, stitching 144 can be wrapped around the frame's supports to mount the leaflet and sleeve assembly. Thus, the lower edge portion of each leaflet follows the diagonal 116 defined by the diagonal row of supports. FIG. 8 The sleeve extends diagonally directly below the frame. Installing the sleeve below the 22nd row of diagonal supports reduces the movement of the sleeve relative to the frame and the resulting wear on the sleeve, thus protecting it from tearing during artificial valve operation.

[0129] In alternative embodiments, similar to FIG. 12 The sleeve can be secured to the frame by placing the fifth sleeve layer 138 on the support and the sixth sleeve layer 140 below the support and securing those layers directly to each other outside the frame (e.g., by stitching).

[0130] FIGS. 16-18 An alternative configuration is shown that utilizes the folded leaflet edge portion to assemble the connecting sleeve 100 and the leaflet 20. FIG. 16 In this configuration, the connecting sleeve 100 is folded around the first leaflet layer 128 and the second leaflet layer 130, thereby forming a first sleeve layer 150 below the second leaflet layer 130, a second sleeve layer 152 between the first leaflet layer 128 and the second leaflet layer 130, and a third sleeve layer 154 above the first leaflet layer 128. The leaflets and the sleeve can be secured to each other using stitches 156 that extend through the sleeve layers 150, 152, and 154, as well as the first leaflet layer 128 and the second leaflet layer 130, and extend longitudinally along the length of the leaflet edge portion 102. FIG. 16 Configuration utilization ratio FIGS. 15A-15DFewer sleeve layers and can permit the prosthetic valve 10 to achieve a smaller overall crimp profile. FIG. 17 Similar to FIG. 16 , except that the first sleeve layer 150 is folded inwardly, forming an additional fourth sleeve layer 158 between the first sleeve layer 150 and the lower surface of the leaflet 20. The fourth sleeve layer 158 can help inhibit the leaflet from being abraded by positioning the edge of the sleeve away from the hinged portion of the leaflet. FIG. 18 Utilizing the same configuration as the embodiment of FIGS. 15A-15D , except in the embodiment of FIG. 18 , the sutures 160 extend through the sleeve layers 124, 126, 134, 136 and the first leaflet layer 128 and the second leaflet layer 130, but not through the fifth sleeve layer 138 and the sixth sleeve layer 140. FIGS. 16-18 The leaflet and sleeve assembly shown in

[0131] FIGS. 19-21 Another configuration for assembling the leaflet 20 and the connecting sleeve 100 is shown. As FIG. 19 shown, the connecting sleeve 100 is folded around the lower edge portion 102 of the leaflet 20 forming a first sleeve layer 170 and a second sleeve layer 172 on the lower surface of the leaflet and a third sleeve layer 174 and a fourth sleeve layer 176 on the upper surface of the leaflet. The inner edges of these folded layers can be secured by sutures 178 that extend through all four sleeve layers 170, 172, 174, 176 and extend longitudinally along the length of the sleeve and leaflet. As FIG. 20 and 21 shown, the connecting sleeve 100 can then be mounted onto the frame 12 by positioning the outer edges of the first sleeve layer 170 and the fourth sleeve layer 176 under the diagonal strut 22 rows and securing these layers to each other and the struts by sutures 180. The sutures 180 extend through the first sleeve layer 170 and the fourth sleeve layer 176 and around the struts 22' that intersect the struts 22 forming the diagonal 116 strut 22 rows.

[0132] FIG. 22 Another configuration for assembling the leaflet 20 and the connecting sleeve 100 is shown. As FIGS. 19-21Similar to the configuration shown in FIG. 1 1, except that the plurality of segments of the lower edge portion 102 of the leaflet extend through the opening of the frame. The inner edge of the lower edge portion 102 of the leaflet and the sleeve layers 170, 172, 174, and 176 can be secured using a first row of sutures 182. The outer edge of the lower edge portion 102 of the leaflet and the sleeve layers 170, 172, 174, and 176 can be secured at a location outside of the frame using a second row of sutures 184. The lower edge portion 102 of the leaflet can be formed with a series of slits 186 spaced along the length of the leaflet corresponding to the location of the post 22 to allow the segments of the lower edge portion 102 to extend through the opening of the frame.

[0133] FIG. 23 is a schematic representation of the use of a connecting sleeve 100 to mount the leaflets 20 to the frame. In the embodiment shown, the outer edge of the connecting sleeve 100 can be secured to an annular inner sleeve 190 (e.g., by suturing, adhesive, or welding), which in turn can be secured to the posts of the frame (e.g., by suturing, adhesive, or welding). Alternatively, the outer edge of the connecting sleeve 100 can be mounted directly to the posts of the frame without an inner sleeve 190, as previously described with respect to the embodiment of FIG. 1 1. The inner edge of the connecting sleeve 100 can be connected to (e.g., by suturing) the respective lower edge portions 102 of the leaflets, which can be spaced apart from the inner surface of the inner sleeve 190 and / or the frame 12 by the connecting sleeve. In particular embodiments, for example, the connecting sleeve 100 width between the lower edge of the respective leaflet 20 and the inner sleeve 190 and / or the inner surface of the frame 12 can be about 1 mm to about 5 mm. FIGS. 8-22

[0134] The connecting sleeves 100 formed of fabric (e.g., PET) can facilitate tissue ingrowth and the formation or deposition of biological components, such as fibrin and other blood components, along the upper surface of the connecting sleeves during the valve procedure. As a result of the material deposition of the connecting sleeves 100, they effectively become thicker and stronger, thereby resisting flexing of the sleeves during the valve cycle. Thus, the normal closed position of the leaflets is determined by the diastolic pressure on the leaflets. During the systolic phase of the heart, the connecting sleeves 100 can remain substantially stationary, creating a gap between the leaflets and the inner sleeve 190 and / or the inner surface of the frame 12 to prevent the leaflets from being abraded by contact with those components of the prosthetic valve.

[0135] FIGS. 24-25B Another configuration for mounting the lower, scalloped edge portion 102 of the leaflets to the frame 12 is shown. As with the previous configuration, the inner edge of the lower edge portion 102 of the leaflets and the sleeve layers 170, 172, 174, and 176 can be secured using a first row of sutures 182. The outer edge of the lower edge portion 102 of the leaflets and the sleeve layers 170, 172, 174, and 176 can be secured at a location outside of the frame using a second row of sutures 184. The lower edge portion 102 of the leaflets can be formed with a series of slits 186 spaced along the length of the leaflets corresponding to the location of the post 22 to allow the segments of the lower edge portion 102 to extend through the opening of the frame. FIG. 24 ​As shown, the lower edge portion 102 of the leaflet 20 can be folded upward toward the outflow end of the frame and against the inner surface of the frame, thereby creating a bending axis between the lower edge portion and the rest of the leaflet so that it can articulate toward and away from the frame during valve circulation. The bending axis of the leaflet is thus spaced inward from the frame, which provides several advantages, including: preventing leaflet abrasion during valve circulation; reducing stress along the lower edge of the leaflet during valve closure; improving blood cleansing of the leaflet (and thus eliminating or at least minimizing early calcification in those areas); and improving the leaflet's closure action. A reinforcing member 200, such as thread, string, cannula, fabric, or suture, can be placed along the upper surface of the leaflet at the bending axis where the lower edge portion 102 intersects with the articulated portion of the leaflet. In other words, the reinforcing member 200 can be placed along the lower surface of the leaflet. The reinforcing suture 200 can include, for example, a multifilament suture (e.g., an Ethibond suture).

[0136] Different techniques or mechanisms can be used to couple leaflet 20 to frame 12. For example... FIGS. 25A-25B As shown, for example, the leaflet 20 can be coupled to the frame 12 via a connecting sleeve 202 having a longitudinal inner edge portion 204 and a longitudinal outer edge portion 206. The inner edge portion 204 can be folded upward against the lower edge portion 102 of the leaflet. The outer edge portion 206 can be folded downward against an outer sleeve 210 (which may include, for example, a sealing member 16) mounted on the outside of the frame. The outer edge portion 206 can contact the outer sleeve 210 through an opening in the frame at a location below the diagonal support row 22. The connecting sleeve 202 can include an outer sleeve layer 202a and an inner sleeve layer 202b, which are formed, for example, by longitudinally folding the sleeve before assembling it onto the leaflet. Alternatively, the connecting sleeve 202 can include a single layer of material.

[0137] The inner edge portion 204 can be secured to the leaflet 20 by sutures 208 extending through the connecting sleeve 202, the leaflet 20, and the reinforcing stitch 200, and extending longitudinally along the leaflet and the sleeve. The outer edge portion 206 can be secured to the outer sleeve 210 by sutures 212 extending through the connecting sleeve 202 and the outer sleeve 210, and extending longitudinally along the connecting sleeve. FIG. 25B As shown, the connecting sleeve 202 is also directly secured to the frame via a stitch 212 or a separate stitch extending through the outer edge portion 206 of the connecting sleeve 202 and around the connection portion 50 at the intersection of the two supports of the frame. The connecting sleeve may be attached all the way to the apex 216 formed by the intersection of the respective support pairs 22 at the inflow end of the frame.

[0138] The row of sutures 212 desirably extend above the apex 216 as shown to prevent the leaflet from protruding below the inflow end of the frame, thereby preventing the leaflet from contacting adjacent native tissue, e.g., a calcified nodule, prior to or during deployment of the prosthetic valve 10. Folding the lower edge portion 102 of the leaflet away from the connecting sleeve 202 and upward toward the outflow end of the frame can minimize the amount of overlapping material layers of the connecting sleeve 202, leaflet 20, and frame 12, thereby reducing the overall crimped profile of the prosthetic valve.

[0139] FIG. 26 An alternative configuration is shown using a connecting sleeve 202 to mount the leaflet 20 to the frame. FIG. 26 Embodiments of FIG. 24 and 25A Embodiments of -25B can be the same as

[0140] FIG. 27 Another alternative configuration is shown using a connecting sleeve 202 to mount the leaflet 20 to the frame. FIG. 27 Embodiments of FIG. 24 and 25A Embodiments of -25B can be the same as

[0141] FIG. 28 and 29 Different ways of suturing the inner edge portion 204 of the connecting sleeve 202 to the lower edge portion 102 of the leaflet 20 are shown in more detail. In FIG. 28 the suture 208 extends through the sleeve inner layer 202b but not through the sleeve outer layer 202a. In FIG. 29 the suture 208 extends through both the sleeve outer layer 202a and the sleeve inner layer 202b.

[0142] FIG. 30 Another configuration for mounting the edge portion 102 of the leaflet to the frame 12 is shown. As FIG. 30As shown, the lower edge portion 102 of the leaflet can be coupled to the frame 12 via a connecting sleeve 230 having an upper edge portion 232 and a lower edge portion 234. The upper edge portion 232 can be secured to the outer sleeve 210 via stitches 236 at a position above the diagonal support row 22, these stitches extending through the outer sleeve and the connecting sleeve. The lower edge portion 234 of the connecting sleeve can be secured to the outer sleeve via stitches 238 at a position below the diagonal support row 22, these stitches extending through the outer sleeve and the connecting sleeve. The middle portion of the connecting sleeve (between the upper edge portion 232 and the lower edge portion 234) can extend above the diagonal support row.

[0143] like FIG. 30 As shown, the spacing between the support row and the seam 236 is desirablely greater than the spacing between the support row and the seam 238, which increases the contact angle between the sleeve and the support 22. FIG. 30 The circular area 240 represents the contact area where the contact between the connecting sleeve 230 and the frame 12 occurs, or the contact area where most of the contact between the connecting sleeve and the frame occurs. During cardiac systole, at the contact area 240, the angle of the connecting sleeve 230 relative to the transverse axis of the frame (which is perpendicular to the longitudinal axis of the frame) is approximately 60 to 90 degrees, or more preferably approximately 70 to 90 degrees, or even more preferably approximately 80 to 90 degrees. Increasing the contact angle of the sleeve can reduce the bending stress in the sleeve during valvular circulation, thereby improving the durability of the sleeve. Furthermore, the size or configuration of the connecting sleeve 230 can be determined such that during cardiac diastole, the connecting sleeve can move slightly radially inward under the influence of blood pressure and separate the connecting sleeve 230 from the strut 22, thereby eliminating or minimizing the contact between the sleeve and the strut.

[0144] FIG. 31 similar FIG. 30 An embodiment shows another configuration in which the lower edge portion 102 of the leaflet is mounted to the frame 12 via a connecting sleeve 230, except that the upper edge portion 232 of the connecting sleeve is fixed to the upper diagonally extending row of supports 22a, and the lower edge portion 234 of the connecting sleeve is fixed to the lower diagonally extending row of supports 22b. In this way, the lower edge portion 102 of the leaflet can be fixed to the connecting sleeve 230 between the upper and lower rows of supports. The upper edge portion 232 of the connecting sleeve can at least partially wrap around the upper row of supports 22a and is secured in place by a circumferential stitch 250 extending through the sleeve and surrounding the supports 22a. The lower edge portion 234 of the connecting sleeve can at least partially wrap around the lower row of supports 22b and is secured in place by a circumferential stitch 252 extending through the sleeve and surrounding the supports 22b. FIG. 31The manner shown in the diagram, in which the connecting sleeve 230 is attached to two adjacent rows of diagonally extending support columns, prevents or at least minimizes relative movement between the connecting sleeve and the frame, thereby improving the durability of the sleeve.

[0145] FIG. 32 Another configuration is shown where the lower edge portion 102 of the leaflet is mounted to the frame 12 without the use of any connecting sleeves. FIG. 32 In this embodiment, the lower edge portion 102 of the leaflet 20 can be folded upward against the diagonal struts 22 and secured in place by circumferential sutures 254 that extend around the struts 22 and pass through the leaflet edge portion 102 at a first location, through the reinforcing suture 200, and through the leaflet edge portion 102 at a second location. Positioning the folded edge portion 102 of the leaflet parallel to the inner surface of the struts minimizes wear on the leaflets caused by movement of these leaflets relative to the frame. In this embodiment, eliminating the sleeve reduces the overall curl profile of the artificial valve and allows for a tighter connection between the leaflet and the frame, thereby reducing relative movement between the two components.

[0146] FIGS. 33-37 A technique for mounting a ferrule structure ferrule to a frame, such as mounting ferrule 32 to frame 12, is shown according to one embodiment. FIG. 33 A leaflet 300 with a lower edge portion 302 is shown, which can be mounted to the frame 12 in any of the methods described in the previously described embodiments. The lower edge portion 302 terminates at its upper end in two laterally extending integral lower tabs 304. An integral upper tab 306 (also referred to as a connecting tab) extends from the upper corner of the leaflet 300. The upper tab 306 may be spaced apart from the lower tabs 304 by side edges 338, thereby defining a laterally extending gap or recess in the leaflet.

[0147] To assemble the joint, each upper tab 306 is folded along the horizontal fold line 308 to form the first and second tab layers 306a, 306b, as shown. FIG. 33 As shown (see also) FIG. 37 A first vertically extending first reinforcing member 310 may be placed against a first patch layer 306a adjacent to its inner edge. A second vertically extending reinforcing member 312 may be placed against a second patch layer 306b opposite to the first reinforcing member 310. The first and second patch layers 306a and 306b may be secured to each other by a stitch 314 extending through the first and second patch layers 306a and 306b and the first and second reinforcing members 310 and 312.

[0148] The first and second bonding layers 306a and 306b can then be laid along, as shown in the figure FIG. 35The illustrated vertical fold lines are folded longitudinally to form a folded outer portion 316 and a folded inner portion 318 extending radially inward from the folded outer portion 316. A third vertically extending reinforcing member 320 can be placed against the first tab layer 306a of the folded outer portion 316, and a commissure attachment member 322 can be placed against the second tab layer 306b of the folded outer portion 316. The folded outer portion 316 can be secured to the commissure attachment member 322 by sutures 324 that extend through the third reinforcing member 320, the first and second tab layers 306a, 306b, and the commissure attachment member 322. The outer edges of the first and second tab layers 306a, 306b can be further secured to the commissure attachment member 322 by sutures 326. The upper tab 306 of the second leaflet 300 can be assembled with a respective reinforcing member and attached to the commissure attachment member 322 adjacent the first leaflet in the same manner to form a commissure 328, as illustrated. FIG. 37 The commissure attachment member 322 can then be secured to the struts of the frame (see, e.g., FIG. 65 ), as further described below.

[0149] The folded first and second tab layers 306a, 306b reinforced by the first and second reinforcing members 310, 312 can be more resistant to buckling or articulation than the portions 330 of the leaflets radially inward from the tab layers. This causes the leaflets 300 to articulate primarily at the inner surfaces 332 of the folded first tab layers 306a in response to blood flowing through the prosthetic valve during operation of the prosthetic valve in the body, as opposed to articulating about respective axes on or adjacent the metal struts of the frame. Since the leaflets articulate at locations spaced radially inward from the frame 12, the leaflets can avoid contact with and damage to the frame. This is particularly advantageous in situations where the prosthetic valve is implanted in a patient's body without fully expanding to its normal size. In this way, the prosthetic valve can be implanted with a greater range of patient annulus sizes.

[0150] At high strengths, the folded first and second tab layers 306a, 306b of adjacent leaflets can splay apart from each other about respective axes 334 FIG. 37 ) adjacent the frame 12, with each folded inner portion 318 folded outward against a respective folded outer portion 316. This can occur, for example, when the prosthetic valve 10 is compressed and mounted onto a shaft of a delivery device, allowing a smaller crimped diameter to be achieved. The folded tab layers can also splay apart about their axes 334 when a balloon of a balloon catheter is inflated during expansion of the prosthetic valve, which can relieve some of the pressure on the commissures caused by the balloon, and such that the commissures are not damaged during expansion.

[0151] When the leaflet 300 is installed to the frame, the lower tab 304 of each leaflet can be folded down against the cusp edge portion 302 and held in place, for example, by a suture. The folded lower tab 304 helps to reinforce the connection between the cusp edge portion 302 of the leaflet and the frame along the upper section of the cusp edge portion adjacent to the commissure. The folded lower tab 304 also moves the bending axis of the upper section of the cusp edge portion inward and away from the inner surface of the frame, preventing or minimizing contact between the leaflet and the frame in the area below the commissure.

[0152] The side edges 338 between the lower tab 304 and the upper tab 306 can be left unattached to the frame of the prosthetic valve (see FIG. 1C ). The unattached side edges 338 provide several advantages, including reducing stress in the leaflets by allowing greater elongation or stretching of the leaflets in the axial direction during crimping when the prosthetic valve is compressed from the radially expanded state to the radially compressed state, and when the prosthetic valve is expanded to its radially expanded state. The unattached side edges 338 also allow blood to flow in the space between a pair of side edges 338 of adjacent leaflets and the inner surface of the frame to reduce stagnant blood flow and thrombus formation. During diastole, the adjacent side edges 338 can come into contact with each other and prevent retrograde blood flow between the side edges 338. During systole, the adjacent side edges 338 can separate from each other and allow antegrade blood flow between the side edges 338 and help flush blood away from the area below the commissure.

[0153] The first, second, and third reinforcing members 310, 312, 320 desirably comprise a relatively soft and flexible non-metallic material. For example, these reinforcing members can comprise a multifilament suture (e.g., Ethibond suture) or a synthetic material strip, such as a woven (e.g., PET) or non-woven material (e.g., silicone or polyurethane), or a natural tissue (e.g., pericardium). The commissure attachment member 322 similarly can comprise a relatively soft and flexible non-metallic material, such as a synthetic material strip, such as a woven (e.g., PET) or non-woven material (e.g., silicone or polyurethane), or a natural tissue (e.g., pericardium). Thus in the illustrated embodiment, the commissure 328 does not include a metal component or other material of similar rigidity. The absence of such materials can reduce abrasion and wear on the leaflet material and reduce the overall crimping profile of the prosthetic valve.

[0154] FIG. 38 Modifications of the illustrated embodiment are shown. FIG. 37 Modifications of the illustrated embodiment are shown. FIG. 38 Embodiments of the illustrated embodiment can be used with FIG. 37The same is shown except that pairs of folded first and second tab layers 306a, 306b of adjacent leaflets 300 can be secured to one another by a suture 336 that extends through the first and second reinforcing members 310, 312 and the first and second tab layers 306a, 306b of each leaflet 300. Securing these leaflets together can enhance the bending axis of the hinged portion 330 of the leaflets during normal valve operation.

[0155] FIG. 39 An alternative embodiment of a leaflet is shown that is similar to the leaflet 300 except that the leaflet includes a plurality of upper tabs 340 that extend laterally a greater distance than the upper tabs 306. Each upper tab 340 can be folded longitudinally along a respective vertical fold line 342 to form two folded tab layers that pair with the folded tab layers of an adjacent leaflet to form a commissure as previously described.

[0156] FIGS. 40-46 Another embodiment of a leaflet and a method for forming a commissure from two leaflets is shown. As FIG. 40 shown, the leaflet 400 includes a lower edge portion 402 that terminates at a lower tab 404, an upper tab 406 (also referred to as a commissure tab) that is spaced apart from the lower tab 404 by a gap 408. The lower tab 404 can be folded downward against the lower edge portion 402 to reinforce those regions of the leaflet and move the bending axis of the upper section of the edge portion 402 (the portion just below the commissure) inward away from the inner surface of the frame as previously described.

[0157] Each upper tab 406 includes a tab lower portion 410, a tab upper portion 412 extending from the tab lower portion, and a tab side portion 414 extending laterally inward from the tab upper portion. To form a commissure, a reinforcing member 418 (e.g., a multi-filament suture or a fabric strip) can be placed vertically along the tab upper portion 412 as FIG. 41 shown. The tab side portion 414 can then be folded against the tab upper portion 412 along a fold line 416 as FIGS. 41-42 shown. The tab side portion 414 and the double layer of the tab upper portion 412 can then be folded against the tab lower portion 410 along a horizontal fold line 420 as FIGS. 42-43 depicted in FIG. 42.

[0158] As FIG. 44As shown, the commissure attachment member 422 can then be placed against the back (outer) surface of the tab lower portion 410 and secured to the upper tab 406 by a suture 424 that extends through the tab upper portion 412, the reinforcing member 418, the tab side portion 414, the tab lower portion 410, and the commissure attachment member 422. The three layers formed by the tab lower portion 410, the tab upper portion 412, and the tab side portion 414 can then be folded into an L-shape to form a folded outer portion 426 adjacent to the commissure attachment member 422 and a folded inner portion 428 extending radially inward from the folded outer portion, as shown. FIG. 46 As shown, the commissure attachment member 422 can then be placed against the back (outer) surface of the tab lower portion 410 and secured to the upper tab 406 by a suture 424 that extends through the tab upper portion 412, the reinforcing member 418, the tab side portion 414, the tab lower portion 410, and the commissure attachment member 422. The three layers formed by the tab lower portion 410, the tab upper portion 412, and the tab side portion 414 can then be folded into an L-shape to form a folded outer portion 426 adjacent to the commissure attachment member 422 and a folded inner portion 428 extending radially inward from the folded outer portion, as shown. FIGS. 45-46 As shown, the commissure attachment member 422 can then be placed against the back (outer) surface of the tab lower portion 410 and secured to the upper tab 406 by a suture 424 that extends through the tab upper portion 412, the reinforcing member 418, the tab side portion 414, the tab lower portion 410, and the commissure attachment member 422. The three layers formed by the tab lower portion 410, the tab upper portion 412, and the tab side portion 414 can then be folded into an L-shape to form a folded outer portion 426 adjacent to the commissure attachment member 422 and a folded inner portion 428 extending radially inward from the folded outer portion, as shown. FIG. 46 As shown, the commissure attachment member 422 can then be placed against the back (outer) surface of the tab lower portion 410 and secured to the upper tab 406 by a suture 424 that extends through the tab upper portion 412, the reinforcing member 418, the tab side portion 414, the tab lower portion 410, and the commissure attachment member 422. The three layers formed by the tab lower portion 410, the tab upper portion 412, and the tab side portion 414 can then be folded into an L-shape to form a folded outer portion 426 adjacent to the commissure attachment member 422 and a folded inner portion 428 extending radially inward from the folded outer portion, as shown.

[0159] As described above, the suture 424 can extend through each of the layers formed by the tab lower portion 410, the tab upper portion 414, and the tab side portion 414. As shown, FIG. 46 The sutures 424 can extend diagonally from each of the upper tabs 406 toward one another so as to compress the folded upper tabs 406 against one another and against the commissure attachment member 422. In alternative embodiments, the suture 424 can be placed through the reinforcing member 418, the tab side portion 414, and the tab lower portion 410 prior to folding the tab upper portion and the tab side portion along the fold line 420. In this way, the suture 424 does not have to extend through the tab upper portion 412, as depicted in FIG. 46 In some embodiments, another reinforcing member 438 can be placed against the outer surface of the commissure reinforcing member 422 FIG. 47 The suture 424 can extend through the reinforcing member 438 at the same location as shown or at a plurality of spaced apart locations from each of the upper tabs 406.

[0160] The commissure 430 can function similarly to the commissure 328 described above. Thus during normal valve cycling, the leaflets 400 can articulate about respective axes at the inner ends 434 of the tab layers 412. Compression of the folded upper tabs 406 by the suture 424 helps maintain the normal flexion axis of the leaflets 400 away from the frame. During valve deployment, the leaflets can flare away from one another adjacent to the axis 436 of the commissure attachment member 422.

[0161] FIG. 47 Alternative configurations for forming a commissure are shown. FIGS. 33-37 Embodiments of the frame 400 are similar toFIG. 48 In embodiments, in addition to the vertical reinforcing member 344 can be placed between the two layers of the upper tab of the leaflet. The commissure can be formed by placing the reinforcing member 344 on the first tab layer 306a before folding the first tab layer 306a along the fold line 308. After folding the upper tab 306, the folded first and second tab layers 306a, 306b can be secured to the commissure attachment member 322 by sutures 346 that extend through the reinforcing member 344, the first and second tab layers 306a, 306b, and the commissure attachment member 322.

[0162] FIG. 46 An alternative configuration for forming a commissure is shown in FIG. 4B, which is similar to that of FIG. 4A, except that each folded upper tab 406 is secured to a separate reinforcing member 438 (one of which is shown in FIG. 4B). Also, sutures 440 can secure the tab side portions 412 to the reinforcing members 418. FIG. 48 FIGS. 49-54 Another embodiment of a leaflet and a method for forming a commissure 32 from two leaflets is shown in FIG. 5. As shown in FIG. 5A, a leaflet 500 includes a lower edge portion 502 that terminates at a lower tab 504, an upper tab 506 (also referred to as a commissure tab) that is spaced apart from the lower tab 504 by a gap 508. The lower tab 504 can be folded downward against the lower edge portion 502 to reinforce those regions of the leaflet and to move the bend axis of the upper section of the edge portion 502 (the portion directly below the commissure) inward toward the inner surface of the frame, as previously described.

[0163] FIG. 49 Each upper tab 506 includes a tab lower portion 510 and a tab upper portion 512. To form the commissure, the tab upper portion 512 is folded against the tab lower portion 510 along a fold line 514. The double layer including the tab lower portion 510 and the tab upper portion 512 can then be folded along a vertical fold line 516 to form each upper tab 506 into a first layer 518, a second layer 520, a third layer 522, and a fourth layer 524, as shown in FIG. 5B. A reinforcing member 526, such as a fabric strip (e.g., PET), can be positioned between the second layer 520 and the third layer 522. FIGS. 50-52 The upper tab 506 of another leaflet 500 is folded in the same manner and placed against the folded upper tab of the first leaflet within a commissure attachment member 528. The commissure attachment member 528 can be secured to the folded upper tabs of the two leaflets by sutures 530 that extend through the reinforcing members 526, the first and second layers 518, 520 of the upper tabs 506, and the commissure attachment member 528.

[0164] FIG. 50

[0165] FIG. 50 ​​​​The parts are folded as shown to form a central outer portion 530, an outer end portion 532, and a side portion 534, each including a first and second material layer 534a, 534b extending from the respective ends of the end portion 532 and the central outer portion 530. The side portion 534 can be placed against the respective fourth layer 524 of the upper tab.

[0166] like FIG. 51 As shown, the first and second material layers 534a, 534b of each side portion 534 can be secured to each other by stitches 536. Each side portion 534 can be secured to the upper tab 506 by stitches 538, which extend through the respective reinforcing member 526, the respective third and fourth layers 522, 524, and the two layers of the respective side portion 534. The joint attachment member 528 can be secured to the pillar 22 of the frame 12 by stitching or other techniques or mechanisms.

[0167] FIG. 51 This illustrates another method of securing the foldable upper tab 506 to the central outer portion 530. (See diagram below.) FIGS. 52-53 As shown, for each upper patch, the inner end portions of the first and second material layers 534a, 534b, the third layer 522 and the fourth layer 524, and the reinforcing member 526 of that side portion can be secured using laterally extending stitch rows 540. The reinforcing member 526, the third layer 522 and the fourth layer 524, and the rear end portions of the first and second material layers 534a, 534b of that side portion can be secured using diagonally extending stitch rows 524.

[0168] like FIG. 54 As shown, each coupling 32 may include an inner sleeve 544 and an outer support member 546. The inner sleeve 544 may include first and second portions 544a and 544b, each extending around the outer side, upper portion, and lower portion of its respective folded upper tab 506. Adjacent upper ends 548 of the first and second portions 544a and 544b may be secured to each other at the center of the coupling 32 (e.g., by stitching). Adjacent lower ends of the first and second portions 544a and 544b may be secured to each other at the center of the coupling 32 in a similar manner (e.g., by stitching). Each of the side portions 534 of the coupling attachment member 528 may be secured to one of the first and second portions 544a and 544b of the inner sleeve (e.g., by stitching). The outer support member 546 may be secured to the central outer portion 530 and / or end portion 532 of the coupling attachment member 528 (e.g., by stitching).

[0169] like FIG. 55As shown, at least a portion of the outer support member 546 can be positioned outside of the frame 12. The outer support member 546 can be secured (e.g., by suturing) to each of the set of struts 22 forming the opening of the frame. For example, in the illustrated embodiment, the outer support member 546 can be sutured to each of the struts in a diamond-shaped opening comprising four struts 22. The inner sleeve 544 and the outer support member 546 can comprise any suitable relatively flexible and soft material as previously described for the reinforcing members and commissure attachment members of the embodiments described above. In particular embodiments, the inner sleeve 544 and the outer support member 546 comprise PET fabric.

[0170] FIGS. 52-54 An alternative embodiment for forming a commissure from two leaflets 300 is shown. The upper tabs 306 can be folded in a similar manner as described above for the embodiment of FIG. 55 FIGS. 52-54 The embodiment of FIG. 56 may be the same as the embodiment of except that the former includes a reinforcing member 554 in the form of a multi-filament suture positioned between the second layer 520 and the third layer 522 of each upper tab 506.

[0171] FIGS. 33-37 An alternative embodiment for forming a commissure from two leaflets 300 is shown. The upper tabs 306 can be folded in a similar manner as described above for the embodiment of FIG. 56 FIGS. 57-58 The embodiment of may be the same as the embodiment of except that the former includes a reinforcing member 554 in the form of a multi-filament suture positioned between the second layer 520 and the third layer 522 of each upper tab 506.

[0172] FIG. 59 An artificial valve 600 according to another embodiment is shown. The artificial valve 600 can be similar to the artificial valve 10 described above, except for the configuration of the sealing member. In the illustrated embodiment, the artificial valve 600 includes a sealing member 602 comprising an inner portion or layer 604 and an outer portion or layer 606. The inner layer 604 is mounted inside the frame 12 and comprises three triangular portions 608. FIGS. 60-61 A sealing member 602 is shown in a flat configuration prior to being attached to a frame. When the sealing member is formed into a tubular or annular shape by the ends being connected to each other, the half-triangular portions at each end of the sealing member form the triangular portions 608. ​

[0173] The upper edge portion 610 of the inner layer is shaped to correspond to the shape of the lower edge portion 102 of the leaflet 20. The lower edge portion 102 of the leaflet 20 can be directly connected (e.g., by suturing) to the upper edge portion 610 of the sealing member 602 using a connecting sleeve (e.g., any of the connecting sleeves described herein, such as the connecting sleeve 100) or other mounting techniques described herein. The upper edge portion 610 of the sealing member 602 can be secured to the strut 22 of the frame 12, for example, by the sutures used to connect the inner layer to the leaflet, or by separate sutures that extend around the strut 22 and through the inner layer. The inner layer 604 functions to prevent antegrade blood from flowing outside the frame through the opening of the frame at the inflow edge of the leaflet.

[0174] The outer layer 606 can be wrapped around the inflow end 26 of the frame and secured to the strut 22 on the outside of the frame 12 along its upper edge portion 612. A single suture can be used to secure the outer layer 606 to the apex at the inflow end 26 of the frame at circumferentially spaced locations.

[0175] The outer layer 606 can be shaped or configured to extend radially outward from the frame when the prosthetic valve is radially expanded to its functional size, creating a space 614 between the frame and the outer layer 606. After deployment in the patient's body, retrograde blood can flow across the outer surface of the leaflet 20, through the opening of the frame, and into the space 614 within the outer layer 606, thereby helping to create a seal with the surrounding tissue. There is no material inside the frame facing the movable portion of the leaflet 20 that can reduce the overall coiled profile of the prosthetic valve, and particularly can inhibit the leaflet 20 from being abraded, especially if the prosthetic valve is not fully expanded to its normal size. This can therefore allow the prosthetic valve to be implanted with a greater range of patient annulus sizes.

[0176] The sealing member 602 can be formed from the same materials and using the same techniques as described above for the sealing member 16.

[0177] FIG. 62 A prosthetic valve 700 according to another embodiment is shown. The prosthetic valve 700 can be similar to the prosthetic valve 10 described above, except for the configuration of the sealing member. In the illustrated embodiment, the prosthetic valve 700 includes a sealing member 702 that includes an inner portion or inner layer 704 and an outer portion or outer layer 706. The inner layer 704 is mounted outside the frame 12 and includes three triangular portions 708. In particular embodiments, the triangular portions 708 are connected only by thin strips 705.

[0178] FIG. 63The sealing member 702 is shown prior to assembly on the frame 12 and folding into its final shape. When installing the sealing member 702 on the frame 12, the sealing member can first be placed on the frame, as shown in FIG. 60 the inflow end portion of the inner layer 704 is adjacent the inflow end 26 of the frame. The triangular portion 708 is formed to correspond to the shape of the lower edge portion 102 of the leaflet 20 and covers the opening in the frame between the adjacent edge portions 102 under each commissure. Due to the shape of the triangular portion 708, the inner layer 704 does not cover this portion of the outflow surface of the frame facing the leaflet.

[0179] The lower edge portion 102 of the leaflet 20 can be connected (e.g., by suturing) directly to the upper edge portion 710 of the inner layer 704 using a connecting sleeve (e.g., any of the connecting sleeves described herein, such as the connecting sleeve 100) or other installation techniques described herein. The inner layer 704 functions to prevent antegrade blood flow out of the frame through the opening under the inflow edge of the leaflet.

[0180] The outer layer 706 can then be folded over the inner layer 704 toward the inflow end 26 of the frame so that the previously folded over upper end of the outer layer becomes the lower (inflow) end of the outer layer and is adjacent the inflow end 26 of the frame, as shown in FIG. 64 Folding the outer layer over the inner layer inverts the outer layer so that in its folded, assembled state, the inner surface of the previously folded over outer layer becomes the outer surface of the outer layer and the outer surface of the previously folded over outer layer becomes the inner surface of the outer layer. FIGS. 57-59 The sealing member 702 is shown in its final folded state, spaced apart from the rest of the prosthetic valve, for purposes of illustration. After folding the outer layer 706, the inflow and / or outflow end of the outer layer can be secured (e.g., by suturing) to the strut 22 of the frame.

[0181] The sealing member 702 can be formed from the same materials and using the same techniques as described above for the sealing member 16. In alternative embodiments, the inner layer 704 and the outer layer 706 can be separate pieces of material that can be secured (e.g., by suturing) to each other at their inflow and / or outflow ends.

[0182] Similar to FIG. 65In embodiments, the outer layer 706 can be shaped or configured to extend radially outward from the frame when the prosthetic valve is radially expanded to its functional size, creating a space 714 between the frame and the outer layer 706. After deployment in the patient's body, retrograde blood can flow in the direction of arrow 716 across the outflow surface 70 of the leaflets 20, through the openings of the frame, and into the space 714 within the outer layer 706, thereby helping to create a seal with the surrounding tissue. The triangular portions 708 prevent antegrade blood from flowing through the frame at certain locations between the tip edge portions 102 of the leaflets. The lack of material inside the frame can reduce the overall crimp profile of the prosthetic valve and can inhibit the leaflets 20 from being abraded, especially if the prosthetic valve is not fully expanded to its normal size. Thus, this can allow the prosthetic valve to be implanted with a greater range of patient annulus sizes.

[0183] FIGS. 60-63 A prosthetic valve 800 is shown in accordance with another embodiment. The prosthetic valve 800 can include a sealing member 802 mounted to the frame 12 as described above in connection with the embodiment of the sealing member 702. The prosthetic valve 800 can include a plurality of leaflets 814 that are connected to each other at their outflow ends to form commissures 810 that are mounted to the openings at the outflow end of the frame. The commissures 810 can be formed by folding over the upper tabs of the leaflets and securing them to commissure attachment members 812. Each commissure attachment member 812 can be sewn to four struts 22 that define the closed openings 24 of the frame. The method for forming the commissures 810 and mounting them to the openings 24 via the commissure attachment members 812 is described in detail below. FIG. 68

[0184] FIGS. 74-78 The sealing member 802 is shown spaced apart from other components of the prosthetic valve. The sealing member 802 includes an inner layer 804 and an outer layer 806. The inner layer 804 can include a plurality of triangular portions 808. The sealing member 802 can have the same or similar construction as the sealing member 702 except that the triangular portions 808 are not connected to each other at their lower (inflow) ends. The sealing member 802 can be mounted to the frame 12 as described above in connection with the sealing member 702.

[0185] Referring to FIGS. 75A-75B , a method for forming the commissures 810 and mounting them to the frame 12 is described. As in the FIG. 75B ​As best shown, each leaflet 814 has a lower or tip edge portion 816, which can be mounted to the frame 12 in any of the manner described in the previously described embodiments. The tip edge portion 816 terminates at its upper end in two laterally extending integral lower tabs 818. An integral upper tab 820 (also referred to as a connecting tab) extends from the upper corner of the leaflet 814. The upper tab 820 may be spaced apart from the lower tabs 818 by side edges 819, thereby forming a laterally extending gap or recess in the leaflet.

[0186] like FIGS. 33-37 As shown, similar to the above regarding FIG. 76 The technique described for the leaflet 300 shown involves folding each upper tab 820 along a fold line 814 to form first and second tab layers 820a, 820b. The upper tabs 820 are fixed to the connecting attachment member 812, forming a connecting portion 810 together with the upper tabs 820 of the adjacent leaflets, as further described below. FIGS. 77-78 A connecting attachment member 812 in a flat configuration before being folded and attached to the leaflet is shown. In the illustrated configuration, each connecting attachment member 812 includes first and second side portions 828a, 828b extending laterally from a central portion 830. As shown, the outer peripheral edges 832 of the first and second side portions 828a, 828b can be configured to correspond to half of the rhomboid opening 24 of the frame 12 to facilitate mounting the connecting attachment member 812 to the support post 22 of the frame 12, as further described below.

[0187] Reference FIG. 78 After folding the upper tab 820 of the leaflet 814, the vertical reinforcing member 826 can be fixed to the inner surface of the tab layer 820a, for example, by stitching. The folded tab layers 820a and 820b can be fixed to the first side portion 828a or the second side portion 828b of the connecting attachment member 812. These folded tab layers can also be folded in an L-shape along the fold line at the reinforcing member 826, such that tab layer 820b forms a first circumferentially extending layer 834a and a first radially extending layer 834b generally perpendicular to layer 834a, and tab layer 820a forms a second circumferentially extending inner layer 836a and a radially extending layer 836b generally perpendicular to the inner layer 836a. Another upper tab 820 of the adjacent leaflet 814 can be similarly folded and fixed to the first side portion 828a or the second side portion 828b of the connecting attachment member 812.

[0188] The connecting component 812 can be attached to the joint as follows FIG. 78The folds are shown to form an inner layer 838 and two intermediate layers 840, as well as two outer layers 842. Each of the folded upper tabs 820 can be secured to the inner layer 383 and the intermediate layers 840 by a suture 844. In the illustrated embodiment, the suture 844 is shown extending through the reinforcing member 826, the inner layers 836a, 834a, the inner layer 838, and the intermediate layers 840. However, multiple sutures can be employed to secure each layer to an adjacent layer as each crease is created during assembly. For example, separate sutures can be used to secure the inner layers 834a, 836a to each other and to the reinforcing member 826, and then additional sutures can be used to secure the leaflet layers to the inner layer 838 of the commissure attachment member 812, and further sutures can be used to secure the intermediate layers 840 to the inner layer 838. As best shown in FIG. 71 The commissure attachment member 812 can be folded so as to leave a small gap 846 between the outer layers 842.

[0189] The outer layers 842 can be secured to the frame 12, for example by suturing the outer peripheral edges 832 to the struts 22 with sutures 848. As mentioned above, the outer peripheral edges 832 of the commissure attachment member 812 can generally correspond to the closed openings of the frame 12. For example, as FIG. 76 shown, in the illustrated embodiment, the frame 12 includes a plurality of generally diamond-shaped openings 24, each of which is formed by struts 22a, 22b, 22c, and 22d. The outer peripheral edges 832 of the commissure attachment member 812 can be sutured to the struts 22a, 22b, 22c, and 22d forming the closed openings 24 using sutures 848. The commissure attachment member 812 can further include upper and lower tabs 850 and 852 extending from the upper and lower edges of the central portion FIG. 70 The upper tabs 850 can also be sutured to the apex 854 formed by the intersection of the struts 22a, 22c, and the lower tabs 852 can be sutured to the junction 856 formed by the intersection of the struts 22b, 22d using sutures 848.

[0190] A plurality of connecting sleeves 860 FIG. 75B may be used to secure the inflow portion or tip edge portion 816 of the leaflet 814 to the frame 12, which can be formed from the same material as described above for the connecting sleeve 100 (e.g., PET fabric). In the illustrated embodiment, a single connecting sleeve 860 is provided for the tip edge portion 816 of each leaflet 814, and is sized to extend along the entire length of the tip edge portion 816 to a position just below the lower tab 818 of the leaflet 814. FIG. 75BA connecting sleeve 860 is shown placed along the cusp edge portion 816 of a leaflet 814 prior to attachment to the leaflet by sutures. The connecting sleeve 860 can include a central portion 860a sized to extend across the central lower edge portion and two side portions 860b sized to extend across the angled side edge portions extending from the central lower portion to the lower tabs 818. The connecting sleeve 860 can be formed with a plurality of slits 862 partially separating the side portions 860b from the central portion 860a to facilitate alignment of the sleeve along the cusp edge portion, as shown in FIG. 69 .

[0191] In alternative embodiments, a plurality of connecting sleeves can be provided for the cusp edge portion of each leaflet (e.g., the central portion 860a and side portions 860b can be separate pieces of fabric). In another embodiment, a single connecting sleeve can be used to secure all of the leaflets to the frame, i.e., the single connecting sleeve can be sized to extend along the cusp edge portions of all of the leaflets.

[0192] The connecting sleeve 860 can be attached to the cusp edge portion of each leaflet prior to attachment of the leaflets to the frame. As shown in FIG. 75B , the connecting sleeve 860 can be folded longitudinally to form two folded layers 864a, 864b and placed against the inflow surface of the cusp edge portion 816. A reinforcing member or chord 866 (e.g., an Ethibond suture) can be placed against the outflow surface of the cusp edge portion opposite the connecting sleeve 860. The reinforcing chord 866 and folded layers 864a, 864b can be sutured to each other and to the cusp edge portion 816 by sutures 868, which can be a single suture or a plurality of sutures extending through one or more layers of material.

[0193] When the reinforcing chord 866 is sutured to the leaflet 814, the lower tabs 818 can be folded down against the cusp edge portion 816 (see FIG. 67 ) and the reinforcing chord 866 can be placed across the folded lower tabs 818. The upper end of the connecting sleeve 860 can be sized to extend across the folded lower tabs 818. The reinforcing chord 866 can be secured in place against the folded lower tabs 818 using sutures 868. In a particular embodiment, as shown in FIG. 69As best shown, the reinforcing chord 866 can extend along the folded lower tab 818 of one leaflet 814, through the space below the commissure 810 between a pair of adjacent lower tabs 818 and a pair of upper tabs 820, and then along the lower tab 818 and tip edge portion of an adjacent leaflet 814. In some embodiments, a single reinforcing chord 866 extends continuously along the tip edge portions 816 of all of the leaflets and through the space below each commissure 810. In other embodiments, multiple reinforcing chords 866 can be used, with one chord secured to the tip edge portion of each leaflet. In cases where multiple reinforcing chords 866 are used, the ends of each chord can be connected (e.g., by tying or knotting) to adjacent ends of other chords. For example, adjacent ends of two chords can be connected to each other in the space below the commissure.

[0194] FIG. 71 、 72 , and 73 illustrate the connection of the connection sleeve 860 to the frame 12, according to one embodiment. As shown, the connection sleeve can be sewn to the strut 22 of the frame, forming a diagonal line extending from the commissure 810 to the inflow end of the frame. In particular embodiments, one or both layers 864a, 864b of the connection sleeve can be secured to the junction 856 by a single suture 872 and further by a plurality of basting sutures 874 formed along the length of the strut 22 between the two junctions 856 FIG. 69 . Each basting suture 874 can extend through the suture 870 and wrap around the strut 22 multiple times along the length of the strut. The basting sutures 874 can optionally extend through the tip edge portion 816, as depicted. FIGS. 10-12B

[0195] In alternative embodiments, any of the techniques described herein can be used to mount the tip edge portions 816 of the leaflets 814 to the frame and / or the inner layer 804 of the sealing member. For example, the leaflets 814 can be mounted to the frame 12 using any of the techniques or configurations described above with respect to FIGS. 33-37 or 14-32, with or without the reinforcing chord 866.

[0196] As described above with respect to FIG. 67 ​The folded lower tabs 818 of the illustrated embodiment help to reinforce the connection between the cusp edge portions 816 of the leaflets adjacent to the commissure 810 along the upper sections of these cusp edge portions. The folded lower tabs 818 also move the bending axis of the upper sections of these cusp edge portions inward and away from the inner surface of the frame to prevent or minimize contact between the leaflets and the frame in the area below the commissure. In the illustrated embodiment, each lower tab 818 forms one additional layer of leaflet material on the upper (outflow) surface of the leaflet. In alternative embodiments, each lower tab 818 can be configured to form multiple additional layers of leaflet material on the upper surface of the leaflet, e.g., two, three, or four layers, to move the bending axis of the leaflet further away from the inner surface of the frame below the commissure.

[0197] The side edges 819 between the lower tabs 818 and the upper tabs 820 can be left unattached to the frame of the prosthetic valve, as FIG. 1C is best shown and as previously described with respect to FIGS. 60-64 The illustrated configuration. As previously described, the unattached side edges 819 allow the leaflets to elongate or stretch more in the axial direction when the prosthetic valve is compressed, and allow the leaflets to elongate or stretch more in the radial direction when the prosthetic valve is expanded. During diastole, the adjacent side edges 819 can come into contact with each other and prevent retrograde blood flow between the side edges 819. During systole, the adjacent side edges 819 can move apart from each other and allow antegrade blood flow between the side edges 819 and help to flush blood away from the area below the commissure 810.

[0198] After the leaflet assembly (the leaflets 814 and the connecting sleeve 860) is installed to the frame, the sealing member 802 can be placed across and installed to the frame, as previously described with respect to FIG. 69 The triangular portions 808 of the inner layer 804 of the sealing member can be sewn to one or both layers 846a, 846b of the connecting sleeve 860 and / or the struts 22 of the frame, e.g., by the sutures 870 (see FIGS. 79-80 ).

[0199] FIG. 67An artificial valve 900 according to another embodiment is shown. Artificial valve 900 can be similar to artificial valve 10 described above, except for the configuration of the sealing member. In the illustrated embodiment, artificial valve 900 includes a sealing member 902 comprising a first layer 902 and a second layer 904 mounted on the exterior of frame 12. First layer 902 includes a plurality of first diamond-shaped portions 908 connected to one another at their outflow ends. Second layer 904 includes a plurality of triangular portions 910 connected to one another at their outflow ends. Triangular portions 910 that are circumferentially aligned with the commissures 906 of the artificial valve are interposed between diamond-shaped portions 908 that are circumferentially aligned with leaflets 20. As shown, diamond-shaped portions 908 and triangular portions 910 can overlap one another to some extent near commissures 906.

[0200] Triangular portions 910 generally correspond to the shape of the space between adjacent leaflets 20. The inflow ends of second layer 904 can be secured (e.g., by suturing) to the inflow end of the frame. As described previously, the lower edge portions 102 of leaflets 20 can be coupled to frame 12, e.g., by connecting sleeves 100, and connecting sleeves 100 can be secured (e.g., by suturing) to the sides of triangular portions 910 through openings of the frame. In this manner, triangular portions 910 block antegrade blood flow out through the openings of the frame. Triangular portions 910 can also engage surrounding tissue to help seal the artificial valve and inhibit paravalvular leakage in conjunction with diamond-shaped portions 908.

[0201] First layer 902 can be secured (e.g., by suturing) to frame 12 at the inflow ends of each diamond-shaped portion 908 and at junctions 912 where outflow edges of diamond-shaped portions 908 connect to one another along the first layer. Diamond-shaped portions 908 are configured to extend radially away from the frame to engage and seal against surrounding tissue when the artificial valve is deployed. The outflow edges of first layer 902 between junctions 912 can remain unattached to the frame to receive retrograde blood between the first layer 902 and the frame. In some embodiments, diamond-shaped portions 908 are configured to form an annular undulating shape around the exterior of the frame, as depicted in FIG. 6B. In some embodiments, the outflow edges of first layer 902 can also be secured (e.g., by suturing) to the frame at locations 914 between junctions 912, causing first layer 902 to assume an undulating shape when the artificial valve is inflated. FIGS. 81-82

[0202] ​While in the illustrated embodiment the first layer has diamond-shaped portions and the second layer has triangular-shaped portions, other shapes are possible. For example, the diamond-shaped portions 908 and the triangular-shaped portions 910 of the first and second layers can be square-shaped, oval-shaped, rectangular-shaped, circular-shaped, or a combination of one or more of these shapes.

[0203] In alternative embodiments, the diamond-shaped portions 908 of the first layer 902 can be separate pieces of material that are not connected to one another. Similarly, the triangular-shaped portions 910 of the second layer 904 can be separate pieces of material that are not connected to one another. For example, FIGS. 83-84 An artificial valve 1000 is shown that includes a sealing member in the form of alternating diamond-shaped portions 1002 and triangular-shaped portions 1004 positioned around the exterior of the frame. The diamond-shaped portions 1002 can be aligned circumferentially with the leaflets 20, and the triangular-shaped portions 1004 can be aligned circumferentially with the commissures 1006 of the leaflets. Each diamond-shaped portion 1002 and triangular-shaped portion 1004 can be a separate piece of material that is stitched or otherwise secured to the frame 12 at its inflow and outflow ends. When the artificial valve is expanded, the diamond-shaped portions 1002 and triangular-shaped portions 1004 can extend away from the frame 12 and engage the surrounding tissue.

[0204] FIGS. 60-63 An artificial valve 1100 is shown according to another embodiment. The artificial valve 1100 can include a sealing member 1102 mounted to the frame 12 as described above with respect to the embodiment of FIGS. 69-73 The artificial valve 1100 can include leaflets 1114 connected to one another at their outflow ends to form a commissure 1110 that is mounted to the opening at the outflow end of the frame. The commissure 1110 can be formed by folding the commissure tabs of the leaflets and securing them to a commissure attachment member 1112 that is in turn mounted to the frame. Each leaflet 1114 can have a lower or tip edge portion 1116 that is folded upwardly toward the outflow end of the frame 12 and secured to the frame with a respective connection sleeve 1118 as described above in connection with the embodiment of FIGS. 85-86 Any other technique for mounting the tip edge portions of the leaflets to the frame disclosed herein can also be used.

[0205] FIG. 86The commissures 1110 formed by the two leaflets 1114 are shown. As shown, each leaflet has a commissure tab that is folded to form a first layer 1120, a second layer 1122, and a third layer 1124. A reinforcing member 1126 can be located between the second layer 1122 and the third layer 1124. The commissure attachment member 1112 can be folded to form a central portion 1128, two side flaps 1130, and two pairs of folded layers 1132, 1134 that extend radially along the third layer 1124 of the leaflet. The folded layers 1132, 1134 of the leaflet layers 1120, 1122, 1124 and the commissure attachment member 1112 can be secured to one another with one or more sutures 1136 and 1138. Each suture 1136, 1138 can form a plurality of internal-external sutures that extend through all of these layers. As shown in FIG. 72 , the suture 1136 can form a suture that extends across the upper edge of the leaflet layers 1120, 1122, 1124. The side flaps 1130 can be secured to the struts 22 of the frame as shown in FIG. 85 and 77 .

[0206] As shown in FIG. 84 , each leaflet can have opposite recessed side edges 1140 under each commissure that can be left unattached to the frame to facilitate blood flow in the area under the commissures, as previously described. Each leaflet can also have an opposite lower tab 1142 OVERALL CONSIDERATIONS similar to the lower tab 818 of the prosthetic valve 800. A reinforcing chord such as the reinforcing chord 866 can be secured to the tip edge portion 1116 of the leaflet as described above in connection with the prosthetic valve 800.

[0207] Any of the prosthetic heart valves disclosed herein can be delivered using any of a variety of delivery techniques. In a retrograde approach, a prosthetic valve can be mounted in a radially compressed state along a distal portion of a delivery catheter, and the delivery catheter and prosthetic valve can be advanced through the aorta into a native aortic valve. Once the prosthetic valve is positioned within the native aortic valve, the prosthetic valve can be expanded, for example, by inflating a balloon or another expansion device.

[0208] As noted above, any of the prosthetic valves disclosed herein can be configured to be self-expandable, or can be expandable by application of an expansion force with a balloon or another type of expansion mechanism. An example of a delivery catheter having an inflatable balloon for implanting a plastically expandable prosthetic heart valve (which can be used to implant any of the prosthetic valves disclosed herein) is disclosed in U.S. Patent Application Publication No. 2017 / 0065415. An example of a delivery catheter (which can be used to implant any of the prosthetic valves disclosed herein) that can be used to deliver a self-expandable prosthetic heart valve is disclosed in U.S. Patent Application Publication No. 2014 / 0343670.

[0209] ​

[0210] For purposes of this summary, certain aspects, advantages, and novel features of the embodiments of the disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination of features, nor do the disclosed embodiments require the presence of any particular advantage or the resolution of any problem.

[0211] A prosthetic heart valve in accordance with the present disclosure can include a radially collapsible and expandable annular frame, a valve structure (e.g., one or more leaflets) mounted within the frame, and one or more of the novel features described above, including but not limited to: any of the sealing members described above; any of the particular leaflet configurations described above; any of the configurations of commissures described above; any of the configurations for connecting the tip edge portions of the leaflets to the frame; and / or combinations thereof.

[0212] Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0213] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Furthermore, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language.

[0214] As used herein, the term “proximal” refers to a location, direction, or portion of a device that is closer to a user and further from an implant site. As used herein, the term “distal” refers to a location, direction, or portion of a device that is further from a user and closer to an implant site. Thus, for example, proximal movement of a device is movement of the device toward a user, while distal movement of a device is movement of the device away from the user. The terms “longitudinal” and “axial” refer to an axis of a component that extends in a lengthwise direction, generally in a proximal and distal direction, unless otherwise specifically defined.

[0215] In view of the many possible embodiments to which the disclosed invention can be applied, it should be recognized that the embodiments described herein are only preferred examples of the invention and should not be considered limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim all that can come within the scope and spirit of these claims.

Claims

1. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame including a plurality of struts defining openings therebetween; a valve structure including a plurality of leaflets, each leaflet including a body, opposing tabs on opposite sides of the body, a coapted edge portion, and a tip edge portion, each tab paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and wherein each leaflet has opposing edge portions between the opposing tabs and the tip edge portion that are unattached to the frame, each unattached edge portion defining a void that extends radially into the body of the leaflet, each void disposed upstream of the coapted edge portion of the respective leaflet of the plurality of leaflets; and wherein the tabs of each leaflet are upper tabs, and wherein each leaflet further includes opposing lower tabs on opposite sides of the body, the lower tabs spaced apart from the upper tabs by the unattached edge portions, wherein each lower tab is folded toward the body of the leaflet; and wherein the tip edge portion of each leaflet is folded toward the outflow end of the frame along a bend axis.

2. The prosthetic heart valve of claim 1, wherein each upper tab is foldable along a fold line to form first and second tab layers, the fold line positioned perpendicularly to a longitudinal axis of the frame.

3. The prosthetic heart valve of claim 1, wherein a reinforcing member is secured to the tip edge portion of each leaflet along the bend axis.

4. The prosthetic heart valve of claim 1, further comprising a sealing member including an outer layer at least partially mounted on a radially outer surface of the frame.

5. The prosthetic heart valve of claim 4, wherein the outer layer includes a fabric having a pile.

6. The prosthetic heart valve of claim 1, further comprising a plurality of triangular fabric portions mounted inside the frame at locations between adjacent tip edge portions of adjacent leaflets of the plurality of leaflets.

7. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame including a plurality of struts defining openings therebetween; a valve structure including a plurality of leaflets, each leaflet including a body, opposing tabs on opposite sides of the body, a coapted edge portion, and a tip edge portion, each tab paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame; and wherein the tip edge portion of each leaflet is connected to the frame by a respective connecting sleeve connected to and disposed between the frame and the tip edge portion of the leaflet, each connecting sleeve being sutured to struts of the frame extending diagonally from the inflow end portion and the outflow end portion; and wherein the tip edge portion of each leaflet is folded toward the outflow end of the frame along a bend axis.

8. The prosthetic heart valve of claim 7, wherein each upper tab is foldable along a fold line to form first and second tab layers, the fold line positioned perpendicularly to a longitudinal axis of the frame.

9. The prosthetic heart valve of claim 7, wherein a reinforcing member is secured to the tip edge portion of each leaflet along the bend axis.

10. The prosthetic heart valve of claim 7, further comprising a sealing member including an outer layer at least partially mounted on a radially outer surface of the frame.

11. The prosthetic heart valve of claim 10, wherein the outer layer includes a fabric having a pile.

12. The prosthetic heart valve of claim 7, further comprising a plurality of triangular fabric portions mounted inside the frame at locations between adjacent tip edge portions of adjacent leaflets of the plurality of leaflets.

8. The prosthetic heart valve of claim 7, wherein a reinforcing member is secured to the tip edge portion of each leaflet along the bend axis.

9. The prosthetic heart valve of claim 7, wherein each connecting sleeve comprises two layers of material stitched to the tip edge portion of the leaflet and the frame.

10. The prosthetic heart valve of claim 7, further comprising a sealing member comprising an outer layer mounted at least partially on a radially outer surface of the frame.

11. The prosthetic heart valve of claim 10, wherein the outer layer comprises a fabric having a pile.

12. The prosthetic heart valve of claim 10, further comprising a plurality of triangular fabric portions mounted to the frame at locations between adjacent tip edge portions of adjacent leaflets of the plurality of leaflets and coupled to the adjacent tip edge portions of the leaflets via one or more connecting sleeves.

13. The prosthetic heart valve of claim 12, wherein the plurality of triangular fabric portions do not cover one or more of the openings in the frame at locations circumferentially aligned with outflow surfaces of the leaflets.

14. The prosthetic heart valve of claim 10, wherein the outer layer extends axially around an inflow edge of the frame.

15. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings therebetween; a valve structure comprising a plurality of leaflets, each leaflet comprising a body, opposing tabs on opposite sides of the body, a commissure edge portion, and a tip edge portion, each tab paired with an adjacent tab of an adjacent leaflet to form a plurality of coaptations that are fixed relative to the frame, and wherein the tip edge portion of each leaflet is folded toward the outflow end of the frame along a bend axis; an outer sleeve mounted on an outer surface of the frame; and a plurality of triangular fabric portions mounted to the frame at locations between adjacent tip edge portions of adjacent leaflets of the plurality of leaflets and coupled to the adjacent tip edge portions of the leaflets via one or more connecting sleeves, each triangular portion having an apex, the apexes of adjacent triangular portions being circumferentially spaced apart from one another around the frame.

16. The prosthetic heart valve of claim 15, wherein the outer sleeve comprises a fabric having a pile.

17. The prosthetic heart valve of claim 15, wherein the plurality of triangular fabric portions do not cover one or more of the openings in the frame at locations circumferentially aligned with outflow surfaces of the leaflets.

18. A prosthetic heart valve, comprising: an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts; a valve structure comprising a plurality of leaflets, each leaflet comprising a body, opposing tabs on opposite sides of the body, a commissure edge portion, and a tip edge portion, each tab paired with an adjacent tab of an adjacent leaflet to form a plurality of coaptations that are fixed relative to the frame, and wherein the tip edge portion of each leaflet is folded toward the outflow end of the frame along a bend axis; and an outer sleeve mounted on an outer surface of the frame. a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame, wherein each leaflet includes opposing tabs on opposite sides of the leaflet and a tip edge portion between the tabs, wherein each tab pairs with an adjacent tab of an adjacent leaflet to form a plurality of commissures connected to the frame; and wherein the tip edge portion of each leaflet is connected to the frame by a connection sleeve connected to and disposed between the tip edge portion of the leaflet and the frame, wherein each connection sleeve includes first and second layers of material that are stitched to the tip edge portion of the leaflet and the frame; wherein the tip edge portion of each leaflet is folded along a fold axis toward the outflow end of the frame; and wherein each connection sleeve further includes third and fourth layers of material, wherein the first and second layers of material are disposed adjacent an inflow surface of the leaflet and the third and fourth layers of material are disposed adjacent an outflow surface of the leaflet.

19. The prosthetic heart valve of claim 18, wherein the connection sleeve is connected to the tip edge portion of the leaflet by a first row of sutures extending through the first, second, third, and fourth layers of material.

20. The prosthetic heart valve of claim 18, wherein each tip edge portion includes one or more slits spaced along the tip edge portion and configured to allow segments of the tip edge portion to extend radially outward through an opening of the frame.

21. A prosthetic heart valve, comprising: an annular frame including an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame includes a plurality of struts; a valve structure mounted within the frame and including a plurality of leaflets that regulate flow of blood through the frame, wherein each leaflet includes opposing tabs on opposite sides of the leaflet and a tip edge portion between the tabs, wherein each tab pairs with an adjacent tab of an adjacent leaflet to form a plurality of commissures connected to the frame, and wherein the tip edge portion of each leaflet is folded along a fold axis toward the outflow end of the frame; wherein each commissure includes an attachment member having a central portion, a first side tab, and a second side tab, wherein the first side tab extends radially inward adjacent a first side of the commissure, the second side tab extends radially inward adjacent a second side of the commissure, and the attachment member is connected to the commissure using sutures; and wherein the first side tab and the second side tab each include two layers of material.

22. The prosthetic heart valve of claim 21, wherein the sutures extend through the first side tab, the commissure, and the second side tab.

23. The prosthetic heart valve of claim 21, wherein each tab of the commissure includes two layers of material.

24. The prosthetic heart valve of claim 23, wherein each tab comprises a first tab portion and a second tab portion, and the first tab portion is folded and connected to the second tab portion to form the two layers of material.

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