Sealing elements for prosthetic heart valves

Abstract

The present application relates to sealing elements for prosthetic heart valves. An implantable prosthetic valve may include a radially expandable and collapsible annular frame comprising an inflow end and an outflow end. The frame may have a plurality of struts forming a plurality of cells, wherein each of the plurality of cells defines an opening in the frame. A leaflet structure may be positioned within and secured to the frame. A plurality of sealing elements may be positioned within and secured to the openings of the plurality of cells of the frame. Each of the plurality of sealing elements may be positioned within a respective one of the openings.

Description

[0001] This application is a divisional application. The application date of the original application is August 17, 2018, the application number is 201880063607.0, and the name of the invention is “Sealing element for prosthetic heart valve”. Technical Field

[0002] The present disclosure relates to implantable, expandable prosthetic devices, and to methods and apparatuses for such prosthetic devices. Background Art

[0003] The human heart may suffer from a variety of valvular diseases. These valvular diseases can lead to major malfunctions of the heart and ultimately require the replacement of the natural valve with an artificial valve. There are a variety of known artificial valves and a variety of known methods for implanting these artificial valves into the human body. Due to the shortcomings associated with conventional open heart surgery, percutaneous and minimally invasive surgical methods are gaining strong attention. In one technique, a prosthetic valve is configured to be inserted through a catheter and implanted in a much less invasive procedure. For example, a collapsible transcatheter prosthetic heart valve can be crimped to a compressed state and introduced percutaneously on a catheter in a compressed state and expanded to a functional size at the desired position by a balloon or by utilizing a self-expanding frame or stent.

[0004] Prosthetic valves used in such procedures may include a radially collapsible and expandable frame to which the leaflets of the prosthetic valve may be coupled. Exemplary collapsible and expandable transcatheter prosthetic heart valves are described, for example, in US Patent Nos. 6,730,118, 7,393,360, 7,510,575, and 7,993,394.

[0005] The prosthetic valve used in such a procedure may include a radially collapsible and expandable frame to which the leaflets of the prosthetic valve may be coupled, and the frame may be introduced percutaneously over a catheter in a collapsed configuration and expanded in the desired position by balloon inflation or by utilizing a self-expanding frame or stent. A challenge with catheter-implanted prosthetic valves is controlling paravalvular leaks around the valve, which may occur some time after initial implantation. Another challenge includes the process of crimping such a prosthetic valve into a profile suitable for percutaneous delivery to a subject. Summary of the Invention

[0006] Disclosed herein are embodiments of radially collapsible and expandable prosthetic valves including improved external sealing elements for reducing paravalvular leakage, and related methods and apparatus including such prosthetic valves. In several embodiments, the disclosed prosthetic valves are configured for implantation as replacement heart valves in a subject.

[0007] In one exemplary embodiment, an implantable prosthetic heart valve may include an annular frame, a leaflet structure positioned within and secured to the frame, and a plurality of sealing elements. The annular frame may include an inflow end, an outflow end, and a plurality of struts forming a plurality of cells. Each of the cells may define an opening in the frame, and the frame may be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The sealing elements may be positioned within the openings of the plurality of cells of the frame and secured to the frame. Each of the sealing elements may be positioned within one of the respective openings.

[0008] In some embodiments, the sealing elements may be substantially rectangular, and two opposing sides of each of the sealing elements may be secured to the frame, while the other two opposing sides of each of the sealing elements may not be secured to the frame.

[0009] In some embodiments, the sealing elements may be substantially rectangular, and two opposing sides of each of the sealing elements may be secured to the struts of the frame, while the other two opposing sides of each of the sealing elements may not be secured to the frame.

[0010] In some embodiments, the frame may include multiple rows of cells. In such embodiments, one of the sealing elements may be secured to each cell of the row of cells closest to the inflow end of the frame.

[0011] In some embodiments, the frame may include multiple rows of cells. In such embodiments, one of the sealing elements may be secured to each cell of the two rows of cells closest to the inflow end of the frame.

[0012] In some embodiments, each of the sealing elements can have the same orientation with respect to the frame.

[0013] In some embodiments, a first set of sealing elements can each have a first orientation with respect to the frame, while the remaining sealing elements not in the first set can each have a second orientation with respect to the frame, the second orientation being different from the first orientation.

[0014] In some embodiments, the first orientation may be a clockwise orientation and the second orientation may be a counterclockwise orientation.

[0015] In some embodiments, the sealing elements in one row of the two rows of units closest to the inflow end of the frame may each have a first orientation relative to the frame, while the sealing elements in the other row of the first two rows of units closest to the inflow end of the frame may each have a second orientation different from the first orientation.

[0016] In some embodiments, the sealing element can be secured to the frame with sutures.

[0017] In some embodiments, the prosthetic valve can further include an annular inner skirt disposed about the inner surface of the frame and secured to the frame.

[0018] In some embodiments, the sealing elements may be loosely secured to the frame such that sealing elements positioned within cells of the frame include excess material to expand away from the frame when blood flows along an outer surface of the frame.

[0019] In some embodiments, the sealing elements can be positioned such that antegrade blood can flow between the frame and the plurality of sealing elements when the prosthetic valve is implanted.

[0020] In another exemplary embodiment, an assembly for implanting a prosthetic heart valve may include a delivery device comprising an elongated shaft and a prosthetic heart valve coupleable to the shaft of the delivery device. The prosthetic heart valve may include an annular frame, a leaflet structure positioned within and secured to the frame, and a plurality of sealing elements. The annular frame may include an inflow end, an outflow end, and a plurality of struts forming a plurality of cells. Each of the cells may define an opening in the frame. The frame may be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The sealing elements may be positioned within the openings of the plurality of cells of the frame and secured to the frame. Each of the sealing elements may be positioned within one of the respective openings.

[0021] In some embodiments, each of the sealing elements can have the same orientation with respect to the frame.

[0022] In some embodiments, a first set of sealing elements can each have a first orientation with respect to the frame, and the remaining sealing elements not in the first set can each have a second orientation different from the first orientation.

[0023] In another representative embodiment, a method for implanting a prosthetic heart valve may include: radially compressing the heart valve to a radially compressed configuration; coupling the prosthetic heart valve to a distal portion of a delivery device; inserting the distal portion of the delivery device and the prosthetic heart valve into the patient's body; positioning the prosthetic heart valve adjacent to a natural valve of the patient's heart; and radially expanding the prosthetic heart valve so that it engages the natural valve. The prosthetic heart valve may include an annular frame, a leaflet structure positioned within the frame and secured to the frame, and a plurality of sealing elements. The annular frame may include an inflow end, an outflow end, and a plurality of struts forming a plurality of cells. Each of the cells may define an opening in the frame. The frame may be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The sealing elements may be positioned within the openings of the plurality of cells of the frame and secured to the frame. Each of the sealing elements may be positioned within one of the respective openings.

[0024] In some embodiments, each of the sealing elements can have the same orientation with respect to the frame.

[0025] In some embodiments, a first set of sealing elements can each have a first orientation with respect to the frame, while the remaining sealing elements not in the first set can each have a second orientation with respect to the frame, the second orientation being different from the first orientation.

[0026] The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1-3 An exemplary embodiment of a prosthetic heart valve is shown.

[0028] Figure 4-10 Shows Figure 1 An exemplary frame for a prosthetic heart valve.

[0029] Figure 11-12 Shows Figure 1 An exemplary inner skirt of a prosthetic heart valve.

[0030] Figure 13 Shown in a collapsed configuration and mounted on an exemplary balloon catheter Figure 1 prosthetic heart valves.

[0031] Figure 14-16 Shows Figure 4 The framework and Figure 11 The inner skirt component.

[0032] Figure 17-18 Components of an exemplary leaflet structure are shown.

[0033] Figure 19 The assembly of the commissure portions of the leaflet structure with the window frame portion of the frame is shown.

[0034] Figure 20-21 The assembly of the leaflet structure along the lower edge of the leaflet and the inner skirt is shown.

[0035] Figure 22 Another exemplary prosthetic heart valve is shown.

[0036] Figure 23 Shows Figure 22 Portions of an exemplary frame of a prosthetic heart valve.

[0037] Figure 24 Another exemplary prosthetic heart valve is shown.

[0038] Figure 25 Shows Figure 24 Portions of an exemplary frame of a prosthetic heart valve.

[0039] Figure 26 An exemplary prosthetic heart valve is shown implanted into a patient's native aortic valve.

[0040] Figure 27 An exemplary prosthetic heart valve and docking device are shown implanted in a patient's pulmonary artery.

[0041] Figure 28 An exemplary prosthetic heart valve and docking device are shown implanted into a patient's native mitral valve.

[0042] Figures 29-30 An alternative embodiment of a docking device for a prosthetic valve is shown.

[0043] Figure 31 The implantation into the patient's inferior vena cava is shown. Figures 29-30 An exemplary prosthetic heart valve and docking device. DETAILED DESCRIPTION

[0044] Figure 1-3 Various views of a prosthetic heart valve 10 are shown according to one embodiment. Although the illustrated prosthetic valve is adapted for implantation in the native aortic valve annulus, in other embodiments it may be adapted for implantation in other native valve annuli of the heart (e.g., the pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be adapted for implantation in other tubular organs or passageways within the body. The prosthetic valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular sealing device or sealing element. The prosthetic valve 10 may have an inflow end portion 15, a middle portion 17, and an outflow end portion 19. In the illustrated embodiment, the paravalvular sealing device includes an outer skirt 18.

[0045] The valve structure 14 may include three leaflets 41 that together form a leaflet structure, which may be arranged to collapse in a tricuspid arrangement, such as Figure 2 The lower edge of the leaflet structure 14 desirably has a wavy, curved, fan-shaped shape ( Figure 21The suture lines 154 shown track the fan-shaped shape of the leaflet structure. By forming the leaflets with this fan-shaped geometry, the stresses on the leaflets are reduced, thereby improving the durability of the prosthetic valve. In addition, with the help of the fan-shaped shape, wrinkles and corrugations at the belly of each leaflet (the central area of ​​each leaflet) are eliminated or at least minimized, which wrinkles and corrugations can cause early calcification in those areas. The fan-shaped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller, more uniform wrinkle profile at the inflow end of the prosthetic valve. The leaflets 41 can be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118.

[0046] Bare frame 12 is shown on Figure 4 In. The frame 12 can be formed with a plurality of circumferentially spaced grooves or commissure windows 20 (three in the exemplary embodiment) suitable for connecting the commissures of the valve structure 14 to the frame, as described in more detail below. The frame 12 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloy (NiTi), such as Nitinol). When constructed of a plastically expandable material, the frame 12 (and therefore the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the prosthetic valve 10) can be crimped into a radially collapsed configuration and constrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0047] Suitable plastically expandable materials that can be used to form the frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy (e.g., Alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). Alloy / UNS R30035 alloy comprises, by weight, 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum. When alloys are used as frame materials, less material is required to achieve equivalent or better radial and crushing force resistance, fatigue resistance, and corrosion resistance than stainless steel. Furthermore, because less material is required, the frame's wrinkle profile can be reduced, providing a lower-profile prosthetic valve assembly for percutaneous delivery to the treatment site within the body.

[0048] refer to Figure 4 and 5 The frame 12 of the exemplary embodiment includes a first lower row I of angled struts 22 arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending angled struts 24; a third row III of circumferentially extending angled struts 26; a fourth row IV of circumferentially extending angled struts 28; and a fifth row V of circumferentially extending angled struts 32 at the outflow end of the frame. A plurality of substantially straight, axially extending struts 34 can be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II. The angled struts 32 of the fifth row V are connected to the angled struts 28 of the fourth row IV via a plurality of axially extending window frame portions 30 (which define the commissure windows 20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30 extends from a position defined by the convergence of the lower ends of two angled struts 32 to another position defined by the convergence of the upper ends of two angled struts 28. Figure 6 、 7 , 8, 9 and 10 are Figure 5 An enlarged view of the portions of the frame 12 identified by letters A, B, C, D and E in FIG.

[0049] Each commissure window frame portion 30 is connected to a respective commissure of the leaflet structure 14. As can be seen, each frame portion 30 is fixed at its upper and lower ends to adjacent rows of struts to provide a sturdy configuration that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to cantilevered struts used to support the commissures of the leaflet structure. This configuration enables a reduction in the thickness of the frame wall to achieve a smaller wrinkle diameter for the prosthetic valve. In a specific embodiment, the thickness T of the frame 12 measured between the inner diameter and the outer diameter is Figure 4 ) is about 0.48 mm or less.

[0050] 30 and 31. The struts and frame portions of the frame together define a plurality of open cells of the frame. At the inflow end of the frame 12, struts 22, 24, and 34 define a lower row of cells that define openings 36. The second, third, and fourth rows of struts 24, 26, and 28 define two intermediate rows of cells that define openings 38. The fourth and fifth rows of struts 28 and 32, together with the frame portion 30 and strut 31, define an upper row of cells that define openings 40. Openings 40 are relatively large and are sized to allow portions of the leaflet structure 14 to extend or protrude into and / or through openings 40 when the frame 12 is crimped to minimize the crimp profile.

[0051] like Figure 7 As best shown in FIG, the lower end of strut 31 is connected to two struts 28 at a node or junction 44, while the upper end of strut 31 is connected to two struts 32 at a node or junction 46. The thickness S1 of strut 31 may be less than the thickness S2 of junctions 44, 46. Junctions 44, 46, along with junction 64, prevent opening 40 from fully closing. Figure 13 The prosthetic valve 10 is shown crimped onto a balloon catheter. As can be seen, in the collapsed configuration, the geometry of struts 31 and joints 44, 46, and 64 help create sufficient space in opening 40 to allow portions of the prosthetic leaflets to protrude or bulge outward through the opening. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if all the leaflet material were confined within the crimped frame.

[0052] The frame 12 is configured to reduce, prevent, or minimize potential over-expansion of the prosthetic valve at a predetermined balloon pressure, particularly at the outflow end portion of the frame supporting the leaflet structure 14. In one aspect, the frame is configured to have relatively large angles 42a, 42b, 42c, 42d, 42e between the struts, such as Figure 5 As shown. The larger the angle, the greater the force required to open (expand) the frame. Therefore, the angles between the struts of the frame can be selected to limit radial expansion of the frame at a given opening pressure (e.g., the inflation pressure of the balloon). In specific embodiments, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more specifically, these angles are up to about 120 degrees when the frame is expanded to its functional size.

[0053] Additionally, due to the "dog-boning" effect of the balloon used to expand the prosthetic valve, the inflow and outflow ends of the frame generally tend to over-expand more than the middle portion of the frame. To prevent over-expansion of the leaflet structure 14, the leaflet structure is desirably secured to the frame 12 below the upper row of struts 32, such as Figure 1Thus, in the event that the outflow end of the frame over-expands, the leaflet structure is positioned at a level below where over-expansion may occur, thereby protecting the leaflet structure from over-expansion.

[0054] In one type of prosthetic valve configuration, if the leaflets are attached too close to the distal end of the frame, portions of the leaflets extend longitudinally beyond the outflow end of the frame when the prosthetic valve is crimped. If the delivery catheter on which the crimped prosthetic valve is mounted includes a pushing mechanism or stop element that pushes against or adjacent the outflow end of the prosthetic valve (e.g., to maintain the position of the crimped prosthetic valve on the delivery catheter), the pushing mechanism or stop element may damage the portion of the exposed leaflets that extends beyond the outflow end of the frame. Another benefit of attaching the leaflets at a location spaced from the outflow end of the frame is that when the prosthetic valve is crimped on the delivery catheter, the outflow end of the frame 12, rather than the leaflets 41, is the most proximal component of the prosthetic valve 10. Therefore, if the delivery catheter includes a pushing mechanism or stop element that pushes against or adjacent the outflow end of the prosthetic valve, the pushing mechanism or stop element contacts the outflow end of the frame and does not contact the leaflets 41, thereby avoiding damage to the leaflets.

[0055] In addition, if Figure 5 18. As can be seen in the figure, the openings 36 in the lowermost row of openings in the frame are relatively larger than the openings 38 in the two middle rows of openings. This allows the frame to assume an overall conical shape when crimped, which tapers from a maximum diameter at the outflow end of the prosthetic valve to a minimum diameter at the inflow end of the prosthetic valve. When crimped, the frame 12 may have a region of reduced diameter extending along the portion of the frame adjacent the inflow end of the frame, the region of reduced diameter generally corresponding to the region of the frame covered by the outer skirt 18. In some embodiments, the diameter of the region of reduced diameter is reduced compared to the diameter of the upper portion of the frame (which is not covered by the outer skirt) so that the outer skirt 18 does not increase the overall crimped profile of the prosthetic valve. When the prosthetic valve is deployed, the frame may expand to Figure 4 The generally cylindrical shape shown. In one example, the frame of a 26-mm prosthetic valve, when crimped, has a first diameter of 14 French at the outflow end of the prosthetic valve and a second diameter of 12 French at the inflow end of the prosthetic valve.

[0056] The primary function of the inner skirt 16 is to help secure the valve structure 14 to the frame 12 and to help form a good seal between the prosthetic valve and the native annulus by preventing blood flow through the open cells of the frame 12 below the lower edge of the leaflets. Although various other synthetic materials or natural materials (e.g., pericardial tissue) may be used, the inner skirt 16 desirably comprises a tough, tear-resistant material, such as polyethylene terephthalate (PET). The thickness of the skirt is desirably less than about 0.15 mm (about 6 mils), and desirably less than about 0.1 mm (about 4 mils), and even more desirably about 0.05 mm (about 2 mils). In a specific embodiment, the skirt 16 may have a variable thickness, for example, the skirt may be thicker at at least one of its edges than at its center. In one embodiment, the skirt 16 may comprise a PET skirt having a thickness of about 0.07 mm at its edges and a thickness of about 0.06 mm at its center. A thinner skirt may provide better crimping performance while still providing a good seal.

[0057] The skirt 16 may be secured to the interior of the frame 12 via stitching 70, such as Figure 21 The valve structure 14 can be attached to the skirt via one or more reinforcing strips 72 (which collectively can form a sleeve), such as thin PET reinforcing strips discussed below, which can secure the sutures and protect the pericardial tissue of the leaflet structure from tearing. The valve structure 14 can be sandwiched between the skirt 16 and the thin PET strips 72, as discussed below. Figure 20 The sutures 154 securing the PET strips and leaflet structure 14 to the skirt 16 may be any suitable suture, such as Ethibond PET suture (Johnson & Johnson, New Brunswick, New Jersey). The suture 154 desirably tracks the curvature of the bottom edge of the leaflet structure 14, as described in more detail below.

[0058] Some fabric skirts consist of a weave of warp and weft fibers that extend perpendicularly to one another, with one set of fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which such a fabric skirt is affixed is radially compressed, the overall axial length of the frame increases. However, the fabric skirt, with its limited elasticity, cannot extend with the frame and therefore tends to deform the frame's struts and prevent uniform wrinkling.

[0059] refer to Figure 12In one embodiment, the skirt 16 is desirably woven from a first set of fibers or yarns or strands 78 and a second set of fibers or yarns or strands 80, neither of which is perpendicular to the upper edge 82 and lower edge 84 of the skirt. In a specific embodiment, the first set of fibers 78 and the second set of fibers 80 extend at an angle of approximately 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the upper and lower edges 82, 84. For example, the skirt 16 can be formed by weaving the fibers at a 45 degree angle relative to the upper and lower edges of the fabric. Alternatively, the skirt 16 can be cut diagonally (offset cut) from a vertically woven fabric (where the fibers extend perpendicular to the edges of the material) so that the fibers extend at a 45 degree angle relative to the cut upper and lower edges of the skirt. Figure 12 As further shown, the opposing short edges 86, 88 of the skirt are desirably not perpendicular to the upper and lower edges 82, 84. For example, the short edges 86, 88 desirably extend at an angle of approximately 45 degrees relative to the upper and lower edges, thereby being aligned with the first group of fibers 78. Thus, the overall general shape of the skirt can be that of a rhombus or a parallelogram.

[0060] Figure 14 and 15 The inner skirt 16 is shown after the opposing short edge portions 90, 92 have been sewn together to form the annular shape of the skirt. As shown, the edge portion 90 can be placed in an overlapping relationship relative to the opposing edge portion 92, and the two edge portions can be sewn together with a stitching line 94 extending diagonally parallel to the short edges 86, 88. The upper edge portion of the inner skirt 16 can be formed with a plurality of protrusions 96 defining a wavy shape that generally follows the shape or contour of the fourth row of struts 28 adjacent the lower ends of the axial struts 31. In this manner, as Figure 16 As best shown in FIG, the upper edge of the inner skirt 16 can be tightly secured to the struts 28 with sutures 70. The inner skirt 16 can also be formed with slits 98 to facilitate attachment of the skirt to the frame. The slits 98 can be sized to allow the upper edge portion of the inner skirt 16 to partially wrap around the struts 28 and allow for stress reduction in the skirt during the attachment procedure. For example, in the illustrated embodiment, the inner skirt 16 is placed inside the frame 12 and the upper edge portion of the skirt is wrapped around the upper surface of the struts 28 and secured in place with sutures 70. Wrapping the upper edge portion of the inner skirt 16 around the struts 28 in this manner provides a more secure and durable attachment of the skirt to the frame. The inner skirt 16 can also be secured to the first, second, and / or third rows of struts 22, 24, and 26, respectively, with sutures 70.

[0061] Reference again Figure 12Because the fibers are oriented at an angle relative to the upper and lower edges in this embodiment, the skirt can undergo greater elongation in the axial direction (ie, in the direction from the upper edge 82 to the lower edge 84).

[0062] Therefore, when the metal frame 12 is wrinkled (eg Figure 13 (as shown), the inner skirt 16 can extend in the axial direction along with the frame, thereby providing a more uniform and predictable crimping profile. Each cell of the metal frame in the exemplary embodiment includes at least four angled struts that rotate in the axial direction when crimped (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each cell act as a mechanism to rotate the fibers of the skirt in the same direction as the struts, thereby allowing the skirt to extend along the length of the struts. This allows for greater elongation of the skirt when the prosthetic valve is crimped and avoids undesirable deformation of the struts.

[0063] In addition, the spacing between the braided fibers or yarns can be increased to promote the skirt to elongate in the axial direction. For example, for a PET inner skirt 16 formed of 20-denier yarn, the yarn density can be about 15% to about 30% lower than a typical PET skirt. In some instances, the yarn spacing of the inner skirt 16 can be about 60 yarns / cm (about 155 yarns / inch) to about 70 yarns / cm (about 180 yarns / inch), such as about 63 yarns / cm (about 160 yarns / inch), while in a typical PET skirt, the yarn spacing can be about 85 yarns / cm (about 217 yarns / inch) to about 97 yarns / cm (about 247 yarns / inch). The inclined edges 86, 88 promote uniform and uniform distribution of the fabric material along the inner circumference of the frame during creasing to promote uniform creasing to the smallest possible diameter. Additionally, cutting the diagonal suture in a perpendicular manner may leave loose fringes along the cut edge. The beveled edges 86, 88 help minimize this from happening.

[0064] In an alternative embodiment, the skirt can be formed from a woven elastic fabric that can stretch in the axial direction during crimping of the prosthetic valve. The warp and weft fibers can extend perpendicularly and parallel to the upper and lower edges of the skirt, or alternatively, as described above, they can extend at an angle between 0 and 90 degrees relative to the upper and lower edges of the skirt.

[0065] The inner skirt 16 can be sewn to the frame 12 at a position away from the suture line 154 so that the skirt can be more flexible in this area. This configuration can avoid stress concentration at the suture line 154 that attaches the lower edge of the leaflet to the inner skirt 16.

[0066] As described above, the leaflet structure 14 in the illustrated embodiment includes three flexible leaflets 41 (although a greater or lesser number of leaflets may be used). Additional information regarding leaflets and other information regarding skirt materials can be found, for example, in U.S. Patent Application No. 14 / 704,861, filed May 5, 2015.

[0067] The leaflets 41 may be secured to one another at their adjacent sides to form commissures 122 of the leaflet structure. A plurality of flexible connectors 124 (one of which is shown in FIG. Figure 17 ) can be used to connect pairs of adjacent sides of the leaflets to each other and to connect the leaflets to the commissure window frame portion 30 ( Figure 5 ).

[0068] Figure 17 The adjacent sides of two leaflets 41 are shown connected to each other by a flexible connector 124. Three flexible connectors 124 can be used to fix the three leaflets 41 side to side with each other, such as Figure 18 Additional information regarding connecting the leaflets to each other and to the frame can be found, for example, in US Patent Application Publication No. 2012 / 0123529.

[0069] As described above, the inner skirt 16 can be used to assist in suturing the leaflet structure 14 to the frame. The inner skirt 16 can have a wavy, temporary marker suture to guide the attachment of the lower edge of each leaflet 41. Before the leaflet structure 14 is secured to the skirt 16, the inner skirt 16 itself can be sutured to the struts of the frame 12 using sutures 70, as described above. The struts that intersect with the marker sutures are desirably not attached to the inner skirt 16. This allows the inner skirt 16 to be more flexible in areas that are not secured to the frame and minimizes stress concentrations along the sutures that sew the lower edges of the leaflets to the skirt. As described above, when the skirt is secured to the frame, the fibers 78, 80 of the skirt (see Figure 12 ) are generally aligned with the angled struts of the frame to promote uniform creasing and expansion of the frame.

[0070] Figure 19 One particular method for securing the commissures 122 of the leaflet structure 14 to the commissure window frame portion 30 of the frame is shown. In this method, the flexible connectors 124 ( Figure 18) are folded transversely and the upper tab portions 112 are folded downwardly against the flexible connectors. Each upper tab portion 112 is bent longitudinally (vertically) to form an L-shape having a first portion 142 folded against the surface of the leaflet and a second portion 144 folded against the connector 124. The second portion 144 can then be sutured to the connector 124 along suture lines 146. Next, the commissure tab assembly is inserted through the commissure windows 20 of the corresponding window frame portion 30, and the folds on the outside of the window frame portion 30 can be sutured to the portions 144.

[0071] Figure 19 Also shown is a downwardly folded upper tab portion 112 that can form a double layer of leaflet material at the commissures. An inner portion 142 of the upper tab portion 112 is positioned flat against the layers of the two leaflets 41 that form the commissures, such that each commissure includes four layers of leaflet material just inside the window frame 30. This four-layer portion of the commissure is more resistant to bending or articulating than the portion of the leaflet 41 just radially inward from the relatively rigid four-layer portion. This causes the leaflets 41 to articulate primarily at the inner edges 143 of the downwardly folded inner portion 142 in response to blood flowing through the prosthetic valve during in vivo operation, as opposed to articulating around or proximal to the axial struts of the window frame 30. Because the leaflets articulate at a location spaced radially inward from the window frame 30, they are protected from contact with and damage by the frame. However, under high forces, the four-layered portion of the commissure can splay apart about the longitudinal axis adjacent to the window frame 30, with each first portion 142 folding outward against its respective second portion 144. This can occur, for example, when the prosthetic valve 10 is compressed and mounted on a delivery shaft, thereby allowing for a smaller wrinkle diameter. When the balloon catheter is inflated during prosthetic valve expansion, the four-layered portion of the commissure can also splay apart about the longitudinal axis, which can relieve some of the pressure on the commissure caused by the balloon, thereby reducing potential damage to the commissure during expansion.

[0072] After all three commissure tab assemblies have been secured to their respective window frame portions 30, the lower edges of the leaflets 41 between the commissure tab assemblies can be sewn to the inner skirt 16. For example, Figure 20 As shown, each leaflet 41 can be made of, for example, Ethibond The PET thread is sewn to the inner skirt 16 along stitching lines 154. The stitching lines can be in-and-out stitching lines that extend through each leaflet 41, the inner skirt 16, and each reinforcement strip 72. Each leaflet 41 and its respective reinforcement strip 72 can be sewn individually to the inner skirt 16. In this way, the lower edge of the leaflet is secured to the frame 12 via the inner skirt 16. Figure 20As shown, the leaflets can be further secured to the skirt by blanket sutures 156 extending through each reinforcement strip 72, the leaflets 41, and the inner skirt 16 while encircling the edges of both the reinforcement strip 72 and the leaflets 41. The blanket sutures 156 can be formed from a PTFE suture material. Figure 21 A side view of the frame 12 , leaflet structure 14 , and inner skirt 16 is shown after securing the leaflet structure 14 and inner skirt 16 to the frame 12 and securing the leaflet structure 14 to the inner skirt 16 .

[0073] Figure 22 Another exemplary prosthetic heart valve 210 is shown in an expanded configuration (eg, when implanted in a patient). Figure 22 The prosthetic heart valve 210 includes: Figure 1-5 The frame 212 is similar in structure to the frame 12, and has Figure 1-3 A valve structure (not shown) having a similar structure to the valve structure 14 of Figure 1-3 An inner skirt 216 similarly constructed as the inner skirt 16 of FIG. 1 , and a sealing element 250 discussed in more detail below. Figure 23 Shows Figure 22 A flattened view of a portion of the frame 212 and the sealing element 250.

[0074] refer to Figure 22 and 23, the frame 212 has an inflow end 215 and an outflow end 219. The frame 212 in the exemplary embodiment includes a first lower row I of angled struts 222a and 222b arranged end-to-end and extending circumferentially at the inflow end 215 of the frame 212; a second row II of circumferentially extending angled struts 224a and 224b; a third row III of circumferentially extending angled struts 226a and 226b; a fourth row IV of circumferentially extending angled struts 228a and 228b; and a fifth row V of circumferentially extending angled struts 232a and 232b at the outflow end 219 of the frame 212. A plurality of substantially straight, axially extending struts 234 may be used to interconnect the struts 222a and 222b of the first row I with the struts 224 of the second row II. The angled struts 232a and 232b of the fifth row (V) are connected to the angled struts 228a and 228b of the fourth row (IV) via a plurality of axially extending window frame portions 230 and a plurality of axially extending struts 231. Each axial strut 231 and each frame portion 230 extends from a position defined by the convergence of the lower ends of the two angled struts 232a and 232b to another position defined by the convergence of the upper ends of the two angled struts 228a and 228b. The angled struts 222a, 224a, 226a, 228a, and 232a are oriented at a first angle relative to the frame 212, while the angled struts 222b, 224b, 226b, 2228b, and 232b are oriented at a second angle relative to the frame 212.

[0075] The struts and frame portions of frame 212 collectively define a plurality of open cells of frame 212. At the inflow end 215 of frame 212, struts 222, 224, and 234 define a lower row A of cells, which define openings 236. The second and third rows of struts 224, 226 define a first intermediate row B of cells, which define openings 238. The third and fourth rows of struts 226, 228 define a second intermediate row C of cells, which define openings 239. The fourth and fifth rows of struts 228 and 232, together with frame portion 230 and strut 231, define an upper row D of cells, which define openings 240.

[0076] The prosthetic heart valve 210 further includes a plurality of sealing elements 250 secured to the frame 212. The sealing elements 250 can be laser cut or otherwise formed from a strong, durable material (e.g., PET, PTFE, ePTFE, polyurethane, polyester, fabric material, or various other suitable synthetic or natural materials) configured to limit and / or prevent blood flow therethrough and having a textured surface or otherwise providing a high micro-surface area. The sealing elements 250 can be formed into a square or rectangular shape. Alternatively, the sealing elements 250 can be formed into any geometric shape. Some of the plurality of sealing elements 250 can have a shape different from that of other sealing elements 250.

[0077] The sealing element 250 may be secured to the frame 212 within the openings of individual cells of the frame 212. The sealing element 250 may be secured to the frame 212 in a tiled pattern, wherein the sealing element 250 may be secured to the frame 212 in the openings of multiple cells around the frame 212. Figure 22 and 23 In the illustrated example, the sealing element 250 is secured to the frame 212 in the openings 236 and 238 in the A-row cells and the B-row cells. In other examples, the sealing element 250 may be secured to the frame 212 in the openings 239 or 240 in the C-row cells or the D-row cells, or in any combination of the openings 236, 238, 239, and / or 240. Figure 22 and 23 In the illustrated example, sealing element 250 is secured to frame 212 in each opening 236 in cells of row A and each opening 238 in cells of row B. Alternatively, sealing element 250 may be secured to frame 212 in some, but not all, of openings 236, 238, 239, and / or 240 in cells of rows A, B, C, and D, respectively.

[0078] The sealing element 250 may be fixed to the frame 212 such that two opposite sides of the sealing element 250 are fixed to the frame 212, while the other two opposite sides of the sealing element 250 are not fixed to the frame 212. The two opposite sides of the sealing element 250 fixed to the frame 212 may each be fixed to a different support of the frame 212. Figure 22 and 23 In the illustrated example, the sealing elements 250 in the cells of row A are secured to struts 222 and 224. The sealing elements 250 in the cells of row B are secured to struts 224 and 226. Alternatively, or in addition, the sealing elements 250 may be secured to struts 228 and / or struts 232. In other examples, the sealing elements 250 may be secured to axially straight struts 234 and / or axial struts 231. In the illustrated example, each sealing element 250 is secured to the frame 212 within the opening of a cell. Alternatively, the sealing elements may span multiple cells. For example, one side of the sealing element may be secured to the angled strut 226 and the opposite side of the sealing element may be secured to the angled strut 222, such that the sealing element spans two adjacent cells, one cell in row A and one cell in row B. Furthermore, the sealing elements 250 may be formed from individual pieces of material sized to cover a single cell, or from one or more pieces of material sized to be attached to multiple cells. In the illustrated example, sealing element 250 can be secured to frame 212 using sutures. Alternatively, sealing element 250 can be secured to frame 212 using adhesive, ultrasonic welding, or other means in addition to or in lieu of sutures.

[0079] exist Figure 22 and 23 In an exemplary embodiment of the present invention, the length of each of the sealing elements 250 is greater than the distance between the struts to which the sealing elements 250 are secured. That is, the sealing elements 250 are not tautly secured to the frame 212, but rather there is excess material in each of the cells of the frame 212 that contain the sealing elements 250. Thus, when the prosthetic heart valve 210 is implanted in the patient's valve, the openings form channels or pathways in which any antegrade blood flow along the exterior of the frame 212 is exposed to more surface area of ​​material, causing the blood flow to slow and induce clotting. The excess material of the sealing elements 250 can also expand away from the frame 212 to help seal any gaps between the prosthetic heart valve 210 and the native anatomy.

[0080] The sealing element 250 can be secured to the frame 212 in one of two orientations, a clockwise orientation or a counterclockwise orientation as defined herein. Figure 22 In the illustrated example, each of the sealing elements 250 is secured to the frame 212 in a clockwise orientation. Figure 24 In the example of the embodiment shown, each of the sealing elements 250 is secured to the frame 212 in a counterclockwise orientation. Figure 22 In the clockwise orientation shown in the example of FIG2 , the sealing elements 250 in the A row cells are secured to the frame 212 at struts 222a and 224a, while the sealing elements 250 in the B row cells are secured to the frame 212 at struts 224a and 226a. This creates a diagonal path along the exterior of the frame 212 in direction 260 along which antegrade blood will be forced by the sealing elements 250. As antegrade blood flows between the frame 212 and the sealing elements 250 in direction 260, the blood travels in a clockwise direction around the frame 212 with respect to the circular cross-section through the frame 212.

[0081] exist Figure 23In the counterclockwise orientation shown, each of the sealing elements 250 in the A row cells is secured to the frame 212 at struts 222b and 224b, while each of the sealing elements 250 in the B row cells is secured to the frame 212 at struts 224b and 226b. This creates a diagonal path along the exterior of the frame 212 in direction 270, along which antegrade blood will be forced by the sealing elements 250 to travel. As antegrade blood flows between the frame 212 and the sealing elements 250 in direction 270, the blood travels in a counterclockwise direction around the frame 212 with respect to the circular cross-section through the frame 212. As described above, by forcing the antegrade blood to flow along a diagonal path about the frame 212, the blood is exposed to more surface area of ​​the sealing elements 250, which can slow the flow of the antegrade blood and induce clotting, which can help seal any gaps between the prosthetic heart valve 210 and the native anatomy. Sealing elements 250 thus cooperate with inner skirt 216 to prevent paravalvular leakage after implantation of prosthetic valve 210. In several embodiments, prosthetic valve 210 can have reduced paravalvular leakage when implanted in a subject, compared to a similar prosthetic valve lacking sealing elements 250.

[0082] Figure 24 Another exemplary prosthetic heart valve 310 is shown in an expanded configuration (eg, when implanted in a patient). Figure 24 The prosthetic heart valve 310 includes: Figure 1-5 The frame 312 is similar in structure to the frame 212 of FIG. Figure 1-3 The valve structure 314 is similar in structure to the valve structure 14, and has Figure 1-3 The inner skirt 316 is similar in structure to the inner skirt 16 of Figure 22-23 The sealing element 250 is similarly constructed as are the sealing elements 350 and 352 . Figure 25 Shows Figure 24 A flattened view of portions of the frame 312 and sealing elements 350 , 352 .

[0083] The components of prosthetic heart valve 310 are identical to those of prosthetic heart valve 210, except that sealing element 350 is secured to frame 312 in a different orientation than sealing element 352, whereas all sealing elements 250 are secured to frame 210 in the same orientation. Figure 24 and 25, the frame 312 has an inflow end 315 and an outflow end 319. The frame 312 in the illustrated embodiment includes a first lower row I of angled struts 322a and 322b arranged end-to-end and extending circumferentially at the inflow end 315 of the frame 312; a second row II of circumferentially extending angled struts 324a and 324b; a third row III of circumferentially extending angled struts 326a and 326b; a fourth row IV of circumferentially extending angled struts 328a and 328b; and a fifth row V of circumferentially extending angled struts 332a and 332b at the outflow end 319 of the frame 312. A plurality of substantially straight, axially extending struts 334 may be used to interconnect the struts 322a and 322b of the first row I with the struts 324 of the second row II. The angled struts 332a and 332b of the fifth row (V) are connected to the angled struts 328a and 328b of the fourth row (IV) via a plurality of axially extending window frame portions 330 and a plurality of axially extending struts 331. Each axial strut 331 and each frame portion 330 extends from a position defined by the convergence of the lower ends of the two angled struts 332a and 332b to another position defined by the convergence of the upper ends of the two angled struts 328a and 328b. Angled struts 322a, 324a, 326a, 328a, and 332a are oriented at a first angle relative to the frame 312, while angled struts 322b, 324b, 326b, 3228b, and 332b are oriented at a second angle relative to the frame 312.

[0084] The struts and frame portions of frame 312 collectively define a plurality of open cells of frame 312. At the inflow end 315 of frame 312, struts 322, 324, and 334 define a lower row A of cells, which define openings 336. The second and third rows of struts 324, 326 define a first intermediate row B of cells, which define openings 338. The third and fourth rows of struts 326, 328 define a second intermediate row C of cells, which define openings 339. The fourth and fifth rows of struts 328 and 332, together with frame portion 330 and strut 331, define an upper row D of cells, which define openings 340.

[0085] The sealing elements 350, 352 are similar in construction to Figure 22-23 The sealing element 250 is similar to the sealing element 250 of FIG. 31 and can be secured to the frame 312 in a similar manner as the sealing element 250 is secured to the frame 212. Figure 24 and 25In the illustrated example, sealing element 350 is secured to frame 312 in opening 336 in cells of row A, while sealing element 352 is secured to frame 312 in cells of row B. In other examples, sealing elements may be secured to frame 312 in opening 339 or opening 340 in cells of row C or row D, or in any combination of openings 336, 338, 339, and / or 340. Figure 24 and 25 In the illustrated example, sealing element 350 is secured to frame 312 in each opening 336 of cells in row A, while sealing element 352 is secured to frame 312 in each opening 338 of cells in row B. Alternatively, sealing elements 350, 352 may be secured to frame 312 in some, but not all, of openings 336, 338, 339, and / or 340 of cells in rows A, B, C, and / or D, respectively.

[0086] exist Figures 24-25 In the example of the example, as above combined Figure 22-23 As depicted, the sealing elements 350 in the A row cells are secured to the frame 312 in a clockwise orientation, while the sealing elements 352 in the B row cells are secured to the frame 312 in a counterclockwise orientation. That is, the sealing elements 350 in the A row cells are secured to the frame 312 at struts 322a and 324a, thereby creating a path along direction 360 through which antegrade blood can flow between the frame 312 and the sealing elements 350 in the openings 336 in the A row cells. The sealing elements 352 in the B row cells are secured to the frame 312 at struts 324b and 326b. This creates a path along direction 370 through which antegrade blood can flow between the frame 312 and the sealing elements 352 in the openings 338 in the B row cells. Because the sealing elements 350 in the A row cells are secured to the frame 312 in a different orientation than the sealing elements 352 in the B row cells, the route of antegrade blood flow between the frame 312 and the sealing elements 350, 352 is necessarily shorter than in FIG. Figure 22-23 The prosthetic valve 310 is more circuitous in the example of , which can further slow this antegrade blood flow and can further improve blood clotting, which can help seal any gaps between the prosthetic heart valve 310 and the native anatomy when the prosthetic heart valve 310 is implanted in the patient. The plurality of sealing elements 350, 352 thus cooperate with the inner skirt 316 to avoid paravalvular leakage after the prosthetic valve 310 is implanted. In several embodiments, the prosthetic valve 310 can have reduced paravalvular leakage when implanted in a subject compared to a similar prosthetic valve lacking the plurality of sealing elements 350, 352. In other examples, the sealing elements 350, 352 can be secured to the frame 312 in a clockwise orientation or a counterclockwise orientation.

[0087] The prosthetic valve 210 or 310 can be configured and mounted on a suitable delivery device for implantation in a subject. Several catheter-based delivery devices can be used; non-limiting examples of suitable catheter-based delivery devices include those disclosed in U.S. Patent Application Publication Nos. 2013 / 0030519 and 2012 / 0123529.

[0088] To implant the plastically expandable prosthetic valve 210 or 310 into a patient, the prosthetic valve 210, 310 may be crimped onto the elongated shaft 180 of a delivery device, such as a Figure 13 . The prosthetic valve and delivery device together can form a delivery assembly for implanting the prosthetic valve 210, 310 into a patient's body. Shaft 180 includes an inflatable balloon 182 for expanding the prosthetic valve in vivo. With balloon 182 deflated, the prosthetic valve 210, 310 can be delivered percutaneously to a desired implantation location (e.g., the native aortic valve region). Once the prosthetic valve 210, 310 is delivered to the implantation site in the body (e.g., the native aortic valve), the prosthetic valve 210, 310 can be radially expanded to its functional state by inflating balloon 182.

[0089] Alternatively, the self-expanding prosthetic valve 210, 310 can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by inserting the prosthetic valve 210, 310 into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve 210, 310 can then be delivered percutaneously to the desired implantation site. Once in the body, the prosthetic valve 210, 310 can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional state.

[0090] Figures 26-28 31 show various implantation positions of a prosthetic heart valve 210 or 310, including implantation within a docking member or anchor member placed within the patient prior to valve implantation. For illustrative purposes, Figures 26-28 Each shows the implantation of a prosthetic heart valve 210. However, it should be understood that Figures 26-28 In each of these, prosthetic heart valve 210 may be replaced with prosthetic heart valve 310 . Figure 26 A prosthetic heart valve 210 is shown implanted in a patient's native aortic valve.

[0091] Figure 27Shown is a prosthetic heart valve 210 implanted in a patient's pulmonary artery, for replacing or enhancing the function of a diseased pulmonary valve. Due to the variation in size and shape of the natural pulmonary valve and the pulmonary artery, the prosthetic valve 210 can be implanted in a radially expandable outer docking device 400. The docking device 400 can comprise a radially expandable and compressible annular stent 402, and a sealing element 404 that covers all or part of the stent and can extend across the inner and / or outer surfaces of the stent. The docking device 400 is configured to engage the inner wall of the pulmonary artery and can adapt to the variation of the patient's anatomical structure. The expanded prosthetic heart valve 410 is much smaller than the blood vessel in which it is placed, and the docking device 400 can also compensate for the expanded prosthetic heart valve 410. The docking device 400 can also be used to support a prosthetic valve in other regions of the patient's anatomical structure (such as the inferior vena cava, superior vena cava, or aorta). Further details of the docking device 400 and methods for implanting the docking device and prosthetic valve are disclosed, for example, in co-pending U.S. application Ser. No. 15 / 422,354, filed on Feb. 1, 2017.

[0092] Figure 28 A prosthetic heart valve 210 is shown implanted in a patient's native mitral valve using a docking device in the form of a helical anchor 500. The helical anchor 500 may include one or more coils 502 deployed in the left atrium and one or more coils 504 deployed in the left ventricle and radially outward of the native mitral valve leaflets 506. When the prosthetic valve 210 is deployed within the native valve, the native leaflets are compressed or clamped between the prosthetic valve 210 and the anchor 500 to hold the prosthetic valve in place. Further details of the helical anchor 500 and methods for implanting the anchor and prosthetic valve are disclosed, for example, in co-pending U.S. application Ser. No. 62 / 395,940, filed Sep. 16, 2016.

[0093] Figure 29 and 30 A docking device 600 for a prosthetic heart valve according to another embodiment is shown. The docking device 600 may include a radially expandable and compressible frame 602 having an outer portion 604, an inner portion 606 coaxially disposed within one end of the outer portion 604, and a curvilinear transition portion 608 extending between and connecting the inner portion 606 and the outer portion 604. The docking device 600 may further include a sealing element 610 extending on an inner surface of the inner portion 606, a portion of an outer surface of the outer portion 604 adjacent to the inner portion 606, and the transition portion 608.

[0094] Figure 31A docking device 600 is shown implanted in a blood vessel 620 (which can be, for example, the inferior vena cava, the superior vena cava, or the ascending aorta). As shown, the prosthetic valve 210 can be deployed within the inner portion 606 of the docking device 600. Similar to the docking device 400, the expanded prosthetic heart valve 210 is much smaller than the blood vessel in which it is placed, and the docking device 600 can compensate for the expanded prosthetic heart valve 210. The docking device 600 is particularly suitable for implanting a prosthetic valve in the inferior vena cava to replace or enhance the function of the native tricuspid valve. Further details of the docking device 600 and methods for implanting the docking device and the prosthetic valve are disclosed, for example, in co-pending U.S. application No. 16 / 034,794 filed on July 13, 2018.

[0095] General considerations

[0096] It should be understood that the disclosed valves can be implanted in any of the heart's native valve annuli (e.g., the pulmonary, mitral, and tricuspid annuli) and can be used with any of a variety of approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The disclosed prostheses can also be implanted in other cavities of the body.

[0097] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure, both individually and in various combinations and subcombinations with one another, is directed to all novel and non-obvious features and aspects of the various disclosed embodiments. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more specific advantages or the resolution of any one or more problems.

[0098] Although certain operations in the disclosed embodiments are described in a particular sequential order for ease of presentation, it should be understood that unless specific language listed below requires a particular order, this description encompasses rearrangement. For example, in some cases, operations described sequentially may be rearranged or performed simultaneously. Furthermore, for the sake of brevity, the accompanying figures may not illustrate the various ways in which the disclosed methods can be used in conjunction with other methods.

[0099] As used in this application and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including."

[0100] As used herein, the term "and / or" used between the last two listed elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0101] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further away from the implant site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further away from the user and closer to the implant site. Thus, for example, the proximal motion of a device is the motion of the device toward the user, while the distal motion of the device is the motion of the device away from the user. Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to the axis extending in the proximal and distal directions.

[0102] As used herein, the terms “coupled” and “associated” generally mean physically coupled or connected and do not exclude the presence of intervening elements between the coupled or associated items in the absence of specific language to the contrary.

[0103] As used herein, in the absence of specific language to the contrary, operations occurring "simultaneously" or "concurrently" generally occur at the same time as one another, although a delay in the occurrence of one operation relative to another operation due to, for example, spacing, gaps, or backlash between mechanical connections (such as threads, gears, etc.) is clearly within the scope of the above terms.

[0104] In view of the many possible embodiments to which the principles disclosed herein may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure, which is rather at least as broad as the scope of the appended claims.

Claims

1. An implantable prosthetic valve comprising: an annular frame comprising an inflow end, an outflow end, and a plurality of struts forming a plurality of cells, wherein each of the cells defines an opening in the frame, and wherein the frame is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; a leaflet structure positioned within and secured to the frame; and a plurality of sealing elements secured to a plurality of legs of the frame, wherein each sealing element of the plurality of sealing elements comprises: radially inwardly facing surface; radially outward facing surface; a first set of two opposing sides; and the second set of two opposite sides; The first set of two opposing sides are fixed to the frame and the second set of two opposing sides are not fixed to the frame to create a diagonal path along the exterior of the annular frame, and antegrade blood will be forced to travel along the diagonal path by the multiple sealing elements.

2. The prosthetic valve of claim 1, wherein the plurality of sealing elements spans a plurality of cells.

3. The prosthetic valve of claim 2 , wherein the plurality of cells comprises a plurality of rows of cells, wherein the plurality of rows of cells comprises a first row of cells and a second row of cells, and wherein the first row of cells and the second row of cells each comprise a first inflow-end angled strut and a second outflow-end angled strut.

4. The prosthetic valve of claim 3, wherein the first set of two opposing sides are secured to the first inflow-end angled struts of the first row of cells and the second outflow-end angled struts of the second row of cells.

5. The prosthetic valve of claim 1 , wherein each sealing element has the same orientation with respect to the frame, and wherein the orientation is a diagonal orientation, wherein each sealing element extends diagonally on the frame.

6. A prosthetic valve according to claim 1, wherein a first group of the plurality of sealing elements each has a first orientation relative to the frame, and the remaining sealing elements of the plurality of sealing elements that are not in the first group each have a second orientation relative to the frame, the second orientation being different from the first orientation, wherein the first orientation and the second orientation are diagonal orientations.

7. The prosthetic valve of claim 6, wherein the first orientation is a clockwise orientation, and wherein the second orientation is a counterclockwise orientation.

8. The prosthetic valve of claim 1, further comprising an inner skirt disposed about an inner surface of the frame and secured to the frame.

9. The prosthetic valve of claim 8, wherein the inner skirt includes a lower edge disposed at the inflow end of the frame and an upper edge extending past the plurality of sealing elements toward the outflow end of the frame.

10. An implantable prosthetic valve comprising: an annular frame comprising an inflow end, an outflow end, and a plurality of rows of angled struts forming a plurality of cells, wherein each of the plurality of rows of angled struts comprises a plurality of struts arranged end to end and extending circumferentially around the frame, and wherein the frame is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; a leaflet structure positioned within and secured to the frame; and a plurality of sealing elements secured to the legs of the frame, wherein each sealing element of the plurality of sealing elements comprises: radially inwardly facing surface; radially outward facing surface; a first set of two opposing sides; and the second set of two opposite sides; wherein the first set of two opposing sides are secured to the frame and the second set of two opposing sides are not secured to the frame to create a diagonal path along the exterior of the annular frame along which antegrade blood will be forced by the plurality of sealing elements; and The length of each sealing element between the first set of two opposite sides is greater than the distance between the pillars to which the first set of two opposite sides are fixed.

11. The prosthetic valve of claim 10, wherein the plurality of sealing elements span a plurality of cells.

12. The prosthetic valve of claim 10, wherein the frame comprises a plurality of rows of cells, and wherein the plurality of cells spanned by the one or more sealing elements are part of different rows of the plurality of rows of cells.

13. An assembly for implanting a prosthetic heart valve, comprising: a delivery device comprising an elongated shaft; and A prosthetic heart valve according to any one of claims 1 to 12.

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