Pericardial sealing element for prosthetic heart valves

Abstract

The present application relates to pericardial sealing elements for prosthetic heart valves. In one embodiment, a delivery assembly may include an annular frame, a leaflet structure positioned within and secured to the frame, and an outer skirt positioned about an outer surface of the frame. The annular frame may include an inflow end and an outflow end, and may be radially contracted and expanded between a radially contracted configuration and a radially expanded configuration. The outer skirt may include pericardial tissue having a fibrous wall layer defining a first surface of the outer skirt and a serosal wall layer defining a second surface of the outer skirt. The outer skirt may be positioned such that the first surface faces away from the frame and the second surface faces the frame.

Description

[0001] This application is a divisional application. The application date of the original application is August 17, 2018, the application number is 201880058407.6, and the name of the invention is “Pericardial 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] 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

[0005] 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.

[0006] In one embodiment, an implantable prosthetic valve may include an annular frame, a leaflet structure positioned within the frame, and an outer skirt positioned around an outer surface of the frame. The annular frame may include an inflow end and an outflow end and may be radially crimped and expandable between a radially collapsed configuration and a radially expanded configuration. The outer skirt may include pericardial tissue having a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt. The outer skirt may be positioned such that the first surface faces away from the frame and the second surface faces the frame.

[0007] In some embodiments, the outer skirt can comprise bovine pericardial tissue.

[0008] In some embodiments, the outer skirt may be laser milled to reduce its thickness.

[0009] In some embodiments, the thickness of the outer skirt may be between 50 μm and 150 μm.

[0010] In some embodiments, the outer skirt may include a plurality of openings or slits.

[0011] In some embodiments, at least one of the openings or the slits may be elongated in an axial direction.

[0012] In some embodiments, the outer skirt may include an outflow edge portion and an inflow edge portion. The outflow edge portion may include a plurality of alternating projections and indentations, and the projections may be fixed to the frame, while the indentations may not be directly fixed to the frame.

[0013] In some embodiments, the prosthetic valve may further include a reinforcing strip wrapped around the inflow end of the frame such that a first end of the reinforcing strip extends at least partially along and is secured to an inner surface of the frame, and a second end of the reinforcing strip extends at least partially along and is secured to an outer surface of the outer skirt.

[0014] In some embodiments, the outer skirt may be secured to the frame with sutures.

[0015] In some embodiments, the prosthetic valve can further include an inner skirt positioned about and secured to the inner surface of the frame.

[0016] In some embodiments, the inner skirt may include an outflow edge portion secured to the frame and an inflow edge portion wrapped around an inflow end of the frame and an inflow end of the outer skirt. In such embodiments, the inflow end portion may extend at least partially along the outer surface of the outer skirt and may be secured to the outer surface of the outer skirt.

[0017] In some embodiments, the prosthetic valve can further include one or more strips positioned around and secured to the outer surface of the outer skirt.

[0018] In some embodiments, the strips may comprise a fabric material.

[0019] In another embodiment, a method of manufacturing a prosthetic heart valve may include: providing a piece of pericardial tissue comprising a fibrous wall layer and a serosal wall layer; reducing the thickness of the piece of pericardial tissue by removing a portion of the serosal wall layer; and positioning the pericardial tissue around an outer surface of a frame of a prosthetic heart valve and securing it to the outer surface of the frame of the prosthetic heart valve. The fibrous wall layer may define a first surface of the tissue, and the serosal wall layer may define a second surface of the tissue. The pericardial tissue may be positioned around the frame such that the first surface faces away from the frame and the second surface faces toward the frame.

[0020] In some embodiments, the thickness of the pericardial tissue can be between 50 μm and 100 μm.

[0021] In some embodiments, the act of reducing the thickness of the sheet of pericardial tissue can include laser milling the serosa.

[0022] In some embodiments, the method can further include forming a slit or opening in the sheet of pericardial tissue prior to positioning the sheet of pericardial tissue on the frame.

[0023] In some embodiments, the method can further include coupling a plurality of prosthetic leaflets to an interior portion of the frame.

[0024] In another embodiment, a method of implanting a prosthetic heart valve may include: inserting a distal portion of a delivery device and a prosthetic heart valve coupled to the distal portion of the delivery device into a patient; positioning the prosthetic heart valve adjacent to a natural valve of the patient's heart; and radially expanding the prosthetic heart valve. The prosthetic heart valve may include an annular frame, a leaflet structure positioned within and secured to the frame, and an outer skirt positioned around an outer surface of the frame. The annular frame may include an inflow end and an outflow end, and may be radially contracted and expanded between a radially contracted configuration and a radially expanded configuration. The outer skirt may include pericardial tissue having a fibrous wall layer defining an outer surface of the skirt and a serosal wall layer defining an inner surface of the skirt. The prosthetic heart valve may be expanded such that the fibrous wall layer may contact surrounding natural tissue.

[0025] In some embodiments, the outer skirt can include a plurality of slits or openings such that antegrade blood can flow through the slits or openings. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1-3 An exemplary embodiment of a prosthetic heart valve is shown.

[0027] Figure 4-10 Shows Figure 1 An exemplary frame for a prosthetic heart valve.

[0028] Figure 11-12 Shows Figure 1 An exemplary inner skirt of a prosthetic heart valve.

[0029] Figure 13 Shown in a collapsed configuration and mounted on an exemplary balloon catheter Figure 1 prosthetic heart valves.

[0030] Figure 14-16 Shows Figure 4 The framework and Figure 11 The inner skirt component.

[0031] Figure 17-18 Components of an exemplary leaflet structure are shown.

[0032] Figure 19 The assembly of the commissure portions of the leaflet structure with the window frame portion of the frame is shown.

[0033] Figure 20-21 The assembly of the leaflet structure along the lower edge of the leaflet and the inner skirt is shown.

[0034] Figure 22 A cross-sectional view of the pericardial tissue that forms the outer skirt is shown.

[0035] Figure 23 Shown by Figure 22 An exemplary outer skirt formed by pericardial tissue.

[0036] Figure 24 Shows the use Figure 23 An exemplary prosthetic heart valve with an outer skirt.

[0037] Figure 25 Shown by Figure 22 Another exemplary outer skirt is formed by pericardial tissue.

[0038] Figure 26 Shows the use Figure 25 Another exemplary prosthetic heart valve with an outer skirt.

[0039] Figures 27-29 Various cross-sectional views of exemplary embodiments of prosthetic heart valves are shown.

[0040] Figure 30 Another exemplary prosthetic heart valve is shown.

[0041] Figure 31 An exemplary prosthetic heart valve is shown implanted into a patient's native aortic valve.

[0042] Figure 32 An exemplary prosthetic heart valve and docking device are shown implanted in a patient's pulmonary artery.

[0043] Figure 33 An exemplary prosthetic heart valve and docking device are shown implanted into a patient's native mitral valve.

[0044] Figures 34-35 An alternative embodiment of a docking device for a prosthetic valve is shown.

[0045] Figure 36 The implantation into the patient's inferior vena cava is shown. Figures 34-35 An exemplary prosthetic heart valve and docking device. DETAILED DESCRIPTION

[0046] 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 (which may also be referred to as an outer sealing element).

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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 1 and 2. An enlarged view of the portion of the frame 12 identified by letters A, B, C, D and E in FIG.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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 leaflet that extends beyond the outflow end of the frame. Another benefit of attaching the leaflets at a position 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 member 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.

[0057] 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.

[0058] 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.

[0059] The skirt 16 may be secured to the interior of the frame 12 via sutures 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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).

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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 ).

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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 .

[0075] Figure 22 A cross-sectional view of a piece or section of pericardial tissue 200 is shown in an alternative embodiment that can be formed into an outer skirt. The pericardial tissue 200 can be bovine pericardium, porcine pericardium, equine pericardium, kangaroo pericardium, or pericardium from another source. The pericardial tissue 200 has a rough layer or fibrous layer 202 having a rough surface 206 on one side and a smooth layer 204 having a smooth surface 208 on an opposite side that is relatively smoother and less fibrous than the rough surface 206. The tissue 200 can be formed from a section of parietal pericardial membrane that includes a fibrous parietal layer (the outermost layer of the pericardium) forming the rough layer 202 and a serous parietal layer (the outer serous layer) forming the smooth layer 204.

[0076] Tissue 200 can be obtained and prepared for use in implants using those techniques and mechanisms known for processing pericardial tissue for heart valve leaflets. The process of preparing pericardial tissue for heart valve leaflets typically involves first obtaining a fresh pericardial sac from a source animal and then cutting the sac along predetermined anatomical landmarks to obtain the parietal pericardium. The parietal pericardium can be flattened and typically cleared of excess fat and other impurities. After trimming clearly unusable areas, a window or patch of tissue is typically fixed by cross-linking the tissue in aldehydes. The rough edges of the tissue block can be removed, and the tissue can be biosorted to produce tissue segments. The process of biosorting includes visually inspecting the unusable areas of the block and trimming segments therefrom. Further details about the process of processing pericardial tissue are disclosed in U.S. Patent Nos. 8,846,390 and 9,358,107.

[0077] exist Figure 22In an example embodiment, after the pericardial tissue is initially processed as described in the previous paragraph, the total thickness of the wall pericardium can be reduced by removing a portion of the smooth layer 204 of the pericardial tissue 200 (such as by using the laser 210 in a laser milling process) until the pericardial tissue has a desired thickness T. In some embodiments, the final thickness T after milling is between 50-150 μm, and more preferably between 100-150 μm, where 100 μm is a specific example. Optionally, the pericardial tissue 200 can be milled or otherwise formed to any other thickness T. After processing the tissue, the pericardial tissue 200 has a smooth layer 204, a rough layer 202, a thickness T, and can be formed to combine the following: Figure 23 and 26 The outer skirt in question.

[0078] In addition to the laser tissue removal described above, various mechanical devices for scraping or shaving tissue, such as razors or planing devices, can be used to remove certain tissues. For example, a device having a flat platen on which a planing razor or blade is translated can replace Figure 22 linear laser configuration. Other physical configurations for producing relative tissue / razor motion are contemplated, such as, for example, utilizing a lathe-like razor to smooth the outer surface of the tissue. Each of these devices may be automatically controlled or computer controlled using an optical surface measurement component to control the depth of cut. Although abrasive tissue removal (e.g., sanding or filing) may also be used, the grit of the tool should be relatively fine. In other embodiments, a dermatome may be used to scrape or shave a portion of the smooth tissue layer 204. Further details regarding the use of a dermatome for removing a portion of tissue from pericardial tissue are disclosed in U.S. Patent No. 8,846,390.

[0079] In alternative embodiments, instead of or in addition to removing a portion of the serosal parietal layer, the thickness of the pericardial tissue 200 may be reduced by removing a portion of the fibrous parietal layer using any of the techniques described above.

[0080] Figure 23-24 Shown by Figure 22 Various views of an exemplary outer skirt 300 formed from pericardial tissue 200. Figure 23 A flattened view of the outer skirt 300 is shown before it is attached to a prosthetic heart valve. Figure 24 The outer skirt 300 is shown attached to the prosthetic heart valve 10 .

[0081] refer to Figure 23 , the outer skirt 300 may include a first end portion 302 (ie, Figure 23The upper end portion depicted in FIG; in the exemplary embodiment, also the outflow end portion), the second end portion 304 (ie, Figure 23 304 ), and an intermediate portion 306 disposed between the first and second ends 302, 304. The first end 302 of the outer skirt 300 may include a plurality of alternating protrusions 308 and indentations 310, or castellations. In other embodiments, the first end 302 may be formed without any protrusions 308 or indentations 310 and, instead, may be substantially straight.

[0082] refer to Figure 24 , outer skirt 300 is attached to prosthetic heart valve 10. Tab 308 of first end portion 302 may be attached to inner skirt 16 and / or frame 12 of prosthetic heart valve 10 using sutures (as shown) and / or adhesive. Lower end portion 304 may be attached to inner skirt 16 and / or frame 12 of prosthetic heart valve 10 using sutures, adhesive, or any other suitable attachment means.

[0083] exist Figure 24 In the illustrated example, the outer skirt 300 is secured to the frame 12 with the rough surface 206 of the pericardial tissue 200 facing away from the frame 12 and the smooth surface 208 facing the frame 12. Figure 24 When the prosthetic heart valve 10 is implanted in a patient, the roughened surface 206 of the pericardium 200 faces the patient's native tissue. The roughened surface 206 facing or in contact with the native tissue can help disrupt antegrade blood flow between the outer skirt 300 and the patient's native anatomy, which can enhance tissue ingrowth and proliferation and help seal any gaps between the prosthetic heart valve 10 and the native anatomy to reduce and / or eliminate paravalvular leakage. Additionally, if the outer skirt 300 extends inwardly through the frame 12 during a cycle or when the prosthetic heart valve 10 is crimped in a radially collapsed configuration, any contact between the valve structure 14 and the outer skirt 300 will be with the smooth surface 208 of the pericardium 200 (which can be less abrasive than an outer skirt made of PET or other fabrics), and thus the outer skirt 300 made of pericardium 200 can help protect the leaflets of the valve structure 14. It should be noted that although the outer skirt 300 is illustrated as being somewhat loosely attached, ie, having some slack in the middle portion 306 of the outer skirt 300 , the outer skirt 300 may also be attached with a more snug fit against the outer surface of the frame 12 .

[0084] Figures 25-26 Shown by Figure 22 Various views of another exemplary outer skirt 400 formed from pericardial tissue 200. Figure 25A flattened view of the outer skirt 400 is shown before it is attached to a prosthetic heart valve.

[0085] refer to Figure 25 , the outer skirt 400 may include a first end portion 402 (ie, Figure 25 ), the second end portion 404 (ie, Figure 25 ), and an intermediate portion disposed between the first and second ends 402, 404. The first end 402 of the outer skirt 400 may include a plurality of alternating protrusions 408 and notches 410 or teeth. As previously described, in other embodiments, the first end 402 may be formed without any protrusions 408 or notches 410 and, instead, may be substantially straight.

[0086] The middle portion 406 may include a plurality of slits or openings 414. The slits 414 may be cut or otherwise formed in the longitudinal direction (i.e., the axial direction when the outer skirt 400 is attached to the frame of the prosthetic heart valve). The slits 414 may be laser cut or formed by any other means. Figure 25 In the exemplary embodiment, the slits 414 are elongated in the axial direction and are arranged in five rows 422, 424, 426, 428, and 430. In other embodiments, the slits 414 may be arranged in more or less than five rows. Figure 25 In the exemplary embodiment, rows 422 , 426 , and 430 of slots 414 are circumferentially aligned with one another and are offset from rows 424 and 428 of slots 414 that are circumferentially aligned with one another.

[0087] In some embodiments, each slit 414 includes first and second opposing longitudinal sides 432a, 432b, respectively, spaced apart from one another to define a permanently open gap therebetween. In other embodiments, in the absence of hemodynamic forces, the longitudinal sides 432a, 432b of the slit 414 contact one another (and do not define a permanently open gap therebetween), but can move away from one another in the presence of hemodynamic forces to allow blood to flow through the skirt via the slit 414.

[0088] exist Figure 25In an exemplary embodiment, the slits 414 are arranged in alternating axially extending columns 420a and 420b. Columns 420a may each include three slits, while columns 420b may each include two slits. In other embodiments, the slits 414 may be arranged on the outer skirt 400 in any pattern including any number of rows and / or columns containing any number of slits, or any other pattern without a specific number of rows and / or columns. Alternatively, the slits 414 may be arranged on the outer skirt 400 in a manner without a specific pattern. In some examples, the slits or openings 414 may have any of a variety of other shapes, such as circular, square, rectangular, triangular, or various combinations thereof. In some examples, the slits or openings 414 may be elongated circumferentially or at any other angle relative to the orientation of the outer skirt 400.

[0089] refer to Figure 26 , the outer skirt 400 can be attached to the aforementioned prosthetic heart valve 10. As described above, when the prosthetic valve 10 is implanted in a patient, the rough layer 202 of the pericardial tissue 200 can help reduce and / or eliminate paravalvular leakage, as described above. Additionally, blood can flow through the slits 414, which can slow the flow of antegrade blood and further enhance blood clotting and tissue ingrowth, which can further help prevent paravalvular leakage. Furthermore, the longitudinal or axial direction of the slits 414 can help reduce stretching or deformation that can be caused by friction between the outer skirt and the inner surface of the sheath during passage of the outer skirt through the sheath. Again, it should be noted that although the outer skirt 400 is illustrated as being somewhat loosely attached, i.e., having some slack in the middle portion 406 of the outer skirt 400, the outer skirt 400 can also be attached with a more snug fit against the outer surface of the frame 12.

[0090] Figures 27-29 Various ways of mounting an outer skirt (e.g., outer skirt 300 or outer skirt 400) to the frame 12 of the prosthetic valve 10 are shown. Figures 27-29 In the drawings, reference numeral 400 is used to denote the outer skirt, but it should be understood that the other outer skirts disclosed herein may be mounted to the frame 12 in the same manner.

[0091] refer to Figure 27 , the inner skirt 16 includes an upper edge portion 48 and a lower edge portion 50. The upper edge portion 48 of the inner skirt 16 can be such as via the aforementioned and Figure 21 70 is secured to the interior of the frame 12 as best shown in FIG. Optionally, in addition to or in lieu of stitches 70, the upper edge portion 48 of the inner skirt 16 may be secured to the interior of the frame 12 via adhesive and / or ultrasonic welding. The upper edge portion 402 of the outer skirt 400 may be secured to the frame 12 with stitches 468. For illustrative purposes, Figure 27In FIG. 4 , upper edge portions 48 and 402 are shown as being loosely attached to the frame, but they are typically Figure 1 As depicted in , are tightly secured to the frame struts.

[0092] The lower edge portion 50 of the inner skirt 16 can be wrapped around the inflow end portion 15 of the frame 12 and around the lower edge portion 404 of the outer skirt 400. The lower edge portion 404 of the outer skirt 400 and the wrapped lower edge portion 50 of the inner skirt 16 can be fixed together and / or fixed to the frame 12, such as with stitches 470 and / or adhesive. Wrapping the lower edge portion 50 of the inner skirt 16 around the lower edge portion 404 of the outer skirt 400 can strengthen the lower edge portion 404, and the stitches 470 are along the lower edge portion 404. For example, in Figure 27 , the lower edge portions 50 and 404 are shown as being loosely attached to the frame, but they would typically be tightly secured to the frame posts with sutures 470.

[0093] Figures 28-29 Another way to attach the outer skirt 400 to the frame 12 is shown. The upper edge portion 402 of the outer skirt 400 can be attached to the frame 12 using sutures 468 as described above. A reinforcing strip 448 having a first edge portion 450 and a second edge portion 452 can be wrapped around the inflow end portion 15 of the frame 12. The reinforcing strip 448 can be made of a fabric material (e.g., PET) or natural tissue (e.g., pericardial tissue). In some embodiments, the reinforcing strip 448 can be used to secure the tip of each leaflet 41 to the frame, such as Figure 29 shown.

[0094] Although not in Figures 28-29 16, but in some embodiments, the inner skirt 16 can also be mounted inside the frame 12. In some embodiments, the reinforcing strip 448 is a component of the inner skirt, and the height of the inner skirt varies around the circumference of the inner skirt, with a maximum height at the commissure of the leaflets (e.g., Figure 27 ), and has a minimum height at a position equidistant between the two commissures (as shown in Figure 28 ). Further details of the reinforcing strips used to attach the tips of the leaflets to the frame, and details of the inner skirt having a maximum height at the commissures of the leaflets and a minimum height between the commissures, are provided in U.S. Provisional Application No. 62 / 369,678, filed August 1, 2016.

[0095] The first edge portion 450 of the reinforcing strip 448 can be positioned inside the frame 12, while the second edge portion 452 can be positioned outside the frame 12. The first and second edge portions 450, 452 can be attached to each other and / or to the frame 12 using stitches 470 and / or adhesive. Figures 28-29In FIG, the edge portions 450, 452 are shown as being loosely attached to the frame, but they would typically be tightly secured to the frame.

[0096] The second edge portion 452 of the reinforcing strip 448 can be wrapped around the lower edge portion 404 of the outer skirt 400 so that the lower edge portion 404 is between the frame 12 and the reinforcing strip 448. The lower edge portion 404 of the outer skirt 400 can be secured to the frame 12 and the second edge portion 452 of the reinforcing strip 448 using sutures 470 and / or adhesive. Figure 29 As depicted, the inferior tip of each leaflet 41 can be secured between the frame 12 and the first edge portion 450 of the reinforcement strip 448 with sutures (eg, with sutures 472) and / or adhesive.

[0097] refer to Figure 29 , showing the outer skirt 400 extending inwardly through the frame 12, which may occur during cycling and / or when the frame 12 is crimped to its radially collapsed configuration. When the outer skirt 400 extends through the frame 12, it may contact one of the leaflets 41. By having the smooth surface 208 of the pericardial tissue facing inwardly toward the frame 12, any contact between the leaflet 41 and the outer skirt 400 will be made with the smooth surface 208 of the pericardial tissue 200 forming the outer skirt 400, thereby preventing or minimizing wear of the leaflet 41.

[0098] Figure 30 A prosthetic heart valve 10 having an outer skirt 500 is shown according to another embodiment. The outer skirt 500 in the illustrated embodiment includes a body or layer of pericardial tissue 502 and a plurality of strips of material 504 mounted to the outer surface of the body 502. The body 502 can be the outer skirt 300 or the outer skirt 400. The strips 504 are desirably made of a substantially inelastic and non-stretchable material. For example, the strips 504 can be sutures, pieces of woven fabric (e.g., strips of PET), pieces of non-woven fabric, or other types of fibrous materials. Figure 30 In an exemplary embodiment, the strips 504 are arranged to form a repeating U-shaped pattern around the body 502. Alternatively, the strips 504 may be arranged in any other pattern (e.g., the strips 504 may extend parallel to the longitudinal axis of the prosthetic valve). The strips 502 may facilitate passage of the prosthetic valve through the guide sheath by reducing contact between the pericardial tissue forming the body 502 and the inner surface of the sheath and by resisting stretching of the pericardial tissue caused by frictional contact with the inner surface of the sheath. Further, when formed from an absorbent material such as fabric, the strips 504 may absorb blood to help enhance blood clotting and tissue ingrowth to further reduce paravalvular leakage. Although the outer skirt 500 is illustrated as being somewhat loosely attached, i.e., with some slack in the body 502 of the outer skirt 300, it may also be attached by a more snug fit against the outer surface of the frame 12.

[0099] The prosthetic valve 10 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.

[0100] To implant the plastically expandable prosthetic valve 10 into a patient, the prosthetic valve 10, including the outer skirt 400 (or alternatively, the outer skirt 300 or 500), may be crimped onto the elongated shaft 180 of a delivery device, such as a Figure 13 . The prosthetic valve, together with the delivery device, can form a delivery assembly for implanting the prosthetic valve 10 into a patient. Shaft 180 includes an inflatable balloon 182 for expanding the prosthetic valve in vivo. With balloon 182 deflated, the prosthetic valve 10 can be delivered percutaneously to a desired implantation site (e.g., the native aortic valve region). Once the prosthetic valve 10 is delivered to the implantation site in the body (e.g., the native aortic valve), the prosthetic valve 10 can be radially expanded to its functional state by inflating balloon 182.

[0101] Alternatively, the self-expanding prosthetic valve 10 can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by inserting the prosthetic valve 10, including the outer skirt 400, into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve 10 can then be delivered percutaneously to the desired implantation site. Once in the body, the prosthetic valve 10 can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional state.

[0102] Figures 31-33 and 36 show various implantation positions of the prosthetic heart valve 10, including an implantation position within a docking or anchoring member placed within the patient prior to valve implantation. Figure 31 A prosthetic heart valve 10 is shown implanted in a patient's native aortic valve.

[0103] Figure 32Shown is a prosthetic heart valve 10 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 10 can be implanted in a radially expandable outer docking device 600. The docking device 600 can include a radially expandable and compressible annular stent 602 and a sealing element 604 that covers all or part of the stent and can extend across the inner and / or outer surfaces of the stent. The docking device 600 is configured to engage the inner wall of the pulmonary artery and can adapt to changes in the patient's anatomical structure. The expanded prosthetic heart valve 10 is much smaller than the blood vessel in which it is placed, and the docking device 600 can also compensate for the expanded prosthetic heart valve 10. The docking device 600 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 600 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.

[0104] Figure 33 A prosthetic heart valve 10 is shown implanted in a patient's native mitral valve using a docking device in the form of a helical anchor 700. The helical anchor 700 may include one or more coils 702 deployed in the left atrium and one or more coils 704 deployed in the left ventricle and radially outward of the native mitral valve leaflets 706. When the prosthetic valve 10 is deployed within the native valve, the native leaflets are compressed or clamped between the prosthetic valve 10 and the anchor 700 to hold the prosthetic valve in place. Further details of the helical anchor 700 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.

[0105] Figure 34 and 35 A docking device 800 for a prosthetic heart valve according to another embodiment is shown. The docking device 800 may include a radially expandable and compressible frame 802 having an outer portion 804, an inner portion 806 coaxially disposed within one end of the outer portion 804, and a curvilinear transition portion 808 extending between and connecting the inner portion 806 and the outer portion 804. The docking device 800 may further include a sealing element 810 extending on the inner surface of the inner portion 806, a portion of the outer surface of the outer portion 804 adjacent to the inner portion 806, and the transition portion 808.

[0106] Figure 36A docking device 800 is shown implanted in a blood vessel 820 (which can be, for example, the inferior vena cava, the superior vena cava, or the ascending aorta). As shown, the prosthetic valve 10 can be deployed within the inner portion 806 of the docking device 800. Similar to the docking device 600, the expanded prosthetic heart valve 10 is much smaller than the blood vessel in which it is placed, and the docking device 800 can compensate for the expanded prosthetic heart valve 10. The docking device 800 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 800 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, which is incorporated herein by reference.

[0107] General considerations

[0108] 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. Furthermore, in addition to prosthetic valves, the delivery assembly embodiments described herein can be adapted for delivery and implantation of various other prosthetic devices, such as stents and / or other prosthetic repair devices.

[0109] 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 relates to all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and subcombinations with each other. 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 require that any one or more problems be solved. For example, an outer skirt for a prosthetic heart valve may include one or more features disclosed with respect to skirt 18, skirt 300, skirt 400, and / or skirt 500.

[0110] 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.

[0111] As used in this application and claims, unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural forms. In addition, the term "comprising" means "including." 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."

[0112] 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 axes extending in the proximal and distal directions.

[0113] 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.

[0114] 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.

[0115] 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 and an outflow end and being 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 an outer skirt positioned about an outer surface of the frame, wherein the outer skirt comprises pericardial tissue having a fibrous wall layer defining a first surface of the outer skirt and a serosal wall layer defining a second surface of the outer skirt, and wherein the outer skirt is positioned such that the first surface faces away from the frame and the second surface faces the frame; wherein the outer skirt includes a plurality of slits configured to allow blood to flow through the outer skirt via the plurality of slits, and wherein the plurality of slits are arranged in a plurality of circumferentially offset rows of slits between an inflow end and an outflow end of the outer skirt, and wherein each of the slits includes a first opposing longitudinal side and a second opposing longitudinal side, such that the first opposing longitudinal sides and the second opposing longitudinal sides of the slits contact each other in the absence of hemodynamic forces, but move away from each other in the presence of hemodynamic forces to allow blood to flow through the outer skirt via the slits.

2. The prosthetic valve of claim 1, wherein the outer skirt comprises bovine pericardial tissue.

3. The prosthetic valve of claim 1 , wherein the outer skirt is laser milled to reduce its thickness, and wherein the first surface is a relatively rough surface compared to the second surface, and wherein the second surface is a relatively smooth surface compared to the first surface.

4. The prosthetic valve of claim 1, wherein the outer skirt has a thickness between 50 μm and 150 μm.

5. The prosthetic valve of claim 1, wherein at least one of the slits is elongated in an axial direction.

6. The prosthetic valve of claim 1 , wherein the outer skirt comprises an outflow edge portion and an inflow edge portion, wherein the outflow edge portion comprises a plurality of alternating protrusions and indentations, and wherein the protrusions are secured to the frame and the indentations are not directly secured to the frame.

7. The prosthetic valve of claim 1, wherein the outer skirt is secured to the frame with sutures.

8. The prosthetic valve of claim 1 , further comprising an inner skirt positioned around and fixed to the inner surface of the frame, wherein the height of the inner skirt varies around the circumference of the inner skirt, wherein the maximum height is arranged according to the commissures of the leaflet structure and the minimum height is arranged at a position equidistant between the two commissures of the leaflet structure.

9. An implantable prosthetic 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; a leaflet structure positioned within and secured to the frame; an outer skirt positioned about an outer surface of the frame, wherein the outer skirt comprises pericardial tissue having a fibrous wall layer defining a first surface of the outer skirt and a serosal wall layer defining a second surface of the outer skirt, and wherein the outer skirt is positioned such that the first surface faces away from the frame and the second surface faces the frame; and one or more strips positioned about, mounted on, and secured to an outer surface of the outer skirt, wherein a length of the one or more strips is oriented in a direction extending from an inflow end to an outflow end of the outer skirt, wherein the strips are configured to reduce contact between a body of the outer skirt, including the pericardial tissue, and an inner surface of the sheath during insertion of the prosthetic valve through the sheath, wherein the outer skirt comprises a plurality of slits, and wherein each of the slits comprises a first opposing longitudinal side and a second opposing longitudinal side, such that the first opposing longitudinal sides and the second opposing longitudinal sides of the slits contact each other in the absence of hemodynamic forces, but move away from each other in the presence of hemodynamic forces to allow blood to flow through the outer skirt via the slits.

10. The prosthetic valve of claim 9, wherein the strips comprise a fabric material and are arranged in a repeating U-shaped pattern around the outer skirt.

11. A method of manufacturing a prosthetic heart valve, comprising: providing a sheet of pericardial tissue comprising a fibrous parietal layer and a serosal parietal layer; reducing a thickness of the sheet of pericardial tissue by removing a portion of the fibrous parietal layer, the fibrous parietal layer defining a first surface of the sheet of pericardial tissue, and the fibrous parietal layer defining a second surface of the sheet of pericardial tissue; positioning the sheet of pericardial tissue around an outer surface of a frame of a prosthetic heart valve and securing it to the outer surface of the frame of the prosthetic heart valve such that the first surface faces away from the frame and the second surface faces the frame; and Prior to positioning the sheet of pericardial tissue on the frame, slits are formed in the sheet of pericardial tissue, wherein each of the slits includes a first opposing longitudinal side and a second opposing longitudinal side, such that the first opposing longitudinal sides and the second opposing longitudinal sides of the slits contact each other in the absence of hemodynamic forces, but move away from each other in the presence of hemodynamic forces to allow blood to flow through the outer skirt via the slits.

12. The method of claim 11, wherein after reducing the thickness of the sheet of pericardial tissue, the thickness of the sheet of pericardial tissue is between 50 μm and 100 μm.

13. The method of claim 11, wherein reducing the thickness of the sheet of pericardial tissue comprises laser milling the parietal serosa.

14. The method of claim 11, wherein the slits comprise a plurality of slits arranged in a plurality of circumferentially offset rows of slits between the inflow and outflow ends of the sheet of pericardial tissue when positioned about the outer surface of the frame.

15. The method of claim 14, wherein at least one of the slits is elongated in an axial direction extending between the inflow end and the outflow end of the sheet of pericardial tissue.

16. The method of claim 11, further comprising coupling a plurality of prosthetic leaflets to an interior portion of the frame.

17. The method of claim 11, further comprising wrapping a reinforcement strip around the inflow end of the frame such that a first end of the reinforcement strip extends at least partially along and is secured to an inner surface of the frame, and a second end of the reinforcement strip extends at least partially along and is secured to a first surface of the sheet of pericardial tissue.

18. The method of claim 17, wherein the reinforcement strip comprises a fabric material and further comprising disposing a plurality of prosthetic leaflets within the interior of the frame and securing a tip edge portion of each prosthetic leaflet between the frame and the first edge portion of the reinforcement strip.

19. The method of claim 11, further comprising mounting a plurality of strips on the first surface of the sheet of pericardial tissue such that the length of each strip is oriented in a direction extending from an inflow end to an outflow end of the sheet of pericardial tissue.

20. A method of manufacturing a prosthetic heart valve, comprising: providing a sheet of pericardial tissue comprising a fibrous parietal layer and a serosal parietal layer; reducing a thickness of the sheet of pericardial tissue by removing a portion of the serosal parietal layer using a laser in a laser milling process, the fibrous parietal layer defining a first surface of the sheet of pericardial tissue, and the serosal parietal layer defining a second surface of the sheet of pericardial tissue; forming a plurality of slits in the sheet of pericardial tissue between a first end and an opposing second end of the sheet of pericardial tissue, wherein each of the slits includes a first opposing longitudinal side and a second opposing longitudinal side, such that the first opposing longitudinal sides and the second opposing longitudinal sides of the slits contact each other in the absence of hemodynamic forces but move away from each other in the presence of hemodynamic forces to allow blood to flow through the outer skirt via the slits; and The sheet of pericardial tissue is positioned around the outer surface of the frame of the prosthetic heart valve and secured to the outer surface of the frame of the prosthetic heart valve such that the first surface faces away from the frame and the second surface faces the frame, and the second end of the sheet of pericardial tissue is disposed at the inflow end of the frame and the first end of the sheet of pericardial tissue is disposed on the frame at a position between the inflow end and the outflow end of the frame.

21. The method of claim 20, wherein each of the plurality of slits is elongated in a longitudinal direction extending between a first end and a second end of the sheet of pericardial tissue.

22. The method of claim 20, further comprising securing a first end of a reinforcing strip to an inner surface of the frame, wrapping the reinforcing strip around the inflow end of the frame and over the first surface of the second end of the sheet of pericardial tissue, and securing a second end of the reinforcing strip to the first surface of the second end of the sheet of pericardial tissue.

23. The method of claim 22, further comprising securing a leaflet structure comprising a plurality of leaflets between the frame and the first edge portion of the reinforcement strip.

24. The method of claim 20, wherein the reduced thickness of the sheet of pericardial tissue is between 50 μm and 100 μm.

25. The method of claim 20, further comprising mounting a plurality of strips on a first surface of the sheet of pericardial tissue such that the length of each strip is oriented in a direction extending from a first end to a second end of the sheet of pericardial tissue, and wherein the strips comprise a fabric material and are arranged in a repeating U-shaped pattern around the sheet of pericardial tissue.

26. A method of manufacturing a prosthetic heart valve, comprising: providing a sheet of pericardial tissue comprising a fibrous parietal layer and a serosal parietal layer; reducing a thickness of the sheet of pericardial tissue by removing a portion of the fibrous parietal layer, the fibrous parietal layer defining a first surface of the sheet of pericardial tissue, and the fibrous parietal layer defining a second surface of the sheet of pericardial tissue, wherein the sheet of pericardial tissue has a first end and a second end disposed opposite each other; positioning the sheet of pericardial tissue about an outer surface of a frame of the prosthetic heart valve and securing it to the outer surface of the frame of the prosthetic heart valve such that the first surface faces away from the frame and the second surface faces the frame, wherein securing to the frame comprises securing a first end of the sheet of pericardial tissue to the frame at a location on the frame between an inflow end and an outflow end of the frame; positioning an inner skirt about an inner surface of the frame and securing a first edge portion of the inner skirt to the frame, secured to the inner surface of the frame; wrapping a second edge portion of the inner skirt around the inflow end of the frame and around the second end portion of the sheet of pericardial tissue, the second edge portion of the inner skirt being disposed opposite the first edge portion of the inner skirt; securing the second end portion of the sheet of pericardial tissue and the wrapped second edge portion of the inner skirt to the inflow end of the frame; and Prior to positioning the sheet of pericardial tissue on the frame, slits are formed in the sheet of pericardial tissue, wherein each of the slits includes a first opposing longitudinal side and a second opposing longitudinal side, such that the first opposing longitudinal sides and the second opposing longitudinal sides of the slits contact each other in the absence of hemodynamic forces, but move away from each other in the presence of hemodynamic forces to allow blood to flow through the outer skirt via the slits.

27. The method of claim 26, wherein securing the second end of the sheet of pericardial tissue and the wrapped second edge portion of the inner skirt to the inflow end of the frame comprises securing the second end of the sheet of pericardial tissue and the second edge portion of the inner skirt together.

28. The method of claim 26, further comprising arranging a leaflet structure comprising a plurality of prosthetic leaflets on an interior of the frame, fixing a connection of the leaflet structure formed by fixing adjacent prosthetic leaflets to each other at their adjacent sides to the frame, and fixing the plurality of prosthetic leaflets to the inner skirt.

29. The method of claim 28, wherein the prosthetic heart valve further comprises a reinforcement strip wrapped around the inflow end of the frame; and wherein the height of the inner skirt varies around the circumference of the inner skirt, wherein the maximum height is arranged according to the commissures of the leaflet structure and the minimum height is arranged at a position equidistant between two commissures of the leaflet structure, and wherein securing the plurality of prosthetic leaflets to the inner skirt comprises securing the tip edge portion of each prosthetic leaflet between the frame and the first edge portion of the reinforcement strip.

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