Prosthetic heart valve

Abstract

To solve the problem that a leaflet opens and closes under the flow of blood through the valve and may contact a frame and / or a skirt, which may cause abrasion of the leaflet.SOLUTION: The implantable prosthetic valve comprises: a radially shrinkable and expandable annular frame and a leaflet structure that regulates a blood flow through the prosthetic valve. A textile inner skirt is positioned along the inner surface of the frame. The inner skirt includes a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and woven with the first set of yarns. The first set of yarns are thinner than the second set of yarns and are woven with the second set of yarns such that the inner surface of the skirt is formed from more of the first set of yarns than the second set of yarns and the outer surface of the skirt is formed from more of the second set of yarns than the first set of yarns.SELECTED DRAWING: Figure 23

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 854,244, filed May 29, 2019, which is incorporated herein by reference.

[0002] The present disclosure relates to implantable, expandable prosthetic devices, and in particular to prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can result in significant dysfunction of the heart, which may ultimately require replacement of the natural valve with an artificial valve. There are many known artificial valves and many known methods of implanting these artificial valves in humans. Due to the drawbacks associated with traditional open-chest surgery, percutaneous minimally invasive surgical approaches have attracted great attention. In one technique, artificial valves are configured to be implanted in a much less invasive procedure by catheterization. For example, collapsible transcatheter artificial heart valves can be crimped in a compressed state, percutaneously introduced in a compressed state on a catheter, and expanded to a functional size at the desired location by balloon inflation or by the use of a self-expanding frame or stent. Examples of transcatheter artificial heart valves are disclosed in U.S. Pat. No. 6,730,118, U.S. Pat. No. 7,393,360, U.S. Pat. No. 7,510,575, and U.S. Pat. No. 7,993,394. These patents are incorporated herein by reference.

[0004] A prosthetic valve for use in such procedures typically includes a radially contractible and expandable frame, a number of leaflets supported by the frame, and one or more textile skirts or cuffs used to seal the paravalvular area and / or strengthen the connection between the leaflets and the frame. During the operating cycle of the prosthetic valve, the leaflets may open and close under blood flow through the valve to contact the frame and / or skirt, which can cause wear of the leaflets. It is therefore desirable to prevent or reduce such wear of the leaflets, which can improve the long-term durability of the prosthetic valve. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 6,730,118 [Patent Document 2] U.S. Patent No. 7,393,360 [Patent Document 3] U.S. Patent No. 7,510,575 [Patent Document 4] U.S. Patent No. 7,993,394 [Patent Document 5] U.S. Patent No. 10,195,025 [Patent Document 6] US Patent Application Publication No. 2012 / 0123529 [Patent Document 7] US Patent Application Publication No. 2013 / 0030519 [Patent Document 8] US Patent Application Publication No. 2017 / 0065415 Summary of the Invention [Means for solving the problem]

[0006] In one exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end and radially contractible and expandable between a radially contracted configuration and a radially expanded configuration, a leaflet structure positioned within the frame, a valve structure configured to permit blood flow from the inflow end to the outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve, and a textile inner skirt positioned along an inner surface of the frame. The inner skirt includes a first set of yarns extending in a first direction and a second set of yarns woven with the yarns of the first set and extending in a second direction, the first set of yarns being thinner than the second set of yarns. The first set of yarns are woven with the second set of yarns such that an inner surface of the skirt is formed from more of the first set of yarns than the second set of yarns and an outer surface of the skirt is formed from more of the second set of yarns than the first set of yarns.

[0007] In some embodiments, the coefficient of friction of the inner surface of the skirt is less than the coefficient of friction of the outer surface.

[0008] In some embodiments, the inner surface of the skirt is smoother than the outer surface of the skirt.

[0009] In some embodiments, a first direction of the first set of threads extends circumferentially relative to the frame and a second direction of the second set of threads extends axially relative to the frame.

[0010] In some embodiments, the first set of yarns and the second set of yarns comprise multifilament yarns.

[0011] In some embodiments, the first set of yarns has a greater number of filaments than the second set of yarns.

[0012] In some embodiments, the skirt comprises a woven fabric characterized by at least two or more adjacent first set yarns over a single second set yarn and at least two or more second set yarns over a single first set yarn.

[0013] In some embodiments, the skirt comprises a woven fabric characterized by at least four or more adjacent first set yarns over a single second set yarn and at least four or more second set yarns over a single first set yarn.

[0014] In some embodiments, the first set of yarns has about 30-40 filaments per strand and the second set of yarns has about 10-20 filaments per strand.

[0015] In some embodiments, the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns.

[0016] In some embodiments, the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns.

[0017] In some embodiments, the skirt comprises a satin weave.

[0018] In some embodiments, the leaflet structure comprises a plurality of leaflets having respective inflow edge portions that are sutured to the skirt.

[0019] In some embodiments, the skirt is sewn to the struts of the frame.

[0020] In another exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end, the frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame; a valve structure configured to permit blood flow from the inflow end to the outflow end of the prosthetic valve and to prevent blood flow from the outflow end to the inflow end of the prosthetic valve; and a textile skirt coupled to the frame, the textile skirt including a first set of threads extending in a first direction and a second set of threads extending in a second direction and woven in a satin weave with the first set of threads.

[0021] In some embodiments, the skirt has an inner surface and an outer surface, the inner surface being smoother than the outer surface.

[0022] In some embodiments, the first set of yarns are warp yarns and the second set of yarns are weft yarns.

[0023] In some embodiments, the inner surface of the skirt is formed from more yarns of the first set than from the second set, and the outer surface of the skirt is formed from more yarns of the second set than from the first set.

[0024] In some embodiments, a first direction of the first set of threads extends circumferentially relative to the frame and a second direction of the second set of threads extends axially relative to the frame.

[0025] In some embodiments, the first set of yarns includes a plurality of first filaments and the second set of yarns includes a plurality of second filaments, the first filaments being thinner than the second filaments.

[0026] In some embodiments, the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns.

[0027] In some embodiments, the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns.

[0028] In some embodiments, the yarns in the first set have more filaments per strand than the yarns in the second set.

[0029] In some embodiments, the first set of yarns has about 30-40 filaments per strand and the second set of yarns has about 10-20 filaments per strand.

[0030] In some embodiments, the skirt is an inner skirt positioned along an inner surface of the frame.

[0031] In some embodiments, the skirt is an outer skirt positioned along an outer surface of the frame.

[0032] In some embodiments, the coefficient of friction of the inner surface of the skirt is less than the coefficient of friction of the outer surface of the skirt.

[0033] In some embodiments, the skirt comprises a woven fabric characterized by at least two or more yarns spanning between an intersection of a first yarn and a second yarn.

[0034] In some embodiments, the skirt comprises a woven fabric characterized by at least four or more yarns spanning between an intersection of a first yarn and a second yarn.

[0035] In another exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end, the frame being radially contractible and expandable between radially contracted and radially expanded configurations, a leaflet structure positioned within the frame, a valve structure configured to permit blood flow from the inflow end to the outflow end of the prosthetic valve and to prevent blood flow from the outflow end to the inflow end of the prosthetic valve, and a textile skirt coupled to the frame, the skirt being fabricated from a woven fabric such that an inner surface of the skirt is smoother than an outer surface of the skirt.

[0036] In some embodiments, the weave comprises a satin weave.

[0037] In some embodiments, the woven fabric comprises a first set of yarns extending in a first direction and a second set of yarns woven with the first set of yarns and extending in a second direction, the first set of yarns being thinner than the second set of yarns, the first set of yarns being woven with the second set of yarns such that an inner surface of the skirt is formed from more of the first set of yarns than the second set of yarns and an outer surface of the skirt is formed from more of the second set of yarns than the first set of yarns.

[0038] In some embodiments, the first set of yarns has about 30-40 filaments per strand and the second set of yarns has about 10-20 filaments per strand.

[0039] In some embodiments, the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns.

[0040] In some embodiments, the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns.

[0041] In some embodiments, the skirt is sewn to the struts of the frame.

[0042] In some embodiments, the skirt comprises a woven fabric characterized by at least two or more yarns spanning between an intersection of a first yarn and a second yarn.

[0043] In some embodiments, the skirt comprises a woven fabric characterized by at least four or more yarns spanning between an intersection of a first yarn and a second yarn.

[0044] In some embodiments, the skirt is an inner skirt positioned along an inner surface of the frame.

[0045] In some embodiments, the skirt is an outer skirt positioned along an outer surface of the frame.

[0046] In another exemplary embodiment, an implantable prosthetic valve includes an annular frame having an inflow end and an outflow end, the frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame, the leaflet structure configured to allow blood flow from the inflow end to the outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve; and a textile skirt coupled to the frame, the textile skirt comprising a weave constructed from a first set of yarns extending in a first direction woven with a second set of yarns extending in a second direction to form a plurality of intersections, the weave being characterized by at least two yarns spanning between intersections of the first and second yarns.

[0047] In some embodiments, the woven fabric is characterized by at least four yarns spanning between the intersection of the first yarn and the second yarn.

[0048] In some embodiments, the coefficient of friction of the inner surface of the skirt is less than the coefficient of friction of the outer surface.

[0049] In some embodiments, the inner surface of the skirt is smoother than the outer surface of the skirt.

[0050] In some embodiments, a first direction of the first set of threads extends circumferentially relative to the frame and a second direction of the second set of threads extends axially relative to the frame.

[0051] In some embodiments, the first set of yarns and the second set of yarns comprise multifilament yarns.

[0052] In some embodiments, the first set of yarns has a greater number of filaments than the second set of yarns.

[0053] In some embodiments, the filaments in the first set of yarns are thinner than the filaments in the second set of yarns.

[0054] In some embodiments, the inner surface of the skirt is formed from more yarns of the first set than from the second set, and the outer surface of the skirt is formed from more yarns of the second set than from the first set.

[0055] In some embodiments, the skirt is an inner skirt positioned along an inner surface of the frame.

[0056] In some embodiments, the skirt is an outer skirt positioned along an outer surface of the frame.

[0057] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0058] [Figure 1] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Diagram 2] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Diagram 3] FIG. 1 illustrates an example embodiment of a prosthetic heart valve. [Figure 4] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Diagram 5] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 6] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 7] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 8] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 9] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 10] FIG. 2 is a diagram showing an example of a frame of the artificial heart valve of FIG. 1. [Figure 11] FIG. 2 shows an example of an inner skirt of the prosthetic heart valve of FIG. 1. [Figure 12] FIG. 2 shows an example of an inner skirt of the prosthetic heart valve of FIG. 1. [Figure 13] FIG. 2 illustrates the prosthetic heart valve of FIG. 1 in a contracted configuration and mounted on an example balloon catheter. [Figure 14] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 15] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 16] 12 shows the assembly of the inner skirt of FIG. 11 with the frame of FIG. 4. FIG. [Figure 17] 1A-1D illustrate an example leaflet structure assembly. [Figure 18] 1A-1D illustrate an example leaflet structure assembly. [Figure 19] 13A-13D show assembly of the commissure portions of the leaflet structure with the window frame portion of the frame. [Figure 20] FIG. 13 illustrates assembly of the leaflet structure with an inner skirt along the lower edge of the leaflet. [Figure 21] FIG. 13 illustrates assembly of the leaflet structure with an inner skirt along the lower edge of the leaflet. [Figure 22] FIG. 2 is a flat view of an example outer skirt. [Figure 23] 1 illustrates an example embodiment of a weave pattern for a fabric skirt viewed from one side of the fabric. [Figure 24] 24 shows the weave pattern of FIG. 23 as viewed from the opposite side of the fabric. [Diagram 25] 24 shows another view of the weave pattern of FIG. 23. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] 1-3 show various views of a prosthetic heart valve 10 according to one embodiment. The illustrated prosthetic valve is configured to be implanted within the native aortic valve annulus, but in other embodiments, it may be configured to be implanted within other native valve annuluses of the heart, such as the pulmonary, mitral, and tricuspid valves. It may also be configured to be implanted within 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 perivalvular sealing means or member. The prosthetic valve 10 may have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. In the illustrated embodiment, the perivalvular sealing means includes an outer skirt 18.

[0060] The valve structure 14 can include three leaflets 41 that collectively form a leaflet structure. The leaflets 41 can be configured to fold in a tricuspid configuration as best shown in FIG. 2. Desirably, the lower edge of the leaflet structure 14 has a wavy curved sector (the suture line 154 shown in FIG. 21 follows the sector of the leaflet structure). Forming the leaflets in this sector geometry reduces stress on the leaflets, which in turn improves the durability of the prosthesis. Additionally, this sector geometry can eliminate or at least minimize folds and undulations in the abdomen (the central region of each leaflet) of each leaflet that can lead to premature calcification. This sector geometry also reduces the amount of tissue material used to form the leaflet structure, which results in a smaller, more uniform crimped profile at the inflow end of the prosthesis. The leaflets 41 may be formed from pericardial tissue (such as bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0061] The bare frame 12 is shown in FIG. 4. The frame 12 may be formed with a plurality (three in the illustrated embodiment) of circumferentially spaced slots or commissure windows 20. These commissure windows 20 are configured for mounting the commissures of the valve structure 14 to the frame as described in more detail below. The frame 12 may be made from any of a variety of suitable plastically expandable materials (such as stainless steel) or self-expanding materials (such as nickel-titanium alloys (NiTi) such as Nitinol) as known in the art. If made from a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially contracted configuration on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. If made from a self-expanding material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially contracted configuration and held in this contracted configuration by insertion into a sheath or equivalent mechanism of the delivery catheter. Once inside the body, the prosthetic valve can be advanced out of the delivery sheath, thereby allowing the prosthetic valve to expand to its functional size.

[0062] Suitable plastically expandable materials that may be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular embodiment, the frame 12 is made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® / UNS R30035 alloy includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. The use of MP35N® alloy to form the frame 12 has been found to provide superior structural results over stainless steel. In particular, when MP35N® alloy is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Furthermore, because less material is required, the crimp profile of the frame can be reduced, thereby enabling a lower profile prosthetic valve assembly for percutaneous delivery to a treatment location within the body.

[0063] 4 and 5, the frame 12 of the illustrated embodiment comprises a first lower row I of end-to-end connected circumferentially extending angled struts 22 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 located at the outflow end of the frame. A plurality of substantially straight axially extending struts 34 may be used to interconnect the struts 24 of the second row II with the struts 22 of the first row I. The angled struts 32 of the fifth row V are connected to the angled struts 28 of the fourth row IV by a plurality of axially extending window frame portions 30 (defining 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. Figures 6, 7, 8, 9, and 10 are enlarged views of the portions of frame 12 designated by the letters A, B, C, D, and E, respectively, in Figure 5.

[0064] Each commissure window frame portion 30 mounts a respective commissure of the leaflet structure 14. As will be appreciated, each frame portion 30 is secured at its upper and lower ends to adjacent rows of struts to provide a robust configuration that improves fatigue resistance under cyclic loading of the prosthetic valve as compared to known cantilever struts for supporting the commissures of the leaflet structure. This configuration allows for a reduced frame wall thickness, thereby enabling a smaller crimp diameter of the prosthetic valve. In certain embodiments, the thickness T (FIG. 4) of the frame 12, measured between the inner diameter and the outer diameter, is about 0.48 mm or less.

[0065] The struts and frame portions of the frame collectively define a plurality of open cells of the frame. At the inflow end of frame 12, struts 22, 24, and 34 define a lower row of cells that define an opening 36. The second row of struts 24, the third row of struts 26, and the fourth row of struts 28 define two middle rows of cells that define an opening 38. The fourth row of struts 28 and the fifth row of struts 32, together with frame portions 30 and struts 31, define an upper row of cells that define an opening 40. The opening 40 is relatively large and sized to allow a portion of the leaflet structure 14 to protrude or bulge into and / or through the opening 40 when the frame 12 is crimped to minimize the crimp profile.

[0066] As best shown in FIG. 7, the lower end of strut 31 is connected to two struts 28 at node or junction 44, and the upper end of strut 31 is connected to two struts 32 at node or junction 46. Strut 31 may have a thickness S1 that is less than the thickness S2 of junctions 44, 46. Junctions 44, 46, along with junction 64, prevent complete closure of opening 40. FIG. 13 shows prosthetic valve 10 crimped onto a balloon catheter. As can be seen, the geometry of struts 31 and junctions 44, 46, and 64 helps provide enough space in the contracted configuration for opening 40 to allow a portion of the prosthetic leaflet to protrude or bulge outwardly through the opening. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if the entire leaflet material was constrained within the crimped frame.

[0067] The frame 12 is configured to reduce, eliminate, or minimize the possibility of overexpansion of the prosthetic valve at a given balloon pressure, particularly at the outflow end portion of the frame that supports the leaflet structures 14. In one aspect, the frame is configured with relatively large angles 42a, 42b, 42c, 42d, 42e between the struts as shown in FIG. 5. The larger the angle, the greater the force required to open (expand) the frame. Thus, the angles between the struts of the frame can be selected to limit the radial expansion of the frame at a given opening pressure (e.g., balloon inflation pressure). In certain embodiments, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more particularly, these angles are up to about 120 degrees when the frame is expanded to its functional size.

[0068] 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 that are located below the lower edge of the leaflets. The inner skirt 16 preferably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), although various other synthetic or natural materials (e.g., pericardial tissue) can be used. Desirably, the skirt has a thickness of less than about 6 mils (0.15 mm), desirably less than about 4 mils (0.1 mm), and even more desirably about 2 mils (0.05 mm). In certain embodiments, the skirt 16 can have a non-constant thickness, for example, the skirt can be thicker at at least one of its edges than at the center. In one implementation, the skirt 16 can include a PET skirt having a thickness of about 0.07 mm at the edges and about 0.06 mm at the center. A thinner skirt may provide better crimp performance while still achieving a good perivalvular seal.

[0069] The skirt 16 may be secured to the interior of the frame 12 by sutures 70, which may extend through the skirt and around the struts of the frame, as shown in FIG. 21. The valve structure 14 may be attached to the skirt via one or more reinforcing strips 72 (which may collectively form a sleeve), such as thin PET reinforcing strips discussed below, which allow for secure suturing and protect the pericardial tissue of the leaflet structures from tearing. The valve structure 14 may be sandwiched between the skirt 16 and the thin PET strips 72, as shown in FIG. 20. The sutures 154 that secure the PET strips and leaflet structures 14 to the skirt 16 may be any suitable suture, such as Ethibond Excel® PET sutures (Johnson & Johnson, New Brunswick, New Jersey). The sutures 154 desirably follow the curvature of the inflow or cusp edge (bottom edge in the illustrated embodiment) of each leaflet structure 41, as described in more detail below.

[0070] Known textile skirts may include a woven arrangement of warp and weft fibers extending perpendicular to one another, one set of fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which the textile skirt is secured is radially compressed, the overall axial length of the frame is stretched. Unfortunately, textile skirts, which have limited elasticity, cannot stretch when the frame is stretched, and therefore, unless they include slack or slack along their length, will deform the struts of the frame when in a radially expanded state, preventing a uniform crimp.

[0071] 12, the skirt 16, in contrast to known textile skirts, is desirably woven from a first set of yarns (multifilament or monofilament yarns) 78 and a second set of yarns (multifilament or monofilament yarns) 80, both of which are non-perpendicular to the upper and lower edges 82 and 84 of the skirt. In certain embodiments, the first and second sets of yarns 78 and 80 extend at an angle of about 45 degrees (e.g., 15-75 degrees or 30-60 degrees) to the upper and lower edges 82 and 84. For example, the skirt 16 may be formed by weaving the yarns at a 45 degree angle to the upper and lower edges of the fabric. Alternatively, the skirt 16 may be diagonally cut (bias cut) from vertically woven fabric (fibers extending perpendicular to the material edges) and the yarns extend at a 45 degree angle to the cut upper and lower edges of the skirt. 12, desirably the opposing short edges 86, 88 of the skirt are non-perpendicular to the upper and lower edges 82, 84. For example, desirably the short edges 86, 88 extend at approximately a 45 degree angle relative to the upper and lower edges and are therefore aligned with the first set of threads 78. Thus, the general overall shape of the skirt is that of a rhomboid or parallelogram.

[0072] 14 and 15 show the inner skirt 16 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 may be placed in overlapping relationship with the opposing edge portion 92, and the two edge portions may be sewn together using a diagonally extending stitching line 94 that is parallel to the short edges 86, 88. The upper edge portion of the inner skirt 16 may be formed with a plurality of projections 96 that define a wavy portion that generally follows the shape or contour of the fourth row of struts 28 immediately adjacent the lower end of the axial strut 31. In this manner, the upper edge of the inner skirt 16 may be tightly secured to the struts 28 by the sutures 70, as best shown in FIG. 16. The inner skirt 16 may also be formed with slits 98 to facilitate attachment of the skirt to the frame. The slits 98 are sized to allow the upper edge portion of the inner skirt 16 to be wrapped partially around the struts 28 to relieve stress on the skirt during the installation procedure. For example, in the illustrated embodiment, the inner skirt 16 is placed on the inside of the frame 12 and the upper edge portion of the skirt is wrapped around the upper surfaces 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 allows for a stronger and more durable attachment of the skirt to the frame. Additionally, the inner skirt 16 may be secured to the first row of struts 22, the second row of struts 24, and / or the third row of struts 26 with sutures 70.

[0073] Referring again to FIG. 12, the angled orientation of the fibers relative to the upper and lower edges allows the skirt to undergo greater elongation in the axial direction (i.e., in the direction from the upper edge 82 to the lower edge 84). Thus, when the metal frame 12 is crimped (as shown in FIG. 14), the inner skirt 16 may elongate axially with the frame, thus achieving a more uniform and predictable crimp profile. Each cell of the metal frame in the illustrated embodiment includes at least four angled struts that rotate axially upon crimping (e.g., the angled struts become more aligned relative to the length of the frame). The angled struts of each cell act as a mechanism for rotating the fibers of the skirt in the same direction as the struts, which allows the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.

[0074] Additionally, the spacing between the interwoven yarns can be increased to promote axial elongation of the skirt. For example, for a PET inner skirt 16 formed from 20 denier yarns, the yarn density can be about 15% to about 30% lower than for a typical PET skirt. In some examples, 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 for 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 beveled edges 86, 88 promote uniform and even distribution of the fibrous material along the inner circumference of the frame during crimping, which reduces or minimizes fiber creasing and facilitates uniform crimping to the smallest possible diameter. Additionally, cutting the diagonal sutures vertically can leave raw edges along the cut edges. The beveled edges 86, 88 are effective in minimizing this occurrence. Compared to conventional skirt designs, the construction of the inner skirt 16 avoids undesirable deformation of the frame struts and allows for a more uniform crimp of the frame.

[0075] In alternative embodiments, the skirt may be formed from woven elastic yarns that are axially stretchable during crimping of the prosthetic valve. The warp and weft yarns may extend vertically and horizontally relative to the upper and lower edges of the skirt, or alternatively, may extend at an angle between 0 and 90 degrees relative to the upper and lower edges of the skirt, as described above.

[0076] The inner skirt 16 can be sewn to the frame 12 at a location away from the suture line 154, allowing the skirt to have more flexibility in that area. This configuration avoids stress concentrations at the suture line 154 which attaches the lower edge of the leaflet to the inner skirt 16.

[0077] As noted above, the leaflet structure 14 in the illustrated embodiment includes three flexible leaflets 41 (although more or fewer leaflets may be used). Further information regarding these leaflets, as well as skirt materials, may be found, for example, in U.S. Patent No. 10,195,025, which is incorporated herein by reference in its entirety.

[0078] The leaflets 41 are secured together at adjacent sides to form the leaflet structure's commissures 122. A number of flexible connectors 124 (one of which is shown in FIG. 17) may be used to interconnect adjacent side pairs of the leaflets and attach them to the commissure window frame portion 30 (FIG. 5).

[0079] Figure 17 shows adjacent sides of two leaflets 41 interconnected by flexible connectors 124. As shown in Figure 18, three leaflets 41 can be secured together side-to-side using three flexible connectors 124. Further information regarding interconnecting leaflets and connecting leaflets to a frame can be found, for example, in U.S. Patent Application Publication No. 2012 / 0123529, which is incorporated herein by reference in its entirety.

[0080] As mentioned above, the inner skirt 16 may be used to assist in suturing the leaflet structure 14 to the frame. The inner skirt 16 may have wavy temporary marking sutures to guide the attachment of the lower edge of each leaflet 41. The inner skirt 16 itself may be sewn to the struts of the frame 12 using sutures 70 as described above prior to securing the leaflet structure 14 to the skirt 16. Desirably, those sutures that cross the marking sutures are not attached to the inner skirt 16. This allows the inner skirt 16 to have more versatility in the areas that are not secured to the frame and minimizes stress concentrations along the suture lines that secure the lower edges of the leaflets to the skirt. As mentioned above, when the skirt is secured to the frame, the skirt threads 78, 80 (see FIG. 12) are generally aligned with the angled struts of the frame to promote uniform crimping and expansion of the frame.

[0081] FIG. 19 illustrates one specific approach for securing the commissure portions 122 of the leaflet structure 14 to the commissure window frame portion 30 of the frame. The flexible connector 124 (FIG. 18) that secures the two adjacent sides of the two leaflets together is folded widthwise, and the upper tab portion 112 of each of the leaflets is folded downwardly against the flexible connector. Each upper tab portion 112 is creased lengthwise (vertically) to form an L-shape with an inner portion 142 folded against the inner surface of the leaflet and an outer portion 144 folded against the connector 124. The outer portion 144 may then be sutured to the connector 124 along a suture line 146. The commissure tab assembly may then be inserted through the commissure window 20 of the corresponding window frame portion 30, and the outer fold of the window frame portion 30 may be sutured to the portion 144.

[0082] 19 also illustrates that the folded upper tab portion 112 may form a double layer of leaflet material at the commissures. The inner portion 142 of the upper tab portion 112 is positioned flush against two layers of leaflets 41 to form the commissures, such that each commissure comprises four layers of leaflet material immediately within the window frame 30. This four-layer portion of the commissure may have a higher resistance to bending or articulation than the portion of the leaflet 41 located radially inward from the four-layer portion, which has a relatively higher stiffness. This allows the leaflets 41 to articulate primarily at the inner edge 143 of the folded inner portion 142 in response to blood flowing through the prosthetic valve during operation in vivo, as opposed to articulating about or proximal to the axial struts of the window frame 30. By articulating the leaflets at a location spaced radially inward from the window frame 30, the leaflets avoid contact with the frame, which may be avoided. However, under high forces, the four-layered portions of the commissures may spread apart about the longitudinal axis adjacent the window frame 30, with each inner portion 142 folding back on its respective outer portion 144. For example, this may occur when the prosthetic valve 10 is compressed and mounted onto a delivery shaft, allowing for a smaller crimp diameter. The four-layered portions of the commissures may also spread apart about the longitudinal axis when the balloon catheter is inflated during expansion of the prosthetic valve, which may partially relieve pressure on the commissures caused by the balloon and reduce the possibility of damage to the commissures during expansion.

[0083] After the three commissure tab assemblies are secured to their respective window frame portions 30, the inflow or cusp edges (lower edges in the illustrated embodiment) of the leaflets 41 between the commissure tab assemblies may be sutured to the inner skirt 16. As shown, for example, in FIG. 20, each leaflet 41 may be sutured to the inner skirt 16 along suture lines 154 using, for example, Ethibond Excel® PET thread. These sutures may be in-and-out sutures that extend through each leaflet 41, the inner skirt 16, and each reinforcement strip 72. Each leaflet 41 and its respective reinforcement strip 72 may be individually sewn to the inner skirt 16. In this manner, the lower edges of the leaflets are secured to the frame 12 via the inner skirt 16. As shown in Figure 20, the leaflets may be further secured to the skirt with blanket stitches 156 that loop around the edges of the reinforcement strips 72 and leaflets 41 and extend through each of the reinforcement strips 72, leaflets 41, and inner skirt 16. The blanket stitches 156 may be formed from PTFE suture material. Figure 21 shows a side view of the frame 12, leaflet structure 14, and inner skirt 16 after securing the leaflet structure 14 and inner skirt 16 to the frame 12, and after securing the leaflet structure 14 to the inner skirt 16.

[0084] 22 shows a flat view of the outer skirt 18 prior to attachment to the frame 12. The outer skirt 18 may be laser cut or otherwise formed from a tough, durable material, such as PET or various other suitable synthetic or natural materials, configured to restrict and / or impede blood flow therethrough. The outer skirt 18 may include a substantially straight lower edge 160 and an upper edge portion 162 defining a plurality of alternating protrusions 164 and notches 166 or castellations. The outer skirt 18 may also include a plurality of openings 167 (e.g., twelve in the illustrated embodiment) disposed on a middle portion 169 of the outer skirt 18 (i.e., the portion between the lower edge 160 and the upper edge portion 162). The openings 167 are spaced from the lower edge 160 and the upper edge portion 162 such that the material of the outer skirt 18 spaces the openings 167 from the lower edge 160 and the upper edge portion 162.

[0085] 3, a lower edge portion 174 of the outer skirt 18 is wrapped around the inflow end 15 of the frame 12, and a lower edge 160 of the outer skirt 18 may be attached to the lower edge 84 of the inner skirt 16 and / or the frame 12 at the inflow end of the prosthetic valve 10. In some embodiments, the outer skirt 18 may be attached to the inner skirt 16, such as by sutures or a suitable adhesive.

[0086] Instead of or in addition to sutures, the outer skirt 18 may be attached to the inner skirt 16 by, for example, ultrasonic welding. Ultrasonic welding may provide several significant advantages. For example, ultrasonic welding may provide improved strength while being relatively quick and inexpensive compared to sewing.

[0087] 1, each projection 164 of the outer skirt 18 may be attached to a strut 26 (FIG. 5) of the third row III of the frame 12. These projections 164 may, for example, overlap a respective strut 26 of row III and be secured with sutures 168.

[0088] As can be seen in Figures 1-3, the outer skirt 18 is secured to the frame 12 such that when the frame is in an expanded configuration (e.g., deployed within a subject), there is excess material between the lower edge 160 and the upper edge portion 162 that is not flush against the outer surface of the frame 12. The outer skirt 18 may be secured directly to the frame 12 and / or indirectly to the frame 12, such as by securing the outer skirt 18 to an inner skirt 16 that is secured directly to the frame 12. In the expanded configuration of the prosthetic valve, the distance between the upper and lower attachment points of the outer skirt 18 is reduced (shortened), resulting in radial expansion of the outer skirt 18. Additionally, the excess material located between the lower and upper edges of the outer skirt 18 allows the frame 12 to stretch axially without resistance from the outer skirt 18 when crimped.

[0089] The outer skirt 18 has an axial length or height H s where H s is the height of the outer skirt 18 excluding the lower edge portion 174 that wraps around the inflow end 15 of the frame 12, as best shown in Figures 1, 3, and 22. In some embodiments, the height H s may be substantially the same as the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. In such an embodiment, the outer skirt 18 may lie flush against the outer surface of the frame 12 when the frame 12 is fully crimped. In other embodiments, the height H of the outer skirt 18 may be substantially the same as the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. s may exceed the axial length between the upper attachment point of the outer skirt 18 to the frame 12 and the inflow end 15 of the frame 12 when the frame 12 is fully crimped. In such an embodiment, the outer skirt 18 may include multiple folds 170 (e.g., twelve in the illustrated embodiment).

[0090] As best shown in FIG. 3, the folds 170 may extend axially from the lower edge 160 of the outer skirt 18 toward the middle portion 169. The folds 170 are circumferentially aligned with the respective projections 164, and the outer skirt 18 may be oriented with respect to the frame 12 such that the folds 170 are circumferentially aligned between each pair of apices 22a (FIG. 5) formed by the struts 22 at the inflow end 15 of the frame 12. For example, the folds 170 may be circumferentially aligned along each vertical line 172 (FIGS. 2 and 5) that is parallel to the longitudinal axis of the frame 12 and bisects the frame 12 equidistant from each tip 22a of each pair of apices 22a. In this manner, the folds 170 may retract excess material of the outer skirt 18 radially inward between the apices 22a into the inflow end 15 of the frame 12 when the prosthetic valve 10 is crimped from the expanded configuration. As best shown in FIG. 2, each fold 170 may be circumferentially aligned with a respective opening 167 and protrusion 164 along a respective line 172 .

[0091] As best seen in FIG. 22, the openings 167 may be spaced laterally (circumferentially in FIGS. 1-3) from adjacent openings 167 and aligned laterally (circumferentially in FIGS. 1-3) with respective projections 164. Also, as best shown in FIGS. 1 and 3, the openings 167 may be circumferentially aligned with respective folds 170. For example, as best shown in FIG. 2, the projections 164, openings 167, and folds 170 may be aligned along respective vertical lines 172. Aligning the openings 167 and folds 170 may allow for rapid ingress of blood into, and thus rapid expansion of, the overlapping portions of the outer skirt 18 with blood, for example, when the prosthetic valve is initially deployed, as described further below.

[0092] Also, openings 167 advantageously allow backflowing blood (e.g., retrograde blood) to enter outer skirt 18 from a different angle or direction than notches 166, thus improving rapid initial expansion of outer skirt 18 and improving perivalvular sealing. Openings 167 may be provided as an alternative or in addition to notches 166.

[0093] The opening 167 can have a variety of shapes. For example, the opening 167 can have a teardrop shape as shown in the illustrated embodiment. In other embodiments, the opening can be circular, oval, rectangular, etc.

[0094] The prosthetic valve 10 may be configured for and mounted on a delivery device suitable for implantation within a subject. Although several catheter-based delivery devices are known, non-limiting examples of suitable catheter-based delivery devices include those disclosed in U.S. Patent Application Publication Nos. 2013 / 0030519 and 2017 / 0065415, which are incorporated by reference herein in their entireties, and U.S. Patent Application Publication No. 2012 / 0123529.

[0095] As best shown in FIG. 13, for implantation of the plastically expandable prosthetic valve 10 in a patient, the prosthetic valve 10 may be crimped onto an elongated shaft 180 of a delivery device. The prosthetic valve, together with the delivery device, may form a delivery assembly for implanting the prosthetic valve 10 in the patient's body. The shaft 180 includes an inflatable balloon 182 for expanding the prosthetic valve in the body. Once the balloon 182 is deflated and the prosthetic valve is crimped around the balloon, the prosthetic valve 10 may then be delivered percutaneously to a desired implantation location (e.g., in the area of ​​the native aortic valve). Once the prosthetic valve 10 is delivered to the implantation site in the body (e.g., in the area of ​​the native aortic valve), the prosthetic valve 10 may be radially expanded to its functional state by inflating the balloon 182.

[0096] As the prosthetic valve 10 expands, the notches 166 and openings 167 allow blood to flow between the outer skirt 18 and the inner skirt 16. This blood flow causes the excess fiber of the outer skirt 18 to bulge further radially away from the inner skirt 16.

[0097] The expanded outer skirt 18 may fill the gap between the frame 12 and the surrounding native annulus to aid in forming a good fluid-tight seal between the prosthetic valve 10 and the native annulus. Thus, the outer skirt 18 cooperates with the inner skirt 16 to avoid paravalvular leakage after implantation of the prosthetic valve 10. In some embodiments, a prosthetic valve 10 with an outer skirt 18 that expands radially outward may reduce paravalvular leakage when implanted in a subject when compared to a similar prosthetic valve having a smaller outer skirt or no outer skirt 18.

[0098] Alternatively, the self-expanding prosthetic valve 10 may be crimped into a radially contracted configuration and held in this contracted configuration by inserting the prosthetic valve 10 into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve 10 may then be delivered percutaneously to a desired implantation location. Once in place within the body, the prosthetic valve 10 may be advanced out of the delivery sheath, thereby allowing the prosthetic valve to expand to its functional state.

[0099] When the outer skirt 18 is exposed from the delivery sheath, the notches 166 and openings 167 allow blood to flow between the outer skirt 18 and the inner skirt 16. This blood flow causes the excess fiber of the outer skirt 18 to further radially expand, away from the inner skirt 16.

[0100] 23-25 ​​show an embodiment of one example of a weaving pattern for forming a textile skirt 200. FIG. 23 shows one side of the skirt 200, and FIG. 24 shows the opposite side of the skirt 200. The skirt 200 can be used as an inner skirt and / or an outer skirt of the prosthetic valve 10. In a particular embodiment, the skirt 200 is the inner skirt of the prosthetic valve 10, with FIG. 23 showing the inner surface 202 of the inner skirt (the surface facing toward the valve cusp 41) and FIG. 24 showing the outer surface 204 of the inner skirt (the surface facing away from the frame 12). The skirt 200 can have the same outer dimensions and shape as the inner skirt 16 described above, and can be assembled to the frame 12 and the valve cusp 41 as described above.

[0101] The skirt 200 comprises a first set of yarns 206 woven with a second set of yarns 208. The yarns 206, 208 may comprise multifilament yarns (yarns containing multiple fibers or filaments) or monofilament yarns (yarns containing a single fiber or filament). In the illustrated embodiment, the yarns 206 are oriented circumferentially about the prosthetic valve 10 and the yarns 208 are oriented axially about the prosthetic valve. During manufacture of the skirt 200, the yarns 206 may be the weft of the fabric and the yarns 208 may be the warp of the fabric. However, in alternative embodiments, the yarns 206 may be the warp of the fabric and the yarns 208 may be the weft of the fabric.

[0102] Due to the weave of the fabric, the inner surface 202 of the skirt is formed from more threads 206 than threads 208, while the outer surface 204 of the skirt is formed from more threads 208 than threads 206. Stated another way, there are more threads 206 exposed on the inner surface 202 than threads 208, and there are more threads 208 exposed on the outer surface 204 than threads 206. Specifically, as best seen in Figure 25, in the illustrated embodiment, each thread 206 extends under one thread 208 at the outer surface 204, over four threads 208 at the inner surface 202, and then under one thread 208 at the outer surface 204, repeating this pattern along the length of the threads. Thus, along the length of each thread 208 in the axial direction of the surface 202 (vertical in FIG. 23), between two crossings of that thread 208 with thread 206, there are four adjacent threads 206 that overlap that thread 208. Similarly, each thread 208 extends over one thread 206 at the inner surface 202, over four threads 206 at the outer surface 204, and then over one thread 206 at the inner surface 202, repeating this pattern along the length of the thread. Thus, along the length of each thread 206 in the circumferential direction of the surface 204 (horizontal in FIG. 24), between two crossings of that thread 206 with thread 208, there are four adjacent threads 208 that overlap that thread 206. In this way, the inner surface 202 of the fabric is dominated by threads 206, and the outer surface 204 of the fabric is dominated by threads 208. Stated another way, a majority of the surface area of ​​inner surface 202 includes threads 206 and a majority of the surface area of ​​outer surface 204 includes threads 208 .

[0103] While the illustrated embodiment is characterized by four spans between crossings (where the yarn extends from one side of the fiber to the opposite side of the fiber), the number of spans for yarns 206, 208 can vary. In certain embodiments, for each yarn 206, 208, there are at least two spans between crossings, at least three spans between crossings, at least four spans between crossings, at least five spans between crossings, at least six spans between crossings, at least seven spans between crossings, at least eight spans between crossings, etc. In certain embodiments, the number of spans between crossings can vary along the length of the yarn and / or between yarns.

[0104] In certain embodiments, the threads 206, 208 comprise PET, although other biocompatible synthetic or natural fibers may be used.

[0105] The fibers shown in Figures 23-25 ​​may be referred to as satin fibers or fibers having a satin weave. As used herein, the term "satin" refers to a weave or fiber having a first set of yarns interwoven with a second set of yarns, with at least two yarns spanning between crossovers such that one side of the fiber is dominated by the first set of yarns and the other side of the fiber is dominated by the second set of yarns. In alternative embodiments, other weave patterns may be employed having a first set of yarns predominating on one side and a second set of yarns predominating on another side, such as a twill weave pattern or a herringbone weave pattern.

[0106] In certain embodiments, the number of threads 206 is greater than the number of threads 208. Also, in certain embodiments, the diameter or thickness of threads 206 is smaller than the diameter or thickness of threads 208. Since the relatively thinner threads 206 dominate the inner surface 202, the inner surface 202 is relatively smoother and less rough than the outer surface 204. Moreover, the inner surface 202 has a lower coefficient of friction than the outer surface 204. Advantageously, the inner surface 202 can reduce abrasion of the leaflets 41 when they contact the inner skirt as they open during the work cycle of the prosthetic valve. Additionally, the relatively thinner threads 206 can reduce creasing and fold over lines in the skirt after the prosthetic valve has radially expanded to its functional size.

[0107] As noted above, components 206, 208 may represent a first thread 206 and a second thread 208 each formed from multiple filaments or fibers and woven together. In certain embodiments, the diameter or thickness of the multiple filaments in each thread 206 is smaller than the diameter or thickness of the filaments in thread 208. Also, in this particular embodiment, thread 206 has more filaments per thread than thread 208. Because the inner surface 202 is dominated by the relatively finer filaments of thread 206, inner surface 202 is relatively smooth and less rough than outer surface 204, and has a lower coefficient of friction.

[0108] In certain embodiments, the yarns 206 have about 20-50 filaments per strand, more preferably about 25-45 filaments per strand, even more preferably about 30-40 filaments per strand, and even more preferably about 30-35 filaments per strand, with 32 filaments per strand being a specific example. The filament thickness of the yarns 206 can be about 2 microns to about 10 microns, more preferably about 4 microns to about 6 microns, with 5 microns being a specific example. The yarns 208 can have about 15-25 filaments per strand, more preferably about 10-20 filaments per strand, and even more preferably about 15-20 filaments per strand, with 18 filaments per strand being a specific example. The filament thickness of the yarns 208 can be about 8 microns to about 16 microns, more preferably about 10 microns to about 12 microns, with 11 microns being a specific example.

[0109] As described above, the outer surface 204 of the skirt 200 may be dominated by the relatively thicker threads 208 and oriented to extend axially along the frame 12 of the prosthetic valve. In some embodiments, the outer surface 204 of the skirt may contact the inner surface of the introducer sheath through an opening in the frame 12. Orienting the threads 208 axially may reduce sliding friction with the introducer sheath and reduce the pushing force required to advance the prosthetic valve through the introducer sheath. Similarly, in some embodiments, the outer surface 204 of the skirt may contact a delivery capsule or sheath (such as in the case of a self-expanding prosthetic valve). Orienting the threads 208 axially may reduce sliding friction with the delivery capsule and reduce the pushing or pulling force required to deploy the prosthetic valve from the delivery capsule.

[0110] In alternative embodiments, threads 206 may be axially oriented and threads 208 may be circumferentially oriented. In further alternative embodiments, threads 206, 208 may be non-perpendicular to the inflow and outflow edges of the skirt, such as those described above for skirt 16 shown in Figures 11 and 12, to facilitate radial crimping of the prosthetic valve. For example, the orientation of threads 206, 208 may be at an angle of about 15-75 degrees relative to the inflow and outflow edges, more desirably about 30-60 degrees relative to the inflow and outflow edges, with 45 degrees being a particular example.

[0111] In an alternative embodiment, for example when the leaflets 41 are not in contact with the skirt during the operating cycle of the prosthetic valve, it may be desirable to reverse the orientation of the inner skirt 200 so that face 202 becomes the outer surface facing toward the frame 12 and face 204 becomes the inner surface facing inward, toward the leaflets 41.

[0112] In alternative embodiments, yarn 208 can have the same number of filaments and / or the same thickness as the filaments in yarn 206, resulting in a relatively smooth fiber on both sides 202 and 204. For example, in certain implementations, yarns 206, 208 have about 20-50 filaments per strand, more preferably about 25-45 filaments per strand, even more preferably about 30-40 filaments per strand, and even more preferably about 30-35 filaments per strand, with 32 filaments per strand being a specific example. The filament thickness of yarns 206, 208 can be from about 2 microns to about 10 microns, more preferably about 4 microns to about 6 microns, with 5 microns being a specific example.

[0113] In another embodiment, the skirt 200 can be the outer skirt of the prosthetic valve. The outer skirt 200 can have an inner surface 202 facing toward the frame 12 and an outer surface 204 facing away from the frame 12. This may be desirable in embodiments of the prosthetic valve where an inner skirt is not provided and the outer skirt can contact the leaflets through the cells of the frame. In other implementations, the orientation of the outer skirt 200 can be reversed so that the face 202 is the outer surface of the outer skirt and the face 204 is the inner surface of the outer skirt. In one particular example, the prosthetic valve 10 can have an outer skirt 200 that can have the same overall shape and configuration as the outer skirt 18 and can be assembled similarly to the outer skirt 18.

[0114] General matters It should be appreciated that embodiments of the present disclosure are configured to deliver and implant prosthetic devices in any native annulus of the heart (e.g., aortic, pulmonary, mitral, and tricuspid annulus, etc.) and may be used with any of a variety of approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0115] For the purpose of this description, some aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The methods, devices, and systems of the present disclosure should not be interpreted as limiting in any respect. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various embodiments disclosed, both alone and in various combinations and subcombinations. These methods, devices, and systems are not limited to any particular aspect or feature thereof or combinations thereof, and the embodiments of the present disclosure do not require that any one or more particular advantages exist or problems are solved.

[0116] Although some operations of the embodiments of the present disclosure are described in a certain sequential order for convenience of presentation, it should be understood that this description style encompasses reordering unless a specific order is required by specific wording below. For example, a series of operations described sequentially may in some cases be reordered or performed simultaneously. Furthermore, for simplicity reasons, the accompanying drawings may not depict the various ways in which the method of the present disclosure may be utilized in combination with other methods. Furthermore, at times, the description uses terms such as "realize" or "achieve" to describe the method of the present disclosure. These terms are highly abstract representations of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are readily recognizable to those skilled in the art.

[0117] In this application and claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "include" means "comprise." Additionally, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0118] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user and distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0119] As used herein, the terms "integrally formed" and "unitary structure" refer to a structure that does not include any welds, fasteners, or other means for fastening separately formed pieces of material together.

[0120] As used herein, the term "coupled" means physically joined or linked and does not exclude the presence of intermediate elements between the coupled items, unless specifically stated to the contrary.

[0121] As used herein, operations that are performed "simultaneously" or "concurrently" are generally performed at the same time relative to one another, but delays in the performance of one operation relative to another due to, for example, spacing, play, or backlash between components, such as threads, gears, and the like, of a mechanical linkage are expressly included within the scope of the term unless specifically stated to the contrary.

[0122] In view of the many possible embodiments to which the inventive principles of this disclosure may be applied, it is to be understood that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Accordingly, everything that comes within the scope and spirit of the claims is claimed as the invention.

[0123] [Section 1] 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame, the leaflet structure configured to permit blood flow from an inflow end to an outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve; a textile inner skirt positioned along an inner surface of the frame, the textile inner skirt including a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and interwoven with the first set of yarns, the first set of yarns being thinner than the second set of yarns; Equipped with the first set of yarns are woven together with the second set of yarns such that an inner surface of the skirt is formed from more of the first set of yarns than the second set of yarns and an outer surface of the skirt is formed from more of the second set of yarns than the first set of yarns. [Section 2] 2. The prosthetic valve of claim 1, wherein the coefficient of friction of the inner surface of the skirt is less than the coefficient of friction of the outer surface. [Section 3] 3. The prosthetic valve of paragraph 1 or paragraph 2, wherein the inner surface of the skirt is smoother than the outer surface of the skirt. [Section 4] 4. The artificial valve according to any one of claims 1 to 3, wherein the first direction of the threads of the first set extends circumferentially relative to the frame, and the second direction of the threads of the second set extends axially relative to the frame. [Section 5] 5. The artificial valve according to any one of claims 1 to 4, wherein the first set of yarns and the second set of yarns comprise multifilament yarns. [Section 6] 6. The prosthetic valve of paragraph 5, wherein the first set of yarns has a greater number of filaments than the second set of yarns. [Section 7] 7. The prosthetic valve of any one of claims 1 to 6, wherein the skirt comprises a woven fabric characterized by at least two or more adjacent yarns of the first set over a single yarn of the second set and at least two or more yarns of the second set over a single yarn of the first set. [Section 8] 8. The prosthetic valve of clause 7, wherein the skirt comprises a woven fabric characterized by at least four or more adjacent yarns of the first set over a single yarn of the second set and at least four or more yarns of the second set over a single yarn of the first set. [Section 9] 6. The prosthetic valve of claim 5, wherein the first set of threads has about 30-40 filaments per thread and the second set of threads has about 10-20 filaments per thread. [Section 10] 6. The artificial valve according to item 5, wherein the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns. [Section 11] 6. The artificial valve according to item 5, wherein the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns. [Section 12] 12. The artificial valve according to any one of claims 1 to 11, wherein the skirt comprises a satin weave. [Section 13] 13. The artificial valve according to any one of claims 1 to 12, wherein the leaflet structure comprises a plurality of leaflets having respective inflow edge portions sutured to the skirt. [Section 14] 14. The artificial valve according to any one of items 1 to 13, wherein the skirt is sutured to struts of the frame. [Section 15] 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame, the leaflet structure configured to permit blood flow from an inflow end to an outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve; a textile skirt attached to the frame, the textile skirt including a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and woven in a satin weave with the first set of yarns; 1. An implantable prosthetic valve comprising: [Section 16] 16. The prosthetic valve of clause 15, wherein the skirt has an inner surface and an outer surface, the inner surface being smoother than the outer surface. [Section 17] 17. The prosthetic valve of clause 15 or clause 16, wherein the first set of threads are warp threads and the second set of threads are weft threads. [Section 18] 18. The prosthetic valve of any one of claims 15 to 17, wherein an inner surface of the skirt is formed from more of the yarns of the first set than from the yarns of the second set, and an outer surface of the skirt is formed from more of the yarns of the second set than from the yarns of the first set. [Section 19] 19. The artificial valve according to any one of items 15 to 18, wherein the first direction of the threads of the first set extends circumferentially relative to the frame, and the second direction of the threads of the second set extends axially relative to the frame. [Section 20] 20. The artificial valve according to any one of items 15 to 19, wherein the first set of threads includes a plurality of first filaments and the second set of threads includes a plurality of second filaments, the first filaments being thinner than the second filaments. [Section 21] 21. The artificial valve according to item 20, wherein the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns. [Section 22] 21. The artificial valve according to item 20, wherein the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns. [Section 23] 23. The artificial valve according to any one of items 20 to 22, wherein the first set of threads includes more filaments per thread than the second set of threads. [Section 24] 24. The artificial valve according to any one of items 20 to 23, wherein the first set of threads has about 30 to 40 filaments per thread and the second set of threads has about 10 to 20 filaments per thread. [Section 25] 25. The artificial valve according to any one of items 15 to 24, wherein the skirt is an inner skirt positioned along an inner surface of the frame. [Section 26] 25. The artificial valve according to any one of items 15 to 24, wherein the skirt is an outer skirt positioned along an outer surface of the frame. [Section 27] 27. The artificial valve according to any one of items 15 to 26, wherein the coefficient of friction of the inner surface of the skirt is smaller than the coefficient of friction of the outer surface of the skirt. [Section 28] 28. The artificial valve according to any one of claims 15 to 27, wherein the skirt comprises a woven fabric characterized by at least two or more threads extending between the intersections of the first thread and the second thread. [Section 29] 30. The prosthetic valve of clause 28, wherein the skirt comprises a woven fabric characterized by at least four or more yarns spanning between the intersection of the first yarn and the second yarn. [Section 30] 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame, the leaflet structure configured to permit blood flow from an inflow end to an outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve; a textile skirt attached to the frame, the textile skirt being made from a woven fabric such that an inner surface of the skirt is smoother than an outer surface of the skirt; 1. An implantable prosthetic valve comprising: [Section 31] 31. The prosthetic valve of clause 30, wherein the weave comprises a satin weave. [Section 32] the woven fabric includes a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and interwoven with the first set of yarns, the first set of yarns being thinner than the second set of yarns; 32. The prosthetic valve of claim 30 or 31, wherein the yarns of the first set are woven with yarns of a second set such that the inner surface of the skirt is formed from more yarns of the first set than from the second set and the outer surface of the skirt is formed from more yarns of the second set than from the first set. [Section 33] 33. The prosthetic valve of claim 32, wherein the first set of threads has about 30-40 filaments per thread and the second set of threads has about 10-20 filaments per thread. [Section 34] 33. The prosthetic valve according to item 32, wherein the filaments of the first set of yarns have a thickness of about 4 microns to about 6 microns. [Section 35] 33. The prosthetic valve according to item 32, wherein the filaments of the second set of yarns have a thickness of about 10 microns to about 12 microns. [Section 36] Item 37. The artificial valve according to any one of items 30 to 36, wherein the skirt is sutured to struts of the frame. [Section 37] 37. The prosthetic valve of any one of claims 32 to 36, wherein the skirt comprises a woven fabric characterized by at least two or more threads extending between the intersections of the first thread and the second thread. [Section 38] 38. The prosthetic valve of clause 37, wherein the skirt comprises a woven fabric characterized by at least four or more yarns spanning between the intersection of the first yarn and the second yarn. [Section 39] Item 39. The artificial valve according to any one of items 30 to 38, wherein the skirt is an inner skirt positioned along an inner surface of the frame. [Section 40] Item 39. The artificial valve according to any one of items 30 to 38, wherein the skirt is an outer skirt positioned along an outer surface of the frame. [Section 41] 1. An implantable prosthetic valve, comprising: an annular frame having an inflow end and an outflow end, the annular frame being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration; a leaflet structure positioned within the frame, the leaflet structure configured to permit blood flow from an inflow end to an outflow end of the prosthetic valve and to block blood flow from the outflow end to the inflow end of the prosthetic valve; a textile skirt attached to the frame, the textile skirt comprising a woven fabric constructed from a first set of yarns extending in a first direction woven with a second set of yarns extending in a second direction to form a plurality of intersections, the woven fabric being characterized by at least two yarns spanning between the intersections of the first yarns and the second yarns; 1. An implantable prosthetic valve comprising: [Section 42] 42. The prosthetic valve of claim 41, wherein the woven fabric is characterized by at least four threads spanning between the intersection of the first thread and the second thread. [Section 43] 43. The prosthetic valve of paragraph 41 or paragraph 42, wherein the coefficient of friction of the inner surface of the skirt is less than the coefficient of friction of the outer surface. [Section 44] 44. The artificial valve according to any one of items 41 to 43, wherein the inner surface of the skirt is smoother than the outer surface of the skirt. [Section 45] Item 45. The artificial valve according to any one of items 41 to 44, wherein the first direction of the threads of the first set extends circumferentially relative to the frame, and the second direction of the threads of the second set extends axially relative to the frame. [Section 46] Item 46. The artificial valve according to any one of items 41 to 45, wherein the first set of yarns and the second set of yarns comprise multifilament yarns. [Section 47] 47. The prosthetic valve of paragraph 46, wherein the first set of yarns has a greater number of filaments than the second set of yarns. [Section 48] 48. The prosthetic valve of paragraph 46 or paragraph 47, wherein the filaments of the first set of yarns are thinner than the filaments of the second set of yarns. [Section 49] 49. The prosthetic valve of any one of paragraphs 41 to 48, wherein an inner surface of the skirt is formed from more of the yarns of the first set than from the yarns of the second set, and an outer surface of the skirt is formed from more of the yarns of the second set than from the yarns of the first set. [Section 50] 50. The artificial valve according to any one of items 41 to 49, wherein the skirt is an inner skirt positioned along an inner surface of the frame. [Section 51] 50. The artificial valve according to any one of items 41 to 49, wherein the skirt is an outer skirt positioned along an outer surface of the frame. [Explanation of symbols]

[0124] 10 Artificial Heart Valves 12 Stents, frames 14 Valve structure, valve cusp structure 15 Inflow end section, inflow end section 16 Inner Skirt 17 Middle part 18 Outer Skirt 19 Outflow end part 20 Commissure window 22 Angled strut 22a Tip 24 Angled strut 26 Angled strut 28 Angled strut 30 Window frame part, commissure window frame part 31 Axial strut 32 Angled strut 34 Axially extending strut 36 Aperture 38 Aperture 40 aperture 41 Valve leaflet 44 nodes, junctions 46 nodes, junctions 64 Junction 70 Sutures 72 Reinforcement strip 78 The First Thread 80 The Second Thread 82 Upper Edge 84 Lower Edge 86 Short Edge, Beveled Edge 88 Short Edge, Beveled Edge 90 Short edge part 92 Short edge part 94 Suture Line 96 Protrusion 98 Slit 112 Upper tab part 122 Commissure, commissure part 124 Flexible Connector 142 Inner part 143 Inner Edge 144 Outer part 146 Suture Line 154 Suture line, suture thread 156 Blanket Stitch 160 Lower Edge 162 Upper edge part 164 Protrusion 166 Notch 167 Aperture 168 Sutures 169 Middle part 170 creases 172 Vertical Line 174 Lower edge part 180 Thin Shaft 182 Inflatable Balloon 200 Textile Skirt 202 Inner surface 204 Outer surface 206 First set of thread 208 Second set of thread

Claims

[Claim 1] 13. An implantable prosthetic valve as described herein.

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