Skirt assembly for an implantable prosthetic valve

Abstract

An implantable prosthetic valve (10, 200) includes an annular frame (12) that is radially expandable from a radially compressed state to a radially expanded state. The frame (12) has a longitudinal axis (L). The prosthetic valve (10, 200) also includes a plurality of leaflets (40) positioned to regulate blood flow from an inflow end to an outflow end of the frame (12), and a skirt assembly (15). The skirt assembly (15) includes a laminate having a textile layer sandwiched between a first encapsulation layer (84) and a second encapsulation layer (86). The first and second encapsulation layers are made of an elastomer, and the textile layer includes a first set of yarns (302) and a second set of yarns (304) interwoven with the first set of yarns, wherein the first and second sets of yarns are neither perpendicular nor parallel to the longitudinal axis.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 931,304, filed November 6, 2019, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to embodiments of prosthetic valves for implantation into human conduits, such as natural heart valve annulus rings. Background Technology

[0004] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious heart dysfunction and eventually require the replacement of natural valves with artificial valves. There are many known artificial valves and many known methods for implanting these artificial valves into the human body.

[0005] Various surgical techniques can be used to replace or repair diseased or damaged valves. Every year, thousands of patients undergo surgery to replace defective heart valves with prosthetic valves due to stenosis and other valvular heart diseases. Another less drastic approach to treating defective valves is through repair or reconstruction, generally used for valves with minimal calcification. The problem with surgical treatment is that it carries significant risks for patients with chronic conditions, whose high morbidity and mortality rates are associated with surgical repair.

[0006] When a natural valve is replaced, surgical implantation of a prosthetic valve generally requires open-heart surgery, during which the heart stops beating and the patient is placed on a cardiopulmonary bypass (so-called a "heart-lung machine"). In a common surgical procedure, the diseased leaflet of the natural valve is removed, and the prosthetic valve is sutured to the surrounding tissue at the valve annulus. Due to the trauma associated with this procedure and the duration of extracorporeal circulation, some patients do not survive the procedure or die shortly thereafter. It is well known that the patient's risk increases with the amount of time required for extracorporeal circulation. Because of these risks, a significant number of patients with defective natural valves are considered inoperable because their condition is too fragile to withstand the procedure. It is estimated that more than 50% of patients over 80 years of age with valvular stenosis are ineligible for valve replacement surgery.

[0007] Due to the drawbacks associated with traditional open-heart surgery, percutaneous and minimally invasive surgical approaches are gaining significant attention. In one technique, a prosthetic valve is configured to be implanted via catheter insertion in a much less invasive procedure. For example, U.S. Patent Nos. 5,411,522 and 6,730,118 (incorporated herein by reference) describe collapsible transcatheter heart valves that can be percutaneously introduced onto a catheter in a compressed state and expanded at the desired location by balloon inflation or using a self-expanding frame or stent.

[0008] Known prosthetic valves include a frame in which the valve structure (e.g., leaflet) is mounted, an inner skirt fixed inside the frame, and an outer skirt optionally fixed outside the frame. The inner skirt can serve several functions. For example, it can act as a sealing member to prevent (or reduce) paravalvular leakage, anchor the leaflet to the frame, and protect the leaflet from damage caused by contact with the frame during valve crimping and during the valve's working cycle. The outer skirt can cooperate with the inner skirt to further reduce or avoid paravalvular leakage after valve implantation. While a variety of other synthetic or natural materials can be used, the inner skirt is desirablely made of a tough, tear-resistant material, such as polyethylene terephthalate (PET).

[0009] The inner and outer skirts are typically secured to the frame by stitching or sewing the corresponding skirt fabric together. The stitching of the inner skirt to the frame exposes the leaflets below the suture line. During the valve's working cycle, repeated contact between the leaflets and the exposed suture line, as well as contact between the leaflets and the skirt fabric material, can lead to leaflet abrasion. Therefore, improvements to the skirt of prosthetic valves are desired. Summary of the Invention

[0010] This disclosure relates to methods and apparatus in connection with prosthetic valves, such as prosthetic heart valves.

[0011] In one representative embodiment, the implantable prosthetic valve may include an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The frame may have an inlet end, an outlet end, and a longitudinal axis extending from the inlet end to the outlet end. The prosthetic valve may also include a plurality of leaflets and a skirt assembly positioned to regulate blood flow from the inlet end to the outlet end of the frame. The skirt assembly may include a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers may be made of an elastomer, and the textile layer may include a first set of yarns and a second set of yarns interwoven with the first set of yarns, wherein the first and second sets of yarns are neither perpendicular to nor parallel to the longitudinal axis.

[0012] In some implementations, the textile layer may have a weave density of less than 150 ppi.

[0013] In some implementations, the textile layer may have a weave density of 50 ppi or less.

[0014] In some implementations, the textile layer may have a weave density of about 30 to about 50 ppi.

[0015] In some embodiments, the skirt assembly may include an outer skirt mounted to the outer surface of the frame.

[0016] In some implementations, the skirt assembly may have an inner skirt that is mounted to the inner surface of the frame.

[0017] In some implementations, the textile layer may be a woven layer.

[0018] In some implementations, the textile layer may be a woven layer.

[0019] In some implementations, the textile layer may be a knitted layer.

[0020] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

[0021] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

[0022] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle of 40 to 50 degrees relative to the longitudinal axis of the frame.

[0023] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at a 45-degree angle relative to the longitudinal axis of the frame.

[0024] In some embodiments, the yarns of the first set of yarns and the second set of yarns may have about 10 to about 50 filaments per yarn.

[0025] In some implementations, the first and second sets of yarns may each have approximately 20 filaments.

[0026] In some implementations, the yarn filaments may have a thickness ranging from about 8 micrometers to about 16 micrometers.

[0027] In some implementations, the yarn filaments can have a thickness of about 10 micrometers.

[0028] In some embodiments, at least some of the yarns in the first set of yarns and the second set of yarns may be texturized so that they remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0029] In some implementations, the textile layer may include leno yarn.

[0030] In some embodiments, the yarns of the first group of yarns and the second group of yarns may include first type yarns and second type yarns. The first type yarns may be inelastic or less elastic than the second type yarns.

[0031] In some embodiments, the textile layer may include a third set of yarns that extends axially and is woven together with the first and second sets of yarns to form a triaxially woven fabric.

[0032] In some embodiments, the third set of yarns may be made of an elastomer configured to stretch axially when the prosthetic valve is radially compressed from a radially expanded state to a radially compressed state.

[0033] In some embodiments, the third set of yarns can be fluffed up so that they remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0034] In some implementations, when the prosthetic valve is in a radially compressed state, the skirt assembly can be axially extended up to at least 40% of its initial length when the prosthetic valve is in a radially expanded state.

[0035] In another representative embodiment, the implantable prosthetic valve may include an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The frame may have an inlet and an outlet. The prosthetic valve may also include a plurality of leaflets and an outer skirt mounted to the outer surface of the frame, the leaflets being positioned to regulate blood flow from the inlet to the outlet of the frame. The outer skirt may include a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers may be made of an elastomer, and the textile layer may include a first set of yarns and a second set of yarns interwoven with the first set of yarns. When the prosthetic valve is in a radially expanded state, the outer skirt may have a first axial length, and when the prosthetic valve is in a radially compressed state, the outer skirt may have a second axial length. The second axial length may be greater than 40% of the first axial length.

[0036] In some implementations, the outer skirt can be configured to snug fit with the frame such that when the prosthetic valve is in a radially expanded state, the outer skirt lies against the outer surface of the frame.

[0037] In some embodiments, when the prosthetic valve is in a radially expanded state, the first set of yarns and the second set of yarns can be parallel to the corresponding supports of the frame connected to the outer skirt, respectively.

[0038] In some implementations, the first set of yarns and the second set of yarns may not be perpendicular to or parallel to the longitudinal axis of the frame extending from the inlet to the outlet.

[0039] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

[0040] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

[0041] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle of 40 to 50 degrees relative to the longitudinal axis of the frame.

[0042] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at a 45-degree angle relative to the longitudinal axis of the frame.

[0043] In some implementations, the textile layer may have a weave density of less than 150 ppi.

[0044] In some implementations, the textile layer may have a weave density of 50 ppi or less.

[0045] In some implementations, the textile layer may have a weave density of about 30 to about 50 ppi.

[0046] In some embodiments, at least some of the yarns in the first set of yarns and the second set of yarns can be fluffed up so that they can remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0047] In some embodiments, the yarns of the first group of yarns and the second group of yarns may include first type yarns and second type yarns. The first type yarns may be inelastic or less elastic than the second type yarns.

[0048] In some embodiments, the textile layer may include a third set of yarns that extends axially and is woven together with the first and second sets of yarns to form a triaxially woven fabric.

[0049] In some embodiments, the third set of yarns may be made of an elastomer configured to stretch axially when the prosthetic valve is radially compressed from a radially expanded state to a radially compressed state.

[0050] In some embodiments, the third set of yarns can be fluffed up so that they remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0051] Some embodiments of this disclosure also relate to a method of assembling a prosthetic valve. The method may include mounting a skirt assembly to an annular frame and attaching a plurality of leaflets to the annular frame. The frame may be radially expanded from a radially compressed state to a radially expanded state. The leaflets may be configured to regulate blood flow from an inflow end to an outflow end of the frame. The skirt assembly may include a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers may be made of an elastomer, and the textile layer may include a first set of yarns and a second set of yarns interwoven with the first set of yarns. When the prosthetic valve is in a radially expanded state, the outer skirt may have a first axial length, and when the prosthetic valve is in a radially compressed state, the outer skirt may have a second axial length. The second axial length may be at least 40% of the first axial length.

[0052] In some embodiments, the skirt assembly may include an inner skirt. Attaching the plurality of leaflets to the annular frame may include mounting the inner skirt to the inner surface of the frame and sewing the plurality of leaflets to the inner skirt.

[0053] In some embodiments, the skirt assembly may include an outer skirt. Attaching the skirt assembly to the annular frame may include placing the outer skirt around the outer surface of the frame and sewing the outer skirt to selected supports of the frame.

[0054] In some embodiments, the method may further include forming a laminate by electrospinning to form a first encapsulation layer, placing a textile layer on the first encapsulation layer, and forming a second encapsulation layer on the textile layer by electrospinning.

[0055] In some embodiments, the method may further include forming a laminate by immersing a textile layer in a liquefied polymer material and then allowing the liquefied polymer material to cure.

[0056] In some embodiments, the method may further include preparing a textile layer such that the first set of yarns and the second set of yarns are neither perpendicular to nor parallel to the longitudinal axis of the frame extending from the inlet to the outlet.

[0057] In some embodiments, preparing the textile layer may include weaving a first set of yarns and a second set of yarns at selected angles relative to the upper and lower edges of the fabric.

[0058] In some embodiments, preparing the textile layer may include cutting the fabric diagonally, with the fabric's weaving yarns extending perpendicular to the fabric's edges.

[0059] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

[0060] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

[0061] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle of 40 to 50 degrees relative to the longitudinal axis of the frame.

[0062] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at a 45-degree angle relative to the longitudinal axis of the frame.

[0063] In some implementations, the textile layer may have a weave density of less than 150 ppi.

[0064] In some implementations, the textile layer may have a weave density of 50 ppi or less.

[0065] In some implementations, the textile layer may have a weave density of about 30 to about 50 ppi.

[0066] In some embodiments, the textile layer may include a third set of yarns that extends axially and is woven together with the first and second sets of yarns to form a triaxially woven fabric.

[0067] In some embodiments, the third set of yarns may be made of an elastomer configured to stretch axially as the prosthetic valve changes from a radially expanded state to a radially compressed state.

[0068] In some embodiments, the third set of yarns can be fluffed up so that they remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0069] Some embodiments of this disclosure further relate to a method of assembling a prosthetic valve, including the steps of mounting a plurality of leaflets to an annular frame capable of radially expanding from a radially compressed state to a radially expanded state, and mounting a skirt assembly to the annular frame. The frame may have an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end. The plurality of leaflets may be configured to regulate blood flow from the inflow end to the outflow end of the frame. The skirt assembly may include a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers may be made of an elastomer, and the textile layer may include a first set of yarns and a second set of yarns interwoven with the first set of yarns. The first and second sets of yarns may be neither perpendicular nor parallel to the longitudinal axis.

[0070] In some implementations, the textile layer may have a weave density of less than 150 ppi.

[0071] In some implementations, the textile layer may have a weave density of 50 ppi or less.

[0072] In some implementations, the textile layer may have a weave density of about 30 to about 50 ppi.

[0073] In some embodiments, the skirt assembly may include an outer skirt mounted to the outer surface of the frame.

[0074] In some implementations, the skirt assembly may include an inner skirt mounted to the inner surface of the frame.

[0075] In some implementations, the textile layer may be a woven layer.

[0076] In some implementations, the textile layer may be a woven layer.

[0077] In some implementations, the textile layer may be a knitted layer.

[0078] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

[0079] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

[0080] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at an angle of 40 to 50 degrees relative to the longitudinal axis of the frame.

[0081] In some embodiments, the yarns of the first set of yarns and the second set of yarns may be oriented at a 45-degree angle relative to the longitudinal axis of the frame.

[0082] In some embodiments, the yarns of the first set of yarns and the second set of yarns may have about 10 to about 50 filaments per yarn.

[0083] In some implementations, the first and second sets of yarns may each have approximately 20 filaments.

[0084] In some implementations, the yarn filaments may have a thickness ranging from about 8 micrometers to about 16 micrometers.

[0085] In some implementations, the yarn filaments can have a thickness of about 10 micrometers.

[0086] In some embodiments, at least some of the yarns in the first set of yarns and the second set of yarns can be fluffed up so that they can remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0087] In some implementations, the textile layer may include leno yarn.

[0088] In some embodiments, the yarns of the first group of yarns and the second group of yarns may include first type yarns and second type yarns. The first type yarns may be inelastic or less elastic than the second type yarns.

[0089] In some embodiments, the textile layer may include a third set of yarns that extends axially and is woven together with the first and second sets of yarns to form a triaxially woven fabric.

[0090] In some embodiments, the third set of yarns may be made of an elastomer configured to stretch axially when the prosthetic valve is radially compressed from a radially expanded state to a radially compressed state.

[0091] In some embodiments, the third set of yarns can be fluffed up so that they remain twisted or coiled when the prosthetic valve is in a radially expanded state, and are pulled until untwisted or uncoiled when the prosthetic valve is in a radially compressed state.

[0092] In some implementations, when the prosthetic valve is in a radially compressed state, the skirt assembly can be axially extended up to at least 40% of its initial length when the prosthetic valve is in a radially expanded state. Attached Figure Description

[0093] Figure 1 A side elevation view of an exemplary embodiment of an implantable prosthetic valve is shown.

[0094] Figure 2 Showing Figure 1 A top-view perspective view of the prosthetic valve.

[0095] Figure 3 Showing Figure 1 An exemplary framework for a prosthetic valve.

[0096] Figure 4 Showing Figure 3 The flat view of the frame shown.

[0097] Figure 5 Showing along Figure 1 The line cut from 5-5 Figure 1 A cross-sectional view of the prosthetic valve.

[0098] Figure 6 Showing according to manufacturing Figure 1 An exemplary process for the inner skirt of a prosthetic valve, the formation of a first covering member on the axial length.

[0099] Figure 7 This illustrates an exemplary process for manufacturing the inner skirt, showing the fabric layers in... Figure 6 Placement on the first covering member shown.

[0100] Figure 8 This illustrates an exemplary process for manufacturing the inner skirt, in which multiple masks are used. Figure 7 The placement on the fabric layer shown.

[0101] Figure 9 This illustrates an exemplary process for manufacturing the inner skirt, in which the second cover member has Figure 8 The masking element is formed on the fabric layer shown.

[0102] Figure 10 This illustrates an exemplary process for manufacturing the inner skirt, in the formation of... Figure 9 The second covering component is shown after the removal of the masking component.

[0103] Figure 11 A cross-sectional view of a portion of the inner skirt is shown, which has a window on one side that exposes the bottommost woven fabric.

[0104] Figure 12 Shown in Figure 11 The window shown shows the stitching thread being threaded through the woven fabric.

[0105] Figure 13 Showing will Figure 11 The inner skirt shown is sutured to the adjacent strut of the prosthetic valve frame.

[0106] Figure 14 This is a perspective view of a prosthetic valve according to another embodiment.

[0107] Figure 15 It is along Figure 14 The line cut at 15-15 Figure 14 Cross-sectional view of the prosthetic valve.

[0108] Figure 16A and Figure 16B The images show portions of the two interlaced yarns of the skirt when the skirt is in a relaxed state (corresponding to the radial expansion state of the prosthetic valve) and an axially stretched state (corresponding to the radial compression state of the prosthetic valve).

[0109] Figure 17 A method for using according to one embodiment is shown. Figures 14-15 The section of the woven layer of the outer skirt of the prosthetic valve. Detailed Implementation

[0110] Figures 1-2 Two different views of a prosthetic valve 10 according to one embodiment are shown. The valve shown is suitable for implantation in a natural aortic valve annulus, but in other embodiments, it may be suitable for implantation in other natural valve annulus of the heart. The valve 10 may have several main components: a stent or frame 12, a valve structure 14, and a skirt assembly 15. The skirt assembly 15 may include an inner skirt 16 and optionally an outer skirt 18.

[0111] Valve structure 14 (or leaflet structure) may include three leaflets 40 that together form the leaflet structure (but more or fewer leaflets may also be used), and the leaflet structure may be arranged to collapse in a tricuspid valve arrangement. Valve structure 14 is configured to allow blood to flow through prosthetic valve 10 in a direction from the inlet end 48 of the prosthetic valve to the outlet end 50 of the prosthetic valve, and to prevent blood from flowing through the prosthetic valve in a direction from the outlet end 50 to the inlet end 48.

[0112] Each leaflet 40 is desirablely to have a curved, generally U-shaped inlet edge or cusp edge 52. In this way, the inlet edge of the valve structure 14 has an undulating, curved fan-shaped shape. By forming leaflets with a fan-shaped geometry, stress on the leaflets can be reduced, thereby improving valve durability. Furthermore, by means of the fan-shaped shape, folds and ripples at the ventral side of each leaflet (the central region of each leaflet) that lead to early calcification in these areas can be eliminated or at least minimized. The fan-shaped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller, more uniform profile at the inlet end of the valve. The leaflet 40 can be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118 (which is incorporated herein by reference).

[0113] bare frame 12 in Figure 3 As shown in the illustration. In the depicted embodiment, the frame 12 has an annular shape defining an inlet end 54 and an outlet end 56, and includes a plurality of struts (or frame members). The frame 12 may be formed by a plurality of circumferentially spaced slits or fusion windows 20 (three in the illustrated embodiment), the slits or fusion windows 20 being adapted to mount the fusion 58 of the valve structure 14 to the frame, as more fully described in U.S. Patent Publication No. 2012 / 0123529 (which is incorporated herein by reference).

[0114] The frame 12 can be made of any of a variety of suitable malleable expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When constructed of a malleable expandable material, the frame 12 (and therefore the valve 10) can be coiled into a radially compressed state on the delivery catheter and then expanded within the patient by an inflatable balloon or other suitable expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the valve 10) can be coiled into a radially compressed state and restrained in the compressed state by a sheath or equivalent mechanism inserted into the delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0115] Suitable malleable expansion materials that can be used to form the frame 12 include, but are not limited to, stainless steel, nickel-based 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, such as MP35N. TM (A trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TMUNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using MP35N to form the frame 12 provides superior structural performance compared to stainless steel. In particular, when MP35N is used as the frame material, the same or better resistance to radial and compressive forces, fatigue, and corrosion is achieved with less material required. Furthermore, due to the reduced material requirement, the frame's curl profile can be reduced, resulting in a smaller profile valve assembly for percutaneous delivery to the treatment site within the body.

[0116] refer to Figure 3 and Figure 4 The frame 12 in the illustrated embodiment includes a lower first row of angled supports 22 arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row of angled supports 24 extending circumferentially; a third row of angled supports 26 extending circumferentially; a fourth row of angled supports 28 extending circumferentially; and a fifth row of angled supports 32 extending circumferentially at the outflow end 56 of the frame. A plurality of substantially straight axially extending supports 34 can be used to interconnect the supports 22 of the first row I with the supports 24 of the second row II. The fifth row of angled supports 32 is attached to the fourth row of angled supports 28 via a plurality of axially extending window frame portions 30 (which define connecting windows 20) and a plurality of axially extending supports 31. Each axial support 31 and each frame portion 30 extends from a position defined by the convergence of the lower ends of two angled supports 32 to another position defined by the convergence of the upper ends of two angled supports 28.

[0117] Each connecting window frame portion 30 mounts its respective connecting 58 to the leaflet structure 14. Thus, each frame portion 30 is fixed at its upper and lower ends to adjacent rows of struts to provide a robust configuration that enhances the valve's fatigue resistance under cyclic loading compared to known cantilever struts used to support the leaflet structure connecting assemblies. This configuration reduces the frame wall thickness, thereby resulting in a smaller valve curl-up diameter. In a specific embodiment, the frame 12 (measured between the inner and outer diameters) Figure 3 The thickness T is approximately 0.48 mm or less.

[0118] The supports and frame sections of the frame together define multiple open units of the frame. At the inflow end of frame 12, supports 22, 24, and 34 define a lower row of units that define an opening 36. Second row supports 24, third row supports 26, and fourth row supports 28 define two intermediate row units that define openings 38. Fourth row supports 28 and fifth row supports 32, together with frame section 30 and supports 31, define an upper row of units that define an opening 60. The opening 60 is relatively large and is sized to allow portions of the leaflet structure 14 to protrude into or through the opening 60 when frame 12 is rolled up, thus minimizing the roll-up profile.

[0119] like Figure 4 As shown, the lower end of strut 31 is connected to two struts 28 at a node or junction 44, and the upper end of strut 31 is connected to two struts 32 at a node or junction 46. The thickness of strut 31 can be less than the thickness of junctions 44, 46. When frame 12 is in a curled state, junctions 44, 46, together with junction 64 (each junction connecting two adjacent struts 32), prevent opening 60 from completely closing. Therefore, the geometry of strut 31 and junctions 44, 46, and 64 helps to create sufficient space in opening 60 in the curled state to allow portions of the leaflet to protrude (i.e., bulge) outward through the opening. This allows the valve to curl to a relatively small diameter compared to confining all leaflet material within the curled frame.

[0120] Frame 12 is configured to prevent or minimize possible over-expansion of the valve under a predetermined balloon pressure, particularly at the outflow 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. The larger the angle, the greater the force required to open (expand) the frame. Therefore, the angles between the frame struts can be selected to limit the 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 expands to its functional size, and even more specifically, at least 120 degrees or greater when the frame expands to its functional size. U.S. Patent Publication No. 2012 / 0123529 further describes frame 12 and other configurations of frames that can be incorporated into prosthetic heart valves.

[0121] like Figures 1-2As shown, the skirt assembly 15 may include an inner skirt 16 located inside the frame 12 and an outer skirt 18 located outside the frame 12. The outer skirt 18 may include a plurality of circumferentially spaced extensions or protrusions 66 and recesses 68 formed along the outflow edge (upper edge in the illustrated embodiment) of the outer skirt between adjacent protrusions. In other embodiments, the outer skirt 18 may have a straight outflow edge without any protrusions or recesses (e.g., Figure 14 (Outer skirt 202).

[0122] The inflow (lower) edge and outflow (upper) edge of the outer skirt 18 can be secured to the frame 12 and / or the inner skirt 16 by, for example, heat bonding, adhesives, and / or suturing. As shown in the illustrated embodiment, the protrusions 66 along the outflow edge of the outer skirt 18 can be secured to the struts of the frame with sutures 70, while the recesses 68 between adjacent protrusions may not be attached to the frame 12 and the inner skirt 16. The outer skirt 18 acts as a sealing member of the prosthetic valve 10 by sealing against the tissue of the natural valve annulus, thereby helping to reduce paravalvular leakage through the prosthetic valve 10.

[0123] In some implementations, such as Figures 1-2 As shown, the outer skirt 18 can be configured to extend radially outward from the frame 12 when the prosthetic valve 10 is in a radially expanded configuration. Optionally, the outer skirt 18 can be configured to form a snug fit with the frame 12 such that when the prosthetic valve 10 is in a radially expanded configuration, the outer skirt 18 abuts against the outer surface of the frame 12 (e.g., ...). Figure 14 The outer skirt 18 can be formed from any of a variety of synthetic materials or natural tissues (e.g., pericardial tissue). Suitable synthetic materials include any of a variety of biocompatible fabrics (e.g., PET fabrics) or non-woven films, including any of the materials disclosed below for the reinforcing layer 88 of the inner skirt 16. Further details of the outer skirt 18 are also disclosed in U.S. Patent Publication No. 2012 / 0123529.

[0124] like Figures 1-2 As shown, in the illustrated embodiment, the inner skirt 16 extends from the entrance end 54 of the frame to the angled post 28 of the fourth row IV. In other embodiments, the inner skirt 16 may extend from the entrance end 54 of the frame to a position not reaching the fourth row IV post (e.g., extending to the second row II or third row III post), or the inner skirt may extend the entire height of the frame 12 (e.g., from the entrance end 54 to the exit end 56). In alternative embodiments, the inner skirt 16 may be positioned and / or sized to be positioned relative to the frame 12. Figures 1-2 It extends on the different configurations shown. For example, in some embodiments, the inflow end of the inner skirt 16 may be axially spaced from the inlet end 54 of the frame 12.

[0125] While the inner skirt 16 is generally tubular or cylindrical (forming a complete circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the valve), the inner skirt 16 does not necessarily extend circumferentially through 360 degrees along the inner surface of the frame 12. In other words, the inner skirt 16 may have a non-circular cross-sectional profile (in a plane perpendicular to the axis of the valve lumen). The inner skirt 16 may initially be formed as a flat strip and then coupled together by opposite edge portions (e.g., by sewing, thermal bonding, and / or adhesive) to form an annular shape. Alternatively, the inner skirt 16 may be formed directly into an annular shape, for example, by constructing the inner layer 16 on a cylindrical mandrel as described below.

[0126] refer to Figure 5 The inner skirt 16 has a first side 72 defining an inner surface of the inner skirt 16 and a second side 74 defining an outer surface of the inner skirt 16. As described more fully below, the frame-facing side 74 of the inner skirt 16 may have one or more windows or openings through which an additionally encapsulated fabric layer can be exposed. Seams can be threaded through these windows and the fabric layer of the inner skirt 16 to secure the inner skirt 16 to the frame 12. For illustrative purposes, Figure 5 The outer skirt section 18 is omitted.

[0127] When the inner skirt 16 is mounted to the frame 12, the first side 72 of the inner skirt 16 faces inward toward the leaflet structure 14 located inside the prosthetic valve 10, while the second side 74 of the inner skirt 16 faces outward toward the inner surface of the frame 12. In a specific embodiment, the inner skirt 16 may include a reinforcing layer 88 sandwiched between a first covering member 84 and a second covering member 86. In a representative embodiment, the reinforcing layer 88 may be a fabric layer. The first covering member 84 and the second covering member 86 may also be referred to as encapsulation layers and form the inner and outer layers of the illustrated inner skirt 16, respectively. In a specific embodiment, the inner surface of the reinforcing layer 88 may be completely covered by the first covering member 84 on the first side 72, while the outer surface of the reinforcing layer 88 is partially covered by the second covering member 86 on the second side 74, wherein the second covering member 86 defines one or more windows or openings 90 on the second side 74 that expose the reinforcing layer 88 (see...). Figure 10 ).

[0128] The reinforcing layer 88 strengthens the inner skirt 16 to resist tearing. It also acts as an anchoring layer for sewing the inner skirt 16 to the frame 12 and for supporting the cusp margin of the leaflet 40, as described more fully below. In addition, the reinforcing layer 88, in conjunction with the encapsulation layers 84 and 86, helps to reduce (or prevent) paravalvular leakage through the prosthetic valve 10 when in an expanded configuration.

[0129] In some embodiments, the reinforcing layer 88 may comprise a woven fabric made of various types of natural or synthetic fibers (or filaments, yarns, or strands), including but not limited to: gauze, PET fibers (e.g., polyester), polyester fibers, polyamide fibers, ultra-high molecular weight polyethylene (UHMWPE) fibers, etc. In some embodiments, the reinforcing layer 88 may have a knitted or braided structure rather than a woven structure. Alternatively, the reinforcing layer 88 may be a woven, knitted, or braided structure formed from metal filaments or threads (e.g., nitinol, stainless steel, or titanium filaments or threads), glass filaments or threads, carbon filaments or threads, or ceramic (e.g., alumina) filaments or threads. Alternatively, the reinforcing layer 88 may comprise filaments, fibers, yarns, or strands made of any of the above materials, wherein the filaments, fibers, yarns, or strands are not necessarily interwoven, braided, or knitted together. For example, the reinforcing layer 88 may comprise a layer of parallel filaments, fibers, yarns, or strands, or (more) layers of filaments, fibers, yarns, or strands stacked on top of each other. In some embodiments, the reinforcing layer 88 may comprise any of a variety of nonwoven fabrics, such as felt. The thickness of the reinforcing layer 88 may vary, but may be less than 6 mils, and preferably less than 4 mils, and even more preferably about 2 mils.

[0130] Optionally, reinforcing layer 88 may comprise one or more layers or films formed from any of a variety of semi-crystalline polymer materials or thermoplastics having aligned or partially aligned (e.g., parallel) molecular chains. Such materials may exhibit anisotropic mechanical properties, such as increased mechanical strength along the longitudinal direction of the molecular chains. Suitable semi-crystalline polymer materials may include, for example, PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc., and layers or films of these materials may be located between and encapsulated by encapsulation layers 84, 86 to reinforce inner skirt 16. Unless otherwise specified, for illustrative purposes, fabric layers are described in the following description as exemplary reinforcing layers, while it should be understood that non-woven layers with sufficiently high tensile strength may also be used as reinforcing layers.

[0131] Encapsulation layers 84 and 86 can be made of any suitable biocompatible material. Desiredly, encapsulation layers 84 and 86 contain a material that is relatively less abrasive than the fabric layer to reduce wear on the leaflet 40. Encapsulation layers 84 and 86 can include, for example, membranes or films formed of nonwoven fibers or non-fibrous materials. The biocompatible material used to form layers 84 and 86 can be a non-absorbable polymer material (i.e., a material that does not dissolve once implanted) and can be an elastomer. Additionally, either encapsulation layer 84 or 86 can have a porous microstructure that promotes inward growth of surrounding tissue to facilitate fixation of the prosthetic valve 10 within the body cavity.

[0132] Examples of encapsulation layer materials include, but are not limited to, ePTFE, non-expanded porous PTFE, polyester or expanded PTFE yarn, PTFE, ultra-high molecular weight polyethylene (UHMWPE), other polyolefins, composite materials (such as ePTFE with PTFE fibers), or UHMWPE films embedded with UHMWPE fibers, polyimide, silicone, polyurethane, hydrogel, fluoroethyl polypropylene (FEP), polypropylfluorinated amines (PFA), other related fluorinated polymers, or various combinations of any of these materials. In specific embodiments, encapsulation layers 84, 86 may be formed from corresponding tubes made of a suitable polymer material (e.g., ePTFE tube or UHMWPE tube) that can bond together when subjected to heat treatment. In some embodiments, encapsulation layers 84, 86 may be formed from the same type of material, but different materials may be used to form the encapsulation layers depending on the specific application.

[0133] Microporous ePTFE tubes can be manufactured using a variety of known methods. Expanded PTFE is typically produced by mixing granular dried polytetrafluoroethylene resin with a liquid lubricant to form a viscous slurry. The mixture can be poured into a mold, typically a cylindrical mold, and then compressed to form a cylindrical preform. The preform can then be ram-extruded into a tubular or sheet structure, referred to in the art as an extrusion. The extrusion contains an extruded PTFE-lubricant mixture referred to as “wet PTFE.” Wet PTFE has a microstructure of coherent PTFE resin particles aggregated in a highly crystalline state. After extrusion, the wet PTFE can be heated to a temperature below the flash point of the lubricant to cause the major portion of the lubricant from the PTFE extrusion to evaporate. The resulting PTFE extrusion, lacking the major portion of the lubricant, is referred to in the art as dry PTFE. Dry PTFE can then be expanded uniaxially, biaxially, or radially using suitable machinery known in the art. Expansion typically occurs at elevated temperatures, for example, above room temperature but below 327°C, which is the melting point of PTFE. Uniaxial, biaxial, or radial expansion of dry PTFE results in the formation of aggregated, condensed PTFE resin fibers emanating from the nodes (regions of aggregated PTFE), with the fibers oriented parallel to the axis of expansion. Once expanded, the dry PTFE is referred to as expanded PTFE (“ePTFE”) or microporous PTFE.

[0134] UHMWPE is composed of very long polyethylene chains with molecular weights in the millions, typically between 2 million and 6 million. It exhibits high resistance to corrosive chemicals, extremely low hygroscopicity, and an extremely low coefficient of friction. It is self-lubricating and highly abrasion-resistant. UHMWPE is manufactured through compression molding, stamping, gel spinning, and sintering. UHMWPE is commercially available as a powder, in sheet or rod form, and as a fiber.

[0135] Encapsulation layers 84 and 86 can be formed using a variety of methods. For example, in one example, encapsulation layers 84 and 86 can be formed using an electrospinning process, which uses electricity to draw charged wires from a polymer solution or polymer melt to fiber diameters on the order of hundreds of nanometers. In another example, encapsulation layers 84 and 86 can be formed using centrifugal spinning. In centrifugal spinning, the spinning fluid is placed in a rotating spinneret. When the rotational speed reaches a critical value, centrifugal force overcomes the surface tension of the spinning fluid to eject a liquid jet from the nozzle tip of the spinneret. The jet then undergoes a stretching process and is eventually deposited on a collector to form solidified nanofibers. In yet another example, encapsulation layers 84 and 86 can be formed using atmospheric plasma spraying (APS), a special variation of the thermal spraying process. APS utilizes an electric arc to ionize flowing process gas, and the hot gas flow can be controlled to melt a very wide range of powder raw materials, thereby coating the target object with a high-quality coating. In other embodiments, the encapsulation layers 84, 86 can be formed using any other suitable method, including, for example, dip coating, spray coating, or melt spinning. For instance, either of the encapsulation layers 84, 86 can be formed by immersing the fabric layer 88 in a liquefied polymer material and then allowing the liquefied polymer material to solidify.

[0136] Figures 6-10 An exemplary process for forming the inner skirt 16 is shown. While the use of electrospinning is described below, it is exemplary in nature and not intended to be limiting. It should be understood that other processes for depositing polymer layers, such as centrifugal spinning, APS, dip coating, and other processes as described above, may also be used.

[0137] First, such as Figure 6As depicted, a first cover member 84 comprising a first coating material can be deposited circumferentially around the outer surface of a cylindrical mandrel 100 by electrospinning (or using other techniques). As known in the art, an electrospinning system may include a spinneret for extruding a polymer solution or polymer melt to form fibers. To deposit the first cover member 84 on the mandrel 100, the electrospinning system may be configured to cause the fibers to be extruded from the spinneret in a circular motion around the mandrel 100. Alternatively, the fiber extrusion spinneret may be configured to remain stationary while the mandrel 100 is positioned in front of the spinneret and rotates about its longitudinal axis.

[0138] Second, such as Figure 7 As depicted herein, fabric layer 88 may be placed on the first covering member 84. Fabric layer 88 may be in the form of a sheet of fabric material tightly wrapped around the first covering member 84. For example, as described above, fabric layer 88 may have a woven structure comprising warp and weft fibers extending perpendicularly to each other. In an alternative embodiment, fabric layer 88 may also be deposited on the first covering member 84. It should be understood that this construction method is not limited to the embodiment where the reinforcing layer is a woven fabric; this method can be used to form a skirt, wherein the reinforcing layer may take any form disclosed herein. For example, as described above, fabric layer 88 may comprise a nonwoven fabric, which itself may be formed by electrospinning and desirably have a relatively higher tensile strength than layers 84, 86. In another example, layer 88 may be a pre-formed woven material wrapped around the first covering member 84. In yet another example, layer 88 may be formed by weaving one or more yarns or filaments around the first covering member 84 to form a woven layer around the first covering member.

[0139] Third, such as Figure 8 As depicted, one or more masking elements 92 can be placed on the fabric layer 88 at a selected area 94 of the fabric. Fourth, as... Figure 9 As depicted, the second covering member 86, comprising a second coating material, can be deposited onto the masking fabric layer 88 via electrospinning (or using other techniques). Next, as... Figure 10 As depicted, the masking element 92 is removed after the second covering member 86 is deposited. This creates one or more windows 90 corresponding to the selected area 94, such that the windows 90 expose the bottommost woven layer 88.

[0140] exist Figures 8-9In the illustrated embodiment, the masking member 92 may temporarily cover selected areas 94 of the fabric layer 88 and prevent these selected areas 94 from being deposited with the second coating material of the second covering member 86. Alternatively, the selected areas 94 may be functionally shielded without the need for the physical masking member 94. For example, the relative movement and operation (e.g., activation and / or deactivation) of the fiber extrusion spinneret about the mandrel 100 may be programmed so that the second coating material of the second covering member 86 may be deposited only on the portions of the fabric layer 88 outside the selected areas 94.

[0141] exist Figures 8-9 In the embodiment depicted, three annular bands of the masking member 92 are shown, each corresponding to one of three selected areas 94 along the outer periphery of the fabric layer 88. Therefore, as... Figure 10 As depicted, three annular windows 90 are created after the removal of the masking element 92. In other embodiments, any of the masking elements 92 may have a non-annular shape so that the corresponding selected area 94 and the resulting window 90 do not completely surround the fabric layer 88. For example, any of the masking elements 92 may be shaped at a customized location to create a customized window 90. Additionally, although three windows 90 are shown in the illustrated embodiment, the inner skirt may have fewer or more windows, and the windows may be positioned at arbitrary locations along the skirt. For example, in some embodiments, the inner skirt may have one or more rows of circumferentially extending windows, each row having multiple circumferentially spaced windows. In other embodiments, one or more windows may be formed along the entrance edge and / or exit edge of the inner skirt.

[0142] Although not shown, it should be understood that anchoring mechanisms may be provided in each of the above steps to temporarily secure the position of each layer. As a non-limiting example, a PTFE tape layer may be wrapped around one or both ends of the second cover member 86 to help secure the position of the second cover member 86 to the bottommost layer of the assembly and to the mandrel 100 during subsequent processing.

[0143] In a representative embodiment, the fabric layer 88 has a plurality of openings that allow the first covering member 84 and the second covering member 86 to be fused together through these openings. In one example, the openings in the fabric layer 88 can be created by weaving, braiding, or knitting fibers or yarns to form the fabric layer. In another example, the fabric layer 88 can have a nonwoven porous structure with openings. In yet another example, when the fabric layer is formed using a nonwoven fabric (e.g., felt), the openings in the fabric layer 88 can be formed by cutting (e.g., laser cutting) openings in the fabric layer.

[0144] In one exemplary embodiment, during the process of depositing the second cover member 86 onto the masked fabric layer 88, fusion between the first cover member 84 and the second cover member 86 through openings in the braided layer 88 can occur simultaneously. As the second coating material extruded from the spinneret is deposited onto the fabric layer 88 to form the second cover member 86, some of the second coating material can penetrate those openings in the fabric layer 88 and fuse with the fibers in the first cover member 84.

[0145] In other embodiments, the fusion between the first covering member 84 and the second covering member 86 can occur after the second covering member 86 is deposited on the masked fabric layer 88. For example, Figure 10 The assembly shown may undergo an encapsulation process, whereby the assembly is subjected to heat and / or pressure to bond the first cover member 84 and the second cover member 86 to each other through openings in the fabric layer 88. Additionally, the fabric layer 88 may have a shorter axial length than the first cover member 84 and the second cover member 86 to facilitate bonding of the first cover member 84 and the second cover member 86 at their respective ends, thereby encapsulating the fabric layer 88 therebetween. Similar encapsulation processes are described in U.S. Patent Publications 2014 / 0209238 and 2016 / 0317305 (both incorporated herein by reference).

[0146] In an exemplary embodiment, ePTFE can be used as a first coating material for depositing the first cover member 84 and / or a second coating material for depositing the second cover member 86. Alternatively, other materials, such as UHMWPE, polyurethane composites, or any of the other non-absorbent polymer materials described above, can also be used. The inner skirt 16 may preferably have a laminated structure in which a fabric layer 88 is sandwiched between two fused layers, namely, the first cover member 84 and the second cover member 86. In some embodiments, the same materials can be used to deposit the first cover member 84 and the second cover member 86. Due to interlayer fusion or bonding, the first cover member 84 and the second cover member 86 can be merged together to effectively create a unitary structure (i.e., no physical interlayer boundaries), in which the fabric layer 88 is encapsulated within the unitary structure. The density of the first cover member 84 may be the same as or different from the density of the second cover member 86. In other embodiments, the first coating material used to deposit the first cover member 84 may be different from the second coating material used to deposit the second cover member 86.

[0147] After the first cover member 84 and the second cover member 86 are securely fused together to encapsulate the fabric layer 88, the inner skirt 16 can be removed from the mandrel 100. One or both ends of the inner skirt 16 can be trimmed to achieve the desired inner skirt height. The inner skirt 16 is then installed onto the frame 12.

[0148] although Figures 6-10 The above description illustrates the process of forming the annular inner skirt 16; however, it should be understood that the same process can be used to form the outer skirt 18. Furthermore, as described above, the inner skirt 16 can initially be formed as a flat strip, and then formed into an annular shape by coupling its two opposing edges together. To form the flat strip, the first covering member 84 and the second covering member 86, as well as the fabric layer 88, can be constructed on a flat substrate, rather than on the cylindrical mandrel 100 as described above.

[0149] Although the above process utilizes the second cover member 86 concealed on the inner skirt 16 to create windows 90, it should be understood that other methods can be used to create these windows 90. For example, the second cover member 86 can initially be deposited on the entire surface of the fabric layer 88. Then, selected areas 94 on the second cover member 86 can be located and removed, for example, by laser cutting, chemical etching, or other means. Thus, windows 90 can be created at selected areas 94 on the second cover member 86, thereby exposing the lowermost fabric layer 88 therein. In another example, the second cover member 86 can be prefabricated such that it lacks the second coating material in selected areas 94. The prefabricated second cover member 86 can then be wrapped around the fabric layer 88. Thus, the fabric layer 88 can be exposed by the windows 90 created at selected areas 94. The assembly (first cover member 84, fabric layer 88, and second cover member 86) can then undergo a heat- and / or pressure-based encapsulation process as described above, thereby bonding the first cover member 84 and the second cover member 86 together.

[0150] The inner skirt 16 can be sewn to the frame 12 at the position of the window 90. For example, the inner skirt 16 can be placed inside the frame 12. The positions of the windows 90 can be arranged to roughly correspond to the first row of pillars 22, the third row of pillars 26, and the fourth row of pillars 28, respectively, but other configurations can also be used. The inner skirt 16 can also be secured to the pillars of the first, third, and fourth rows of pillars by stitches extending around the pillars and passing through the fabric layer 88 at the position of the window 90, as follows. Figures 11-13 Further described. Since the windows in the illustrated embodiment extend continuously around the entire perimeter of the inner skirt, continuous circumferentially extending whip stitches can be formed along each row of the pillars and at each window 90 in the fabric layer 88.

[0151] As described above, the window 90 can be created at a selected location and can have any of a variety of shapes, allowing the inner skirt to be sewn to different locations on the frame. For example, as described above, the inner skirt can be formed with rows of circumferentially spaced windows that allow for the placement of individual seams or stitches that do not extend continuously along the entire row of supports, such as at selected sections of the inner skirt that are more susceptible to tension or stress.

[0152] Figures 11-13 An exemplary method for sewing the inner skirt 16 to the frame 12 is shown. Figure 11 A cross-sectional view of a portion of an inner skirt 16 having a first side 72 and a second side 74 is shown. As described above, the inner skirt 16 has an encapsulated fabric layer 88 sandwiched between a first covering member 84 on the first side 72 and a second covering member 86 on the second side 74. Figure 11 A window 90 on the second covering member 86 of the inner skirt 16 is also depicted, exposing the lowest fabric layer 88. When the encapsulating layers 84, 86 are formed using the same material, the interlayer boundaries (as shown by dashed lines) may not exist, and the encapsulating layers 84, 86 may be fused or bonded together to form a single, integral structure encapsulating the fabric. In the depicted embodiment, the fabric layer 88 shows a woven structure comprising woven filaments, fibers, or yarns 96. As described below, the woven filaments 96 are expected to have sufficient strength to act as anchors to hold the seams 98 in place.

[0153] Figure 12 The diagram schematically illustrates how a suture 98 is threaded through a window 90 between the fabric layer 88 and the first covering member 84. In the depicted embodiment, the suture 98 is attached to a needle 102. The tip 108 of the needle 102 is desiccated. By sliding the needle 102 from the second side 74 through the window 90 while applying a slight force at the needle tip 108, the first covering member 84 can be slightly pushed away from the fabric layer 88, thereby creating a space for the needle 102 to insert between the first covering member 84 and the fabric layer 88. As shown, the needle 102 and the attached suture 98 can slide into the fabric layer 88 from the first end 104 of the window 90, behind one or more filaments 96 (e.g., 96a and 96b) exposed by the window 90, and then slide out of the fabric layer 88 at the second end 106 of the window 80. In this way, the suture 98 does not extend through the entire thickness of the inner skirt 16. In some embodiments, the first cover member 84 may not pass through the insertion pin 102 (e.g., Figure 12 (As depicted in the image) separated from the fabric layer 88, in which case the needle 102 and the attached stitch 98 can partially pass through the thickness of the first covering member 84, but do not extend through the entire thickness of the inner skirt.

[0154] Figure 13The diagram schematically illustrates the stitching of the fabric layer 88 of the inner skirt 16 to the adjacent post 22 of the frame 12. Ideally, the first side 72 of the inner skirt 16 faces inward toward the leaflet structure 14 located inside the prosthetic valve 10, while the second side 74 of the inner skirt 16 faces outward toward the frame 12. By threading a needle 102 and the attached suture 98 through a window 90 between the fabric layer 88 and the first covering member 84, the woven filaments 96 (e.g., 96a and 96b) between the first end 104 and the second end 106 of the window 80 can collectively act as anchors to hold the suture 98 in place. The suture 98 can then be wrapped around the adjacent post 22, thereby securing these woven filaments (e.g., 96a and 96b) to the adjacent post 22. Thus, the inner skirt 16 can be securely attached to the frame 12. For illustrative purposes, Figure 13 Post 22 is depicted. It should be understood that the inner skirt 16 can be sewn to the other posts of the frame (e.g., 26, 28, 32) in a similar manner.

[0155] As described above, the fabric layer 88 can also have a nonwoven structure without obvious woven threads 96. In this case, the stitch 98 can be attached to a needle with a pointed tip. The needle can be used to pierce the fabric layer 88 and allow the stitch 98 to pass through the fabric layer. In this way, the portion of the fabric layer 88 located between the first end 104 and the second end 106 of the window 90 can act as an anchor, thereby holding the stitch 98, which in turn secures this portion of the fabric to the adjacent support 22. Thus, the inner skirt 16 can be securely attached to the frame 12.

[0156] Because the suture 98 is routed between the first covering member 84 and the fabric layer 88, it is not exposed on the first side 72 of the inner skirt 16. In other words, the suture 98 is covered by the first covering member 84. The inner surface of the fabric layer is also covered by the first covering member. Therefore, wear of the leaflet 40 due to repeated contact between the leaflet 40 and the inner skirt 16 and between the leaflet 40 and the suture 98 can be avoided during the working cycle of the prosthetic valve 10. Desiredly, the inner skirt 16 is sutured to the frame 12 only at one or more windows 90 on the second covering member 86, so that contact between the movable portion of the leaflet 40 and the suture 98 can be avoided. In addition, the first covering member 84 is expected to cover the entire extent of the inner surface of the fabric layer, or at least the portion of the fabric layer that would otherwise come into contact with the movable portion of the leaflet during the working cycle of the prosthetic valve. In some embodiments, the suture 98 may pass through the entire thickness of the inner skirt, for example, at a location on the inner skirt that will not come into contact with the movable portion of the leaflet.

[0157] As described above, the leaflets 40 can be secured to each other on their adjacent sides to form ferrules 58. Each ferrule 58 can be secured to a corresponding ferrule window 20 of the frame 12, as described in U.S. Patent Publication No. 2012 / 0123529. The inflow edge or cusp edge 52 of the leaflet 40 can be sewn to the inner skirt 16 along sutures that follow the curvature of the fan-shaped inflow edge of the leaflet structure. The fabric layer 88 provides the strength required to hold the sutures in place. Any suitable suture, such as Ethibond sutures, can be used to secure the leaflets 40 to the fabric layer 88 of the inner skirt.

[0158] In some embodiments, the inflow edge 52 of the leaflet 40 is secured to the inner skirt 16 before the inner skirt 16 is mounted to the frame. After the leaflet 40 is secured to the inner skirt 16, the inner skirt is then secured to the frame as described above, and the leaflet's ferrule 58 is mounted to the frame. In other embodiments, the inner skirt 16 may be mounted to the frame without being mounted to the leaflet, and then the inflow edge 52 of the leaflet is secured to the inner skirt.

[0159] In some embodiments, the inflow edge 52 of the leaflet 40 can be secured to the inner skirt via a thin PET reinforcing strip (not shown), as disclosed in U.S. Patent No. 7,993,394 (which is incorporated herein by reference). As disclosed in U.S. Patent No. 7,993,394, the reinforcing strip can be sutured to the inflow edge of the leaflet. The reinforcing strip and the lower edge of the leaflet can then be sutured to the inner skirt 16. The reinforcing strip is preferably secured to the inner surface of the leaflet 40 such that when the leaflet and the reinforcing strip are secured to the inner skirt, the inflow edge 52 of the leaflet is sandwiched between the reinforcing strip and the inner skirt. The reinforcing strip enables a strong suture and protects the pericardial tissue of the leaflet structure from tearing.

[0160] As described above, the outer skirt 18 can be constructed similarly to the inner skirt 16. That is, the outer skirt 18 can also have a reinforcing layer (e.g., fabric layer 88) sandwiched between the encapsulation layers 84 and 86. Similarly, a window 90 can be created on one of the encapsulation layers 84 and 86. Since the outer skirt 18 is attached to the outside of the frame 12, it is desirable to arrange the outer layer 18 such that the side of the frame 12 facing the outer skirt 18 with the window 90. In this arrangement, the outer skirt 18 can be attached to the frame 12 by sewing the encapsulated fabric layer 88 to the frame 12 through the window 90 facing the frame.

[0161] In another embodiment, the outer skirt 18 may have a fabric layer 88 coated with only one of the encapsulation layers 84, 86. When attaching the outer skirt 18 to the frame 12, the outer skirt 18 may be arranged such that the uncoated side of the fabric layer 88 faces inward toward the frame 12, such that the outer skirt 18 is attached to the frame 12 by sewing the exposed fabric layer 88 to the frame 12.

[0162] Alternatively, the outer skirt 18 may consist only of the fabric layer 88, without any encapsulating layers 84, 86. Thus, the outer skirt 18 can be directly sewn to the frame 12. Since the sutures on the outer skirt 18 are not subjected to repeated contact with the moving leaflets 40, the leaflet abrasion caused by the sutures on the outer skirt 18 may be less than that caused by the sutures on the inner skirt 16. By eliminating one or both encapsulating layers 84, 86, the outer layer 18 can be constructed to be thinner, thereby reducing its overall profile when the valve 10 is curled into a radially compressed state.

[0163] Figure 14 A prosthetic valve 200 according to another embodiment is shown. The prosthetic valve 200 may have the same characteristics as... Figures 1-2 The prosthetic valve 10 has the same structure and components, except that the prosthetic valve 200 includes a different outer skirt. Figures 1-2 and Figure 14 Common components are assigned the same reference number and are not described further.

[0164] The prosthetic valve 200 includes an outer skirt 202, which is constructed similarly to the inner skirt 16. Thus, the outer skirt 202 includes an inner encapsulation layer 204, an outer encapsulation layer 206, and a reinforcing layer 208 disposed between layers 204 and 206. The outer skirt is mounted on the outer side of the frame 12. The skirt 202 can be formed and mounted to the frame 12 using any of the techniques described above in conjunction with the skirt 16. Figure 15 A cross-sectional view of the frame 12 and the outer skirt 202 is shown, with other components of the prosthetic valve removed for illustrative purposes. The outer skirt 202 can be configured to fit the frame 12 such that when the prosthetic valve 200 is in a radially expanded configuration, the outer skirt 202 abuts against the outer surface of the frame 12, as... Figures 14-15 As shown in the image.

[0165] When the prosthetic valve 200 is radially compressed or rolled into a radially compressed state for delivery into the patient (e.g., on the balloon of the delivery device), the frame 12 elongates along the longitudinal axis L of the frame. When the prosthetic valve expands radially from a radially compressed state to a radially expanded state, the frame 12 shortens axially along the axis L. When the outer skirt is relatively tight or fits snugly around the frame 12, it is desirable that the outer skirt exhibit sufficient elongation or stretchability in the axial direction so as not to inhibit the elongation of the frame 12 during the roll-up of the prosthetic valve.

[0166] For this purpose, in a specific embodiment, the reinforcing layer 208 includes yarns, filaments, fibers, or threads that serve as the non-perpendicular upper edge 214 and lower edge 216 of the skirt 202, respectively. In other words, the yarns, filaments, fibers, or threads extend at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis L of the frame 12 (the yarns, filaments, fibers, or threads are neither parallel nor perpendicular to the longitudinal axis L of the frame).

[0167] In some embodiments, the reinforcing layer 208 comprises a textile with interwoven yarns, such as a woven, braided, or knitted structure. In a particular implementation, the reinforcing layer 208 comprises a fabric, such as a plain weave fabric, having a first set of yarns 210 woven together with a second set of yarns 212, wherein the yarns 210, 212 are not perpendicular to the upper edge 214 and lower edge 216 of the skirt, respectively. In other words, the yarns 210, 212 extend at an angle greater than 0 degrees and less than 90 degrees relative to the longitudinal axis L of the frame 12.

[0168] In some examples, yarns 210 and 212 extend at an angle ranging from 20 to 70 degrees relative to the upper edge 214 and the lower edge 216, and more preferably at an angle ranging from 30 to 60 degrees relative to the upper edge 214 and the lower edge 216, and more preferably at an angle ranging from 40 to 50 degrees relative to the upper edge 214 and the lower edge 216. In a specific implementation, yarns 210 and 212 extend at a 45-degree angle relative to the upper edge 214 and the lower edge 216 and the longitudinal axis L of the prosthetic valve.

[0169] In some embodiments, when the prosthetic valve is in an expanded state, the yarns 210, 212 are parallel to the struts of the frame to which the outer skirt is connected. In a specific embodiment, the skirt 202 is sewn to one or more of the angled struts 22, 24, 26, and 28 (see [link to specific embodiment]). Figure 4 The frame struts connected to the outer skirt are also referred to as "skirt support struts". Generally, although not necessarily, the skirt support struts are oriented at an angle of 45 degrees relative to the longitudinal axis L. However, in other embodiments, the skirt support struts and yarns 210, 212 may be at an angle greater than or less than 45 degrees relative to the longitudinal axis L, depending on the specific frame configuration.

[0170] Fabric layer 208 can be formed by weaving yarns at a selected angle (e.g., 45 degrees) relative to the upper and lower edges of the fabric. Alternatively, fabric layer 208 can be cut diagonally from a vertically woven fabric (where the yarns extend perpendicular to the edges of the material) such that the fibers extend at a selected angle (e.g., 45 degrees) relative to the upper and lower edges of the cut in the fabric. Yarns 210, 212 can comprise multifilament yarns (yarns containing multiple fibers or filaments) or monofilament yarns (yarns containing a single fiber or filament).

[0171] In some embodiments, the frame 12 may be partially rolled up during the assembly of the prosthetic valve, such that the skirt support struts are parallel to the yarns 210, 212 in the partially rolled-up state. The skirt 202 can then be mounted to the frame in the partially rolled-up state, such as via any of the techniques described herein.

[0172] Due to the orientation of the yarns relative to the upper and lower edges, the fabric layer can undergo a longer elongation in the axial direction (i.e., in a direction parallel to the axis L from the upper edge 214 to the lower edge 216). Therefore, when the metal frame 12 is rolled up, the skirt 202 can elongate axially with the frame, thus providing a more uniform and predictable roll profile. In the illustrated embodiment, each unit of the metal frame includes at least four angled struts (e.g., struts 22, 24, 26) that rotate in the axial direction (i.e., the angled struts become more aligned with the length of the frame). The angled struts of each unit function as a mechanism for rotating the yarns 210, 212 of the fabric layer 208 in the same direction as the struts, thereby allowing the skirt 202 to elongate along the length of the struts. This allows for a longer elongation of the skirt and avoids undesirable strut deformation when the prosthetic valve is rolled up. As described above, the encapsulation layers 204 and 206 can be made of any of the various elastomers (such as silicone or polyurethane) described above in conjunction with layers 84 and 86, which are capable of axial stretching when the prosthetic valve curls and the frame elongates.

[0173] The movement of yarns 210 and 212 during crimping is as follows Figure 16A and Figure 16B As shown. Figure 16A This shows portions of the two interlaced yarns 210, 212 when the outer skirt 202 is in a relaxed state (corresponding to the radially expanded state of the prosthetic valve 200). Figure 16B The diagram shows yarns 210 and 212 when the outer skirt 202 is in an axially stretched or elongated state (corresponding to the radially compressed state of the curled prosthetic valve). As shown, yarns 210 and 212 move from an orientation at a 45-degree angle relative to the longitudinal axis L towards a direction where the yarns are closer to being parallel to the longitudinal axis L.

[0174] Furthermore, the spacing between the woven (or braided or knitted) yarns can be increased to promote elongation of the skirt 202 in the axial direction. For example, in specific embodiments, the fabric layer 208 may have a weave density of less than 150 ppi (weft yarns per inch), more preferably less than 100 ppi, more preferably less than 70 ppi, and even more preferably 50 ppi or less. In some embodiments, the fabric layer 208 may have a weave density of about 30 to about 50 ppi compared to a known fabric skirt with a weave density of about 150 to 160 ppi. This configuration can allow the skirt 202 to stretch or elongate axially up to at least 40% of its initial length D (the initial length D is the distance between the upper edge 214 and the lower edge 216 of the skirt when the prosthetic valve is radially compressed) when the prosthetic valve is radially expanded. At such a low weave density, textiles with interlaced yarns (e.g., woven, braided, or knitted structures) may be unstable and tend to unravel. Advantageously, the encapsulation layers 204 and 206 encapsulate the yarn and act as a support mechanism to prevent relatively loose weaving from unraveling. Furthermore, in conjunction with the above... Figures 6-10 During the assembly process described, the first encapsulation layer ( Figures 6-10 Layer 84 can be attached to the textile reinforcement layer (layer 88), which helps stabilize the textile and prevents it from unraveling before the second encapsulation layer (layer 86) is formed or placed on the textile reinforcement layer. Furthermore, as described above, in some embodiments, the textile reinforcement layer can be woven around the first encapsulation layer supported on the mandrel 100, which further helps stabilize the woven fabric.

[0175] In some embodiments, yarns 210, 212 may have about 10 to about 50 filaments per yarn, with 20 filaments per yarn as a specific example. The thickness of the filaments in yarns 210, 212 may range from about 8 micrometers to about 16 micrometers, with 10 micrometers as a specific example. The filaments in yarns 210, 212 may be made of PET or UHMWPE, but the filaments may be made of any of the materials described above in conjunction with reinforcing layer 88.

[0176] In a specific embodiment, yarns 210, 212 may be texturized to increase the axial elasticity of the skirt. For example, the yarns may be bulked, wherein, for example, the yarns are twisted or coiled, heat-set, untwisted, or decoiled, such that the yarns retain their deformed (e.g., twisted or coiled) shape in a relaxed or unstretched configuration. When the prosthetic valve is radially compressed and the skirt 202 is axially stretched, yarns 210, 212 can straighten from their deformed (e.g., twisted or coiled) state to increase the elasticity and elongation of the skirt. Fabrics incorporating texturized yarns are further disclosed in U.S. Publication No. 2018 / 0206982 (which is incorporated herein by reference). Since yarns 210, 212 may be embedded within elastomeric encapsulation layers 204, 206, the encapsulation layers may be axially stretched to accommodate the straightening of yarns 210, 212. When the prosthetic valve is radially compressed, the use of such fluffy yarns 210, 212 allows the skirt 202 to be stretched axially by more than 40% of its initial length D.

[0177] In some embodiments, reinforcing layer 208 may be a fabric as described above, wherein additional one or more leno yarns are woven into the fabric to increase its stability. Any of a variety of leno weaving patterns may be used to weave leno yarns into fabric layer 208. Further details regarding fabric skirts incorporating leno weaving are disclosed in U.S. Publication No. 2019 / 0192296, filed July 24, 2019 (which is incorporated herein by reference).

[0178] In alternative embodiments, reinforcing layer 208 may have any structure and may be made of any of the materials described above in conjunction with reinforcing layer 88. Additionally, reinforcing layer 208 may be or include any of the textiles disclosed in U.S. Publication No. 2019 / 0192296 and U.S. Application No. 16 / 521,226. For example, reinforcing layer 208 may be a braided or knitted layer, wherein the braided or knitted layer is formed of yarns, filaments, or threads made of any of the aforementioned materials (including synthetic materials, metals, glass, carbon, or ceramics). Alternatively, reinforcing layer 208 may include filaments, fibers, yarns, or threads made of any of the aforementioned materials, wherein the filaments, fibers, yarns, or threads are not necessarily interwoven, braided, or knitted together. For example, reinforcing layer 208 may include a single layer of parallel filaments, fibers, yarns, or threads, or multiple layers of filaments, fibers, yarns, or threads stacked on top of each other.

[0179] In embodiments where the reinforcing layer 208 comprises a woven or knitted layer, the yarns, fibers, or threads may be oriented at a non-perpendicular angle (e.g., 45 degrees) relative to the upper edge 214 and lower edge 216 of the skirt 202 to promote skirt elongation during prosthetic valve curling. Similarly, in cases where the reinforcing layer is formed of unwoven, unknitted, or unknitted yarns, fibers, or threads, the yarns, fibers, or threads may be oriented at a non-perpendicular angle (e.g., 45 degrees) relative to the upper edge 214 and lower edge 216 of the skirt 202 to promote skirt elongation during prosthetic valve curling.

[0180] Figure 17 An example of a cross-section of the woven reinforcement layer 300 that can be used for the skirt 202 is shown. Figure 17 In the diagram, the x-axis represents the circumferential direction of the skirt 202, while the y-axis represents the axial direction of the skirt 202. The woven layer 300 is constructed from a first set of yarns 302 and a second set of yarns 304 woven together in a biaxial knitting pattern. Figure 17 The braided layer 300 is shown when the prosthetic valve is radially expanded. This can be a relaxed state of the braided layer, meaning that the braided layer is not stretched or elongated in any direction (or at least not stretched or elongated in the axial direction). As shown, yarns 302, 304 can be oriented at a 45-degree angle relative to the longitudinal axis L and can form a 90-degree braid angle 306. Therefore, in some embodiments, when the frame is in a radially expanded state, yarns 302, 304 can extend parallel to the struts of the frame 12.

[0181] The woven layer 300 can have a similar weave density as described above with respect to the fabric layer 208 to facilitate the elongation of the skirt. Thus, the woven layer 300 can have a weave density of less than 150 ppi, more preferably less than 100 ppi, more preferably less than 70 ppi, and even more preferably 50 ppi or less. In some examples, the woven layer 300 has a weave density of about 30 to about 50 ppi.

[0182] To stabilize the fabric, layer 300 may include a third set of axially extending yarns 308 woven together with yarns 302, 304. Yarns 308 may be made of an elastomer (e.g., polyurethane (PU), such as thermoplastic polyurethane (TPU)) that can be axially stretched when the prosthetic valve is radially compressed. Instead of being formed of an elastomer, or in addition to being formed of an elastomer, yarns 308 may be fluffed up as disclosed above to increase the elasticity of the skirt in the axial direction. Yarns 302, 304 may be made of the same material as yarns 308 or a different material.

[0183] Furthermore, reinforcing layers 208 and 300 can be blended textiles (e.g., woven, braided, or knitted structures) incorporating yarns or filaments of different materials with different material properties. For example, one or more yarns of the textile may be relatively inelastic or less elastic than one or more other yarns of the textile. In one implementation, for example, one or more relatively inelastic yarns may be made of PET, while one or more relatively elastic yarns may be made of PU, TPU, or other elastomers. The less elastic yarns may (according to a predetermined pattern) be selectively positioned within the textile to reinforce it, while the more elastic yarns may (according to a predetermined pattern) be selectively positioned to promote elasticity in a given direction (e.g., along the axial direction). For example, in Figure 17 In this embodiment, yarns 302 and 304 can be made of PET, while yarn 308 can be made of PU or TPU.

[0184] It should be understood that the inner skirt 16 may have any of the configurations disclosed above with respect to the outer skirt 202. For example, in some embodiments, the inner skirt 16 of the prosthetic valve 10, 200 may similarly have yarns, fibers or threads oriented at a non-perpendicular angle (e.g., 45 degrees) relative to the upper and lower edges of the skirt 16 to promote skirt elongation during prosthetic valve curling.

[0185] In some embodiments, the prosthetic valve 200 may have an inner skirt 16 comprising a conventional woven fabric without any encapsulating layer. In other embodiments, the prosthetic valve may not include an inner skirt 16.

[0186] General Considerations

[0187] It should be understood that the disclosed embodiments are suitable for delivering and implanting the prosthetic device into any of the heart's natural valve annulus (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus) and can be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatricular, etc.).

[0188] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of various disclosed embodiments, individually and in various combinations and sub-combinations of each other. Methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or the resolution of any one or more problems. Techniques from any example may be combined with techniques described in any one or more of the other examples. Given the many possible implementations to which the principles of the disclosed technology can be applied, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosed technology.

[0189] Although some operations in the disclosed embodiments are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach includes rearrangement unless the specific language used below requires a particular order. For example, in some cases, the sequentially described operations may be rearranged or performed concurrently. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, this specification sometimes uses terms such as “provide” or “implement” to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily identified by one of ordinary skill in the art.

[0190] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise. Additionally, the term “comprising” means “including.” Furthermore, the terms “coupled” and “connected” generally refer to electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and in the absence of specific contrasting language, the existence of intermediate elements between coupled or associated items is not excluded.

[0191] Orientation and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as “inner,” “outer,” “top,” “bottom,” “internal,” “external,” etc., may be used. Where applicable, such terms are used to provide a certain clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms do not imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the “upper” portion can become the “lower” portion by simply flipping the object. However, it is still the same portion, and the object remains the same. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0192] Given the numerous possible implementations to which the principles of the disclosed invention can be applied, it should be understood that the exemplified embodiments are merely preferred examples and should not be considered as limiting the scope of the invention. Specifically, the scope of the invention is defined by the appended claims. Therefore, we claim protection for all contents falling within the scope and spirit of these claims.

Claims

1. An implantable prosthetic valve, characterized by comprises: an annular frame radially expandable from a radially compressed state to a radially expanded state, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end; a plurality of leaflets positioned to regulate blood flow from the inflow end to the outflow end of the frame, and a skirt assembly comprising a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer, wherein the first encapsulation layer and the second encapsulation layer are made of an elastomer, and the textile layer comprises a first set of yarns and a second set of yarns interwoven with the first set of yarns, wherein the first set of yarns and the second set of yarns are not perpendicular and not parallel to the longitudinal axis, wherein the textile layer has a weave density less than 150 ppi, wherein the textile layer comprises a third set of yarns that extend axially and are woven together with the first set of yarns and the second set of yarns to form a tri-axial weave, wherein the third set of yarns are made of an elastomer configured to stretch axially when the prosthetic valve is radially compressed from the radially expanded state to the radially compressed state; and / or wherein the third set of yarns are lofted such that the third set of yarns can maintain a twisted or coiled state when the prosthetic valve is in the radially expanded state, and the third set of yarns are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

2. The prosthetic valve of claim 1, wherein wherein the textile layer has a weave density of 50 ppi or less.

3. The prosthetic valve of claim 2, wherein wherein the textile layer has a weave density of 30 to 50 ppi.

4. The prosthetic valve of any of the preceding claims, wherein wherein the skirt assembly comprises an outer skirt mounted to an outer surface of the frame.

5. The prosthetic valve of claim 1, wherein wherein the skirt assembly comprises an inner skirt mounted to an inner surface of the frame.

6. The prosthetic valve of claim 1, wherein wherein the textile layer is a woven layer.

7. The prosthetic valve of claim 1, wherein wherein the textile layer is a knit layer.

8. The prosthetic valve of claim 1, wherein wherein the textile layer is a braided layer.

9. The prosthetic valve of claim 1, wherein wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

10. The prosthetic valve of claim 9, wherein wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

11. The prosthetic valve of claim 10, wherein wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 40 to 50 degrees relative to the longitudinal axis of the frame.

12. The prosthetic valve of claim 11, wherein wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle of 45 degrees relative to the longitudinal axis of the frame.

13. The prosthetic valve of claim 1, wherein wherein the yarns of the first set of yarns and the second set of yarns have 10 to 50 filaments per yarn.

14. The prosthetic valve of claim 13, wherein wherein the yarns of the first set of yarns and the second set of yarns have 20 filaments per yarn.

15. The prosthetic valve of claim 13, wherein wherein the filaments of the yarns have a thickness ranging from 8 microns to 16 microns.

16. The prosthetic valve of claim 15, wherein wherein the filaments of the yarns have a thickness of 10 microns.

17. The prosthetic valve of claim 1, wherein wherein at least some of the yarns of the first and second sets of yarns are lofted such that at least some of the yarns of the first and second sets of yarns are capable of retaining a twisted or coiled state when the prosthetic valve is in the radially expanded state and are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

18. The prosthetic valve of claim 1, wherein wherein the textile layer comprises leno woven yarns.

19. The prosthetic valve of claim 1, wherein wherein the yarns of the first and second sets of yarns comprise first and second types of yarns, wherein the first type of yarn is inelastic or less elastic than the second type of yarn.

20. The prosthetic valve of claim 1, wherein wherein the skirt assembly is axially elongated by up to at least 40% of its original length when the prosthetic valve is in the radially expanded state when the prosthetic valve is in the radially compressed state.

21. An implantable prosthetic valve, comprising comprising: an annular frame radially expandable from a radially compressed state to a radially expanded state, the frame having an inflow end and an outflow end; a plurality of leaflets positioned to regulate blood flow from the inflow end to the outflow end of the frame; and an outer skirt mounted to an outer surface of the frame, the outer skirt comprising a laminate having a textile layer sandwiched between first and second encapsulation layers, wherein the first and second encapsulation layers are made of an elastomer and the textile layer comprises a first set of yarns and a second set of yarns interwoven with the first set of yarns; wherein the outer skirt has a first axial length when the prosthetic valve is in the radially expanded state and a second axial length when the prosthetic valve is in the radially compressed state, wherein the second axial length is greater than 40% of the first axial length, wherein the textile layer has a weave density of less than 150 ppi, wherein the textile layer comprises a third set of yarns that axially extend and are braided with the first and second sets of yarns to form a triaxial braid, wherein the third set of yarns are made of an elastomer configured to axially stretch when the prosthetic valve is radially compressed from the radially expanded state to the radially compressed state; and / or wherein the third set of yarns are lofted such that the third set of yarns are capable of retaining a twisted or coiled state when the prosthetic valve is in the radially expanded state and are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

22. The prosthetic valve of claim 21, wherein wherein the outer skirt is configured to form a snug fit with the frame such that the outer skirt abuts an outer surface of the frame when the prosthetic valve is in the radially expanded state.

23. The prosthetic valve of any of claims 21-22, wherein wherein the first and second sets of yarns are parallel to corresponding struts of the frame to which the outer skirt is connected, respectively, when the prosthetic valve is in the radially expanded state.

24. The prosthetic valve of claim 21, wherein wherein the first and second sets of yarns are neither perpendicular nor parallel to a longitudinal axis of the frame extending from the inflow end to the outflow end.

25. The prosthetic valve of claim 24, wherein wherein the yarns of the first and second sets of yarns are oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

26. The prosthetic valve of claim 25, wherein wherein the yarns of the first and second sets of yarns are oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

27. The prosthetic valve of claim 26, wherein wherein the yarns of the first and second sets of yarns are oriented at an angle ranging from 40 to 50 degrees relative to the longitudinal axis of the frame.

28. The prosthetic valve of claim 27, wherein wherein the yarns of the first and second sets of yarns are oriented at an angle of 45 degrees relative to the longitudinal axis of the frame.

29. The prosthetic valve of claim 21, wherein wherein the textile layer has a weave density of 50 ppi or less.

30. The prosthetic valve of claim 29, wherein wherein the textile layer has a weave density of 30 to 50 ppi.

31. The prosthetic valve of claim 21, wherein wherein at least some of the yarns of the first and second sets of yarns are lofted such that at least some of the yarns of the first and second sets of yarns are capable of retaining a twisted or coiled state when the prosthetic valve is in the radially expanded state and are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

32. The prosthetic valve of claim 21, wherein wherein the yarns of the first and second sets of yarns comprise a first type of yarn and a second type of yarn, wherein the first type of yarn is inelastic or less elastic than the second type of yarn.

33. A method of assembling a prosthetic valve, comprising: mounting a skirt assembly to an annular frame, the frame being radially expandable from a radially compressed state to a radially expanded state; and attaching a plurality of leaflets to the annular frame, the leaflets being configured to regulate blood flow from an inflow end to an outflow end of the frame; wherein the skirt assembly comprises an outer skirt, and the outer skirt comprises a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer, wherein the first and second encapsulation layers are made of an elastomer, and the textile layer comprises a first set of yarns, a second set of yarns interwoven with the first set of yarns, and a third set of yarns, the third set of yarns extending axially and being braided with the first and second sets of yarns to form a triaxial braid; wherein the outer skirt has a first axial length when the prosthetic valve is in the radially expanded state and a second axial length when the prosthetic valve is in the radially compressed state, wherein the second axial length is up to at least 40% of the first axial length, wherein the textile layer has a weave density of less than 150 ppi, wherein the third set of yarns is made of an elastomer configured to stretch axially when the prosthetic valve changes from the radially expanded state to the radially compressed state; and / or wherein the third set of yarns is lofted such that the third set of yarns is capable of retaining a twisted or coiled state when the prosthetic valve is in the radially expanded state and is straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

34. The method of claim 33, wherein the skirt assembly includes an inner skirt, and the act of attaching the plurality of leaflets to the annular frame includes mounting the inner skirt to an inner surface of the frame and suturing the plurality of leaflets to the inner skirt.

35. The method of any one of claims 33-34, wherein the act of attaching the skirt assembly to the annular frame includes placing the outer skirt around an outer surface of the frame and suturing the outer skirt to selected struts of the frame.

36. The method of claim 33, further comprising forming the laminate by electrospinning the first encapsulation layer, placing the textile layer on the first encapsulation layer, and electrospinning the second encapsulation layer on the textile layer.

37. The method of claim 33, further comprising forming the laminate by immersing the textile layer in a liquefied polymeric material and then allowing the liquefied polymeric material to solidify.

38. The method of claim 33, further comprising preparing the textile layer such that the first set of yarns and the second set of yarns are neither perpendicular nor parallel to a longitudinal axis of the frame extending from the inflow end to the outflow end.

39. The method of claim 38, wherein preparing the textile layer includes weaving the first set of yarns and the second set of yarns at a selected angle relative to an upper edge and a lower edge of the fabric.

40. The method of claim 38, wherein preparing the textile layer includes cutting along a diagonal from a fabric whose woven yarns extend perpendicular to edges of the fabric.

41. The method of claim 38, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle in the range of 20 to 70 degrees relative to the longitudinal axis of the frame.

42. The method of claim 41, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle in the range of 30 to 60 degrees relative to the longitudinal axis of the frame.

43. The method of claim 42, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle in the range of 40 to 50 degrees relative to the longitudinal axis of the frame.

44. The method of claim 43, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle of 45 degrees relative to the longitudinal axis of the frame.

45. The method of claim 33, wherein the textile layer has a weave density of 50 ppi or less.

46. The method of claim 45, wherein the textile layer has a weave density of 30 to 50 ppi.

47. A method of assembling a prosthetic valve, comprising: mounting a plurality of leaflets to an annular frame expandable radially from a radially compressed state to a radially expanded state, wherein the frame has an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, wherein the plurality of leaflets are configured to regulate blood flow from the inflow end to the outflow end of the frame; and mounting a skirt assembly to the annular frame, wherein the skirt assembly comprises a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer, wherein the first encapsulation layer and the second encapsulation layer are made of an elastomer, and the textile layer comprises a first set of yarns, a second set of yarns interwoven with the first set of yarns, and a third set of yarns extending axially and braided with the first set of yarns and the second set of yarns to form a triaxial braid, wherein the first set of yarns and the second set of yarns are not perpendicular and not parallel to the longitudinal axis, wherein the textile layer has a weave density less than 150 ppi, wherein the third set of yarns are made of an elastomer configured to stretch axially when the prosthetic valve is radially compressed from the radially expanded state to the radially compressed state; and / or wherein the third set of yarns are lofted such that the third set of yarns can maintain a twisted or coiled state when the prosthetic valve is in the radially expanded state, and the third set of yarns are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

48. The method of claim 47, wherein the textile layer has a weave density of 50 ppi or less.

49. The method of claim 48, wherein the textile layer has a weave density of 30 to 50 ppi.

50. The method of any one of claims 47-49, wherein the skirt assembly comprises an outer skirt mounted to an outer surface of the frame.

51. The method of claim 47, wherein the skirt assembly comprises an inner skirt mounted to an inner surface of the frame.

52. The method of claim 47, wherein the textile layer is a braided layer.

53. The method of claim 47, wherein the textile layer is a woven layer.

54. The method of claim 47, wherein the textile layer is a knitted layer.

55. The method of claim 47, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 20 to 70 degrees relative to the longitudinal axis of the frame.

56. The method of claim 55, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 30 to 60 degrees relative to the longitudinal axis of the frame.

57. The method of claim 56, wherein the yarns of the first set of yarns and the second set of yarns are oriented at an angle ranging from 40 to 50 degrees relative to the longitudinal axis of the frame.

58. The method of claim 57, wherein the yarns of the first and second sets of yarns are oriented at an angle of 45 degrees relative to the longitudinal axis of the frame.

59. The method of claim 47, wherein the yarns of the first and second sets of yarns have 10 to 50 filaments per yarn.

60. The method of claim 59, wherein the yarns of the first and second sets of yarns have 20 filaments per yarn.

61. The method of claim 59, wherein the filaments of the yarns have a thickness in the range of 8 to 16 microns.

62. The method of claim 61, wherein the filaments of the yarns have a thickness of 10 microns.

63. The method of claim 47, wherein at least some of the yarns of the first and second sets of yarns are lofted such that at least some of the yarns of the first and second sets of yarns are capable of retaining a twisted or coiled state when the prosthetic valve is in the radially expanded state and are straightened to an untwisted or uncoiled state when the prosthetic valve is in the radially compressed state.

64. The method of claim 47, wherein the textile layer comprises leno woven yarns.

65. The method of claim 47, wherein the yarns of the first and second sets of yarns comprise a first type of yarn and a second type of yarn, wherein the first type of yarn is inelastic or less elastic than the second type of yarn.

66. The method of claim 47, wherein the skirt assembly is axially elongated up to at least 40% of its original length when the prosthetic valve is in the radially expanded state when the prosthetic valve is in the radially compressed state.

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