Method of assembling a prosthetic heart valve

Abstract

The method of assembling a prosthetic heart valve includes fixing a suture loop having at least a first winding portion and a second winding portion to an outflow edge portion of an inner skirt. The first winding portion and the second winding portion are arranged in a repeated 8-shaped curve pattern, and each winding portion has a plurality of first segments attached to the outflow edge portion of the inner skirt and a plurality of second segments not attached to the inner skirt. The inner skirt is placed on the inner side of an annular frame, and the second segments of the first winding portion and the second winding portion are placed above the apex of the outflow end of the frame so that the second segments of the first winding portion and the second winding portion reside on the outside of the frame. The second segment of the winding portion is inserted inwardly through an opening in the frame and attached to a selected position on the inner skirt.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 832,402, filed April 11, 2019, which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to embodiments of prosthetic valves for implantation in body ducts, such as a native heart valve annulus, and methods of assembling prosthetic heart valves. Background Art

[0004] The human heart may suffer from various valve diseases. These valve diseases may lead to severe dysfunction of the heart and eventually require replacement of the natural valve with an artificial valve. There are many known artificial valves and many known methods of implanting these artificial valves in the body.

[0005] Various surgical techniques can be used to replace or repair diseased or damaged valves. Due to stenosis and other heart valve diseases, thousands of patients undergo surgery each year in which a defective native heart valve is replaced with a prosthetic valve. Another less drastic method of treating a defective valve is by repair or reconstruction, which is usually used for valves with minimal calcification. The problem with surgical treatment is that it imposes a significant risk of high morbidity and mortality associated with surgical repair on these chronic patients.

[0006] When replacing a native valve, surgical implantation of a prosthetic valve typically requires an open-chest surgery during which the heart is stopped and the patient is placed on cardiopulmonary bypass (the so-called "heart-lung machine"). In one common surgical procedure, the diseased native valve leaflets are excised and the prosthetic valve is sutured to the surrounding tissue at the valve annulus. Due to the trauma associated with the procedure and the concomitant duration of extracorporeal blood circulation, some patients do not survive the surgical procedure or die shortly thereafter. It is well known that the risk to the patient increases with the amount of time required for extracorporeal circulation. Due to these risks, a large number of patients with defective native valves are deemed inoperable because their condition is too frail to withstand the procedure. According to some estimates, more than 50% of subjects over the age of 80 with valvular stenosis cannot undergo valve replacement surgery.

[0007] Due to the shortcomings associated with traditional open heart surgery, percutaneous and minimally invasive surgical methods are attracting strong attention. In one technique, a prosthetic valve is configured to be implanted by catheterization in a much less invasive procedure. For example, U.S. Patent Nos. 5,411,522 and 6,730,118 (which are incorporated herein by reference) describe a collapsible transcatheter heart valve that can be percutaneously introduced in a compressed state on a catheter and expanded by balloon expansion or by utilizing a self-expanding frame or stent in a desired position.

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

[0009] The inner and outer skirts are typically secured to the frame by sewing or stitching the fabric of the respective skirts to the frame. The leaflets of the prosthetic valve, or at least the tip edge portions of the leaflets, are typically sewn to the inner skirt of the frame. As can be appreciated, the process of assembling the soft components of the prosthetic valve (e.g., leaflets and skirts) to the frame is time consuming and labor intensive. Further, sewing the leaflets to the inner skirt creates stress points on the leaflets, particularly during diastole. Therefore, improvements in the skirts of prosthetic valves and methods of assembling the same are desired. Summary of the invention

[0010] In a representative embodiment, a method of assembling a prosthetic heart valve includes: securing a suture loop having at least first windings and second windings to an outflow edge portion of an inner skirt, wherein the first windings and the second windings are arranged in a repeating figure-eight shape curves pattern and each winding has a plurality of first segments attached to the outflow edge portion of the inner skirt and a plurality of second segments not attached to the inner skirt; placing the inner skirt inside an annular frame and placing the second segments of the first windings and the second windings above the apex of the outflow end of the frame such that the second segments of the first windings and the second windings reside outside the frame; inserting the second segments of the windings inwardly through openings in the frame; and attaching the second segments of the windings to selected locations on the inner skirt.

[0011] In some embodiments, the outflow edge portion of the inner skirt is connected to the frame only by the suture loop.

[0012] In some embodiments, the act of securing the suture loop to the outflow edge portion of the inner skirt includes forming a stitch with a first section of each meander extending through the outflow edge portion of the inner skirt.

[0013] In some embodiments, the act of forming stitches with the first segment of each meander includes forming in-and-out stitches along adjacent segments of the outflow edge portion of the inner skirt.

[0014] In some embodiments, the act of securing the suture loop to the outflow edge portion of the inner skirt includes attaching the first segment of each convolution to the outflow edge portion of the inner skirt with a separate suture.

[0015] In some embodiments, first segments of the first convolutions alternate with first segments of the second convolutions along the length of the suture loop.

[0016] In some embodiments, the second segments of the first convolutions alternate with the second segments of the second convolutions along the length of the suture loop.

[0017] In some embodiments, the method further comprises attaching the leaflets to the inner skirt.

[0018] In some embodiments, the act of attaching the second section of the meander portion to the selected location on the inner skirt includes securing the second section of the meander portion to the selected location on the inner skirt with sutures.

[0019] In another representative embodiment, a method of assembling a prosthetic heart valve includes: providing a skirt having an inflow edge portion and an outflow edge portion; securing a plurality of first segments of a suture ring to one of the inflow edge portion and the outflow edge portion of the skirt; and after securing the suture ring to the skirt, placing the skirt on an annular frame, inserting a plurality of second segments of the suture ring through an opening of the frame, and securing the second segments of the suture ring to the skirt.

[0020] In some embodiments, the skirt includes an inner skirt and placing the skirt on the annular frame includes placing the inner skirt on the inside of the frame.

[0021] In some embodiments, the act of securing the plurality of first segments of the suture loop includes securing the plurality of first segments to an outflow edge portion of the inner skirt.

[0022] In some embodiments, the skirt includes an outer skirt and placing the skirt on the annular frame includes placing the outer skirt outside the frame.

[0023] In some embodiments, the suture loop is formed from a single length of suture material.

[0024] In some embodiments, the suture loop is formed from only two lengths of suture material.

[0025] In some embodiments, the suture loop includes a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments include a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments include a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion.

[0026] In some embodiments, the method further comprises attaching a leaflet to the skirt.

[0027] In some embodiments, the act of securing the second section of the suture loop to the skirt includes securing the second section of the suture loop to the skirt with a separate suture.

[0028] In another representative embodiment, a prosthetic heart valve includes: an annular frame that can be radially expanded from a radially compressed configuration to a radially expanded configuration; an annular skirt having an inflow edge portion and an opposite outflow edge portion; and a suture ring that includes a plurality of first segments fixed to one of the inflow edge portion and the outflow edge portion of the skirt and a plurality of second segments extending through openings in the frame and fixed to the skirt to couple the skirt to the frame.

[0029] In some embodiments, the skirt includes an inner skirt positioned inside the frame.

[0030] In some embodiments, the plurality of first segments of the suture loop are secured to the outflow edge portion of the inner skirt.

[0031] In some embodiments, the plurality of first segments of the suture loop are secured to the inflow edge portion of the inner skirt.

[0032] In some embodiments, the skirt includes an outer skirt positioned outside of the frame.

[0033] In some embodiments, the plurality of first segments of the suture loop are secured to the outflow edge portion of the outer skirt.

[0034] In some embodiments, the plurality of first segments of the suture loop are secured to the inflow edge portion of the outer skirt.

[0035] In some embodiments, the prosthetic valve further includes a plurality of leaflets supported by the skirt.

[0036] In some embodiments, the leaflets have a pointed edge that is sewn to the skirt.

[0037] In some embodiments, the suture loop includes a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments include a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments include a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion.

[0038] In another representative embodiment, a prosthetic heart valve includes: an annular frame that is radially expandable from a radially compressed configuration to a radially expanded configuration, wherein the frame includes a plurality of circumferentially extending rows of angled struts connected end-to-end at a junction; an annular skirt having an inflow edge portion and an opposing outflow edge portion; and a suture ring that extends along the entire length of the outflow edge portion of the skirt and couples the outflow edge portion of the skirt to one of the rows of struts of the frame without being sewn around any struts extending between the junctions of the row.

[0039] In some embodiments, the suture loop includes a plurality of first segments secured to the outflow edge portion of the skirt and a plurality of second segments extending through the openings in the frame and secured to the skirt to couple the skirt to the frame.

[0040] In some embodiments, the suture loop includes a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments include a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments include a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion.

[0041] In some embodiments, the first convolution and the second convolution are formed from a single continuous piece of suture material.

[0042] In some embodiments, the first convolution and the second convolution are formed from separate pieces of suture material.

[0043] In some embodiments, the skirt includes an inner skirt positioned inside the frame.

[0044] In some embodiments, the skirt includes an outer skirt positioned outside of the frame.

[0045] In some embodiments, the prosthetic heart valve further includes a plurality of leaflets supported by the skirt.

[0046] In some embodiments, the leaflets have a pointed edge that is sewn to the skirt.

[0047] In some embodiments, the outflow edge portion of the skirt is connected to the frame only by the suture loop.

[0048] In another representative embodiment, a prosthetic heart valve includes: an annular frame, which can be radially expanded from a radially compressed configuration to a radially expanded configuration; an annular inner skirt, which has an inflow edge portion and an opposite outflow edge portion; a suture ring, which includes a plurality of first segments fixed to the outflow edge portion of the inner skirt and a plurality of second segments extending through openings in the frame and fixed to the inner skirt to couple the inner skirt to the frame; and a plurality of leaflets, which are positioned on the inner side of the frame, wherein each leaflet has an inflow end sutured to the inner skirt.

[0049] In some embodiments, the outflow edge portion of the inner skirt is connected to the frame only by the suture loop.

[0050] In some embodiments, the first section of the suture loop forms a stitch that is sewn to the outflow edge portion of the inner skirt.

[0051] In some embodiments, a first section of the suture loop forms an in-and-out stitch along an adjacent section of the outflow edge portion of the inner skirt.

[0052] In some embodiments, the first section of the suture loop is secured to the outflow edge portion of the inner skirt by a separate suture.

[0053] In some embodiments, the suture loop includes a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments include a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments include a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion.

[0054] In some embodiments, the leaflets form commissures that connect to the frame.

[0055] In some embodiments, the second section of the suture loop is secured to a selected location on the inner skirt by suture.

[0056] In some embodiments, the frame includes first and second circumferentially extending rows of angled struts connected end-to-end at a junction, and wherein the opening through which the second segment of the suture loop extends is defined by the first and second rows of struts.

[0057] In another representative embodiment, a prosthetic heart valve includes: an annular frame that can be radially expanded from a radially compressed configuration to a radially expanded configuration; an annular inner skirt having an inflow edge portion and an opposite outflow edge portion; and a suture ring having at least a first winding portion and a second winding portion fixed to the outflow edge portion of the inner skirt, wherein the first winding portion and the second winding portion are arranged in a repeating figure-8 curve pattern, and each winding portion has a plurality of first segments attached to the outflow edge portion of the inner skirt and a plurality of second segments extending through an opening in the frame and fixed to the inner skirt to couple the inner skirt to the frame.

[0058] In some embodiments, the prosthetic heart valve further comprises a plurality of leaflets positioned inside the frame, wherein each leaflet has an inflow end sutured to the inner skirt.

[0059] In some embodiments, the leaflets form commissures that connect to the frame.

[0060] In some embodiments, the outflow edge portion of the inner skirt is connected to the frame only by the suture loop.

[0061] In some embodiments, the first section of the meander forms a stitch sewn to the outflow edge portion of the inner skirt.

[0062] In some embodiments, the first section of the meander forms an inlet and outlet stitch along an adjacent section of the outflow edge portion of the inner skirt.

[0063] In some embodiments, the first section of the meander is secured to the outflow edge portion of the inner skirt by a single line of suture.

[0064] In some embodiments, the second section of the meander is secured to a selected location on the inner skirt by sutures.

[0065] In some embodiments, the outflow edge portion of the inner skirt has a sawtooth pattern having a plurality of angled segments defining a series of peaks and valleys.

[0066] In some embodiments, each first segment of the first bend is attached to two adjacent angled segments that define a corresponding valley, and each first segment of the second bend is attached to two adjacent angled segments, and the two adjacent angled segments to which each first segment of the second bend is attached define a corresponding valley between the angled segments to which the corresponding first segment of the first bend is attached.

[0067] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 is a side view of a prosthetic heart valve according to one embodiment.

[0069] Figure 2 yes Figure 1 A stereoscopic view of a prosthetic heart valve.

[0070] Figure 3 yes Figure 1 A stereoscopic view of the frame of a prosthetic heart valve.

[0071] Figure 4 Shown in a flat configuration Figure 3 framework.

[0072] Figure 5-Figure 8 A method of mounting an inner skirt to a frame of a prosthetic heart valve is shown according to one embodiment.

[0073] Fig.9A and Fig. 9B Magnified views of a cell of the framework in radially expanded and radially compressed configurations, respectively.

[0074] Fig.10 An alternative method of mounting a suture loop to the inner skirt for mounting the inner skirt on the frame is shown. DETAILED DESCRIPTION

[0075] Figure 1-Figure 2Two different views of a prosthetic valve 10 according to one embodiment are shown. The illustrated valve is adapted for implantation in a native aortic valve annulus, but in other embodiments it may be adapted for implantation in other native valve annuli 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.

[0076] The valve structure 14 (or leaflet structure) can include three leaflets 40 (although a greater or lesser number of leaflets can be used) that together form a leaflet structure that can be arranged to collapse in a tricuspid arrangement. The valve structure 14 is configured to allow blood to flow through the prosthetic valve 10 in a direction from an inlet end 48 of the prosthetic valve to an 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.

[0077] Each leaflet 40 desirably has a curved, generally U-shaped inlet edge or tip edge 52. In this way, the inlet edge of the valve structure 14 has an undulating, curved, scalloped shape. By forming leaflets having such a scalloped geometry, stresses on the leaflets can be reduced, thereby improving the durability of the valve. In addition, with the aid of the scalloped shape, folds and corrugations at the belly of each leaflet (the central region of each leaflet) can be eliminated or at least minimized, which can cause early calcification in those regions. The scalloped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing a smaller, more uniform folded profile at the inflow end of the valve. The leaflet 40 can be formed of 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). Further, the leaflet is configured to allow blood to flow from the inflow end to the outflow end and prevent blood from flowing from the outflow end to the inflow end.

[0078] Bare frame 12 is shown on Figure 3 In the depicted embodiment, the frame 12 has an annular shape defining an inflow end 54 and an outflow end 56 and includes a plurality of struts (or frame members). The frame 12 may be formed with a plurality of circumferentially spaced slots or commissure windows 20 (three in the illustrated embodiment) adapted to mount the commissures 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.

[0079] The frame 12 can be made of any of various suitable plastic expandable materials known in the art (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When constructed of a plastic expandable material, the frame 12 (and therefore the valve 10) can be folded into a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or another suitable expansion mechanism. When constructed of a self-expandable material, the frame 12 (and therefore the valve 10) can be folded into a radially compressed state and restrained in a compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0080] Suitable plastically expandable materials that can be used to form the frame 12 include, without limitation, 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 (e.g., MP35N TM (a trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum by weight. It has been found that using MP35N to form the frame 12 provides structural results that are superior to stainless steel. Specifically, when MP35N is used as the frame material, less material is required to achieve the same or better radial force and crushing force resistance, fatigue resistance and corrosion resistance. In addition, because less material is required, the fold profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment location in the body.

[0081] refer to Figure 3 and Figure 4, the frame 12 in the illustrated embodiment includes a first lower row I of angled struts 22 arranged end to end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending angled struts 24; a third row III of circumferentially extending angled struts 26; a fourth row IV of circumferentially extending angled struts 28; and a fifth row V of circumferentially extending angled struts 32 at the outflow end 56 of the frame. A plurality of substantially straight axially extending struts 34 may be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II. The angled struts 32 of the fifth row V are connected to the angled struts 28 of the fourth row IV by a plurality of axially extending window frame portions 30 (which define the commissure windows 20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30 extends from a position defined by the convergence of the lower ends of two angled struts 32 to another position defined by the convergence of the upper ends of two angled struts 28.

[0082] Each commissure window frame portion 30 secures a corresponding commissure 58 of the leaflet structure 14. As can be seen, each frame portion 30 is secured at its upper and lower ends to adjacent rows of struts to provide a secure configuration for supporting the commissures of the leaflet structure with enhanced fatigue resistance under cyclic loading of the valve compared to known cantilevered struts. This configuration enables a reduction in the thickness of the frame wall to achieve a smaller fold diameter of the valve. In a specific embodiment, the thickness T of the frame 12 measured between the inner diameter and the outer diameter is Figure 3 ) is about 0.48 mm or less.

[0083] The struts and frame portions of the frame together define a plurality of open cells of the frame. At the inflow end of the frame 12, struts 22, struts 24, and struts 34 define a lower row of cells that define openings 36. The second, third, and fourth rows of struts 24, 26, and 28 define two intermediate rows of cells that define openings 38. The fourth and fifth rows of struts 28 and 32 together with the frame portion 30 and struts 31 define an upper row of cells that define openings 60. The openings 60 are relatively large and are sized to allow portions of the leaflet structure 14 to extend or protrude into and / or through the openings 60 when the frame 12 is creased to minimize the crease profile.

[0084] like Figure 4As shown in , the lower end of the strut 31 is connected to two struts 28 at a node or joint 44, and the upper end of the strut 31 is connected to two struts 32 at a node or joint 46. The thickness of the strut 31 can be less than the thickness of the joints 44, 46. The joints 44, 46, together with the joint 64 (each of which connects two adjacent struts 32) prevent the opening 60 from being completely closed when the frame 12 is in the folded state. Therefore, in the folded state, the geometry of the strut 31 and the joints 44, 46 and 64 help create enough space in the opening 60 to allow a portion of the leaflet to extend outward (i.e., bulge) through the opening. This allows the valve to be folded to a relatively smaller diameter than if all of the leaflet material were confined within the folded frame.

[0085] The frame 12 is configured to prevent or at least minimize possible over-expansion of the valve at a predetermined balloon pressure, particularly at the outflow end of the frame supporting the leaflet structure 14. On the one hand, the frame is configured to have relatively large angles 42a, 42b, 42c, 42d, 42e between the pillars. The larger the angle, the greater the force required to open (expand) the frame. Therefore, the angle between the pillars of the frame 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 a specific embodiment, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more specifically, these angles are at least 120 degrees or greater when the frame is expanded to its functional size. U.S. Patent Publication No. 2012 / 0123529 further describes other configurations of the frame 12 and the frame that can be incorporated into a prosthetic heart valve.

[0086] like Figure 1-Figure 2 As shown in , 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 inflow (lower) edge and the outflow (upper) edge of the inner skirt 16 may be fixed to the frame 12 and / or the outer skirt 16 by, for example, thermal bonding, adhesives and / or stitching. Typically, the inflow edge is stitched to the corresponding row of pillars, such as the pillars of the first row I, and the outflow edge is stitched to the corresponding row of pillars, such as the pillars of the third row III or the fourth row IV. The outer skirt 18 may include a plurality of circumferentially spaced extensions or protrusions 66 formed along the outflow edge (upper edge in the example embodiment) of the outer skirt and recesses 68 between adjacent protrusions. In other embodiments, the outer skirt 18 may have a straight outflow edge without any protrusions or recesses.

[0087] The inflow (lower) and outflow (upper) edges of the outer skirt 18 may be secured to the frame 12 and / or the inner skirt 16 by, for example, thermal bonding, adhesives, and / or suturing. As shown in the illustrated embodiment, the extensions 66 along the outflow edge of the outer skirt 18 may be secured to the struts of the frame with sutures 70, while the recesses 68 between adjacent extensions may not be attached to the frame 12 and the inner skirt 16. The outer skirt 18 serves as a sealing member for the prosthetic valve 10 by sealing against the tissue of the native annulus, thereby helping to reduce paravalvular leakage through the prosthetic valve 10.

[0088] In some embodiments, Figure 1-Figure 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 tight fit with the frame 12 so that it lies flat against the outer surface of the frame 12 when the prosthetic valve 10 is in a radially expanded configuration, as disclosed in WIPO Publication No. 2018 / 222799, which is incorporated herein by reference. The outer skirt 18 can be formed by any of various synthetic materials or natural tissues (e.g., pericardial tissue). Suitable synthetic materials include any of various biocompatible fabrics (e.g., PET fabrics) or non-fabric films, including any of the materials for the reinforcement layer 88 of the inner skirt 16 disclosed below. Further details of the outer skirt 18 are also disclosed in U.S. Patent Publication No. 2012 / 0123529 and WIPO Publication No. 2018 / 222799.

[0089] like Figure 1-Figure 2 As further shown in the example embodiment, the inner skirt 16 extends from the inlet end 54 of the frame to the angled support 28 of the fourth row IV. In other embodiments, the inner skirt 16 may extend from the inlet end 54 of the frame to a position shorter than the support of the fourth row IV (e.g., to the support of the second row II or the third row III), or the inner skirt may extend the entire height of the frame 12 (e.g., from the inlet end 54 to the outlet end 56). In alternative embodiments, the inner skirt 16 may be positioned and / or sized to be at the same height as the frame 12. Figure 1-Figure 2 For example, in some embodiments, the inlet end of the inner skirt 16 can be axially spaced from the inlet end 54 of the frame 12 .

[0090] Although the inner skirt 16 is generally tubular or cylindrical in shape (forming a complete circle in a cross-sectional profile in a plane perpendicular to the longitudinal axis of the valve), the inner skirt 16 need not extend through 360 degrees along the inner surface of the frame 12 in a circumferential direction. In other words, the inner skirt 16 can have a cross-sectional profile that is not a complete circle (in a plane perpendicular to the axis of the cavity of the valve). The inner skirt 16 can be initially formed as a flat band and then formed into an annular shape by coupling relative edge portions together, such as by sewing, thermal bonding and / or an adhesive. Alternatively, the inner skirt 16 can be formed directly in an annular shape, for example, by constructing the inner layer 16 on a cylindrical mandrel described below.

[0091] As described above, the leaflets 40 can be secured to each other at adjacent sides thereof to form commissures 58. Each commissure 58 can be secured to a corresponding commissure window 20 of the frame 12, as described in U.S. Patent Publication No. 2012 / 0123529. The inflow or tip edge 52 of the leaflet 40 can be sutured to the inner skirt 16 along a suture line that tracks the curvature of the scalloped inflow edge of the leaflet structure.

[0092] In some embodiments, the inflow edges 52 of the leaflets 40 are secured to the inner skirt 16 prior to mounting the inner skirt 16 to the frame. After the leaflets 40 are secured to the inner skirt 16, the inner skirt is then secured to the frame and the commissures 58 of the leaflets are mounted to the frame as described above. In other embodiments, the inner skirt 16 can be mounted to the frame without the leaflets, after which the inflow edges 52 of the leaflets are then secured to the inner skirt.

[0093] In certain embodiments, the inflow edge 52 of the leaflet 40 can be secured to the inner skirt via a thin PET reinforcement band (not shown), as disclosed in U.S. Pat. No. 7,993,394, which is incorporated herein by reference. As described in U.S. Pat. No. 7,993,394, the reinforcement band can be sutured to the inflow edge of the leaflet. The reinforcement band and the lower edge of the leaflet can then be sutured to the inner skirt 16. The reinforcement band is desirably secured to the inner surface of the leaflet 40 so that when the leaflet and the reinforcement band are secured to the inner skirt, the inflow edge 52 of the leaflet is sandwiched between the reinforcement band and the inner skirt. The reinforcement band enables secure suturing and protects the pericardial tissue of the leaflet structure from tearing.

[0094] Figure 5-Figure 8Optional techniques for mounting the soft components of a prosthetic valve (e.g., the inner skirt 16, the outer skirt 18, and / or the leaflets 40) to the frame of the prosthetic valve are illustrated. The depicted embodiment illustrates a method of mounting the inner skirt 16 and the leaflets 40 to a frame 120. The frame 120 has an inflow end 122 and an outflow end 124. The frame in the example embodiment includes a plurality of circumferentially extending rows of struts, including angled struts 126 in a first row I, angled struts 128 in a second row II, angled struts 130 in a third row III, and angled struts 132 in a fourth row IV. The struts 132 form a plurality of vertices 134 at the outflow end 124 of the frame. In other embodiments, the frame 120 may have a greater or lesser number of rows of struts.

[0095] An exemplary method of assembling the skirt 16 to the frame 120 includes securing the main suture loop 136 to the outflow edge portion 138 of the inner skirt 16. The outflow edge portion 138 of the inner skirt 16 may have an undulating or sawtooth pattern that defines a series of peaks and valleys corresponding to the shape of the struts 130 of the third row III. Figure 6 As best shown in FIG. 1 , the suture loop 136 in the example embodiment is configured as a repeating figure-eight curve pattern arranged end-to-end to form a series of or two or more sub-loops 140a, 140b, 140c, 140d, 140e along the length of the main loop 136. The number of sub-loops 140a-e is desirably equal to the number of vertices 134 at the outflow end 124 of the frame 120. In one example, the frame 120 has 12 vertices 134 (similar to the frame 12) and 12 sub-loops 140a-e. However, the number of sub-loops may vary depending on the particular application.

[0096] The suture loop 136 in the example embodiment has at least first and second meanders 142a, 142b, respectively, forming respective sinusoidal curves. The curves are offset or shifted by half a "wavelength" from each other (a full wavelength is the length of the meanders 142a, 142b from the first location 162a where the meanders intersect to the second location 162b where the meanders intersect). In this manner, the first meander 142a has a plurality of half-wavelength segments 164a that curve in one direction, alternating with a plurality of half-wavelength segments 164b that curve in the opposite direction. Similarly, the second meander 142b has a plurality of half-wavelength segments 166a that curve in one direction, alternating with a plurality of half-wavelength segments 166b that curve in the opposite direction. Each segment 164a is paired with a corresponding segment 166b and each segment 164b is paired with a corresponding segment 166a to form sub-loops 140a-e.

[0097] The suture loop 136 can be formed of any of various types and sizes of sutures, including any of various monofilament or multifilament sutures. In a specific embodiment, for example, the suture loop 136 is made of a 2-0 or 3-0 size suture, such as a Dyneema or Ethibond suture. In some embodiments, the suture loop 136 can be made of a braided or twisted multifilament suture material.

[0098] In one embodiment, the primary suture loop 136 is formed as a primary suture loop when it is secured to the outflow edge portion 138 of the skirt 16. Figure 5-Figure 6 This can be achieved by using a single length of suture and securing the first meandering portions 142a of the suture at intervals along the outflow edge portion 138. Specifically, the first meandering portions 142a are secured to each pair of adjacent segments 144 of the outflow edge portion 138, such as by forming in and out stitches along the segments 144 while skipping each pair of adjacent segments 146 located between the segments 144, such that the meandering segments 164b are attached to the skirt segments 144 while the segments 164a are not attached to the skirt.

[0099] After the first winding portion 142a is secured along the entire length of the outflow edge portion 138 (skipping pairs of adjacent segments 146), the second winding portion 142b of the stitching is secured to each pair of adjacent skirt segments 146, for example by forming in and out stitches along the segments 146 while skipping each pair of adjacent segments 144 located between the segments 146, so that the winding segment 166b is attached to the skirt segment 146 and the winding segment 166a is not attached to the skirt. In this manner, the first and second winding portions 142a, 142b form a repeating figure-8 pattern that defines Figure 5 The plurality of sub-loops 140a-e shown. Thereafter, the ends of the sutures may be tied or otherwise secured to one another to form a continuous loop. In other embodiments, the ends of the sutures need not be connected to one another to form a continuous loop, but may instead be tied or otherwise secured to the struts of the frame when the inner skirt 16 is subsequently placed on the frame. The skirt 16 is desirably in a flat (non-cylindrical) configuration when the main suture loop 136 is secured to the skirt to facilitate the sewing process.

[0100] In alternative embodiments, two separate suture pieces or two separate lengths of suture may be used to form the main suture loop 136. A first length of suture may be secured to the skirt segment 144 as described above to form the first winding portion 142a, and a separate second length of suture may be secured to the segment 146 as described above to form the second winding portion 142b. Adjacent ends of the first and second lengths of suture may be tied or otherwise secured to one another to form a continuous loop. In other embodiments, the adjacent ends of the winding portions 142a, 142b need not be connected to one another to form a continuous loop, but may instead be tied or otherwise secured to the struts of the frame when the inner skirt 16 is later placed on the frame.

[0101] When forming the main suture loop 136, each segment 164a, 164b of the first winding portion 142a and each segment 166a, 166b of the second winding portion 142b desirably has an overall length equal to or approximately equal to twice the length L of the strut 130. This allows the unattached segments 164a, 166a of the winding portions 142a, 142b to be later secured to the skirt at a location adjacent to the junction of the struts 130 of the third row III, as further described in more detail below.

[0102] Reference Figure 7 , after securing the primary suture loop 136 to the skirt 16, the skirt can be placed inside the frame 120 with the unattached sections 164a, 166a of the meanders 142a, 142b placed on the apex 134 at the outflow end of the frame. When the outflow edge portion 138 is aligned with the struts 130 of the third row III, the unattached sections 164a, 166a of the meanders 142a, 142b extend behind the struts 132 of the fourth row IV on the outside of the frame 120. The unattached sections 164a, 166a of the meanders 142a, 142b can then be inserted inwardly into the interior of the frame through the cell opening 150 defined between the third and fourth rows of struts, as indicated by arrows 152 (e.g., by pushing or pulling the sections 164a, 166a through the cell opening 150).

[0103] The unattached sections 164a, 166a of the meander portions 142a, 142b may now be attached to the inner skirt 16 at a selected location. Figure 8As shown in , the unattached sections 164a, 166a can be attached to the outflow edge portion 138 at a position adjacent to the frame joint 154 between the second and third rows of pillars. Specifically, each section 164a can be attached to the outflow edge portion 138 adjacent to the corresponding joint 154a, and each section 166a can be attached to the outflow edge portion 138 adjacent to the corresponding joint 154b. The sections 164a, 166a of the winding portion can be attached to the outflow edge portion 138 using a separate suture 156 at each joint 154a, 154b. Each suture 156 can form one or more stitches that extend through the skirt material and around adjacent winding sections 164a, 166a. Conventional techniques can be used, such as by sewing the skirt 16 to the pillars 126 of the first row I with sutures 158 to fix the inflow edge portion 139 of the skirt to the skirt.

[0104] It should be noted that for the purpose of illustration, Figure 8 142a, 142b is drawn into the interior of the frame, the previously unattached sections 164a, 166a of the meanders 142a, 142b being slightly longer than the corresponding attached sections 164b, 166b of the meanders 142a, 142b. However, these sections are desirably of equal length. Thus, after being secured with the sutures 158, the sections 164a, 166a can track or correspond to the shape of the outflow edge portion 138 of the skirt and the stitches formed by the sections 164b, 166b.

[0105] Fig.9A and Fig. 9B The frame 120 is shown in a radially expanded configuration ( Fig.9A ) and radial compression configuration ( Fig. 9B ), a representative frame cell of the uppermost row of cells of the frame (the cells formed by the third row of struts 130 and the fourth row of struts 132). As shown, the height of the cell in the axial direction decreases when the frame is radially expanded and increases when the frame is radially compressed. As described above, each segment 164a, 164b of the first winding portion 142a and each segment 166a, 166b of the second winding portion 142b desirably has an overall length equal to or approximately equal to twice the length L of the strut 130. This accommodates the shortening of the frame cells when the prosthetic valve is radially expanded.

[0106] After the inner skirt 16 is mounted to the frame 120, the valve structure, such as a plurality of leaflets 40, can be mounted to the inner skirt 16 and / or the frame 120. For example, the tip (inflow) edge of the leaflet 40 can be sutured to the inner skirt 16, and the commissures of the leaflets can be sutured to adjacent cells of the inner skirt and / or the frame. In an optional embodiment, the tip edge of the leaflet 40 can be fixed (e.g., sutured) to the skirt 16 before the inner skirt is assembled on the frame. After the inner skirt and leaflets are placed inside the frame, the commissures of the leaflets 40 can be fixed to the cells of the frame. Further details about assembling the leaflets 40 to the inner skirt and the frame are disclosed in U.S. Patent Publication Nos. 2010 / 0049313, 2012 / 0123529, and 2018 / 0028310, which are incorporated herein by reference.

[0107] In a particular embodiment, the sutures 156 used to attach the winding portions 142a, 142b to the skirt do not directly secure the outflow edge portion 138 of the skirt to the frame 120. In other words, in this embodiment, the sutures 156 do not extend around any of the struts of the frame. In a particular embodiment, in contrast to known prosthetic valves, no sewing is utilized to secure the outflow edge portion of the inner skirt to the struts of the frame. Instead, in this embodiment, the outflow edge portion 138 is only indirectly secured or connected to the frame via a main suture loop 136 that extends into and out of the frame at a frame junction 160 between the third and fourth rows of struts and need not include any sewing around the struts 130 between the junctions 154 and 160. In this manner, the outflow edge portion 138 of the inner skirt 16 is suspended from the frame 120 by the main suture loop 136. During diastole, the leaflets 40 are suspended from the frame 120 by the flow of retrograde blood (along the Figure 8 The diastolic load is transmitted from the leaflets to the inner skirt to the frame via the main suture ring 136. In this way, most of the forces acting on the prosthetic valve during diastole are borne by the metal struts of the frame rather than by the leaflets, which are more susceptible to wear and tear. Therefore, as can be appreciated, the disclosed methods and configurations can improve the long-term wear resistance and performance of prosthetic valves.

[0108] Furthermore, in known prosthetic valves, the outflow edge portion of the inner skirt is usually secured to the frame by sewing, which secures the outflow edge portion of the inner skirt to the entire row of struts of the frame, which is a time-consuming and laborious process. The disclosed method greatly facilitates the assembly process, since no sewing is required to secure the outflow edge portion of the inner skirt directly to the struts of the frame.

[0109] Fig.10An alternative way of securing the main suture loop 136 to the inner skirt 16 is shown. In this embodiment, the winding portions 142a, 142b are arranged against one side of the inner skirt, such as Fig.10 As shown, the first and second winding sections 164b and 166b are made to extend along the outflow edge portion 138. The winding sections 164b, 166b are then secured to the outflow edge portion 138 using a suitable technique or mechanism. For example, the winding sections can be secured to the inner skirt 16 by stitches 180 placed at selected locations along the outflow edge portion. For example, Fig.10 As shown, sutures 180 can be placed near the valleys and peaks of the outflow edge portion 138 of the inner skirt. After the main suture loop 136 is secured to the inner skirt 16, the inner skirt 16 can be placed on and secured to the frame, as previously described in conjunction with Figure 5-Figure 8 Further, the valve structure, such as the plurality of leaflets 40, can be mounted to the inner skirt 16 and / or the frame 120 as previously described.

[0110] In the above described embodiment, the main suture loop 136 has the first and second winding portions 142a, 142b. In an alternative embodiment, the main suture loop 136 may have more than two winding portions, such as three, four or more winding portions.

[0111] In the method described above, the main suture loop 136 is used to secure the outflow edge portion 138 of the inner skirt 16 to the frame 120. However, in other embodiments, the same method can be used to secure the inflow edge portion 139 of the inner skirt 16 to the frame. For example, another main suture loop 136 can be secured to the inflow edge portion 139 of the inner skirt (such as Figure 5 or Fig.10 ) and then secured to the inflow end of the frame (similar to Figure 5-Figure 8 , but with the sub-rings 140a-e positioned around the apex at the inflow end 122 of the frame). In some embodiments, the inflow edge portion 139 of the skirt 16 can be shaped similarly to the outflow edge portion 138 so that it has a series of peaks and valleys that follow the shape of the struts 126 of the first row I to facilitate placement of the sub-rings 140a-e around the apex at the inflow end 122 of the frame.

[0112] In an alternative embodiment, the method of assembling the inner skirt 16 to the frame 120 disclosed herein can also be used to assemble the outer skirt (e.g., the outer skirt 18) to the frame of the prosthetic valve. For example, the main suture ring 136 can be fixed to the outflow edge portion of the outer skirt, and the outer skirt can be fixed to the frame 120, as described above in conjunction with Figure 5-Figure 8As described, except that the outer skirt is placed outside the frame and the sub-rings 140a-e are placed on the apex 134 so that the unattached section of the winding portion is located inside the frame. The unattached section of the winding portion can then be pulled outward through the opening 150 of the frame 120 and then attached to the outer skirt, for example, by sutures (similar to sutures 156). In further embodiments, the inflow edge portion of the outer skirt can be mounted to the frame by suture loops 136, or the inflow edge portion and outflow edge portion of the outer skirt can be mounted to the frame by corresponding suture loops 136.

[0113] General Considerations

[0114] It should be understood that the disclosed embodiments may be suitable for delivery and implantation of a prosthetic device in any of the natural valve annuli of the heart (e.g., the aortic valve annulus, the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0115] For the purpose of this description, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure, individually and in various combinations and sub-combinations with each other, all relate to all novel and non-obvious features and aspects of the various disclosed embodiments. The methods, devices and systems are not limited to any specific aspects or features or combinations thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or require any one or more problems to be solved. The technology from any example can be combined with the technology described in one or more other examples. In view of the various possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be regarded as limitations on the scope of the disclosed technology.

[0116] Although certain operations in the disclosed embodiments are described in a specific sequential order for ease of presentation, it should be understood that unless the specific language set forth below requires a specific order, this description includes rearrangement. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed method can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary according to the specific embodiment and are easily discernible by those of ordinary skill in the art.

[0117] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly indicates otherwise. In addition, the term "including" means "comprising". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intervening elements between coupled or associated items in the absence of specific language to the contrary.

[0118] Direction and other relative references (e.g., inside, outside, up, down, 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 "inside," "outside," "top," "down," "inside," "outside," etc. may be used. Where applicable, such terms are used to provide some clarity when dealing with relative relationships, particularly with respect to exemplary embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion may become the "lower" portion simply by turning the object over. Nevertheless, it is still the same portion, and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0119] In view of the many possible embodiments to which the principles of the disclosed invention can be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be considered to limit the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Therefore, I claim all that falls within the scope and spirit of these claims as my invention.

Claims

1. A method of assembling a prosthetic heart valve, the method comprising: providing a skirt having an inflow edge portion and an outflow edge portion; securing a plurality of first segments of suture loops to one of the inflow edge portion and the outflow edge portion of the skirt; and After securing the suture loop to the skirt, placing the skirt on an annular frame, inserting a plurality of second segments of the suture loop through the opening of the annular frame, and securing the plurality of second segments of the suture loop to the skirt; wherein the act of securing the plurality of second segments of the suture loop to the skirt comprises securing the plurality of second segments of the suture loop to selected locations on the skirt with separate sutures; and wherein the suture loop comprises a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments comprises a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments comprises a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion. 2 . The method of claim 1 , wherein the skirt comprises an inner skirt and the placing the skirt on the annular frame comprises placing the inner skirt inside the annular frame. 3 . The method of claim 2 , wherein the act of securing the plurality of first segments of the suture loop comprises securing the plurality of first segments to an outflow edge portion of the inner skirt.

4. The method of claim 1, wherein the skirt comprises an outer skirt and the placing the skirt on the annular frame comprises placing the outer skirt outside the annular frame.

5. The method of any one of claims 1-4, wherein the suture loop is formed from a single length of suture material.

6. The method of any one of claims 1-4, wherein the suture loop is formed from only two lengths of suture material.

7. The method of claim 2 or 3, further comprising attaching leaflets to the inner skirt.

8. Prosthetic heart valves, including: an annular frame radially expandable from a radially compressed configuration to a radially expanded configuration; an annular skirt having an inflow edge portion and an opposing outflow edge portion; and a suture loop comprising a plurality of first segments secured to one of an inflow edge portion and an outflow edge portion of the annular skirt and a plurality of second segments extending through openings in the annular frame and secured to the annular skirt to couple the annular skirt to the annular frame, the plurality of second segments of the suture loop being secured to the annular skirt with separate sutures, wherein the suture loop comprises a first winding portion and a second winding portion arranged in a repeating figure-8 curve pattern, the plurality of first segments comprises a plurality of first segments of the first winding portion alternating with a plurality of first segments of the second winding portion, and the plurality of second segments comprises a plurality of second segments of the first winding portion alternating with a plurality of second segments of the second winding portion.

9. The prosthetic heart valve of claim 8, wherein the annular skirt comprises an inner skirt positioned inside the annular frame.

10. The prosthetic heart valve of claim 9, wherein the plurality of first segments of the suture ring are secured to an outflow edge portion of the inner skirt.

11. The prosthetic heart valve of claim 9, wherein the plurality of first segments of the suture ring are secured to the inflow edge portion of the inner skirt.

12. The prosthetic heart valve of claim 8, wherein the annular skirt comprises an outer skirt positioned outside of the annular frame.

13. The prosthetic heart valve of claim 12, wherein the plurality of first segments of the suture ring are secured to an outflow edge portion of the outer skirt.

14. The prosthetic heart valve of claim 12, wherein the plurality of first segments of the suture ring are secured to an inflow edge portion of the outer skirt.

15. The prosthetic heart valve of any one of claims 8-14, further comprising a plurality of leaflets supported by the annular skirt.

16. The prosthetic heart valve of claim 15, wherein the leaflets have tip edges sewn to the annular skirt.

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