Sealing element for prosthetic heart valve

Abstract

To provide improved paravalvular sealing elements for prosthetic heart valves.SOLUTION: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured to the frame, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and separated from the first woven portion along the longitudinal axis of the frame. At least a part of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] SUMMARY OF THE INVENTION The present application relates to embodiments of sealing elements for prosthetic heart valves and methods for making the same. [Background technology]

[0002] The heart can suffer from a variety of valvular diseases or malformations that result in significant cardiac dysfunction and ultimately require replacement of native heart valves with prosthetic valves. Procedures in which radially collapsible transcatheter heart valves are percutaneously introduced in a compressed state on a catheter and expanded at the treatment location have become popular, especially among patient populations at high risk of morbidity or mortality from traditional surgical procedures.

[0003] It can be important to reduce or prevent blood leakage through a prosthetic valve after implantation. Therefore, transcatheter heart valves often include sealing elements, such as a perivalvular leakage skirt, that reduce the amount of leakage through the prosthetic valve. However, differences in diameter between the prosthetic valve and the native annulus into which the valve is implanted, combined with characteristics of a particular patient's anatomy, such as calcification, tissue bulges, indentations, and folds, can make it difficult to achieve a seal between the prosthetic valve and the native annulus. Therefore, there is a need for improved perivalvular sealing elements for prosthetic heart valves. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2018 / 0153689 [Patent Document 2] U.S. Patent No. 6,730,118 [Patent Document 3] U.S. Patent No. 7,393,360 [Patent Document 4] U.S. Patent No. 7,510,575 [Patent Document 5] U.S. Patent No. 7,993,394 [Patent Document 6] U.S. Patent No. 8,652,202 [Patent Document 7] U.S. Patent No. 9,393,110 [Patent Document 8] US Patent Application Publication No. 2017 / 0065415 [Patent Document 9] US Patent Application Publication No. 2013 / 0030519 [Non-patent literature]

[0005] [Non-Patent Document 1] Zoghbi et al., ASE Guidelines and Standards: Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation - A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance, Journal of the American Society of Echocardiography, April 2017 Summary of the Invention [Means for solving the problem]

[0006] Certain embodiments of the present disclosure relate to prosthetic valves including various embodiments of sealing elements. In an exemplary embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A valve leaflet structure is positioned within and secured to the frame, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion to form a loop extending radially outward from the frame.

[0007] In some embodiments, the filaments forming the loops extend from and return to the first woven portion.

[0008] In some embodiments, the first woven portion comprises a first row of loops and the second woven portion comprises a second row of loops, and the loops of the second row of loops can comprise filaments extending from and back to the second woven portion.

[0009] In some embodiments, the loops of the second row of loops are circumferentially offset from the loops of the first row of loops.

[0010] In some embodiments, the plurality of interwoven filaments of the first woven portion further comprises at least one first filament interwoven with a plurality of second filaments, wherein a portion of the at least one first filament forms a loop in the first woven portion.

[0011] In some embodiments, the sealing element further comprises an intermediate sealing portion between the first and second woven portions, the intermediate sealing portion comprising a plurality of second filaments, a portion of at least one first filament extending between the first and second woven portions along the longitudinal axis of the frame and interwoven with the second filaments of the intermediate sealing portion.

[0012] In some embodiments, a portion of at least one first filament forms a loop in the second woven portion.

[0013] In some embodiments, the second filaments are warp yarns and the at least one first filament is a weft yarn.

[0014] In some embodiments, at least one of the warp and weft yarns comprises textured yarn.

[0015] In some embodiments, the warp and weft threads comprise fibers having a diameter of 1 μm to 20 μm that promote thrombus formation around the sealing element.

[0016] In some embodiments, the filaments forming the loops originate in the first woven portion and extend in a curved manner along the longitudinal axis of the frame to the second woven portion.

[0017] In some embodiments, the filaments forming the loops exit the weave of the first woven portion and are incorporated into the loops of the second woven portion such that the loops form a float portion between the first and second woven portions.

[0018] In some embodiments, the float portion comprises a first loop layer and a second loop layer radially outward from the first loop layer.

[0019] In some embodiments, the sealing element comprises a first fabric piece, a second fabric piece, and a third fabric piece. A plurality of filaments forming loops extend between the first and second fabric pieces, and a plurality of filaments forming loops extend between the second and third fabric pieces. The sealing element is folded around the second fabric piece so that the first and third fabric pieces are adjacent to one another to form a first woven portion, with the filaments extending between the first and second fabric pieces to form a first loop layer and the filaments extending between the second and third fabric pieces to form a second loop layer.

[0020] In some embodiments, the sealing element is secured to the frame such that the filaments exiting the weave of the first woven portion form a loop when the frame is in the expanded configuration and are pulled straight when the frame is in the collapsed configuration.

[0021] In another exemplary embodiment, a method includes mounting any of the prosthetic valves described herein on a distal end portion of a delivery device, advancing the delivery device through the patient's vascular system to the heart, and expanding the prosthetic valve within the native heart valve of the heart such that the prosthetic valve regulates blood flow through the native heart valve.

[0022] In another exemplary embodiment, a method of making a sealing element for a prosthetic heart valve includes weaving at least one weft thread with a plurality of warp threads to form a first woven portion, dropping the at least one weft thread from the weave of the first woven portion, and looping the at least one weft thread around the removable warp thread. The removable warp thread is spaced from the first woven portion, and the at least one weft thread is looped around the removable warp thread such that the at least one weft thread extends over but does not interweave with a warp thread disposed between the first woven portion and the removable warp thread. The method further includes reincorporating the at least one weft thread into the weave of the first woven portion such that the at least one weft thread forms a loop extending from and back into the first woven portion, and removing the removable warp thread from the sealing element to release the loop formed by the at least one weft thread.

[0023] In some embodiments, before removing the removable warp threads, the method further includes repeating the weaving, dropping, looping, and reincorporating to form multiple loops around the circumference of the sealing element.

[0024] In some embodiments, the method further includes shape-locking the plurality of loops such that the loops extend outwardly from the closure element.

[0025] In some embodiments, the method further includes weaving at least one weft yarn with the warp yarns before removing the removable warp yarns, such that the at least one weft yarn extends beyond the removable warp yarns to form a second woven section spaced apart from the first woven section. The method further includes dropping the at least one weft yarn from the weave of the second woven section and looping the at least one weft yarn around the second removable warp yarn spaced apart from the second woven section. The at least one weft yarn can be looped around the second removable warp yarn, such that the at least one weft yarn extends over but does not interweave with the warp yarns disposed between the second woven section and the second removable warp yarn. The method further includes reincorporating the at least one weft yarn into the weave of the second woven section, such that the at least one weft yarn forms a second loop extending from and back to the second woven section.

[0026] The above and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a perspective view showing a prosthetic heart valve including an exemplary embodiment of a perivalvular leak seal including a looped filament. [Figure 2] FIG. 2 is a perspective view of the paravalvular leak seal of FIG. 1. [Figure 3] 2 is a schematic diagram illustrating an exemplary method for weaving the paravalvular leak seal of FIG. 1. [Figure 4] FIG. 1 is a side view showing textured yarn and raw silk. [Figure 5] 1 is a perspective view illustrating a prosthetic heart valve including another embodiment of a perivalvular leak seal including a woven portion and a plurality of filaments extending from the woven portion. [Figure 6] FIG. 6 is a schematic diagram of the paravalvular leak seal of FIG. 5. [Figure 7]6 is a perspective view showing the prosthetic heart valve of FIG. 5 including another embodiment of a perivalvular leak seal including multiple woven portions arranged in a tiered arrangement on the exterior of the valve. [Figure 8] 6 is a side view showing the prosthetic heart valve of FIG. 5 including another embodiment of a paravalvular leak seal in which the woven portions extend in a zigzag pattern around the valve parallel to the strut members of the frame. [Figure 9] FIG. 10 is a perspective view illustrating another embodiment of a prosthetic heart valve including a perivalvular leak seal having a first woven portion, a second woven portion, and a plurality of threads extending between the first and second woven portions to form loops. [Figure 10] 10 is a top view of an exemplary embodiment of the paravalvular leak seal of FIG. 9. [Figure 11] FIG. 10 is a perspective view showing the paravalvular leak seal of FIG. 9 folded over on itself prior to attachment to a prosthetic valve. [Figure 12A] 10 is a side view of a portion of the frame of the prosthetic valve of FIG. 9 in an expanded configuration, showing the longitudinally extending threads of the perivalvular leak seal curving outward from the frame. [Figure 12B] 12B is a side view of the portion of the frame of FIG. 12A in a radially folded configuration, showing the longitudinally extending threads of the perivalvular leak seal pulled straight along the longitudinal axis of the valve. [Figure 13] FIG. 10 is a side view of a portion of the frame of the prosthetic valve of FIG. 9, with a first woven portion of the perivalvular leak seal coupled to a first stage of the frame struts and a second woven portion coupled to a third stage of the frame struts. [Figure 14] FIG. 10 is a side view of a portion of the frame of the prosthetic valve of FIG. 9, with a first woven portion of the perivalvular leak seal coupled to the first stage of the frame struts and a second woven portion coupled to the fourth stage of the frame struts. [Figure 15] FIG. 10 is a side view of a portion of the frame of the prosthetic valve of FIG. 9 with a paravalvular leak seal draped along the struts of the frame. [Figure 16A] 10 shows another embodiment of the paravalvular leak seal of FIG. 9, in which the longitudinally extending threads extend at an angle between the first and second woven portions of the seal. [Figure 16B] 10 shows another embodiment of the paravalvular leak seal of FIG. 9, in which the longitudinally extending threads extend at an angle between the first and second woven portions of the seal. [Figure 17] 10 is a perspective view of the prosthetic heart valve of FIG. 9 including another embodiment of a perivalvular leak seal including a single layer of longitudinally extending threads. [Figure 18] FIG. 18 is a top view of a portion of the paravalvular leak seal of FIG. 17. [Figure 19] FIG. 18 is a bottom view of the prosthetic heart valve of FIG. 17. [Figure 20] 10 is a perspective view of the prosthetic heart valve of FIG. 9 including another embodiment of a paravalvular leak seal. [Figure 21] 1A and 1B are perspective views illustrating an exemplary embodiment of a delivery device. [Figure 22] 10A-10C show another embodiment of the sealing element, in which a thread forming a loop extends from the sealing element. [Figure 23] 10A-10C show another embodiment of the sealing element, in which a thread forming a loop extends from the sealing element. [Figure 24] 10A-10C show another embodiment of the sealing element, in which a thread forming a loop extends from the sealing element. [Figure 25] 10A-10C show another embodiment of the sealing element, in which a thread forming a loop extends from the sealing element. [Figure 26] FIG. 10 is a perspective view illustrating a portion of a sealing member including a plurality of loops embroidered into the base skirt fabric, according to one embodiment. [Figure 27] FIG. 27 is a cross-sectional view of the sealing member of FIG. 26. [Figure 28] FIG. 10 is a perspective view showing a pattern of a plush loop portion formed on a sealing member. [Figure 29] FIG. 10 is a perspective view showing a pattern of a plush loop portion formed on a sealing member. [Figure 30] FIG. 10 is a perspective view showing a pattern of a plush loop portion formed on a sealing member. [Figure 31]10 is a side view illustrating a prosthetic heart valve including a sealing member comprising multiple pieces of fabric including fringe portions, according to another embodiment. [Figure 32] 10 is a plan view illustrating a sealing member of a prosthetic heart valve including a woven portion and a floating thread portion, according to another embodiment. [Figure 33] 33 is an enlarged view of a first woven portion of the sealing member of FIG. 32. FIG. [Figure 34] 33 is an enlarged view of a second woven portion of the sealing member of FIG. 32. FIG. [Figure 35] FIG. 33 is an enlarged view of the floating thread portion of the sealing member of FIG. 32 in a relaxed state. [Figure 36] FIG. 36 shows the floating thread portion of FIG. 35 in an extended state. [Figure 37] FIG. 33 is a plan view of the sealing member of FIG. 32 in an extended state. [Figure 38] FIG. 33 is a perspective view showing an edge portion of the sealing member of FIG. 32. [Figure 39A] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39B] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39C] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39D] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39E] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39F] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39G] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39H] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39I] 1A-1C illustrate examples of leno weave patterns and techniques. [Figure 39J] 1A-1C illustrate examples of leno weave patterns and techniques. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present disclosure relates to embodiments of sealing elements for implantable prosthetic devices, such as prosthetic heart valves. The inventors have surprisingly discovered that effective sealing can be achieved by a sealing element that includes a plurality of filaments, such as threads and / or fibers, extending therefrom and configured to stimulate a biological response at the cellular level to promote thrombus formation around the sealing element.

[0029] For example, the sealing elements described herein can be configured as a fabric skirt including a woven portion from which filaments or threads extend to contact and / or conform to surrounding anatomical structures, enhancing the sealing properties of the skirt. In certain configurations, the filaments are knotted at both ends to form loops extending radially outward from the skirt. As used herein, the term "loop" refers to a closed or partially open curve formed by a thread or other filament. In some embodiments, the threads forming the loops extend from and return to the same fabric portion of the skirt. In such configurations, the loops can be arranged in one or more rows extending circumferentially around the skirt. In other configurations, the threads extend from one fabric portion to another spaced apart fabric portion, such that the loops are arranged in rows circumferentially around the valve and oriented along the longitudinal axis of the valve. In still other embodiments, the filaments are knotted at one end and have free ends extending outward from the skirt.

[0030] In such a configuration, the filaments can be configured to slow retrograde blood flow through the valve, and features such as filament diameter, shape, surface texture, and coating can induce thrombus formation around the filaments to enhance the sealing properties of the skirt.

[0031] FIG. 1 illustrates an exemplary embodiment of a radially collapsible and expandable prosthetic valve 10 shown in a deployed and expanded configuration. The prosthetic valve may include an annular stent or frame 12 and a leaflet structure 14 mounted within and coupled to the frame 12. The frame 12 may have an inflow end portion 16 and an outflow end portion 18. The leaflet structure may include multiple leaflets 22, such as three leaflets arranged to collapse in a tricuspid configuration similar to the aortic valve. Alternatively, the prosthetic valve may include two leaflets 22 configured to collapse in a bicuspid configuration similar to the mitral valve, or more than three leaflets, depending on the particular application. The prosthetic valve 10 may define a longitudinal axis 24 extending through the inflow end portion 16 and the outflow end portion 18.

[0032] The frame 12 can be made of any of a variety of biocompatible materials, such as stainless steel or a nickel-titanium alloy ("NiTi"), e.g., Nitinol. Referring to FIG. 1 , the frame 12 can include a plurality of interconnected lattice struts 26 arranged in a lattice pattern, forming a plurality of apexes 28 at the outflow end 18 of the prosthetic valve. The struts 26 can also form similar apexes at the inflow end 16 of the prosthetic valve (covered by a skirt 30, described in more detail below). The lattice struts 26 are shown positioned diagonally or angularly offset from the longitudinal axis 24 of the prosthetic valve and radially offset therefrom. In other implementations, the lattice struts 26 can be offset by a different amount than shown in FIG. 1 , or some or all of the lattice struts 26 can be positioned parallel to the longitudinal axis 24 of the prosthetic valve.

[0033] The lattice struts 26 can be pivotally coupled to one another. In the illustrated embodiment, for example, end portions of the struts 26 forming apexes 28 at the outflow end 18 and the inflow end 16 of the frame can have respective openings 32. The struts 26 can also be formed with apertures 34 located between opposing ends of the struts. Respective hinges can be formed at the apexes 28 and between the ends of the frame where the struts 26 overlap one another via fasteners 36, which can include rivets or pins, extending through the apertures 32, 34. The hinges can allow the struts 26 to pivot relative to one another when the frame 12 is expanded or contracted, such as during assembly, preparation, or implantation of the prosthetic valve 10. For example, the frame 12 (and thus the prosthetic valve 10) can be manipulated into a radially compressed or contracted configuration coupled to a delivery device and inserted into a patient's body for implantation. Once inside the body, the prosthetic valve 10 can be manipulated into an expanded state and then released from the delivery apparatus, as described in more detail with reference to Figure 21. Further details regarding the frame 12, the delivery apparatus, and devices and techniques for radially expanding and collapsing the frame can be found in U.S. Patent Application Publication No. 2018 / 0153689.

[0034] As shown in FIG. 1 , the prosthetic valve 10 can include a sealing element configured as a skirt 30. The skirt 30 can be configured to establish a seal with native tissue at the treatment site to reduce or prevent paravalvular leakage. The skirt 30 can include a main body portion 38 disposed around the periphery of the frame 12. The skirt 30 can be secured to the frame by a plurality of sutures 41 extending in a zigzag pattern along selected strut members 26, for example, between a first edge portion (e.g., an inflow edge portion) 40 and a second edge portion (e.g., an outflow edge portion) 42 of the skirt 30. For example, in certain embodiments, the skirt 30 can be sutured to the frame 12 along suture lines 66 corresponding to the scalloped edges defined by the valve leaflets 22, thereby allowing the valve to radially expand and contract without interference or pinching by the skirt. Further details regarding transcatheter prosthetic heart valves, including techniques that can be used to couple the leaflets 22 to the frame 12, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202.

[0035] In the illustrated embodiment, the skirt 30 may include a plurality of outwardly extending filaments configured as loops 44 (also referred to as looped filaments). The loops 44 may extend from an outer surface 46 of the main portion 38. In certain embodiments, the loops 44 may be arranged in rows or columns 48 that extend circumferentially around the frame 12 and are spaced apart from one another along the longitudinal axis 24. For example, in the illustrated embodiment, the loops 44 are arranged in three rows 48, with a first row 48A adjacent the inflow edge portion 40 of the skirt and rows 48B and 48C positioned above the first row 48A along the longitudinal axis 24 of the valve. In other embodiments, the skirt 30 may include more or fewer loop rows, depending on the particular characteristics desired. For example, the skirt 30 may include a single loop row 44 (e.g., adjacent the inflow end of the frame) or multiple loop rows substantially along the entire height dimension of the skirt 30.

[0036] In certain embodiments, the skirt 30 can comprise a textile material, such as a woven or knitted fabric. FIG. 2 illustrates in more detail a portion of an exemplary embodiment of a skirt 30 made from such a textile. The textile can comprise a plurality of first yarns 50, oriented horizontally in FIG. 2 , and one or more second yarns 52, oriented vertically in FIG. 2 , selectively interwoven with the first yarns 50 on a loom. In certain configurations, the first yarns 50 can be warp yarns, i.e., held by the loom during the weaving process, and the second yarns 52 can be weft yarns, interwoven with the warp yarns by a moving shuttle or weft holding mechanism during the weaving process. However, in other embodiments, the first yarns 50 can be weft yarns and the second yarns 52 can be warp yarns. In the illustrated configuration, the textile comprises a single weft yarn 52 selectively interwoven with the warp yarns 50 to form the looped filaments 44, although in other embodiments, more than one weft yarn can be used.

[0037] FIG. 3 illustrates an exemplary weave pattern that can be used to create the skirt 30. Referring to FIG. 3, a first portion 52A of weft yarns can extend over and under the warp yarns of the fabric from the first edge portion 40 to the second edge portion 42. At the second edge portion 42, the weft yarns 52 are turned back, and a second portion 52B of the weft yarns extends over and under each of the warp yarns of the fabric in a direction back toward the first edge portion 40 in a plain weave configuration. This can define the side edges of the fabric and prevent the fabric from unraveling when removed from the loom. At the first edge portion 40, the weft yarns 52 can be turned back again, so that a third portion 52C extends over and under the warp yarns 50 of the first woven portion, configured as a fully woven strip 54A of fabric. In the illustrated configuration, the fabric may include four such woven pieces 54A-54D spaced apart between the first and second edge portions 40, 42 and extending parallel to the warp yarns 50. The woven pieces 54A-54D may be separated by respective portions or semi-woven portions 55A-55C (also referred to as intermediate sealed portions). In the fully woven pieces 54A-54D, all of the weft yarn 52 passes may be incorporated into the weave. In contrast, in the semi-woven portions 55A-55C, only a portion of the weft yarn passes are incorporated into the weave. In certain examples, in the woven pieces 54A-54D, the warp and weft yarns 50, 52 are woven together in a plain weave (or another suitable weave). In other embodiments, the skirt 30 need not include a woven portion 54D above the last loop row 44, depending on the particular application.

[0038] Continuing with reference to FIG. 3 , at the top edge 56 of woven piece 54A, weft portion 52C can exit the weave (e.g., weft portion 52C is “dropped” from the weave) and extend or “float” above the warp yarns 50 of semi-woven portion 55A for a distance d1. In FIG. 3 , the portion of weft yarn 52 incorporated into the weave is shown in solid lines, while the portion of weft yarn 52 not incorporated into the weave (such as portion 52C) is shown in dashed lines. Portion 52C can then form a loop around removable warp yarn 50A (also called selvage yarn), and fourth portion 52D can extend back above the warp yarns and outside the weave toward first edge portion 40. When weft portion 52D reaches woven piece 54A, portion 52D can be reincorporated into the weave such that the warp yarns of woven piece 54A extend above and below weft portion 52D.

[0039] At the first edge portion 40, the warp yarns 52 can be folded back again, and the fifth portion 52E can extend in a direction toward the second edge portion 42. The fifth portion 52E can be incorporated into the weave through the semi-woven portion 55A and the woven piece 54B until it reaches the top edge 58 of the woven piece 54B, at which point the sixth portion 52F can exit the weave, or "drop" from the weave. The sixth portion 52F can extend or float above the warp yarns 50 of the semi-woven portion 55B in a direction toward the second edge portion 42 a distance d2. The sixth portion 52F can then form a loop around the removable warp yarns 50B, and the seventh portion 52G of the weft yarns can extend outside the weave back toward the first edge portion 40.

[0040] When seventh portion 52G reaches top edge 58 of woven piece 54B, seventh portion 52G can be reincorporated into the weave such that the warp yarns of woven piece 54B extend above and below seventh portion 52G. When seventh portion 52G reaches bottom edge portion 60 of woven piece 54B, the weft yarns can turn back and eighth portion 52H can extend in a direction toward second edge portion 42. Eighth portion 52H can be incorporated into the weave through semi-woven portion 55B and woven piece 54C until the eighth portion reaches top edge portion 62 of woven piece 54C. At this point, ninth portion 52I can exit the weave and extend a distance d3 over warp yarns 50 of semi-woven portion 55C toward second edge portion 42. In the woven piece 54D, the ninth portion 52I can form a loop around the removable warp yarn 50C, and the tenth weft portion 52J can extend back toward the first edge portion 40 on the outside of the weave.

[0041] When the tenth portion 52J reaches the top edge 62 of the woven piece 54C, the weft yarn can be reincorporated into the weave, with the eleventh weft yarn portion 52K extending back into the weave toward the first edge portion 40. When portion 52K reaches the first edge portion 40, the weft yarn can turn back, repeating the pattern described above along the length of the fabric (e.g., toward the right in FIG. 3). FIG. 3 shows two complete examples of the weave patterns described above.

[0042] Once the weave pattern has been repeated a selected number of times (to produce a fabric having a length corresponding to the circumference of the prosthetic valve), removable warp yarns 50A-50C can be removed from the weave. For example, in the embodiment shown in FIG. 3, warp yarns 50A-50C can be pulled from the fabric in the directions of respective arrows 64A-64C, thereby releasing the portions of weft yarns 50 on the outside of the weave from the fabric, thereby forming loops 44. For example, when removable warp yarn 50A is removed from the weave, weft yarn portions 52C and 52D can be released from the fabric and form looped filaments 44A extending from weave piece 54A (e.g., in the form of a terry weave). Similarly, removing warp yarn 50B can release weft portions 52F and 52G to form looped filaments 44B extending from woven piece 54B, and removing warp yarn 50C can release weft portions 52I and 52J to form looped filaments 44C extending from woven piece 54C.

[0043] Thus, removing warp yarns 50A-50C results in a plurality of looped filaments 44 arranged in three rows 48A-48C extending lengthwise along skirt 30, as described above. FIG. 2 shows skirt 30 with removable warp yarn 50A removed for illustrative purposes. Returning to FIG. 3, and with reference to the Cartesian x- and y-axes of reference, rows 48A-48C of loops 44 can be offset from one another in a direction along the y-axis (e.g., parallel to the longitudinal axis of the valve) by a distance equal to the length of the loop plus the width of woven piece 54A from which the loop extends. For example, first row 48A of loops 44 adjacent first edge portion 40 is offset from second row 48B of loops by a distance equal to the width W of woven piece 54A plus a distance d1, the length of loop 44.

[0044] However, while the loops 44 are shown axially aligned in FIG. 1 for illustrative purposes, the loops 44 can also be spaced apart from one another in a direction along the x-axis (e.g., circumferentially around the prosthetic valve when the skirt 30 is secured to the valve). For example, in the embodiment shown in FIG. 3, the center or apex of loop 44B is spaced apart from the center or apex of loop 44A by a distance x1, which corresponds to the distance along the x-axis occupied by weft portions 52D and 52E of the weave. Thus, in the illustrated configuration, each loop 44 is offset from the subsequent loop 44 in the adjacent row by a distance x1 in a direction along the x-axis. Thus, loop 44A is offset from loop 44B in the negative x-direction by a distance x1, and loop 44C is offset from loop 44B in the positive x-direction by a distance x1. Loops 44 in the same row are offset from one another along the x-axis by a distance equal to 3x1.

[0045] In certain embodiments, once the fabric has been removed from the loom and the removable warp yarns 50A-50C have been removed from the weave, the loops 44 can be shape-set to extend out of the plane of the fabric (e.g., transverse to the longitudinal axis of the valve and therefore transverse to the direction of flow through the valve). For example, referring again to FIG. 1, the loops 44 can be shape-set to extend radially outward from the surface 46 of the skirt 30 at an angle when the skirt is secured to the frame.

[0046] In certain configurations, one or both of the warp and weft yarns 50, 52 can also comprise textured yarn. A representative example is shown in FIG. 4, which illustrates an exemplary textured yarn 70 and raw silk 80. The textured yarn 70 includes multiple constituent fibers 72 that have been crimped, coiled, crinkled, looped, or otherwise textured so that the fibers are not as tightly bundled as the fibers 82 of the raw silk 80. This can increase the surface area of ​​the textured yarn 70, thereby improving the blood clotting properties of the yarn, as discussed further below. Additionally, the fibers 72 from which the yarns 50, 52 are formed can be sized to promote a biological response or interaction at the cellular level between the yarns 50, 52 and the blood flowing through the skirt.

[0047] For example, blood cells typically range in size from 2 μm to 15 μm. For example, red blood cells typically range in diameter from 6 μm to 8 μm, and platelets typically range in diameter from 2 μm to 3 μm. Therefore, utilizing fibers 72 with diameters sized to appropriately match the diameters of blood cells (e.g., 1 μm to 20 μm) can promote cellular interactions between the fibers and blood cells. For example, fibers 72 can be configured to promote thrombus formation along skirt 30, particularly along looped filaments 44, thereby improving the sealing properties of the skirt.

[0048] In certain configurations, the warp and weft yarns may comprise various biocompatible materials, such as natural fibers (e.g., silk, cotton, etc.), synthetic polymeric materials (e.g., polyethylene terephthalate (PET), nylon, polytetrafluoroethylene (PTFE), etc.), or metals (e.g., nitinol, gold, etc.). In other embodiments, the skirt 30 may not comprise a woven fabric, but may comprise a thin polymer film or laminate integrally formed with or to which the looped filaments are attached.

[0049] The skirt 30 can provide a number of significant advantages over known skirt embodiments. For example, the loops 44 can impede blood flow through the valve, reducing the rate and amount of blood that leaks past the valve after implantation. By impeding flow, the loops 44 can increase the residence time of blood near the skirt. This, combined with the fiber diameter described above, can induce thrombus formation and promote a seal between the skirt and surrounding tissue.

[0050] Additionally, the loops 44 are flexible, allowing them to adapt to the shape of the surrounding anatomy. Because the loops 44 extend radially outward from the surface of the skirt 30, the free end portions of the loops can extend into folds and crevices in the surrounding anatomy to promote a more complete seal. Furthermore, when the prosthetic valve is implanted into the native aortic valve, blood around the exterior of the valve can exert a force on the loops 44 in a direction opposite to the direction of blood flow through the valve during ventricular diastole. This can reinforce the bending of the loops 44 away from the skirt 30, further improving the sealing properties. Additionally, by extending outward from the exterior of the valve, the loops 44 can also prevent blood clots from migrating beyond the valve, reducing the likelihood of stroke.

[0051] 5 shows a prosthetic valve 10 including another embodiment of a sealing member or skirt 100. In the illustrated embodiment, the skirt 100 can include a woven portion configured as a fabric piece 102 and a fringe portion 104 including multiple filaments configured as threads 106 extending from an edge portion 108 of the fabric piece 102. In certain examples, the threads 106 can be warp threads extending from the weave of the fabric piece 102 that are not interwoven with any weft threads, or vice versa. In some embodiments, the threads 106 can be frayed threads. For example, the threads 106 can include multiple fibers or threads spun together.

[0052] FIG. 6 schematically illustrates a portion of such a skirt 100 in greater detail. In the configuration shown in FIG. 6, the yarn 106 can be frayed such that the constituent fibers 110 of the yarn are separated from one another, forming fan-like structures 112. For example, in some embodiments, the fibers 110 of the yarn 106 can have a diameter of 1 μm to 20 μm, a size that allows electrostatic forces between the fibers to prevail over gravity, causing the fibers to spread out. This can increase the surface area of ​​the yarn 106, thereby promoting a biological response at the cellular level between blood and the skirt fibers 110, as described above with respect to the embodiment of FIG. 1. Thus, the fibers 110 can be configured to promote thrombus formation along the fringe portions 104, thereby improving the sealing properties of the skirt 100.

[0053] In certain embodiments, the yarn 106 can include any of a variety of hydrophobic surface treatments or coatings to promote separation of the fibers 110 and increase the surface area of ​​the fringe portion 104. In other embodiments, the yarn 106 can include a hydrophilic surface treatment, such as polyethylene glycol (PEG) or other coating covalently bonded to the fiber. The yarn 106 can also include a coating or treatment that promotes a biological response (e.g., thrombus formation) from blood in contact with the yarn, and / or a lubricious coating, such as the Serene™ lubricious coating available from Surmodics, Inc. In other embodiments, an electrostatic charge can be applied to the yarn 106 to cause the fibers 110 to repel each other, increasing fiber separation. In still other embodiments, the fibers 110 can be processed fibers, such as those described above with respect to the embodiment of FIG. 1, or small diameter staple fibers that are coated or felted. In other examples, the yarn 106 can form loops.

[0054] 7, in another configuration, the skirt 100 can include multiple pieces of fabric 102 arranged one above the other in a tiered arrangement. For example, in the illustrated embodiment, the skirt 100 can include three pieces of fabric 102A-102C arranged such that the frayed edge portion 108 of each piece is oriented toward the outflow end 18 of the frame. While the illustrated embodiment includes three pieces of fabric 102A-102C, the skirt 100 can include any suitable number of pieces of fabric 102 depending, for example, on the width of the pieces of fabric, the length of the prosthetic valve, etc. In other embodiments, both longitudinal edges of the pieces of fabric 102 can include threads 106.

[0055] In another configuration shown in Figure 8, the skirt 100 can be secured to the support member 26 so that it extends along the support member, forming a zigzag shape. Depending on the particular application, multiple skirts 100 can be secured in this manner to the frame support member 26.

[0056] 9 illustrates another embodiment of a prosthetic valve 200 configured as Edwards Lifesciences Corporation's SAPIEN® 3 prosthetic heart valve, which is described in detail in U.S. Pat. No. 9,393,110. The prosthetic valve 200 includes a radially expandable and collapsible frame 202 formed by a plurality of angled strut members 204 and having an inflow end 206 and an outflow end 208. Although not shown, the prosthetic valve 200 may also include a leaflet structure with two leaflets, three leaflets, or any other suitable number of leaflets mounted and secured within a frame such as that described in U.S. Pat. No. 9,393,110.

[0057] The prosthetic valve 200 can include an inner skirt 211 secured to the inner surface of the frame and an outer sealing element configured as a skirt 212 disposed around the exterior of the frame 202. In the illustrated configuration, the skirt 212 can include a first circumferentially extending portion 214 located adjacent the inflow end 206 of the frame and a second circumferentially extending portion 216. The circumferential portions 214, 216 can be spaced apart from one another along the longitudinal axis 218 of the frame and joined together by a plurality of filaments 220. The filaments 220 can extend longitudinally along the exterior of the frame between the portions 214, 216 and can bend outward from the frame to form loops when the frame is in an expanded configuration. The looped filaments 220 can be configured to promote sealing by impeding blood flow through the skirt and increasing blood residence time in the vicinity of the filaments, as described above.

[0058] In certain configurations, circumferential portions 214, 216 can be configured as one or more pieces of woven fabric. Filaments 220 can be threads incorporated into the fabric of portions 214 and 216 and extending axially therebetween. While skirt 212 shown in FIG. 9 includes a single layer of looped filaments 220 for ease of illustration, skirt embodiments described herein can include two or more layers of looped filaments, depending on the number of fabric pieces incorporated into portions 214, 216. Increasing the number of looped filaments (e.g., by increasing the number of fabric pieces) can increase the total surface area of ​​the sealing element available for thrombus formation.

[0059] For example, FIG. 10 shows an exemplary embodiment of a skirt 212, expanded for illustrative purposes, configured to provide two layers of looped filaments 220 when secured to a frame. The skirt 212 can include a main body 224 including a first fabric piece 226A, a second fabric piece 226B, and a third fabric piece 226C. The fabric piece 226B can be positioned between the fabric pieces 226A and 226C. The fabric piece 226B can be separated from the fabric piece 226A by a float portion 228A comprising a plurality of filaments or yarns 220. Similarly, the fabric piece 226C can be separated from the fabric piece 226B by a float portion 228B comprising a plurality of yarns 220.

[0060] In the illustrated configuration, the first fabric piece 226A can include warp and weft yarns woven together. At an edge portion 230 of the fabric piece 226A, the yarn 220 can exit the weave and extend or "float" to the second fabric piece 226B, forming a float yarn portion 228A. When the float yarn 220 reaches the second fabric piece 226B, the yarn can be reincorporated into the woven fabric of the fabric piece 226B. At an edge portion 232 of the fabric piece 226B, the yarn 220 can exit the weave and extend or float from the fabric piece 226B to the fabric piece 226C, forming a float yarn portion 228B. When the float yarn 220 reaches the fabric piece 226C, it can be reincorporated into the weave of the fabric piece 226C. In certain configurations, the yarns 220 are warp yarns, but the yarns 220 may also be weft yarns or a combination of warp and weft yarns depending on the particular application.

[0061] 11 , main body 224 of skirt 212 can be folded around fabric piece 226B, with fabric piece 226C adjacent to fabric piece 226A and with float portions 228A and 228B overlapping or coextensive with one another. The folded skirt 212 can then be secured (e.g., by stitching) to a frame, with fabric pieces 226A and 226C forming first portion 214 and fabric piece 226B forming second portion 216. In this manner, the longitudinally extending yarns 220 of float portion 228A form the first, or radially inner, layer of curved yarns or loops, and the longitudinally extending yarns 220 of float portion 228B form the second, or radially outer, layer of curved yarns or loops (or vice versa). To produce the single layer of looped filaments 220 shown in FIG. 9, skirt 212 need only include, for example, woven pieces 226A and 226B and float portion 228A.

[0062] 12A and 12B, which show a portion of a frame 202, the strut members 204 can be arranged end-to-end to form multiple rows or columns of strut members extending circumferentially around the frame 202. For example, the frame 202 can include a first, or lower, column I of angled strut members forming the inflow end 206 of the frame, a second column II of strut members above the first column, a third column III of strut members above the second column, a fourth column IV of strut members above the third column, and a fifth column V of strut members above the fourth column and forming the outflow end 208 of the frame. The structure and characteristics of columns I-V of strut members 204 are described in more detail in U.S. Pat. No. 9,393,110. The strut members 204 of the frame 202 can also be grouped into columns. For example, frame 202 may include a plurality of first or "Type A" columns and second or "Type B" columns arranged alternately around the circumference of the frame. In the illustrated configuration, a Type A column includes a support member 204 to the left of a diamond-shaped window 205 defined by rows IV and V of support members and extending downward therefrom. A Type B column includes a support member 204 to the right of window 205 and extending downward therefrom.

[0063] 9-12A, a first portion 214 of the skirt 212 can be secured (e.g., by stitching) to a first row I of strut members 204 adjacent the outflow end of the frame. A second portion 216 can be secured along the intersection of second and third rows II and III of struts 204. The length of thread 220 can be configured such that the thread curves radially outward from the surface of the frame 202 and forms a loop when the frame is in the expanded configuration. For example, when coupled to the frame, the skirt 30 can have a length L that approximately corresponds to the sum of the lengths of strut members 204A, 204B, and 204C shown in FIG. 12A. In this way, when the frame 202 is in a radially compressed or crimped configuration (the strut members 204A, 204B, and 204C are axially aligned or nearly aligned with one another), the threads 220 can be pulled straight to reduce the crimp profile of the valve during insertion into the delivery sheath.

[0064] In the configuration shown in FIGS. 9-12B, portions 214, 216 of skirt 212 extend substantially parallel to one another and are not angled relative to longitudinal axis 218 of the frame. In other configurations, one or both of portions 214, 216 can be attached to the frame so as to be angled relative to longitudinal axis 218 of the frame. For example, FIG. 13 illustrates a configuration in which portion 214 is secured to first row I of strut members such that portion 214 extends parallel to angled strut members 204 around the circumference of frame 202. In other words, portion 214 forms a zigzag pattern along first row I of strut members that corresponds to the zigzag pattern of strut members in first row I. Portion 216 is secured to third row III of strut members 204 and also extends parallel to the angled strut members of third row III.

[0065] In embodiments in which the portions 214, 216 of the skirt 212 extend parallel to the strut members 204 in their respective rows, the skirt 212 can extend between even rows of strut members, between odd rows of strut members, or from odd rows to even rows, or vice versa. For example, in the configuration shown in FIG. 13, the first portion 214 is secured to a first row I and the second portion 216 is secured to a third row III, such that the skirt extends between two odd rows of strut members. For the frame 202 shown in FIGS. 9-15, in which the skirt extends from an odd row to another odd row (e.g., from row I to row III) or from an even row to another even row (e.g., from row II to row IV), the portions 214, 216 can be positioned such that the threads 220 extend in a direction parallel to the longitudinal axis 218 of the frame. In other words, when the skirt 212 extends between odd or even rows, a given thread 220 can extend from a position along a first portion 214 secured to a column of type A to a position along a second portion 216 also secured to a column of type A.

[0066] In configurations in which the skirt extends from odd rows to even rows (or vice versa), the portions 214, 216 can be circumferentially offset from one another such that the yarns 220 extend at an angle relative to the longitudinal axis 218. For example, with reference to FIG. 14 , the first portion 214 is coupled to the first row I of strut members, and the second portion 216 is coupled to the fourth row IV of strut members. As shown in FIG. 14 , the first and second portions 214, 216 of the skirt are offset from one another around the circumference of the frame such that a given yarn 220 extending from a location along the first portion 214 secured to a column of Type A strut members is coupled to a location along the second portion 216 secured to a column of Type B strut members. This allows the yarns 220 to extend parallel to the longitudinal axis of the frame when the frame is crimped.

[0067] 15 shows an alternative configuration in which skirt 212 is draped between intersections or apexes 234 of support members 204, with portions 214, 216 depending from frame 202. For example, in the configuration shown, portion 214 is secured to the intersections of support members in row I, and portion 216 is secured to the intersections of support members in rows III and IV. Either or both portions 214, 216 can be secured in this manner, depending on the particular characteristics desired.

[0068] In certain examples, the skirt 212 can include twisted or untwisted yarns. The skirt 212 can also include core-spun yarns, in which wrapper fibers are spun around a core yarn. The wrapper fibers may be thin bundles or splayed to increase the surface area of ​​the core-spun yarns and promote a biological response, as described above. In certain embodiments, the skirt 212 can also include loops similar to the loops 44 of FIG. 1 in addition to the float yarn portions 228.

[0069] 16A and 16B show another skirt 212 in which yarns 220 extend at an angle between fabric pieces 226A, 226B, and 226C. For example, referring to FIG. 16A, yarns 220 of float portion 228A extend at an angle relative to fabric pieces 226A and 226B. Yarns 220 of float portion 228B can also extend at an angle relative to fabric pieces 226B and 226C. In this manner, when main body 224 is folded, yarns 220 of float portion 228A can be at an angle to or "cross" over the yarns of float portion 228B to form a mesh or web as shown in FIG. 16B. In some embodiments, the yarns can extend at an angle between 10 and 40 degrees. In certain configurations, the yarns of float portions 228A and 228B may cross each other at an angle to reduce the likelihood of gaps between the yarns due to the yarns clumping together. In some embodiments, the yarns of float portions 228A and 228B may be parallel to each other.

[0070] FIG. 17 illustrates the prosthetic valve 200 and frame 202 of FIG. 9 , including another embodiment of a skirt 300. Similar to skirt 212, skirt 300 can include first and second circumferentially extending portions 302, 304 spaced apart from one another and connected together by multiple filaments configured as threads 306 extending longitudinally along the frame. In the embodiment illustrated in FIG. 17 , portions 302, 304 can be relatively wider than portions 214, 216 of skirt 212, such that, in an expanded configuration, edge portions of portions 302, 304, along with filaments 306, curve outward from frame 202. Second portion 304 can also include multiple connecting portions 308 extending upwardly from portion 304 (e.g., toward the outflow end 208 of the frame) and secured to struts 204 (e.g., by sutures).

[0071] In the illustrated configuration, the skirt 300 includes a single layer of longitudinally extending yarns 306. Figure 18 shows a representative configuration of the skirt 300 laid flat before the skirt is attached to a frame. The first and second portions 302, 304 can include woven pieces, similar to the skirt 212. The fabric portions 302, 304 can be separated by float portions 310 through which the yarns 306 extend. In some embodiments, the yarns 306 can be warp yarns, and the float portions 310 can be formed by removing weft yarns from the float portions or by removing selected weft yarns from the weave.

[0072] When the skirt 300 is secured to the frame, the first portion 302 can be folded around the inflow end portion 206 of the frame 202 such that the first portion is partially disposed within the frame. After implantation, blood can drain through the floating thread portion 310 and out of the skirt. In certain configurations, the skirt 300 can have a reduced crimp profile because it is not folded before being secured to the frame. In other configurations, the portions 302, 304 can be sized such that the floating thread portion 310 is located on the underside or distal surface of the skirt when the frame is expanded. For example, FIG. 19 is a perspective view of the distal or inflow end portion of the frame 202, showing the thread 306 located distal to the inflow end portion 206.

[0073] 20 illustrates another configuration of the skirt 212 in which the yarn 220 is configured to curve over or around portions 214, 216 before being incorporated into the weave. For example, referring to FIGS. 10 and 20, the skirt 212 can be secured to the frame with the yarn 220 extending from the distal edge portion of fabric piece 226A, folding back, and extending proximally and over fabric piece 226B to the proximal edge portion of fabric flap 226B, where the yarn forms a C-shaped arc. In other embodiments, one or both of fabric pieces 226A, 226B can be omitted, and the yarn 220 can be secured to the frame by looping it through the strut members 204.

[0074] The disclosed prosthetic valve embodiments can be radially collapsed and delivered percutaneously to the heart using any of a variety of catheter-based delivery systems. For example, FIG. 21 shows a representative example of a delivery assembly 400, described in U.S. Patent Application Publication No. 2018 / 0153689, configured for use with the prosthetic valve 10 of FIGS. 1-8. The delivery assembly 400 can include a handle 402, an elongate shaft 404 extending distally from the handle 402, and a plurality of actuation members 406 (e.g., in the form of positioning tubes) extending through the shaft and distally outward from a distal end 408 of the shaft 404. The actuation members 406 can be coupled to select apexes of the valve frame 12.

[0075] Initially, the prosthetic valve 10 can be in a radially collapsed configuration within a sheath 410 on the shaft 404. Once the distal end of the delivery device has been advanced through the patient's vascular system to the treatment site, a rotatable actuator 412 on the handle 402 can be used to advance the prosthetic valve 10 from the sheath 410. A release assembly, generally designated 414, can then be used to position, expand, and deploy the prosthetic valve 10 at the treatment site. Other delivery systems that can be used in combination with the prosthetic valve embodiments described herein can be found in U.S. Patent Application Publication Nos. 2017 / 0065415 and 2013 / 0030519.

[0076] 22-25 illustrate additional embodiments of a textile sealing element that includes multiple threads or fibers extending from the sealing element to form loops in a looped pile pattern to increase the surface area available for thrombus formation and tissue growth. For example, FIG. 22 schematically illustrates a portion of a sealing element 500 that includes multiple first threads 502 interwoven with multiple second threads 504. In certain embodiments, the first threads 502 can be warp threads and the second threads 504 can be weft threads, or vice versa. The warp threads 502 can be configured to form loops 506 that extend outward from the plane of the page and over one or more weft threads 504. For example, in the embodiment of FIG. 22, the sealing element can include warp threads 502A and 502B. The warp threads 502A can form loops 506, and one or more warp threads 502B can be sandwiched between the warp threads 502A. For example, in the illustrated embodiment, there are two warp threads 502B between two warp threads 502A, but there may be any number of warp threads 502B depending, for example, on the desired spacing between loops 506.

[0077] The warp threads 502A may also vary in direction to form the loops 506. For example, in the embodiment of FIG. 22, the loops 506 may extend across one or more weft threads 504 at an angle relative to the weft threads 504. In other words, the points at which the loops 506 return may be offset from one another along the x-axis (note that Cartesian coordinate axes are illustrated). The loops 506 may extend alternately in the positive x-direction and the negative x-direction, with the straight sections of the threads 502A between the loops 506 offset from one another along the x-axis. This may provide certain advantages, such as preventing or "locking" the warp threads 502A from moving relative to the weft threads 504. Additionally, with the warp threads 502 extending axially in the direction of the valve's longitudinal axis, the width W of the loops 506 may be oriented perpendicular or substantially perpendicular to the direction of blood flow through the valve, such that the loops 506 present a relatively large flow obstruction when the sealing member 500 is attached to the prosthetic valve. This can promote blood stasis and sealing around the prosthetic valve. The pile loop density (e.g., number of loops per inch (2.54 cm)) can be varied, for example, by changing the length of the straight portion of yarn 502A between loops 506. Reducing the distance between loops 506 can increase the pile loop density, as shown in FIGS. 23 and 24, while increasing the distance between loops 506 can decrease the pile loop density. The width of loop 506 can be determined, for example, by the number of warp yarns over which the loop extends. For example, in FIG. 25, loop 506 is wider than loop 506 in FIG. 22 because the loop extends over two warp yarns 502B.

[0078] In certain embodiments, warp knitting techniques can be used to form the loops 506. In a particular example, the first warp yarns 502A can include a 20 denier, 18 filament (20D / 18f) and / or a 30D / 18f textured yarn. The second warp yarns 502B can include a 20D / 18f yarn with 12 twists per inch (tpi). In a particular example, the weft yarns 504 can be a 20D / 18f yarn with 12 tpi. The warp and weft yarns can be made from any of a variety of biocompatible polymers, such as PET, UHMWPE, PTFE, etc. In other embodiments, the warp and / or weft yarns can have any selected denier and / or filament count and can be made from any suitable natural or synthetic material.

[0079] In some embodiments, loops may be formed on the prosthetic valve skirt by embroidery. Exemplary embroidery techniques involve embroidering threads into or through a base or foundation layer (e.g., fabric) to create various shapes or patterns on the surface of the foundation layer. FIG. 26 illustrates a portion of a skirt 600 including multiple loops 602 embroidered into a base skirt fabric 604, according to one embodiment. The base skirt fabric may include multiple first threads 610 interwoven with multiple second threads 612, e.g., in a plain weave. Referring to FIG. 27 , the loops 602 may be formed using a third thread configured as an embroidery thread 606, which may be a relatively dense thread or suture. In certain embodiments, in addition to the first or foundation layer 604, the skirt 600 may also optionally include a second layer configured as an anchoring layer 608. In certain embodiments, the anchoring layer 608 may include a relatively low density, lightweight, and / or thin thread or suture that can be used to anchor the embroidery thread 606 to the rear of the foundation layer 604.

[0080] As described above, loops may be embroidered on the surface of the prosthetic valve skirt in any specified position, length, width, spacing, shape, and / or pattern. Figures 28-30 show some examples of patterns that may be produced using the embroidery techniques described above. For example, Figure 28 shows a prosthetic valve skirt 700 including multiple loops, generally designated 702, embroidered on the skirt to form a plush portion or pile 706. The plush portion 706 can include multiple angled portions 712 that extend circumferentially around the skirt 700 in a zigzag pattern from an end portion 708 (e.g., the inflow end portion) of the skirt to midway through the skirt's height. Figure 29 shows another variation of the plush portion 706, in which the plush portion defines cells 710. In certain embodiments, the cells 710 can correspond to openings or cells defined by struts of a frame, such as the struts 26 of the prosthetic valve 10 of Figure 1. In other embodiments, the cells of plush portion 706 can correspond to the size and shape of the frame openings defined by the posts of frame 702 in Figure 9. Figure 30 shows another variation of plush portion 706, including straight portions 714 extending between adjacent angled portions 712. In certain embodiments, loops 44 in Figure 1 can be formed in the fabric underlying skirt 30 by embroidery.

[0081] FIG. 31 shows a prosthetic heart valve 800 including another embodiment of a sealing member or skirt 802 on a frame 804, configured as the frame of Edwards Lifesciences Corporation's SAPIEN® 3 prosthetic heart valve. The skirt 802 can include multiple woven portions configured as fabric pieces 806 extending circumferentially around the frame. Each of the fabric pieces 806 can include a corresponding fringe portion 808 including multiple filaments 810 extending radially outward at an angle from a circumferential edge portion (e.g., an inflow or outflow edge portion) of the fabric piece 806, similar to the skirt 100 of FIG. 7 described above. In the illustrated embodiment, the skirt 802 can include three fabric pieces 806A-C with corresponding fringe portions 808A-C. The fringe portion 808A of the fabric piece 806A can extend from an inflow edge 812 of the fabric piece 806A that is positioned proximate the inflow end 814 of the prosthetic valve. The filaments 810 of the fringe portion 808A can extend to about the second row II of the strut members (see FIG. 12B ). The filaments 810 of the second fabric piece 806B can extend from the inflow edge 816 of the fabric piece 806B and can extend to about the height of the third row III of the struts. The filaments 810 of the third fabric piece 806C can extend from the outflow edge 818 of the fabric piece 806C to about the height of the fourth row IV of the struts.

[0082] The filaments 810 may include or be based on loose yarns, textured yarns, etc. In certain embodiments, the fabric piece 806 of the sealing member 802 may include a thread density of 50-500 threads per inch (2.54 cm), 100-400 threads per inch, 150-350 threads per inch, or 150-300 threads per inch. In certain embodiments, the fabric piece of the sealing member 802 may have a thread density of 150 threads per inch (2.54 cm), or 300 threads per inch. The yarns may have any suitable filament density, such as 5-100 filaments per yarn, 10-50 filaments per yarn, or 10-20 filaments per yarn. In certain embodiments, the yarns may include textured yarns with 18 filaments per yarn. The filaments may have a thickness of 1 μm-100 μm, 1 μm-50 μm, or 1 μm-20 μm. In certain embodiments, the filaments can have a thickness or diameter of 10 μm.

[0083] 32-37 illustrate a primary cushioning layer, covering, or sealing member 1000 according to another embodiment. The sealing member 1000 can comprise a fabric body having multiple woven portions and multiple elastic, extensible portions configured as float portions and can be incorporated into any of the outer coverings of the prosthetic valves described herein. FIG. 32 illustrates the sealing member 1000 in a flat, laid-out configuration with the x-axis corresponding to the circumferential direction and the y-axis corresponding to the axial direction when the sealing member is attached to the frame of the prosthetic valve. The sealing member 1000 can comprise multiple first woven portions 1002 configured as woven pieces or stripes extending along the x-axis, multiple second woven portions 1004 configured as woven pieces or stripes extending along the x-axis, and multiple float portions, strips, or stripes 1006 extending along the x-axis. The various woven and float portions can be spaced apart from one another along the y-axis. In the illustrated configuration, the first woven portion 1002 can have a different weave pattern than the weave pattern of the second woven portion 1004, as will be described in more detail below.

[0084] For example, in the configuration shown, the sealing member 1000 can include a first woven portion 1002A. In order along the positive y-axis, the sealing member 1000 can further include a second woven portion 1004A, a float portion 1006A, a second woven portion 1004B, a float portion 1006B, a second woven portion 1004C, a float portion 1006C, a second woven portion 1004D, a float portion 1006D, a second woven portion 1004E, a first woven portion 1002B, a second woven portion 1004F, a float portion 1006E, a second woven portion 1004G, and a first woven portion 1002C at an end of the sealing member opposite the first woven portion 1002A. In other words, the first woven portion 1002B and each of the floating thread portions 1006A-1006E can be positioned between two second woven portions 1004 such that the first woven portion 1002B and each of the floating thread portions 1006A-1006E are joined or bordered in a direction along the x-axis by the respective second woven portion 1004.

[0085] 32 and 33, the sealing member 1000 can include a plurality of first threads 1008 oriented generally along the x-axis and a plurality of second threads 1010 oriented generally along the y-axis. In certain configurations, the first threads 1008 can be warp threads, i.e., the threads 1008 are held by the loom during the weaving process, and the second threads 1010 are weft threads, interwoven with the warp threads by a moving shuttle or weft holding mechanism during the weaving process. However, in other embodiments, the first threads 1008 can be weft threads and the second threads 1010 can be warp threads.

[0086] The first yarn 1008 and the second yarn 1010 can each include multiple constituent filaments 1012 that are spun, wound, twisted, commingled, entangled, etc. together to form the respective yarn. Exemplary individual filaments 1012 of the second yarn 1010 can be found in Figures 33-36. In some embodiments, the first yarn 1008 can have a denier of from about 1D to about 200D, from about 10D to about 100D, from about 10D to about 80D, from about 10D to about 60D, or from about 10D to about 50D. In some embodiments, the first yarn 1008 can have a filament count of 1 to about 600 filaments per yarn, about 10 to about 300 filaments per yarn, about 10 to about 100 filaments per yarn, about 10 to about 60 filaments per yarn, about 10 to about 50 filaments per yarn, or about 10 to about 30 filaments per yarn. In certain embodiments, the first yarn 1008 can have a denier of about 40D and a filament count of 24 filaments per yarn. The first yarn 1008 can also be a twisted or untwisted yarn. In the illustrated embodiment, the filaments 1012 of the first yarn 1008 are untextured. However, in other embodiments, the first yarn 1008 may include textured filaments.

[0087] The second yarn 1010 can be a textured yarn comprising a plurality of textured filaments 1012. For example, the filaments 1012 of the second yarn 1010 can be textured, for example, by twisting the filaments, heat setting them, and untwisting the filaments, as described above. In some embodiments, the second yarn 1010 can have a denier of about 1D to about 200D, about 10D to about 100D, about 10D to about 80D, or about 10D to about 70D. In some embodiments, the filament count of the second yarn 1010 can be 1 to about 100 filaments per yarn, about 10 to about 80 filaments per yarn, about 10 to about 60 filaments per yarn, or about 10 to about 50 filaments per yarn. In certain embodiments, the second yarn 1010 can have a denier of about 68D and a filament count of 36 filaments per yarn.

[0088] The first thread 1008 and the second thread 1010 can be woven together to form the woven portion of the sealing member, as described above. For example, in the first woven portions 1002A-1002C, the first and second threads 1008, 1010 can be woven together in a plain weave pattern, in which the second thread 1010 (e.g., weft thread) passes over the first thread 1008 (e.g., warp thread) and then under the next first thread in a repeating pattern. This weave pattern is shown in detail in FIG. 33. In some embodiments, the density of the first thread 1008 can be about 10 to about 200 threads per inch (2.54 cm), about 50 to about 200 threads per inch, or about 100 to about 200 threads per inch. In certain embodiments, first woven portion 1002A and first woven portion 1002C can be configured as selvedge portions and can have a lower thread density than first woven portion 1002B to facilitate assembly onto the valve frame. Other weave patterns, such as two over and two under, or two over and one under, can also be used. The first woven portion can also be woven in a pattern derived from a plain weave, such as twill, satin, or any combination thereof.

[0089] In the second woven portions 1004A-1004G, the first and second yarns 1008, 1010 can be interwoven in a different pattern than the weave pattern of the first woven portions 1002A-1002C. For example, in the illustrated embodiment, the first and second yarns 1008, 1010 can be woven together in a leno weave pattern in the second woven portions 1004A-1004G. FIG. 34 shows the leno weave of the second woven portion 1004B in more detail. With reference to FIG. 34, the leno weave can include one or more leno yarns or "leno ends" 1014 and four first yarns 1008A, 1008B, 1008C, and 1008D, also referred to as "warp ends." The pattern shown in FIG. 34 includes a single leno yarn 1014 in the form of a half leno weave. However, in other embodiments, the leno weave pattern may be a full leno weave or other leno-derived weave including two intertwining leno yarns 1014. Examples of various leno weaves and related weaving techniques are shown in Figures 39A-39J.

[0090] In the half leno weave shown in FIG. 34, the first yarns 1008A-1008D can extend parallel to the x-axis, and the second yarn 1010 can be interwoven with the first yarns 1008A-1008D, for example, in a plain weave. The leno yarn 1014 can be woven around the first yarns 1008A-1008D such that the leno yarn 1014 passes over or over each first yarn 1008A-1008D in the positive y-direction, passes under or behind the next second yarn 1010 in the x-direction, and then extends back over the first yarns 1008A-1008D in the negative y-direction. This pattern can be repeated along the length of the second woven portion 1004B. In this manner, the second woven portion 1004 can be a relatively narrow, strong woven portion that is axially spaced apart from one another along the frame when the sealing element is attached to the frame. The loop yarns 1014 can serve to hold the first yarns 1008A-1008D and the second yarns 1010 in place relative to one another as the prosthetic valve is crimped and expanded, imparting strength to the second woven portion 1004 while minimizing its width.

[0091] In certain embodiments, each of the second woven portions 1004A-1004G can include the leno weave pattern described above. In other embodiments, one or more of the second woven portions 1004A-1004G can be configured differently, such as by incorporating a greater or lesser number of first threads 1008 into the leno weave, by weaving multiple leno yarn ends around multiple groups of threads 1008, etc. In still other embodiments, a chemical locking method can be used, in which the leno weave and / or plain weave includes warp yarns with core-sheath structural filaments. The sheath of the individual filaments can be made of a low-melting temperature polymer, such as biocompatible polypropylene, and the core of the filaments can be made of another biocompatible polymer, such as polyester. After the weaving process, the sheath can be softened and / or melted by a heat-setting process, as described below. Upon cooling, the softened sheath polymer can bond to the core polyester filaments, creating a bonded body that allows the woven structure to be locked.

[0092] Referring again to FIG. 32 , the float portion 1006 can include yarns that extend uniaxially between the respective second woven portions 1004 spaced apart from one another along the y-axis. For example, taking float portion 1006A as an example, float portion 1006A can include a plurality of second yarns 1010 that exit the leno weave of second woven portion 1004A, extend across float portion 1006A, and are incorporated into the leno weave of second woven portion 1004B. In some embodiments, the density of the second yarns in float portion 1006 can be about 10 to about 200 threads per inch, about 50 to about 200 threads per inch, or about 100 to about 200 threads per inch. In certain embodiments, the density of the second yarns 1010 can be about 60 to 80 threads per inch. In other embodiments, the floating yarn portion may include a first yarn 1008 that is disposed below or above, but not interwoven with, a second yarn 1010, such that the second yarn floats on the first yarn, or vice versa. In still other embodiments, the floating yarn portion may instead be configured as any other elastically stretchable structure, such as an elastically stretchable woven, knitted, braided, or nonwoven fabric, or polymeric membrane, among others, that is elastically stretchable at least in the axial direction of the prosthetic valve.

[0093] In the illustrated embodiment, each of the woven portions 1002A-1002C and 1004A-1004G and each of the float portions 1006A-1006E can have a width dimension along the y-axis. The component widths can be configured such that the overall length L1 ( FIG. 32 ) of the sealing member 1000 approximately corresponds to the axial length of the prosthetic heart valve in its expanded configuration. For example, in the illustrated embodiment, the first woven portions 1002A and 1002C can each have a width W1. In certain embodiments, the width W1 can be configured to allow portions of the first woven portions 1002A and 1002C to be folded over the inflow and outflow ends of the prosthetic valve frame.

[0094] First woven portion 1002B can have a width W2. Referring to FIG. 12B, when sealing member 1000 is used in combination with Edwards Lifesciences Corporation's SAPIEN® 3 prosthetic heart valve, width W2 can be configured to correspond to the axial dimension of the frame opening defined by the strut members between the fourth row IV and the fifth row V of struts. In some embodiments, width W2 of first woven portion 1002B can be from about 2 mm to about 20 mm, from about 2 mm to about 12 mm, or from about 3 mm to about 10 mm. In one embodiment, width W2 can be about 7 mm.

[0095] The second woven portions 1004A-1004G can have a width W3 (FIG. 34). In the illustrated embodiment, the second woven portions 1004A-1004G all have a width W3, although one or more of the second woven portions can have different widths. In certain embodiments, the width W3 can be relatively short, such as from about 0.1 mm to about 3 mm, from about 0.1 mm to about 2 mm, or from about 0.1 mm to about 1 mm. In certain embodiments, the width W3 can be about 1 mm.

[0096] 32 and 35-38, in certain embodiments, the sealing member 1000, and particularly the float segments 1006A-1006E, can be elastically stretchable between a first, natural or relaxed configuration (FIGS. 32 and 35), which corresponds to a radially expanded state of the prosthetic valve, and a second, elongated or tensioned configuration (FIGS. 37 and 38), which corresponds to a radially compressed state of the prosthetic valve. Accordingly, the float segments 1006A-1006E can have an initial width W4 when the sealing member 1000 is in a relaxed, unstretched state. FIG. 35 shows a portion of the float segment 1006B in its natural, relaxed state. When the fabric is in a relaxed state, the textured filaments 1012 of the second yarn 1010 can twist and swirl in many directions such that the float segment 1006B has a lofty, undulating, or pillow-like character. When tensioned, the twists, kinks, etc. of the filament 1012 can be pulled at least partially straight along the y-axis to elongate the second thread 1010. Referring to FIG. 36 , the width of the float thread portion 1006 can thus be increased to a second width W5 that is wider than the initial width W4.

[0097] The cumulative effect of the floating thread portions 1006A-1006E increasing the width from the initial width W4 to the second width W5 is to increase the overall axial dimension of the sealing member 1000 from the initial length L1 ( FIG. 32 ) to a second overall length L2 ( FIG. 37 ) that is longer than the first length L1. FIG. 37 shows the sealing member 1000 in an extended configuration, with the second threads 1010 of the floating thread portions 1006A-1006E straightened under tension such that the overall length of the sealing member increases to the second length L2. In certain embodiments, the size, number, spacing, etc. of the floating thread portions 1006 and the degree of fabrication of the component second threads 1010 can be selected such that the second length L2 of the sealing member 1000 corresponds to the length of the frame of the prosthetic valve when the prosthetic valve is crimped for delivery with a delivery device. In certain embodiments, the relaxed initial width W4 of the float thread portion 1006 can be between about 1 mm and about 10 mm, between about 1 mm and about 8 mm, or between about 1 mm and about 5 mm. In certain embodiments, the initial width W4 can be about 4 mm.

[0098] 38 shows an edge portion of the sealing member 1000 grasped between a pair of graspers 1050. In certain embodiments, the bulky and undulating nature of the textured yarn 1010 in the floating thread portion 1006 allows the floating thread portion 1006 to have a thickness t1 that is greater than the thickness t2 of the woven portions 1002 and 1004. For example, in certain embodiments, the thickness t1 of the floating thread portion 1006 can be two, three, four, five, six, or even ten times or more the thickness t2 of the woven portions 1002 and 1004 when the sealing member is in a relaxed state. This can allow the floating thread portion 1006 to cushion the natural valve leaflets between the valve body and / or against the anchor or ring in which the prosthetic valve is implanted. The floating thread portion 1006 can also occupy voids or spaces in the anatomy and / or promote tissue growth into the floating thread portion, as in the embodiments described above. When tension is applied to stretch the floating yarn portion 1006, the thickness t1 can increase as the textured second yarn 1010 straightens. In certain embodiments, the thickness t1 can be equal to or approximately equal to the thickness t2 of the woven portions 1002 and 1004 when the sealing member is in a tensioned state. When the tension on the sealing member 1000 is released, such as during expansion of the prosthetic valve, the yarns 1012 can resume their textured shape and the thickness of the floating yarn portion 1006 can return to the initial thickness t1.

[0099] In certain embodiments, the floating thread portions 1006A-1006E can be configured to allow the sealing member 1000 to stretch between about 10% and about 500%, between about 10% and about 300%, between about 10% and about 200%, between about 10% and about 100%, between about 10% and about 80%, or between about 10% and about 50%. In certain embodiments, the floating thread portions 1006A-1006E can be configured to allow the sealing member 1000 to stretch about 30%, which corresponds to the stretch of the frame 1022 between the expanded and crimped configurations. As discussed above, an increase in the width of the floating thread portions 1006A-1006E can correspondingly decrease the thickness of the floating thread portions, thereby reducing the crimp profile of the prosthetic valve during delivery.

[0100] In some embodiments, the first and second threads 1008 and 1010 can comprise any of a variety of biocompatible thermoplastic polymers, such as PET, nylon, ePTFE, UHMWPE, or other suitable natural or synthetic fibers. In certain embodiments, the sealing member 1000 can be woven on a loom and then heat-treated or heat-set to achieve a desired size and configuration. For example, depending on the material selected, heat-setting can shrink the sealing member 1000. Heat-setting can also provide a processing effect or increase the amount of processing of the second thread 1010. After heat-setting, openings 1016 can be created in the first woven portion 1002B (e.g., by laser cutting) to allow the sealing member to be incorporated into a covering, such as a covering 1018, for incorporation onto a prosthetic valve. In some embodiments, the openings 1016 can also be created before heat-setting.

[0101] The loops, filaments, floating portions, etc. of the prosthetic sealing members described herein can be configured to promote a biological response to form a seal between the prosthetic valve and the surrounding anatomical structure, as described above. In certain configurations, the sealing elements described herein can be configured to form a seal for a selected period of time. For example, in certain embodiments, the open, porous nature of the loops, filaments, threads, etc. can allow a selected amount of paravalvular leakage around the prosthetic valve for a period of time after implantation. Because the biological response to the loops, filaments, threads, etc. can result in blood clotting, thrombus formation, etc., the amount of paravalvular leakage through the sealing structure may be gradually reduced over a selected period of time. In some embodiments, the sealing members of the perivalvular sealing structure, particularly the loops, filaments, threads, etc., may be treated with one or more agents that inhibit the biological response to the sealing structure. For example, in certain embodiments, the loops, filaments, threads, etc. may be treated with heparin. In certain embodiments, the amount or concentration of the agent may be selected such that the agent is depleted after a selected period of time (e.g., days, weeks, or months) after valve implantation. As the drug is depleted, the biological response to the sealing structure loops, filaments, threads, etc. may increase so that a perivalvular seal gradually forms over a selected period of time. This can be advantageous in patients with left atrial remodeling (e.g., due to mitral regurgitation) by providing an opportunity for remodeling to reverse as regurgitation through the prosthetic valve is gradually reduced.

[0102] 39A-39J illustrate various leno weaves and leno weave techniques that may be used to create the sealing member 1000 or any of the other sealing members described herein. FIG. 39A is a cross-sectional view showing a shed (e.g., a temporary separation of warp yarns to form upper and lower warp yarns) in which a leno yarn, "leno yarn end," or "cross end" 1060 forms an upper shed above a weft yarn 1064 on the left side of the figure, and a standard warp yarn 1062 forms a lower shed. FIG. 39B illustrates a continuous shed in which the leno yarn 1060 forms an upper shed to the right of the standard warp yarn 1062. In FIGS. 39A and 39B, the leno yarn 1060 may cross under the standard yarn 1062 in a pattern known as bottom douping. Alternatively, the leno thread 1060 may cross over the top of the standard thread 1062, known as the upper doping, as in Figures 39H and 39I.

[0103] Figure 39C shows a leno interlaced pattern produced when one warp spool is used on the loom and the strain or tension in the leno yarn 1060 and the standard yarn 1062 is equal, such that both yarn 1060 and yarn 1062 curve around the leno yarn 1064. Figure 39D shows a leno openwork pattern produced when multiple warp spools are used and the tension in the leno yarn 1060 is weaker than the standard yarn 1062, such that the standard yarn 1062 remains relatively straight and perpendicular to the weft yarn 1064, and the leno yarn 1060 curves around the standard yarn 1062.

[0104] Figure 39E corresponds to Figure 39C, but shows an interlaced pattern in which adjacent leno yarns 1060 have opposite knitting directions because the alternating leno yarns 1060 are point-drafted (e.g., a technique in which the leno yarns are pulled through a heddle). Figure 39F corresponds to Figure 39D, but shows an interlaced pattern in which adjacent leno yarns 1060 have opposite knitting directions because the leno yarns 1060 are point-drafted.

[0105] FIG. 39G is a cross-sectional view of the plain leno weave construction viewed through weft yarn 1064.

[0106] Figure 39J shows a typical leno weave from the reverse side of the fabric. [Example]

[0107] In a first representative example, acute animal studies were conducted in which prosthetic heart valves containing various skirts of the type shown in Figure 31 were implanted into the aortic valves of sheep. The first prosthetic valve tested included a sealing member or skirt with a thread density of 300 threads per inch (2.54 cm), and the threads had a fringe or filament density of 18 filaments per thread. The second prosthetic valve had a skirt with a thread density of 150 threads per inch, and the threads had a filament density of 18 filaments per thread. A prosthetic valve without an external skirt was also implanted as a control.

[0108] Prior to implantation, the prosthetic valve was partially crimped, and a stack of prosthetic annuli (e.g., two concentrically stacked prosthetic annuli) was attached around the exterior of the prosthetic valve with sutures. Each prosthetic annulus stack had a plastic cable tie tightened around the body of the prosthetic annulus. The stack of prosthetic annuli was attached to the prosthetic valve with the head of the cable tie positioned between the outer skirt of the prosthetic valve and the body of the prosthetic annulus. In other words, the head of the cable tie served to separate the body of the prosthetic annulus from the prosthetic valve, defining axially extending channels between the outer skirt and the prosthetic annulus on both sides of the head of the cable tie to induce paravalvular leakage through the prosthetic valve. In the case of a control prosthetic valve without an outer skirt, the head of the cable tie separated the prosthetic annulus from the outer surface of the prosthetic valve frame.

[0109] The prosthetic valve was surgically implanted. The baseline amount of paravalvular leakage through the space between the prosthetic valve frame and the prosthetic annulus stack was determined using echocardiography and / or angiography while the patient was heparinized. The heparinization was then reversed (e.g., by administration of protamine sulfate), and paravalvular leakage was assessed over a 5-30 minute period using echocardiography and angiography. The prosthetic valve was then surgically retrieved.

[0110] For the first prosthesis, which had a skirt density of 300 threads per inch (2.54 cm), no paravalvular leakage was observed before or after heparin deactivation. Upon explantation, the space between the outer skirt and the attached prosthetic annulus was completely sealed by thrombus formation, and the cable tie heads were at least partially enclosed by one or more thrombi.

[0111] For the second prosthetic valve with a skirt density of 150 threads per inch (2.54 cm), angiographic grade 2+ paravalvular leakage was observed by echocardiography and grade 1+ by angiography before heparin deactivation. As used herein, "paravalvular leakage" or "regurgitation," e.g., graded as 1+, 2+, 3+, or 4+, refers to the angiographic grading guidelines provided by the American Society of Echocardiography, using evaluation techniques including, for example, echocardiography, angiography, color flow Doppler, and fluoroscopy (Zoghib et al., ASE Guidelines and Standards: Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation - A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance, Journal of the American Society of Echocardiography, April 2017). After heparin deactivation, no paravalvular leakage was detected by either echocardiography or angiography. Upon explantation, the space between the outer skirt and the attached prosthetic annulus was completely sealed by thrombus formation, and the head of the cable tie was at least partially enclosed by one or more thrombi.

[0112] The immediate and rapid decrease in paravalvular leakage observed for both the first and second prosthetic valves containing the fringe skirt may be attributable to the interaction between blood and the thread filaments. The subsequent gradual decrease in paravalvular leakage observed for the second prosthetic valve after heparin deactivation may be attributable to the ongoing cellular biological response leading to thrombus formation and sealing. For the first prosthetic valve with a thread density of 300 threads per inch (2.54 cm), sealing of the space between the frame and the prosthetic annulus occurred almost immediately. For the second prosthetic valve with a thread density of 150 threads per inch (2.54 cm), the time to complete closure or sealing of the space between the frame and the prosthetic annulus (e.g., no detectable paravalvular leakage) ranged from 5 to 30 minutes.

[0113] In control prosthetic valves without an outer skirt, paravalvular leaks of grade 2+ or higher were observed under heparinization. After heparin reversal, angiographic grades of 2+ to 3+ paravalvular leaks were observed. At explantation, the space between the prosthetic annulus and the prosthetic valve frame was fully or patent, and no appreciable bioseal had formed.

[0114] Overview Any of the embodiments of the sealing elements disclosed herein can be used in combination with any of the embodiments of the prosthetic heart valves and / or frames disclosed. A prosthetic heart valve can also include any of the sealing elements, or portions thereof, described herein, in any combination.

[0115] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages be present or problems be solved.

[0116] Although some operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that this methodology encompasses rearrangements unless a specific order is required by specific language below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms provide a high level of abstraction of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0117] As used in this specification and claims, the singular forms "a," "an," and "the" include plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "comprising." Furthermore, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between things that are coupled or associated, unless specific language to the contrary is used.

[0118] In the context of this specification, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, in a particular configuration, the lower end of a valve is its inflow end and the upper end of the valve is its outflow end.

[0119] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device toward the user, and distal movement of a device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0120] Unless otherwise indicated, all numbers expressing quantities of ingredients, molecular weights, percentages, temperatures, times, and the like, when used in the specification or claims, should be understood to be modified by the term "about." Thus, unless otherwise indicated, either implicitly or explicitly, the numerical parameters described are approximations that may vary depending on the desired properties sought and / or limits of detection under testing conditions / methods well known to those of ordinary skill in the art. Where the embodiment is directly and explicitly distinguished from the prior art discussed, the numbers of the embodiment are not approximations unless the word "about" is indicated. Furthermore, not all alternatives set forth herein are equivalent.

[0121] In some instances, a value, procedure, or device may be referred to as a "lowest," "best," "smallest," etc. Such descriptions are intended to indicate that a selection can be made among many options, and that such a selection is not necessarily better, lesser, or otherwise preferred than other options.

[0122] Certain terms may be used throughout the specification, such as "top," "bottom," "upper," "lower," "horizontal," "vertical," "left," "right," etc. These terms are used, where applicable, to provide some clarity of description when dealing with relative relationships. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" surface may become a "lower" surface by turning the object over, while still remaining the same object.

[0123] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be understood as limiting the scope of the present disclosure, which is, instead, at least as broad as the following claims. [Explanation of symbols]

[0124] 10 Artificial valve 12 frames 14 Valve leaflet structure 16 Inlet end part 18 Outflow end part 22 Valve leaflet 24 Longitudinal axis 26 Posts 28 Vertex 30 Skirt 32 aperture 34 aperture 36 Fasteners 38 Main body part 40 first edge portion 41 Sutures 42 second edge portion 44 Loops 44A Loop 44B Loop 44C Loop 46 External surface 48A 1st row 48B Second row 48C Third row 50 warp threads 50A warp 50B warp 50C warp 52 Weft 52A Weft 52B weft 52C weft 52D weft 52E weft 52F weft 52G weft 52H weft 52I weft 52J weft 52K weft 54A Woven piece 54B Woven piece 54C woven piece 54D woven piece 55A Semi-woven section 55B Semi-woven section 55C semi-woven part 56 Upper edge 58 Upper edge 60 Lower edge part 62 Upper edge part 64A Arrow 64B Arrow 64C Arrow 66 Suture 70 Textured Yarn 72 Fiber 80 Raw Silk 82 Fiber 100 skirt 102 Fabric Pieces 102A Fabric piece 102B Fabric piece 102C Fabric piece 104 Fringe part 106 Thread 108 Edge section 110 Fiber 112 Fan-shaped structure 200 Artificial Valves 202 frames 204 Support members 204A Support Members 204B Support member 204C Support Members 205 Window 206 Inflow end 208 Outflow end 211 Skirt 212 Skirt 214 Circumferential section 216 Circumferential section 218 Longitudinal Axis 220 filament 224 Main body 226A Fabric piece 226B Fabric piece 226C Fabric piece 228A Floating thread part 228B Floating thread part 230 Edge part 232 Edge part 300 skirt 302 First Part 304 Second Part 306 filament 308 Connection part 310 Floating thread part 400 Delivery Assembly 402 Handle 404 Shaft 406 Actuating member 408 Distal end 410 Sheath 412 Actuator 414 Release Assembly 500 sealing elements 502 Warp 502A Warp 502B warp 504 weft 506 Loop 600 Skirt 602 Loop 604 First Layer 606 Embroidery thread 608 Second Layer 610 First Thread 612 Second Thread 700 Artificial valve skirt 702 Loop 706 Plush part 710 cells 712 Angled section 714 Straight section 800 Artificial Heart Valves 802 Skirt 804 frames 806 Fabric Pieces 806A Fabric piece 806B Fabric piece 806C Fabric piece 808 Fringe part 808A Fringe part 808B Fringe part 808C Fringe part 810 filament 812 Inflow edge 814 Inlet end 816 Inflow edge 818 Outflow edge 1000 Sealing material 1002 First woven part 1002A First woven portion 1002B First woven portion 1002C First woven portion 1004 Second woven part 1004A Second woven portion 1004B Second woven portion 1004C Second woven portion 1004D Second woven portion 1004E Second woven part 1004F Second woven part 1004G Second woven part 1006 Floating thread part 1006A Floating thread part 1006B Floating thread part 1006C Floating thread part 1006D Floating thread part 1006E Floating thread part 1008 First Thread 1008A First Thread 1008B First Thread 1008C First thread 1008D First thread 1010 Second Thread 1012 filament 1014 Tangled thread 1050 Gripping tool 1060 Twine 1062 Warp 1064 weft d1 distance d2 distance d3 distance L length L1 length L2 length t1 thickness T2 thickness W width W1 width W2 width W3 width W4 width W5 width X1 distance

Claims

1. an annular frame having an inlet end and an outlet end; a leaflet structure positioned within the annular frame; an outer skirt positioned on an exterior of the annular frame, the outer skirt including a hydrophilic surface treatment; A prosthetic heart valve comprising: the outer skirt comprising a plurality of portions including a plurality of filaments extending outwardly from an outer surface of the outer skirt; the outer skirt includes a plurality of sections lacking filaments extending outwardly from the outer surface, the sections lacking filaments being interleaved with the sections including outwardly extending filaments; a plurality of segments each lacking outwardly extending fibers, the segments including outwardly extending fibers being separated from one another by the plurality of segments lacking outwardly extending fibers;

2. 2. The prosthetic heart valve of claim 1, wherein the outer skirt comprises a plurality of filaments, at least some of the filaments being coated with a hydrophilic substance to form the hydrophilic surface treatment.

3. 3. The prosthetic heart valve of claim 2, wherein the hydrophilic surface treatment is covalently bonded to the fibers of the coated filament.

4. 3. The prosthetic heart valve of claim 2, wherein ends of selected ones of the plurality of filaments extend from an edge of the outer skirt to form a fringe portion extending outwardly from an outer surface of the outer skirt.

5. 5. The prosthetic heart valve of claim 4, wherein a filament of the plurality of filaments of the fringe portion comprises a plurality of fibers.

6. 2. The prosthetic heart valve of claim 1, wherein the hydrophilic surface treatment comprises a polyethylene glycol (PEG) coating.

7. 2. The prosthetic heart valve of claim 1, wherein the hydrophilic surface treatment is on the outer surface of the outer skirt.

8. 10. The prosthetic heart valve of claim 1, wherein the outer skirt comprises a polymeric film.

9. 2. The prosthetic heart valve of claim 1, wherein the hydrophilic surface treatment comprises a lubricious coating.

10. 2. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is radially expandable and compressible, and in a radially compressed state, the prosthetic heart valve is sized and shaped to be disposed within a sheath of a delivery device for transcatheter delivery of the prosthetic heart valve in the radially compressed state.

11. 11. The prosthetic heart valve of claim 10, wherein the prosthetic heart valve is sized and shaped to advance the prosthetic heart valve from the sheath of the delivery device to deploy the prosthetic heart valve at a delivery site.

12. The prosthetic heart valve of claim 1; 1. A delivery device comprising: A shaft, a sheath disposed on the end of the shaft, the sheath being sized and shaped to receive the prosthetic heart valve therein in a radially compressed state; a delivery device comprising:

1. A prosthetic heart valve delivery system comprising:

13. an annular frame having an inlet end and an outlet end; a leaflet structure positioned within the annular frame; an outer skirt positioned on the exterior of the annular frame, the outer skirt including a polymeric film, a hydrophilic coating, and a plurality of portions including outwardly extending fibers extending outwardly relative to an outer surface of the polymeric film, the portions including outwardly extending fibers being separated from one another by a plurality of pieces lacking outwardly extending fibers, the pieces lacking outwardly extending fibers being interleaved with the portions including outwardly extending fibers; An artificial heart valve comprising:

14. 14. The prosthetic heart valve of claim 13, wherein the hydrophilic coating comprises a polyethylene glycol (PEG) coating.

15. 14. The prosthetic heart valve of claim 13, wherein the hydrophilic coating comprises a lubricious coating.

16. The prosthetic heart valve of claim 13; 1. A delivery device comprising: A shaft, a sheath disposed on the end of the shaft, the sheath being sized and shaped to receive the prosthetic heart valve therein in a radially compressed state; a delivery device comprising:

1. A prosthetic heart valve delivery system comprising:

17. an annular frame having an inlet end and an outlet end; a leaflet structure positioned within the annular frame; an outer skirt positioned on the exterior of the annular frame, the outer skirt comprising a polymeric film, a plurality of outwardly extending fibers extending outwardly relative to an outer surface of the polymeric film, and a polyethylene glycol (PEG) coating covalently bonded to the outer surface of the outer skirt, the PEG coating forming a lubricious surface on the outer surface of the outer skirt; An artificial heart valve comprising:

18. 18. The prosthetic heart valve of claim 17, wherein the polyethylene glycol (PEG) coating is covalently bonded to the plurality of fibers.

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