Sealing elements for prosthetic heart valves

Abstract

This application relates to a sealing element for a prosthetic heart valve. An implantable prosthetic valve, radially collapsible into a collapsible configuration and radially expandable into an expandable configuration, includes an annular frame having an inlet end, an outlet end, and a longitudinal axis. Leaflet structures are positioned within and secured to the frame, and a sealing element is secured to the frame. The sealing element includes a first braided portion extending circumferentially around the frame. The first braided portion includes a plurality of interlaced filaments. The sealing element also includes a second braided portion extending circumferentially around the frame and spaced from the first braided portion along the longitudinal axis of the frame. At least a portion of the filaments exits the braid of the first braided portion and forms loops extending radially outward from the frame.

Description

[0001] This application is a divisional application. The original application was filed on August 10, 2018, with application number 201880062205.9 and invention title "Sealing element for prosthetic heart valve". Technical Field

[0002] This application relates to embodiments of sealing elements for prosthetic heart valves and methods of manufacturing thereof. Background Technology

[0003] The heart can suffer from various valvular diseases or malformations, leading to severe cardiac dysfunction and ultimately requiring the replacement of natural heart valves with artificial ones. The procedure of percutaneously introducing radially constrictable transcatheter heart valves in a compressed state through a catheter and expanding them at the treatment site is becoming increasingly popular, especially among patient populations at high risk of morbidity or death with traditional surgical methods.

[0004] Reducing or preventing blood leakage through the prosthetic valve after implantation is important. Therefore, transcatheter heart valves typically include sealing elements, such as a paravalvular leakage skirt, to minimize leakage through the prosthetic valve. However, differences between the diameter of the prosthetic valve and the natural annulus to which it is implanted, as well as the anatomical characteristics of a specific patient (such as calcification, tissue protrusions, depressions, folds, etc.), can make achieving a seal between the prosthetic valve and the natural annulus challenging. Therefore, improved paravalvular sealing elements are needed for prosthetic heart valves. Summary of the Invention

[0005] Some embodiments of this disclosure relate to prosthetic valves, including various embodiments of sealing elements. In a representative embodiment, an implantable prosthetic valve that can radially collapse into a collapsed configuration and radially expand into an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. Leaflet structures are positioned within and secured to the frame, and the sealing element is secured to the frame. The sealing element includes a first weave portion extending circumferentially around the frame. The first weave portion includes a plurality of interlaced filaments. The sealing element also includes a second weave portion extending circumferentially around the frame and spaced from the first weave portion along the longitudinal axis of the frame. At least a portion of the filaments exits the weave of the first weave portion and forms loops extending radially outward from the frame.

[0006] In some embodiments, the filaments forming loops extend from the first braided portion and return to the first braided portion.

[0007] In some embodiments, the first braided portion includes a first row of loops, and the second braided portion includes a second row of loops. The loops in the second row may include filaments extending from and returning to the second braided portion.

[0008] In some implementations, the rings in the second row of rings are offset circumferentially relative to the rings in the first row of rings.

[0009] In some embodiments, the plurality of interwoven filaments of the first braided portion further include at least one first filament interwoven with a plurality of second filaments, and a portion of the at least one first filament forms a loop in the first braided portion.

[0010] In some embodiments, the sealing element further includes an intermediate sealing portion between the first braided portion and the second braided portion. The intermediate sealing portion includes a plurality of second filaments, and a portion of the at least one first filament extends along the longitudinal axis of the frame between the first braided portion and the second braided portion and interweaves with the second filaments of the intermediate sealing portion.

[0011] In some embodiments, at least a portion of the first filament forms a loop in the second braided portion.

[0012] In some embodiments, the second filament is a warp yarn, and the at least one first filament is a weft yarn.

[0013] In some embodiments, at least one of the warp and weft yarns includes textured yarn.

[0014] In some embodiments, the warp and weft yarns comprise fibers with a diameter of 1 μm to 20 μm to promote thrombus formation around the sealing element.

[0015] In some embodiments, the filaments forming the loops originate from the first braided section and extend curvilinearly along the longitudinal axis of the frame to the second braided section.

[0016] In some embodiments, the filaments forming the loops leave the knitting body of the first knitting section and are incorporated into the knitting body of the second knitting section, such that the loops are formed in the floating yarn portion between the first and second knitting sections.

[0017] In some embodiments, the floating yarn portion includes a first loop and a second loop radially outside the first loop.

[0018] In some embodiments, the sealing element includes a first fabric strip, a second fabric strip, and a third fabric strip. A plurality of filaments forming loops extend between the first and second fabric strips, and also between the second and third fabric strips. The sealing element is folded around the second fabric strip such that the first and third fabric strips are adjacent to each other to form a first woven portion, the filaments extending between the first and second fabric strips form a first layer of loops, and the filaments extending between the second and third fabric strips form a second layer of loops.

[0019] In some embodiments, the sealing element is fixed to the frame such that the filaments of the braided body that leave the first braided portion form loops when the frame is in an expanded configuration, and are straightened when the frame is in a contracted configuration.

[0020] In another representative embodiment, the method includes mounting any of the prosthetic valves described herein to a distal portion of a delivery device, advancing the delivery device toward the heart through the patient's vascular system, and dilating the prosthetic valve within the heart's natural heart valves such that the prosthetic valve modulates blood flow through the natural heart valves.

[0021] In another representative embodiment, a method of manufacturing a sealing element for a prosthetic heart valve includes: weaving at least one weft yarn together with a plurality of warp yarns to form a first woven portion, removing the at least one weft yarn from the weave of the first woven portion, and looping the at least one weft yarn around removable warp yarns. The removable warp yarns are spaced apart from the first woven portion, and the at least one weft yarn loops around the removable warp yarns such that the at least one weft yarn extends over the warp yarns disposed between the first woven portion and the removable warp yarns without interlacing with them. The method further includes reincorporating the at least one weft yarn into the weave of the first woven portion, such that the at least one weft yarn forms a loop extending from and returning to the first woven portion; and removing the removable warp yarns from the sealing element to release the loops formed by the at least one weft yarn.

[0022] In some implementations, the method further includes repeating the weaving, withdrawing, looping, and re-incorporating processes before removing the removable warp yarns to form multiple loops around the circumference of the sealing element.

[0023] In some embodiments, the method further includes setting the shape of the plurality of rings such that the rings extend outward from the sealing element.

[0024] In some embodiments, the method further includes weaving the at least one weft yarn together with the warp yarn before removing the removable warp yarn, such that the at least one weft yarn extends beyond the removable warp yarn and forms a second weave portion spaced from the first weave portion. The method further includes withdrawing the at least one weft yarn from the knit of the second weave portion and looping the at least one weft yarn around a second removable warp yarn spaced from the second weave portion. The at least one weft yarn may loop around the second removable warp yarn such that the at least one weft yarn extends over the warp yarn disposed between the second weave portion and the second removable warp yarn without interlacing with it. The method may further include reincorporating the at least one weft yarn into the knit of the second weave portion, such that the at least one weft yarn forms a second loop extending from and returning to the second weave portion.

[0025] The foregoing and other objects, features and advantages of this disclosure will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0026] Figure 1 This is a perspective view of a prosthetic heart valve, including a representative embodiment of a paravalvular leak seal comprising annular filaments.

[0027] Figure 2 yes Figure 1 A perspective view of the periplasmic leak seal.

[0028] Figure 3 It is weaving Figure 1 A schematic diagram of a representative method for sealing peripheral leaks.

[0029] Figure 4 These are side elevation views of example textured yarns and fully drawn yarns.

[0030] Figure 5 This is a perspective view of an example prosthetic heart valve, which includes another embodiment of a paravalvular leak seal, the valve leak seal comprising a braided portion and a plurality of filaments extending from the braided portion.

[0031] Figure 6 yes Figure 5 A schematic diagram of a periplasmic leak seal.

[0032] Figure 7 yes Figure 5 A perspective view of a prosthetic heart valve, including another embodiment of a paravalvular leak seal comprising a plurality of woven portions arranged in a layered manner on the exterior of the valve.

[0033] Figure 8 yes Figure 5A side elevation view of a prosthetic heart valve, including another embodiment of a paravalvular leak seal, wherein the braided portion extends in a zigzag pattern parallel to the strut members of the valve and frame.

[0034] Figure 9 This is a perspective view of another embodiment of a prosthetic heart valve, which includes a paravalvular leak seal having a first braided portion, a second braided portion, and a plurality of yarns extending between the first and second braided portions to form loops.

[0035] Figure 10 yes Figure 9 A top view of a representative embodiment of a periplasmic leak seal.

[0036] Figure 11 It folds itself before being attached to the prosthetic valve. Figure 9 A perspective view of the periplasmic leak seal.

[0037] Figure 12A yes Figure 9 A side elevation view of a portion of the frame of a prosthetic valve in an expanded configuration, illustrating the longitudinally extending yarn of the perivalvular leak seal that curves outward from the frame.

[0038] Figure 12B yes Figure 12A The side elevation view of that part of the frame in a radially wrinkled configuration illustrates the longitudinal extension yarn of the perivalvular leak seal stretched along the longitudinal axis of the valve.

[0039] Figure 13 This is an example. Figure 9 A side elevation view of a portion of the frame of a prosthetic valve, wherein a first braided portion of the perivalvular leak seal is coupled to a first-stage frame strut, and a second braided portion is coupled to a third-stage frame strut.

[0040] Figure 14 This is an example. Figure 9 A side elevation view of a portion of the frame of a prosthetic valve, wherein a first braided portion of the perivalvular leak seal is connected to a first-stage frame strut, and a second braided portion is connected to a fourth-stage frame strut.

[0041] Figure 15 This is an example. Figure 9 A side elevation view of a portion of the frame of a prosthetic valve, wherein the perivalvular leak seal is suspended along the struts of the frame.

[0042] Figure 16A and 16B Example Figure 9Another embodiment of the periplasmic leak seal, wherein longitudinally extending yarns extend at an angle between the first and second braided portions of the seal.

[0043] Figure 17 yes Figure 9 A perspective view of a prosthetic heart valve, including another embodiment of a paravalvular leak seal comprising a single layer of longitudinally extending yarn.

[0044] Figure 18 yes Figure 17 A top view of a portion of the periplasmic leak seal.

[0045] Figure 19 yes Figure 17 A top view of a prosthetic heart valve.

[0046] Figure 20 yes Figure 19 A perspective view of a prosthetic heart valve, including another embodiment of a paravalvular leak sealing element.

[0047] Figure 21 This is a perspective view of a representative implementation of the delivery device.

[0048] Figure 22-25 Examples of various other embodiments of a sealing element in which yarns form a loop extending from the sealing element are provided.

[0049] Figure 26 This is a perspective view of a portion of a sealing member according to one embodiment, the sealing member comprising a plurality of embroidered loops into the base skirt fabric.

[0050] Figure 27 yes Figure 26 Side view cross-sectional view of the sealing component.

[0051] Figures 28-30 This is a perspective view of examples of plush ring sections formed on sealing members in various styles.

[0052] Figure 31 This is a side elevation view of a prosthetic heart valve according to another embodiment, the prosthetic heart valve including a sealing member comprising a plurality of woven fabric strips including tassel-like portions.

[0053] Figure 32 This is a plan view of a sealing member for a prosthetic heart valve according to another embodiment, the sealing member including a braided portion and a floating yarn portion.

[0054] Figure 33 yes Figure 32 An enlarged view of the first braided portion of the sealing component.

[0055] Figure 34 yes Figure 32 An enlarged view of the second braided portion of the sealing component.

[0056] Figure 35 It is in a relaxed state. Figure 32 An enlarged view of the floating yarn portion of the sealing component.

[0057] Figure 36 An example of a stretched state. Figure 35 The floating yarn part.

[0058] Figure 37 It is in a stretched state. Figure 32 A plan view of the sealing component.

[0059] Figure 38 This is an example. Figure 32 A perspective view of the edge portion of the sealing component.

[0060] Figures 39A-39J Examples of various leno weaving patterns and techniques are provided. Detailed Implementation

[0061] This 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 comprising a plurality of filaments, such as yarns and / or fibers, extending from the sealing element and configured to promote a biological response at the cellular level to facilitate thrombus formation around the sealing element.

[0062] For example, the sealing element described herein can be configured as a fabric skirt comprising a braided portion from which filaments or yarns extend, and which the braided portion may contact and / or conform to the surrounding anatomy to enhance the sealing properties of the skirt. In some configurations, the ends of the filaments are bound and form loops extending radially outward from the skirt. As used herein, the term "loop" refers to a closed or partially open curve formed by yarns or other filaments. In some embodiments, the yarns forming the loops extend from the same fabric portion of the skirt and return to the same fabric portion of the skirt. In such configurations, the loops may be arranged in one or more rows extending circumferentially around the skirt. In other configurations, the yarns extend from one fabric portion to another spaced-apart fabric portion, such that the loops are arranged circumferentially around the valve and oriented along the longitudinal axis of the valve. In still other embodiments, one end of the filament is bound and has a free end extending outward from the skirt.

[0063] In this configuration, the filaments can be arranged to slow retrograde blood flow across the valve. Characteristics of the filaments, such as diameter, shape, surface texture, and coating, can induce thrombus formation around the filaments, thereby enhancing the sealing properties of the skirt.

[0064] Figure 1 An exemplary embodiment of a radially collapsible and expandable prosthetic valve 10 in its deployment and expansion configuration is illustrated. The prosthetic valve may include an annular stent or frame 12 and leaflet structures 14 located within and coupled to the frame 12. The frame 12 may have an inflow portion 16 and an outflow portion 18. The leaflet structure may include a plurality of leaflets 22, such as three leaflets, arranged to collapsible in a tricuspid arrangement similar to that of the aortic valve. Alternatively, depending on the application, the prosthetic valve may include two leaflets 22—configured to collapsible in a bicuspid arrangement similar to that of the mitral valve—or may include more than three leaflets. The prosthetic valve 10 may define a longitudinal axis 24 extending through the inflow portion 16 and the outflow portion 18.

[0065] Frame 12 can be made of any of a variety of biocompatible materials, such as stainless steel or nickel-titanium alloys (“NiTi”), for example, nitinol. Reference Figure 1 The frame 12 may include a plurality of interconnected grid struts 26 arranged in a grid pattern and forming a plurality of vertices 28 at the outflow end 18 of the prosthetic valve. The struts 26 may also form similar vertices at the inflow end 16 of the prosthetic valve (covered by the skirt 30, described in more detail below). The grid struts 26 are shown to be diagonally positioned, or offset at an angle relative to the longitudinal axis 24 of the prosthetic valve, and radially offset relative to the longitudinal axis 24 of the prosthetic valve. In other embodiments, the offset of the grid struts 26 may differ from... Figure 1 As shown, some or all of the grid struts 26 can be positioned parallel to the longitudinal axis of the prosthetic valve.

[0066] The grid struts 26 can be pivotally connected to each other. In an example embodiment, for example, the end portions of the struts 26 forming apexes 28 at the outflow end 18 and inflow end 16 of the frame may have corresponding openings 32. The struts 26 may also be formed with holes 34 located between opposite ends of the struts. Corresponding hinges may be formed at the apexes 28 and at locations where the struts 26 overlap each other between the ends of the frame by fasteners 36, which may include rivets or pins extending through the holes 32, 34. The hinges allow the struts 26 to pivot relative to each other as the frame 12 expands or contracts, such as during the assembly, preparation, or implantation of the prosthetic valve 10. For example, the frame 12 (and therefore the prosthetic valve 10) may be manipulated into a radially compressed or contracted configuration, coupled to a delivery device, and inserted into the patient for implantation. Once in the body, the prosthetic valve 10 may be manipulated into an expanded state and then released from the delivery device, as referenced below. Figure 21A more detailed description is available. Further details regarding frame 12, the delivery device, and the means and techniques for radially expanding and contracting the frame can be found in U.S. Publication No. 2018 / 0153689.

[0067] like Figure 1 For example, the prosthetic valve 10 may include a seal configured as a skirt 30. The skirt 30 may be configured to establish a seal with natural tissue at the treatment site to reduce or prevent paravalvular leakage. The skirt 30 may include a body portion 38 arranged around the outer periphery of the frame 12. The skirt 30 may be secured to the frame by, for example, a plurality of sutures 41 extending in a zigzag pattern along selected strut members 26 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 some embodiments, the skirt 30 may be sutured to the frame 12 along sutures 66 corresponding to the scalloped edges defined by the leaflets 22, which may allow the valve to expand and contract radially without skirt interference or skirt pinching. Further details regarding transcatheter prosthetic heart valves, including the manner in which leaflet 22 can be attached to frame 12, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202.

[0068] In an example embodiment, the skirt 30 may include a plurality of outwardly extending filaments (also referred to as looping filaments) configured as loops 44. Loops 44 may extend from the outer surface 46 of the body portion 38. In some embodiments, the loops 44 may be arranged as rows or layers 48 extending circumferentially around the frame 12 and spaced apart from each other along the longitudinal axis 24. For example, in an example embodiment, the loops 44 are arranged in three rows 48, wherein the first row 48A is adjacent to the inflow edge portion 40 of the skirt, and rows 48B, 48C are located above the first row 48A along the longitudinal axis 24 of the valve. In other embodiments, depending on the desired specific properties, the skirt 30 may include more or fewer rows of loops. For example, the skirt 30 may include a single row of loops 44 (e.g., adjacent to the inflow end of the frame) or multiple rows of loops along substantially the entire height dimension of the skirt 30.

[0069] In a specific embodiment, the skirt 30 may include fabric, such as woven or knitted fabric. Figure 2 A portion of a representative embodiment of a skirt 30 made of this fabric is illustrated in more detail. The fabric may include... Figure 2 Multiple first yarns 50 in the horizontal orientation and in Figure 2One or more vertically oriented second yarns 52 are selectively interwoven with the first yarn 50 on a loom. In some configurations, the first yarn 50 may be a warp yarn, meaning that the yarn 50 is fixed to the loom during weaving, while the second yarn 52 is a weft yarn, which is interwoven with the warp yarn by a moving shuttle or weft carrying mechanism during weaving. However, in other embodiments, the first yarn 50 may be a weft yarn, and the second yarn 52 may be a warp yarn. In the example configuration, the fabric includes a single weft yarn 52, which is selectively interwoven with the warp yarn 50 to form looped filaments 44, although more than one weft yarn may be used in other embodiments.

[0070] Figure 3 An example knit pattern that can be used to produce skirts is shown. Reference Figure 3 The first portion 52A of the weft yarn can extend in the fabric above and below the warp yarns from the first edge portion 40 to the second edge portion 42. At the second edge portion 42, the weft yarn 52 is folded back along its original path, and the second portion 52B of the weft yarn extends in the fabric above and below each warp yarn in a plain weave direction back to the first edge portion 40. This defines the side edges of the fabric and prevents the fabric from unraveling when removed from the loom. At the first edge portion 40, the weft yarn 52 can again be folded back along its original path, such that the third portion 52C extends above and below the warp yarns 50 of the first woven portion of the fully woven strip 54A configured as the fabric. In the example configuration, the fabric may include four such woven strips 54A-54D, spaced apart from each other between the first edge portion 40 and the second edge portion 42, and extending parallel to the warp yarns 50. The woven strips 54A-54D may be separated by corresponding partially woven or half-woven portions 55A-55C (also referred to as intermediate sealing portions). In fully woven sections 54A-54D, each pass of the weft yarn 52 can be incorporated into the weave. In contrast, in the semi-woven sections 55A-55C, only a portion of the weft yarn's pass is incorporated into the weave. In some instances, in woven sections 54A-54D, the warp and weft yarns 50, 52 are woven together in a plain weave (weave) (or another suitable weave). In other embodiments, depending on the specific application, the skirt 30 does not need to include the woven section 54D above the last row of loops 44.

[0071] Still referencing Figure 3 At the upper edge 56 of the braided section 54A, a portion 52C of the weft yarn can leave the braid (e.g., the yarn portion 52C is "withdrawn" from the braid) and can extend or "float" a distance d1 above the warp yarn 50 of the semi-woven section 55A. Figure 3In the diagram, solid lines represent portions of weft yarn 52 incorporated into the knitting body, while dashed lines represent portions of weft yarn 52 not incorporated into the knitting body (such as portion 52C). Portion 52C can then loop around a removable warp yarn 50A (also called selvage yarn), and a fourth portion 52D can extend above the warp yarns, facing the first edge portion 40, and outside the knitting body. When weft portion 52D reaches the knitting tape 54A, portion 52D can be reincorporated into the knitting body, such that the warp yarns of the knitting tape 54A extend above and below weft portion 52D.

[0072] At the first edge portion 40, the warp yarn 52 can be folded back along the same path, and the fifth portion 52E can extend in the direction toward the second edge portion 42. The fifth portion 52E can be incorporated into the knitting body, passing through the half-knitting portion 55A and the knitting tape 54B until it reaches the upper edge 58 of the knitting tape 54B, where the sixth portion 52F can leave or "remove" from the knitting body. The sixth portion 52F can extend or float a distance d2 above the warp yarn 50 of the half-knitting portion 55B in the direction toward the second edge portion 42. Then, the sixth portion 52F can loop around the removable warp yarn 50B, and the seventh portion 52G of the weft yarn can extend outside the knitting body in the opposite direction toward the first edge portion 40.

[0073] When the seventh portion 52G reaches the upper edge 58 of the braided tape 54B, it can be reintegrated into the knitting body, allowing the warp yarns of the braided tape 54B to extend above and below it. When the seventh portion 52G reaches the lower edge 60 of the braided tape 54B, the weft yarn can be folded back along its original path, and the eighth portion 52H can extend towards the second edge 42. The eighth portion 52H can be integrated into the knitting body, passing through the half-knitted portion 55B and the braided tape 54C until it reaches the upper edge 62 of the braided tape 54C. Here, the ninth portion 52I can leave the knitting body and extend a distance d3 towards the second edge 42 on the warp yarns 50 of the half-knitted portion 55C. At the braided tape 54D, the ninth portion 52I can loop around the removable warp yarns 50C, and the tenth weft portion 52J can extend outwards towards the first edge 40 outside the knitting body.

[0074] When the tenth portion 52J reaches the upper edge 62 of the braided tape 54C, the weft yarn can be reincorporated into the knit, causing the eleventh weft portion 52K to extend in the knit in the opposite direction to the first edge portion 40. When portion 52k reaches the first edge portion 40, the weft yarn can be folded back along its original path, and the aforementioned pattern can be repeated along the length of the fabric (e.g., Figure 3 (Right side). Figure 3 Two complete examples of the aforementioned weaving pattern are provided.

[0075] When the knitting pattern has been repeated a selected number of times (e.g., to produce a fabric with a length corresponding to the circumference of the prosthetic valve), the removable warp yarns 50A-50C can be removed from the knitting. For example, in Figure 3 In the example implementation, warp yarns 50A-50C can be pulled out of the fabric in the directions of corresponding arrows 64A-64C. This allows the portion of the weft yarn 50 outside the knitting body to be released from the fabric, thereby forming loops 44. For example, when the removable warp yarn 50A is removed from the knitting body, portions 52C and 52D of the weft yarn are released from the fabric and can form looped filaments 44A as they extend from the weave tape 54A (e.g., in a terrycloth manner). Similarly, removing warp yarn 50B can release weft yarn portions 52F and 52G, causing them to form looped filaments 44B extending from the weave tape 54B, and removing warp yarn 50C can release weft yarn portions 52I and 52J, causing them to form looped filaments 44C extending from the weave tape 54C.

[0076] Therefore, removing the warp yarns 50A-50C generates a plurality of looped filaments 44, which are arranged in three rows 48A-48C and extend along the length of the skirt 30, as described above. For illustrative purposes, Figure 2 This example demonstrates removing the skirt 30 from the removable warp 50A. Return Figure 3 And with reference to the Cartesian x-axis and y-axis, the loops 44 of rows 48A-48C can be offset from each other in a direction along the y-axis (e.g., parallel to the longitudinal axis of the valve), the offset distance being equal to the loop length plus the width of the braided tape 54 (from which the loops extend). For example, the offset distance of the loop 44 of the first row 48A adjacent to the first edge portion 40 relative to the loop of the second row 48B is equal to the width W of the braided tape 54A plus the distance d1 (the length of the loop 44).

[0077] At the same time, although for the purpose of exemplification Figure 1 The image shows the rings 44 axially aligned, but the rings 44 can also be spaced apart from each other in the x-axis direction (e.g., circumferentially spaced around the prosthetic valve when the skirt 30 is fixed to the valve). For example, in Figure 3 In the example implementation, the center or vertex of loop 44B is spaced x1 from the center or vertex of loop 44A, the distance x1 corresponding to, for example, the distance occupied by weft portions 52D and 52E along the x-axis in the knit. Therefore, in the example configuration, each loop 44 is offset by a distance x1 relative to the adjacent sequential loops 44 in the x-axis direction. Thus, loop 44A is offset by a distance x1 relative to loop 44B in the negative x-direction, and loop 44C is offset by a distance x1 relative to loop 44B in the positive x-direction. The distance by which loops 44 in the same row are offset from each other along the x-axis is equal to 3x1.

[0078] In some embodiments, when the fabric has been removed from the loom and the removable warp yarns 50A-50C have been removed from the knitting, the loop 44 can be shaped such that it extends beyond the plane of the fabric (e.g., perpendicular to the longitudinal axis of the valve, and therefore perpendicular to the flow direction through the valve). For example, refer again... Figure 1 The ring 44 can be shaped such that it extends radially outward from the surface 46 of the skirt 30 at a certain angle when the skirt is fixed to the frame.

[0079] In some configurations, one or both of the warp and weft yarns 50 and 52 may also include textured yarns. Representative examples are shown in... Figure 4 The diagram illustrates an exemplary textured yarn 70 and a fully drawn yarn 80. Textured yarn 70 comprises multiple component fibers 72 that have been crimped, coiled, wound, looped, etc., such that the fibers are not as tightly bound together as the fibers 82 of the fully drawn yarn 80. This increases the surface area of ​​the textured yarn 70, which can improve the yarn's blood clotting properties, as further described below. Additionally, the dimensions of the fibers 72 forming the yarns 50, 52 can be configured to promote a cellular-level biological response or interaction between the yarns 50, 52 and the blood flowing through the skirt.

[0080] For example, the size of blood cells typically ranges from 2 μm to 15 μm. Similarly, the diameter of red blood cells typically ranges from 6 μm to 8 μm, and the diameter of platelets typically ranges from 2 μm to 3 μm. Therefore, utilizing fibers 72 with a diameter set to approximately match the diameter of blood cells (e.g., 1 μm to 20 μm) can promote cellular-level interactions between fibers and blood cells. For example, fibers 72 can be configured to promote thrombus formation along the skirt 30, and specifically along the looping filaments 44, thereby improving the sealing properties of the skirt.

[0081] In some configurations, the warp and weft yarns may comprise various biocompatible materials, such as natural fibers (e.g., silk, cotton, etc.), synthetic polymer materials (e.g., polyethylene terephthalate (PET), nylon, polytetrafluoroethylene (PTFE), etc.), or metals (e.g., nitinol, gold, etc.). In other embodiments, the skirt 30 need not comprise a woven fabric, but may comprise a thin polymer film or laminate integrally formed with or attached to looped filaments.

[0082] Compared to known skirt implementations, the skirt 30 offers several significant advantages. For example, the annulus 44 impedes blood flow across the valve, thereby reducing the velocity and volume of blood leaking through the valve after implantation. The flow impediment provided by the annulus 44 increases the residence time of blood near the skirt. This, together with the aforementioned fiber diameter, can induce thrombosis and promote a seal between the skirt and surrounding tissue.

[0083] Additionally, the ring 44 can be flexible, allowing it to conform to the shape of the surrounding anatomy. Since the ring 44 extends radially outward from the surface of the skirt 30, the free end portion of the ring can also extend into folds and gaps in the surrounding anatomy to promote a more complete seal. Furthermore, when a prosthetic valve is implanted into a natural aortic valve, blood surrounding the valve can exert force on the ring 44 during ventricular diastole in the opposite direction to the blood flow through the valve. This can enhance the curvature of the ring 44 away from the skirt 30, further enhancing the sealing properties. Additionally, by extending outward from the outside of the valve, the ring 44 can also prevent thrombus movement across the valve, reducing the likelihood of stroke.

[0084] Figure 5 An example of a prosthetic valve 10 is provided, which includes another embodiment of a sealing member or skirt 100. In the example embodiment, the skirt 100 may include a woven portion configured as a fabric strip 102 and a spike-like portion 104 comprising a plurality of filaments configured as yarns 106 extending from an edge portion 108 of the fabric strip 102. In some instances, the yarn 106 may be a warp yarn extending from the woven portion of the fabric strip 102 without interlacing with any weft yarns, or vice versa. In some embodiments, the yarn 106 may be a loose yarn. For example, the yarn 106 may comprise a plurality of fibers or threads spun together.

[0085] Figure 6 A portion of this skirt 100 is illustrated in more detail. Figure 6 In the example configuration, yarn 106 can be frayed, such that the component fibers 110 of the yarn are separated from each other and form a fan-shaped structure 112. For example, in some embodiments, the fibers 110 of yarn 106 can have a diameter of 1 μm to 20 μm—the size at which electrostatic forces between the fibers govern gravity, resulting in the fibers opening. This can increase the surface area of ​​yarn 106, which can promote cellular-level biological responses between blood and the skirt fibers 110, as described above. Figure 1 As described in the embodiments. Therefore, the fiber 110 can be configured to promote thrombus formation along the spike portion 104, thereby improving the sealing properties of the skirt 100.

[0086] In some embodiments, yarn 106 may include any of a variety of hydrophobic surface treatments or coatings to facilitate the separation of fibers 110 and increase the surface area of ​​the tufted portion 104. In other embodiments, yarn 106 may include hydrophilic surface treatments such as polyethylene glycol (PEG) or other coatings covalently bonded to the fibers. Yarn 106 may also include coatings or treatments that promote a biological response (e.g., thrombosis) to blood in contact with the yarn, and / or lubricating coatings such as Serene, available from Surmodics, Inc. TM A lubricating coating. In other embodiments, an electrostatic charge may be applied to yarn 106, causing fibers 110 to repel each other to increase fiber separation. In still other embodiments, fibers 110 may be textured fibers, as described above. Figure 1 As described in the embodiments; or coated or felted with short-length, small-diameter fibers. In other examples, yarn 106 may also form loops.

[0087] refer to Figure 7 In another configuration, the skirt 100 may include a plurality of fabric strips 102 arranged in a layered manner, one on top of the other. For example, in an exemplary embodiment, the skirt 100 may include three fabric strips 102A-102C, arranged such that the frayed edge portions 108 of each strip are oriented toward the outlet end 18 of the frame. Although the exemplary embodiment includes three fabric strips 102A-102C, the skirt 100 may include any suitable number of fabric strips 102 depending on, for example, the width of the fabric strips, the length of the prosthetic valve, etc. In other embodiments, both longitudinal edges of the fabric strips 102 may include yarns 106.

[0088] exist Figure 8 In another configuration of the example, the skirt 100 can be secured to the support 26 such that it extends along the support and forms a Z-shape. Depending on the specific application, multiple skirts 100 can be secured to the support members 26 of the frame in this manner.

[0089] Figure 9 Another embodiment of the prosthetic valve 200 is illustrated, configured as described in detail in US Patent No. 9,393,110 by Edwards Lifesciences Corporation. 3. Prosthetic Heart Valve. The prosthetic valve 200 includes a radially expandable and collapsible frame 202 formed by a plurality of angled strut members 204 and having an inlet end 206 and an outlet end 208. Although not shown, the prosthetic valve 200 may also include a leaflet structure comprising two, three, or any other suitable number of leaflets, located within and secured to the frame, as described in U.S. Patent No. 9,393,110.

[0090] The prosthetic valve 200 may include an inner skirt 211 fixed to the inner surface of a frame, and an outer sealing element of a skirt 212 configured to surround the exterior of the frame 202. In an example configuration, the skirt 212 may include a first circumferential extension 214 and a second circumferential extension 216 located adjacent to the inflow end 206 of the frame. The circumferential portions 214, 216 may be spaced apart from each other along the longitudinal axis 218 of the frame and connected together by a plurality of filaments 220. The filaments 220 may extend longitudinally between portions 214, 216 along the exterior of the frame and may be bent outward from the frame to form loops when the frame is in an expanded configuration. The looping filaments 220 may be configured to facilitate sealing by impeding blood flow through the skirt and increasing the residence time of blood near the filaments, as described above.

[0091] In some configurations, the circumferential portions 214, 216 may be configured as one or more woven fabric strips. The filaments 220 may be yarns incorporated into the fabric of portions 214 and 216 and extending axially therebetween. Figure 9 The skirt 212 in the example includes a single layer of looped filaments 220 for illustrative purposes, although the skirt embodiments described herein may include two or more layers of looped filaments depending on the number of fabric strips incorporated in portions 214, 216. Increasing the number of looped filaments (e.g., by increasing the number of fabric strips) can increase the total surface area of ​​the sealing element available for thrombus formation.

[0092] For example, Figure 10 A representative embodiment of a skirt 212 configured to provide two layers of looped filaments 220 when fixed to a frame is illustrated, and laid flat for illustrative purposes. The skirt 212 may include a body 224 comprising a first fabric strip 226A, a second fabric strip 226B, and a third fabric strip 226C. Fabric strip 226B may be located between fabric strips 226A and 226C. Fabric strip 226B may be spaced from fabric strip 226A by a float portion 228A, which includes a plurality of filaments or yarns 220. Similarly, fabric strip 226C may be spaced from fabric strip 226B by a float portion 228B, which includes a plurality of yarns 220.

[0093] In the example configuration, the first fabric strip 226A may include warp and weft yarns woven together. At the edge portion 230 of fabric strip 226A, yarn 220 may leave the weave and extend or “float” to the second fabric strip 226B to form a floating yarn portion 228A. When the floating yarn 220 reaches the second fabric strip 226B, the yarn can be reintegrated into the woven fabric of strip 226B. At the edge portion 232 of fabric strip 226B, yarn 220 may again leave the weave and extend or float from strip 226B to strip 226C to form a floating yarn portion 228B. When the floating yarn 220 reaches fabric strip 226C, it can be reintegrated into the weave of fabric strip 226C. In some configurations, yarn 220 is warp yarn, although depending on the specific application, yarn 220 may also be weft yarn, or a combination of warp and weft yarns.

[0094] refer to Figure 11 The main body 224 of the skirt 212 can be folded around the fabric strip 226B, such that the fabric strip 226C is adjacent to the fabric strip 226A, and the floating yarn portions 228A and 228B overlap each other or extend together. The folded skirt 212 can then be secured to a frame (e.g., by sewing), such that the fabric strips 226A and 226C form a first portion 214, and the fabric strip 226B forms a second portion 216. In this way, the longitudinally extending yarns 220 of the floating yarn portion 228A form a first or radially inward layer of curved yarns or loops, and the longitudinally extending yarns 220 of the floating yarn portion 228B form a second or radially outward layer of curved yarns or loops (or vice versa). To produce Figure 9 The single-layer looped filament 220 shown in the diagram, the skirt 212 only needs to include, for example, braided strips 226A and 226B and a floating yarn portion 228A.

[0095] refer to Figure 12A and 12B—As part of the example frame 202, the support members 204 may be arranged end-to-end to form multiple rows or tiers of support members extending circumferentially around the frame 202. For example, the frame 202 may include angled support members in a first or lower row I forming the inflow end 206 of the frame; support members in a second row II above the first row; support members in a third row III above the second row; support members in a fourth row IV above the third row; and support members in a fifth row V above the fourth row and forming the outflow end 208 of the frame. The structure and features of the support members 204 in row IV are described in more detail in U.S. Patent No. 9,393,110. The support members 204 of the frame 202 may also be grouped in columns. For example, the frame 202 may include a plurality of first or “A-type” columns and second or “B-type” columns arranged alternately around the circumference of the frame. In the example configuration, the A-type column includes support members 204 to the left of the diamond-shaped window 205 defined by the support members of rows IV and V, and support members extending downward therefrom. The B-type column includes a support member 204 to the right of window 205 and support members extending downward therefrom.

[0096] refer to Figure 9 and 12A The first portion 214 of the skirt 212 can be secured (e.g., by sewing) to the support member 204 of the first row I adjacent to the outlet end of the frame. The second portion 216 can be secured along the intersection of the supports 204 of the second row III and the third row III. The length of the yarn 220 can be configured such that the yarn bends radially outward from the surface of the frame 202 and forms loops when the frame is in an expanded configuration. For example, when attached to the frame, the skirt 30 may have a length L that approximately corresponds to... Figure 12A The sum of the lengths of the support members 204A, 204B, and 204C identified in the diagram. In this way, when the frame 202 is in a radially compressed or pleated configuration (where the support members 204A, 204B, and 204C are aligned or nearly aligned with each other in the axial direction), the yarn 220 can be straightened to reduce the pleated profile of the valve for insertion into the delivery sheath.

[0097] exist Figure 9-12B In the example configuration, portions 214 and 216 of the skirt 212 extend generally parallel to each other and do not form an angle with respect to the longitudinal axis 218 of the frame. In other configurations, one or both of portions 214 and 216 may be attached to the frame such that they form an angle with respect to the longitudinal axis 218 of the frame. For example, Figure 13An example configuration is shown where portion 214 is fixed to the support member of the first row I, such that portion 214 extends parallel to the angled support member 204 around the circumference of the frame 202. In other words, portion 214 forms a Z-shape along the support member 204 of the first row I, corresponding to the Z-shape of the support member of the first row I. Portion 216 is fixed to the support member 204 of the third row III, and also extends parallel to the angled support member of the third row III.

[0098] In embodiments where portions 214 and 216 of the skirt 212 extend parallel to the corresponding row of support members 204 that are fixed thereto, the skirt 212 may extend between even-numbered rows of support members, between odd-numbered rows of support members, or from odd-numbered rows to even-numbered rows, or vice versa. For example, in Figure 13 In the example configuration, the first part 214 is fixed to the first row I, and the second part 216 is fixed to the third row III, such that the skirt extends between the two odd-numbered rows of support members. Regarding Figure 9-15 In the example frame 202—where the skirt extends from one odd-numbered row to another (e.g., from row I to row III), or from one even-numbered row to another (e.g., from row II to row IV)—sections 214, 216 can be arranged such that yarn 220 extends in a direction parallel to the longitudinal axis 218 of the frame. In other words, when the skirt 212 extends between odd-numbered rows or between even-numbered rows, a given yarn 220 can extend from a position fixed along the line of the first section 214 to a position fixed along the line of the A-row column to a position fixed along the line of the second section 216 also to the A-row column.

[0099] In a skirt configuration where the skirt extends from odd-numbered rows to even-numbered rows (or vice versa), portions 214 and 216 can be circumferentially offset from each other, causing yarn 220 to extend at an angle relative to the longitudinal axis 218. For example, see reference. Figure 14 The first part 214 is connected to the support member of the first row I, and the second part 216 is connected to the support member of the fourth row IV. Figure 14 As shown, the first portion 214 and the second portion 216 of the skirt are offset from each other around the circumference of the frame, such that a given yarn 220 extends from the first portion 214 along the line to the position where it is fixed to the A-type railing post member, to the second portion 216 along the line to the position where it is fixed to the B-type railing post member. This allows the yarn 220 to extend parallel to the longitudinal axis of the frame when the frame is folded.

[0100] Figure 15Another configuration is illustrated, in which the skirt 212 is suspended between the intersections or vertices 234 of the support members 204, such that portions 214, 216 hang from the frame 202. For example, in the illustrated configuration, portion 214 is fixed to the intersection of the support members in row I, and portion 216 is fixed to the intersection of the support members in rows III and IV. Depending on the specific desired properties, one or both of portions 214, 216 may be fixed in this manner.

[0101] In some instances, skirt 212 may comprise twisted or untwisted yarn. Skirt 212 may also comprise core-spun yarn, wherein wrapped fibers are spun around a core yarn. The wrapped fibers may be wispy or dispersed to increase the surface area of ​​the core-spun yarn, thereby promoting a biological response, as described above. In some embodiments, in addition to the floating yarn portion 228, skirt 212 may also include [missing information - likely related to yarn type and structure]. Figure 1 The ring 44 is similar to the ring.

[0102] Figure 16A and 16B Another skirt section 212 is illustrated, in which yarns 220 extend at an angle between fabric strips 226A, 226B, and 226C. For example, see reference... Figure 16A The yarns 220 of the floating yarn portion 228A extend at an angle relative to the fabric strips 226A and 226B. The yarns 220 of the floating yarn portion 228B can also extend at an angle relative to the fabric strips 226B and 226C. In this way, when the body 224 is folded, the yarns 220 of the floating yarn portion 228A can be at an angle or "criss-crossed" with the yarns of the floating yarn portion 228B to form a mesh or net-like structure, such as... Figure 16B As shown. In some embodiments, the yarns can extend at an angle of 10 to 40 degrees. In some configurations, the yarns of the float portions 228A and 228B crossing each other at an angle can reduce the likelihood of yarns bunching together and causing gaps between the yarns. In some embodiments, the yarns of the float portions 228A and 228B can be parallel to each other.

[0103] Figure 17 Another embodiment including the skirt 300 is illustrated. Figure 9 The prosthetic valve 200 and frame 202. The skirt 300 may include first and second circumferentially extending portions 302, 304, which are spaced apart from each other and coupled together by a plurality of filaments configured as yarns 306 extending longitudinally along the frame. Figure 17In the example implementation, portions 302, 304 may be relatively wider than portions 214, 216 of skirt 212, such that the edge portions of portions 302, 304, together with filaments 306, bend outward from the expanded frame 202. The second portion 304 may also include a plurality of connecting portions 308 that extend upward from portion 304 (e.g., toward the outlet end 208 of the frame) and are secured to the support post 204 (e.g., by stitching).

[0104] In the example configuration, the skirt 300 comprises a single layer of longitudinally extending yarns 306. Figure 18 A representative configuration of skirt 300 laid flat before being attached to the frame is illustrated. First portion 302 and second portion 304 may comprise woven fabric strips, similar to skirt 212. Fabric portions 302, 304 may be separated by float portions 310 through which yarns 306 extend. In some embodiments, yarns 306 may be warp yarns, and float portions 310 may be formed by omitting weft yarns in the float portions or by removing selected weft yarns from the knit.

[0105] 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 positioned within the frame. After implantation, blood can flow through the floating gauze portion 310 and drain from the skirt. In some configurations, the skirt 300 may have a reduced pleated profile because the skirt is not folded before being secured to the frame. In other configurations, portions 302, 304 can be sized such that when the frame expands, the floating gauze portion 310 is located on the underside or distal side of the skirt. For example, Figure 19 This is a perspective view of the far end or inlet portion of frame 202, illustrating yarn 306 located on the far side of inlet portion 206.

[0106] Figure 20 Another configuration of skirt 212 is illustrated, in which yarn 220 is configured to bend over or around portions 214, 216 before being reincorporated into the knit. For example, see reference... Figure 10 and 20 The skirt portion 212 can be secured to the frame such that the yarn 220 extends from the distal edge of the fabric strip 226A, folds back along the same path, and extends proximally above the fabric strip 226B to the proximal edge of the strip 226B, forming a C-shaped arc. In other embodiments, one or both of the fabric strips 226A and 226B may be omitted, and the yarn 220 may be secured to the frame by looping through the support member 204.

[0107] The prosthetic valve embodiments disclosed herein can be radially constricted and percutaneously delivered to the heart using any of a variety of catheter-based delivery systems. For example, Figure 21 A representative instance of delivery component 400 is shown, which is configured with... Figure 1-8 The prosthetic valve 10 is used in conjunction with the prosthetic valve and is described in detail in U.S. Publication No. 2018 / 0153689. The delivery assembly 400 may include a handle 402, an elongated shaft 404 extending distally from the handle 402, and a plurality of actuating members 406 (e.g., in the form of a positioning tube) extending through the shaft and distally outwardly from a distal end 408 of the shaft 404. The actuating members 406 may be coupled to select the apex of the valve frame 12.

[0108] Initially, the prosthetic valve 10 can be in a radially constricted configuration within the sheath 410 of axis 404. Once the distal end of the delivery device has been advanced to the treatment site via the patient's vasculature, the prosthetic valve 10 can be pushed out of the sheath 410 using a rotatable actuator 412 on handle 402. The prosthetic valve 10 can then be positioned, expanded, and deployed at the treatment site using a release assembly generally indicated at 414. Other delivery systems that can be used in conjunction with the prosthetic valve implementation described herein can be found in U.S. Patent Application Publication No. 2017 / 0065415 and U.S. Patent Application Publication No. 2013 / 0030519.

[0109] Figure 22-25 Other embodiments of the fabric sealing element are illustrated, which include a plurality of yarns or fibers extending from the sealing element and forming loops in a looped pile manner, thereby increasing the surface area available for thrombosis and tissue growth. For example, Figure 22 A portion of a sealing element 500 is schematically illustrated, comprising a plurality of first yarns 502 interwoven with a plurality of second yarns 504. In some embodiments, the first yarns 502 may be warp yarns, and the second yarns 504 may be weft yarns, or vice versa. The warp yarns 502 may be configured to form loops 506 extending outward from the page plane and extending over one or more weft yarns 504. For example, in Figure 22 In some embodiments, the sealing element may include warp yarns 502A and warp yarns 502B. Warp yarns 502A may form loops 506, while one or more warp yarns 502B may be interposed between warp yarns 502A. For example, in an exemplary embodiment, there are two warp yarns 502B between two warp yarns 502A, although any number of warp yarns 502B may be present depending on, for example, the desired spacing between loops 506.

[0110] The warp yarn 502A can also change direction at the position where it forms the loop 506. For example, in Figure 22In this implementation, the loop 506 may extend at an angle relative to the weft yarn 504 through one or more weft yarns 504. In other words, the start and return points of the loop 506 may be offset from each other along the x-axis (note the Cartesian coordinate axis shown). The loop 506 may extend alternately along the positive and negative x-directions, such that the straight portions of the yarns 502A between the loops 506 are offset from each other along the x-axis. This can provide certain advantages, such as preventing the warp yarns 502A from moving relative to the weft yarns 504 or "locking" the warp yarns 502A relative to the weft yarns 504. Additionally, when the sealing member 500 is attached to the prosthetic valve by the warp yarns 502 extending axially along the longitudinal axis of the valve, the width W of the loop 506 may be oriented perpendicular or substantially perpendicular to the direction of blood flow through the valve, such that the loop 506 presents a relatively large flow hindrance. This can promote blood homeostasis and sealing around the prosthetic valve. The loop density of the pile (e.g., the number of loops per inch) can be changed, for example, by altering the length of the straight portions of yarn 502A between loops 506. Shortening the distance between loops 506 increases the loop density of the pile, as... Figure 23 and 24 As shown, increasing the distance between loops 506 can reduce the loop density of the pile. The width of loop 506 can be determined, for example, by the number of warp yarns with loops extending from it. For example, in Figure 25 In the middle, the loops extend on two warp yarns 502B, making... Figure 25 The ring 506 relative to Figure 22 The 506 ring is wider.

[0111] In some embodiments, warp-knitting techniques can be used to form loops 506. In some embodiments, the first warp 502A may comprise 20 denier-18 filament (20d / 18f) and / or 30d / 18f textured yarn. The second warp 502B may comprise 20d / 18f yarn twisted at 12 twists per inch (tpi). In some embodiments, the weft 504 may be 20d / 18f yarn with 12 tpi. The warp and weft yarns may 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 may have any selected denier and / or filament count and may be made from any suitable natural or synthetic material.

[0112] In some implementations, loops can be formed on the skirt of the prosthetic valve by embroidery. In representative embroidery techniques, yarns or threads are sewn to or through a base or substrate (e.g., fabric), allowing various shapes or patterns to be created on the surface of the base layer. Figure 26An example is shown of a portion of a skirt 600 according to one embodiment, the skirt 600 including a plurality of loops 602 embroidered into a base skirt fabric 604. The base skirt fabric may include a plurality of first yarns 610 interwoven with a plurality of second yarns 612 in, for example, a plain weave. Reference Figure 27 Loops 602 can be formed using a third yarn configured as embroidery yarn 606, which can be a relatively high-density yarn or thread. In some embodiments, in addition to the first or base layer 604, the skirt 600 may optionally include a second layer configured as a locking layer 608. In specific embodiments, the locking layer 608 may include relatively low-density, lightweight, and / or fine yarns or threads, which can be used to lock the embroidery yarn 606 to the back of the base layer 604.

[0113] As described above, loops can be embroidered on the surface of the prosthetic valve skirt, having any specified location, length, width, spacing, shape, and / or style. Figures 28-30 Only a few examples of styles that can be produced using the embroidery techniques described above are shown. For example, Figure 28 An example is a prosthetic valve skirt 700, which includes a plurality of loops generally indicated at 702, embroidered on the skirt and forming a plush portion or pile 706. The plush portion 706 may include a plurality of angled portions 712 that extend circumferentially around the skirt 700 in a zigzag pattern from an end portion 708 (e.g., an inlet portion) of the skirt to the middle of the skirt height. Figure 29 Another variation of the plush portion 706 is illustrated, wherein the plush portion defines unit 710. In some embodiments, unit 710 may correspond to a frame support (such as...) Figure 1 The opening or unit is defined by the strut 26 of the prosthetic valve 10. In other embodiments, the unit of the plush portion 706 may correspond to that defined by the strut 26 of the prosthetic valve 10. Figure 9 The support pillars of frame 202 define the size and shape of the frame opening. Figure 30 Another variation of the plush portion 706 is illustrated, which includes a straight portion 714 extending between adjacent angled portions 712. In some embodiments, Figure 1 The loops 44 can be formed by embroidery on the lower layer of fabric of the skirt 30.

[0114] Figure 31 An example is given of a prosthetic heart valve 800, which includes another embodiment of a sealing member or skirt 802 on a frame 804 configured by Edwards Lifesciences Corporation. 3. Framework for the prosthetic heart valve. The skirt 802 may include multiple woven portions configured as fabric strips 806 extending circumferentially around the framework. Each fabric strip 806 may include a corresponding tassel portion 808 comprising 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 strip 806, similar to the description above. Figure 7 The skirt 100. In an exemplary embodiment, the skirt 802 may include three fabric strips 806A-806C having corresponding tassel portions 808A-808C. The tassel portion 808A of the fabric strip 806A may extend from the inflow edge 812 of the fabric strip 806A positioned near the inflow end 814 of the prosthetic valve. The filaments 810 of the tassel portion 808A may extend to the strut member approximately in the second row II (see Figure 12B The filaments 810 of the second fabric strip 806B can extend from the inflow edge 816 of the fabric strip 806B and can extend to the level of the third near the III pillar. The filaments 810 of the third fabric strip 806C can extend from the outflow edge 818 of the fabric strip 806C to the level of approximately the fourth IV pillar.

[0115] The filaments 810 may include or be derived from spun yarn, textured yarn, etc. In some embodiments, the fabric tape 806 of the sealing member 802 may include yarn densities of 50 to 500 yarns per inch, 100 to 400 yarns per inch, 150 to 350 yarns per inch, or 150 to 300 yarns per inch. In some embodiments, the fabric tape of the sealing member 802 may have a yarn density of 150 yarns per inch or 300 yarns per inch. The yarn may have any suitable filament density, such as 5 to 100 filaments per yarn, 10 to 50 filaments per yarn, or 10 to 20 filaments per yarn. In a specific embodiment, the yarn may include textured yarn having 18 filaments per yarn. The thickness of the filaments may be 1 μm to 100 μm, 1 μm to 50 μm, or 1 μm to 20 μm. In a specific embodiment, the filament may have a thickness or diameter of 10 μm.

[0116] Figure 32-37 An example of a primary buffer layer, cover, or sealing member 1000 according to another embodiment is provided. Sealing member 1000 may include a fabric body having multiple woven portions and multiple elastically stretchable portions—configured as float portions—and may be incorporated into any prosthetic valve overlay described herein. Figure 32An example of a flattened configuration of a sealing member 1000 is illustrated, wherein the x-axis corresponds to the circumferential direction and the y-axis corresponds to the axial direction—when the sealing member is attached to a frame of a prosthetic valve. The sealing member 1000 may include a plurality of first braided portions 1002 configured as braided strips or bands extending along the x-axis; a plurality of second braided portions 1004 configured as braided strips or bands extending along the x-axis; and a plurality of float portions, strips, or bands 1006 extending along the x-axis. The various braided and float portions may be spaced apart from each other along the y-axis. In the illustrated configuration, the first braided portions 1002 may include a braided pattern different from the braided pattern of the second braided portions 1004, as described in more detail below.

[0117] For example, in the example configuration, the sealing member 1000 may include a first braided portion 1002A. Moved in the direction along the positive y-axis, the sealing member 1000 may further include a second braided portion 1004A, a floating yarn portion 1006A, a second braided portion 1004B, a floating yarn portion 1006B, a second braided portion 1004C, a floating yarn portion 1006C, a second braided portion 1004D, a floating yarn portion 1006D, a second braided portion 1004E, a first braided portion 1002B, a second braided portion 1004F, a floating yarn portion 1006E, a second braided portion 1004G, and a first braided portion 1002C—at the end of the sealing member opposite to the first braided portion 1002A. In other words, the first braided portion 1002B and each of the floating yarn portions 1006A-1006E can be located between the two second braided portions 1004, such that the first braided portion 1002B and each of the floating yarn portions 1006A-1006E are bound or edged in the direction along the x-axis by the corresponding second braided portion 1004.

[0118] refer to Figure 32 and 33 The sealing member 1000 may include a plurality of first yarns 1008 generally oriented along the x-axis and a plurality of second yarns 1010 generally oriented along the y-axis. In some configurations, the first yarns 1008 may be warp yarns, meaning that the yarns 1008 are fixed by the loom during weaving, while the second yarns 1010 are weft yarns, which are interwoven with the warp yarns during weaving by a moving shuttle or weft yarn carrying mechanism. However, in other embodiments, the first yarns 1008 may be weft yarns, and the second yarns 1010 may be warp yarns.

[0119] Each of the first yarn 1008 and the second yarn 1010 may include multiple component filaments 1012, which are spun, wound, twisted, mixed, interlaced, etc., to form the corresponding yarn. Figure 33-36As seen in the text. In some embodiments, the first yarn 1008 may have a denier number of about 1D to about 200D, about 10D to about 100D, about 10D to about 80D, about 10D to about 60D, or about 10D to about 50D. In some embodiments, the first yarn 1008 may have a filament count of about 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 a specific embodiment, the first yarn 1008 may have a denier number of about 40D and a filament count of 24 filaments per yarn. The first yarn 1008 may also be a twisted yarn or an untwisted yarn. In the example embodiment, the filaments 1012 of the first yarn 1008 are not deformed. However, in other embodiments, the first yarn 1008 may include deformed yarns.

[0120] The second yarn 1010 may be a textured yarn comprising a plurality of textured filaments 1012. For example, the filaments 1012 of the second yarn 1010 may 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 may have a denier number 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 may be from 1 filament per yarn 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 a specific embodiment, the second yarn 1010 may have a denier number of about 68D and a filament count of about 36 filaments per yarn.

[0121] The first yarn 1008 and the second yarn 1010 can be woven together to form a woven portion of the sealing member, as described above. For example, in the first woven portions 1002A-1002C, the first yarn 1008 and the second yarn 1010 can be woven together in a plain weave pattern, wherein the second yarn 1010 (e.g., weft yarn) passes over the first yarn 1008 (e.g., warp yarn) in a repeating pattern and then under the next yarn. This weave pattern is... Figure 33Detailed examples are provided below. In some embodiments, the density of the first yarn 1008 can be from about 10 yarns per inch to about 200 yarns per inch, from about 50 yarns per inch to about 200 yarns per inch, or from about 100 yarns per inch to about 200 yarns per inch. In some embodiments, the first braided portions 1002A and 1002C can be configured as selvage portions and can have a lower yarn density than the first braided portion 1002B to facilitate assembly onto the valve frame. Other weave patterns, such as 2-over-2, 2-over-1, etc., can also be used. The first braided portions can also be woven in plain weave derivatives, such as twill, satin, or any combination thereof.

[0122] In the second weaving sections 1004A-1004G, the first yarn 1008 and the second yarn 1010 can be interwoven in a different pattern than that of the first weaving sections 1002A-1002C. For example, in an exemplary embodiment, the first yarn 1008 and the second yarn 1010 can be woven together in a leno weave pattern in the second weaving sections 1004A-1004G. Figure 34 A more detailed example of the leno knit of the second knit section 1004B is provided. (See reference) Figure 34 A leno braid may 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". Figure 34 The example pattern includes a single leno yarn 1014 in a half-leno weave. However, in other embodiments, the leno weave pattern can be a full leno weave comprising two interlaced leno yarns 1014, or other leno-derived weaves. Examples of various leno weaves and related weaving techniques are shown in [the original text]. Figures 39A-39J Example from the Chinese text.

[0123] exist Figure 34In the illustrated semi-leno weave, first yarns 1008A-1008D can extend parallel to the x-axis, and second yarns 1010 can be interwoven with first yarns 1008A-1008D, for example, in a plain weave. Leno yarns 1014 can be woven around the first yarns 1008A-1008D such that the leno yarns 1014 pass above or on top of the first yarns 1008A-1008D (each pass along the positive y-direction), pass below or behind the next second yarn 1010 along the x-direction, and extend in the opposite direction along the negative y-direction above the first yarns 1008A-1008D. This pattern can be repeated along the length of the second woven portion 1004B. In this way, when the sealing element is mounted to the frame, the second woven portion 1004 can be a relatively narrow and stable woven portion axially spaced from each other along the frame. The leno yarn 1014 can be used to keep the first yarns 1008A-1008D and the second yarn 1010 in proper position relative to each other when the prosthetic valve wrinkles and expands, and can impart strength to the second braided portion 1004 while minimizing the width.

[0124] In some embodiments, each of the second braided portions 1004A-1004G may include the aforementioned leno weave pattern. In other embodiments, one or more of the second braided portions 1004A-1004G may be configured differently, such as by incorporating more or fewer first yarns 1008 into the leno weave, causing multiple leno ends to be woven around multiple sets of yarns 1008, and so on. In still other embodiments, a chemical locking method may be used, wherein the leno weave and / or plain weave comprises warp yarns of filaments having a core-sheath structure. The outer sheath of each filament may be made of a low-melting-temperature polymer such as biocompatible polypropylene, and the core of the filament may be made of another biocompatible polymer such as polyester. After the weaving process, a heat setting process described below can soften and / or melt the outer sheath. Upon cooling, the softened outer sheath polymer can bond the core polyester yarns together. This can form an adhesive capable of locking the braided structure.

[0125] Refer again Figure 32The floating yarn portion 1006 may include yarns extending along only one axis between corresponding second knitting portions 1004 spaced apart from each other along the y-axis. For example, taking floating yarn portion 1006A as a representative example, floating yarn portion 1006A may include a plurality of second yarns 1010 that exit the leno knit of second knitting portion 1004A, extend across floating yarn portion 1006A, and are incorporated into the leno knit of second knitting portion 1004B. In some embodiments, the density of the second yarns in floating yarn portion 1006 may be about 10 to about 200 yarns per inch, about 50 to about 200 yarns per inch, or about 100 to about 200 yarns per inch. In a specific embodiment, the density of the second yarns 1010 may be about 60-80 yarns per inch. In other embodiments, the floating portion may include a first yarn 1008 disposed below or above the second yarn 1010, but not interwoven with it, such that the second yarn floats above the first yarn, or vice versa. In still other embodiments, instead, the floating portion may be configured as any other elastically stretchable structure, such as an elastically stretchable woven, knitted, braided, or non-woven fabric, or polymer membrane, as examples, which is elastically stretchable at least in the axial direction of the prosthetic valve.

[0126] In the example embodiment, each braided portion 1002A-1002C and 1004A-1004G, and each floating yarn portion 1006A-1006E, can have a width dimension in the y-axis direction. The width of the component portions can be configured such that the total length L1 of the sealing member 1000 ( Figure 32 This generally corresponds to the axial length of the prosthetic heart valve in its expanded configuration. For example, in an exemplary embodiment, the first braided portions 1002A and 1002C may each have a width W1. In some embodiments, the width W1 may be configured such that portions of the first braided portions 1002A and 1002C can be folded over the inlet and outlet ends of the prosthetic valve frame.

[0127] The first knitted section 1002B may have a width W2. (See reference) Figure 12B When sealing component 1000 is used with Edwards Lifesciences When used in conjunction with the prosthetic heart valve frame, the width W2 can be configured to correspond to the axial dimension of the frame opening defined by the strut member between the fourth row IV and the fifth row V struts. In some embodiments, the width W2 of the first braided portion 1002B can be about 2 mm to about 20 mm, about 2 mm to about 12 mm, or about 3 mm to about 10 mm. In a specific embodiment, the width W2 can be about 7 mm.

[0128] The second weave section 1004A-1004G can have a width W3 ( Figure 34 In the example embodiment, all of the second braided portions 1004A-1004G have a width W3, but one or more of the second braided portions may also have different widths. In some embodiments, the width W3 may be relatively short, such as about 0.1 mm to about 3 mm, about 0.1 mm to about 2 mm, or about 0.1 mm to about 1 mm. In a specific embodiment, the width W3 may be about 1 mm.

[0129] refer to Figure 32 and Figures 35-38 In some embodiments, the sealing member 1000, and specifically the floating yarn portions 1006A-1006E, can be in a first, natural, or relaxed configuration corresponding to the radial expansion state of the prosthetic valve. Figure 32 and Figure 35 ) and the second, elongated or tensioned configuration corresponding to the radial compression state of the prosthetic valve ( Figure 37 and 38 The parts 1006A-1006E are elastically stretchable. Therefore, when the sealing member 1000 is in a relaxed and unstretched state, the floating yarn portions 1006A-1006E can have an initial width W4. Figure 35 An example is shown of a portion of the floating yarn portion 1006B in a naturally relaxed state. When the fabric is in a relaxed state, the deformed filaments 1012 of the second yarn 1010 can twist and bend in multiple directions, giving the floating yarn portion 1006B a bulky, wavy, or pillow-like quality. When tensioned, the twists, bends, etc., of the filaments 1012 can be at least partially straightened along the y-axis, causing the second yarn 1010 to elongate. (Reference) Figure 36 Therefore, the width of the floating yarn portion 1006 can be increased to a second width W5, which is greater than the initial width W4.

[0130] The cumulative effect of increasing the width of the floating yarn portion 1006A-1006E from the initial width W4 to the second width W5 is that the total axial dimension of the sealing member 1000 can be increased from the initial length L1 ( Figure 32 ) increased to the second total length L2 ( Figure 37 The second total length L2 is greater than the first length L1. Figure 37An example is provided of a sealing member 1000 in a stretched configuration, wherein the second yarns 1010 of the floating yarn portions 1006A-1006E are straightened under tension, increasing the total length of the sealing member to a second length L2. In some embodiments, the size, number, spacing, etc., of the floating yarn portions 1006, as well as the degree of deformation of the component second yarns 1010, can be selected such that the second length L2 of the sealing member 1000 corresponds to the length of the prosthetic valve frame when the prosthetic valve is folded for delivery on a delivery device. In specific embodiments, the initial relaxation width W4 of the floating yarn portions 1006 can be about 1 mm to about 10 mm, about 1 mm to about 8 mm, or about 1 mm to about 5 mm. In specific embodiments, the initial width W4 can be about 4 mm.

[0131] Figure 38 An example is shown of the edge portion of the sealing member 1000 clamped between a pair of clamps 1050. In some embodiments, the bulky, wavy nature of the textured yarn 1010 in the floating yarn portion 1006 can cause the thickness t1 of the floating yarn portion 1006 to be greater than the thickness t2 of the braided portions 1002 and 1004. For example, in some embodiments, when the sealing member is in a relaxed state, the thickness t1 of the floating yarn portion 1006 can be two, three, four, five, six, or even ten times or more greater than the thickness t2 of the braided portions 1002 and 1004. This can allow the floating yarn portion 1006 to cushion the natural leaflets between the valve bodies and / or against the anchors or rings into which the prosthetic valve is implanted. The floating yarn portion 1006 can also occupy gaps or spaces in the anatomical structure and / or promote tissue growth into the floating yarn portion, as in the embodiments described above. When tension is applied to stretch the floating yarn portion 1006, the thickness t1 may decrease as the deformed second yarn 1010 straightens. In some embodiments, when the sealing member is under tension, the thickness t1 may be equal to or nearly equal to the thickness t2 of the braided portions 1002 and 1004. When the tension on the sealing member 1000 is released, such as during prosthetic valve dilation, the yarn 1012 may return to its deformed shape, and the thickness of the floating yarn portion 1006 may return to its initial thickness t1.

[0132] In some embodiments, the floating yarn portions 1006A-1006E can be configured such that the sealing member 1000 can elongate by about 10% to about 500%, about 10% to about 300%, about 10% to about 200%, about 10% to about 100%, about 10% to about 80%, or about 10% to about 50%. In a specific embodiment, the floating yarn portions 1006A-1006E can be configured to allow the sealing member 1000 to elongate by about 30%, corresponding to the elongation of the frame 1022 between expansion and folding configurations. As described above, the increased width of the floating yarn portions 1006A-1006E can also result in a corresponding decrease in the thickness of the floating yarn portions, reducing the folding profile of the prosthetic valve during delivery.

[0133] In some embodiments, the first yarn 1008 and the second yarn 1010 may comprise any of a variety of biocompatible thermoplastic polymers such as PET, nylon, ePTFE, UHMWPE, etc., or other suitable natural or synthetic fibers. In some embodiments, the sealing member 1000 may be woven on a loom and then heat-treated or heat-set to obtain the desired size and configuration. For example, depending on the material chosen, heat setting may cause the sealing member 1000 to shrink. Heat setting may also cause deformation of the second yarn 1010 or increase its deformation. After heat treatment, an opening 1016 may be formed in the first woven portion 1002B (e.g., by laser cutting), and the sealing member may be incorporated into an external covering, such as covering 1018, for assembly onto the prosthetic valve. In some embodiments, the opening 1016 may also be formed prior to heat treatment.

[0134] The rings, filaments, floating portions, etc., of the prosthetic sealing member described herein can be configured to promote a biological response to form a seal between the prosthetic valve and surrounding anatomical structures, as described above. In some configurations, the sealing element described herein can be configured to seal over a selected time period. For example, in some embodiments, the open, porous nature of the rings, filaments, yarns, etc., allows for a selective amount of paravalvular leakage around the prosthetic valve during this time period after implantation. The amount of paravalvular leakage through the sealing structure can gradually decrease over the selected time period due to blood clotting, thrombosis, etc., resulting from the biological response to the rings, filaments, yarns, etc. In some embodiments, the sealing member, and specifically the rings, filaments, yarns, etc., of the paravalvular sealing structure, can be treated with one or more agents that inhibit the biological response to the sealing structure. For example, in some embodiments, the rings, filaments, yarns, etc., can be treated with heparin. In some embodiments, the amount or concentration of the agent (one or more) can be selected such that the agent is depleted after a selected time period (e.g., multiple days, multiple weeks, or multiple months) after valve implantation. When the reagents (one or more) are depleted, the biological response to the sealing structure's rings, filaments, yarns, etc., can increase, allowing the perivalvular seal to gradually form over a selected period of time. This can be advantageous for patients with left atrial remodeling (e.g., due to mitral regurgitation) by providing the opportunity for the remodeling to reverse as regurgitation gradually decreases through the prosthetic valve.

[0135] Figures 39A-39J Examples of various leno braids and leno weaving techniques that can be used to prepare sealing member 1000 or any other sealing member described herein are provided. Figure 39A This is a cross-sectional view of an example shed (e.g., a temporary separation of warp yarns to form an upper warp and a lower warp), in which leno yarns, "leno ends" or "cross ends" 1060 form the upper shed above the weft yarn 1064 on the left side of the figure, and the standard warp yarn 1062 forms the lower shed. Figure 39B An example of a continuous shed is provided, in which the leno yarn 1060 forms the upper shed to the right of the standard warp yarn 1062. Figure 39A and 39B In this process, the gauze yarn 1060 can be passed underneath the standard yarn 1062 in a pattern known as bottom douping. Alternatively, the gauze yarn 1060 can be passed over the standard yarn 1062, a pattern known as top douping, such as... Figure 39H And 391.

[0136] Figure 39C The example illustrates the interlacing pattern of a leno weave when a single warp bundle is used on a loom, and the twist or tension of the leno yarn 1060 and the standard yarn 1062 are equal, such that both yarn 1060 and yarn 1062 are bent around the weft yarn 1064. Figure 39D The example illustrates a lacing pattern when multiple warp bundles are used, and the tension of the lacing yarn 1060 is less than that of the standard yarn 1062, such that the standard yarn 1062 remains relatively straight in the lacing and perpendicular to the weft yarn 1064, while the lacing yarn 1060 bends around the standard yarn 1062.

[0137] Figure 39E Examples are provided for the corresponding Figure 39C The pattern is an interlaced design, but the alternating gauze yarns 1060 are point-drafted (e.g., a technique of stretching gauze yarns through heddles), so that adjacent gauze yarns 1060 have opposite braiding directions.

[0138] Figure 39G It is a cross-sectional view of a regular leno weave structure cut through weft yarn 1064.

[0139] Figure 39J A representative leno weave is shown as an example viewed from the reverse side of the fabric.

[0140] Example 1

[0141] In a first representative embodiment, an acute animal study was conducted, including... Figure 1 Various types of prosthetic heart valves with different skirts were implanted into sheep aortic valves. The first prosthetic valve tested included a sealing member or skirt with a yarn density of 300 threads per inch, wherein the yarn had a tassel or filament density of 18 filaments per thread. The second prosthetic valve had a skirt with a yarn density of 150 threads per inch, wherein the yarn had a filament density of 18 filaments per thread. A prosthetic valve without an external skirt was also implanted as a control.

[0142] Prior to implantation, the prosthetic valve is partially folded, and stacked annuloplasty rings (e.g., two concentrically stacked annuloplasty rings) are attached to the outer periphery of the prosthetic valve by sutures. Each stacked annuloplasty ring has a plastic cable tie tightened around the annuloplasty ring body. The stack of annuloplasty rings is attached to the prosthetic valve such that the head of the cable tie is positioned between the outer skirt of the prosthetic valve and the annuloplasty ring body. In other words, the head of the cable tie acts to separate the annuloplasty ring body away from the prosthetic valve, thereby defining an axially extending channel on both sides of the cable tie head between the outer skirt and the annuloplasty ring to induce paravalvular leakage through the prosthetic valve. For a control prosthetic valve without an outer skirt, the head of the cable tie separates the annuloplasty ring away from the outer surface of the prosthetic valve frame.

[0143] A prosthetic valve is surgically implanted. While the patient is heparinized, echocardiography and / or angiography are used to determine the baseline amount of paravalvular leakage through the space between the prosthetic valve frame and the stack of annuloplasty rings. Heparinization is then reversed (e.g., by administration of protamine sulfate), and paravalvular leakage is assessed using echocardiography and angiography over a period of 5 to 30 minutes. The prosthetic valve is then surgically removed.

[0144] For the first prosthetic valve with a skirt having a yarn density of 300 threads per inch, no paravalvular leakage was observed before or after heparin reversal. After the explant (implantation), the space between the outer skirt and the attached annuloplasty ring became completely sealed by thrombosis, and the head of the suture band became at least partially wrapped by one or more thrombi.

[0145] For the second prosthetic valve with a skirt having a yarn density of 150 yarns per inch, a paravalvular leak of grade 2+ was observed by echocardiography and grade 1+ was observed by angiography before heparin reversal. As used herein, references to "paravalvular leak" or "regurgitation" in grades such as 1+, 2+, 3+, or 4+ refer to the echocardiographic grading guidelines provided by the American Society of Echocardiography, which utilize assessment techniques including echocardiography, angiography, color flow Doppler, and fluorescence imaging. (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). Paravalvular leak was not detected by echocardiography or angiography after heparin reversal. Following explantation (implantation), the space between the outer skirt and the attached annuloplasty ring became completely sealed by thrombosis, and the head of the suture band was at least partially wrapped by one or more thrombi.

[0146] For the first and second prosthetic valves, which include a tasseled skirt, the immediate and dramatic reduction in paravalvular leakage can be attributed to the interaction between blood and the yarn filaments. The sustained, gradual reduction in paravalvular leakage observed in the second prosthetic valve after heparin reversal can be attributed to a sustained biological response at the cellular level leading to thrombus formation and sealing. For the first prosthetic valve with a yarn density of 300 filaments per inch, sealing of the space between the frame and the annuloplasty ring occurs almost immediately. For the second prosthetic valve with a yarn density of 150 filaments per inch, complete closure or sealing of the space between the frame and the annuloplasty ring (e.g., no detectable paravalvular leakage) takes 5 to 30 minutes.

[0147] For control prosthetic valves without an outer skirt, paravalvular leaks of grade 2+ or higher were observed under heparinization. Paravalvular leaks of grade 2+ to 3+ were observed on angiography after heparin reversal. Following explantation (implantation), the space between the annuloplasty ring and the prosthetic valve frame was completely open or exposed, and no known biological seal occurred.

[0148] General Precautions

[0149] Any sealing element implementation disclosed herein can be used in combination with any prosthetic heart valve and / or frame implementation disclosed herein. Prosthetic heart valves can also include any sealing element or portion thereof described herein in any combination.

[0150] For descriptive purposes, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The methods, apparatus, and systems of this disclosure should not be construed as limiting in any way. Instead, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments—individually and in various combinations and sub-combinations of each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and embodiments of this disclosure do not require the presence of any one or more specific advantages or problems to be solved.

[0151] Although some embodiments of this disclosure are described in a specific ordered order for ease of illustration, it should be understood that this descriptive style includes rearrangement unless a specific order is required by the specific language described below. For example, operations described in sequence may be rearranged or performed simultaneously in certain circumstances. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the methods of this disclosure can be combined with other methods. Additionally, the description sometimes uses terms such as “provide” or “implement” to describe the methods of this disclosure. These terms are highly abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily identified by those skilled in the art.

[0152] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise. Additionally, the term “comprising” means “including.” Furthermore, the terms “connected” and “associated” generally refer to an electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) connection or link, and do not exclude the presence of intermediate elements between connected or associated items—unless specifically stated otherwise.

[0153] In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, in some configurations, the lower end of the valve is its inflow end, and the upper end of the valve is its outflow end.

[0154] As used herein, the term "proximal" refers to the location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending along the proximal and distal directions, respectively.

[0155] Unless otherwise stated, all numerical values ​​used in the specification or claims indicating component quantities, molecular weights, percentages, temperatures, times, etc., should be understood to be modified by the term "about". Therefore, unless otherwise indicated—implied or implied—the numerical parameters are approximate values ​​that may depend on the desired properties sought and / or the detection limits under test conditions / methods well known to those skilled in the art. When embodiments are directly and explicitly distinguished from the prior art discussed, the numerical values ​​of the embodiments are not approximate values ​​unless the word "about" is used. Furthermore, not all alternatives described herein are equivalent.

[0156] In some embodiments, the value, program, or device may be referred to as “lowest,” “best,” “minimum,” etc. It should be understood that such descriptions are intended to indicate that a choice can be made among a variety of alternatives, and that such choice is not necessarily superior to, less than, or otherwise preferred over other choices.

[0157] In descriptions, certain terms may be used, such as "upper," "lower," "upper part," "lower part," "horizontal," "vertical," "left," "right," etc. These terms are used, where applicable, to provide clarity in dealing with relative relationships. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, simply by flipping the object over, the "upper" surface can become the "lower" surface. Nevertheless, it remains the same object.

[0158] Given that the principles of this disclosure can be applied to a variety of possible implementations, it should be understood that the exemplary implementations are merely preferred examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is at least as broad as the appended claims.

Claims

1. An implantable prosthetic valve that is radially crimpable to a crimped configuration and radially expandable to an expanded configuration, the prosthetic valve comprising: an annular frame having an inflow end, an outflow end, and a longitudinal axis; a leaflet structure positioned within and secured to the frame; and a sealing element secured to the frame, the sealing element comprising: a first braided portion extending circumferentially around the frame, the first braided portion comprising a plurality of interwoven filaments; a second braided portion extending circumferentially around the frame and spaced from the first braided portion along the longitudinal axis of the frame; wherein at least portions of the filaments exit the braid of the first braided portion and form loops, the loops extending radially outward from the frame and curvilinearly along the longitudinal axis of the frame to the second braided portion, and wherein the loops form a partially open curve.

2. The prosthetic valve of claim 1, wherein: the first braided portion comprises a first row of loops; and the second braided portion comprises a second row of loops spaced downstream from the first row of loops.

3. The prosthetic valve of claim 2, wherein: the plurality of interwoven filaments of the first braided portion further comprise at least one first filament interwoven with a plurality of second filaments; and portions of the at least one first filament form the loops of the first braided portion.

4. The prosthetic valve of claim 3, wherein the second filaments are warp yarns and the at least one first filament is a weft yarn.

5. The prosthetic valve of claim 4, wherein at least one of the warp yarns and weft yarns comprises a textured yarn.

6. The prosthetic valve of claim 4, wherein the warp yarns and weft yarns comprise fibers having a diameter of 1 pm to 20 pm to promote thrombosis around the sealing element.

7. The prosthetic valve of claim 1, wherein the filaments forming the loops exit the braid of the first braided portion and are incorporated into the braid of the second braided portion such that the loops form a floating portion between the first and second braided portions.

8. The prosthetic valve of claim 7, wherein the floating portion comprises a first layer of loops and a second layer of loops radially outward of the first layer of loops.

9. The prosthetic valve of claim 8, wherein: the sealing element comprises a first fabric band, a second fabric band, and a third fabric band; a plurality of the filaments forming the loops extend between the first fabric band and the second fabric band; a plurality of the filaments forming the loops extend between the second fabric band and the third fabric band; and ​ The sealing element is folded about the second fabric band such that the first fabric band and the third fabric band are adjacent to one another to form the first braided portion, the filaments extending between the first fabric band and the second fabric band form the first layer of loops, and the filaments extending between the second fabric band and the third fabric band form the second layer of loops.

10. The prosthetic valve of claim 1, wherein the sealing element is secured to the frame such that the filaments of the braided body exiting the first braided portion form the loops when the frame is in the expanded configuration and are straightened when the frame is in the crimped configuration.

11. The prosthetic valve of claim 1, wherein the filaments forming the loops are oriented along the longitudinal axis of the frame.

12. The prosthetic valve of claim 7, wherein a thickness of the float portion is configured to decrease as a width of the float portion increases.

13. The prosthetic valve of claim 7, wherein the float portion comprises yarns extending along only one axis between corresponding second braided portions spaced from one another along a y-axis.

14. The prosthetic valve of claim 1, wherein the second braided portions comprise a leno weave pattern.

15. A sealing element for a prosthetic heart valve, comprising: at least one weft yarn braided with a first plurality of warp yarns to form a first braided portion, the at least one weft yarn withdrawn from the braided body of the first braided portion, and the at least one weft yarn looped about a removable warp yarn to form a first plurality of loops, wherein the first plurality of loops are shaped such that the first plurality of loops extend outwardly from the sealing element.

16. The sealing element of claim 15, wherein the first plurality of loops extend from and return to a first braided portion of the sealing element comprising the first plurality of warp yarns.

17. The sealing element of claim 15, wherein the at least one weft yarn is a textured yarn.

18. The sealing element of claim 17, wherein the textured yarn comprises a plurality of fibers having a diameter of 1 μm to 20 μm.

19. A prosthetic heart valve, comprising: a ring-shaped frame having an inflow end, an outflow end, and a longitudinal axis; a leaflet structure positioned within and secured to the frame; and a sealing element according to claim 15 disposed circumferentially about and secured to the frame.

20. The prosthetic heart valve of claim 19, wherein the sealing element comprises a plurality of circumferentially extending rows of loops, the rows of loops spaced along the longitudinal axis of the frame.

21. The prosthetic heart valve of claim 20, wherein the sealing element comprises a first braided portion and a second braided portion spaced apart from the first braided portion along the longitudinal axis of the prosthetic heart valve, and the second braided portion comprises a second plurality of loops that are shaped such that the second plurality of loops extend outwardly from the sealing element.

22. The prosthetic heart valve of claim 21, wherein the second plurality of loops extend from and return to the second braided portion.

23. The prosthetic heart valve of claim 21, wherein the second plurality of loops of the second braided portion are circumferentially offset relative to the first plurality of loops of the first braided portion.

24. The prosthetic heart valve of claim 21, wherein the sealing element further comprises a half-braided portion disposed between the first braided portion and the second braided portion, wherein the at least one weft yarn does not interweave with the warp yarns of the half-braided portion at loop positions of the first plurality of loops.

25. A method of manufacturing a sealing element of a prosthetic heart valve, comprising: braiding at least one weft yarn with a first plurality of warp yarns to form a first braided portion, withdrawing the at least one weft yarn from the braided body of the first braided portion, and looping the at least one weft yarn around a removable warp yarn to form a first plurality of loops; and shape setting the first plurality of loops such that the first plurality of loops extend outwardly from the sealing element.

26. The method of claim 25, further comprising braiding the at least one weft yarn with the first plurality of warp yarns to form a first braided portion, and such that the first plurality of loops extend from and return to the first braided portion.

27. The method of claim 26, further comprising braiding the at least one weft yarn with a second plurality of warp yarns to form a second braided portion spaced apart from the first braided portion, the second braided portion comprising a second plurality of loops.

28. The method of claim 27, wherein the second plurality of loops are formed from the at least one weft yarn and extend from and return to the second braided portion.

29. The method of claim 27, wherein: the first plurality of warp yarns extend along a first axis; the at least one weft yarn extends along a second axis perpendicular to the first axis; and the second plurality of loops of the second braided portion are offset relative to the first plurality of loops of the first braided portion along the first axis.

30. The method of claim 27, further comprising: looping the at least one weft yarn around a removable warp yarn spaced apart from the first braided portion, the at least one weft yarn looped around the removable warp yarn such that the at least one weft yarn extends over and does not interweave with warp yarns between the first braided portion and the removable warp yarn; and ​ reintegrating the at least one weft yarn into the weave of the first knitted portion such that the at least one weft yarn forms a loop that extends from the first knitted portion and back to the first knitted portion.

31. The method of claim 30, further comprising removing the removable warp yarn from the sealing element to release a loop of the first plurality of loops.

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