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WO2025170971A1 - Dispositifs médicaux implantables - Google Patents

Dispositifs médicaux implantables

Info

Publication number
WO2025170971A1
WO2025170971A1 PCT/US2025/014546 US2025014546W WO2025170971A1 WO 2025170971 A1 WO2025170971 A1 WO 2025170971A1 US 2025014546 W US2025014546 W US 2025014546W WO 2025170971 A1 WO2025170971 A1 WO 2025170971A1
Authority
WO
WIPO (PCT)
Prior art keywords
yarn
deniers
article
pile
yarns
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/014546
Other languages
English (en)
Inventor
Sandip Vasant PAWAR
Gillian Irene ARMSTRONG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025170971A1 publication Critical patent/WO2025170971A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/02—Pile fabrics or articles having similar surface features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene

Definitions

  • a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For instance, U.S. Pat.
  • TSVs collapsible transcatheter heart valves
  • Coupled generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items.
  • fiber includes fibers of extreme or indefinite length (i.e., filaments) and fibers of short length (i.e., staple fibers). It is also understood that the terms fiber and filament can be used interchangeably.
  • various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention.
  • a description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range.
  • a description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any whole and partial increments therebetween. This applies regardless of the breadth of the range.
  • the specific values are disclosed between two end values, it is understood that these end values can also be included.
  • any ranges can be formed between any exemplary values within the broadest range.
  • a weight percent (wt. %) of a component is based on the total weight of the formulation or composition in which the component is included.
  • proximal refers to a position, direction, or portion of a component that is closer to the user and/or a handle of the delivery apparatus that is outside the patient
  • distal refers to a position, direction, or portion of a component that is further away from the user/or the handle of the delivery apparatus and close to the implantation site.
  • longitudinal refers to an axis extending the proximal and distal directions unless otherwise expressly defined.
  • the term “substantially” can, in some aspects, refer to at least about at least about 90 %, at least about 91 %, at least about 92 %, at least about 93 %, at least about 94 %, at least about 95 %, at least about 96 %, at least about 97 %, at least about 98 %, at least about 99 %, or about 100 % of the stated property, component, composition, or other condition for which substantially is used to characterize or otherwise quantify an amount.
  • the term “substantially free,” when used in the context of a composition or component of a composition that is substantially absent, is intended to indicate that the recited component is not intentionally batched and added to the composition, but can be present as an impurity along with other components being added to the composition.
  • the term “substantially free,” is intended to refer to trace amounts that can be present in the batched components, for example, it can be present in an amount that is less than about 1 % by weight, e.g., less than about 0.5 % by weight, less than about 0.1 % by weight, less than about 0.05 % by weight, or less than about 0.01 % by weight of the stated material, based on the total weight of the composition.
  • the term “substantially free,” when used in the context of the presence of a disclosed component, is to indicate that the recited component is not intentionally present.
  • the term “substantially,” in, for example, the context “substantially identical” or “substantially similar” refers to a method or a system, or a component that is at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% by similar to the method, system, or the component it is compared to.
  • the attached figures may not show the various ways (readily discernable, based on this disclosure, by one of ordinary skill in the art) in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses. Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed method. These terms are high-level abstractions of the actual operations that can be performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are, based on this disclosure, readily discernible by one of ordinary skill in the art.
  • ARTICLE Described herein are various articles comprising knitted fabrics. Still further described herein are knitted fabrics that can be used as coverings and/or sealing members in implantable devices such as prosthetic heart valves and so on. Also disclosed herein are members of making such articles and knitted fabrics.
  • an article comprising: a knitted fabric having a first dimension defined by a first edge and a second edge and a second dimension, which is perpendicular to the first dimension and defined by a third edge and a fourth edge.
  • the knitted fabric disclosed herein can comprise a mesh layer and a pile layer.
  • the pile layer can comprise a plurality of pile yarns extending outwardly from at least a portion of an outer surface of the mesh layer.
  • an inner surface of the mesh layer can be substantially free of the pile yarns.
  • the mesh layer at at least one of the first edge and the second edge of the knitted fabric comprises a first edge portion and/or a second edge portion that is substantially free of the pile yarn.
  • the first edge portion and/or the second edge portion can comprise a first inlaid yarn inserted into the mesh layer along the second dimension of the knitted fabric.
  • the disclosed herein article and, more particularly, the disclosed herein knitted fabric can be an outer sealing member in an implantable medical device. In certain exemplary aspects, and as discussed in detail below, when the disclosed article is the outer sealing member, such a member can be positioned on an annular frame of the implantable medical device.
  • the disclosed prosthetic valves can also be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve).
  • the prosthetic valve 10 can have four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18.
  • the prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19.
  • the inner skirt 16 can be arranged on and/or coupled to an inner surface of frame 12, while the outer skirt 18 can be arranged on and/or coupled to an outer surface of frame 12.
  • the outer skirt 18 can be formed from the disclosed herein knitted fabric.
  • the valvular structure 14 can comprise three leaflets 40 (as shown, for example, in FIG.10), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although, in other aspects, there can be greater or fewer number of leaflets (e.g., one or more leaflets 40).
  • the leaflets 40 can be secured to one another at their adjacent sides to form commissures 124 of the leaflet structure 14.
  • the lower edge of valvular structure 14 can have an undulating, curved, scalloped shape and can be secured to the inner skirt 16 by sutures (not shown).
  • the leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Pat.
  • a plurality of flexible connectors 124 can be used to interconnect pairs 116 of adjacent sides of the leaflets and to mount the leaflets to the commissure window frame portions 30 (FIG. 5).
  • FIG.9 shows the adjacent sides of two leaflets 40 interconnected by a flexible connector 124.
  • Three leaflets 40 can be secured to each other side-to-side using three flexible connectors 124, as shown in FIG.10. Additional information regarding connecting the leaflets to each other, as well as connecting the leaflets to the frame, can be found, for example, in U.S. Patent Application Publication No.2012/0123529, which is incorporated by reference herein in its entirety.
  • the bare frame 12 is shown in FIG.4.
  • Frame 12 can be formed with a plurality of circumferentially spaced slots or commissure windows, 20 (three are shown in the illustrated and unlimiting aspect) that are adapted to mount the commissures of the valvular structure 14 to the frame, as described in greater detail below.
  • the frame 12 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self- expanding materials (e.g., nickel titanium alloy (NiTi), such as nitinol) known in the art.
  • NiTi nickel titanium alloy
  • frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded at the implantation site by an inflatable balloon or equivalent expansion mechanism.
  • frame 12 When constructed of a self-expandable material, frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.
  • Suitable plastically-expandable materials that can be used to form the frame 12 include, without limitation, stainless steel, biocompatible, high-strength alloys (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloys), polymers, or combinations thereof.
  • frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pa.), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02).
  • MP35N® alloy/UNS R30035 alloy comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that the use of MP35N® alloy to form frame 12 provides superior structural results over stainless steel. In particular, when MP35N® alloy is used as the frame material, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistance, and corrosion resistance.
  • frame 12 in the illustrated aspect comprises a first, lower row I of angled struts 22 arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending angled struts 24; a third row III of circumferentially extending, angled struts 26; a fourth row IV of circumferentially extending angled struts 28; and a fifth row V of circumferentially extending, angled struts 32 at the outflow end of the frame.
  • a plurality of substantially straight axially extending struts 34 can be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II.
  • the fifth row V of angled struts 32 is connected to the fourth row IV of angled struts 28 by a plurality of axially extending window frame portions 30 (which define the commissure windows 20) and a plurality of axially extending struts 31.
  • Each axial strut 31 and each frame portion 30 extends from a location defined by the convergence of the lower ends of two angled struts 32 to another location defined by the convergence of the upper ends of two angled struts 28.
  • FIGS.6, 7, 8, 9, and 10 are enlarged views of the portions of frame 12 identified by letters A, B, C, D, and E, respectively, in FIG. 5.
  • Each commissure window frame portion 30 mounts a respective commissure of the leaflet structure 14.
  • each frame portion 30 is secured at its upper and lower ends to the adjacent rows of struts to provide a robust configuration that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to known, cantilevered struts for supporting the commissures of the leaflet structure. This configuration enables a reduction in the frame wall thickness to achieve a smaller crimped diameter of the prosthetic valve.
  • the thickness T of frame 12 (FIG.4) measured between the inner diameter and outer diameter ranges from 0.40 mm to 0.50 mm. In certain aspects, the thickness T of frame 12 (FIG.4) measured between the inner diameter and outer diameter is about 0.48 mm or less.
  • the struts and frame portions of the frame collectively define a plurality of open cells of the frame. At the inflow end of frame 12, struts 22, struts 24, and struts 34 define a lower row of cells defining openings 36. The second, third, and fourth rows of struts 24, 26, and 28 define two intermediate rows of cells defining openings 38.
  • the fourth and fifth rows of struts 28 and 32, along with frame portions 30 and struts 31, define an upper row of cells defining openings 41.
  • the openings 41 are relatively large and are sized to allow portions of the leaflet structure 14 to protrude, or bulge, into and/or through the openings 41 when the frame 12 is crimped in order to minimize the crimping profile.
  • the lower end of the strut 31 is connected to two struts 28 at a node or junction 44, and the upper end of the strut 31 is connected to two struts 32 at a node or junction 46.
  • the strut 31 can have a thickness S 1 that is less than the thicknesses S 2 of the junctions 44 and 46.
  • junctions 4446 prevent full closure of openings 41.
  • FIG.5 The geometry of the struts 31, and junctions 44, and 46, assists in creating enough space in openings 41 in the collapsed configuration to allow portions of the prosthetic leaflets to protrude or bulge outwardly through openings. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if all of the leaflet material were constrained within the crimped frame.
  • Frame 12 is configured to reduce, prevent, or minimize possible over-expansion of the prosthetic valve at a predetermined balloon pressure, especially at the outflow end portion of the frame, which supports the leaflet structure 14.
  • the frame is configured to have relatively larger angles 42a, 42b, 42c, 42d, 42e between struts, as shown in FIG.5.
  • the angles between the struts of the frame can be selected to limit the radial expansion of the frame at a given opening pressure (e.g., inflation pressure of the balloon).
  • these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more particularly, these angles are up to about 120 degrees when the frame is expanded to its functional size.
  • the inflow 15 and outflow 19 end portions of a frame generally tend to over-expand more so than the middle portion of the frame due to the “dog-boning” effect of the balloon used to expand the prosthetic valve.
  • the leaflet structure desirably is secured to the frame 12 below the upper row of struts 32.
  • the leaflet structure is positioned at a level below where over-expansion is likely to occur, thereby protecting the leaflet structure from over-expansion.
  • the outflow end of the frame 12 rather than the leaflets 40 is the proximal-most component of the prosthetic valve 10.
  • the delivery catheter includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve, the pushing mechanism or stop member contacts the outflow end of the frame, and not leaflets 40, so as to avoid damage to the leaflets.
  • the openings 36 of the lowermost row of openings in the frame are relatively larger than the openings 38 of the two intermediate rows of openings.
  • frame 12 when crimped, to assume an overall tapered shape that tapers from a maximum diameter at the outflow end of the prosthetic valve to a minimum diameter at the inflow end of the prosthetic valve.
  • frame 12 has a reduced diameter region extending along a portion of the frame adjacent the inflow end of the frame that generally corresponds to the region of the frame covered by the outer skirt 18.
  • the reduced diameter region is reduced compared to the diameter of the upper portion of the frame (which is not covered by the outer skirt) such that the outer skirt 18 does not increase the overall crimp profile of the prosthetic valve.
  • the frame can expand to the generally cylindrical shape shown in FIG.4.
  • the frame of a 26-mm prosthetic valve when crimped, had a first diameter of 14 French at the outflow end of the prosthetic valve and a second diameter of 12 French at the inflow end of the prosthetic valve.
  • the prosthetic valve Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.
  • the exemplary valve 100 as shown in FIG.1, can optionally include an inner skirt 16.
  • the main functions of the inner skirt 16 are to assist in securing the valvular structure 14 to the frame 12 and to assist in forming a good seal between the prosthetic valve and the native annulus by blocking the flow of blood through the open cells of the frame 12 below the lower edge of the leaflets.
  • the inner skirt 16 desirably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), although various other synthetic materials or natural materials (e.g., pericardial tissue) can be used.
  • PET polyethylene terephthalate
  • the thickness of the skirt is desirably less than about 0.15 mm (about 6 mil), and desirably less than about 0.10 mm (about 4 mil), and even more desirably about 0.05 mm (about 2 mil).
  • inner skirt 16 can have a variable thickness, for example, the skirt can be thicker at at least one of its edges than at its center.
  • inner skirt 16 can comprise a PET skirt having a thickness of about 0.07 mm at its edges and about 0.06 mm at its center. The thinner skirt can provide for better crimping performances while still providing good perivalvular sealing.
  • the inner skirt can be secured to the frame with the sutures (not shown).
  • Valvular structure 14 can be attached to the skirt via one or more reinforcing strips (not shown) (which collectively can form a sleeve), for example, thin, PET reinforcing strips, discussed below, which enable a secure suturing and protect the pericardial tissue of the leaflet structure from tears. Valvular structure 14 can be sandwiched between skirt 16 and the thin PET strips.
  • the fabric of the inner skirts can comprise a weave of warp and weft fibers that extend perpendicularly to each other and, with one set of fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which the fabric of the inner skirt is secured is radially compressed, the overall axial length of the frame increases.
  • the exemplary inner skirt 16 as disclosed herein can be woven from a first set of fibers, or yarns or strands, 78 and a second set of fibers, or yarns or strands, 80, both of which are non-perpendicular to the upper edge 82 and the lower edge 84 of the skirt.
  • the first set of fibers 78 and the second set of fibers 80 extend at angles of about 45 degrees relative to the upper and lower edges 82, 84.
  • the first set of fibers 78 and the second set of fibers 80 extend at angles other than about 45 degrees relative to the upper and lower edges 82, 84, e.g., at angles of 15 and 75 degrees, respectively, or 30 and 60 degrees, respectively, relative to the upper and lower edges 82, 84.
  • the inner skirt 16 can be formed by weaving the fibers at 45 degree angles relative to the upper and lower edges of the fabric.
  • the inner skirt 16 can be diagonally cut (cut on a bias) from a vertically woven fabric (where the fibers extend perpendicularly to the edges of the material) such that the fibers extend at 45-degree angles relative to the cut upper and lower edges of the skirt.
  • the opposing short edges 86, 88 of the inner skirt can be, for example, non-perpendicular to the upper and lower edges 82, 84.
  • the short edges 86, 88 can extend at angles of about 45 degrees relative to the upper and lower edges and, therefore, are aligned with the first set of fibers 78. Therefore, the overall general shape of the inner skirt is that of a rhomboid or parallelogram. Without wishing to be bound by any theory, it is noted that the 45 degree angle orientation can provide dimensional compliance to a rigid woven cloth as the inner skirt sees dimensional changes during crimping and expansion.
  • the opposing short edge portions 90 and 92 are sewn together to form the annular shape of the skirt.
  • the edge portion 90 can be placed in an overlapping relationship relative to the opposite edge portion 92, and the two edge portions can be sewn together with a diagonally extending suture line that is parallel to short edges 86, 88.
  • the upper edge portion of the inner skirt 16 can be formed with a plurality of projections 96 that define an undulating shape that generally follows the shape or contour of the fourth row of struts 28 immediately adjacent the lower ends of axial struts 31.
  • the inner skirt 16 can also be formed with slits 98 to facilitate attachment of the skirt to the frame.
  • each cell of the metal frame in the illustrated aspect includes at least four angled struts that rotate towards the axial direction on crimping (e.g., the angled struts become more aligned with the length of the frame).
  • the angled struts of each cell function as a mechanism for rotating the fibers of the skirt in the same direction as the struts, allowing the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.
  • the spacing between the woven fibers or yarns can be increased to facilitate the elongation of the skirt in the axial direction.
  • the yarn density can be about 15% to about 30% lower than in a typical PET skirt.
  • the yarn spacing of the inner skirt 16 can be from about 60 yarns per cm (about 155 yarns per inch) to about 70 yarns per cm (about 180 yarns per inch), such as about 63 yarns per cm (about 160 yarns per inch), whereas in a typical PET skirt the yarn spacing can be from about 85 yarns per cm (about 217 yarns per inch) to about 97 yarns per cm (about 247 yarns per inch).
  • the inner skirt can be formed from woven elastic fibers that can stretch in the axial direction during the crimping of the prosthetic valve.
  • the warp and weft fibers can run perpendicularly and parallel to the upper and lower edges of the skirt, or alternatively, they can extend at angles between 0 and 90 degrees relative to the upper and lower edges of the skirt, as described above.
  • the inner skirt 16 can be used to assist in suturing the leaflet structure 14 to the frame.
  • the inner skirt 16 can have an undulating temporary marking suture to guide the attachment of the lower edges of each leaflet 40.
  • the inner skirt 16 itself can be sutured to the struts of frame 12 using sutures, as noted above, before securing the leaflet structure 14 to the skirt 16.
  • the struts that intersect the marking suture desirably are not attached to the inner skirt 16. This allows the inner skirt 16 to be more pliable in the areas not secured to the frame and minimizes stress concentrations along the suture line that secures the lower edges of the leaflets to the skirt.
  • the fibers 78, 80 of the skirt generally align with the angled struts of the frame to promote uniform crimping and expansion of the frame.
  • these portions can be comprised of only mesh layer of the skirt.
  • the lower, second fold 123 may be longer, in the axial direction, than the upper, first fold 121.
  • this exemplary configuration can help to reduce the crimp profile and overall bulkiness of the valve 100 at the inflow end 66.
  • the skirt can be attached to the struts 72 of the valve 100 with the stitches 146.
  • the outflow end of the valve is shown as 68.
  • An exemplary knitted fabric 110 having a first dimension 120, of the present disclosure, that can serve as an outer sealing member 102 before it is positioned on the valve 100 is shown in FIG.3.
  • the one or more weft yarns can form a plurality of courses extending along the first dimension of the knitted fabric. While in other aspects, the at least one warp yarn is configured to form a plurality of warp loops that connect each course of the plurality of courses to an adjacent course along the second dimension of the knitted fabric, thus forming a plurality of wales.
  • FIG.13 The schematic view of a middle portion (not a portion that is adjacent to the first, second, third or fourth edges of the fabric) of an exemplary fabric structure 110 is shown in FIG.13. Specifically, FIG.13 shows a schematic of the different yarn components that are knit together to form the pile layer 150 and the mesh layer 152 of the knitted fabric 110.
  • the pile layer extends outwardly from the at least a portion of the outer surface of the mesh layer, such that the inner surface of the mesh layer remains substantially free of the pile yarn.
  • the exemplary pile layer of the disclosed herein knitted fabric is shown in FIG.15A, while the inner surface of the mesh layer is shown in FIG.15B.
  • the knitted fabric 110 can be crochet knitted and/or warp- knitted fabric and/or weft-knit fabric.
  • the one or more weft yarns can form the plurality of courses that run in a course direction 170 (along the first direction).
  • the at least one warp yarn can form the plurality of wales running in the wale direction 172 (along the second direction).
  • FIG.13 shows a portion of the fabric 110 in an orientation, as it is knit (e.g., constructed), while FIGS.15A and 15B show a portion of the fabric 110 in the orientation in which it is arranged in the article.
  • the course direction is substantially parallel with the central longitudinal axis 108 of the valve (as shown in FIG.2).
  • the fabric can be constructed from different yarns. These different yarns can have different deniers, filament counts, physical properties, different textures, and the like.
  • the one or more weft yarns can comprise a first weft yarn and a second weft yarn.
  • the mesh layer can have different wales and course densities.
  • the wales density is about 10 to about 50 wales per inch, including exemplary values of about 12 wales per inch, about 14 wales per inch, about 16 wales per inch, about 18 wales per inch, about 20 wales per inch, about 22 wales per inch, about 24 wales per inch, about 26 wales per inch, about 28 wales per inch, about 30 wales per inch, about 32 wales per inch, about 34 wales per inch, about 36 wales per inch, about 38 wales per inch, about 40 wales per inch, about 42 wales per inch, about 44 wales per inch, about 46 wales per inch, and about 48 wales per inch.
  • the wales density can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the wales density can be about 12 wales per inch to about 44 wales per inch, or about 16 wales per inch to about 24 wales per inch, or about 14 wales per inch to about 42 wales per inch, or about 16 wales per inch to about 32 wales per inch and so on.
  • ranges can also be formed within the range, for example, if a range of about 14 wales per inch to about 42 wales per inch is disclosed, this range also includes about 14 wales per inch to about 38 wales per inch, or about 14 wales per inch to about 32 wales per inch or about 16 wales per inch to about 40 wales per inch or about 18 wales per inch to about 28 wales per inch, or and so on.
  • the mesh layer can have a course density from about 25 courses per inch to about 85 courses per inch, including exemplary values of about 30 courses per inch, about 35 courses per inch, about 40 courses per inch, about 45 courses per inch, about 50 courses per inch, about 55 courses per inch, about 60 courses per inch, about 65 courses per inch, about 70 courses per inch, about 75 courses per inch, and about 80 courses per inch.
  • the course density can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the course density can be about 25 courses per inch to about 80 courses per inch, or about 30 courses per inch to about 70 courses per inch, or about 35 courses per inch to about 65 courses per inch, or about 40 courses per inch to about 50 courses per inch, or about 25 courses per inch to about 50 courses per inch, or about 30 courses per inch to about 40 courses per inch, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 25 courses per inch to about 70 courses per inch is disclosed, this range also includes about 30 courses per inch to about 50 courses per inch, or about 30 courses per inch to about 40 courses per inch or about 40 courses per inch to about 65 courses per inch, or and so on.
  • the one or more weft yarns can comprise the same yarns or different yarns. In some aspects, the one or more weft yarns can comprise a twisted yarn, a flat yarn, a textured yarn, or any combination thereof. [0101] In some aspects, for example, and without limitations, the first weft yarn can comprise a twisted yarn, a flat yarn, or a combination thereof. In certain aspects, the first weft yarn 164 is shown in FIG.13.
  • the twisted yarn and/flat yarn can have a size of about 10 deniers to about 40 deniers, including about 12 deniers, about 14 deniers, about 16 deniers, about 18 deniers, about 20 deniers, about 22 deniers, about 24 deniers, about 26 deniers, about 28 deniers, about 30 deniers, about 32 deniers, about 34 deniers, about 36 deniers, and about 38 deniers.
  • the first weft yarn can have a size that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the first weft yarn can be about 10 deniers to about 38 deniers, or about 12 deniers to about 36 deniers, or about 12 deniers to about 34 deniers, or about 12 deniers to about 30 deniers, or about 12 deniers to about 26 deniers, or about 12 deniers to about 20 deniers, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 12 deniers per inch to about 36 deniers is disclosed, this range also includes about 12 deniers to 34 about deniers, or about 16 deniers to about 27 deniers or about 19 deniers to about 33 deniers, or and so on.
  • the second weft yarns can be the same or different from the first weft yarn 164.
  • the second weft yarn can comprise a textured yarn.
  • the textured yarn has a size of about 20 deniers to about 160 deniers, including exemplary values of 22 deniers, about 25 deniers, about 28 deniers, about 30 deniers, about 32 deniers, about 35 deniers, about 38 deniers, about 40 deniers, about 42 deniers, about 45 deniers, about 48 deniers, about 50 deniers, about 52 deniers, about 55 deniers, about 58 deniers, about 60 deniers, about 62 deniers, about 65 deniers, about 68 deniers, about 70 deniers, about 72 deniers, about 75 deniers, about 78 deniers, about 80 deniers, about 82 deniers, about 85 deniers, about 88 deniers, about 90 deniers, about 92 deniers, about 95 deniers, about 98 deniers, about 100 den
  • the second weft yarn can have a size that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the second weft yarn can be about 20 deniers to about 155 deniers, or about 30 deniers to about 148 deniers, or about 40 deniers to about 140 deniers, or about 50 deniers to about 100 deniers, or about 50 deniers to about 78 deniers, or about 74 deniers to about 120 deniers, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 40 deniers to about 140 deniers is disclosed, this range also includes about 40 deniers to about 100 deniers or about 40 deniers to about 88 deniers or about 40 deniers to about 78 deniers, or and so on.
  • Such exemplary aspects are shown in FIG.13, wherein the flat yarn 164 (first weft yarn) is combined with the textured yarn 166 to form the plurality of courses. In such exemplary aspects, the textured yarn can fill gaps in the mesh layer.
  • the one or more yarns are monofilament and/or multifilament yarns.
  • first weft yam 164 can comprise a one or more filaments that extend through a central portion of each course 174 while the second weft yarn 166 can comprise one or more filaments that extend around or on the outsides of the strands/yarns of the first weft yarn 164.
  • the one or more yarns are multifilament yarns having a filament count of about 5 filaments up to about 200 filaments, including exemplary values, including exemplary values of about 10 filaments, about 25 filaments, 40 filaments, about 55 filaments, about 70 filaments, about 85 filaments, about 100 filaments, about 115 filaments, about 130 filaments, about 145 filaments, about 160 filaments, about 175 filaments, and about 190 filaments.
  • the number of filaments in the yarn can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the number of filaments can be about 10 filaments to about 155 filaments, or about 36 filaments to about 142 filaments, or about 44 filaments to about 105 filaments, and so on. It is further understood that the ranges can also be formed within the range, for example, if a range of about 10 filaments to about 155 filaments is disclosed, this range also includes about 20 filaments to about 155 filaments or about 32 filaments to about 150 filaments or about 36 filaments to about 144 filaments, or and so on. [0107] In still further aspects, the one or more weft yarns can comprise any materials suitable for the desired application.
  • the one or more weft yarns can comprise a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • the polyurethane can be a thermoplastic polyurethane.
  • the thermoplastic polyurethane can further comprise an amount of Si.
  • the addition of Si can change the hydrophilicity of the knitted fabric by making it more hydrophobic. It is also understood that the addition of Si can improve the elasticity of the fiber and its abrasion resistance.
  • the addition of Si can improve the biocompatibility of the TPUs with non-thrombogenic response for long-term implants.
  • the amount of Si can be of about 0.5 wt% to about 5 wt%, including exemplary values of about 1 wt%, about 1.5 wt%, about 2 wt%, about 2.5 wt%, about 3 wt%, about 3.5 wt%, about 4 wt%, and about 4.5 wt%.
  • the Si can be present in any amount that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the Si can be present in an amount of about 0.5 wt% to about 4.5 wt%, about 0.7 wt% to about 4.3 wt%, about 0.9 wt% to about 4.1 wt%, about 1.3 wt% to about 3.8 wt%, about 2.5 wt% to about 3.5 wt%, and so on.
  • ranges can also be formed within the range, for example, if a range of about 0.5 wt% to about 4.5 wt% is disclosed, this range also includes about 0.5 wt% to about 4.1 wt%, or about 0.6 wt% to about 3.9 wt%, or about 1.8 wt% to about 2.7 wt%, or and so on.
  • the yarn is comprised of polyester, any known in the art polyesters can be used.
  • the polyester can comprise a polyethylene terephthalate (PET), PCDT (poly-1, 4-cyclohexylene-dimethylene terephthalate), and PTT (polytrimethylene terephthalate), or any combination thereof.
  • PET polyethylene terephthalate
  • PCDT poly-1, 4-cyclohexylene-dimethylene terephthalate
  • PTT polytrimethylene terephthalate
  • the yarn is comprised of polyamide
  • the polyamide can comprise nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • the fluorinated polymers can comprise PTFE, ePTFE, or a combination thereof.
  • the one or more weft yarns can comprise a polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), Nylon, UHMWPE, PEEK, Liquid Crystalline Polymer, thermoplastic polyurethane (TPU), or a combination thereof. Still further, any other suitable natural or synthetic fibers or any combination thereof can be used.
  • the one or more weft yarns can also comprise a compound yarn.
  • the compound yarn can comprise a core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • the core yarn and the wrap yarn are the same or different and can be selected from any disclosed above polymeric materials.
  • at least one filament of the monofilament yarn and/or multifilament yarn of the one or more weft yarns can comprise a bi-component filament in a sheath-core configuration, side-by-side configuration, eccentric configuration, island-in-the- sea configuration, segmented-pie configuration, or any combination thereof.
  • each course 174 is connected to an adjacent course 174 by one warp loop 176 of a series of spaced apart warp loops in the course 174, each warp loop 176 in one course 174 being part of a different wale 178.
  • FIG.15B the longitudinal arrangement (relative to the central longitudinal axis of the frame of the valve) of the series of consecutive courses 174 are shown. Further, FIG.15B shows the horizontal (circumferential direction (second dimension) when arranged on the frame of the valve) arrangement of the series of spaced apart (e.g., spaced apart by a section of each course) wales 178.
  • the warp yarn 168 that forms the warp loops can be fully- drawn, or low or not twisted. In yet other aspects, any combinations of the disclosed herein or other known yarns can be utilized.
  • the warp yarn if it is twisted, it can be about 2 turns per inch to about 16 turns per inch, including exemplary values of about 4 turns per inch, about 6 turns per inch, about 8 turns per inch, about 10 turns per inch, about 12 turns per inch, and about 14 turns per inch.
  • the warp yarn can have any number of turns that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the yarn can have about 2 turns per inch to about 14 turns per inch, or about 4 turns per inch to about 12 turns per inch or about 3 turns per inch to about 15 turns per inch, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 2 turns per inch to about 15 turns per inch is disclosed, this range also includes about 3 turns per inch to about 14 turns per inch, or about 4 turns per inch to about 13 turns per inch, or about 5 turns per inch to about 15 turns per inch, or and so on.
  • the warp yarn can have a size of about 10 deniers to about 40 deniers, including about 12 deniers, about 14 deniers, about 16 deniers, about 18 deniers, about 20 deniers, about 22 deniers, about 24 deniers, about 26 deniers, about 28 deniers, about 30 deniers, about 32 deniers, about 34 deniers, about 36 deniers, and about 38 deniers.
  • the warp yarn can have a size that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the warp yarn can be about 10 deniers to about 38 deniers, or about 12 deniers to about 36 deniers, or about 12 deniers to about 34 deniers, or about 12 deniers to about 30 deniers, or about 12 deniers to about 26 deniers, or about 12 deniers to about 20 deniers, and so on.
  • the warp yarn has a filament count from about 6 to about 56 filaments, including exemplary values of about 8, about 10, about 12, about 14, about 16, about 18, about 20, about 22, about 24, about 26, about 28, about 30, about 32, about 34, about 36, about 38, about 40, about 42, about 44, about 46, about 48, about 50, about 52, and about 54 filaments.
  • the number of filaments in the warp yarn can fall within any two foregoing values or form any range within the broadest disclosed range or between any mentioned values.
  • the number of filaments can be about 6 filaments to about 55 filaments, or about 6 filaments to about 50 filaments, or about 10 filaments to about 40 filaments, and so on.
  • ranges can also be formed within the range, for example, if a range of about 6 filaments to about 56 filaments is disclosed, this range also includes about 7 filaments to about 53 filaments or about 12 filaments to about 30 filaments or about 16 filaments to about 20 filaments, or and so on.
  • the warp yarn can have tenacity from about 30 cN/tex to about 400 cN/tex, including exemplary values of about 32 cN/tex, about 35 cN/tex, about 38 cN/tex, about 40 cN/tex, about 42 cN/tex, about 45 cN/tex, about 48 cN/tex, about 50 cN/tex, about 52 cN/tex, about 55 cN/tex, about 58 cN/tex, about 60 cN/tex, about 62 cN/tex, about 65 cN/tex, about 68 cN/tex, about 70 cN/tex, about 72 cN/tex, about 75 cN/tex, about 80 cN/tex, d about 82 cN/tex, about 85 cN/tex, about 90 cN/tex, about 95 cN/tex, about 100 cN/tex, about 110 cN/tex, about 150 cN/tex,
  • the tenacity of the warp yarn can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the tenacity can be about 30 cN/tex to about 350 cN/tex, or about 50 cN/tex to about 300 cN/tex, or about 75 cN/tex to about 250 cN/tex, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 30 cN/tex to about 400 cN/tex is disclosed, this range also includes about 35 cN/tex to about 350 cN/tex, or about 40 cN/tex to about 300 cN/tex or about 65 cN/tex to about 254 cN/tex, or and so on.
  • the warp yarn can comprise any materials suitable for the desired application.
  • the warp yarn can comprise a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • the polyurethane can be a thermoplastic polyurethane.
  • the thermoplastic polyurethane can further comprise an amount of Si.
  • the addition of Si can change the hydrophilicity of the knitted fabric by making it more hydrophobic. It is also understood that the addition of Si can improve the elasticity of the fiber and its abrasion resistance.
  • the amount of Si can be of about 0.5 wt% to about 5 wt%, including exemplary values of about 1 wt%, about 1.5 wt%, about 2 wt%, about 2.5 wt%, about 3 wt%, about 3.5 wt%, about 4 wt%, and about 4.5 wt%.
  • the Si can be present in any amount that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the Si can be present in an amount of about 0.5 wt% to about 4.5 wt%, about 0.7 wt% to about 4.3 wt%, about 0.9 wt% to about 4.1 wt%, about 1.3 wt% to about 3.8 wt%, about 2.5 wt% to about 3.5 wt%, and so on.
  • the polyester can comprise a polyethylene terephthalate (PET), PCDT (poly-1, 4-cyclohexylene-dimethylene terephthalate), and PTT (polytrimethylene terephthalate), or any combination thereof.
  • PET polyethylene terephthalate
  • PCDT poly-1, 4-cyclohexylene-dimethylene terephthalate
  • PTT polytrimethylene terephthalate
  • the warp yarn is comprised of polyamide
  • the polyamide can comprise nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • the fluorinated polymers can comprise PTFE, ePTFE, or a combination thereof.
  • the core yarn and the wrap yarn are the same or different and can be selected from any disclosed above polymeric materials.
  • at least one filament of the monofilament yarn and/or multifilament yarn of the warp can comprise a bi-component filament in a sheath-core configuration, side-by-side configuration, eccentric configuration, island-in-the-sea configuration, segmented-pie configuration, or any combination thereof.
  • the knitted fabric comprises pile yarns. As shown in FIG.13, the knitted fabric 110 comprises the pile yams 154, which are incorporated into the mesh layer 152.
  • the pile yarns 154 are formed as one or more loops that extend from the first and second weft yarns 164 and 166 respectively of the mesh layer 152.
  • the pile yarns are arranged to form a looped pile or wherein the pile yarns are cut to form a cut pile.
  • the pile yarn can comprise a flat yarn or textured yarn.
  • the pile yarn can be a multifilament yarn, monofilament yarn, or a combination thereof.
  • the pile yarn has a size from about 20 deniers to about 200 deniers, including exemplary values of 22 deniers, about 25 deniers, about 28 deniers, about 30 deniers, about 32 deniers, about 35 deniers, about 38 deniers, about 40 deniers, about 42 deniers, about 45 deniers, about 48 deniers, about 50 deniers, about 52 deniers, about 55 deniers, about 58 deniers, about 60 deniers, about 62 deniers, about 65 deniers, about 68 deniers, about 70 deniers, about 72 deniers, about 75 deniers, about 78 deniers, about 80 deniers, about 82 deniers, about 85 deniers, about 88 deniers, about 90 deniers, about 92 deniers, about 95 deniers, about 98 deniers, about 100 deniers, about 102 deniers, about 105 deniers, about 108 deniers, about 110 deniers, about 112 deniers, about 115 deniers, about 118 deniers, about 120 deniers, about 122 deniers, about 125 deniers
  • the pile yarn can have a filament count from about 1 to about 200, including exemplary values of about 2 filaments, about 5 filaments, 10 filaments, about 25 filaments, 40 filaments, about 55 filaments, about 70 filaments, about 85 filaments, about 100 filaments, about 115 filaments, about 130 filaments, about 145 filaments, about 160 filaments, about 175 filaments, and about 190 filaments.
  • the number of filaments in the pile yarn can fall within any two foregoing values or form any range within the broadest disclosed range or between any mentioned values.
  • the pile yarn can comprise a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • the polyurethane can be a thermoplastic polyurethane.
  • the thermoplastic polyurethane can further comprise an amount of Si.
  • the addition of Si can change the hydrophilicity of the knitted fabric by making it more hydrophobic. It is also understood that the addition of Si can improve the elasticity of the fiber and its abrasion resistance.
  • the ranges can also be formed within the range, for example, if a range of about 0.5 wt% to about 4.5 wt% is disclosed, this range also includes about 0.5 wt% to about 4.1 wt%, or about 0.6 wt% to about 3.9 wt%, or about 1.8 wt% to about 2.7 wt%, or and so on.
  • the pile yarn is comprised of polyester, any known in the art polyesters can be used.
  • the polyester can comprise a polyethylene terephthalate (PET), PCDT (poly-1, 4-cyclohexylene-dimethylene terephthalate), and PTT (polytrimethylene terephthalate), or any combination thereof.
  • PET polyethylene terephthalate
  • PCDT poly-1, 4-cyclohexylene-dimethylene terephthalate
  • PTT polytrimethylene terephthalate
  • the pile yarn is comprised of polyamide
  • any known in the art polyamides can be used.
  • the polyamide can comprise nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • the fluorinated polymers can comprise PTFE, ePTFE, or a combination thereof.
  • the pile yarn can comprise a polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), Nylon, UHMWPE, PEEK, Liquid Crystalline Polymer, thermoplastic polyurethane (TPU), or a combination thereof. Still further, any other suitable natural or synthetic fibers or any combination thereof can be used.
  • the pile yarn can also comprise a compound yarn.
  • the compound yarn can comprise a core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • the core yarn and the wrap yarn are the same or different and can be selected from any disclosed above polymeric materials.
  • at least one filament of the monofilament yarn and/or multifilament yarn of the pile yarn can comprise a bi-component filament in a sheath-core configuration, side-by-side configuration, eccentric configuration, island-in-the-sea configuration, segmented-pie configuration, or any combination thereof.
  • a filament in the monofilament or multifilament pile yarn can have a size of about 6 microns to about 300 microns in diameter, including exemplary values of about 10 microns, about 20 microns, about 50 microns, about 80 microns, about 100 microns, about 120 microns, about 150 microns, about 180 microns, about 200 microns, about 220 microns, about 250 microns, and about 280 microns.
  • the monofilament or multifilament pile yarn can have a size that falls within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the monofilament or multifilament pile yarn can have a size of about 6 microns to about 258 microns, or about 10 microns to about 200 microns, or about 20 microns to about 150 microns, and so on. It is further understood that the ranges can also be formed within the range, for example, if a range of about 6 microns to about 300 microns is disclosed, this range also includes about 8 microns to about 289 microns or about 20 microns to about 199 microns, or and so on. [0140] In still further aspects, the pile layer can include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc.
  • the loops of the pile yams 154 as shown in FIG.13 in the pile layer 150 can have a certain pattern, such that they are not knitted on each wale 178, but they are alternating with a ratio of 1:1 (1 wale of loop and 1 empty wale), 1:2 (1 wale of loop and 2 empty wale), or 2:1, such that the density of the loops on the plush surface 150 is adjusted based upon the size and filament count of the pile yarn 154 used.
  • the loops of the pile yams 154 on the plush surface 150 may have a certain pattern, such that they are not knitted on each course so that different densities of loops are achieved.
  • the height of the pile yarns 154 can vary along the length or width of the knitted fabric so as to vary the thickness of the knitted fabric. In certain aspects, it is preferable that the height of the pile along the length of the valve is not varied. Also, while the height of the pile yarn along the circumference can vary, it may not be preferable as it can leave gaps in the axial direction of the valve, which is the direction of the flow of blood. As a result, the sealing of the valve can be affected. [0145]
  • the pile layer 150 has a much greater surface area than similarly sized skirts formed from flat or woven materials and, therefore, can enhance tissue ingrowth compared to known skirts.
  • the pores in the base of the edge section are exposed, so adding the warp inlaid yarn(s) reduces the porosity in the wales where no pile yarns have been knitted intentionally, and thus help preserve the PVL sealing feature of the skirt in those areas (i.e., each of the edge section of the skirt).
  • the addition of the warp inlaid yarns 1406 aids the assembler in suturing the skirt onto the valve frame and leaflets by providing contact points for the needle and suture.
  • the warp inlay yarn size can range from about 20 denier to about 100 denier.
  • the warp inlay yarn size can be about 20 denier, about 30 denier, about 40 denier, about 70 denier, about 80 denier, or about 100 denier. It is understood that the warp inlay yarn size can fall within any range formed by any of the disclosed above values or fall between any two of the disclosed above values. For example, the warp inlay yarn size can be about 20 denier to about 90 denier, or about 20 denier to about 60 denier, and so on.
  • the filament size within these yarns can range from about 0.3 denier per filament to about 4 denier per filament, including exemplary values of about 0.5 denier, about 0.8 denier, about 1 denier, about 1.2 denier, about 1.5 denier, about 1.7 denier, about 2 denier, about 2.2 denier, about 2.5 denier, about 2.8 denier, about 3 denier, about 3.2 denier, about 3.5 denier, and about 3.8 denier. It is understood that the filament size can fall within any range formed by any of the disclosed above values or fall between any two of the disclosed above values. For example, it can be about 0.3 denier to about 3.5 denier, or about 0.8 denier to about 2.9 denier, and so on.
  • the filament used for warp inlaid can be flat or textured type. There can typically be 1 warp inlaid yarn but based up on the size of the yarn, it can be up to 5 yarns.
  • the edge portion can have any width.
  • the edge portion can be up to about 1 mm wide, up to about 2 mm wide, up to about 3 mm wide, up to about 4 mm wide, up to about 5 mm wide, or up to about 10 mm wide.
  • the edge portion can be defined by the number of wales that the inlaid yarn can be used in.
  • the edge portion can have up to 1 wale, up to 2 wales, or up to 3 wales.
  • the first inlaid yarn can have a size from about 20 denier to about 100 denier, including exemplary values of 22 deniers, about 25 deniers, about 28 deniers, about 30 deniers, about 32 deniers, about 35 deniers, about 38 deniers, about 40 deniers, about 42 deniers, about 45 deniers, about 48 deniers, about 50 deniers, about 52 deniers, about 55 deniers, about 58 deniers, about 60 deniers, about 62 deniers, about 65 deniers, about 68 deniers, about 70 deniers, about 72 deniers, about 75 deniers, about 78 deniers, about 80 deniers, about 82 deniers, about 85 deniers, about 88 deniers, about 90 deniers, about 92 deniers, about 95 deniers, and about 98 deniers.
  • the first inlaid yarn can have a size that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the first inlaid yarn can be about 20 deniers to about 98 deniers, or about 30 deniers to about 94 deniers, or about 40 deniers to about 90 deniers, or about 50 deniers to about 70 deniers, or about 50 deniers to about 60 deniers, or about 28 deniers to about 84 deniers, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 20 deniers to about 98 deniers is disclosed, this range also includes about 20 deniers to about 90 deniers or about 23 deniers to about 87 deniers or about 35 deniers to about 75 deniers, or and so on.
  • the number of filaments can be from about 1 to about 200 filaments, including exemplary values of about 2 filaments, about 5 filaments, 10 filaments, about 25 filaments, 40 filaments, about 55 filaments, about 70 filaments, about 85 filaments, about 100 filaments, about 115 filaments, about 130 filaments, about 145 filaments, about 160 filaments, about 175 filaments, and about 190 filaments.
  • the number of filaments in the pile yarn can fall within any two foregoing values or form any range within the broadest disclosed range or between any mentioned values.
  • the number of filaments can be about 1 filament to about 155 filaments, or about 10 filaments to about 142 filaments, or about 2 filaments to about 105 filaments, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 1 filament to about 155 filaments is disclosed, this range also includes about 2 filaments to about 155 filaments or about 20 filaments to about 150 filaments or about 36 filaments to about 144 filaments, or and so on.
  • the first inlaid yarn can be a monofilament and/or multifilament.
  • such yarn can have a filament count of about 2 to about 100 filaments, including exemplary values of about 2 filaments, about 5 filaments, 10 filaments, about 15 filaments, 20 filaments, about 25 filaments, about 30 filaments, about 35 filaments, about 40 filaments, about 45 filaments, about 50 filaments, about 55 filaments, about 60 filaments, about 65 filaments, about 70 filaments, about 75 filaments, about 80 filaments, about 85 filaments, about 90 filaments, and about 95 filaments.
  • the number of filaments in the inlaid yarn can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the number of filaments can be about 1 filament to about 18 filaments, or about 10 filaments to about 24 filaments, or about 10 filaments to about 27 filaments, or about 10 filaments to about 34 filaments and so on.
  • the ranges can also be formed within the range, for example, if a range of about 1 filament to about 100 filaments is disclosed, this range also includes about 2 filaments to about 100 filaments or about 20 filaments to about 90 filaments or about 36 filaments to about 85 filaments, or and so on.
  • the disclosed herein knit fabric as it is arranged on the exemplary valve is shown in FIG.15A.
  • the edge portion 180 does not have the looped pile yarns 154 and instead has the first inlaid yarns 1404. This may help to provide the tapered edge portions of the fabric.
  • adding the inlaid yarn(s) reduces the porosity in the wales where no pile yarns have been knitted intentionally and thus improves the PVL sealing of the skirt in those areas.
  • adding the inlaid yarns aids the assembler in suturing the skirt onto the valve frame and leaflets by providing contact points for the needle and suture reinforcing the section of the skirt where stitches are applied for connection with the frame. This helps ensure suture retention strength is maintained for the durability of the valve.
  • the first inlaid yarn comprises one or more filaments having an average diameter of about 6 microns to about 250 microns, including exemplary values of about 10 microns, about 20 microns, about 50 microns, about 80 microns, about 100 microns, about 120 microns, about 150 microns, about 180 microns, about 200 microns, and about 220 microns.
  • the first inlaid yarn comprises one or more filaments having a size that falls within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the first inlaid yarn comprises one or more filaments that can have a size of about 6 microns to about 245 microns, or about 10 microns to about 200 microns, or about 20 microns to about 150 microns, and so on. It is further understood that the ranges can also be formed within the range, for example, if a range of about 6 microns to about 250 microns is disclosed, this range also includes about 8 microns to about 239 microns or about 20 microns to about 199 microns, or and so on. [0162] In still further aspects, the first inlaid yarn can comprise any known in the art yarn that is suitable for the desired application.
  • the first inlaid yarn comprises a flat yarn, twisted yarn, textured yarn, or any combination thereof. If twisted yarn is present, it can have a number of turns similar to the twisted yarn described above.
  • the first inlaid yarn comprises a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof. It is understood that if the polyurethane is present, it can be a thermoplastic polyurethane. In some aspects, and as disclosed above, the thermoplastic polyurethane can further comprise an amount of Si.
  • the Si can be present in an amount of about 0.5 wt% to about 4.5 wt%, about 0.7 wt% to about 4.3 wt%, about 0.9 wt% to about 4.1 wt%, about 1.3 wt% to about 3.8 wt%, about 2.5 wt% to about 3.5 wt%, and so on.
  • polyester can comprise a PET.
  • polyamide can comprise nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • fluorinated polymers comprise PTFE, ePTFE, or a combination thereof.
  • the first inlaid yarn can comprise a compound yarn.
  • the compound yarn can comprise a core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • the core yarn and the wrap yarn are the same or different.
  • the inlaid yarn can have one or more filaments that are bi-component filaments in a sheath-core configuration, side-by-side configuration, eccentric configuration, island-in-the-sea configuration, segmented-pie configuration, or any combination thereof.
  • the first inlaid yarn, the mesh layer and the pile layer are knitted simultaneously. While in other aspects, the first inlaid yarn is embroidered into the knitted fabric.
  • the pile layer can be present in a pattern. It is understood that any pattern that is suitable for the desired application can be utilized.
  • the pile layer can form a pattern such that at least some portions different from the first, second, third, and/or fourth edges of the knitted fabric are substantially free of the pile yarn.
  • the pattern can be a wavy pattern having a plurality of waves defined by a plurality of peaks and valleys. Such an exemplary pattern is shown in FIGs.16A-16B.
  • some portions are free of the pile yarn.
  • the portions 1602 can comprise the mesh yarn only.
  • the pile yarn can have a plurality of valleys 1602a and 1602b and a plurality of peaks 1602c and 1602d.
  • FIG.16B shows an exemplary photograph of such a pattern, where the pile layer forms a wavy pattern 1620 with the plurality of valleys 1620a and 1620b and plurality of peaks 1620c and 1620d, and portions that are free of the pile yarn 1610.
  • the pattern can have a frequency of peaks/valleys of about 0.25 per cm to about 2 per cm, including exemplary values of about 0.5 per cm, about 0.75 per cm, about 1 per cm, about 1.25 per cm, about 1.5 per cm, and about 1.75 per cm.
  • the pattern can have a frequency that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the pattern can have a frequency of about 0.25 per cm to about 1.9 per cm, or about 0.7 per cm to about 1.8 per cm, or about 1 per cm to about 1.5 per cm, and so on.
  • the ranges can also be formed within the range, for example, if a range of about 0.25 per cm to about 1.75 per cm is disclosed, this range also includes about 0.27 per cm to about 1.72 per cm or about 0.32 per cm to about 1.2 per cm, and so on.
  • the frequency of peaks/valleys of the waves is the same along a substantially entire surface of the knitted fabric. Yet, in other aspects, the frequency of peaks/valleys of the waves is varied along a surface of the knitted fabric.
  • the plurality of waves are defined by an amplitude from about 2 mm to about 20 mm, including exemplary values of about 4 mm, about 8 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, and about 18 mm.
  • the pattern can have a frequency that can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the plurality of waves can have an amplitude of about 2 mm to about 19 mm, or about 2.5 mm to about 15 mm, or about 3.3 mm to about 13 mm, and so on.
  • the waves are positioned such that the plurality of peaks and valleys of at least two waves are offset from each other.
  • the at least some portions different from the first, second, third, and/or fourth edges of the knitted fabric that are substantially free of the pile yarn form a plurality of gaps between the plurality of waves ranging from about 1 mm to about 10 mm, including exemplary values of about 2 mm, about 3 mm, about 4 mm, about 6 mm, about 7 mm, about 8 mm, and about 9 mm.
  • the gaps size can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the gap can be of about 1 mm to about 10 mm, or about 1.5 mm to about 8.3 mm, or about 2 mm, about 7 mm, and so on.
  • the wavy pattern can be formed by the velour pattern of the loop yarn.
  • the waviness can be knitted only in the body while the edges of the components are knitted as flat knit without the wavy or velour section that ensures the edges are compatible for sewing without fraying of the yarns and for seam integrity.
  • the wavy velour section can be made of microsized textured multifilament yarn.
  • Such a yarn can have any of the disclosed above denier and number of filaments.
  • the height of the formed pile can be anywhere from about 1 mm to about 5 mm, including exemplary values of about 1.2 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.5 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.5 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.5 mm, and about 4.8 mm.
  • the height of the formed pile can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the height of the formed pile can be of about 1 mm to about 4.8 mm, or about 1.5 mm to about 4.5 mm, or about 2 mm, about 3 mm, and so on.
  • the knitted fabric as disclosed herein can have any thickness that is suitable for the desired application.
  • the thickness of the fabric can be from about 0.1 mm to about 3 mm, including exemplary values of about 0.2 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.5 mm, about 2.8 mm.
  • the thickness of the knitted fabric can fall within any two foregoing values or forms any range within the broadest disclosed range or between any mentioned values.
  • the thickness of the knitted fabric can be of about 0.1 mm to about 2.8 mm, or about 0.5 mm to about 2 mm, or about 1 mm to about 2.3 mm, and so on.
  • the knitted fabric 1700 can comprise one or more second inlaid yarns 1710 inserted into a weft direction across the first dimension 1760 of the knitted fabric.
  • any of the disclosed yarns can be used as the one or more second inlaid yarns.
  • the one or more second inlaid yarns comprise a low-melt polymer.
  • the fabric can also comprise the third edge 1706 and the fourth edge 1708 comprising a third edge portion 1706a and the fourth edge portion 1708a that are substantially free of pile yarn.
  • Such portions 1740 can be represented by the mesh layer.
  • first edge 1702 and the second edge 1704 can also comprise the first inlaid yarn 1720 along the second dimension 1750.
  • the fabrics disclosed herein can have various combinations of the yarns. For example, some of the yarns can be monofilament, while others can be multifilament. Yet in still further aspects, all the yarns are multifilament, or all the yarns are monofilament. It is understood that the type of yarn can be selected depending on the desired application. In certain aspects, the velour can be knitted as a hybrid arrangement of loops using multifilament and monofilament yarns together.
  • the type of polymers used in the yarns of the disclosed herein fabric can also be selected based on the desired application. Any of the disclosed above yarns can be used.
  • the yarns can comprise low-melt polymers.
  • the low-melt polymer can be low-melt PET polymer.
  • a low melt temperature PET yarn can be used at the edges along with the first and/or the one or more second inlaid yarns or as the first and/or the one or more second inlaid yarns. When exposed to heat to the tune of the softening temperature of this polymer, it will fuse with surrounding filaments and lock the structure for integrity.
  • a low melt temperature PET having a melting point temperature (MP) of 200 °C can soften around 180 °C to create the fusion with other polymer filaments that have higher MP
  • MP melting point temperature
  • the first dimension of the knitted fabric defines a height of the outer sealing member while the second dimension of the knitted fabric is along a circumference of the annular frame.
  • the first dimension can be knitted to the desired lengths such that no laser cut is needed.
  • an implantable medical device comprising: (a) an annular frame having an inner surface and an outer surface, an inflow end, and an outflow end; wherein the annular frame is compressible and expandable between a radially compressed configuration and a radially expanded configuration; and (b) any of the disclosed herein articles, wherein the article is an outer sealing member mounted circumferentially around the outer surface of the annular frame.
  • the article can be attached to the annular frame along the first edge and the second edge.
  • the third edge and the fourth edge are connected to each other and optionally to the annular frame.
  • the present disclosure also provides for a method of forming an implantable prosthetic valve comprising: a) providing an annular frame having an inner surface and an outer surface wherein the frame has an inflow end and an outflow end; wherein the annular frame is compressible and expandable between a radially compressed configuration and a radially expanded configuration; b) circumferentially mounting an outer sealing member comprising any of the disclosed herein articles.
  • the methods disclosed herein can comprise a step of impregnating any of the disclosed herein textile materials with a pharmaceutically active agent, depending on the desired application.
  • the methods disclosed herein can comprise a step of coating any of the disclosed herein textile materials with any known in the art materials that can provide for any additional desired properties.
  • Example 1 An article comprising: a knitted fabric having a first dimension defined by a first edge and a second edge, and a second dimension, which is perpendicular to the first dimension and defined by a third edge and a fourth edge; wherein the knitted fabric comprises a mesh layer and a pile layer, wherein the pile layer comprises a plurality of pile yarns extending outwardly from at least a portion of an outer surface of the mesh layer, wherein an inner surface of the mesh layer is substantially free of the pile yarns, wherein the mesh layer at at least one of the first edge and the second edge of the knitted fabric comprises a first edge portion and/or a second edge portion that is substantially free of the pile yarn; and wherein the first edge portion and/or the second edge portion comprise a first inlaid yarn inserted into the mesh layer along the second dimension of the knitted fabric.
  • Example 2 The article of any one of the examples herein, particularly Example 1, wherein the mesh layer comprises one or more weft yarns forming a plurality of courses extending along the first dimension of the knitted fabric and at least one warp yarn configured to form a plurality of warp loops that connect each course of the plurality of courses to an adjacent course along the second dimension of the knitted fabric thus forming a plurality of wales.
  • Example 3 The article of any one of the examples herein, particularly Example 2, wherein the one or more weft yarns comprise a first weft yarn and a second weft yarn.
  • Example 7 The article of any one of the examples herein, particularly Example 2 or 3, wherein the mesh layer has a wales density from about 10 to about 50 wales per inch.
  • Example 5 The article of any one of the examples herein, particularly Examples 2-4, wherein the mesh layer has a course density from about 25 to about 85 courses per inch.
  • Example 6 The article of any one of the examples herein, particularly Examples 2-5, wherein the one or more weft yarns comprise a twisted yarn, a flat yarn, a textured yarn, or any combination thereof.
  • Example 7 Example 7.
  • Example 8 The article of any one of the examples herein, particularly Examples 3-7, wherein the second weft yarn comprises a textured yarn, wherein the textured yarn has a size of about 20 deniers to about 160 deniers.
  • Example 9 The article of any one of the examples herein, particularly Examples 2-8, wherein the one or more yarns are monofilament and/or multifilament yarns.
  • Example 11 The article of any one of the examples herein, particularly Example 9, wherein the one or more yarns are multifilament yarns having a filament count of about 5 filaments up to about 200 filaments.
  • Example 11 The article of any one of the examples herein, particularly Examples 2-10, wherein the one or more weft yarns comprise a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • Example 12 The article of any one of the examples herein, particularly Example 11, wherein polyurethane is a thermoplastic polyurethane.
  • Example 13 Example 13
  • Example 12 The article of any one of the examples herein, particularly Example 12, wherein the thermoplastic polyurethane further comprises an amount of Si.
  • Example 14 The article of any one of the examples herein, particularly Example 13, wherein the amount of Si is about 0.5 wt% to about 5 wt%.
  • Example 15 The article of any one of the examples herein, particularly Example 11, wherein polyester comprises a PET.
  • Example 16 The article of any one of the examples herein, particularly Example 11, wherein polyamide comprises nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • Example 17 The article of any one of the examples herein, particularly Example 11, wherein the fluorinated polymers comprise PTFE, ePTFE, or a combination thereof.
  • Example 18 The article of any one of the examples herein, particularly Example 11, wherein the fluorinated polymers comprise PTFE, ePTFE, or a combination thereof.
  • Example 19 The article of any one of the examples herein, particularly Examples 18, wherein the compound yarn comprises core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • Example 20 The article of any one of the examples herein, particularly Example 19, wherein the core yarn and the wrap yarn are the same or different.
  • Example 22 The article of any one of the examples herein, particularly Examples 2-21, wherein the warp yarn is fully-drawn, or low or not twisted. [0215] Example 23.
  • Example 24 The article of any one of the examples herein, particularly Examples 2- 22, wherein the warp yarn has a size from about 10 deniers to about 40 deniers and a filament count from about 6 to about 56 and/or wherein the warp yarn has a tenacity from about 30 to about 400 cN/tex.
  • Example 24 The article of any one of the examples herein, particularly Examples 2-23, wherein the warp yarn comprises a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • Example 25 The article of any one of the examples herein, particularly Example 24, wherein polyurethane is a thermoplastic polyurethane.
  • Example 26 The article of any one of the examples herein, particularly Example 25, wherein the thermoplastic polyurethane further comprises an amount of Si.
  • Example 27 The article of any one of the examples herein, particularly Example 26, wherein the amount of Si is about 0.5 wt% to about 5 wt%.
  • Example 28 The article of any one of the examples herein, particularly Example 24, wherein polyester comprises a PET.
  • Example 29 The article of any one of the examples herein, particularly Example 24, wherein polyamide comprises nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • Example 30 Example 30.
  • Example 31 The article of any one of the examples herein, particularly Example 24, wherein the fluorinated polymers comprise PTFE, ePTFE, or a combination thereof.
  • Example 31 The article of any one of the examples herein, particularly Examples 2-30, wherein the warp yarn comprises a compound yarn.
  • Example 32 The article of any one of the examples herein, particularly Example 31, wherein the compound yarn comprises core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • Example 33 The article of any one of the examples herein, particularly Example 32, wherein the core yarn and the wrap yarn are the same or different.
  • Example 34 Example 34.
  • Example 35 The article of any one of the examples herein, particularly Examples 1-34, wherein the knitted fabric is crochet knitted and/or warp-knitted fabric and/or weft-knit fabric. [0228] Example 36.
  • Example 37 The article of any one of the examples herein, particularly Examples 1-36, wherein the pile yarn comprises a flat yarn or textured yarn.
  • Example 38 The article of any one of the examples herein, particularly Examples 1-37, wherein the pile yarn is a multifilament yarn, monofilament yarn, or a combination thereof.
  • Example 39 The article of any one of the examples herein, particularly Examples 1-35, wherein the pile yarns are arranged to form a looped pile or wherein the pile yarns are cut to form a cut pile.
  • Example 40 The article of any one of the examples herein, particularly Examples 1-38, wherein the pile yarn has a size from about 20 deniers to about 200 deniers and/or wherein the pile yarn has a filament count from about 1 to about 200.
  • Example 40 The article of any one of the examples herein, particularly Examples 1-39, wherein the pile yarn comprises a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • Example 41 The article of any one of the examples herein, particularly Example 40, wherein polyurethane is a thermoplastic polyurethane.
  • Example 42 The article of any one of the examples herein, particularly Example 40, wherein polyurethane is a thermoplastic polyurethane.
  • thermoplastic polyurethane further comprises an amount of Si.
  • Example 43 The article of any one of the examples herein, particularly Example 42, wherein the amount of Si is about 0.5 wt% to about 5 wt%.
  • Example 44 The article of any one of the examples herein, particularly Example 40, wherein polyester comprises a PET.
  • Example 45 The article of any one of the examples herein, particularly Example 40, wherein polyamide comprises nylon 6, nylon 6,6, nylon 12, or any combination thereof.
  • fluorinated polymers comprise PTFE, ePTFE, or a combination thereof.
  • Example 47 The article of any one of the examples herein, particularly Examples 1-46, wherein the pile yarn comprises a compound yarn.
  • Example 48 The article of any one of the examples herein, particularly Example 47, wherein the compound yarn comprises core yarn-wrap yarn configuration, wherein a core yarn and/or a wrap yarn are monofilament yarns and/or multifilament yarns.
  • Example 49 The article of any one of the examples herein, particularly Example 48, wherein the core yarn and the wrap yarn are the same or different.
  • Example 50 Example 50.
  • Example 51 The article of any one of the examples herein, particularly Examples 37-50, wherein a filament in the monofilament or multifilament yarn has a size of about 6 microns to about 300 microns in diameter.
  • Example 52 The article of any one of the examples herein, particularly Examples 37-50, wherein a filament in the monofilament or multifilament yarn has a size of about 6 microns to about 300 microns in diameter.
  • Example 53 The article of any one of the examples herein, particularly Examples 1-51, wherein the first inlaid yarn has a size from about 20 denier to about 100 denier.
  • Example 53 The article of any one of the examples herein, particularly Examples 1-52, wherein the first inlaid yarn is a monofilament and/or multifilament.
  • Example 54 The article of any one of the examples herein, particularly Example 53, wherein the multifilament yarn has a filament count of about 2 to about 100 filaments.
  • Example 55 The article of any one of the examples herein, particularly Example 53 or 54, wherein the first inlaid yarn comprises one or more filaments having an average diameter of about 6 microns to about 250 microns.
  • Example 56 The article of any one of the examples herein, particularly Examples 1-51, wherein the first inlaid yarn has a size from about 20 denier to about 100 denier.
  • Example 53 The article of any one of the examples herein, particularly Examples 1-52, wherein the first inlaid yarn is a monofila
  • Example 57 The article of any one of the examples herein, particularly Examples 52-55, wherein the first inlaid yarn comprises a flat yarn, twisted yarn, textured yarn, or any combination thereof.
  • Example 57 The article of any one of the examples herein, particularly Examples 52-56, wherein the first inlaid yarn comprises a polyester, co-polyester, polyamide, polyolefin, fluorinated polymers, polyaryletherketones, aromatic polymers, polyurethane, or any combination thereof.
  • Example 58 The article of any one of the examples herein, particularly Example 57, wherein the polyurethane is a thermoplastic polyurethane.
  • Example 59 The article of any one of the examples herein, particularly Example 57, wherein the polyurethane is a thermoplastic polyurethane.
  • Example 70 The article of any one of the examples herein, particularly Examples 1-68, wherein the first inlaid yarn, the mesh layer and the pile layer are knitted simultaneously.
  • Example 70 The article of any one of the examples herein, particularly Examples 1-68, wherein the first inlaid yarn is embroidered into the knitted fabric.
  • Example 71 The article of any one of the examples herein, particularly Examples 1-70, wherein the pile layer is present in a pattern.
  • Example 72 The article of any one of the examples herein, particularly Examples 1-71, wherein the pile layer forms a pattern such that at least some portions different from the first, second, third, and/or fourth edges of the knitted fabric are substantially free of the pile yarn.
  • Example 73 Example 73.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Textile Engineering (AREA)
  • Prostheses (AREA)

Abstract

Sont divulgués ici des articles comprenant : un tissu tricoté ayant une première dimension définie par un premier bord et un deuxième bord, et une seconde dimension, qui est perpendiculaire à la première dimension et définie par un troisième bord et un quatrième bord ; le tissu tricoté comprenant une couche de maille et une couche de poil, la couche de maille au niveau d'au moins l'un du premier bord et du deuxième bord du tissu tricoté comprenant une première partie de bord et/ou une seconde partie de bord qui est sensiblement exempte du fil de poil ; et la première partie de bord et/ou la seconde partie de bord comprenant un premier fil incrusté inséré dans la couche de maille le long de la seconde dimension du tissu tricoté.
PCT/US2025/014546 2024-02-06 2025-02-05 Dispositifs médicaux implantables Pending WO2025170971A1 (fr)

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US63/550,344 2024-02-06

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Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411522A (en) 1993-08-25 1995-05-02 Linvatec Corporation Unitary anchor for soft tissue fixation
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US20120123529A1 (en) 2010-10-05 2012-05-17 Edwards Lifesciences Corporation Prosthetic heart valve
US20120330093A1 (en) * 2011-04-21 2012-12-27 Itv Denkendorf Produktservice Gmbh Medical product and production thereof
US20140277390A1 (en) 2013-03-14 2014-09-18 CardiAQ Value Technologies, Inc. Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US20140277427A1 (en) 2013-03-14 2014-09-18 Cardiaq Valve Technologies, Inc. Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US20140277422A1 (en) 2013-03-14 2014-09-18 Cardiaq Valve Technologies, Inc. Prosthesis with outer skirt
US20150320556A1 (en) 2014-05-12 2015-11-12 Edwards Lifesciences Corporation Prosthetic heart valve
US20150328000A1 (en) 2014-05-19 2015-11-19 Cardiaq Valve Technologies, Inc. Replacement mitral valve with annular flap
US20180036530A1 (en) 2011-04-29 2018-02-08 Medtronic, Inc. Dual prophylactic and abortive electrical stimulation
US20190328515A1 (en) 2016-07-21 2019-10-31 Edwards Lifesciences Corporation Replacement heart valve prosthesis
WO2021202636A1 (fr) 2020-04-03 2021-10-07 Edwards Lifesciences Corporation Revêtement multicouche pour valvule cardiaque prothétique
US20230355382A1 (en) * 2021-01-14 2023-11-09 Edwards Lifesciences Corporation Implantable medical devices

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411522A (en) 1993-08-25 1995-05-02 Linvatec Corporation Unitary anchor for soft tissue fixation
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US20120123529A1 (en) 2010-10-05 2012-05-17 Edwards Lifesciences Corporation Prosthetic heart valve
US20120330093A1 (en) * 2011-04-21 2012-12-27 Itv Denkendorf Produktservice Gmbh Medical product and production thereof
US20180036530A1 (en) 2011-04-29 2018-02-08 Medtronic, Inc. Dual prophylactic and abortive electrical stimulation
US20140277427A1 (en) 2013-03-14 2014-09-18 Cardiaq Valve Technologies, Inc. Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US20140277422A1 (en) 2013-03-14 2014-09-18 Cardiaq Valve Technologies, Inc. Prosthesis with outer skirt
US20140277390A1 (en) 2013-03-14 2014-09-18 CardiAQ Value Technologies, Inc. Prosthesis for atraumatically grasping intralumenal tissue and methods of delivery
US20150320556A1 (en) 2014-05-12 2015-11-12 Edwards Lifesciences Corporation Prosthetic heart valve
US20150328000A1 (en) 2014-05-19 2015-11-19 Cardiaq Valve Technologies, Inc. Replacement mitral valve with annular flap
US20190328515A1 (en) 2016-07-21 2019-10-31 Edwards Lifesciences Corporation Replacement heart valve prosthesis
WO2021202636A1 (fr) 2020-04-03 2021-10-07 Edwards Lifesciences Corporation Revêtement multicouche pour valvule cardiaque prothétique
US20230355382A1 (en) * 2021-01-14 2023-11-09 Edwards Lifesciences Corporation Implantable medical devices

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