Implantable radiopaque fibers, yarns and textiles

Abstract

Radiopaque particles included in a polymer to form fibers, yarns, textiles, implants, and / or other medical devices improve monitoring of medical devices by imaging. In some implementations, a fiber (10) or filament includes a non-radiopaque polymeric core (12) surrounded by a radiopaque layer (14). In such implementations, the polymeric core provides strength, while the radiopaque layer around the core permits imaging the fiber or filament. In some implementations, a lubricious coat (18) is disposed about the radiopaque layer, and protects the radiopaque layer from degradation. A fiber or filament in accordance with such implementations can be incorporated into a yarn (112) or into a fabric (114), for example with other, non-radiopaque fibers or filaments.

Description

B UP A T-23773 WOoiIMPLANTABLE RADIOPAQUE FIBERS, YARNS AND TEXTILESCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to Provisional US Patent Application 63 / 733,290 to Vaid et al., titled "Implantable radiopaque fibers, yarns and textiles", filed 12 December 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Various imaging techniques are used to monitor functionality of implanted medical devices over time, using two-dimensional or three-dimensional imaging techniques. Many such imaging techniques have poor visualization of regions of the heart, for various reasons including the location of the implant, shadowing of the implant by tissue, poor ECG triggering due to arrhythmias, and other reasons. Some imaging techniques further result in development of imaging artefacts, which interfere with the interpretation of images.

[0003] Over the years, various materials have been developed to enhance the visibility of implants for viewing thereof using imaging techniques, once the implants are in place. These have included polymer-based agents, and radiopaque agents and devices. Polymer-based agents can have decreased toxicity, good biocompatibility, and controllable degradability, but they are radiolucent and as such are typically invisible using conventional imaging techniques, such as X-ray and CT. By contrast, radiopaque agents and devices assist in visibility in most imaging techniques, but are much more brittle, or fragile, than polymeric agents, and as such can lack the tensile strength required for implanted devices.

[0004] There is thus a need in the art for fibers, yarns, and textiles that are sufficiently radiopaque to be easily visible using a variety of imaging techniques, while having sufficient tensile strength to be implanted in the body of a human subject, and preventing unintentional degradation of the radiopaque material within the body.SUMMARY

[0005] Some implementations of the present disclosure relate to inclusion of radiopaque particles with a polymer to form libers, yarns, textiles, implants, and / or other medical devices, e.g., in order to improve their suitability for use in medical devices (e.g., implants, etc.) that need to be monitored using imaging techniques.

[0006] In some implementations, a fiber or filament includes a non-radiopaque polymeric core surrounded by a radiopaque layer. In such implementations, the polymeric core provides tensile strength and other mechanical strength properties to the fiber filament, while the radiopaque layer around the core provides the ability to image the fiber or filament using modern imaging techniques. In some implementations, a lubricious coat is disposed about the radiopaque layer, and protects the radiopaque layer from degradation. A fiber orB UP A T-23773 WOoi filament in accordance with such implementations can be incorporated into a yarn or into a fabric, for example with other, non-radiopaque fibers or filaments.

[0007] In some implementations, a fiber or filament is entirely formed of a mixture of a polymer with a radiopaque material. In some such implementations, the fiber or filament is manufactured by creating a sheet of the mixture, and then cutting the sheet into narrow ribbons, or strips, which function as the fiber or filament. Formation of the fiber or filament in this manner allows for use of a mixture having a high weight percentage of the radiopaque material, which typically cannot be used with typical methods such as extrusion.

[0008] A fiber or filament in accordance with such implementations can be incorporated into a yarn or into a fabric, for example with other, non-radiopaque fibers or filaments.

[0009] There is therefore provided, in accordance with some implementations, a filament for use within a human body, including: (i) a core formed of a first polymer; and / or (ii) a radiopaque layer surrounding the core, the radiopaque layer formed of a mixture including a second polymer and particles of a radiopaque material.

[0010] In some implementations, a tensile strength of the filament is substantially equal to the tensile strength of the core.

[0011] In some implementations, the first polymer and the second polymer are the same polymer.

[0012] In some implementations, the first polymer is different from the second polymer.

[0013] In some implementations, the particles of the radiopaque material each have a diameter of 5—8 microns.

[0014] In some implementations, the radiopaque layer has a thickness of 8-12 microns.

[0015] In some implementations, the core has a diameter of 5-5000 microns.

[0016] In some implementations, the diameter of the core is 10—1000 microns.

[0017] In some implementations, the diameter of the core is 10-750 microns.

[0018] In some implementations, the diameter of the core is 10-500 microns.

[0019] In some implementations, the diameter of the core is 10—200 microns.

[0020] In some implementations, the diameter of the core is 10-100 microns.

[0021] In some implementations, the diameter of the core is 10-80 microns.

[0022] In some implementations, the diameter of the core is 10—50 microns.

[0023] In some implementations, the diameter of the core is 10-30 microns.B UP A T-23773 WOoi

[0024] In some implementations, the first polymer is a polyethylene.

[0025] In some implementations, the first polymer is a fluoropolymer.

[0026] In some implementations, the first polymer is a polyester.

[0027] In some implementations, the first polymer is a polyamide.

[0028] In some implementations, the radiopaque material includes a salt.

[0029] In some implementations, the particles are metallic.

[0030] In some implementations, the particles are nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0031] In some implementations, the radiopaque material includes a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0032] In some implementations, a weight percentage of the radiopaque material within the mixture is smaller than 40 wt%.

[0033] In some implementations, weight percentage of the radiopaque material within the mixture is smaller than 35 wt%.

[0034] In some implementations, weight percentage of the radiopaque material within the mixture is smaller than 30 wt%.

[0035] In some implementations, the weight percentage of the radiopaque material within the mixture is smaller than 25 wt%.

[0036] In some implementations, the weight percentage of the radiopaque material within the mixture is greater than 5 wt%.

[0037] In some implementations, the weight percentage of the radiopaque material within the mixture is greater than 10 wt%.

[0038] In some implementations, the weight percentage of the radiopaque material within the mixture is greater than 15 wt%.

[0039] In some implementations, the weight percentage of the radiopaque material within the mixture is greater than 20 wt%.

[0040] In some implementations, wherein the weight percentage of the radiopaque material within the mixture is in a range of 20—25 wt%.

[0041] In some implementations, the filament further includes a lubricious coat coating the radiopaque layer.B UP A T-23773 WOoi

[0042] In some implementations, the lubricious coat has a thickness of 2—3 microns.

[0043] In some implementations, the lubricious coat is thermally curable.

[0044] In some implementations, the lubricious coat is UV curable.

[0045] In some implementations, the lubricious coat imparts thrombogenic properties to the filament.

[0046] In some implementations, a tensile strength of the core is at least 5 N.

[0047] There is further provided, in accordance with some implementations, a yarn including multiple filaments, at least one of the multiple filaments is one of the above filaments.

[0048] In some implementations, each of the multiple filaments is one of the above filaments.

[0049] In some implementations, the yarn further includes an exterior lubricious layer, disposed about an exterior surface of the yarn.

[0050] In some implementations, the yarn is braided.

[0051] In some implementations, the yarn is twisted.

[0052] There is further provided, in accordance with some implementations, a textile for use within the human body, including at least one strand of any of the above yarns.

[0053] In some implementations, wherein the textile further includes a lubricious layer disposed on exterior surfaces of the textile.

[0054] In some implementations, the textile is woven.

[0055] In some implementations, the textile is knit.

[0056] There is further provided, in accordance with some implementations, a method, including (a) into an extruder, loading (i) a first polymer, and (ii) a radiopaque mixture that includes a second polymer and radiopaque particles suspended in the second polymer; and / or (b) coextruding the first polymer and the radiopaque mixture to form a filament having a core formed of the first polymer, surrounded by a radiopaque layer of the radiopaque mixture.

[0057] In some implementations, the method further includes mixing the second polymer and the radiopaque particles to form the radiopaque mixture.

[0058] In some implementations, the method further includes melting the first polymer and the radiopaque mixture prior to the coextruding.B UP A T-23773 WOoi

[0059] In some implementations, the method further includes, following the coextruding, passing the filament through a quenching chamber.

[0060] In some implementations, the method further includes, following the coextruding, stretching the filament to extend its length.

[0061] In some implementations, the method further includes coating the radiopaque layer of the filament with a lubricious coat, the lubricious coat adapted to prevent abrasion of the radiopaque layer.

[0062] In some implementations, the coextruding includes forming the filament such that the core and the radiopaque layer are concentric.

[0063] In some implementations, the loading includes loading of the radiopaque mixture, wherein the radiopaque particles each have a diameter of 5-8 microns.

[0064] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the radiopaque layer has a thickness of 8-12 microns.

[0065] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 5-5000 microns.

[0066] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—1000 microns.

[0067] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10-750 microns.

[0068] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10-500 microns.

[0069] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—200 microns.

[0070] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—100 microns.B UP A T-23773 WOoi

[0071] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—80 microns.

[0072] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—50 microns.

[0073] In some implementations, the coextruding includes coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10-30 microns.

[0074] In some implementations, the coextruding includes coextruding a polyethylene as the first polymer.

[0075] In some implementations, the coextruding includes coextruding a fluoropolymer as the first polymer.

[0076] In some implementations, the coextruding includes coextruding a polyester as the first polymer.

[0077] In some implementations, the coextruding includes coextruding a polyamide as the first polymer.

[0078] In some implementations, the loading includes loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and a radiopaque salt.

[0079] In some implementations, the loading includes loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0080] In some implementations, the loading includes loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0081] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 40 wt%.

[0082] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 35 wt%.B UP A T-23773 WOoi

[0083] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 30 wt%.

[0084] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 25 wt%.

[0085] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 5 wt%.

[0086] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 10 wt%.

[0087] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 15 wt%.

[0088] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 20 wt%.

[0089] In some implementations, the loading includes loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is in a range of 20-25 wt%.

[0090] In some implementations, the coating includes applying a hydrophilic lubricious coat to an exterior of the filament, and curing the lubricious coat.

[0091] In some implementations, the curing includes UV curing the lubricious coat.

[0092] In some implementations, the curing includes thermally curing the lubricious coat.

[0093] In some implementations, the method further includes forming a yam including the filament and at least one other filament.

[0094] In some implementations, the forming of the yarn includes forming the yarn from multiple said filaments.

[0095] In some implementations, the method further includes coating the yarn with a lubricious coat.B UP A T-23773 WOoi

[0096] In some implementations, the coating includes applying a hydrophilic lubricious coat to an exterior of the yarn, and curing the lubricious coat.

[0097] In some implementations, the curing includes UV curing the lubricious coat.

[0098] In some implementations, the curing includes thermally curing the lubricious coat.

[0099] In some implementations, forming the yarn includes braiding the filament and the at least one other filament.

[0100] In some implementations, forming the yarn includes twisting the filament and the at least one other filament.

[0101] In some implementations, the method further includes forming a textile for use within the human body, the textile including at least one strand of the yarn.

[0102] In some implementations, the method further includes forming a textile for use within the human body, the textile including at least one strand of the filament.

[0103] In some implementations, forming the textile includes weaving the textile.

[0104] In some implementations, forming the textile includes knitting the textile.

[0105] In some implementations, the method further includes coating at least a portion of the textile with a lubricious coat.

[0106] In some implementations, the coating includes applying a hydrophilic lubricious coat to an exterior of the at least a portion of the textile, and curing the lubricious coat.

[0107] In some implementations, the curing includes UV curing the lubricious coat.

[0108] In some implementations, the curing includes thermally curing the lubricious coat.

[0109] There is further provided, in accordance with some implementations, a method, including (a) forming a radiopaque film from a mixture of a polymer and a radiopaque material; (b) cutting the radiopaque film into a plurality of radiopaque ribbons; and / or (c) incorporating at least one of the plurality radiopaque ribbons into a yarn or a textile.

[0110] In some implementations, the method further includes mixing the polymer and the radiopaque material to form the mixture.

[0111] In some implementations, forming the radiopaque film includes forming a radiopaque film having a thickness of 20 microns to 1000 microns.

[0112] In some implementations, forming the radiopaque film includes forming a radiopaque film having a thickness of too microns to 600 microns.B UP A T-23773 WOoi

[0113] In some implementations, forming the radiopaque film includes forming a radiopaque film having a thickness of 200 microns to 400 microns.

[0114] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, the mixture including a majority, by weight, of the radiopaque material.

[0115] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 40 wt%.

[0116] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 50 wt%.

[0117] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 60 wt%.

[0118] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 70 wt%.

[0119] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is up to 90 wt%.

[0120] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material, a radiopaque salt.

[0121] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material nanoparticles containing at least one element selected from the group consisting of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0122] In some implementations, forming the radiopaque film includes forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material, a compound including at least one element selected from the group consisting of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0123] In some implementations, the cutting includes cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 50 microns to 5 mm.B UP A T-23773 WOoi

[0124] In some implementations, the cutting includes cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of too microns to 3 mm.

[0125] In some implementations, the cutting includes cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 200 microns to 2.5 mm.

[0126] In some implementations, the cutting includes cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 300 microns to 2 mm.

[0127] In some implementations, the cutting includes cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 500 microns to 1.5 mm.

[0128] In some implementations, the incorporating includes twisting the at least one of the plurality radiopaque ribbons, together with other filaments, to form the yarn.

[0129] In some implementations, the incorporating includes braiding the at least one of the plurality radiopaque ribbons, together with other filaments, to form the yarn.

[0130] In some implementations, the incorporating includes forming the yarn such that the at least one of the plurality of radiopaque ribbons is surrounded by the other filaments.

[0131] In some implementations, the braiding includes forming a triaxial braid, in which the at least one of the plurality of radiopaque ribbons includes an axial filament.

[0132] In some implementations, the incorporating includes weaving the textile using the at least one of the plurality radiopaque ribbons as a warp yarn or as a weft yarn.

[0133] There is further provided, in accordance with some implementations, an apparatus for use within the human body, the apparatus including a radiopaque filament formed of a mixture of a polymer and a radiopaque material, wherein (a) the radiopaque material constitutes a majority, by weight, of the radiopaque filament; and / or (b) the radiopaque filament has a thickness of 20 microns to 1000 microns, and a width of 50 microns to 5 mm.

[0134] In some implementations, the width of the radiopaque filament is too microns to 3 mm.

[0135] In some implementations, the width of the radiopaque filament is 200 microns to2.5 mm.

[0136] In some implementations, the width of the radiopaque filament is 300 microns to 2 mm.

[0137] In some implementations, the width of the radiopaque filament is 500 microns to1.5 mm.B UP A T-23773 WOoi

[0138] In some implementations, the thickness of the radiopaque filament is 100-600 microns.

[0139] In some implementations, the thickness of the radiopaque filament is 200-400 microns.

[0140] In some implementations, the apparatus further includes at least one other filament, wherein the radiopaque filament and the at least one other filament form a yarn.

[0141] In some implementations, the yarn includes a triaxial braided yarn, and the radiopaque filament forms an axial filament of the triaxial braided yarn.

[0142] In some implementations, the at least one other filament includes a plurality of other filaments, and the radiopaque filament forms a central core of the yarn, and is surrounded by the plurality of other filaments.

[0143] In some implementations, the apparatus further includes at least one other filament, wherein the radiopaque filament and the at least one other filament form a textile.

[0144] In some implementations, the textile is woven.

[0145] In some implementations, the radiopaque material includes a salt.

[0146] In some implementations, the radiopaque material is metallic.

[0147] In some implementations, the radiopaque material includes nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0148] In some implementations, the radiopaque material includes a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0149] In some implementations, a weight percentage of the radiopaque material within the radiopaque filament is at least 60 wt%.

[0150] In some implementations, a weight percentage of the radiopaque material within the radiopaque filament is at least 70 wt%.

[0151] In some implementations, a weight percentage of the radiopaque material within the radiopaque filament is up to 90 wt%.

[0152] There is further provided, in accordance with some implementations, a yarn for use within a human body, including: (a) a radiopaque component including a mixture of a polymer and a radiopaque material; and / or (b) an exterior layer, disposed exteriorly to the radiopaque component, the exterior layer adapted to protect the radiopaque component from degradation,B UP A T-23773 WOoi

[0153] wherein the yarn has a tensile strength of at least 150 N.

[0154] In some implementations, the radiopaque component includes a radiopaque filament including: (a) a core formed of a first polymer; and / or (b) a radiopaque layer surrounding the core, the radiopaque layer formed of the mixture which includes a second polymer as the polymer, and particles of the radiopaque material.

[0155] In some implementations, the radiopaque component includes a radiopaque filament formed of the mixture of the polymer and the radiopaque material, wherein: (a) the radiopaque material constitutes a majority, by weight, of the radiopaque filament; and / or (b) the radiopaque filament has a thickness of 20 microns to 1000 microns, and a width of 50 microns to 5 mm.

[0156] In some implementations, the width of the radiopaque filament is too microns to3 mm.

[0157] In some implementations, the width of the radiopaque filament is 200 microns to2.5 mm.

[0158] In some implementations, the width of the radiopaque filament is 300 microns to2 mm.

[0159] In some implementations, the width of the radiopaque filament is 500 microns to1.5 mm.

[0160] In some implementations, the thickness of the radiopaque filament is 100-600 microns.

[0161] In some implementations, the thickness of the radiopaque filament is 200-400 microns.

[0162] In some implementations, the exterior layer includes a plurality of filaments, twisted about the radiopaque component.

[0163] In some implementations, the exterior layer includes a plurality of filaments, braided about the radiopaque component.

[0164] In some implementations, the radiopaque material includes a salt.

[0165] In some implementations, the radiopaque material is metallic.

[0166] In some implementations, the radiopaque material includes nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.B UP A T-23773 WOoi

[0167] In some implementations, the radiopaque material includes a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0168] In some implementations, the filament is sterilized.

[0169] In some implementations, the yarn is sterilized.

[0170] In some implementations, the textile is sterilized.

[0171] The term “yarn” as used herein can encompass a variety of elongate components like yarn, sutures, thread, string, etc.

[0172] The various systems, devices, apparatuses, filaments, yarns, textiles, etc. in this disclosure can be sterilized e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of the present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0173] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.BRIEF DESCRIPTION OF THE DRAWINGS

[0174] Figs. 1A and 1B are a schematic perspective sectional illustration and a schematic end-on sectional illustration of a filament for use in yarns and / or textiles in accordance with some implementations;

[0175] Fig. 2 is a schematic illustration of a technique for manufacturing the filament of Figs. 1A and 1B, in accordance with some implementations;

[0176] Figs. 3A, 3B, 3C, and 3D are schematic illustrations of uses of the filament of Figs. 1A and 1B in yarns and textiles, in accordance with some implementations;

[0177] Fig. 4 is a schematic illustration illustrating at least some steps of a technique for manufacturing a yarn or a textile including a radiopaque filament in accordance with some implementations; andB UP A T-23773 WOoi

[0178] Figs. 5A and 5B are schematic illustrations of radiopaque sutures in accordance with some implementations.DETAILED DESCRIPTION

[0179] Reference is made to Figs. 1A and 1B, which are schematic illustrations of a filament 10, in accordance with some implementations. Fig. 1A is a perspective sectional drawing, and Fig. 1B is an end-on sectional drawing. Filament 10 may be for use in or as a yarn (e.g. as a filament in a multifilament yarn, or as the filament in a monofilament yarn), and may be for use in a textile (e.g. a fabric).

[0180] Filament 10 includes a core 12 surrounded by a radiopaque layer 14. Core 12 is formed of a polymer (e.g. a first polymer). Radiopaque layer 14 is formed of a mixture in which radiopaque particles 16 are disposed (e.g. suspended) in a polymer (e.g. a second polymer). The polymer of layer 14 may be the same as, or different to, the polymer of core 12. The first polymer and / or the second polymer can be, for example, a matrix polymer.

[0181] For some implementations, core 12 and radiopaque layer 14 are coaxial.

[0182] For some implementations, filament 10 may further include a lubricious coat 18, coating radiopaque layer 14. For some implementations, lubricious coat 18 may prevent abrasion of radiopaque layer 14. For some implementations, lubricious coat 18 may increase the column strength or stiffness of filament 10.

[0183] For some implementations, a tensile strength of core 12 is at least 5 N - e.g. at least 8 N, such as at least 10 N.

[0184] For some implementation, a tensile strength of filament 10 is substantially equal to the tensile strength of core 12.

[0185] For some implementations, the tensile strength of core 12 and / or of filament 10 is measured by measuring the breaking load of the core or filament.

[0186] For some implementations, radiopaque layer 14 and / or lubricious coat 18 add negligible strength to filament 10, beyond the strength of core 12.

[0187] As such, filament 10 has sufficient mechanical strength, provided by core 12, while incorporating the radiopaque material in a functional area of the filament, thus ensuring visibility of the filament via imaging techniques (e.g. fluoroscopy).

[0188] In general, for a filament formed from a mixture containing a polymer and radiopaque particles mixed therein, as the dosage (e.g. the proportion within the mixture, by weight) of radiopaque particles increases, the mechanical (e.g. tensile) strength of the resulting filament decreases. However, since the radiopaque particles of filament 10 are contained in layer 14, which is not the primary load-bearing component of the filament, it isB UP A T-23773 WOoi feasible to utilize, within radiopaque layer 14, a dosage of radiopaque particles 16 that is relatively high (e.g. a dosage that materially reduces mechanical (e.g. tensile) strength), without materially reducing the mechanical (e.g. tensile) strength of the filament as a whole.

[0189] For example, for some implementations, radiopaque particles 16 constitute at least 5 wt% (e.g. at least 10 wt%, e.g. at least 15 wt%, such as at least 20 wt%) of the mixture used for forming radiopaque layer 14.

[0190] For some implementations, radiopaque particles 16 constitute at most 40 wt%, at most 35 wt%, at most 30 wt%, or at most 25 wt% of the mixture used for forming radiopaque layer 14.

[0191] For some implementations, radiopaque particles 16 constitute 15-40 wt% (e.g. 20-40 wt%, e.g. 20-30 wt%, such as 20—25 wt%) of the mixture used for forming radiopaque layer 14.

[0192] For some implementations, the first polymer and / or the second polymer can be, or can include, a polyethylene (e.g., polyethylene terephthalate (PET) or ultra high molecular weight polyethylene (UHMWPE)), a polyester (e.g., polybutylene terephthalate (PBT)), an aliphatic polyester, an aromatic polyester, a fluoropolymer (e.g., polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyvinylidene fluoride or polyvinylidene difluoride (PVDF)), and / or a polyamide (e.g., PEBAX® polyether block amide).

[0193] For some implementations, radiopaque particles 16 comprise or consist of (e.g. the radiopaque material is or includes), a salt having a molecular weight no greater than 400 g / mol. For example, the salt can be barium subcarbonate (Ba202C03), barium sulfate (BaSO4), bismuth trioxide (Bi2O3), bismuth oxychloride (BiOCl), or bismuth subcarbonate (Bi202C03). Particles 16 may be crystals of such a salt.

[0194] For some implementations, particles 16 are metallic.

[0195] For some implementations, particles 16 are nanoparticles.

[0196] For some implementations, particles 16 contain at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold. For example, the radiopaque material of the particles may be or include a compound containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0197] For some implementations, particles 16 each have a diameter in the range of 5-8 microns, indicated in Fig. 1B as Dp.

[0198] For some implementations, radiopaque layer 14 has a thickness in the range of 8— 12 microns, indicated in Fig. 1B as Dro.B UP A T-23773 WOoi

[0199] F°rsome implementations, core 12 has a diameter in the range of 5—5000 microns, 10-1000 microns, 10—750 microns, 10—500 microns, 10-200 microns, 10-100 microns, 10-80 microns, 10-50 microns, or 10-30 microns, indicated in Fig. 1B as Dc.

[0200] For some implementations, lubricious coat 18 has a thickness in the range of 2-3 microns, indicated in Fig. 1B as Dj.

[0201] For some implementations, filament 10 has a diameter in the range of 30-50 microns, or in the range of 30-45 microns, indicated in Fig. 1A as Df.

[0202] For some implementations, lubricious coat 18 is curable by application of energy such as heat or ultraviolet (UV) radiation.

[0203] For some implementations, lubricious coat 18 imparts antithrombogenic properties to filament 10.

[0204] As explained in further detail hereinbelow with respect to Figs. 3A to 3D, for some implementations, multiple filaments 10 may be braided or twisted together to form a yarn, and / or may be used to form a textile (e.g. a fabric).

[0205] For some implementations, the yarn or textile is formed from filaments 10 prior to application of lubricious coat 18 to each of the filaments, and the lubricious coat is applied to the resulting yarn or textile.

[0206] For other implementations, lubricious coat 18 is applied to each filament 10 prior to forming the yarn or textile from the filaments. For some such implementations, an additional layer of lubricious coat 18 can be applied to the resulting yarn or textile, following formation thereof.

[0207] Reference is now made to Fig. 2, which is a schematic illustration of a technique for manufacturing filament 10, in accordance with some implementations.

[0208] As seen in Fig. 2, a first polymer 20 is disposed in (e.g. loaded into) a first receptacle (e.g. hopper) 22 of an extruder 24, and a mixture 26 including a second polymer having radiopaque particles 16 (Figs. 1A-1B) of radiopaque material suspended therein is disposed in (e.g. loaded into) a second receptacle 28 of the extruder. The first polymer, the second polymer, and the radiopaque particles can be substantially as described hereinabove with respect to Figs. 1A and 1B.

[0209] For some implementations, the second polymer and radiopaque particles are mixed together to form mixture 26 prior to loading thereof into second receptacle 28. For some other implementations, the second polymer and the radiopaque particles are loaded into second receptacle separately, and are mixed within second receptacle 28 to form mixture 26.B UP A T-23773 WOoi

[0210] For some implementations, first polymer 20 is melted by heating — e.g. to a temperature in the range of 200-300 degrees C (e.g. 250-280 degrees C, such as 260-270 degrees C).

[0211] For some implementations, mixture 26 is melted by heating - e.g. to a temperature in the range of 200-300 degrees C e.g. 250-280 degrees C, such as 260-270 degrees C).

[0212] First polymer 20 and mixture 26 are fed (e.g. pushed) concurrently toward a coextrusion nozzle 30. In the example shown this feeding is performed by respective screw pumps 23 and 29, but it is to be understood that other feed mechanisms may be used.

[0213] Coextrusion nozzle 30 may include an annular channel 38 in fluid communication with second receptacle 28, and an interior channel 32, in fluid communication with first receptacle 22. Annular channel 38 may circumscribe interior channel 32. Channels 38 and 32 maybe coaxial — e.g. as shown.

[0214] First polymer 20 and mixture 26 are coextruded, via respective channels 32 and 38, to form core 12 and radiopaque layer 14 of filament 10, described hereinabove with respect to Figs. 1A and 1B.

[0215] For some implementations, the co-extruded filament 10 is passed through a quench chamber 40, for example for cooling.

[0216] For some implementations, co-extruded filament 10 can be fed and / or tensioned using a one or more rollers 42 (e.g. drivewheels, capstans, etc.), and / or can be wound onto a spool 44 for storage.

[0217] For some implementations, the rotation rates of rollers 42 is selected so as to stretch filament 10. For some implementations, such stretching could occur during heating of filament 10. For some implementations, stretching of filament 10 by rollers 42 can extend the length of filament 10 by a factor of five times the original length of the filament (xs), thereby making the stretched filament narrower, or have a smaller diameter, than the coextruded filament.

[0218] It is to be appreciated that stretching of filament 10, following the coextrusion thereof, can cause alignment of the first polymers and / or of the second polymers, which can strengthen the filament.

[0219] It is to be appreciated that stretching of filament 10 allows for the co-extrusion of the filament to be at a larger scale (e.g. wider) than the desired final dimensions, thereby easing the tolerances required during the extrusion process.B UP A T-23773 WOoi[o22o] For some implementations, filament to can be further coated with a lubricious coat, as explained hereinabove. For some such implementations, coating of filament to includes unwinding a portion of the filament from spool 44, and dipping the filament within a tub 46 including lubricious coating material 48, suitable for forming lubricious coat 18 described hereinabove with respect to Figs. 1A and 1B. Lubricious coating material 48 is substantially as described hereinabove with respect to Figs. 1A and 1B.

[0221] Following coating thereof, filament 10, including lubricious coat 18, can be rolled onto another spool 50.

[0222] For some implementation, and as illustrated, tub 46 can include multiple rollers 52, such that filament 10 is passed between the rollers within the tub. This may assist in maintaining the lubricious coat applied to filament 10 at a desired thickness.

[0223] For some implementations, following application of lubricious coating material48 onto filament 10 and prior to rolling of the filament onto spool 50, the lubricious coating material is cured, so as to form lubricious coat 18. For some such implementations, the lubricious coating material is cured by application of heat thereto, as indicated by thermometer 54. For some other implementations, the lubricious coating is cured by application of UV illumination thereto, as indicated by illumination arrows 56.

[0224] For some implementations, filament 10 can be used in forming a yarn or a textile (e.g. a fabric), as shown for example in Figs. 3Ato 3D.

[0225] For some implementations, filament 10 is included in the yarn and / or textile following application of the lubricious coat to the filament.

[0226] For some implementations, filament 10 is included in the yarn and / or textile prior to application of the lubricious coat to the filament. For some such implementations, the lubricious coat may be applied to the yarn or textile after formation thereof.

[0227] Reference is now made to Figs. 3A, 3B, 3C, and 3D, which are schematic illustrations of uses of filament 10 of Figs. 1A and 1B in yarns and textiles, in accordance with some implementations.

[0228] In Fig. 3A, filament 10 is used as a strand in a multi-filament, or multi-strand yarn 60. In the illustrated implementation, filament 10 is twisted with two other filaments, 64a and 64b, to form yarn 60. For some implementations, filaments 64a and 64b are not radiopaque.

[0229] It is to be appreciated that filament 10 can be used as a strand or filament in any type of yarn, including a twisted yarn or a braided yarn. Any number of strands of that yarn can be formed from filament 10. As such, for some implementations, a multi-strand yarn canB UP A T-23773 WOoi include one strand formed of filament 10, or multiple strands formed of filament 10. For some implementations, all the strands of the yarn can be formed of filament 10.

[0230] For some implementations, yarn 60 has a minimal tensile strength of 150 N. For some implementations, the tensile strength of yarn 60 is measured by measuring the breaking load of the yarn.

[0231] In Fig. 3B, filament 10 is used as a weft yarn of a woven textile 66 e.g. a fabric), while warp yarns 68 of the woven textile are not radiopaque.

[0232] For some implementations, filament 10 may be used as at least one warp yarn of textile 66 in addition to or instead of being used as the weft yarn.

[0233] In Figs. 3C and 3D, filament 10 is used as part of a knit textile 70. For some implementations, and as illustrated in Fig. 3C, filament 10 may form a course 72 of knit textile 70. For some implementations, and as illustrated in Fig. 3D, filament 10 may form a wale 74 of knit textile 70.

[0234] It is to be appreciated that filament 10, yarn 60, and / or textiles 66 and 70 can be used in a variety of medical devices suitable for implantation in the human heart and / or in the human circulatory system. For example, filament 10 can be used as part of a prosthetic heart valve, a prosthetic heart leaflet, and / or a suture used within the heart or within the circulatory system, and the like.

[0235] It is to be appreciated that, for some implementations, one or more filaments 10 may be incorporated into a textile e.g. a fabric) to form a specific shape or to indicate a location that may specifically need to be more visible than other locations of the textile.

[0236] Reference is now made to Fig. 4, which is a schematic illustration illustrating at least some steps of a technique for manufacturing a yarn or a textile (e.g. a fabric) including a radiopaque filament in accordance with some implementations.

[0237] As shown in section A, a polymer too (e.g., a matrix polymer) is mixed with a radiopaque material 102, to form a radiopaque mixture 104.

[0238] For some implementations, matrix polymer too can be, or can include, a thermoplastic polyurethane (TPU). For some implementations, matrix polymer too can be, or can include, a polycarbonate-based polymer. For some implementations, matrix polymer too can be, or can include, a silicone. For some implementations, matrix polymer too can be, or can include, a polyethylene (e.g., polyethylene terephthalate (PET) or ultra high molecular weight polyethylene (UHMWPE)), a polyester (e.g., polybutylene terephthalate (PBT)), an aliphatic polyester, an aromatic polyester, a fluoropolymer (e.g., polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyvinylideneB UP A T-23773 WOoi fluoride or polyvinylidene difluoride (PVDF)), and / or a polyamide (e.g., PEBAX® polyether block amide)

[0239] For some implementations, radiopaque material 102 can be, or can include, a radiopaque salt, such as barium subcarbonate (Ba202C03), barium sulfate (BaSO4), bismuth trioxide (Bi2O3), bismuth oxychloride (BiOCI), or bismuth subcarbonate (Bi2O2CO3).

[0240] Radiopaque material 102 is, or includes, metallic particles. For some implementations, radiopaque material 102 comprises nanoparticles.

[0241] For some implementations, radiopaque material 102 comprises at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold. For example, radiopaque material 102 may be or include a compound containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

[0242] For some implementations, matrix polymer 100 functions as a binder within mixture 104.

[0243] Mixture 104 may be liquefied. In some implementations, mixture 104 includes a solvent in which polymer too and / or radiopaque material 102 is dissolved or suspended. In some implementations, mixture 104 is melted.

[0244] In section B, mixture 104 is formed into a thin radiopaque film 106. For some implementations, film 106 has a thickness T that is at least 20 microns and / or no more than 1000 microns. For some implementations, thickness T is in the range of 100-600 microns, or in the range of 200-400 microns. A film form factor may facilitate higher dosing of a radiopaque material within the polymer - e.g. may have greater structural integrity compared with a filament. Therefore, in some implementations, radiopaque material 102 may constitute at least 40 wt% (e.g. at least 50 wt%, e.g. least 60 wt%, such as at least 70 wt%) of mixture 104. In some implementations, radiopaque material 102 constitutes up to 90 wt% of mixture 104.

[0245] The formation of film 106 may be achieved by pouring, molding, pressing, rolling, or any other suitable technique. For some implementations, film 106 can be extruded, and then heat stretched at a temperature higher than a softening temperature threshold of matrix polymer 100.

[0246] In section C, film 106 is cut into ribbons 108. Each of ribbons 108 has a width W that is at least 20 microns and / or no more than 5 mm. For some implementations, width W is in the range of too microns to 3 mm, 200 microns to 2.5 mm, 300 microns to 2 mm, or 500 microns to 1.5 mm (1500 microns).B UP A T-23773 WOoi

[0247] The tensile strength of each ribbon 108 maybe smaller than that of a comparable ribbon formed of polymer too alone. Nonetheless, the tensile strength and / or structural integrity of a yarn or a textile in which one or more ribbons 108 is integrated {e.g. woven) may not be materially diminished due to the presence of other filaments or yarns. The resulting yarn or textile may therefore advantageously have both optimal mechanical and radiopaque properties.

[0248] It is to be appreciated that ribbons 108, having a quadrilateral or rectangular cross section, can also be formed by extrusion of filaments forming the ribbons.

[0249] For example, in some implementations, and as illustrated in option I of section D, a ribbon 108 can be twisted, together with a plurality of filaments 110a, to form a twisted yarn 112a.

[0250] In another example, in some implementations, and as illustrated in option II of section D, a ribbon 108 can be braided, together with a plurality of filaments nob, to form a braided yarn 112b.

[0251] In some implementations, ribbon 108 is retained at the center of yarn 112a or yarn 112b - e.g. as a core. In this arrangement, filaments 110a or nob disposed around ribbon 108 can protect ribbon 108 from abrasion or degradation.

[0252] It is to be appreciated that for some implementations, because of the formation of ribbons 108 from film 106, ribbons 108 have a limited longitudinal length. In order to form a yarn which is longer than the length of a single ribbon 108, multiple ribbons 108 may be fed into the braid one after the other as the braid is formed, in a similar manner to the way wool is spun from shorter fibers. In the resulting braid, the multiple ribbons 108 are somewhat colinear, and form a substantially continuous core.

[0253] In yet another example, in some implementations, and as illustrated in option III of section D, at least one ribbon 108 is used as a yarn in a woven textile 114 {e.g. a fabric). In the example shown, half of the warp yarns of textile 114 are ribbons 108. However, it is to be understood that ribbons 108 may form a smaller proportion, or a larger proportion {e.g. all) of the warp yarns of textile 114.

[0254] For some implementations, additional warp yarns 116, and / or weft yarns 118 of woven textile 114 are not radiopaque.

[0255] For some implementations, ribbon(s) 108 may be used as the weft yarns of textile 114, in addition to or instead of being used as the warp yarns.

[0256] For some implementations, and as illustrated in option IV of section D, at least one ribbon 108 is used as a filament in a triaxial braided yarn 120. For example, as shown inB UP A T-23773 WOoi the enlarged inset view, ribbons 108 can serve as axial filaments of the triaxial braid forming yarn 120. In such implementations, bias angle filaments 122 (also termed bias filaments) of the triaxial braid are disposed around ribbons 108, and can protect ribbons 108 from abrasion or degradation.

[0257] Alternatively or additionally, one or more ribbons 108 may serve as a bias angle filament of a triaxial braided yarn.

[0258] For some implementations, triaxial braided yarn 120 can have a braid pick density in the range of 20-300 picks per inch (PPI). For some implementations, triaxial braided yarn 120 can have a braid end count of 8-144 ends, reflecting the use of 8-144 filaments to form the triaxial braided yarn.

[0259] For some implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 can be line yarns, for example having a density in the range of 10-140 denier (e.g. 20-120 denier).

[0260] For some implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 can be, or can include, polymers such as UHMWPE or PET. For some implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 can be, or can include, metallic filaments, such as metal or nitinol wires.

[0261] For some implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 can have a diameter in the range of 0.001-0.01 inches, or in the range of 25-250 microns.

[0262] For some implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 contribute toward the required column strength, column stiffness, and / or tensile strength of the respective yarns or textiles 112a, 112b, 114, and / or 120. in which they are included. For some such implementations, filaments / yarns 110a, 110b, 116, 118, and / or 122 are the loadbearing components of respective yarns or textiles 112a, 112b, 114, and / or 120.

[0263] For some implementations, a tensile strength of filaments / yarns 110a, 110b, 116, 118, and / or 122 is at least 10 N. For some implementations, the tensile strength of the filaments / yarns is measured by measuring the breaking load of the filaments / yarns.

[0264] For some implementations, ribbon 108, which is shielded or protected by filaments / yarns 110a, 110b, 116, 118, and / or 122, contributes toward the structural strength of respective yarns or textiles 112a, 112b, 114, and / or 120 by straining responsively to loads. For some such implementations, ribbon 108 has an elastic elongation of up to 20% under a tensile load in the range of 15-20 N.B UP A T-23773 WOoi

[0265] For some implementations, yarns 112a, 112b, and / or 120 have a tensile strength of at least 150 N. For some implementations, the tensile strength of the yarns is measured by measuring the breaking load of the yarns.

[0266] Reference is now made to Figs. 5A and 5B, which are schematic illustrations of radiopaque yarns, or sutures, in accordance with some implementations.

[0267] As seen in Fig. 5A, a radiopaque core 150 is surrounded by a structural sheath 152, to form a suture 154, or a yarn. The structural sheath 152 provides at least some, and in some implementations most, of the mechanical strength to suture 154.

[0268] For some implementations, and as illustrated, radiopaque core 150 includes, or consists of, a metal filament or wire. For some implementations, radiopaque core 150 includes, or consists of, a twisted or braided metal yarn.

[0269] For some implementations, radiopaque core 150 may include or consist of a yarn including one or more filaments 10 as described hereinabove with respect to Figs. 1A and 1B, such as yarn 60 of Fig. 3A.

[0270] For some implementations, radiopaque core 150 may include or consist of a yarn including one or more ribbons 108 as described hereinabove with respect to Fig. 4, such as any one of yarns 112a, 112b, or 120.

[0271] For some implementations, yarn 154 has a tensile strength of at least 150 N. For some implementations, the tensile strength of yarn 154 is measured by measuring the breaking load of the yarn.

[0272] In Fig. 5B, a radiopaque sheath 162 is disposed about a structural, non- radiopaque core 160, to form a yarn 164.

[0273] For some implementations, radiopaque sheath 162 is a metallic sheath, which may be formed from a wire wound around core 160. For some implementations, core 160 may be a typical suture, commonly used in cardiac implantation processes.

[0274] For the purposes of this specification and the claims that follow, the term “substantially” is defined as “at least 95%” of the related quantity. For example, “substantially perpendicular” means at least 95% perpendicular, or having an angle in the range of 85 degrees to 95 degrees.

[0275] The various systems, devices, apparatuses, filaments, yarns, textiles, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of theB UP A T-23773 WOoi present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0276] It should be understood that the use of “and / or” is defined inclusively such that the term “a and / or b” should be read to include the sets: “a and b,” “a or b,” “a,” “b.”

[0277] The present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

[0278] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.

Claims

B UP A T-23773 WOoiWHAT IS CLAIMED IS:

1. A filament for use within a human body, comprising: a core formed of a first polymer; and a radiopaque layer surrounding the core, the radiopaque layer formed of a mixture including a second polymer and particles of a radiopaque material.

2. The filament according to claim i, wherein a tensile strength of the filament is substantially equal to the tensile strength of the core.

3. The filament according to claim 1, wherein the first polymer and the second polymer are the same polymer.

4. The filament according to claim 1, wherein the first polymer is different from the second polymer.

5. The filament according to any one of claims 1-4, wherein the particles of the radiopaque material each have a diameter of 5-8 microns.

6. The filament according to any one of claims 1-5, wherein the radiopaque layer has a thickness of 8-12 microns.

7. The filament according to any one of claims 1-6, wherein the core has a diameter of 5—5000 microns.

8. The filament according to claim 7, wherein the diameter of the core is 10- 1000 microns.

9. The filament according to claim 8, wherein the diameter of the core is 10-750 microns.

10. The filament according to claim 9, wherein the diameter of the core is 10-500 microns.

11. The filament according to claim 10, wherein the diameter of the core is 10— 200 microns.

12. The filament according to claim 11 wherein the diameter of the core is 10-100 microns.

13. The filament according to claim 12, wherein the diameter of the core is 10-80 microns.

14. The filament according to claim 13, wherein the diameter of the core is 10—50 microns.

15. The filament according to claim 14, wherein the diameter of the core is 10-30 microns.B UP A T-23773 WOoi16. The filament according to any one of claims 1-15, wherein the first polymer is a polyethylene.

17. The filament according to any one of claims 1-15, wherein the first polymer is a fluoropolymer.

18. The filament according to any one of claims 1-15, wherein the first polymer is a polyester.

19. The filament according to any one of claims 1-15, wherein the first polymer is a polyamide.

20. The filament according to any one of claims 1-19, wherein the radiopaque material comprises a salt.

21. The filament according to any of claims 1-19, wherein the particles are metallic.

22. The filament according to any one of claims 1-19, wherein the particles are nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

23. The filament according to any one of claims 1-19, wherein the radiopaque material comprises a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

24. The filament according to any one of claims 1-23, wherein a weight percentage of the radiopaque material within the mixture is smaller than 40 wt%.

25. The filament according to claim 24, wherein the weight percentage of the radiopaque material within the mixture is smaller than 35 wt%.

26. The filament according to claim 25, wherein the weight percentage of the radiopaque material within the mixture is smaller than 30 wt%.

27. The filament according to claim 26, wherein the weight percentage of the radiopaque material within the mixture is smaller than 25 wt%.

28. The filament according to any one of claims 1-27, wherein a weight percentage of the radiopaque material within the mixture is greater than 5 wt%.

29. The filament according to claim 28, wherein the weight percentage of the radiopaque material within the mixture is greater than 10 wt%.

30. The filament according to claim 29, wherein the weight percentage of the radiopaque material within the mixture is greater than 15 wt%.B UP A T-23773 WOoi31. The filament according to claim 30, wherein the weight percentage of the radiopaque material within the mixture is greater than 20 wt%.

32. The filament according to any one of claims 1-31, wherein a weight percentage of the radiopaque material within the mixture is in a range of 20-25 wt%.

33. The filament according to any one of claims 1-32, further comprising a lubricious coat coating the radiopaque layer.

34. The filament according to claim 33, wherein the lubricious coat has a thickness of 2-3 microns.

35. The filament according to any one of claims 33-34, wherein the lubricious coat is thermally curable.

36. The filament according to any one of claims 33-34, wherein the lubricious coat is UV curable.

37. The filament according to any one of claims 33-34, wherein the lubricious coat imparts thrombogenic properties to the filament.

38. The filament according to any one of claims 1-37, wherein a tensile strength of the core is at least 5 N.

39. A yarn including multiple filaments, at least one of the multiple filaments being a filament according to any one of claims 1-38.

40. The yarn according to claim 39, wherein each of the multiple filaments is a filament according to any one of claims 1-38.

41. The yarn according to any one of claims 39-40, further including an exterior lubricious layer, disposed about an exterior surface of the yarn.

42. The yarn according to any one of claims 39-41, wherein the yarn is braided.

43. The yarn according to any one of claims 39-41, wherein the yarn is twisted.

44. A textile for use within the human body, including at least one strand of the yarn according to any one of claims 39-43.

45. The textile according to claim 44, further comprising a lubricious layer disposed on exterior surfaces of the textile.

46. The textile according to any one of claims 44-45, wherein the textile is woven.

47. The textile according to any one of claims 44—45, wherein the textile is knit.

48. A method, comprising:B UP A T-23773 WOoi into an extruder, loading (i) a first polymer, and (ii) a radiopaque mixture that comprises a second polymer and radiopaque particles suspended in the second polymer; and coextruding the first polymer and the radiopaque mixture to form a filament having a core formed of the first polymer, surrounded by a radiopaque layer of the radiopaque mixture.

49. The method according to claim 48, further comprising mixing the second polymer and the radiopaque particles to form the radiopaque mixture.

50. The method according to any one of claims 48-49, further comprising melting the first polymer and the radiopaque mixture prior to the coextruding.

51. The method according to any one of claims 48—50, further comprising, following the coextruding, passing the filament through a quenching chamber.

52. The method according to any one of claims 48—51, further comprising, following the coextruding, stretching the filament to extend its length.

53. The method according to any one of claims 48-52, further comprising coating the radiopaque layer of the filament with a lubricious coat, the lubricious coat adapted to prevent abrasion of the radiopaque layer.

54. The method according to any one of claims 48—53, wherein the coextruding comprises forming the filament such that the core and the radiopaque layer are concentric.

55. The method according to any one of claims 48—54, wherein the loading comprises loading of the radiopaque mixture, wherein the radiopaque particles each have a diameter of 5—8 microns.

56. The method according to any one of claims 48-55, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the radiopaque layer has a thickness of 8-12 microns.

57. The method according to any one of claims 48-56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 5-5000 microns.

58. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—1000 microns.

59. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—750 microns.B UP A T-23773 WOoi60. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—500 microns.

61. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—200 microns.

62. The method according to any one of claims 48-56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10-100 microns.

63. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—80 microns.

64. The method according to any one of claims 48—56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10—50 microns.

65. The method according to any one of claims 48-56, wherein the coextruding comprises coextruding the radiopaque mixture and the first polymer so that in the filament, the core has a diameter of 10-30 microns.

66. The method according to any one of claims 48-65, wherein the coextruding comprises coextruding a polyethylene as the first polymer.

67. The method according to any one of claims 48—65, wherein the coextruding comprises coextruding a fluoropolymer as the first polymer.

68. The method according to any one of claims 48-65, wherein the coextruding comprises coextruding a polyester as the first polymer.

69. The method according to any one of claims 48-65, wherein the coextruding comprises coextruding a polyamide as the first polymer.

70. The method according to any one of claims 48—69, wherein the loading comprises loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and a radiopaque salt.

71. The method according to any one of claims 48—69, wherein the loading comprises loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.B UP A T-23773 WOoi i. The method according to any one of claims 48—69, wherein the loading comprises loading the radiopaque mixture, wherein the radiopaque mixture includes the second polymer and a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

73. The method according to any one of claims 48—72, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 40 wt%.

74. The method according to any one of claims 48-72, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 35 wt%.

75. The method according to any one of claims 48—72, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 30 wt%.

76. The method according to any one of claims 48—72, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is smaller than 25 wt%.

77. The method according to any one of claims 48-76, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 5 wt%.

78. The method according to any one of claims 48-76, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 10 wt%.

79. The method according to any one of claims 48—76, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 15 wt%.

80. The method according to any one of claims 48—76, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is greater than 20 wt%.

81. The method according to any one of claims 48-72, wherein the loading comprises loading the radiopaque mixture, wherein a weight percentage of the radiopaque particles within the radiopaque mixture is in a range of 20-25 wt%.

82. The method according to any one of claims 53-81, wherein the coating comprises applying a hydrophilic lubricious coat to an exterior of the filament, and curing the lubricious coat.B UP A T-23773 WOoi83- The method according to claim 82, wherein the curing comprises UV curing the lubricious coat.

84. The method according to claim 82, wherein the curing comprises thermally curing the lubricious coat.

85. The method according to any one of claims 48-84, further comprising forming a yarn including the filament and at least one other filament.

86. The method according to claim 85, wherein the forming of the yarn comprises forming the yarn from multiple said filaments.

87. The method according to any one of claims 85—86, further comprising coating the yarn with a lubricious coat.

88. The method according to claim 87, wherein the coating comprises applying a hydrophilic lubricious coat to an exterior of the yarn, and curing the lubricious coat.

89. The method according to claim 88, wherein the curing comprises UV curing the lubricious coat.

90. The method according to claim 88, wherein the curing comprises thermally curing the lubricious coat.

91. The method according to any one of claims 85-90, wherein forming the yarn comprises braiding the filament and the at least one other filament.

92. The method according to any one of claims 85—90, wherein forming the yarn comprises twisting the filament and the at least one other filament.

93. The method according to any one of claims 85—92, further comprising forming a textile for use within the human body, the textile including at least one strand of the yarn.

94. The method according to any one of claims 48-84, further comprising forming a textile for use within the human body, the textile including at least one strand of the filament.

95. The method according to any one of claims 93-94, wherein forming the textile comprises weaving the textile.

96. The method according to any one of claims 93—94, wherein forming the textile comprises knitting the textile.

97. The method according to any one of claims 93-96, further comprising coating at least a portion of the textile with a lubricious coat.B UP A T-23773 WOoi98. The method according to claim 97, wherein the coating comprises applying a hydrophilic lubricious coat to an exterior of the at least a portion of the textile, and curing the lubricious coat.

99. The method according to claim 98, wherein the curing comprises UV curing the lubricious coat. too. The method according to claim 98, wherein the curing comprises thermally curing the lubricious coat.

101. A method, comprising: forming a radiopaque film from a mixture of a polymer and a radiopaque material; cutting the radiopaque film into a plurality of radiopaque ribbons; and incorporating at least one of the plurality radiopaque ribbons into a yarn or a textile.

102. The method according to claim 101, further comprising mixing the polymer and the radiopaque material to form the mixture.

103. The method according to any one of claims 101-102, wherein forming the radiopaque film comprises forming a radiopaque film having a thickness of 20 microns to 1000 microns.

104. The method according to any one of claims 101-102, wherein forming the radiopaque film comprises forming a radiopaque film having a thickness of 100 microns to 600 microns.

105. The method according to any one of claims 101-102, wherein forming the radiopaque film comprises forming a radiopaque film having a thickness of 200 microns to 400 microns.

106. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, the mixture including a majority, by weight, of the radiopaque material.

107. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 40 wt%.

108. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 50 wt%.

109. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 60 wt%.B UP A T-23773 WOoi no. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is at least 70 wt%.

111. The method according to any one of claims 101-105, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein a weight percentage of the radiopaque material within the mixture is up to 90 wt%.

112. The method according to any one of claims 101-111, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material, a radiopaque salt.

113. The method according to any one of claims 101-111, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material nanoparticles containing at least one element selected from the group consisting of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

114. The method according to any one of claims 101-111, wherein forming the radiopaque film comprises forming the radiopaque film from the mixture, wherein the mixture includes, as the radiopaque material, a compound including at least one element selected from the group consisting of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

115. The method according to any one of claims 101-114, wherein the cutting comprises cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 50 microns to 5 mm.

116. The method according to any one of claims 101-114, wherein the cutting comprises cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 100 microns to 3 mm.

117. The method according to any one of claims 101-114, wherein the cutting comprises cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 200 microns to 2.5 mm.

118. The method according to any one of claims 101-114, wherein the cutting comprises cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 300 microns to 2 mm.

119. The method according to any one of claims 101-114, wherein the cutting comprises cutting the radiopaque film such that each of the plurality of radiopaque ribbons has a width of 500 microns to 1.5 mm.B UP A T-23773 WOoi120. The method according to any one of claims 101-119, wherein the incorporating comprises twisting the at least one of the plurality radiopaque ribbons, together with other filaments, to form the yarn.

121. The method according to any one of claims 101-119, wherein the incorporating comprises braiding the at least one of the plurality radiopaque ribbons, together with other filaments, to form the yarn.

122. The method according to any one of claims 120-121, wherein the incorporating comprises forming the yarn such that the at least one of the plurality of radiopaque ribbons is surrounded by the other filaments.

123. The method according to claim 121, wherein the braiding comprises forming a triaxial braid, in which the at least one of the plurality of radiopaque ribbons comprises an axial filament.

124. The method according to any one of claims 101-119, wherein the incorporating comprises weaving the textile using the at least one of the plurality radiopaque ribbons as a warp yarn or as a weft yarn.

125. An apparatus for use within the human body, the apparatus comprising a radiopaque filament formed of a mixture of a polymer and a radiopaque material, wherein: the radiopaque material constitutes a majority, by weight, of the radiopaque filament; and the radiopaque filament has a thickness of 20 microns to 1000 microns, and a width of 50 microns to 5 mm.

126. The apparatus according to claim 125, wherein the width of the radiopaque filament is 100 microns to 3 mm.

127. The apparatus according to claim 125, wherein the width of the radiopaque filament is 200 microns to 2.5 mm.

128. The apparatus according to claim 125, wherein the width of the radiopaque filament is 300 microns to 2 mm.

129. The apparatus according to claim 125, wherein the width of the radiopaque filament is 500 microns to 1.5 mm.

130. The apparatus according to any one of claims 125-129, wherein the thickness of the radiopaque filament is 100-600 microns.

131. The apparatus according to any one of claims 125-129, wherein the thickness of the radiopaque filament is 200-400 microns.B UP A T-23773 WOoi132. The apparatus according to any one of claims 125-131, further comprising at least one other filament, wherein the radiopaque filament and the at least one other filament form a yarn.

133. The apparatus according to claim 132, wherein the yarn comprises a triaxial braided yarn, and wherein the radiopaque filament forms an axial filament of the triaxial braided yarn.

134. The apparatus according to claim 132, wherein the at least one other filament comprises a plurality of other filaments, and the radiopaque filament forms a central core of the yarn, and is surrounded by the plurality of other filaments.

135. The apparatus according to claim any one of claims 125-130, further comprising at least one other filament, wherein the radiopaque filament and the at least one other filament form a textile.

136. The apparatus according to claim 135, wherein the textile is woven.

137. The apparatus according to any one of claims 125-136, wherein the radiopaque material comprises a salt.

138. The apparatus according to any one of claims 125-136, wherein the radiopaque material is metallic.

139. The apparatus according to any one of claims 125-136, wherein the radiopaque material comprises nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

140. The apparatus according to any one of claims 125-136, wherein the radiopaque material comprises a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

141. The apparatus according to any one of claims 125-140, wherein a weight percentage of the radiopaque material within the radiopaque filament is at least 60 wt%.

142. The apparatus according to any one of claims 125-140, wherein a weight percentage of the radiopaque material within the radiopaque filament is at least 70 wt%.

143. The apparatus according to any one of claims 125-142, wherein a weight percentage of the radiopaque material within the radiopaque filament is up to 90 wt%.

144. A yarn for use within a human body, comprising: a radiopaque component including a mixture of a polymer and a radiopaque material; andB UP A T-23773 WOoi an exterior layer, disposed exteriorly to the radiopaque component, the exterior layer adapted to protect the radiopaque component from degradation, wherein the yarn has a tensile strength of at least 150 N.

145. The yarn according to claim 144, wherein the radiopaque component comprises a radiopaque filament comprising: a core formed of a first polymer; and a radiopaque layer surrounding the core, the radiopaque layer formed of the mixture which includes a second polymer as the polymer, and particles of the radiopaque material.

146. The yarn according to claim 144, wherein the radiopaque component comprises a radiopaque filament formed of the mixture of the polymer and the radiopaque material, wherein: the radiopaque material constitutes a majority, by weight, of the radiopaque filament; and the radiopaque filament has a thickness of 20 microns to 1000 microns, and a width of 50 microns to 5 mm.

147. The yarn according to claim 146, wherein the width of the radiopaque filament is too microns to 3 mm.

148. The yarn according to claim 146, wherein the width of the radiopaque filament is 200 microns to 2.5 mm.

149. The yarn according to claim 146, wherein the width of the radiopaque filament is 300 microns to 2 mm.

150. The yarn according to claim 146, wherein the width of the radiopaque filament is 500 microns to 1.5 mm.

151. The yarn according to any one of claims 146-150, wherein the thickness of the radiopaque filament is 100—600 microns.

152. The yarn according to any one of claims 146-150, wherein the thickness of the radiopaque filament is 200-400 microns.

153. The yarn according to any one of claims 144-152, wherein the exterior layer comprises a plurality of filaments, twisted about the radiopaque component.

154. The yarn according to any one of claims 144-152, wherein the exterior layer comprises a plurality of filaments, braided about the radiopaque component.

155. The yarn according to any one of claims 144-154, wherein the radiopaque material comprises a salt.B UP A T-23773 WOoi156. The yarn according to any one of claims 144-154, wherein the radiopaque material is metallic.

157. The yarn according to any one of claims 144-154, wherein the radiopaque material includes nanoparticles containing at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

158. The yarn according to any one of claims 144-154, wherein the radiopaque material comprises a compound including at least one of iodine, barium, tantalum, bismuth, tungsten, platinum, iridium, or gold.

159. The filament according to any of the preceding claims, wherein the filament is sterilized.

160. The yarn according to any of the preceding claims, wherein the yarn is sterilized.

161. The textile according to any of the preceding claims, wherein the textile is sterilized.

162. A filament for use within a human body, comprising a polymeric core and a radiopaque region disposed on or within the filament, the radiopaque region including a polymer and a radiopaque material.

163. A filament for use within a human body, comprising a polymeric body and a radiopaque additive distributed along at least a portion of an outer surface layer, wherein a majority of the tensile load is borne by the polymeric body.

164. A method, comprising co-forming a polymeric core and a radiopaque composition to yield a filament having the core and a radiopaque region adjacent thereto, wherein the radiopaque composition comprises a polymer and a radiopaque material.

165. A method, comprising providing a polymeric core and applying, in a continuous process, a radiopaque coating to at least a portion of the core to produce a filament comprising a radiopaque layer.

166. A method, comprising forming an elongated radiopaque member from a mixture of a polymer and a radiopaque material and incorporating the elongated radiopaque member into a yarn or a textile.

167. A method, comprising preparing a radiopaque mixture including a polymer and a radiopaque material at a loading of at least 40 wt% and forming the mixture into one or more non-cylindrical filaments that are incorporated into a yarn or a textile.B UP A T-23773 WOoi168. An apparatus for use within a human body, comprising a radiopaque filament formed of a polymer and a radiopaque material, the filament having a non-zero width and thickness defining a ribbon-like cross-section.

169. An apparatus for use within a human body, comprising a radiopaque filament including a polymeric matrix and a radiopaque material, wherein the radiopaque filament is configured to be integrated with at least one other filament to form a yarn or a textile.

170. A yarn for use within a human body, comprising a radiopaque component including a polymer and a radiopaque material, wherein the yarn comprises an exterior region configured to protect the radiopaque component from degradation in vivo.

171. A yarn for use within a human body, comprising at least one radiopaque filament including a polymer and a radiopaque material, wherein the yarn is configured to resist abrasion in vivo.

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