Anti-migration stent

Abstract

An endoprosthesis for implantation within a blood vessel may include a tubular scaffold formed from one or more interwoven filaments, the tubular scaffold configured to shift between a radially collapsed configuration and a radially expanded configuration, a polymeric covering secured to the tubular scaffold, and an anti-migration element extending radially outward from the tubular scaffold. The anti-migration element extends helically in a first helical direction along at least a portion of the length of the tubular scaffold. The anti-migration element may include a wire extending along an outer surface of the tubular scaffold. The anti-migration element may include a second polymeric covering disposed over the wire.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods of making and / or using medical devices. More particularly, the present disclosure relates to improved designs for endoprostheses or stents. [Background technology]

[0002] Stents, grafts, stent-grafts, and equivalent implantable medical devices, hereinafter generally referred to as stents, are radially expandable or self-expanding endoprostheses, which are endovascular or endoscopic grafts that can be implanted transluminally, either percutaneously or endoscopically. Stents can be implanted in various body lumens or vessels, such as the vasculature, urinary tract, bile duct, gastrointestinal tract, airways, etc. Stents can be used to open narrowed body lumens. Stents can be used to reinforce body vessels and to prevent restenosis after angioplasty in the vasculature. They can be self-expanding, mechanically expanding, or hybrid expanding. Generally, self-expanding stents are mounted on a two-tube delivery device. Stents are delivered by sliding the outer tube to expose and release the stent.

[0003] A stent is typically a tubular member that, when deployed at a treatment site, is radially expandable from a reduced diameter configuration to an expanded configuration for delivery through a patient's body lumen. Stents may be formed from tubular members on which a pattern is subsequently formed by etching or cutting material from the tubular member. Alternatively, stents may be made from wires or filaments using techniques such as braiding, knitting, or weaving. Desirable stent characteristics include sufficient flexibility to allow conformance to tortuous body lumens during delivery, as well as sufficient stiffness to resist migration once deployed at a treatment site.

[0004] In some stents, the compressibility and flexibility properties that aid in stent delivery may also tend to cause the stent to migrate from its original deployed position. Stent migration affects many endoscopic stents, including esophageal, duodenal, colonic, pancreatic, biliary, and airway stents. It is therefore desirable to provide a stent configuration that resists migration after deployment.

[0005] Several techniques have been developed to prevent stent migration, including adding barbs and flares to the stent itself, or using clips or sutures to attach the stent to the vessel wall, however, there remains a need for improved stents that resist migration. Summary of the Invention

[0006] In one example, an endoprosthesis for implantation within a blood vessel includes a tubular scaffold having a length, the tubular scaffold formed from one or more filaments interwoven to define interstices therebetween, and configured to shift between a radially collapsed configuration and a radially expanded configuration. The endoprosthesis can include a polymeric covering secured to the tubular scaffold and an anti-migration element extending radially outward from the tubular scaffold. The anti-migration element can extend helically in a first helical direction along at least a portion of the length of the tubular scaffold.

[0007] In addition or in the alternative to any example disclosed herein, the anti-migration element has a cross-sectional shape having a first circumferential width at a base and a second circumferential width at a radially outer tip that is greater than the first width.

[0008] In addition, or in the alternative, to any of the examples disclosed herein, the cross-sectional shape has a flat radially outer surface at the radially outer tip. In addition or in the alternative to any of the examples disclosed herein, the anti-migration element includes a wire extending along an outer surface of the tubular scaffold.

[0009] In addition or in the alternative to any of the examples disclosed herein, the wires are secured to the tubular scaffold at multiple attachment points. In addition, or in the alternative, to any of the examples disclosed herein, the endoprosthesis can further include a second polymeric coating disposed over the wire and the plurality of attachment points.

[0010] In addition or in the alternative to any of the examples disclosed herein, the anti-migration element extends continuously from the proximal end of the anti-migration element to the distal end of the anti-migration element. In addition or in the alternative to any of the examples disclosed herein, the anti-migration element extends discontinuously from a proximal end of the anti-migration element to a distal end of the anti-migration element such that multiple independent segments of the anti-migration element are spaced apart from one another.

[0011] Additionally or alternatively to any example disclosed herein, each segment of the plurality of independent segments extends circumferentially for less than one complete revolution around the tubular scaffold.

[0012] In addition or in the alternative to any of the examples disclosed herein, the endoprosthesis can further include a second anti-migration element extending radially outward from the tubular scaffold. The second anti-migration element can extend helically along at least a portion of the length of the tubular scaffold in a second helical direction opposite the first helical direction such that the anti-migration element intersects the second anti-migration element at multiple intersections.

[0013] In addition or in the alternative to any examples disclosed herein, the anti-migration element and the second anti-migration element can each extend a first radial distance outward from the tubular scaffold between the nodes. The multiple nodes can extend a first radial distance outward from the tubular scaffold.

[0014] In addition or in lieu of any examples disclosed herein, the anti-migration element and the second anti-migration element can each extend outwardly from the tubular scaffold between the nodes a first radial distance, and the nodes can extend outwardly from the tubular scaffold a second radial distance greater than the first radial distance.

[0015] In addition or in the alternative to any of the examples disclosed herein, the pitch between adjacent turns of the anti-migration element varies along the length of the tubular scaffold. In addition or in the alternative to any examples disclosed herein, the pitch between adjacent turns of the anti-migration element is wider along a middle region of the tubular scaffold than the pitch between adjacent turns of the anti-migration element along a proximal end region of the tubular scaffold and / or a distal end region of the tubular scaffold.

[0016] In addition to or in place of any of the examples disclosed herein, the migration prevention element may include: a first anti-migration element including a first plurality of helical windings disposed along a proximal end region of the tubular scaffold; and a second anti-migration element including a second plurality of helical windings disposed along a distal end region of the tubular scaffold, the second anti-migration element being longitudinally spaced from the first anti-migration element by an intermediate region of the tubular scaffold.

[0017] In addition to or in lieu of any examples disclosed herein, a method of manufacturing an endoprosthesis for implantation within a blood vessel may include forming a tubular scaffold having a length from one or more filaments interwoven to define gaps therebetween; applying a polymeric coating to at least a portion of the tubular scaffold; positioning the tubular scaffold under a nozzle configured to apply beads of polymeric material onto the polymeric coating; and using the nozzle to apply the beads of polymeric material onto the polymeric coating previously applied to the tubular scaffold such that the beads of polymeric material form anti-migration elements extending radially outward from the polymeric coating and spiraling along at least a portion of the length of the tubular scaffold.

[0018] In addition to or in the alternative to any examples disclosed herein, the method may further include rotating and translating the tubular scaffold longitudinally relative to the nozzle to vary the pitch between adjacent turns of the anti-migration element.

[0019] In addition to or in the alternative to any examples disclosed herein, a method of manufacturing an endoprosthesis for implantation within a blood vessel may include forming a tubular scaffold having a length from one or more filaments interwoven to define gaps therebetween, applying a polymeric coating to at least an intermediate region of the tubular scaffold, helically wrapping a wire around the tubular scaffold over the polymeric coating, securing the wire to an uncoated portion of the tubular scaffold, and then applying a second polymeric coating over the wire and the uncoated portion of the tubular scaffold.

[0020] In addition or in the alternative to any examples disclosed herein, the uncovered portion of the tubular scaffold includes a proximal end region disposed proximal to the intermediate region and a distal end region disposed distal to the intermediate region.

[0021] In addition or in the alternative to any examples disclosed herein, the uncovered portion of the tubular scaffold includes a plurality of attachment points of the tubular scaffold defined by removing a portion of the polymer covering from the tubular scaffold. Securing the wires to the uncovered portion of the tubular scaffold can include securing the wires to the tubular scaffold at the plurality of attachment points.

[0022] The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0023] The present disclosure may be more fully understood from consideration of the following detailed description in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0024] [Figure 1] 1A-1D are schematic diagrams of selected embodiments of endoprostheses. [Diagram 2] FIG. 2 is a detailed view illustrating selected embodiments of the endoprosthesis of FIG. 1. [Diagram 3] 2A-2D depict selected embodiments of the endoprosthesis of FIG. 1. [Figure 4A] 2A-2C are partial cross-sectional views illustrating selected embodiments of the endoprosthesis of FIG. 1. [Figure 4B] 2A-2C are partial cross-sectional views illustrating selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 4C] 2A-2C are partial cross-sectional views illustrating selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 4D] 2A-2C are partial cross-sectional views illustrating selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Diagram 5] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 6] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 7A]7A-7C are partial cross-sectional views illustrating selected embodiments of the endoprosthesis of FIG. 6. [Figure 7B] 7A-7C are partial cross-sectional views illustrating selected aspects of alternative configurations of the endoprosthesis of FIG. 6. [Figure 8] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 8A] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 9] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 9A] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 10] 2A-2D illustrate selected embodiments of a method for making the endoprosthesis of FIG. 1. [Figure 11] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 12] 12A-12D depict selected embodiments of the endoprosthesis of FIG. 11. [Figure 13] 13A-13C are partial cross-sectional views illustrating selected embodiments of the endoprosthesis of FIGS. 11 and 12. [Figure 14] 2A-2D illustrate selected aspects of alternative configurations of the endoprosthesis of FIG. 1. [Figure 15] 15A-15C depict selected embodiments of the endoprosthesis of FIG. 14. [Figure 16] 16A-16C are partial cross-sectional views illustrating selected embodiments of the endoprosthesis of FIGS. 14 and 15. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] While aspects of the present disclosure are amenable to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0026] The following description should be read with reference to the drawings, which are not necessarily to scale, but in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, rather than limit, the present disclosure. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings show exemplary aspects of the present disclosure. However, for clarity and ease of understanding, not all features and / or elements may be shown in each drawing, although it can be understood that the features and / or elements are present unless otherwise specified.

[0027] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values ​​are assumed to be modified by the term "about", whether or not expressly indicated. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numerical contexts) may be assumed to have their normal, customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0028] The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, one of ordinary skill in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0029] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of including "and / or," unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiment. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or described in detail below. It will be understood, however, that the following description may equally apply to any and / or all of the components present in more than one instance, unless expressly stated to the contrary.

[0030] Relative terms such as "proximal," "distal," "advance," "retract," and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retract" indicating or referring to being closer to or toward the user, and "distal" and "advance" indicating or referring to being further from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and such cases will be readily apparent to those of ordinary skill in the art. Other relative terms such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a body lumen, lumen such as a blood vessel, or within a device. Still other relative terms such as "axial," "circumferential," "longitudinal," "lateral," "radial," and / or variations thereof generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structure or device.

[0031] The term "range" can be understood to mean the maximum measurement of a stated or specified dimension, unless the range or dimension is prefaced with or specified as "minimum," which can be understood to mean the minimum measurement of the stated or specified dimension. For example, an "outer range" can be understood to mean an outer dimension, a "radial range" can be understood to mean a radial dimension, and a "longitudinal range" can be understood to mean a longitudinal dimension. Each instance of "range" can be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be clear to one of ordinary skill in the art from the context of the particular use. In general, a "range" can be considered the maximum possible dimension measured according to the intended application, while a "minimum range" can be considered the minimum possible dimension measured according to the intended application. In some cases, a "range" can be generally measured orthogonally in a plane and / or cross section, but can also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), as will be clear from the particular context.

[0032] The terms "monolithic" and "unitary" shall generally refer to an element or elements made up of or consisting of a single structure or base unit / element. Monolithic and / or unitary element shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0033] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," and the like, indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, if a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one of ordinary skill in the art to use the particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with one another to form other additional embodiments or to complement and / or enhance the described embodiments, as would be understood by one of ordinary skill in the art.

[0034] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, modifications and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0035] The figures show selected components and / or arrangements of an endoprosthesis or stent. It should be noted that in any given figure, some features of an endoprosthesis or stent may not be shown or may be shown in schematic form for simplicity. Further details regarding some of the components of an endoprosthesis or stent may be shown in more detail in other figures. It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiment. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated to the contrary. For example, reference to a "filament," "cell," "strut," or other feature may equally refer to all instances and quantities of more than one of that feature. Thus, it will be understood that the following description may equally apply to any and / or all of the components present in more than one endoprosthesis or stent unless expressly stated to the contrary. Moreover, for clarity, not all instances of some elements or features are shown in every figure.

[0036] FIG. 1 is a schematic diagram of an endoprosthesis 10. The term "stent" may be used interchangeably herein with the term "endoprosthesis." Endoprosthesis 10 may be defined by and / or may have a central longitudinal axis 12 extending between a first end 18 and a second end 20. Endoprosthesis 10 may include a tubular scaffold 16 defining an outer surface 14 that is generally cylindrical. Tubular scaffold 16 may extend from a first end 18 to a second end 20. Tubular scaffold 16 may include a lumen extending longitudinally therethrough from the first end 18 to the second end 20. In some embodiments, first end 18 may be a proximal end and second end 20 may be a distal end. In some embodiments, the endoprosthesis 10 and / or the tubular scaffold 16 can include a proximal end region, a distal end region, and an intermediate region extending between the proximal end region and the distal end region. In some embodiments, the proximal end region can include a flared first end (not shown). In some embodiments, the distal end region can include a flared second end (not shown). In some embodiments, the tubular scaffold 16 can include a body portion extending along the intermediate region and / or between the flared first end and the flared second end of the endoprosthesis 10. Other configurations are also envisioned. The endoprosthesis 10 and / or the tubular scaffold 16 can be configured to shift between a radially collapsed configuration and a radially expanded configuration. Thus, the endoprosthesis 10 and / or the tubular scaffold 16 can be radially expandable from a radially constrained delivery configuration to a radially expanded deployed configuration. In some embodiments, the endoprosthesis 10 and / or the tubular scaffolding 16 can be self-expanding, mechanically expandable, or balloon-expandable. Other configurations are also envisioned.

[0037] 2 is an end view of the endoprosthesis 10. In some embodiments, the endoprosthesis 10 and / or the tubular scaffold 16 can be formed from one or more interwoven filaments that define interstices 26 (e.g., openings) therebetween. In some embodiments, the one or more interwoven filaments can include a first filament 22 that extends around the central longitudinal axis 12 in a first helical direction and a second filament 24 that extends around the central longitudinal axis 12 in a second helical direction. In some embodiments, the one or more interwoven filaments can include a plurality of first filaments that extend around the central longitudinal axis 12 in a first helical direction and a plurality of second filaments that extend around the central longitudinal axis 12 in a second helical direction. In some embodiments, the one or more interwoven filaments can form a braided tubular scaffold. In such embodiments, a first filament crosses over and / or under the second filament at multiple crossing locations. The one or more interwoven filaments can define the outer surface 14 (e.g., FIG. 1) of the endoprosthesis 10. In some embodiments, the one or more interwoven filaments can include a wire(s), a thread(s), a strand(s), or the like.

[0038] In some embodiments, one or more interwoven filaments may extend in a helical direction, crossing over and under one another along the length of the tubular scaffold 16. In some embodiments, the first filament 22 and / or the plurality of first filaments may extend in a first helical path about the central longitudinal axis 12 in a first direction (e.g., a first helical direction) from the first end 18 toward and / or to the second end 20. In some embodiments, the first direction may be clockwise. In some embodiments, the second filament 24 and / or the plurality of second filaments may extend in a second helical path about the central longitudinal axis 12 in a second direction (e.g., a second helical direction) from the first end 18 toward and / or to the second end 20. In some embodiments, the second direction may be opposite to the first direction. In some embodiments, the second direction may be counterclockwise. Other configurations are envisioned.

[0039] In some alternative configurations, the endoprosthesis 10 and / or tubular scaffold 16 may be cut from a tube as a monolithic structure. In some alternative configurations, the endoprosthesis and / or tubular scaffold 16 may be cut from a flat sheet, rolled to form a tubular structure / shape, and then welded together to form the tubular scaffold 16. In some alternative configurations, the endoprosthesis 10 and / or tubular scaffold 16 may be knitted, woven, or otherwise assembled. Other configurations are also envisioned. Some suitable, but non-limiting, materials for the endoprosthesis 10, tubular scaffold 16, first filament 22, second filament 24, and / or components or elements thereof, e.g., metallic and / or polymeric materials, are discussed below.

[0040] The endoprosthesis 10 and / or the tubular scaffold 16 can be substantially tubular and / or can include a lumen extending axially through the endoprosthesis 10 and / or the tubular scaffold 16 along a central longitudinal axis 12 of the endoprosthesis 10 and / or the tubular scaffold 16 from a first end 18 to a second end 20. In some embodiments, the endoprosthesis 10 and / or the tubular scaffold 16 can have a length measured from the first end 18 to the second end 20 of about 20 millimeters to about 250 millimeters, about 40 millimeters to about 225 millimeters, about 60 millimeters to about 200 millimeters, about 80 millimeters to about 175 millimeters, about 100 millimeters to about 150 millimeters, or another suitable range. In some embodiments, the endoprosthesis 10 and / or tubular scaffolding 16 can have an outer radial dimension or range between about 2 millimeters and about 30 millimeters, between about 5 millimeters and about 25 millimeters, between about 8 millimeters and about 20 millimeters, between about 10 millimeters and about 15 millimeters, or another suitable range. Other configurations are also contemplated.

[0041] In some embodiments, the endoprosthesis 10 can be used in conjunction with a stent delivery system (not shown) for delivery and / or implantation of the endoprosthesis 10 into a body lumen. The system can include an elongated tubular member (e.g., an outer tubular member) having a lumen extending therein and / or therethrough. In some alternative embodiments, the elongated tubular member can include multiple lumens extending therein and / or therethrough. In at least some embodiments, the system can include an elongated inner member disposed within the lumen of the elongated tubular member. In some embodiments, the elongated inner member can be a tubular member having a lumen extending therein and / or therethrough. In some embodiments, the lumen of the elongated inner member can be a guidewire lumen. In some embodiments, the lumen of the elongated inner member can be used for irrigation and / or aspiration. Other configurations are also envisioned. In some alternative embodiments, the elongated inner member can be a solid shaft.

[0042] In some embodiments, the elongate inner member may be axially movable relative to the elongate tubular member. In some embodiments, the elongate inner member may be proximally movable relative to the elongate inner member. For example, the elongate inner member may be held in a fixed position while the elongate tubular member is withdrawn proximally. In some embodiments, the elongate tubular member and the elongate inner member may be configured to be advanced together and / or simultaneously to the target site. In at least some embodiments, during advancement to the target site, the elongate tubular member and the elongate inner member may be disposed and / or held in an axially fixed relationship relative to one another. Other configurations are envisioned.

[0043] In some embodiments, endoprosthesis 10 can be disposed within the lumen of the elongated tubular member in a radially folded configuration. In some embodiments, the elongated tubular member can constrain endoprosthesis 10 in the folded configuration when endoprosthesis 10 is disposed within the lumen of the elongated tubular member. In some embodiments, endoprosthesis 10 can be radially disposed between the elongated tubular member and an elongated inner member. In some embodiments, endoprosthesis 10 can be attached to, crimped onto, and / or otherwise retained by the elongated inner member. Other configurations are also envisioned.

[0044] During delivery to a treatment site, endoprosthesis 10 and / or tubular scaffold 16 can be disposed within the lumen of the elongate tubular member in a radially collapsed configuration. Upon removal and / or release of the elongate tubular member from the lumen, endoprosthesis 10 and / or tubular scaffold 16 can and / or can shift from the radially collapsed configuration to a radially deployed configuration.

[0045] In some embodiments, the endoprosthesis 10 can include a polymeric coating 30 extending along and / or secured to the tubular scaffold 16, as seen in FIG. 3 . In some embodiments, the tubular scaffold 16 can be completely covered with the polymeric coating 30. In some embodiments, the polymeric coating 30 can be coterminous with the tubular scaffold 16. In some embodiments, the polymeric coating 30 can be rigidly secured, bonded, or otherwise attached along and / or around the circumference of the tubular scaffold 16. In some embodiments, the polymeric coating 30 can be rigidly secured, bonded, or otherwise attached to the tubular scaffold 16 at least some of the locations where the polymeric coating 30 contacts the tubular scaffold 16. In some embodiments, the polymeric covering 30 may be rigidly secured, bonded, or otherwise attached to the tubular scaffold 16 at each and every location where the polymeric covering 30 contacts the tubular scaffold 16. In some embodiments, the tubular scaffold 16, one or more interwoven filaments, first filaments 22, second filaments 24, etc., and / or portions thereof may be at least partially embedded within the polymeric covering 30. Other configurations are envisioned.

[0046] In some embodiments, the polymeric coating 30 can extend along the entire length of the endoprosthesis 10 and / or tubular scaffold 16. In some embodiments, the polymeric coating 30 can extend along a portion of the length of the endoprosthesis 10 and / or tubular scaffold 16. In some embodiments, the polymeric coating 30 can extend continuously from a first end 18 of the endoprosthesis 10 and / or tubular scaffold 16 to a second end 20 of the endoprosthesis 10 and / or tubular scaffold 16. Other configurations are envisioned. Some suitable, but non-limiting, materials, e.g., polymeric materials, for the polymeric coating 30 are discussed below.

[0047] In some embodiments, the endoprosthesis 10 can include anti-migration elements 40 extending radially outward from the tubular scaffold 16. In some embodiments, the anti-migration elements 40 can extend radially outward from the polymeric covering 30. In some embodiments, the anti-migration elements 40 can be rigidly secured, bonded, or otherwise attached to the tubular scaffold 16 and / or the polymeric covering 30. In at least some embodiments, the anti-migration elements 40 can extend helically in a first helical direction (e.g., clockwise) along at least a portion of the length of the tubular scaffold 16. In some embodiments, the tubular scaffold 16, or a portion thereof, can maintain a constant outer diameter, and the anti-migration elements 40 extend radially outward from the constant outer diameter of the tubular scaffold 16.

[0048] In some embodiments, the migration prevention element 40 may be formed from a polymeric material. In some embodiments, the migration prevention element 40 may be applied and / or bonded to the outer surface of the polymeric coating 30 during a subsequent manufacturing step after the polymeric coating 30 is applied to the tubular scaffold 16 and cured. In some embodiments, the migration prevention element 40 may be formed from a polymeric material bead applied over the polymeric coating 30. Several suitable but non-limiting materials, e.g., polymeric materials, for the migration prevention element 40 and / or the polymeric material bead are discussed below. In one non-limiting example, the migration prevention element 40 and / or the polymeric material bead may be formed from silicone or polyamide. In some embodiments, the migration prevention element 40 and / or the polymeric material bead may be formed from the same polymeric material as the polymeric coating 30 or a different polymeric material than the polymeric coating 30. Other configurations are also envisioned.

[0049] In some embodiments, the migration prevention element 40 may be bioabsorbable. Additionally / alternatively, the migration prevention element 40 may include a bioabsorbable material. In some embodiments, the migration prevention element 40 may include an adhesive material and / or a bioadhesive material. In some embodiments, the bioadhesive material may include natural polymeric materials, as well as synthetic materials and synthetic materials formed from biological monomers, such as sugars. In some embodiments, the bioadhesive is designed to adhere to biological tissue. For example, the migration prevention element 40 may be configured to adhere to tissue in situ. Some examples of bioadhesives may include, but are not limited to, mucoadhesives, aminoadhesives, adhesive surface proteins, adhesive modified polymers, catechol moieties, polymeric materials, polysaccharides, hydrogels, crosslinked or non-crosslinked minigel particles, and the like, as well as mixtures and / or combinations thereof.

[0050] In some embodiments, the endoprosthesis 10 can be delivered with the adhesive and / or bioadhesive in a substantially inactive state. In the substantially inactive state, the adhesive and / or bioadhesive can exhibit non-reactive and / or non-adhesive properties to adjacent elements of the endoprosthesis 10, the stent delivery system, and / or the body lumen. For example, in the substantially inactive state, the adhesive and / or bioadhesive can not adhere to the endoprosthesis, the elongate inner member, and / or the elongate tubular member. Additionally, in the substantially inactive state, the adhesive and / or bioadhesive can not adhere to the body lumen. In some embodiments, in the substantially inactive state, the adhesive and / or bioadhesive can be substantially dry, dehydrated, or devoid of moisture. In some embodiments, the adhesive and / or bioadhesive can be activated by adding or introducing a fluid(s), moisture, and / or a selected type of fluid to the adhesive and / or bioadhesive. In situations and / or configurations in which the adhesive and / or bioadhesive material becomes "sticky," "tacky," etc., to adjacent structures and / or elements, it may be assumed that the adhesive and / or bioadhesive material is no longer in a substantially inactive state.

[0051] In some embodiments, the adhesive and / or bioadhesive can be activated by wetting the adhesive and / or bioadhesive with a fluid. In other examples, the adhesive and / or bioadhesive can be activated by another stimulus. In at least some embodiments, the adhesive and / or bioadhesive can be pressure sensitive. In some embodiments, the adhesive and / or bioadhesive can be disposed radially outward of the endoprosthesis 10, the tubular scaffold 16, and / or the polymeric coating 30. In some embodiments, the pressure sensitive adhesive and / or bioadhesive can be activated by a radially outward expansive force applied to the adhesive and / or bioadhesive by the endoprosthesis 10 and / or the tubular scaffold 16 after deployment of the endoprosthesis 10. Other configurations are also envisioned.

[0052] 4A-4D show examples of cross-sectional shapes of the migration preventing element 40. The migration preventing element 40 can include a base 42 disposed directly adjacent to a radially outwardly facing surface of the tubular scaffold 16 and / or the polymeric covering 30. In some embodiments, the migration preventing element 40 can have a cross-sectional shape having a radially outwardly facing surface (e.g., a radially outwardly facing surface) 44 that is convexly curved, as seen in FIG. 4A. In some embodiments, the cross-sectional shape of the migration preventing element 40 can be dome-shaped, arched, and / or hemispherical. In some embodiments, the migration preventing element 40 can have a cross-sectional shape having a radially outwardly facing surface 44 that is flat or planar, as seen in FIG. 4B. In some embodiments, the cross-sectional shape of the migration preventing element 40 can be polygonal, square, rectangular, trapezoidal, etc. In some embodiments, the radially outer surface (e.g., radially outwardly facing surface) 44 may not have an intersection with the tubular scaffold 16 and / or the polymeric covering 30 and / or may not be in direct contact with the tubular scaffold 16 and / or the polymeric covering 30. For example, in some embodiments, the radially outer surface 44 of the migration preventing element 40 may be radially spaced from the base 42 of the migration preventing element 40 by a side surface 46 of the migration preventing element 40. The side surface 46 may be separate from and / or distinguishable from the radially outer surface 44. For example, the side surface 46 may intersect the base 42 and / or the radially outer surface 44 at a non-zero angle, such as perpendicular or oblique.

[0053] In some embodiments, the anti-migration element 40 may have a cross-sectional shape with a first circumferential width at the base 42 and a second circumferential width at a radially outer tip that is greater than the first circumferential width at the base 42, as seen in Figures 4C and 4D. In some embodiments, the cross-sectional shape of the anti-migration element 40 has a flat radially outer surface 44 at the radially outer tip (e.g., Figure 4C). In some embodiments, the cross-sectional shape of the anti-migration element 40 has a curved radially outer surface 44, such as a convex or concave curvature, at the radially outer tip (e.g., Figure 4D). Other configurations are also envisioned.

[0054] In some embodiments, the migration preventing element 40 can extend continuously from a proximal end of the migration preventing element 40 to a distal end of the migration preventing element 40, for example, as seen in FIG. 3. In some cases, a first end of the migration preventing element 40 can be disposed proximate a first end 18 of the endoprosthesis 10 or tubular scaffold 16, and / or a second end of the migration preventing element 40 can be disposed proximate a second end 20 of the endoprosthesis 10 and / or tubular scaffold 16. In some embodiments, the migration preventing element 40 can extend intermittently and / or discontinuously from a proximal end of the migration preventing element 40 to a distal end of the migration preventing element 40 such that the multiple independent segments 41 of the migration preventing element 40 are spaced apart from one another, for example, as seen in FIG. 5. Thus, a portion of the outer surface of the polymeric covering 30 can appear helical between adjacent segments of the multiple independent segments 41 of the migration preventing element 40. In at least some embodiments, multiple individual segments 41 of anti-migration element 40 can be circumferentially spaced apart from one another.

[0055] In some embodiments, each segment of the multiple independent segments 41 of the anti-migration element 40 can extend circumferentially for more than one complete revolution around the circumference of the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the anti-migration element 40 can extend along an arc length of at least 360 degrees around the circumference of the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the anti-migration element 40 can extend along an arc length of about 360 degrees around the circumference of the tubular scaffold 16.

[0056] In some embodiments, each segment of the multiple independent segments 41 of the migration preventing element 40 may extend circumferentially for less than one complete revolution around the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the migration preventing element 40 may extend along an arc length less than 360 degrees around the circumference of the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the migration preventing element 40 may extend along an arc length less than or equal to 180 degrees around the circumference of the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the migration preventing element 40 may extend along an arc length less than or equal to 90 degrees around the circumference of the tubular scaffold 16. In some embodiments, each segment of the multiple independent segments 41 of the migration preventing element 40 may extend along an arc length less than or equal to 45 degrees around the circumference of the tubular scaffold 16. Other configurations are envisioned.

[0057] In some embodiments, the endoprosthesis 10 can include a second migration preventing element 50 extending radially outward from the tubular scaffold 16, as seen in FIG. 6. In some embodiments, the second migration preventing element 50 can extend radially outward from an outer surface (e.g., a radially outward surface) of the polymeric covering 30. In some embodiments, the second migration preventing element 50 can be rigidly secured, bonded, or otherwise attached to the tubular scaffold 16 and / or the polymeric covering 30. In at least some embodiments, the second migration preventing element 50 can extend helically in a second helical direction (e.g., counterclockwise) opposite the first helical direction along at least a portion of the length of the tubular scaffold 16 such that the migration preventing element 40 intersects with the second migration preventing element 50 at one or more, i.e., multiple, intersection points 52.

[0058] In some embodiments, the second migration preventing element 50 may be formed from a polymeric material. In some embodiments, the second migration preventing element 50 may be applied and / or bonded to the outer surface of the polymeric coating 30 during a subsequent manufacturing step after the polymeric coating 30 is applied to the tubular scaffold 16 and cured. In some embodiments, the second migration preventing element 50 may be formed from a polymeric material bead applied over the polymeric coating 30. Several suitable but non-limiting materials, e.g., polymeric materials, for the second migration preventing element 50 and / or the polymeric material bead are discussed below. In one non-limiting example, the second migration preventing element 50 and / or the polymeric material bead may be formed from silicone or polyamide. In some embodiments, the second migration preventing element 50 and / or the polymeric material bead may be formed from the same polymeric material as the polymeric coating 30 or a different polymeric material than the polymeric coating 30. In some embodiments, the second migration preventing element 50 may be formed from the same polymeric material as the migration preventing element 40. Alternatively, second anti-migration element 50 may be formed from a different polymeric material than anti-migration element 40. Other configurations are also envisioned.

[0059] In some embodiments, the second migration preventing element 50 may be bioabsorbable. And / or the second migration preventing element 50 may include a bioabsorbable material. In some embodiments, the second migration preventing element 50 may include an adhesive material and / or a bioadhesive material similar to the adhesive material and / or bioadhesive material described herein with respect to the migration preventing element 40. In some embodiments, the second migration preventing element 50 may have a cross-sectional shape similar to the cross-sectional shape of the migration preventing element 40. In some embodiments, the second migration preventing element 50 may have a cross-sectional shape that is the same as the cross-sectional shape of the migration preventing element 40. In some embodiments, the second migration preventing element 50 may have a cross-sectional shape that is different from the cross-sectional shape of the migration preventing element 40. The structural features and / or details regarding the cross-sectional shape of the second migration preventing element 50 may be similar to those described herein with respect to the migration preventing element 40 and FIGS. 4A-4D. They will not be repeated for the sake of brevity.

[0060] In some embodiments, the anti-migration element 40 can extend a first radial distance R1 outward from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 between the intersections of the plurality of intersections 52, as seen in FIG. 6 . In some embodiments, the second anti-migration element 50 can extend a first radial distance R1 outward from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 between the intersections of the plurality of intersections 52. In some embodiments, the anti-migration element 40 and the second anti-migration element 50 can each extend a first radial distance R1 outward from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 between the intersections of the plurality of intersections 52.

[0061] In some embodiments, the plurality of nodes 52 extend outwardly from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a first radial distance R1, as seen in FIG. In some embodiments, at least some of the plurality of nodes 52 extend outwardly from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a first radial distance R1. In some embodiments, each of the plurality of nodes 52 extends outwardly from an outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a first radial distance R1. In at least some embodiments, the migration prevention element 40 and the second migration prevention element 50 intersect and do not overlap each other at the plurality of nodes 52. Thus, the first radial distance R1 is maintained at the plurality of nodes 52.

[0062] In some embodiments, the plurality of nodes 52 extend outwardly from the outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a second radial distance R2, as seen in FIG. 7B. In some embodiments, at least some of the plurality of nodes 52 extend outwardly from the outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a second radial distance R2. In some embodiments, each of the plurality of nodes 52 extends outwardly from the outer surface of the tubular scaffold 16 and / or the polymeric covering 30 a second radial distance R2. In at least some embodiments, the migration preventing element 40 and the second migration preventing element 50 cross and overlap each other at the plurality of nodes 52. For example, the second migration preventing element 50 may overlap the migration preventing element 40, or vice versa. Thus, the multiple intersections 52 extend outwardly from the outer surface of the tubular scaffold 16 and / or polymeric covering 30 a second radial distance R2. In some embodiments, the second radial distance R2 can be about twice the first radial distance R1. In some embodiments, the second radial distance R2 can be less than twice the first radial distance R1. Other configurations are envisioned. In all embodiments in which the second migration prevention element 50 overlaps with the migration prevention element 40, or vice versa, the second radial distance R2 is greater than the first radial distance R1.

[0063] In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 4.0 millimeters. In some embodiments where the second radial distance R2 is about 4.0 millimeters, the first radial distance R1 is less than 4.0 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 3.5 millimeters. In some embodiments where the second radial distance R2 is about 3.5 millimeters, the first radial distance R1 is less than 3.5 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 3.0 millimeters. In some embodiments where the second radial distance R2 is about 3.0 millimeters, the first radial distance R1 is less than 3.0 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 2.5 millimeters. In some embodiments where the second radial distance R2 is about 2.5 millimeters, the first radial distance R1 is less than 2.5 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 2.0 millimeters. In embodiments where the second radial distance R2 is about 2.0 millimeters, the first radial distance R1 is less than 2.0 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 1.5 millimeters. In embodiments where the second radial distance R2 is about 1.5 millimeters, the first radial distance R1 is less than 1.5 millimeters. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 1.0 millimeters. In embodiments where the second radial distance R2 is about 1.0 millimeters, the first radial distance R1 is less than 1.0 millimeters. Other configurations are also envisioned.

[0064] In some embodiments, the pitch between adjacent turns of the migration preventing element 40 and / or the second migration preventing element 50 can vary along the length of the tubular scaffold 16. In some embodiments, as seen in FIG. 8 , the pitch between adjacent turns of the migration preventing element 40 and / or the second migration preventing element 50 along a mid-region and / or body portion of the tubular scaffold 16 is wider and larger than the pitch between adjacent turns of the migration preventing element 40 and / or the second migration preventing element 50 along a proximal end region of the tubular scaffold 16 and / or a distal end region of the tubular scaffold 16. 8A , the pitch between adjacent turns of the migration preventing element 40 and / or the pitch between adjacent turns of the second migration preventing element 50 along the intermediate region and / or body portion of the tubular scaffold 16 is wider and larger than the pitch between adjacent turns of the migration preventing element 40 and / or the pitch between adjacent turns of the second migration preventing element 50 along the flared first end 17 of the tubular scaffold 16 and / or the flared second end 19 of the tubular scaffold 16. In other embodiments, the pitch between adjacent turns of the migration preventing element 40 and / or the pitch between adjacent turns of the second migration preventing element 50 along the proximal end region of the tubular scaffold 16 and / or the distal end region of the tubular scaffold 16 is wider and larger than the pitch between adjacent turns of the migration preventing element 40 and / or the second migration preventing element 50 along the intermediate region and / or body portion of the tubular scaffold 16. In some embodiments, the pitch between adjacent turns of the anti-migration element 40 and / or the pitch between adjacent turns of the second anti-migration element 50 along the flared first end 17 of the tubular scaffold 16 and / or the flared second end 19 of the tubular scaffold 16 is wider and / or larger than the pitch between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the intermediate region and / or body portion of the tubular scaffold 16. Note that the pitch of the other helical anti-migration elements described herein can also be varied along the length of the tubular scaffold 16 in a similar manner. Other configurations are envisioned.

[0065] In some embodiments, the migration preventing element can include a proximal migration preventing element 60 including a first plurality of helical windings 62 disposed along a proximal end region of the tubular scaffold 16, as seen in FIG. 9 , and a distal migration preventing element 66 including a second plurality of helical windings 68 disposed along a distal end region of the tubular scaffold 16, the distal migration preventing element 66 being longitudinally spaced from the proximal migration preventing element 60 by a middle region of the tubular scaffold 16. In some embodiments, the migration preventing element may include a proximal migration preventing element 60 including a first plurality of helical windings 62 disposed along the flared first end 17 of the tubular scaffold 16, as seen in FIG 9A, and a distal migration preventing element 66 including a second plurality of helical windings 68 disposed along the flared second end 19 of the tubular scaffold 16, the distal migration preventing element 66 being longitudinally spaced from the proximal migration preventing element 60 by a mid-region of the tubular scaffold 16. Other configurations are envisioned.

[0066] A method of manufacturing an endoprosthesis 10 for implantation within a blood vessel can include forming a tubular scaffold 16 from one or more interwoven filaments defining interstices therebetween, as described herein. The method can include applying a polymeric coating 30 to at least a portion of the tubular scaffold 16. In some embodiments, the method can include applying the polymeric coating 30 along the entire length of the tubular scaffold 16, such as via a spray coating or dip coating process.

[0067] In some embodiments, a method of forming an endoprosthesis 10 can include placing a tubular scaffold 16 previously coated with a polymeric coating 30 under a nozzle 100 configured to apply beads of polymeric material onto the tubular scaffold 16 and / or the polymeric coating 30, as seen in FIG. 10. In some embodiments, the method can include applying beads of polymeric material onto the tubular scaffold 16 and / or the polymeric coating 30 previously applied to the tubular scaffold 16 using the nozzle 100 such that the beads of polymeric material form anti-migration elements 40 extending radially outward from the tubular scaffold 16 and / or the polymeric coating 30. In some embodiments, the method may include applying a bead of second polymeric material using the nozzle 100 onto the tubular scaffold 16 and / or polymeric coating 30 previously applied to the tubular scaffold 16 such that the bead of second polymeric material forms a second migration preventing element 50 extending radially outward from the tubular scaffold 16 and / or polymeric coating 30. In some embodiments, the method may include rotating and translating the tubular scaffold 16 longitudinally relative to the nozzle 100 as the polymeric material is emitted from the nozzle 100 to form a helical configuration of the migration preventing element 40 and / or the second migration preventing element 50. In some cases, the rotational speed and / or longitudinal speed may be held constant to provide a uniform pitch between the windings of the migration preventing element and / or the second migration preventing element 50. In other examples, the rotational speed and / or longitudinal speed may be varied to change the pitch between adjacent windings of anti-migration element 40 (e.g., as seen in Figures 8-9A) and / or second anti-migration element 50.

[0068] In some embodiments, the anti-migration element 40 may include a wire 70 extending along the outer surface 14 of the tubular scaffold 16 and / or the outer surface of the polymeric coating 30, as seen in FIGS. 11-16. In some embodiments, the wire 70 may be formed from a metallic material. In some embodiments, the wire 70 may be formed from a polymeric material. In some embodiments, the wire 70 may be formed from a composite material. In some embodiments, the tubular scaffold 16 and the wire 70 may both be formed from a metallic material. In some embodiments, the tubular scaffold 16 and the wire 70 may both be formed from a polymeric material. In some embodiments, the tubular scaffold 16 and the wire 70 may both be formed from a composite material. Other configurations are also envisioned, including, but not limited to, the tubular scaffold 16 and the wire 70 formed from different materials.

[0069] In some embodiments, a method of manufacturing an endoprosthesis 10 for implantation within a blood vessel can include forming a tubular scaffold 16 from one or more interwoven filaments defining gaps therebetween, as described herein. The method can include applying a polymer coating 30 to at least an intermediate portion of the tubular scaffold 16, as seen in FIG. 11, thus leaving proximal and / or distal end regions of the tubular scaffold 16 bare or uncovered. In some embodiments, the method can include applying the polymer coating 30 along the entire length of the tubular scaffold 16. In some embodiments, the method can include leaving at least a portion of the proximal end region and at least a portion of the distal end region of the tubular scaffold 16 uncovered by the polymer coating 30, such that the proximal and / or end regions of the tubular scaffold 16 remain bare. In some embodiments, the method may include helically wrapping the wire 70 around the tubular scaffold 16 over the polymer coating 30 after applying the polymer coating 30 to the tubular scaffold 16. In some embodiments, the method may include securing the wire 70 to an uncoated portion of the tubular scaffold 16. In some embodiments, the uncoated portion of the tubular scaffold 16 may include a proximal end region disposed proximal to the mid-region and / or a distal end region disposed distal to the mid-region. In some embodiments, the method may include securing the wire 70 to the uncoated portions of the proximal end region and the distal end region of the tubular scaffold 16. In some embodiments, securing the wire 70 to the uncoated portion of the tubular scaffold 16 may include fixedly attaching, adhesively bonding, welding, brazing, reflowing, etc. the wire 70 to the uncoated portion of the tubular scaffold 16.

[0070] In at least some embodiments, the method may then include applying a second polymer coating 80 over the wires 70 and polymer coating 30 and uncoated portions of the tubular scaffold 16, as seen in FIG. 12. In some embodiments, the method may then include applying a second polymer coating 80 over the wires 70 and polymer coating 30 and uncoated portions of the proximal and distal end regions of the tubular scaffold 16. In some embodiments, applying the second polymer coating 80 over the wires 70 may form and / or define the migration prevention elements 40, as shown in FIG. 13. In some embodiments, the wires 70 may be at least partially embedded within and / or at least partially surrounded by the migration prevention elements 40. In some embodiments, the tubular scaffold 16 and wires 70 may be completely surrounded by the combination of the polymer coating 30 and the second polymer coating 80, and / or may be embedded within and / or between the combination of the polymer coating 30 and the second polymer coating 80.

[0071] Several suitable, but non-limiting, materials, e.g., polymeric materials, for the second polymer coating 80 are discussed below. In some embodiments, the second polymer coating 80 may be formed as an additional layer of the polymer coating 30. In some embodiments, the second polymer coating 80 may be formed from the same polymeric material as the polymer coating 30. In some embodiments, the second polymer coating 80 may be formed from a different polymeric material than the polymer coating 30. Other configurations are also envisioned.

[0072] In some embodiments, a method of manufacturing an endoprosthesis 10 for implantation in a blood vessel can include forming a tubular scaffold 16 from one or more interwoven filaments defining gaps therebetween, as described herein. The method can include applying a polymeric coating 30 to at least an intermediate portion of the tubular scaffold 16, as seen in FIG. 14, thus leaving proximal and / or distal end regions of the tubular scaffold 16 bare or uncoated. In some embodiments, the method can include applying the polymeric coating 30 along the entire length of the tubular scaffold 16. In some embodiments, the method can include wrapping a wire 70 helically around the tubular scaffold 16 over the polymeric coating 30 after applying the polymeric coating 30 to the tubular scaffold 16. In some embodiments, the method can include securing the wire 70 to the uncoated portion of the tubular scaffold 16. In some embodiments, the uncoated portion of the tubular scaffold 16 may include a plurality of attachment points 90 of the tubular scaffold 16 defined by removing a portion of the polymer coating 30 from the tubular scaffold 16. In some embodiments, the plurality of attachment points 90 may include an uncoated portion of a proximal end region disposed proximal to the mid-region and / or a distal end region disposed distal to the mid-region. In some embodiments, securing the wire 70 to the uncoated portion of the tubular scaffold 16 may include securing the wire 70 to the tubular scaffold 16 at the plurality of attachment points 90. In some embodiments, securing the wire 70 to the uncoated portion of the tubular scaffold 16 may include fixedly attaching, adhesively bonding, welding, brazing, reflowing, etc. the wire 70 to the uncoated portion of the tubular scaffold 16. In some embodiments, securing the wires 70 to the uncoated portion of the tubular scaffold 16 can include fixedly attaching, adhesively bonding, welding, brazing, reflowing, etc. the wires 70 to the tubular scaffold 16 at a plurality of attachment points 90.

[0073] In at least some embodiments, the method may then include applying a second polymer coating 80 over the wires 70 and polymer coating 30 and uncoated portions of the tubular scaffold 16, as seen in FIG. 15. In some embodiments, the method may then include applying a second polymer coating 80 over the wires 70 and polymer coating 30 and the plurality of attachment points 90. In some embodiments, applying the second polymer coating 80 over the wires 70 and the plurality of attachment points 90 may form and / or define the migration prevention element 40, as shown in FIG. 16. In some embodiments, the wires 70 may be at least partially embedded within and / or at least partially surrounded by the migration prevention element 40. In some embodiments, the tubular scaffold 16 and wires 70 may be completely surrounded by the combination of the polymer coating 30 and the second polymer coating 80, and / or may be embedded within and / or between the combination of the polymer coating 30 and the second polymer coating 80.

[0074] Several suitable, but non-limiting, materials, e.g., polymeric materials, for the second polymer coating 80 are discussed below. In some embodiments, the second polymer coating 80 may be formed as an additional layer of the polymer coating 30. In some embodiments, the second polymer coating 80 may be formed from the same polymeric material as the polymer coating 30. In some embodiments, the second polymer coating 80 may be formed from a different polymeric material than the polymer coating 30. Other configurations are also envisioned.

[0075] The various components of the systems disclosed herein and materials that can be used for the various elements thereof may include those commonly associated with medical devices. For purposes of simplicity, the following description refers to systems. However, this is not intended to limit the systems, devices, and / or methods described herein, and the discussion may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, endoprostheses, tubular scaffolds, polymeric covering(s), anti-migration element(s), wires, etc., and / or elements or components thereof.

[0076] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials.

[0077] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates, and / or other polyester elastomers such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), ... (registered trademark)), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the system and / or components thereof can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0078] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as INCONEL® 625; UNS:N06022, such as HASTELLOY® C-22®; HASTELLOY® C276®); (UNS:N10276 such as HASTELLOY® alloys, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® alloys, other HASTELLOY® alloys, etc.), nickel-cobalt alloys (e.g., UNS:N10276 such as HASTELLOY® alloys, other HASTELLOY® alloys, B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), platinum-rich stainless steels, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0079] In at least some embodiments, some or all of the system and / or its components may also be doped with, made of, or otherwise include radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the system in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the system to achieve the same results.

[0080] In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the systems and / or components or portions thereof may be made of materials that do not substantially distort the image and do not cause substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may cause artifacts in the MRI image. The systems or portions thereof may also be made of materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, etc., and others.

[0081] In some embodiments, the systems and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be comprised of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE), ePTFE), polyolefin-based materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0082] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. Additionally, at least one of the synthetic yarns may be a metal yarn, glass or ceramic yarn, or fiber. Useful metal yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr based alloys. The yarns may further include carbon fibers, glass fibers, or ceramic fibers. Desirably, the yarns are made from thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarns may be of the multifilament, monofilament, or spun type. The type and denier of the yarn selected may be selected to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure, having desirable properties.

[0083] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and and ropivacaine); anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation enhancers); vascular cell growth inhibitors (growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin, etc.); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0084] It will be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, using any of the features of one exemplary embodiment in other embodiments. The scope of the present disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An endoprosthesis for implantation into a blood vessel, comprising: The endoprosthesis comprises a tubular scaffold having a length, the tubular scaffold formed from one or more filaments interwoven to define interstices therebetween, the tubular scaffold configured to shift between a radially collapsed configuration and a radially expanded configuration; The endoprosthesis comprises a polymeric covering secured to the tubular scaffold; The endoprosthesis includes an anti-migration element extending radially outward from the tubular scaffold; the anti-migration element extends helically in a first helical direction along at least a portion of the length of the tubular scaffold.

2. 2. The endoprosthesis of claim 1, wherein the anti-migration element has a cross-sectional shape having a first circumferential width at a base and a second circumferential width at a radially outer tip that is greater than the first width.

3. The endoprosthesis of claim 2 , wherein the cross-sectional shape has a flat radially outer surface at the radially outer tip.

4. the anti-migration element includes a wire extending along an outer surface of the tubular scaffold; The endoprosthesis of claim 1 , wherein the wires are secured to the tubular scaffold at multiple attachment points.

5. The endoprosthesis of claim 4 , further comprising a second polymeric coating disposed over the wire and the plurality of attachment points.

6. the anti-migration element extends discontinuously from a proximal end of the anti-migration element to a distal end of the anti-migration element such that a plurality of separate segments of the anti-migration element are spaced apart from one another; The endoprosthesis of any one of claims 1 to 3, wherein each segment of the plurality of independent segments extends circumferentially for less than one complete revolution around the tubular scaffold.

7. a second anti-migration element extending radially outward from the tubular scaffold; 4. The endoprosthesis of any one of claims 1-3, wherein the second anti-migration element extends helically in a second helical direction opposite the first helical direction along at least a portion of the length of the tubular scaffold such that the anti-migration element intersects the second anti-migration element at multiple intersections.

8. the anti-migration element and the second anti-migration element each extend a first radial distance outward from the tubular scaffold between intersections; The endoprosthesis of claim 7 , wherein the plurality of nodes extend outwardly from the tubular scaffold the first radial distance.

9. the anti-migration element and the second anti-migration element each extend a first radial distance outward from the tubular scaffold between intersections; 8. The endoprosthesis of claim 7, wherein the plurality of intersections extend outwardly from the tubular scaffold a second radial distance that is greater than the first radial distance.

10. The endoprosthesis of any one of claims 1-9, wherein a pitch between adjacent turns of the anti-migration element varies along the length of the tubular scaffold.

11. the anti-migration element comprises a first anti-migration element, the first anti-migration element comprising a first plurality of helical windings disposed along a proximal end region of the tubular scaffold; the anti-migration element includes a second anti-migration element including a second plurality of helical windings disposed along a distal end region of the tubular scaffold; The endoprosthesis of any one of claims 1-10, wherein the second anti-migration element is longitudinally spaced from the first anti-migration element by an intermediate region of the tubular scaffold.

12. 1. A method of manufacturing an endoprosthesis for implantation in a blood vessel, comprising: forming a tubular scaffold having a length from one or more filaments interwoven to define gaps therebetween; applying a polymeric coating to at least a portion of the tubular scaffold; placing the tubular scaffold under a nozzle configured to apply beads of polymeric material onto the polymer coating; applying a polymeric material bead onto the polymeric coating previously applied to the tubular scaffold using the nozzle such that the polymeric material bead forms an anti-migration element extending radially outward from the polymeric coating and spiraling along at least a portion of the length of the tubular scaffold; A method comprising:

13. 1. A method of manufacturing an endoprosthesis for implantation in a blood vessel, comprising: forming a tubular scaffold having a length from one or more filaments interwoven to define gaps therebetween; applying a polymeric coating to at least an intermediate region of the tubular scaffold; helically wrapping a wire around the tubular scaffold over the polymer coating; securing the wire to an uncovered portion of the tubular scaffold; thereafter, applying a second polymer coating over the wire and the uncoated portion of the tubular scaffold; A method comprising:

14. 14. The method of claim 13, wherein the uncovered portion of the tubular scaffold comprises a proximal end region disposed proximal to the intermediate region and a distal end region disposed distal to the intermediate region.

15. the uncovered portion of the tubular scaffold comprises a plurality of attachment points of the tubular scaffold defined by removing a portion of the polymer covering from the tubular scaffold; 14. The method of claim 13, wherein securing the wire to the uncovered portion of the tubular scaffold comprises securing the wire to the tubular scaffold at the plurality of attachment points.

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