Anti-migration stent

Abstract

An endoprosthesis for implantation within a vascular lumen may include a tubular stent formed of one or more interwoven filaments, a polymeric covering secured to the tubular stent, and an anti-migration element extending radially outward from the tubular stent, wherein the tubular stent is configured to be displaced between a radially contracted configuration and a radially expanded configuration. The anti-migration element extends helically along at least a portion of the length of the tubular stent in a first helical direction. The anti-migration element may include a wire extending along an outer surface of the tubular stent. The anti-migration element may include a second polymeric cover disposed over the wire.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 325,797, filed on March 31, 2022, which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to medical devices and methods for making and / or using medical devices. More particularly, the present disclosure relates to improved designs for endoprostheses or stents. Background Art

[0003] Stents, grafts, stent grafts and similar implantable medical devices, hereinafter collectively referred to as stents, are radially expandable or self-expandable endoprostheses that are intravascular or endoscopic implants that can be percutaneously or endoscopically implanted intraluminally. Stents can be implanted in various body cavities or blood vessels, such as in the vascular system, urinary tract, bile duct, gastrointestinal tract, airway, etc. Stents can be used to open constricted body cavities. Stents can be used to strengthen body vessels and prevent restenosis after angioplasty in the vascular system. They can be self-expandable, mechanically expandable or hybrid expandable. Typically, self-expanding stents are mounted on a delivery device consisting of two tubes. The stent is delivered by sliding the outer tube to expose and release the stent.

[0004] A stent is typically a tubular member that, once deployed at a treatment site, can be radially expanded from a reduced diameter configuration for delivery through a patient's body lumen to an expanded configuration. The stent can be formed from a tubular member, wherein a pattern is subsequently formed by etching or cutting material from the tubular member, or the stent can be made from wires or filaments using techniques such as braiding, knitting, or weaving. Desirable stent properties include sufficient flexibility to be able to conform to the tortuosity of the body lumen during delivery, but sufficient rigidity to resist migration once deployed at the treatment site.

[0005] In some stents, the compressible nature and flexibility that aid in stent delivery may also cause the stent to tend to migrate from its initial deployment position. Stent migration affects many endoscopic stents, including esophageal stents, duodenal stents, colon stents, pancreatic stents, biliary stents, and airway stents. Therefore, it is desirable to provide a stent construction that resists migration after deployment.

[0006] Some techniques that have been developed to prevent stent migration include 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 an improved stent that resists migration. Summary of the invention

[0007] In one example, an endoprosthesis for implantation in a lumen of a blood vessel may include a tubular scaffold having a length, a polymer covering secured to the tubular scaffold, and an anti-migration element extending radially outward from the tubular scaffold, the tubular scaffold being formed of one or more interwoven filaments defining interstices therebetween, wherein the tubular scaffold is configured to shift between a radially contracted configuration and a radially expanded configuration. The anti-migration element may extend helically along at least a portion of the length of the tubular scaffold in a first helical direction.

[0008] Additionally or alternatively to any examples 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.

[0009] Additionally or alternatively to any examples disclosed herein, the cross-sectional shape has a flat radially outer surface at the radially outer tip.

[0010] Additionally or alternatively to any examples disclosed herein, the anti-migration element comprises a wire extending along an outer surface of the tubular stent.

[0011] Additionally or alternatively to any examples disclosed herein, the wires are secured to the tubular stent at a plurality of attachment points.

[0012] In addition or in lieu of any of the examples disclosed herein, the endoprosthesis can further include a second polymer covering disposed over the plurality of attachment points and wires.

[0013] Additionally or alternatively to any examples disclosed herein, the anti-migration element extends continuously from a proximal end of the anti-migration element to a distal end of the anti-migration element.

[0014] Additionally or alternatively to any 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 individual segments of the anti-migration element are spaced apart from one another.

[0015] Additionally or alternatively to any examples disclosed herein, each individual segment of the plurality of individual segments extends circumferentially around the tubular stent less than a full turn.

[0016] In addition to or as an alternative to any of the examples disclosed herein, the endoprosthesis can also include a second anti-migration element extending radially outward from the tubular stent. The second anti-migration element can extend helically along at least a portion of the length of the tubular stent in a second helical direction opposite to the first helical direction, such that the anti-migration element intersects the second anti-migration element at a plurality of intersection points.

[0017] Additionally or alternatively to any examples disclosed herein, the anti-migration element and the second anti-migration element may each extend outwardly from the tubular stent a first radial distance between intersections.A plurality of intersections may extend outwardly from the tubular stent the first radial distance.

[0018] Additionally or alternatively to any examples disclosed herein, the anti-migration element and the second anti-migration element can each extend outwardly from the tubular stent a first radial distance between intersections.Multiple intersections can extend outwardly from the tubular stent a second radial distance greater than the first radial distance.

[0019] Additionally or alternatively to any examples disclosed herein, the spacing between adjacent windings of the anti-migration element varies along the length of the tubular stent.

[0020] Additionally or alternatively to any examples disclosed herein, spacing between adjacent turns of the anti-migration element along the middle region of the tubular stent is wider than spacing between adjacent turns of the anti-migration element along the proximal region of the tubular stent and / or the distal region of the tubular stent.

[0021] In addition to or as an alternative to any examples disclosed herein, the anti-migration element includes a first anti-migration element and a second anti-migration element, wherein the first anti-migration element includes a first plurality of helical windings arranged along a proximal region of the tubular support, and the second anti-migration element includes a second plurality of helical windings arranged along a distal region of the tubular support, and the second anti-migration element is longitudinally separated from the first anti-migration element by a middle region of the tubular support.

[0022] In addition to or in lieu of any examples disclosed herein, a method of manufacturing an endoprosthesis for implantation within a vascular lumen may include: forming a tubular stent from one or more interwoven filaments defining voids therebetween, the tubular stent having a length; applying a polymer covering to at least a portion of the tubular stent; positioning the tubular stent beneath a nozzle configured to apply beads of polymer material to the polymer covering; and using the nozzle to apply the beads of polymer material to the polymer covering previously applied to the tubular stent, such that the beads of polymer material form an anti-migration element extending radially outward from the polymer covering, wherein the anti-migration element extends helically along at least a portion of the length of the tubular stent.

[0023] Additionally or alternatively to any examples disclosed herein, the method may further include rotating and moving the tubular support longitudinally relative to the nozzle to change the spacing between adjacent windings of the anti-migration element.

[0024] In addition to or as an alternative to any examples disclosed herein, a method of manufacturing an endoprosthesis for implantation into a vascular lumen may include: forming a tubular stent from one or more interwoven filaments defining voids therebetween, the tubular stent having a length; applying a polymer covering to at least a middle region of the tubular stent; spirally wrapping a wire around the tubular stent on the polymer covering; securing the wire to an uncovered portion of the tubular stent; and thereafter, applying a second polymer covering over the uncovered portion of the tubular stent and the wire.

[0025] Additionally or alternatively to any examples disclosed herein, the uncovered portion of the tubular stent includes a proximal region disposed proximal to the intermediate region and a distal region disposed distal to the intermediate region.

[0026] In addition to or as an alternative to any examples disclosed herein, the uncovered portion of the tubular stent includes a plurality of attachment points of the tubular stent, the attachment points being defined by removing some of the polymer covering from the tubular stent. Securing the wire to the uncovered portion of the tubular stent may include securing the wire to the tubular stent at the plurality of attachment points.

[0027] The above description 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present disclosure may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0029] Figure 1 is a schematic illustration of selected aspects of an endoprosthesis;

[0030] Figure 2 Yes Description Figure 1 detailed views of selected aspects of the endoprosthesis;

[0031] Figure 3 Explained Figure 1 Aspects of endoprosthesis selection;

[0032] Figure 4A Yes Description Figure 1 partial cross-sectional views of selected aspects of an endoprosthesis;

[0033] Figure 4B Yes Description Figure 1 partial cross-sectional views of selected aspects of an alternative configuration of an endoprosthesis;

[0034] Figure 4C Yes Description Figure 1 partial cross-sectional views of selected aspects of an alternative configuration of an endoprosthesis;

[0035] Figure 4D Yes Description Figure 1 partial cross-sectional views of selected aspects of an alternative configuration of an endoprosthesis;

[0036] Figure 5 Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0037] Figure 6 Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0038] Fig. 7A Yes Description Figure 6 partial cross-sectional views of selected aspects of an endoprosthesis;

[0039] Figure 7B Yes Description Figure 6 partial cross-sectional views of selected aspects of an alternative configuration of an endoprosthesis;

[0040] Figure 8-8A Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0041] Figure 9-9A Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0042] Fig.10 Explains the manufacturing Figure 1selected aspects of methods of using endoprostheses;

[0043] Fig.11 Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0044] Fig.12 Explained Fig.11 Aspects of endoprosthesis selection;

[0045] Fig.13 Yes Description Figure 11-12 partial cross-sectional views of selected aspects of an endoprosthesis;

[0046] Fig.14 Explained Figure 1 selected aspects of an alternative configuration of an endoprosthesis;

[0047] Fig.15 Explained Fig.14 selected aspects of the endoprosthesis; and

[0048] Fig.16 Yes Description Figure 14-15 Partial cross-sectional view of selected aspects of an endoprosthesis.

[0049] Although various aspects of the present disclosure are susceptible to various modifications and alternative forms, the details thereof have been shown in the drawings by way of example and will be described in detail. Nevertheless, it should be understood that the various aspects of the present disclosure are not limited to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0050] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals indicate the same elements throughout the several views. The detailed description (specific embodiments) and the accompanying drawings are intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description (specific embodiments) and the accompanying drawings illustrate exemplary aspects of the present disclosure. However, for clarity and ease of understanding, although each feature and / or element may not be shown in each of the accompanying drawings, the features and / or elements may be understood to exist in any case unless otherwise stated.

[0051] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0052] All numerical values ​​herein are considered to be modified by the term "approximately", whether or not explicitly indicated. In terms of numerical values, the term "approximately" generally refers to a numerical range that is considered by those skilled in the art to be equivalent to the recorded value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "approximately" or "around" or "around" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions, as understood from the context of the specification and consistent with the context of the specification.

[0053] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0054] Although some suitable sizes, ranges and / or values ​​are disclosed in connection with various components, features and / or specifications, those skilled in the art will appreciate in light of this disclosure that the desired sizes, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0055] As used in this specification and the appended claims, the singular forms "a" and "the" and the situation where no quantifier is used include plural indicators, unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or", unless the content clearly stipulates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in singular form, even if those features may be plural or repeated in the disclosed embodiments. Unless clearly stated to the contrary, each instance of a feature may include a single disclosure and / or be covered by a single disclosure. For the purpose of simplicity and clarity, all elements of the present disclosure are not necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any and / or all components in which there are more than one component, unless clearly stated to the contrary.

[0056] Relative terms (such as "proximal", "distal", "advance", "retraction" and their variations, etc.) can generally be considered relative to the positioning, orientation and / or operation of various elements relative to the user / operator / manipulator of the device, wherein "proximal" and "retraction" indicate or refer to being closer to or toward the user, while "distal" and "advance" indicate or refer to being away from or away from the user. In some cases, in order to facilitate understanding of the present disclosure, the terms "proximal" and "distal" can be arbitrarily specified, and such situations will be obvious to those skilled in the art. Other relative terms (such as "upstream", "downstream", "inflow" and "outflow") refer to the direction of fluid flow inside a lumen (such as a body lumen, a blood vessel) or inside a device. Other relative terms (such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and / or their variations) generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0057] The term "extent / range" may be understood to mean the maximum measurement of a dimension being expressed or identified, unless the range or dimension in question is preceded by "minimum" or identified as "minimum", which may be understood to mean the minimum measurement of the dimension being expressed or identified. For example, "external extent" may be understood to mean an external dimension, "radial extent" may be understood to mean a radial dimension, "longitudinal extent" may be understood to mean a longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and will be apparent to one skilled in the art from the context of individual use. Typically, "range" may be considered to be the maximum possible dimension measured in accordance with the intended use, while "minimum extent" may be considered to be the minimum possible dimension measured in accordance with the intended use. In some cases, "range" may generally be measured orthogonally within a plane and / or cross section, but as will be apparent from the particular context, may be measured in different ways, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and the like.

[0058] The terms "monolithic" and "single-piece" shall generally refer to one or more elements made of or composed of a single structure or basic unit / element. Monolithic and / or single-piece elements shall exclude structures and / or features made by assembling or otherwise connecting together multiple discrete structures or elements.

[0059] Note that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include specific features, structures, characteristics, but not every embodiment necessarily includes the specific features, structures and / or characteristics. In addition, such phrases do not necessarily refer to the same embodiment. Further, unless explicitly stated to the contrary, when specific features, structures, or characteristics are described in conjunction with an embodiment, it will be within the knowledge of those skilled in the art to use the specific features, structures, or characteristics in conjunction with other embodiments, whether or not explicitly described. That is, as will be understood by those of ordinary skill in the art, the various individual elements described below are expected to be combinable with each other or to be arranged to form other additional embodiments or to supplement and / or enrich the described embodiments, even if not explicitly shown in a particular combination.

[0060] For the sake of clarity, certain identification numerical nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various descriptions and / or claimed features. It should be understood that numerical nomenclature is not intended to be restrictive, and is exemplary only. In some embodiments, for simplicity and clarity, the numerical nomenclature previously used can be changed and deviated. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., subsequently, or can be completely omitted, and / or another different feature can be referred to as a "first" element. The meaning and / or name in each case will be obvious to those skilled in the art.

[0061] The accompanying drawings illustrate selected components and / or arrangements of an endoprosthesis or stent. It should be noted that in any given accompanying drawings, for simplicity, some features of an endoprosthesis or stent may not be shown, or may be schematically shown. Additional details about some components of an endoprosthesis or stent may be shown in more detail in other accompanying drawings. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in singular form, even if those features may be plural or repeated in the disclosed embodiments. Unless explicitly stated to the contrary, each instance of a feature may include a single disclosure and / or be covered by a single disclosure. For example, reference to "filaments", "units", "pillars" or other features may equally refer to all instances and quantities exceeding one of the features. As such, it will be understood that the following discussion may be equally applicable to any and / or all components of more than one component present inside an endoprosthesis or stent, unless explicitly stated to the contrary. In addition, for clarity, not all instances of some elements or features may be shown in each accompanying drawing.

[0062] Figure 1is a schematic diagram of an endoprosthesis 10. The term "stent" may be used interchangeably with the term "endoprosthesis" herein. The 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. The endoprosthesis 10 may include a tubular stent 16 defining a generally cylindrical outer surface 14. The tubular stent 16 may extend from the first end 18 to the second end 20. The tubular stent 16 may include an inner cavity extending longitudinally from the first end 18 through the tubular stent 16 to the second end 20. In some embodiments, the first end 18 may be a proximal end and the second end 20 may be a distal end. In some embodiments, the endoprosthesis 10 and / or the tubular stent 16 may include a proximal region, a distal region, and an intermediate region extending between the proximal region and the distal region. In some embodiments, the proximal region may include a flared first end (not shown). In some embodiments, the distal region may include a flared second end (not shown). In some embodiments, the tubular stent 16 may include a main body portion extending along the middle region and / or between the flared first end and the flared second end of the endoprosthesis 10. Other configurations are also contemplated. The endoprosthesis 10 and / or the tubular stent 16 may be configured to switch between a radially contracted configuration and a radially expanded configuration. Thus, the endoprosthesis 10 and / or the tubular stent 16 may be a radially expandable to radially expanded deployment configuration from a radially restricted delivery configuration. In some embodiments, the endoprosthesis 10 and / or the tubular stent 16 may be self-expanding, mechanically expandable, or balloon expandable. Other configurations are also contemplated.

[0063] Figure 2 is a detailed view illustrating a portion of the endoprosthesis 10. In some embodiments, the endoprosthesis 10 and / or the tubular stent 16 can be formed from one or more interwoven filaments that define gaps 26 (e.g., openings) therebetween. In some embodiments, the one or more interwoven filaments can include a first filament 22 extending around the central longitudinal axis 12 in a first helical direction and a second filament 24 extending 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 extending around the central longitudinal axis 12 in a first helical direction and a plurality of second filaments extending 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 stent in which the first filaments intersect with the second filaments and cross above and / or below the second filaments at multiple crossing locations. The one or more interwoven filaments can define an outer surface 14 (e.g., Figure 1 ). In some embodiments, the one or more interwoven filaments may include wires, threads, strands, etc.

[0064] In some embodiments, one or more interwoven filaments can extend in a spiral direction while crossing each other above and below along the length of the tubular stent 16. In some embodiments, the first filament 22 and / or a plurality of first filaments can extend and / or extend to the second end 20 from the first end 18 in a first spiral path around the central longitudinal axis 12 in a first direction (e.g., a first spiral direction). In some embodiments, the first direction can be clockwise. In some embodiments, the second filament 24 and / or a plurality of second filaments can extend and / or extend to the second end 20 from the first end 18 in a second spiral path around the central longitudinal axis 12 in a second direction (e.g., a second spiral direction). In some embodiments, the second direction can be opposite to the first direction. In some embodiments, the second direction can be clockwise. Other configurations may also be considered.

[0065] In some alternative configurations, the endoprosthesis 10 and / or the tubular support 16 can be cut from a tube into a one-piece structure. In some alternative configurations, the endoprosthesis and / or the tubular support 16 can be cut from a flat plate, rolled to form a tubular structure and / or shape, and then welded together to form the tubular support 16. In some alternative configurations, the endoprosthesis 10 and / or the tubular support 16 can be knitted, woven or otherwise assembled. Other configurations are also contemplated. Some suitable but non-limiting materials for the endoprosthesis 10, the tubular support 16, the first filament 22, the second filament 24 and / or its parts or elements are described below, such as metallic materials and / or polymeric materials.

[0066] The endoprosthesis 10 and / or tubular stent 16 can be substantially tubular, and / or can include an inner cavity extending axially from a first end 18 through the central longitudinal axis 12 of the endoprosthesis 10 and / or tubular stent 16 to a second end 20. In some embodiments, the endoprosthesis 10 and / or tubular stent 16 can have a length of about 20 mm to about 250 mm, about 40 mm to about 225 mm, about 60 mm to about 200 mm, about 80 mm to about 175 mm, about 100 mm to about 150 mm, or another suitable range measured from the first end 18 to the second end 20. In some embodiments, the endoprosthesis 10 and / or tubular stent 16 can have a radial outer dimension or radial range of about 2 mm to about 30 mm, about 5 mm to about 25 mm, about 8 mm to about 20 mm, about 10 mm to about 15 mm, or another suitable range. Other configurations are also contemplated.

[0067] In some embodiments, the endoprosthesis 10 can be used in combination with a stent delivery system (not shown) for delivering and / or implanting the endoprosthesis 10 in a body lumen. The system may include an elongated tubular member (e.g., an outer tubular member) having an inner cavity extending therein and / or passing therethrough. In some alternative embodiments, the elongated tubular member may include a plurality of inner cavities extending therethrough and / or passing therethrough. In at least some embodiments, the system may include an elongated inner member disposed inside the inner cavity of the elongated tubular member. In some embodiments, the elongated inner member may be a tubular member having an inner cavity extending therethrough and / or passing therethrough. In some embodiments, the inner cavity of the elongated inner member may be a guidewire lumen. In some embodiments, the inner cavity of the elongated inner member may be used for flushing and / or suction. Other configurations are also contemplated. In some alternative embodiments, the elongated inner member may be a solid shaft.

[0068] In some embodiments, the elongated inner member can be axially translatable relative to the elongated tubular member. In some embodiments, the elongated tubular member can be translatable in a proximal direction relative to the elongated inner member. For example, when the elongated tubular member is withdrawn proximally, the elongated inner member can remain in a fixed position. In some embodiments, the elongated tubular member and the elongated inner member can be configured to be advanced to the target site together and / or simultaneously. In at least some embodiments, during advancement to the target site, the elongated tubular member and the elongated inner member can be arranged and / or maintained in an axially fixed relationship relative to each other. Other configurations are also contemplated.

[0069] In some embodiments, the endoprosthesis 10 can be disposed inside the lumen of the elongated tubular member in a radially contracted configuration. In some embodiments, when the endoprosthesis 10 is disposed in the lumen of the elongated tubular member, the elongated tubular member can constrain the endoprosthesis 10 in a radially contracted configuration. In some embodiments, the endoprosthesis 10 can be disposed radially between the elongated tubular member and the elongated inner member. In some embodiments, the endoprosthesis 10 can be attached to the elongated inner member, crimped onto the elongated inner member, and / or otherwise maintained by the elongated inner member. Other configurations are also contemplated.

[0070] During delivery to the treatment site, the endoprosthesis 10 and / or tubular stent 16 can be disposed within the lumen of the elongated tubular member in a radially contracted configuration. Upon removal and / or release from the lumen of the elongated tubular member, the endoprosthesis 10 and / or tubular stent 16 can be transformed from the radially contracted configuration to the radially expanded configuration, and / or can be transformed from the radially contracted configuration to the radially expanded configuration.

[0071] In some embodiments, the endoprosthesis 10 may include a polymer covering 30 extending along and / or fixed to the tubular stent 16, such as Figure 3 As shown. In some embodiments, the tubular support 16 can be completely covered by the polymer cover 30. In some embodiments, the polymer cover 30 can be coterminous with the tubular support 16. In some embodiments, the polymer cover 30 can be immovably fixed, bonded, or otherwise attached along and / or around the circumference of the tubular support 16. In some embodiments, in at least some positions where the polymer cover 30 contacts the tubular support 16, the polymer cover 30 can be immovably fixed to, bonded to, or otherwise attached to the tubular support 16. In some embodiments, the polymer cover 30 can be immovably fixed to, bonded to, or otherwise attached to the tubular support 16 at each position where the polymer cover 30 contacts the tubular support 16. In some embodiments, the tubular support 16, the one or more interwoven filaments, the first filament 22, the second filament 24, etc., and / or portions thereof can be at least partially embedded in the polymer cover 30. Other configurations are also contemplated.

[0072] In some embodiments, the polymeric covering 30 can extend along the entire length of the endoprosthesis 10 and / or tubular stent 16. In some embodiments, the polymeric covering 30 can extend along a portion of the length of the endoprosthesis 10 and / or tubular stent 16. In some embodiments, the polymeric covering 30 can extend continuously from the first end 18 of the endoprosthesis 10 and / or tubular stent 16 to the second end 20 of the endoprosthesis 10 and / or tubular stent 16. Other configurations are also contemplated. Some suitable but non-limiting materials, such as polymeric materials, for the polymeric covering 30 are discussed below.

[0073] In some embodiments, the endoprosthesis 10 can include an anti-migration element 40 extending radially outward from the tubular stent 16. In some embodiments, the anti-migration element 40 can extend radially outward from the polymeric covering 30. In some embodiments, the anti-migration element 40 can be non-removably fixed to, bonded to, or otherwise attached to the tubular stent 16 and / or the polymeric covering 30. In at least some embodiments, the anti-migration element 40 can extend helically along at least a portion of the length of the tubular stent 16 in a first helical direction (e.g., clockwise). In some embodiments, the tubular stent 16 or a portion thereof can maintain a constant outer diameter, wherein the anti-migration element 40 extends radially outward from the constant outer diameter of the tubular stent 16.

[0074] In some embodiments, the anti-migration element 40 can be formed of a polymer material. In some embodiments, the anti-migration element 40 can be applied to and / or bonded to the outer surface of the polymer cover 30 during a subsequent manufacturing step after the polymer cover 30 has been applied to the tubular support 16 and cured. In some embodiments, the anti-migration element 40 can be formed by a bead of polymer material applied over the polymer cover 30. Some suitable but non-limiting materials for the anti-migration element 40 and / or the bead of polymer material are described below, such as polymer materials. In one non-limiting example, the anti-migration element 40 and / or the bead of polymer material can be formed of silicone or polyamide. In some embodiments, the anti-migration element 40 and / or the bead of polymer material can be formed of the same polymer material as the polymer cover 30 or a different polymer material than the polymer cover 30. Other configurations are also contemplated.

[0075] In some embodiments, the anti-migration element 40 can be bioabsorbable and / or can include a bioabsorbable material. In some embodiments, the anti-migration element 40 can include an adhesive material and / or a bioadhesive material. In some embodiments, the bioadhesive material can include a natural polymer material, as well as a synthetic material and a synthetic material formed from a biological monomer (such as a sugar). In some embodiments, the bioadhesive is designed to adhere to biological tissue. For example, the anti-migration element 40 can be configured to adhere to the tissue in situ. Some examples of bioadhesives can include, but are not limited to, mucoadhesives, amino adhesives, adhesive surface proteins, adhesive modified polymers, catechol moieties, polymeric materials, polysaccharides, hydrogels, cross-linked or uncross-linked microgel particles, etc., as well as mixtures and / or combinations thereof. Adhesive material Adhesive material Adhesive material

[0076] In some embodiments, the endoprosthesis 10 can be delivered with a bonding material and / or a bioadhesive material under a substantially inert state. Under a substantially inert state, the bonding material and / or the bioadhesive material can be non-reactive and / or can exhibit non-adhesive properties relative to adjacent elements of the endoprosthesis 10, the stent delivery system, and / or the body lumen. For example, under a substantially inert state, the bonding material and / or the bioadhesive material can not adhere to the endoprosthesis, the elongated internal member, and / or the elongated tubular member. In addition, under a substantially inert state, the bonding material and / or the bioadhesive material can not adhere to the body lumen. In some embodiments, under a substantially inert state, the bonding material and / or the bioadhesive material can be substantially dry, dehydrated, or have no moisture. In some embodiments, adding or introducing fluid, moisture, and / or a selected type of fluid to the bonding material and / or the bioadhesive material can activate the bonding material and / or the bioadhesive material. In situations and / or configurations where the adhesive and / or bioadhesive material is "sticky," "adhesive," etc. relative to adjacent structures and / or elements, it can be assumed that the adhesive and / or bioadhesive material is no longer in a substantially inert state.

[0077] In some embodiments, wetting adhesive material and / or bioadhesive material with fluid can activate adhesive material and / or bioadhesive material. In other cases, adhesive material and / or bioadhesive material can be activated by another stimulus. In at least some embodiments, adhesive material and / or bioadhesive material can be pressure-sensitive. In some embodiments, adhesive material and / or bioadhesive material can be arranged on the radially outer side of endoprosthesis 10, tubular support 16 and / or polymer covering 30. In some embodiments, after deploying endoprosthesis 10, the radially outward expansion force applied on adhesive material and / or bioadhesive material by endoprosthesis 10 and / or tubular support 16 can activate pressure-sensitive adhesive material and / or bioadhesive material. Other configurations are also considered.

[0078] Figures 4A-4D 4 illustrates an example of a cross-sectional shape of an anti-migration element 40. The anti-migration element 40 may include a base 42 disposed proximate to a radially outward surface of the tubular stent 16 and / or the polymer cover 30. In some embodiments, the anti-migration element 40 may have a cross-sectional shape having a convexly curved radially outer surface (e.g., a radially outwardly facing surface) 44, such as Figure 4A In some embodiments, the cross-sectional shape of the anti-migration element 40 can be dome-shaped, arched, and / or hemispherical. In some embodiments, the anti-migration element 40 can have a cross-sectional shape having a flat or planar radial outer surface 44, such as Figure 4BAs shown. In some embodiments, the cross-sectional shape of the anti-migration element 40 can be polygonal, square, rectangular, trapezoidal, etc. In some embodiments, the radially outer surface (e.g., the radially outward surface) 44 can have no intersection with the tubular stent 16 and / or the polymer cover 30 and / or is not in direct contact with the tubular stent 16 and / or the polymer cover 30. For example, in some embodiments, the radially outer surface 44 of the anti-migration element 40 can be radially spaced apart from the base 42 of the anti-migration element 40 by the side surface 46 of the anti-migration element 40. The side surface 46 can be different from and / or distinguishable from the radially outer surface 44. For example, the side surface 46 can intersect the base 42 and / or the radially outer surface 44 at a non-zero angle (such as a vertical or oblique angle).

[0079] In some embodiments, the anti-migration element 40 can have a cross-sectional shape having a first circumferential width at the base 42 and a second circumferential width at the radially outer tip that is greater than the first circumferential width at the base 42, such as Figure 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 radially outer surface 44 at the radially outer tip (eg, Figure 4D ), which is curved, for example convex or concave. Other configurations are also contemplated.

[0080] In some embodiments, the anti-migration element 40 may extend continuously from the proximal end of the anti-migration element 40 to the distal end of the anti-migration element 40, for example Figure 3 In some cases, the first end of the anti-migration element 40 can be located near the first end 18 of the endoprosthesis 10 or the tubular stent 16, and / or the second end of the anti-migration element 40 can be located near the second end 20 of the endoprosthesis 10 and / or the tubular stent 16. In some embodiments, the anti-migration element 40 can extend intermittently and / or discontinuously from the proximal end of the anti-migration element 40 to the distal end of the anti-migration element 40, such that the plurality of individual segments 41 of the anti-migration element 40 are spaced apart from one another, for example, Figure 5 Thus, portions of the outer surface of the polymer cover 30 may be seen spirally between adjacent segments of the plurality of individual segments 41 of the anti-migration element 40. In at least some embodiments, the plurality of individual segments 41 of the anti-migration element 40 may be circumferentially spaced apart from one another.

[0081] In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 can extend circumferentially more than one full turn around the circumference of the tubular stent 16. In some embodiments, each of the plurality of individual 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 stent 16. In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 can extend along an arc length of approximately 360 degrees around the circumference of the tubular stent 16.

[0082] In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 may extend circumferentially around the tubular stent 16 for less than one full circle. In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 may extend along an arc length of less than 360 degrees around the circumference of the tubular stent 16. In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 may extend along an arc length of 180 degrees or less or less than 180 degrees around the circumference of the tubular stent 16. In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 may extend along an arc length of 90 degrees or less or less than 90 degrees around the circumference of the tubular stent 16. In some embodiments, each of the plurality of individual segments 41 of the anti-migration element 40 may extend along an arc length of 45 degrees or less or less than 45 degrees around the circumference of the tubular stent 16. Other configurations are also contemplated.

[0083] In some embodiments, the endoprosthesis 10 may include a second anti-migration element 50 extending radially outward from the tubular support 16, such as Figure 6 In some embodiments, the second anti-migration element 50 can extend radially outward from an outer surface (e.g., a radially outward surface) of the polymeric cover 30. In some embodiments, the second anti-migration element 50 can be non-removably fixed to, bonded to, or otherwise attached to the tubular stent 16 and / or the polymeric cover 30. In at least some embodiments, the second anti-migration element 50 can extend helically along at least a portion of the length of the tubular stent 16 in a second helical direction (e.g., counterclockwise) opposite to the first helical direction, such that the anti-migration element 40 intersects the second anti-migration element 50 at one or more intersections 52 or a plurality of intersections 52.

[0084] In some embodiments, the second anti-migration element 50 can be formed of a polymer material. In some embodiments, the second anti-migration element 50 can be applied to and / or bonded to the outer surface of the polymer cover 30 during a subsequent manufacturing step after the polymer cover 30 has been applied to the tubular stent 16 and cured. In some embodiments, the second anti-migration element 50 can be formed of a bead of polymer material applied over the polymer cover 30. Some suitable but non-limiting materials for the second anti-migration element 50 and / or the bead of polymer material are described below, such as polymer materials. In one non-limiting example, the second anti-migration element 50 and / or the bead of polymer material can be formed of silicone or polyamide. In some embodiments, the second anti-migration element 50 and / or the bead of polymer material can be formed of the same polymer material as the polymer cover 30 or a different polymer material from the polymer cover 30. In some embodiments, the second anti-migration element 50 can be formed of the same polymer material as the anti-migration element 40 or a different polymer material from the anti-migration element 40. Other configurations are also contemplated.

[0085] In some embodiments, the second anti-migration element 50 can be bioabsorbable and / or can include a bioabsorbable material. In some embodiments, the second anti-migration element 50 can include an adhesive material and / or a bioadhesive material, similar to the adhesive material and / or bioadhesive material described herein with respect to the anti-migration element 40. In some embodiments, the second anti-migration element 50 can have a cross-sectional shape similar to the cross-sectional shape of the anti-migration element 40. In some embodiments, the second anti-migration element 50 can have a cross-sectional shape that is the same as the cross-sectional shape of the anti-migration element 40. In some embodiments, the second anti-migration element 50 can have a cross-sectional shape that is different from the cross-sectional shape of the anti-migration element 40. Structural features and / or details related to the cross-sectional shape of the second anti-migration element 50 can be similar to those described herein with respect to the anti-migration element 40 and Figures 4A-4D those discussed, and are not repeated for the sake of brevity.

[0086] In some embodiments, the anti-migration element 40 can extend outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 a first radial distance R1 between the intersections of the plurality of intersections 52, such as Figure 6 In some embodiments, the second anti-migration element 50 can extend outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 a first radial distance R1 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 outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 a first radial distance R1 between the intersections of the plurality of intersections 52.

[0087] In some embodiments, the plurality of intersections 52 extend outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 by a first radial distance R1, such as Fig. 7A In some embodiments, at least some of the plurality of intersections 52 extend outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 by a first radial distance R1. In some embodiments, each of the plurality of intersections 52 extends outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 by a first radial distance R1. In at least some embodiments, the anti-migration element 40 and the second anti-migration element 50 intersect each other at the plurality of intersections 52 and do not overlap. As such, the first radial distance R1 is maintained at the plurality of intersections 52.

[0088] In some embodiments, the plurality of intersections 52 extend outwardly from the outer surface of the tubular stent 16 and / or the polymeric covering 30 by a second radial distance R2, such as Figure 7B As shown. In some embodiments, at least some of the plurality of intersections 52 extend outwardly from the outer surface of the tubular support 16 and / or the polymer cover 30 by a second radial distance R2. In some embodiments, each of the plurality of intersections 52 extends outwardly from the outer surface of the tubular support 16 and / or the polymer cover 30 by a second radial distance R2. In at least some embodiments, the anti-migration element 40 and the second anti-migration element 50 intersect and overlap each other at the plurality of intersections 52. For example, the second anti-migration element 50 may overlap the anti-migration element 40, or vice versa. As such, the plurality of intersections 52 extend outwardly from the outer surface of the tubular support 16 and / or the polymer cover 30 by a second radial distance R2. In some embodiments, the second radial distance R2 may be about twice the first radial distance R1. In some embodiments, the second radial distance R2 may be less than twice the first radial distance R1. Other configurations are also contemplated. In all embodiments where the second anti-migration element 50 overlaps the anti-migration element 40, or vice versa, the second radial distance R2 is greater than the first radial distance R1.

[0089] In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 4.0 mm. In some embodiments where the second radial distance R2 is about 4.0 mm, the first radial distance R1 is less than 4.0 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 3.5 mm. In some embodiments where the second radial distance R2 is about 3.5 mm, the first radial distance R1 is less than 3.5 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 3.0 mm. In some embodiments where the second radial distance R2 is about 3.0 mm, the first radial distance R1 is less than 3.0 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 2.5 mm. In some embodiments where the second radial distance R2 is about 2.5 mm, the first radial distance R1 is less than 2.5 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 2.0 mm. In an embodiment where the second radial distance R2 is about 2.0 mm, the first radial distance R1 is less than 2.0 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 1.5 mm. In an embodiment where the second radial distance R2 is about 1.5 mm, the first radial distance R1 is less than 1.5 mm. In some embodiments, the first radial distance R1 and / or the second radial distance R2 may be about 1.0 mm. In an embodiment where the second radial distance R2 is about 1.0 mm, the first radial distance R1 is less than 1.0 mm. Other configurations are also contemplated.

[0090] In some embodiments, the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 can vary along the length of the tubular stent 16. In some embodiments, the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the middle region and / or the main body of the tubular stent 16 is wider and / or greater than the spacing (pitch) between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the proximal region of the tubular stent 16 and / or the distal region of the tubular stent 16, such as Figure 8 In some embodiments, the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the middle region and / or the main body of the tubular stent 16 is wider and / or larger than the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the flared (trumpet-shaped) first end 17 of the tubular stent 16 and / or the flared (trumpet-shaped) second end 19 of the tubular stent 16, such as Fig. 8AAs shown. In other embodiments, the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the proximal region of the tubular stent 16 is wider and / or larger than the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the middle region and / or the main body of the tubular stent 16. In some embodiments, the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the flared first end 17 of the tubular stent 16 and / or the flared second end 19 of the tubular stent 16 is wider and / or larger than the spacing between adjacent turns of the anti-migration element 40 and / or the second anti-migration element 50 along the middle region and / or the main body of the tubular stent 16. It should be noted that the spacing of other spiral anti-migration elements described herein may also vary along the length of the tubular stent 16 in a similar manner. Other configurations are also contemplated.

[0091] In some embodiments, the anti-migration element may include a proximal anti-migration element 60 including a first plurality of helical windings 62 disposed along a proximal region of the tubular stent 16 and a distal anti-migration element 66 including a second plurality of helical windings 68 disposed along a distal region of the tubular stent 16, the distal anti-migration element 66 being longitudinally spaced apart from the proximal anti-migration element 60 by a middle region of the tubular stent 16, as shown. Fig. 9 In some embodiments, the anti-migration element can include a proximal anti-migration element 60 and a distal anti-migration element 66, wherein the proximal anti-migration element 60 includes a first plurality of helical turns 62 disposed along the flared first end 17 of the tubular stent 16, and the distal anti-migration element 66 includes a second plurality of helical turns 68 disposed along the flared second end 19 of the tubular stent 16, and the distal anti-migration element 66 is longitudinally spaced apart from the proximal anti-migration element 60 by a middle region of the tubular stent 16, as shown. Fig. 9A Other configurations are also contemplated.

[0092] A method of manufacturing an endoprosthesis 10 for implantation in a vascular lumen may include forming a tubular stent 16 from one or more interwoven filaments defining interstices therebetween, as described herein. The method may include applying a polymeric covering 30 to at least a portion of the tubular stent 16. In some embodiments, the method may include applying the polymeric covering 30 along the entire length of the tubular stent 16, such as via a spray coating or dip coating process.

[0093] In some embodiments, a method of forming an endoprosthesis 10 may include positioning a tubular stent 16 previously coated with a polymer covering 30 beneath a nozzle 100 configured to apply a bead of polymer material to the tubular stent 16 and / or the polymer covering 30, such as Fig.10In some embodiments, the method may include applying a bead of polymer material to the tubular stent 16 and / or the polymer covering 30 previously applied to the tubular stent 16 using the nozzle 100, such that the bead of polymer material forms an anti-migration element 40 extending radially outward from the tubular stent 16 and / or the polymer covering 30. In some embodiments, the method may include applying a second bead of polymer material to the tubular stent 16 and / or the polymer covering 30 previously applied to the tubular stent 16 using the nozzle 100, such that the second bead of polymer material forms a second anti-migration element 50 extending radially outward from the tubular stent 16 and / or the polymer covering 30. In some embodiments, the method may include rotating and moving the tubular stent 16 longitudinally relative to the nozzle 100 as the polymer material is discharged from the nozzle 100 to form a spiral configuration of the anti-migration element 40 and / or the second anti-migration element 50. In some cases, the rotation and / or longitudinal speed may be kept constant to provide a uniform pitch between turns of the anti-migration element and / or the second anti-migration element 50. In other cases, the rotational and / or longitudinal speeds may be varied to change the anti-migration element 40 (e.g., Figure 8-9A as shown) and / or the spacing between adjacent windings of the second anti-migration element 50.

[0094] In some embodiments, the anti-migration element 40 may include a wire 70 extending along the outer surface 14 of the tubular stent 16 and / or the outer surface of the polymer covering 30, such as Figure 11-16 As shown. In some embodiments, the wire 70 can be formed of a metal material. In some embodiments, the wire 70 can be formed of a polymer material. In some embodiments, the wire 70 can be formed of a composite material. In some embodiments, both the tubular member 16 and the wire 70 can be formed of a metal material. In some embodiments, both the tubular member 16 and the wire 70 can be formed of a polymer material. In some embodiments, both the tubular member 16 and the wire 70 can be formed of a composite material. Other configurations can also be considered, including but not limited to a tubular stent 16 and a wire 70 formed of different materials.

[0095] In some embodiments, a method of manufacturing an endoprosthesis 10 for implantation in a vascular lumen may include forming a tubular stent 16 from one or more interwoven filaments defining interstices therebetween, as described herein. The method may include applying a polymeric covering 30 to at least a middle portion of the tubular stent 16, such as Fig.11As shown, the proximal and / or distal regions of the tubular stent 16 are exposed or uncovered. In some embodiments, the method may include applying a polymer covering 30 along the entire length of the tubular stent 16. In some embodiments, the method may include leaving at least a portion of the proximal region and at least a portion of the distal region of the tubular stent 16 uncovered by the polymer covering 30, so that the proximal region and / or the distal region of the tubular stent 16 are exposed. In some embodiments, the method may include, after applying the polymer covering 30 to the tubular stent 16, spirally winding the wire 70 around the tubular stent 16 above the polymer covering 30. In some embodiments, the method may include fixing the wire 70 to the uncovered portion of the tubular stent 16. In some embodiments, the uncovered portion of the tubular stent 16 may include a proximal region disposed proximal to the middle region and / or a distal region disposed distal to the middle region. In some embodiments, the method may include fixing the wire 70 to the uncovered portions of the proximal region and the distal region of the tubular stent 16. In some embodiments, securing the wire 70 to the uncovered portion of the tubular stent 16 may include non-removably attaching, bonding, welding, soldering, or reflowing the wire 70 to the uncovered portion of the tubular stent 16 .

[0096] In at least some embodiments, the method may include thereafter applying a second polymer covering 80 to the wire 70 and polymer covering 30 and the uncovered portion of the tubular stent 16, such as Fig.12 In some embodiments, the method may include thereafter applying a second polymer covering 80 to the wire 70 and the polymer covering 30 and the uncovered portions of the proximal and distal regions of the tubular stent 16. In some embodiments, applying the second polymer covering 80 to the wire 70 may form and / or define the anti-migration element 40, such as Fig.13 In some embodiments, the wire 70 can be at least partially embedded within the anti-migration element 40 and / or at least partially surrounded by the anti-migration element 40. In some embodiments, the tubular stent 16 and the wire 70 can be completely surrounded by the combination of the polymer cover 30 and the second polymer cover 80 and / or embedded within and / or between the combination of the polymer cover 30 and the second polymer cover 80.

[0097] Some suitable but non-limiting materials, such as polymer materials, for the second polymer cover 80 are discussed below. In some embodiments, the second polymer cover 80 can be formed as an additional layer of the polymer cover 30. In some embodiments, the second polymer cover 80 can be formed of the same polymer material as the polymer cover 30. In some embodiments, the second polymer cover 80 can be formed of a different polymer material than the polymer cover 30. Other configurations are also contemplated.

[0098] In some embodiments, a method of manufacturing an endoprosthesis 10 for implantation in a vascular lumen may include forming a tubular stent 16 from one or more interwoven filaments defining interstices therebetween, as described herein. The method may include applying a polymeric covering 30 to at least a middle portion of the tubular stent 16, such as Fig.14 As shown, the proximal and / or distal regions of the tubular stent 16 are exposed or uncovered. In some embodiments, the method may include applying a polymer covering 30 along the entire length of the tubular stent 16. In some embodiments, the method may include, after applying the polymer covering 30 to the tubular stent 16, spirally winding the wire 70 around the tubular stent 16 over the polymer covering 30. In some embodiments, the method may include fixing the wire 70 to the uncovered portion of the tubular stent 16. In some embodiments, the uncovered portion of the tubular stent 16 may include a plurality of attachment points 90 of the tubular stent 16, which are defined by removing some of the polymer covering 30 from the tubular stent 16. In some embodiments, the plurality of attachment points 90 may include an uncovered portion of a proximal region disposed proximal to the middle region and / or a distal region disposed distal to the middle region. In some embodiments, fixing the wire 70 to the uncovered portion of the tubular stent 16 may include fixing the wire 70 to the tubular stent 16 at a plurality of attachment points 90. In some embodiments, securing the wire 70 to the uncovered portion of the tubular stent 16 may include non-removably attaching, bonding, welding, soldering, reflowing, etc. the wire 70 to the uncovered portion of the tubular stent 16. In some embodiments, securing the wire 70 to the uncovered portion of the tubular stent 16 may include non-removably attaching, bonding, welding, soldering, reflowing, etc. the wire 70 to the tubular stent 16 at a plurality of attachment points 90.

[0099] In at least some embodiments, the method may include thereafter applying a second polymer covering 80 to the wire 70 and polymer covering 30 and the uncovered portion of the tubular stent 16, such as Fig.15 In some embodiments, the method may include thereafter applying a second polymer covering 80 to the wire 70 and the polymer covering 30 and the plurality of attachment points 90. In some embodiments, applying the second polymer covering 80 to the wire 70 and the plurality of attachment points 90 may form and / or define the anti-migration element 40, such as Fig.16In some embodiments, the wire 70 can be at least partially embedded within the anti-migration element 40 and / or at least partially surrounded by the anti-migration element 40. In some embodiments, the tubular stent 16 and the wire 70 can be completely surrounded by the combination of the polymer cover 30 and the second polymer cover 80 and / or embedded within and / or between the combination of the polymer cover 30 and the second polymer cover 80.

[0100] Some suitable but non-limiting materials, such as polymer materials, for the second polymer cover 80 are discussed below. In some embodiments, the second polymer cover 80 can be formed as an additional layer of the polymer cover 30. In some embodiments, the second polymer cover 80 can be formed of the same polymer material as the polymer cover 30. In some embodiments, the second polymer cover 80 can be formed of a different polymer material than the polymer cover 30. Other configurations are also contemplated.

[0101] The materials that can be used for the various components of the systems disclosed herein and their various elements can include materials that are commonly associated with medical devices. For simplicity, the following discussion relates to the system. However, this is not intended to limit the systems, devices and / or methods described herein, as such discussion can be applied to other elements, components, parts or devices disclosed herein, such as but not limited to endoprostheses, tubular stents, polymer coverings, anti-migration elements, wires, etc. and / or their elements or parts.

[0102] In some embodiments, the system and / or components thereof may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials.

[0103] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g. ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as ), polyamides (e.g. or ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name obtained under the following conditions), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polyethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyethylene oxide (PPO), polyterephthalamide (e.g. ), polysulfone, nylon, nylon-12 (e.g. ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane-silicone copolymers (e.g. or ), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof. In some embodiments, the system and / or its components can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0104] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; low carbon 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 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (such as UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g. UNS: 10665, such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, e.g. etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0105] In at least some embodiments, part or all of the system and / or its components may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that are capable of producing relatively bright images on a fluoroscopic screen or other imaging techniques during medical procedures. Such relatively bright images assist the user of the system in determining their position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer 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.

[0106] 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 system and / or its components or portions can be made of materials that do not substantially distort the image and do not produce a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The system or portions thereof can also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g. UNS: R30035, such as etc.), Nitinol, etc., and other materials.

[0107] In some embodiments, the system and / or other elements disclosed herein may include a fabric material disposed above or inside the structure. The fabric material may be composed of a biocompatible material (e.g., a polymer material or a biomaterial) suitable for promoting tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (e.g., polyethylene, polypropylene), polyester, polyurethane and / or blends or combinations thereof.

[0108] In some embodiments, system disclosed herein and / or other elements may include fabric material, and / or be formed by textile material.Some examples of suitable textile material may include synthetic yarn, which may be flat, shaped, twisted, textured, pre-contracted or uncontracted.Synthetic biocompatible yarns suitable for the present disclosure include but are not limited to polyester, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyethylene, polymethyl acetate, polyamide, naphthalene dicarboxylic acid derivatives, natural silk and polytetrafluoroethylene.In addition, at least one synthetic yarn may be metal yarn or glass or ceramic yarn or fiber.Useful metal yarns include those yarns made of stainless steel, platinum, gold, titanium, tantalum or Ni-Co-Cr based alloy or containing stainless steel, platinum, gold, titanium, tantalum or Ni-Co-Cr based alloy.Yarn may further include carbon, glass or ceramic fiber.Ideally, yarn is made of thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene etc. The yarns may be of multifilament, monofilament or spun-filament type. The type and denier of the selected yarn may be selected in such a way as to form a biocompatible and implantable prosthesis, more specifically, a vascular structure having the desired properties.

[0109] 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 may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (e.g., enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (e.g., dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); anti-tumor / antiproliferative / anti-mitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (e.g., lidocaine, bupivacaine, and ropivacaine); anticoagulants (e.g., D-Phe-Pro- Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation initiators); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0110] It should be understood that the present disclosure is merely illustrative in many respects. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. To the extent appropriate, this may include using any features of an exemplary embodiment used in other embodiments. Of course, the scope of the disclosure provided is defined in the language of the appended claims.

Claims

1. An endoprosthesis for implantation in a blood vessel cavity, comprising: a tubular stent having a length, the tubular stent being formed from one or more interwoven filaments defining interstices therebetween, wherein the tubular stent is configured to transition between a radially contracted configuration and a radially expanded configuration; a polymer covering secured to the tubular stent; as well as an anti-migration element extending radially outward from the tubular stent; Wherein the anti-migration element extends helically in a first helical direction along at least a portion of the length of the tubular stent.

2. The endoprosthesis according to 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 circumferential width.

3. The endoprosthesis according to claim 2, wherein: The cross-sectional shape has a flat radially outer surface at the radially outer top end.

4. The endoprosthesis according to claim 1, wherein: The anti-migration element includes a wire extending along an outer surface of the tubular stent. Wherein the wire is secured to the tubular stent at a plurality of attachment points.

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

6. The endoprosthesis according to any one of claims 1 to 3, wherein 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 individual segments of the anti-migration element are spaced apart from one another; Each of the plurality of individual segments extends circumferentially around the tubular stent less than one full turn.

7. The endoprosthesis according to any one of claims 1 to 3, further comprising a second anti-migration element extending radially outward from the tubular stent; Wherein the second anti-migration element extends helically along at least a portion of the length of the tubular stent in a second helical direction opposite to the first helical direction such that the anti-migration element intersects the second anti-migration element at a plurality of intersection points.

8. The endoprosthesis of claim 7, wherein the anti-migration element and the second anti-migration element each extend outwardly from the tubular stent a first radial distance between intersections; Wherein the plurality of intersection points extend outwardly from the tubular support by the first radial distance.

9. The endoprosthesis of claim 7, wherein the anti-migration element and the second anti-migration element each extend outwardly from the tubular stent a first radial distance between intersections; The plurality of intersection points extend outwardly from the tubular support by a second radial distance greater than the first radial distance.

10. The endoprosthesis according to any one of claims 1 to 9, wherein the spacing between adjacent windings of the anti-migration element varies along the length of the tubular stent.

11. An endoprosthesis according to any one of claims 1-10, wherein the anti-migration element comprises a first anti-migration element and a second anti-migration element, the first anti-migration element comprising a first plurality of helical turns arranged along a proximal region of the tubular stent, the second anti-migration element comprising a second plurality of helical turns arranged along a distal region of the tubular stent, and the second anti-migration element being longitudinally spaced apart from the first anti-migration element by a middle region of the tubular stent.

12. A method for manufacturing an endoprosthesis for implantation in a blood vessel lumen, comprising: forming a tubular stent from one or more interwoven filaments, the interwoven filaments defining interstices therebetween, the tubular stent having a length; applying a polymeric covering to at least a portion of the tubular stent; positioning the tubular support beneath a nozzle configured to apply a bead of polymeric material to the polymeric covering; and The bead of polymer material is applied using the nozzle to the polymer covering previously applied to the tubular stent such that the bead of polymer material forms an anti-migration element extending radially outward from the polymer covering, wherein the anti-migration element extends helically along at least a portion of the length of the tubular stent.

13. A method for manufacturing an endoprosthesis for implantation in a blood vessel lumen, comprising: forming a tubular stent from one or more interwoven filaments, the interwoven filaments defining interstices therebetween, the tubular stent having a length; applying a polymeric covering to at least a middle region of the tubular stent; winding a wire helically around the tubular stent over the polymer covering; securing the wire to the uncovered portion of the tubular stent; and Thereafter, a second polymer covering is applied over the uncovered portion of the tubular stent and the wires.

14. The method of claim 13, wherein the uncovered portion of the tubular stent includes a proximal region disposed proximal to the middle region and a distal region disposed distal to the middle region.

15. The method of claim 13, wherein the uncovered portion of the tubular stent comprises a plurality of attachment points of the tubular stent, the attachment points being defined by removing some of the polymeric covering from the tubular stent; Wherein securing the wire to the uncovered portion of the tubular stent includes securing the wire to the tubular stent at the plurality of attachment points.

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