STENT HAVING IMPROVED DEPLOYMENT CHARACTERISTICS - Patent application

The braided stent's alternating open and closed cell structure addresses the issue of 'sea folds' by self-adjusting to lumen diameters, ensuring secure anchoring and radial strength, thus improving delivery and implantation outcomes.

JP7603160B2Active Publication Date: 2024-12-19BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
JP2023533701
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-12-02
Filing Date
2021-12-01
Publication Date
2024-12-19
Estimated Expiration
2041-12-01

AI Technical Summary

Technical Problem

Braided stents face challenges in delivery and implantation due to the formation of 'sea folds' when improperly sized, leading to incomplete stenosis resolution, stent migration, and lumen occlusion.

Method used

A braided stent design with alternating open and closed cells along its length, allowing for self-adjustment to varying lumen diameters, preventing the formation of 'sea folds' by absorbing excess filament material and maintaining radial force.

Benefits of technology

The design enables flexible deployment and secure anchoring within body lumens, minimizing complications such as stent migration and lumen occlusion, while maintaining radial strength and adaptability to varying anatomical conditions.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

A braided stent extending along a central longitudinal axis may include filaments forming a plurality of cells arranged in a plurality of columns and a plurality of rows. The plurality of rows may extend parallel to the central longitudinal axis. The plurality of columns may extend circumferentially around the central longitudinal axis. The plurality of rows may include a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows. Each cell in the plurality of loop rows may include a circumferential loop element connected to two longitudinally oriented connector elements. The plurality of weft rows may include a plurality of circumferential weft elements connected to adjacent loop rows. A majority of the plurality of loop rows may include open cells having open ends. At least one of the plurality of loop rows may include a plurality of closed cells having a closed end.
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Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, methods of making medical devices, and uses thereof. More particularly, the present disclosure relates to stents for implantation in a body lumen, and related methods. [Background technology]

[0002] Implantable medical devices (e.g., expandable stents) can be designed to treat a variety of conditions within the body. For example, some expandable stents may be designed to radially expand to support a body lumen and / or provide a fluid pathway for digestive matter, blood, or other fluids to flow therethrough following a medical procedure. Some medical devices may include radially expandable stents or self-expanding stents that can be implanted transluminally by various medical device delivery systems. These stents can be implanted in a variety of body lumens, such as coronary or peripheral arteries, esophageal tract, gastrointestinal tract (including intestines, stomach, and colon), tracheobronchial tract, urinary tract, bile duct, vasculature, etc.

[0003] In some cases, it may be desirable to design a stent to include sufficient flexibility while maintaining sufficient radial force to open the body lumen at the treatment site. In some cases, the radial force can help anchor the stent and prevent migration within the lumen. In some cases, different stent configurations may provide different deliverability, flexibility, radial force / strength, and / or anchoring characteristics. For example, a braided stent may be considered to have superior flexibility and / or radial strength characteristics. However, a braided stent is not easy to re-constrain and / or reposition.

[0004] In some cases, a braided stent may be the most appropriate or desirable type of stent in a particular lumen or use (e.g., gastrointestinal and / or tracheobronchial anatomies). However, delivery and implantation of a braided stent may be difficult if the stent is not appropriately sized. In some cases, if the target lumen and / or vessel is smaller than specified for the stent and / or if the stent is too large for the target lumen and / or vessel, a phenomenon known as a "sea-fold" may occur. A "sea-fold" may cause and / or promote incomplete resolution of the stenosis, stent migration, food and / or fluid impingement against the lumen wall, and / or occlusion of the lumen.

[0005] There is a continuing need to provide alternative stent configurations and / or methods with improved delivery characteristics that avoid and / or prevent the formation of "sea-folds." Summary of the Invention

[0006] In one example, a braided stent extending along a central longitudinal axis may include filaments forming a plurality of cells arranged in a plurality of columns and a plurality of rows. The plurality of rows may extend parallel to the central longitudinal axis from a first end of the braided stent to a second end of the braided stent. The plurality of columns may extend circumferentially around the central longitudinal axis. The plurality of rows may include a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows. Each cell in the plurality of loop rows may include a circumferential loop element connected to two longitudinally oriented connector elements. The plurality of weft rows may include a plurality of circumferential weft elements connected to adjacent loop rows. A majority of the plurality of loop rows may include open cells disposed between two longitudinally oriented connector elements and having an open end opposite the circumferential loop elements. At least one of the plurality of loop rows may include a plurality of closed cells having a closed end formed by crossing two longitudinally oriented connector elements at a location opposite the circumferential loop element.

[0007] In addition or in the alternative to any of the examples disclosed herein, the circumferential loop elements of each cell are oriented toward the first end of the braided stent. In addition or alternatively to any of the examples disclosed herein, the plurality of closed cells is disposed proximate the first end or the second end of the braided stent.

[0008] In addition to or in the alternative to any of the examples disclosed herein, a plurality of circumferential weft elements are connected at both ends to one of two longitudinally oriented connector elements from each adjacent loop row.

[0009] In addition or in the alternative to any examples disclosed herein, at least one of the plurality of loop rows includes a first portion of the first loop row and a second portion of the first loop row longitudinally spaced from the first portion, the first portion including a first plurality of closed cells and the second portion including a second plurality of closed cells.

[0010] In addition or alternatively to any example disclosed herein, the first plurality of closed cells are disposed immediately adjacent to one another along the central longitudinal axis, and the second plurality of closed cells are disposed immediately adjacent to one another along the central longitudinal axis.

[0011] In addition or in the alternative to any of the examples disclosed herein, a first portion of the first loop row is disposed within a first end portion of the braided stent and a second portion of the first loop row is disposed within a second end portion of the braided stent, the first end portion and the second end portion being spaced apart by a body portion of the braided stent.

[0012] Additionally or alternatively to any examples disclosed herein, in the radially expanded configuration of the braided stent, the first end portion has a first outer diameter that is greater than an outer diameter of the body portion. Additionally or alternatively to any example disclosed herein, in the radially expanded configuration of the braided stent, the second end portion has a second outer diameter that is greater than an outer diameter of the body portion.

[0013] In addition or in the alternative to any example disclosed herein, at least one of the plurality of loop rows includes a first loop row extending from a first end of the braided stent to a second end of the braided stent, and the plurality of closed cells are disposed immediately adjacent to one another within the first loop row from the first end of the braided stent to the second end of the braided stent.

[0014] In addition or alternatively to any example disclosed herein, at least one of the plurality of loop rows further includes a second loop row extending from the first end of the braided stent to the second end of the braided stent, the second loop row being circumferentially spaced from the first loop row, the second loop row including a plurality of closed cells disposed immediately adjacent to one another within the second loop row from the first end of the braided stent to the second end of the braided stent.

[0015] In addition or alternatively to any of the examples disclosed herein, all of the closed cells of the braided stent are arranged in a single loop row. In addition to or in the alternative to any of the examples disclosed herein, a braided stent extending along a central longitudinal axis may include filaments forming a plurality of cells arranged in a plurality of columns and a plurality of rows. The plurality of rows may extend parallel to the central longitudinal axis from a first end of the braided stent to a second end of the braided stent. The plurality of columns may extend circumferentially around the central longitudinal axis. The plurality of rows may include a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows. Each cell in the plurality of loop rows may include a circumferential loop element connected to two longitudinally oriented connector elements. The plurality of weft rows may include a plurality of circumferential weft elements having both ends connected to adjacent loop rows. The braided stent may include a first end portion, a second end portion, and a body portion disposed between the first end portion and the second end portion. In a radially expanded configuration, the first end portion and the second end portion may each have an outer diameter greater than an outer diameter of the body portion. Within the body portion, the plurality of loop rows may be formed of open cells disposed between two longitudinally oriented connector elements and having open ends opposite the circumferential loop element. Within the first end portion, at least one of the plurality of loop rows may include a first plurality of closed cells having closed ends formed by intersecting two longitudinally oriented connector elements opposite the circumferential loop element. Within the second end portion, at least one of the plurality of loop rows may include a second plurality of closed cells having closed ends formed by intersecting two longitudinally oriented connector elements opposite the circumferential loop element.

[0016] In addition or in the alternative to any example disclosed herein, the sum of the cells of the loop rows in the first end portion, the second end portion, and the body portion comprises at least 90% open cells.

[0017] In addition or in the alternative to any examples disclosed herein, a first plurality of closed cells extends from the body portion of the braided stent to a first end, and a second plurality of closed cells extends from the body portion of the braided stent to a second end.

[0018] In addition or in the alternative to any examples disclosed herein, the first plurality of closed cells exerts a first circumferential force on a first end portion of the braided stent and the second plurality of closed cells exerts a second circumferential force on a second end portion of the braided stent.

[0019] In addition or alternatively to any of the examples disclosed herein, all of the closed cells of the braided stent are arranged in a single loop row. In addition to or in the alternative to any of the examples disclosed herein, a braided stent extending along a central longitudinal axis may include filaments forming a plurality of cells arranged in a plurality of columns and a plurality of rows. The plurality of rows may extend parallel to the central longitudinal axis from a first end of the braided stent to a second end of the braided stent. The plurality of columns may extend circumferentially around the central longitudinal axis. The plurality of rows may include a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows. Each cell in the plurality of loop rows may include a circumferential loop element connected to two longitudinally oriented connector elements. The plurality of weft rows may include a plurality of circumferential weft elements connected to adjacent loop rows. A majority of the plurality of loop rows may include open cells disposed between two longitudinally oriented connector elements and having an open end opposite the circumferential loop elements. At least one of the plurality of loop rows may include a plurality of closed cells having a closed end formed by crossing two longitudinally oriented connector elements at a location opposite the circumferential loop element. The plurality of closed cells may be longitudinally spaced apart from one another within at least one of the plurality of loop rows.

[0020] In addition or in the alternative to any example disclosed herein, each of the consecutive pairs of the plurality of closed cells is longitudinally spaced from one another by one open cell within at least one of the plurality of loop rows.

[0021] In addition or in the alternative to any example disclosed herein, each of the consecutive pairs of the plurality of closed cells is longitudinally spaced from one another by two open cells within at least one of the plurality of loop rows.

[0022] The above summary of some embodiments 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] FIG. 2 is a flat pattern diagram showing a portion of a braided stent having an open loop structure. [Diagram 2] FIG. 2 is an end view of a braided stent. [Diagram 3] 1 is an end view of a sized braided stent deployed within a body lumen. [Figure 4] 1 is an end view of a braided stent deployed in a body lumen smaller than the braided stent was designed for. [Diagram 5] 1 is a flat pattern view showing a portion of a braided stent including rows of twisted loops. [Figure 6] A flat pattern view showing a portion of a braided stent including multiple rows of twisted loops. [Figure 7] 1 is a diagram of a braided stent including rows of twisted loops extending from a first end of the braided stent to a second end of the braided stent. [Figure 8A] 1 is a diagram of a braided stent including rows of twisted loops extending within a first end portion and a second end portion of the braided stent. [Figure 8B] A diagram of a braided stent having a flared end including rows of twisted loops extending into a first flared end portion and a second flared end portion of the braided stent. [Figure 9A] A diagram of a portion of a braided stent including rows having a pattern of open loops and twisted loops alternating every other row. [Figure 9B]A diagram of a portion of a braided stent including rows with a pattern of twisted loops arranged in third rows with two rows of open loops between them. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] While the present disclosure is 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 disclosure to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure.

[0026] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate, rather than limit, the scope of the claims. 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 depict exemplary embodiments of the present disclosure.

[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 a person 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" can include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in non-numerical contexts) can 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 disclosure. 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. However, it will be understood that the following description may be equally applicable to any and / or all of the components present in more than one instance, unless expressly stated to the contrary. Moreover, for clarity, not all instances of some elements or features are shown in each figure.

[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" may 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 may be understood to mean the minimum measurement of the stated or specified dimension. For example, an "outer range" may be understood to mean an outer dimension, a "radial range" may be understood to mean a radial dimension, and a "longitudinal range" may be understood to mean a longitudinal dimension. Each instance of "range" may 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" may be considered the maximum possible dimension measured according to the intended application, while a "minimum range" may be considered the minimum possible dimension measured according to the intended application. In some cases, a "range" may generally be measured orthogonally in a plane and / or cross section, but may 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 one or more 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 up 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 may necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when 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 implement 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 present disclosure. 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 shows a flat pattern view of a conventional braided stent 10 according to one known example. The braided stent 10 may be a basic self-expanding configuration stent with multiple open end loops interlaced with each other. Conventional braided self-expanding stents are generally designed using an automated weft knitting process that produces parallel rows 20 of stitches oriented generally perpendicular to the central longitudinal axis AA of the stent in both the expanded relaxed configuration and the elongated constrained configuration, and parallel rows 30 and 40 of stitches oriented parallel to the central longitudinal axis AA of the stent in both the expanded relaxed configuration and the elongated constrained configuration. The parallel rows 40 are generally smaller and / or denser than the parallel rows 30. Conventional braided stents have certain advantages and disadvantages. For example, the braided stent 10 may provide good radial strength with minimal foreshortening, which may be desirable in esophageal and tracheobronchial applications as well as some post-bariatric surgery applications. However, braided stent 10 can be difficult to constrain, especially within a coaxial delivery system, and therefore may be delivered using a system that does not provide a method of recapture, such as a crocheted delivery system.

[0037] FIG. 2 shows a schematic end view of the braided stent 10. In practice, the braided stent 10 may have a generally circular cross-sectional shape. However, as seen in FIG. 2, if the parallel rows 30 were formed as straight legs, the parallel rows 30 would form the "sides" of a polygonal stent structure, and the parallel rows 40 would form the "corners" of the polygonal stent structure. The parallel rows 30 may be circumferentially disposed between adjacent parallel rows 40 and / or the parallel rows 40 may be circumferentially disposed between adjacent parallel rows 30. Although the parallel rows 40 do not form perfectly angled corners, the figure shows at what angles the parallel rows 30 would be disposed relative to one another if the parallel rows 30 were formed as straight legs. In practice, the parallel rows 30 are curved radially outward, thus giving the braided stent a more circular shape. When braided stent 10 expands, its weft elements (e.g., parallel rows 30) are tied off at each end where its loop elements (e.g., parallel rows 40) are formed, thereby allowing each weft element to act independently of its neighboring weft elements and to react to restraint resistance at its own location.

[0038] FIG. 3 shows a schematic of braided stent 10 in a radially expanded configuration when properly sized for placement within a body lumen 80. In a conventional braided stent, when properly sized for a body lumen, parallel rows 30 and 40 cooperate to uniformly expand around the circumference of body lumen 80. Generally, each weft element (e.g., "side" or parallel row 30) of the stent can expand with equal radial force without resistance, allowing braided stent 10 to exhibit an effectively circular cross-section in the radially expanded configuration. When braided stent 10 is deployed, the loop elements (e.g., parallel rows 40) tend to shorten axially, forcing filament material into adjacent weft elements, radially expanding and increasing the outer diameter of braided stent 10 to the diameter of body lumen 80.

[0039] FIG. 4 illustrates diagrammatically the effect of an undersized body lumen 82 for the same braided stent 10, or an inappropriate size of the braided stent 10 that is larger than the body lumen 82. When the braided stent 10 is deployed from a crochet delivery device, the resistance to the expansion of the braided stent 10 decreases in an orderly manner, clockwise (or counterclockwise) on the individual weft elements (e.g., parallel rows 30). As a result of the manner in which the braided stent 10 is delivered, not all of the weft elements are in a position to radially expand at the same time. This imbalance allows the first released weft element to begin expanding into its local space, while the later weft elements must wait for the resistance from the delivery device to be removed. All of the weft elements maintain or attempt to maintain their respective expanded size when released. In the example of FIG. 4, this uneven expansion results in the formation of a "sea fold" 50. This is because the last weft element is not in position to expand due to a lack of space within the body lumen 82 and increased resistance from the weft elements already expanded in position against the walls of the body lumen 82. As the relative size difference between the body lumen 82 and the braided stent 10 increases (e.g., as the body lumen 82 becomes smaller relative to the braided stent 10, or as the braided stent 10 becomes larger relative to the body lumen 82), the process may become larger and the severity of the "sea fold" 50 may worsen. Once the braided stent 10 has expanded to this configuration (e.g., where a "sea fold" 50 has formed), it may be difficult or impossible to reverse the situation, especially at that location.

[0040] Alternative self-expanding braided stents are desired that can overcome the conditions that cause "sea-folds" to form and / or that can make the braided stent more adaptable to a wider range of body lumen diameters. Although the embodiments disclosed herein are described with reference to esophageal and tracheobronchial stents, it is envisioned that the stents described herein can be used, and sized for use, in other locations, such as, but not limited to, body tissues, body organs, vascular cavities, non-vascular cavities, and combinations thereof, including, but not limited to, the coronary or peripheral vasculature, trachea, bronchi, colon, small intestine, bile duct, urinary tract, prostate, brain, stomach, etc.

[0041] FIG. 5 shows a flat pattern view of a portion of a braided stent 100 constructed in accordance with the present disclosure. The braided stent 100 may form a tubular member extending along a central longitudinal axis BB from a first end of the braided stent 100 to a second end of the braided stent 100. The braided stent 100 may be configured to transition from a radially collapsed configuration to a radially expanded configuration upon deployment. For example, the tubular member may self-expand from a compressed diameter during delivery to an expanded diameter when not constrained by a constraining member surrounding the tubular member. The braided stent 100 may include a lumen extending from the first end to the second end to allow the passage of fluids, food, and the like. The braided stent 100 may include and / or be formed from filaments 110 forming a plurality of cells arranged in a plurality of columns 112 and a plurality of rows 114. In some embodiments, the braided stent 100 may be formed from only a single filament interwoven and / or intertwined with itself to form a plurality of cells. In some embodiments, the filament 110 may be a monofilament, while in other embodiments, the filament 110 may be two or more filaments. In some embodiments, the inner and / or outer surfaces of the braided stent 100 may be entirely, substantially, or partially covered with a polymeric covering or coating. The polymeric covering or coating may extend over and / or occlude one or more of the plurality of cells formed and / or defined by the filament 110. The polymeric covering or coating may aid in reducing food impaction and / or tumor or tissue ingrowth. In some embodiments, the braided stent 100 may include a one-way valve (not shown), such as an elastomeric slit valve or duckbill valve, disposed within the lumen of the braided stent 100 to prevent backflow of fluid.

[0042] The plurality of rows 114 may extend parallel to the central longitudinal axis BB from a first end of the braided stent 100 to a second end of the braided stent 100. The plurality of columns 112 may extend circumferentially about the central longitudinal axis BB. Note that each column 112 may extend circumferentially and slightly helically about the central longitudinal axis BB such that, when braided from a single filament, adjacent columns 112 are formed after each complete turn. In some embodiments, the plurality of columns 112 may be oriented perpendicular to the central longitudinal axis BB. The plurality of rows may include a plurality of loop rows 120 and a plurality of weft rows 130 interposed between adjacent loop rows 120. Thus, the loop rows 120 may alternate with the weft rows 130 along the circumference of the tubular member. Each pair of circumferentially adjacent and / or consecutive loop rows 120 may be circumferentially spaced from one another by one of the weft rows 130. Each cell in the plurality of loop rows 120 may include a circumferential loop element 122 connected to two longitudinally oriented connector elements 124, the circumferential loop elements 122 being generally circumferentially oriented about the central longitudinal axis BB. The circumferential loop element 122 of each cell may be oriented and / or disposed within its respective cell toward a first end of the braided stent 100. Each of the plurality of weft rows 130 may include a plurality of circumferential weft elements 132 connected to adjacent loop rows 120, the plurality of circumferential weft elements 132 being generally circumferentially oriented about the central longitudinal axis BB. Each of the plurality of circumferential weft elements 132 may be connected at both ends to one of the two longitudinally oriented connector elements 124 from each adjacent loop row 120. For example, one circumferential weft element 132 may be connected at a first end to one of two longitudinally oriented connector elements 124 from a first loop row 126 and at a second end to one of two longitudinally oriented connector elements 124 from a second loop row 128 disposed circumferentially adjacent to the first loop row 126 (and circumferentially spaced from the first loop row 126 by a weft row 130 that includes the circumferential weft element 132). In some embodiments, the multiple circumferential weft elements 132 may have a length of about 0.1 millimeters to about 10.0 millimeters in a radially expanded configuration.In another example, the circumferential weft elements 132 may have a length between 1 millimeter and 5 millimeters. In yet another example, the circumferential weft elements 132 may have a length between 2 millimeters and 3 millimeters.

[0043] A majority of the plurality of loop rows 120 includes open cells 121 each having an open end 123 disposed between two longitudinally oriented connector elements 124 and located opposite the circumferential loop element 122. Thus, the plurality of open cells 121 may alternatively and / or interchangeably be referred to as "open loops" or "standard loops." In some embodiments, at least one of the plurality of loop rows 120 includes a plurality of closed cells 125 each having a closed end 127 formed by twisting or crossing two longitudinally oriented connector elements 124 at a location opposite the circumferential loop element 122. Thus, the plurality of closed cells 125 may alternatively and / or interchangeably be referred to as "twisted loops." In some embodiments, the plurality of closed cells 125 may be located adjacent to a first end or a second end of the braided stent 100. In some embodiments, the plurality of closed cells 125 may be located adjacent to a first end and a second end of the braided stent 100. In some embodiments, all of the closed cells 125 of the braided stent 100 may be disposed within a single loop row 120. In some embodiments, multiple closed cells 125 may be disposed immediately adjacent to one another within a single loop row 120 along the central longitudinal axis BB from a first end of the braided stent 100 to a second end of the braided stent 100. Each of the two longitudinally oriented connector elements 124 forming each of the multiple closed cells 125 may be directly connected to one circumferential weft element 132 from each adjacent weft row 130.

[0044] When a braided stent 100 having a plurality of closed cells 125 (e.g., twisted loops) as described herein is deployed, the two longitudinally oriented connector elements 124 of each open cell 121 (e.g., standard loops) are axially shortened, thereby forcing filament material into adjacent and / or directly connected weft elements 132 and radially expanding the braided stent 100. The plurality of closed cells 125 are configured and / or capable of receiving and / or absorbing excess filament material from the two longitudinally oriented connector elements 124 of adjacent loop rows 120. Similarly, the plurality of closed cells 125 (e.g., twisted loops) may be configured to longitudinally stretch and / or deform upon receiving filament material from the two directly connected circumferential weft elements 132 and / or the two longitudinally oriented connector elements 124 of adjacent loop rows 120, allowing the diameter of the braided stent 100 to be achieved without the formation of "sea folds." Thus, the plurality of closed cells 125 may act as a suspension feature within the braided stent 100, allowing the braided stent 100 to flex and / or self-adjust if the braided stent 100 becomes improperly sized for a body lumen. Because, in at least some embodiments, the plurality of closed cells 125 (e.g., twist loops) may stretch by different amounts depending on the difference between the designed and / or labeled outer diameter of the braided stent 100 and the inner diameter of the target body lumen, the plurality of closed cells 125 may be positioned and / or configured to open and / or release last during deployment of the braided stent 100 in order to optimize and / or maximize the adaptability of the braided stent 100 to changing body lumen diameters.

[0045] FIG. 6 shows a flat pattern view of another configuration of braided stent 200 similar to braided stent 100. Thus, many of the characteristics and / or advantages are the same. Braided stent 200 may form a tubular member extending along a central longitudinal axis CC from a first end of braided stent 200 to a second end of braided stent 200. Braided stent 200 may be configured to transition from a radially collapsed configuration to a radially expanded configuration upon deployment. For example, the tubular member may self-expand from a compressed diameter during delivery to an expanded diameter when not constrained by a constraining member surrounding the tubular member. Braided stent 200 may include a lumen extending from the first end to the second end to allow the passage of fluids, food, and the like. Braided stent 200 may include and / or be formed from filaments forming a plurality of cells arranged in a plurality of columns 212 and a plurality of rows 214. In some embodiments, the braided stent 200 may be formed from only a single filament interwoven and / or intertwined with itself to form a plurality of cells. In some embodiments, the filament may be a monofilament, while in other embodiments, the filament may be two or more filaments. In some embodiments, the inner and / or outer surfaces of the braided stent 200 may be entirely, substantially, or partially covered with a polymeric covering or coating. The polymeric covering or coating may extend over and / or occlude one or more of the plurality of cells formed and / or defined by the filament. The polymeric covering or coating may aid in reducing food impaction and / or tumor or tissue ingrowth. In some embodiments, the braided stent 200 may include a one-way valve (not shown), such as an elastomeric slit valve or duckbill valve, disposed within the lumen of the braided stent 200 to prevent backflow of fluid.

[0046] The plurality of rows 214 may extend parallel to the central longitudinal axis CC from a first end of the braided stent 200 to a second end of the braided stent 200. The plurality of columns 212 may extend circumferentially about the central longitudinal axis CC. It should be noted that when braided from a single filament, each column 212 may extend circumferentially and slightly helically about the central longitudinal axis CC such that an adjacent column 212 is formed every full turn. In some embodiments, the plurality of columns 212 may be oriented perpendicular to the central longitudinal axis CC. The plurality of rows may include a plurality of loop rows 220 and a plurality of weft rows 230 interposed between adjacent loop rows 220. Thus, the loop rows 220 may alternate with the weft rows 230 along the circumference of the tubular member. Each of the plurality of loop rows 220 of each circumferentially adjacent and / or consecutive pair may be circumferentially spaced from one another by one of the weft rows 230. Each cell in the plurality of loop rows 220 may include a circumferential loop element 222 connected to two longitudinally oriented connector elements 224, the circumferential loop element 222 being generally circumferentially oriented about a central longitudinal axis CC. The circumferential loop element 222 of each cell may be oriented and / or disposed within its respective cell toward a first end of the braided stent 200. Each of the plurality of weft rows 230 may include a plurality of circumferential weft elements 232 connected to adjacent loop rows 220, the plurality of circumferential weft elements 232 being generally circumferentially oriented about a central longitudinal axis CC. Each of the plurality of circumferential weft elements 232 may be connected at both ends to one of the two longitudinally oriented connector elements 224 from each adjacent loop row 220. For example, one circumferential weft element 232 may be connected at a first end to one of two longitudinally oriented connector elements 224 from one loop row and at a second end to one of two longitudinally oriented connector elements 224 from another loop row that is positioned circumferentially adjacent to the one loop row (and circumferentially spaced from the one loop row 220 by the weft row 230 that includes the circumferential weft element 232).

[0047] A majority of the plurality of loop rows 220 includes open cells 221 each having an open end 223 disposed between two longitudinally oriented connector elements 224 and located opposite the circumferential loop element 222. Thus, the plurality of open cells 221 may alternatively and / or interchangeably be referred to as "open loops" or "standard loops." In some embodiments, at least one of the plurality of loop rows 220 includes a plurality of closed cells 225 each having a closed end 227 formed by twisting or crossing two longitudinally oriented connector elements 224 at a location opposite the circumferential loop element 222. Thus, the plurality of closed cells 225 may alternatively and / or interchangeably be referred to as "twisted loops." In some embodiments, at least one of the plurality of loop rows 220 including a plurality of closed cells 225 may include a first loop row and a second loop row circumferentially spaced from the first loop row 220. In some embodiments, the first loop row and the second loop row may be disposed on circumferentially opposing portions of the braided stent 200. For example, in some embodiments, the first loop row may be circumferentially and / or radially offset from the second loop row by about 140 degrees, about 150 degrees, about 160 degrees, about 162 degrees, about 168 degrees, about 170 degrees, about 180 degrees, about 189 degrees, about 190 degrees, about 192 degrees, about 198 degrees, about 200 degrees, about 210 degrees, about 220 degrees, or another suitable angle depending on the number of loop rows present in the braided stent 200, as measured circumferentially and / or radially about the central longitudinal axis CC.

[0048] In some embodiments, the plurality of closed cells 225 may be disposed proximate to the first end or the second end of the braided stent 200. In some embodiments, the plurality of closed cells 225 may be disposed proximate to the first end and the second end of the braided stent 200. In at least some embodiments, the plurality of closed cells 225 may extend from the first end of the braided stent 200 to the second end of the braided stent 200. In some embodiments, the plurality of closed cells 225 may be disposed immediately adjacent to one another along the central longitudinal axis CC from the first end of the braided stent 200 to the second end of the braided stent 200 within the first loop row and / or the second loop row. Each of the two longitudinally oriented connector elements 224 forming each of the plurality of closed cells 225 may be directly connected to one circumferential weft element 232 from each adjacent weft row 230.

[0049] When a braided stent 200 having a plurality of closed cells 225 (e.g., twisted loops) as described herein is deployed, the two longitudinally oriented connector elements 224 of each open cell 221 (e.g., standard loops) are axially shortened, thereby forcing filament material into adjacent and / or directly connected weft elements 232 and radially expanding the braided stent 200. The plurality of closed cells 225 are configured and / or can receive and / or absorb excess filament material from the two longitudinally oriented connector elements 224 of adjacent loop rows 220. Similarly, the plurality of closed cells 225 (e.g., twisted loops) can be configured to longitudinally stretch and / or deform upon receiving filament material from the two directly connected circumferential weft elements 232 and / or the two longitudinally oriented connector elements 224 of adjacent loop rows 220, allowing the diameter of the braided stent 200 to be achieved without the formation of "sea folds." Thus, the plurality of closed cells 225 may act as a suspension feature within the braided stent 200, allowing the braided stent 200 to flex and / or self-adjust if the braided stent 200 becomes improperly sized for a body lumen. Because, in at least some embodiments, the plurality of closed cells 225 (e.g., twist loops) may stretch by different amounts depending on the difference between the designed and / or labeled outer diameter of the braided stent 200 and the inner diameter of the target body lumen, the plurality of closed cells 225 may be positioned and / or configured to open and / or release last during deployment of the braided stent 200 in order to optimize and / or maximize the adaptability of the braided stent 200 to changing body lumen diameters.

[0050] FIG. 7 is a side view of a portion of an example braided stent 100 that may include the features described above with respect to FIG. 5. In another configuration, FIG. 7 may be considered to show a portion of a braided stent 200 that may include the features described above with respect to FIG. 6. For purposes of simplicity, the following description is directed to the braided stent 100, but such description is not intended to be limiting. The braided stent 100 may include a first end portion 102 proximate and / or extending from a first end 101, a second end portion 108 proximate and / or extending from a second end 109, and a body portion 105 axially and / or longitudinally disposed between the first end portion 102 and the second end portion 108 along a central longitudinal axis BB.

[0051] In at least some embodiments, at least one of the plurality of loop rows 120 including the plurality of closed cells 125 may include a first loop row 119 extending along and / or parallel to the central longitudinal axis BB within the first end portion 102, the body portion 105, and the second end portion 108. In some embodiments, the first loop row 119 may extend along and / or parallel to the central longitudinal axis BB from the first end 101 of the braided stent 100 to the second end 109 of the braided stent 100. In some embodiments, at least some of the plurality of closed cells 125 may be interwoven and / or intertwined with one another within the first loop row 119. In some embodiments, the plurality of closed cells 125 may be disposed immediately adjacent to one another within the first loop row 119 from the first end 101 of the braided stent 100 to the second end 109 of the braided stent 100. In some embodiments, all of the closed cells of braided stent 100 can be disposed in first loop row 119. In some embodiments, the total number of cells in loop rows 120 in first end portion 102, second end portion 108, and body portion 105 can include at least 90% open cells.

[0052] In some embodiments, the plurality of closed cells 125 (e.g., twisted loops) may apply a circumferential force to the first end portion 102, the body portion 105, and / or the second end portion 108 of the braided stent 100. In some embodiments, the plurality of closed cells 125 (e.g., twisted loops) may allow a constant radial force to be applied to the first end portion 102, the body portion 105, and / or the second end portion 108 of the braided stent 100 while maintaining any circumferential expansion appropriate for the vessel dimensions associated with the first end portion 102, the body portion 105, and / or the second end portion 108 of the braided stent 100, which may be similar or different depending on anatomical differences.

[0053] FIG. 8A is a side view of a portion of another example of a braided stent 100 that may include the features described above with respect to FIG. 5. In another configuration, FIG. 8A may be considered to show a portion of a braided stent 200 that may include the features described above with respect to FIG. 6. For purposes of simplicity, the following description is directed to a braided stent 100, but such description is not intended to be limiting. The braided stent 100 may include a first end portion 102 proximate and / or extending from a first end 101, a second end portion 108 proximate and / or extending from a second end 109, and a body portion 105 axially and / or longitudinally disposed between the first end portion 102 and the second end portion 108 along a central longitudinal axis BB.

[0054] In some embodiments, within the body portion 105, the plurality of loop rows 120 may be formed entirely and / or entirely of open cells having open ends 123 disposed between two longitudinally oriented connector elements 124 and on opposite sides of the circumferential loop element 122 (e.g., FIG. 5). In some embodiments, within the first end portion 102, at least one of the plurality of loop rows 120 includes a first plurality of closed cells having closed ends 127 formed by intersecting two longitudinally oriented connector elements 124 at a location opposite the circumferential loop element 122 (e.g., FIG. 5). In some embodiments, within the second end portion 108, at least one of the plurality of loop rows 120 includes a second plurality of closed cells having closed ends 127 formed by intersecting two longitudinally oriented connector elements 124 at a location opposite the circumferential loop element 122 (e.g., FIG. 5).

[0055] In at least some embodiments, at least one of the plurality of loop rows 120 including a plurality of closed cells 125 may include a first portion of the first loop row 119 and a second portion of the first loop row 119 axially and / or longitudinally spaced from the first portion. In some embodiments, the first portion of the first loop row 119 may extend and / or be disposed within the first end portion 102 along and / or parallel to the central longitudinal axis BB. In some embodiments, the second portion of the first loop row 119 may extend and / or be disposed within the second end portion 108 along and / or parallel to the central longitudinal axis BB. The first end portion 102 and the second end portion 108 may be spaced apart by the body portion 105 of the braided stent 100.

[0056] As seen in FIG. 8B, in some embodiments, the first end portion 102 and the second end portion 108 may each have an outer diameter greater than the outer diameter of the body portion 105. In some embodiments, in the radially expanded configuration of the braided stent 100, the first end portion 102 may have a first outer diameter greater than the outer diameter of the body portion 105. In such embodiments, the first end portion 102 may be considered and / or referred to as a first flared end portion. In some embodiments, in the radially expanded configuration of the braided stent 100, the second end portion 108 may have a second outer diameter greater than the outer diameter of the body portion 105. In such embodiments, the second end portion 108 may be considered and / or referred to as a second flared end portion. In some embodiments, the first outer diameter may be the same as the second outer diameter. In some embodiments, the first outer diameter may be different from the second outer diameter. In the example of FIG. 8B, both the first outer diameter and the second outer diameter are different from the outer diameter of the body portion 105. 8A, the first outer diameter and the second outer diameter are both substantially identical (e.g., the same) as the outer diameter of body portion 105. Other configurations are envisioned. For example, the first outer diameter of first end portion 102 may be larger than the outer diameter of body portion 105 and the second outer diameter of second end portion 108 may be substantially the same as the outer diameter of body portion 105, or vice versa.

[0057] 8A and 8B , in some embodiments, a first portion of the first loop row 119 can extend from the body portion 105 along and / or parallel to the central longitudinal axis BB toward and / or to the first end 101 of the braided stent 100, and a second portion of the first loop row 119 can extend from the body portion 105 along and / or parallel to the central longitudinal axis BB toward and / or to the second end 109 of the braided stent 100. In some embodiments, the first portion can include a first plurality of closed cells 117 and the second portion can include a second plurality of closed cells 118. In some embodiments, the plurality of closed cells 125 (e.g., twisted loops) described herein may include a first plurality of closed cells 117 and / or a second plurality of closed cells 118, and the properties and / or characteristics of each may be used and / or applied interchangeably, unless expressly specified otherwise.

[0058] In some embodiments, the first plurality of closed cells 117 may be interwoven and / or intertwined with one another within the first loop row 119. In some embodiments, the second plurality of closed cells 118 may be interwoven and / or intertwined with one another within the first loop row 119. In some embodiments, the first plurality of closed cells 117 may extend from the body portion 105 to the first end 101 of the braided stent 100 along the central longitudinal axis BB and / or within the first loop row 119 and / or may be disposed immediately adjacent to one another. In some embodiments, the second plurality of closed cells 118 may extend from the body portion 105 to the second end 109 of the braided stent 100 along the central longitudinal axis BB and / or within the first loop row 119 and / or may be disposed immediately adjacent to one another. In some embodiments, all of the closed cells of the braided stent 100 may be disposed within the first loop row 119. In some embodiments, the total number of cells in the plurality of loop rows 120 in the first end portion 102, the second end portion 108, and the body portion 105 can include at least 90% open cells.

[0059] In some embodiments, the first plurality of closed cells 117 (e.g., twist loops) may exert a first circumferential force on the first end portion 102 of the braided stent 100. In some embodiments, the second plurality of closed cells 118 (e.g., twist loops) may exert a second circumferential force on the second end portion 108 of the braided stent 100. In some embodiments, the first circumferential force may be substantially the same as the second circumferential force. In some embodiments, the first circumferential force may be different from the second circumferential force. For example, in some embodiments, the first circumferential force may be greater than the second circumferential force, or vice versa. In some embodiments, the first plurality of closed cells 117 (e.g., twisted loops) may allow for a constant radial force to be applied to the first end portion 102 of the braided stent 100 while maintaining any circumferential expansion appropriate for the vessel dimension associated with the first end portion 102 of the braided stent 100, which may be similar or different depending on anatomical variations. In some embodiments, the second plurality of closed cells 118 (e.g., twisted loops) may allow for a constant radial force to be applied to the second end portion 108 of the braided stent 100 while maintaining any circumferential expansion appropriate for the vessel dimension associated with the second end portion 108 of the braided stent 100, which may be similar or different depending on anatomical variations.

[0060] The first and / or second flared end portions may be configured to engage a wall of a body lumen. It is contemplated that the transition from the body portion to the first and / or second flared end portions may occur in a gradual, gradual, or abrupt step, as desired. In some embodiments, the outer diameter of the body portion may be within a range of about 15 millimeters to about 25 millimeters. In some embodiments, the first outer diameter of the first flared end portion and / or the second outer diameter of the second flared end portion may be within a range of about 20 millimeters to about 30 millimeters. It is contemplated that the outer diameter of the braided stent 100 may be varied to suit a desired application.

[0061] 9A and 9B are side views of a portion of another configuration of the braided stent 100 of FIG. 7. Alternatively, FIGS. 9A and 9B may be considered to show a portion of a braided stent 200. For purposes of simplicity, the following discussion is directed to the braided stent 100, but such discussion is not intended to be limiting. The braided stent 100 may include a first end portion 102 proximate and / or extending from a first end 101, a second end portion 108 proximate and / or extending from a second end 109, and a body portion 105 axially and / or longitudinally disposed between the first end portion 102 and the second end portion 108 along a central longitudinal axis BB.

[0062] In some embodiments, a majority of the plurality of loop rows 120 include open cells having open ends 123 disposed between two longitudinally oriented connector elements 124 and on opposite sides of the circumferential loop element 122 (e.g., FIG. 5). At least one of the plurality of loop rows 120 includes a plurality of closed cells 125 having closed ends 127 formed by crossing two longitudinally oriented connector elements 124 at a location opposite the circumferential loop element 122 (e.g., FIG. 5). In some embodiments, at least one of the plurality of loop rows 120 including a plurality of closed cells 125 may include a first loop row 119 extending within the first end portion 102, the body portion 105, and the second end portion 108 along and / or parallel to the central longitudinal axis BB. In some embodiments, the first loop row 119 can extend along and / or parallel to the central longitudinal axis BB from the first end 101 of the braided stent 100 to the second end 109 of the braided stent 100.

[0063] In some embodiments, at least some of the plurality of closed cells 125 may be interwoven and / or intertwined with open cells within the first loop row 119. For example, in some embodiments, the plurality of closed cells 125 are longitudinally spaced apart from one another within at least one of the plurality of loop rows 120 and / or within the first loop row 119. In some embodiments, the plurality of closed cells 125 are longitudinally spaced apart from one another within the first loop row 119 from the first end 101 of the braided stent 100 to the second end 109 of the braided stent 100. In some embodiments, each consecutive pair of the plurality of closed cells 125 may be longitudinally spaced apart from one another within at least one of the plurality of loop rows 120 and / or within the first loop row 119 by one open cell, as shown in FIG. 9A. In some embodiments, each consecutive pair of the plurality of closed cells 125 may be longitudinally spaced apart from one another by two open cells within at least one of the plurality of loop rows 120 and / or within the first loop row 119, as shown in FIG. 9B. Other configurations are envisioned. In some embodiments, all of the closed cells of the braided stent 100 may be disposed within the first loop row 119. In some embodiments, the total of the plurality of cells of the plurality of loop rows 120 in the first end portion 102, the second end portion 108, and the body portion 105 may include at least 90% open cells.

[0064] The various components of the braided stent 100 / 200 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 will refer to the braided stent 100 / 200. However, this is not intended to limit the devices and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, the expandable framework, anchoring portion, body portion, linking portion, polymeric cover, and / or elements or components thereof.

[0065] In some embodiments, the braided stent 100 / 200 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, etc., or other suitable materials.

[0066] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates, and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. Atochem's 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®), 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., EMS American GRILAMID® available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0067] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625, UNS: N06022, such as HASTELLOY® C-22®, HASTELLOY® C276®, 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®, etc.); B2®), other nickel alloys such as 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®, etc.); platinum-rich stainless steels; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0068] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Material Co., Ltd., Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, may be used to achieve the desired properties.

[0069] In at least some embodiments, the braided stent 100 / 200 and / or some or all of its components may also be doped with, made of, or 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 endoprosthesis 100 / 200 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 endoprosthesis 100 / 200 to achieve the same results.

[0070] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the braided stent 100 / 200 and / or other elements disclosed herein. For example, the braided stent 100 / 200 and / or components or portions thereof may be made of materials that do not substantially distort images and do not cause substantial artifacts (i.e., gaps in images). For example, certain ferromagnetic materials may not be suitable because they may cause artifacts in MRI images. The braided stent 100 / 200 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.

[0071] In some embodiments, the braided stent 100 / 200 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.

[0072] In some embodiments, the braided stent 100 / 200 and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk, or unshrunk. Synthetic biocompatible yarns suitable for use in the present invention 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, a glass or ceramic yarn, or a 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 fiber, glass fiber, or ceramic fiber. 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 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 desired properties.

[0073] In some embodiments, the braided stent 100 / 200 and / or other components 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 ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptide); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins, etc.); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0074] 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. A braided stent extending along a central longitudinal axis, comprising: a filament forming a plurality of cells arranged in a plurality of rows and a plurality of columns; the plurality of rows extend parallel to the central longitudinal axis from a first end of the braided stent to a second end of the braided stent; The plurality of rows extend circumferentially about the central longitudinal axis; the plurality of rows includes a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows; each cell in the plurality of loop rows includes a circumferential loop element connected to two longitudinally oriented connector elements; the plurality of weft rows includes a plurality of circumferential weft elements connected to adjacent loop rows; a majority of the plurality of loop rows include open cells, the open cells being disposed between the two longitudinally oriented connector elements and having open ends opposite the circumferential loop element; at least one of the plurality of loop rows includes a plurality of closed cells, the plurality of closed cells having closed ends formed by intersecting the two longitudinally oriented connector elements at a location opposite the circumferential loop element; the at least one of the plurality of loop rows includes a first loop row extending from the first end of the braided stent to the second end of the braided stent, the plurality of closed cells being disposed immediately adjacent to one another within the first loop row from the first end of the braided stent to the second end of the braided stent. Braided stent.

2. The braided stent of claim 1 , wherein the circumferential loop elements of each cell are oriented toward the first end of the braided stent.

3. 3. The braided stent of claim 1 or 2, wherein the plurality of closed cells are disposed proximate the first end or the second end of the braided stent.

4. The braided stent of any one of claims 1 to 3, wherein the plurality of circumferential weft elements are connected at both ends to one of the two longitudinally oriented connector elements from each adjacent loop row.

5. The braided stent of any one of claims 1 to 4, wherein the at least one of the plurality of loop rows includes a first portion of a first loop row and a second portion of the first loop row longitudinally spaced from the first portion, the first portion including a first plurality of closed cells and the second portion including a second plurality of closed cells.

6. 6. The braided stent of claim 5, wherein the first plurality of closed cells are disposed immediately adjacent to one another along the central longitudinal axis and the second plurality of closed cells are disposed immediately adjacent to one another along the central longitudinal axis.

7. 6. The braided stent of claim 5, wherein the first portion of the first loop row is disposed within a first end portion of the braided stent and the second portion of the first loop row is disposed within a second end portion of the braided stent, the first end portion and the second end portion being spaced apart by a main body portion of the braided stent.

8. 8. The braided stent of claim 7, wherein in a radially expanded configuration of the braided stent, the first end portion has a first outer diameter that is greater than an outer diameter of the body portion.

9. The braided stent of claim 7 , wherein in a radially expanded configuration of the braided stent, the second end portion has a second outer diameter that is greater than an outer diameter of the body portion.

10. The braided stent of any one of claims 1 to 9, wherein all closed cells of the braided stent are arranged in a single loop row.

11. the at least one of the plurality of loop rows further includes a second loop row extending from the first end of the braided stent to the second end of the braided stent, the second loop row being circumferentially spaced from the first loop row; 2. The braided stent of claim 1, wherein the second loop row includes a plurality of closed cells disposed immediately adjacent to one another within the second loop row from the first end of the braided stent to the second end of the braided stent.

12. The braided stent of any one of claims 7 to 9, wherein a total of the plurality of cells of the plurality of loop rows in the first end portion, the second end portion, and the main body portion comprises at least 90% open cells.

13. 1. A braided stent extending along a central longitudinal axis, comprising: a filament forming a plurality of cells arranged in a plurality of rows and a plurality of columns; the plurality of rows extend parallel to the central longitudinal axis from a first end of the braided stent to a second end of the braided stent; The plurality of rows extend circumferentially about the central longitudinal axis; the plurality of rows includes a plurality of loop rows and a plurality of weft rows interposed between adjacent loop rows; each cell in the plurality of loop rows includes a circumferential loop element connected to two longitudinally oriented connector elements; the plurality of weft rows includes a plurality of circumferential weft elements connected to adjacent loop rows; a majority of the plurality of loop rows include open cells, the open cells being disposed between the two longitudinally oriented connector elements and having open ends opposite the circumferential loop element; at least one of the plurality of loop rows includes a plurality of closed cells, the plurality of closed cells having closed ends formed by intersecting the two longitudinally oriented connector elements at a location opposite the circumferential loop element; The braided stent, wherein the plurality of closed cells are longitudinally spaced apart from one another within the at least one of the plurality of loop rows.

14. 14. The braided stent of claim 13, wherein each of the consecutive pairs of closed cells is longitudinally spaced from one another by one open cell or by two open cells within the at least one of the plurality of loop rows.

Citation Information

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