Stent with shaped wires

Abstract

To provide a novel stent structure.SOLUTION: A stent generally can include a tubular structure having circumferentially positioned undulating wires that extend over a majority of the length of the stent such that the undulations oscillate circumferentially to define the circumference of the stent. The undulations can wrap over and under adjacent undulations to form an interwoven structure. Additionally, or alternatively, adjacent wires can be joined. Wires forming the stent can be cut from elastic tubing such that each wire has a three-dimensional shape.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to implantable stent medical devices and methods for manufacturing same, and more specifically to novel stent structures. [Background technology]

[0002] Medical stents are used to support, maintain, or repair lumens, passageways, or openings in living organisms. Stent designs are specific to the location and purpose of treatment, as the stent must be flexible enough in a collapsed state to navigate the body lumen to reach the treatment site, structurally robust enough in an implanted state to provide the structural support necessary to repair the treatment site, and flexibly expandable to provide high conformability in treatment sites with tapered, bent, or other non-linear or non-tubular shapes. Flexibility, structural integrity, and conformability are often competing design objectives, which will vary depending on the location of the treatment site, the purpose of the treatment, and the shape of the treatment site.

[0003] A wire, or braided, stent is typically braided from flexible wire to form a tube of wire that helically wraps around a central axis of the stent, with roughly half of the wires wrapping clockwise and the other half wrapping counterclockwise, so that the wires extending in opposite directions wrap over and under each other at an angle in an alternating manner. Although wire stents can be extremely flexible, can achieve high conformability within a body lumen, including bends, and can be resistant to kinking, wire stents generally lack the structural integrity required in some treatments because they exert a radial outward force against the lumen wall.

[0004] A common approach for stent design where structural integrity is desired employs laser-cut patterns from a length of elastic tubing, typically made of a shape memory metal such as Nitinol or Nitinol alloy. Typically, material is removed from the tubing to form a cell pattern. Generally speaking, sufficient material must remain such that the overall structural integrity of the laser-cut stent will provide sufficient outward force against the lumen wall once implanted. Material is strategically removed to increase the flexibility of the stent for delivery to the treatment site and conformance to the lumen wall within the treatment site, including bent or otherwise uneven wall structure. In many stent designs, the pattern is cut to form rings that are connected longitudinally and substantially circumferentially by bridge struts. In such designs, bridge struts are added to achieve greater structural integrity and removed to achieve greater flexibility.

[0005] Attempts have been made to design stents with greater flexibility and kink resistance compared to stents cut from elastic tubing, and greater structural integrity compared to wire stents. One such approach employs cutting elastic tubing into a single helical structure that wraps circumferentially around the stent body, with adjacent helical turns longitudinally interconnected with bridge struts (e.g., U.S. Pat. No. 5,925,061). Another approach employs cutting a sheet of material to form a lattice strand that may be wrapped as a single helix around a mandrel, with adjacent turns then interconnected (e.g., U.S. Pat. No. 5,370,683). Such designs can typically achieve greater flexibility compared to laser-cut tubular stents that utilize circumferential rings, but at the expense of structural integrity; while such designs can achieve greater structural integrity compared to wire stents, they cannot achieve the compliance and kink resistance of most wire stents. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, a need exists for alternative stent designs to achieve flexibility, structural integrity, and conformability to meet the needs of various treatment objectives at various treatment sites with various anatomical geometries. [Means for solving the problem]

[0007] Disclosed herein are various exemplary stents of the present invention that may address the above needs. The stent may generally include a tubular structure having circumferentially positioned undulating wires that extend over most of the length of the stent, the undulations oscillating in a circumferential direction, the undulations of the wires collectively defining the circumference of the stent. The undulations may wrap around the tops and bottoms of adjacent undulations to form an interwoven structure. Additionally or alternatively, adjacent wires may be joined.

[0008] An exemplary stent may include a stent length measured from a first open end to a second open end, and two or more wires each having a three-dimensional oscillating portion that extends across a majority of the stent length and is movable independently of all other oscillating portions of the one or more wires. The oscillating portion of each wire may have a oscillating portion length measured parallel to the z-axis, a curved portion that extends circumferentially across an arc of less than 360° around the z-axis at a constant radius from the z-axis, and a waveform that oscillates across the length of the oscillating portion across the arc. Each oscillating portion of the one or more wires may be movable independently of all others of the one or more wires.

[0009] Another exemplary stent having a circumference and length may include two or more wires, each having a three-dimensional corrugation that oscillates circumferentially in an arc about a z-axis that is parallel to the stent length, such that each corrugation extends parallel to the z-axis for most of the stent length and maintains a substantially constant radial distance from the z-axis. The wires of the stent may be positioned circumferentially adjacent to one another around the circumference of the stent to define the circumference of the stent. Each wire may be movable along most of the length of the stent independently of all other wires in the stent.

[0010] Another exemplary stent having a tubular structure having a circumference and a length may include a plurality of wires positioned around the circumference of the stent, each wire may be independently formed, may undulate circumferentially to form a wave pattern extending over most of the length of the stent, may pass under and over adjacent wires in a repeating manner while maintaining an adjacent position relative to adjacent wires over most of the length of the stent, and may circumferentially intertwine with other wires to form a tubular stent.

[0011] Another exemplary stent having a tubular structure may include circumferentially positioned undulating wires that extend over a majority of the length of the stent. The wires may each have circumferentially oscillating undulations. The undulations of each wire may be circumferentially recessed within the undulations of adjacent wires, such that the circumferential positioning of the undulating wires may define the perimeter of the stent, and the circumferential positioning of the undulating wires may solely define the perimeter of the stent without any additional structure to define the perimeter of the stent.

[0012] In any of the exemplary stents, each wire of the stent may be formed independently of all other wires of the stent. Each wire of the stent may be joined to a circumferentially adjacent wire at one or more locations. The stent may include a first junction that secures a first wire to a second wire near a first open end. This first junction may be the only secured junction between the first wire and the second wire. Additionally or alternatively, to secure the adjacent wires, the first wire may cross both below and above the second wire within one oscillation period of the first wire's waveform.

[0013] In any of the exemplary stents, the stent may include a first end structure positioned adjacent the first open end and extending between the first open end of the stent and the vibrating portion, and the stent may include a second end structure positioned adjacent the second open end and extending between the second open end of the stent and the vibrating portion, One or both of the first and second end structures may have an atraumatic shape.

[0014] In any of the exemplary stents, the wires of the stent can have widths that vary along the length of the stent.

[0015] In any of the exemplary stents, one or more of the wires can include a shape memory material. At least one wire can have a predetermined three-dimensional shape curved along an arc, the three-dimensional shape having an undulating wave pattern within the arc.

[0016] An exemplary method for manufacturing a stent, including any of the exemplary stents described herein, may include providing an elastic tubing, cutting the tubing to form a plurality of substantially similar wave patterns, separating each of the plurality of wave patterns from the tubing, positioning each wave pattern to extend over a majority of the length of the stent, and forming a majority of a tubular stent body from the plurality of wave patterns. Each wave pattern may have an amplitude that extends circumferentially over an arc within the circumference of the tubing from which it is cut, an axis that extends along at least a portion of the length of the tubing along which the wave pattern repeats, and a curved inner surface that is a cut portion of the luminal surface of the tubing.

[0017] Another exemplary method for manufacturing a stent, including any of the exemplary stents described herein, may include providing an elastic tubing having a circumference and a length, cutting individual wires from the tubing such that each wire has a peak-to-peak oscillating wave pattern over a portion of the circumference, and weaving the wires to form a tubular shape.

[0018] Any of the exemplary methods may include any combination of the steps of cutting individual wires from the provided tubing so that each wire has a peak-to-peak oscillating wave pattern over a portion of its circumference, separating the cut wires from the tubing so that the wires are decoupled from one another, joining a first wire to a second wire in one or more locations, joining the first wire to the second wire near an end of the stent body, and / or intertwining each wire with adjacent wires in a clockwise direction and adjacent wires in a counterclockwise direction. [Brief description of the drawings]

[0019] The above and further aspects of the present invention comprise: Consider further with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily to scale, with the focus instead being on illustrating the principles of the invention. The figures depict one or more implementations of the apparatus of the present invention, by way of example only and not by way of limitation. [Figure 1] FIG. 1 is a three-dimensional perspective view of a stent according to the present invention. [Figure 2A] FIG. 2 is a side view of a stent in an expanded state according to the present invention. [Figure 2B] FIG. 2B is a side view of the stent of FIG. 2A in a collapsed state in accordance with the present invention. [Figure 3A] 2 is a two-dimensional representation of the wires of a stent according to the present invention. [Figure 3B] 3B is a three-dimensional representation of the wire of FIG. 3A according to the present invention. [Figure 3C] FIG. 3C is a schematic diagram of a coordinate system for describing the three-dimensional shape of a wire of a stent, such as the wire depicted in FIG. 3B. [Figure 4] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Diagram 5] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Figure 6] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Figure 7] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Figure 8] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Figure 9] 1 is a two-dimensional depiction of the wires of a stent illustrating an exemplary wire arrangement around the circumference of a stent in accordance with the present invention. [Figure 10A]1 illustrates an exemplary wave or undulating pattern for the wires of a stent according to the present invention. [Figure 10B] 1 illustrates an exemplary wave or undulating pattern for the wires of a stent according to the present invention. [Figure 10C] 1 illustrates an exemplary wave or undulating pattern for the wires of a stent according to the present invention. [Figure 10D] 1 illustrates an exemplary wave or undulating pattern for the wires of a stent according to the present invention. [Figure 10E] 1 illustrates an exemplary wave or undulating pattern for the wires of a stent according to the present invention. [Figure 11] 1 illustrates an exemplary wire weave pattern for a stent according to the present invention. [Figure 12A] 1 illustrates an exemplary wire segment having variable width in accordance with the present invention. [Figure 12B] 1 illustrates an exemplary wire segment having variable width in accordance with the present invention. [Figure 12C] 1 illustrates an exemplary wire segment having variable width in accordance with the present invention. [Figure 12D] 1 illustrates an exemplary wire segment having variable width in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Various exemplary stents that can address the above needs are described herein. In general, the stent may have a generally tubular structure with circumferentially positioned undulating wires that extend over most of the length of the stent. The undulations of each wire may oscillate in a circumferential direction and may be recessed within the undulations of adjacent wires, such that the recesses of each wire into each other define the circumference of the stent. Adjacent wires may be joined in some locations, such as at the ends, or not necessarily at all locations, such that each individual wire is movable independently of all other wires. Additionally or alternatively, the undulations may wrap around the tops and bottoms of adjacent undulations to form an interwoven structure.

[0021] In general, the exemplary stents described herein may be prepared by cutting a metal tube into separate wires that retain their helical curvature from the tube wall from which they are cut. The wires may be cut from the tube to be substantially independent of one another, and the wires may be braided, woven, or otherwise intertwined to form a tubular shape. In some applications, it may be desirable to utilize 8-16 laser cut wires to form a stent with the desired flexibility, structural integrity, and conformability. The wires in some exemplary stents may move independently of one another to some extent, for example, the wires of the exemplary stents may be movable similar to how wires in known braided or woven structures are generally movable independently of one another. Additionally or alternatively, the wires in some exemplary stents may be welded or otherwise joined to one another at one or more locations along the length of each of the wires. The joined wires may form an interlocking structure and increase the structural integrity of the stent.

[0022] Because the wires of some exemplary stents can be made to be substantially movable relative to one another, some exemplary stents may have improved flexibility and kink resistance compared to known laser cut tube designs and may achieve similar flexibility and kink resistance as known wire braided stent designs. Because the wires of some exemplary stents can be cut from metal tubes, some exemplary stents may provide greater radial force compared to known wire braided stent designs, the wires of the stents may be designed to have atraumatic end structures (which are typically not achievable by using cut wires in known wire braided stent designs), and the stents may have wires that vary in thickness and shape along the length of the stent (which is generally not possible in known wire braided stent designs that utilize constant diameter wires). Potential applications of some exemplary stents may support embolic coils within an aneurysm, with treatment sites to be reached requiring navigation of tortuous anatomy.

[0023] FIG. 1 is a three-dimensional perspective view of a stent 100 having four wires 200a, 200b, 200c, 200d. As can be appreciated and understood from the figure, the stent 100 may include as few or as many wires as needed to achieve the desired flexibility, structural integrity, and conformability. A stent with more wires may be needed, for example, when treating a body lumen having a larger diameter. The stent may also be designed to have spaces between the wires through which a microcatheter for delivering an embolic implant can pass, in which case it may be desirable to create holes between the wires that are small enough to provide sufficient structural support, but large enough to provide a coiled microcatheter that can fit through the holes. In some applications, it may be desirable to utilize 8 to 16 laser cut wires.

[0024] FIG. 2A is a side view of a stent 100 in an expanded state, similar to the stent of FIG. 1, having four wires 200a, 200b, 200c, 200d. The stent 100 may have a substantially tubular body shape having a first open end 112, a second open end 114, and a length 110 extending in a longitudinal direction 10 from the first open end 112 to the second open end 114. The stent 100 may be designed to have a length to meet the needs of the treatment, for example, the length 110 may be sized larger than the neck of the aneurysm, such that an aneurysm with a larger neck opening may be treated using a longer stent. The tubular body shape of the stent 100 may have a substantially uniform circumference 20 along the length 110 of the body shape in the expanded state. Alternatively (not shown), the stent may have a tubular body shape that has a larger circumference at a first open end and tapers to a smaller circumference at a second open end. Such a tapered design may be advantageous, for example, when treating a tapered body lumen.

[0025] FIG. 2B is a side view of the stent of FIG. 2A in a collapsed state. In this collapsed state, the stent 100 can be sized to be delivered to a treatment site in the vasculature through a microcatheter. Because the stent 100 can be made with a small number of wires, each of which can be stretched in the longitudinal direction 10 to occupy a small cross-sectional profile, an advantage of the stent 100 is that it can be collapsed to a thinner dimension than a laser-cut tubular stent. Laser-cut tubular stents typically have little ability to stretch in the longitudinal direction. The thinner collapsed dimension can allow the stent 100 in some applications to be delivered to a treatment site through a smaller catheter, and thus reach treatment sites that may be difficult or impossible to reach using other stent designs.

[0026] A wire 200 is illustrated in two dimensions in FIG. 3A and in three dimensions in FIG. 3B. The wire 200 has a three-dimensional shape as illustrated in FIG. 3B, and the two-dimensional illustration in FIG. 3A is provided to aid in visualization and discussion of the wire 200. With collective reference to FIGS. 3A and 3B, the wire 200 may have a vibrating portion 210 having a vibrating portion length 211 measured parallel to the z-axis 12. The vibrating portion 210 may have a waveform that repeats over the length 211 of the vibrating portion 210, the waveform repeating with an oscillation period 212. The waveform may be a sine wave having a series of peaks 202, troughs 204, and an intermediate segment 206 extending between the peaks 202 and the troughs 204. The vibrating portion 210 may extend over a majority of the length of the stent, and the wire 200 may also have an end structure 220 at the end of each wire 200. Each end structure 220 may have an atraumatic shape.

[0027] FIG. 3C is a schematic diagram of a cylindrical coordinate system for describing the three-dimensional shape of a wire 200 of a stent 100, such as the wire depicted in FIG. 3B. In this cylindrical coordinate system, the z-axis 12 is understood to be perpendicular to the page and positioned at the center of the circle illustrated in FIG. 3C. In general, the location of a point in a cylindrical coordinate system may be defined by coordinate axes r, θ, and z, where the r coordinate defines the distance from the z-axis, the θ coordinate defines the angle from the r-axis, and the z coordinate defines the linear position along the z-axis. Thus, a tube contains a point where r is equal to the constant R over a given length of the z-axis, and an arc within the tube is limited to an angle of θ, or a range of values ​​of θ, which may be less than 360°. Thus, the exemplary wire 200 illustrated in FIG. 3B may be described as having a curve extending circumferentially over an arc 216 of about 180° that maintains a substantially constant radius 214 from the z-axis. The waveform can be described as circumferentially oscillating, confined within an arc of curvature, and extending in the z-direction over the length 211 of the vibrating portion 210 .

[0028] With reference to Figure 3A, the amplitude of the corrugations may be described as the distance between the peaks 202 and the troughs 204. Thus, with reference to Figures 3B and 3C, the amplitude of the corrugations may be expressed as a function of the arc of the bends 216 and the radius 214. As will be appreciated and understood from the figures, the bends may be made wider or narrower to achieve the desired characteristics of the stent. For example, corrugations with a larger amplitude may result in a stent design that is generally more flexible, whereas corrugations with a smaller amplitude may result in a stent design that is generally easier to deliver through a microcatheter.

[0029] 3B and 3C, the wire may be formed by cutting wire from a portion of elastic tubing. The tubing may have a radius 214, which may be cut so that the resulting wire 200 has an oscillating portion that maintains the radius 214 of the tubing. The wire 200 may be cut from an arc defined by at least a portion of the circumference of the tubing such that the resulting wire 200 oscillates within an arc 216, and the resulting wire may have a peak-to-peak oscillating wave pattern across the cut portion of the circumference of the tube.

[0030] The tubing may have a lumen with an inner luminal surface. The wire 200 may be cut from the tubing with an inner surface, which is cut from the luminal surface of the tubing. The wire 200 may be cut from the tubing so that a majority of the vibrating portion 210 is movable independently of the other vibrating portions 210 of the wire. Once cut, the wire 200 may be separated from the tubing and formed independently of the formed wire 200.

[0031] Figures 4-9 are two-dimensional depictions of the wires of a stent illustrating exemplary wire placement around the circumference of the stent. The illustrative diagrams are provided in two dimensions for purposes of discussion and visualization. Collectively referring to Figures 4-8, the illustrative diagrams depict the placement of four wires 200a, 200b, 200c, 200d in a circumferential direction to form a stent. The bottom wire 200a is redrawn as a dashed wire 200a' above the top wire 200d, and the top wire 200d is redrawn as a dashed wire 200d' below the bottom wire 200a to illustrate the placement and connection of the wires shown as the top and bottom wires 200d, 200a in a three-dimensional stent.

[0032] The wires 200a, 200b, 200c, 200d may be cut from tubing and each wire may be positioned to define a circumference of a stent. The wires may be positioned such that each vibrating portion 210 extends across the length of the stent. The inner curved surfaces of each vibrating portion 210 of each wire 200a, 200b, 200c, 200d may be aligned to collectively form the circumference of the stent. The wires 200a, 200b, 200c, 200d may be joined and / or woven to form a tubular shape.

[0033] Figure 4 is a two-dimensional illustration of four wires arranged to define the circumference of a stent similar to that depicted in Figures 1 and 2A. Each wire may be circumferentially recessed within the undulations of a circumferentially adjacent wire, such that the circumferential positioning of the undulating wires defines the circumference of the stent. Each wire may be independently formed and movable, at least to some extent, relative to every other wire.

[0034] FIG. 5 is a two-dimensional illustrative view of four wires arranged to define a stent circumference similar to the pattern shown in FIG. 4. Each wire may be connected to each adjacent wire by a single junction 230a, 230b, 230c, 230d, 230d'. As shown, a first junction 230c may join a first wire 200c to a second wire 200d adjacent to the first wire 200c, and the first junction 230c may be the only anchoring junction between the first wire 200c and the second wire 200d. The first wire 200c may also be joined to a third wire 200b using a second junction 230b. As shown, each wire 200a, 200b, 200c, 200d may be joined to its two adjacent wires by a single junction for each neighboring wire. Minimal connections 230a, 230b, 230c, 230d may allow the wires to move independently of one another over most of the length of the stent.

[0035] As can be appreciated and understood from the figures, each joint can be formed by any conventional means, such as welding, brazing, soldering, gluing, tying, etc. Alternatively, or in addition, the stent can be cut from a single piece of tubing such that the joints 230a, 230b, 230c, 230d are uncut portions of the tubing. In one example, wires 200a, 200b, 200c, 200d that are joined to adjacent wires by uncut portions of tubing may not be completely separated from their neighbors during manufacturing. However, the uncut portions may be placed at joint locations 230a, 230b, 230c, 230d similar to those shown in Figures 5 and 6 and described herein to allow wires 200a, 200b, 200c, 200d to move independently of adjacent wires and other wires over a majority of the length of the stent.

[0036] FIG. 6 is a two-dimensional, illustrative view of four wires arranged to define a circumference of a stent with one junction 230a, 230b, 230c, 230d, 230d' connecting each pair of adjacent wires. As can be appreciated and understood from the figure, the junctions 230a, 230b, 230c, 230d, 230d' can be positioned in any number of locations. FIG. 6 illustrates an alternative configuration of the four wires 200a, 200b, 200c, 200d and the four junctions 230a, 230b, 230c, 230d illustrated in FIG. 5. As can be appreciated and understood from the figure, any number of junctions can be used and any number of wires can be connected to achieve the desired flexibility, structural integrity, and conformability of the stent. Minimal connections 230a, 230b, 230c, 230d may allow wires 200a, 200b, 200c, 200d to move independently of one another over most of the length of the stent.

[0037] FIG. 7 is a two-dimensional illustrative view of four wires arranged to define the circumference of a stent, which are interwoven to define the circumference of the stent. Each wire may cross at the top and bottom of each adjacent wire. As illustrated, a first wire 200a may cross at the bottom 244 of a first adjacent wire 200d' and at the top 246 of the same wire 200d' within one vibration period of the first wire 200a. The first wire 200a may cross at the bottom 242 of a second adjacent wire 200b and at the top 248 of the second adjacent wire 200b within the same vibration period of the first wire 200a. The interwoven structure of the wires 200a, 200b, 200c, 200d may be sufficient to maintain the structural integrity of the stent without any joints to secure the wires. Thus, the wires may be independently formed and independently movable. As can be appreciated and understood from the figures, the wires 200a, 200b, 200c, 200d may be intertwined with other wave patterns in any number of patterns.

[0038] FIG. 8 is a two-dimensional illustrative view of four wires arranged to define a circumference of a stent, the wires being interwoven to define a circumference of the stent, similar to that illustrated in FIG. 7. The stent may have both interwoven wires 200a, 200b, 200c, 200d, and junctions 230a, 230b, 230c, 230d to join adjacent wires. As illustrated, junction 230b may be positioned to connect first wire 200c and second wire 200b at the intersection. Junctions 230a, 230b, 230c, 230d may be positioned near the ends of the wires, and only one junction may be used to connect each wire to each adjacent wire. As can be appreciated and understood from the figure, any number of junctions may be used to connect the wires and at various locations along the length of the stent. Minimal connections 230a, 230b, 230c, 230d may allow wires 200a, 200b, 200c, 200d to move independently of one another over most of the length of the stent.

[0039] 9 is a two-dimensional, illustrative view of four wire segments 200a, 200b, 200c, 200d joined by three bends 230, the wire segments being arranged to define a circumference of a stent, with each wire segment 200a, 200b, 200c, 200d being joined to an adjacent segment by a bend 230. As illustrated, each bend 230 may be positioned at either the first or second open end of the stent to connect the first wire 200a and the second wire 200b. When connected in this manner, the wire segments 200a, 200b, 200c, 200d may be joined to form a continuous wire characterized by longitudinal undulating segments 200a, 200b, 200c, 200d that are alternately joined at bends 230 positioned at each end of the stent. The continuous wire may include an atraumatic end 220 positioned at the end of the first wire segment 200a and at the end of the last wire segment 200d in the chain of segments. Alternatively (not shown), the stent may be constructed using multiple independent wires made of wire segments joined at bends. The wires and wire segments may be joined or interwoven otherwise as described in other examples shown herein or as known in the art.

[0040] 10A-10E illustrate exemplary wave or undulation patterns for the wires of a stent, which may be used in addition to or in place of other wave patterns depicted and described herein. As will be appreciated and understood, many wave patterns may be utilized to achieve the desired flexibility, structural integrity, and conformability for a stent, including those not shown and those known in the art.

[0041] FIG. 11 illustrates an exemplary wire weave pattern that may be utilized to form a stent in addition to, or in place of, other weave patterns depicted and described herein.

[0042] 12A-12D illustrate exemplary wire segments having variable widths that may be utilized to form a stent in addition to or in lieu of other wire features depicted and described herein. As illustrated in FIG. 12A, the wire may have an undulating pattern with thicker segments near each end of the wire and a thinner segment positioned in the center of the wire. The thinner central segment may allow the stent to pass more easily through a microcatheter, whereas the thicker end segments may improve the structural integrity at the stent ends for anchoring within a body lumen. As illustrated in FIG. 12B, the wire may have a thin segment near one end and a thicker segment at the other end. As illustrated, the segments may become gradually thicker or thinner from one end of the wire to the other. Stents formed from wire segments having gradually varying segment thicknesses may be formed to have a tapered structure that may be advantageous in achieving conformance to the sidewalls of a body lumen when implanted in a tapered body lumen.

[0043] The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention in any way. As described herein, the invention contemplates many variations and modifications of the stent, including, for example, alternative shapes for vibrating portions of the wires, alternative shapes for the atraumatic end segments of the wires, alternative means for joining or connecting the wires, alternative patterns for intertwining wires to form a stent, using any number of wires to form a stent, or utilizing any of a great many materials or manufacturing means for a stent. These modifications will be apparent to those skilled in the art to which the invention pertains, and are intended to be within the scope of the following claims.

[0044] [Embodiment] (1) A stent comprising: a stent length measured from the first open end to the second open end; and Two or more wires each including a three-dimensional vibrating portion, said vibrating portions comprising: the vibrating portion length measured parallel to the z-axis; a curved portion that extends circumferentially about the z-axis over an arc of less than 360 degrees, extends the length of the vibrating portion, and maintains a substantially constant radius from the z-axis along the vibrating portion length; a wire that oscillates in a circumferential direction and is confined within the arc of the bend and extends over the oscillating portion length; the vibrating portion length extends over a majority of the stent length; A stent wherein the vibrating portion of each of the one or more wires is movable independently of all other vibrating portions of the one or more wires. (2) The stent of embodiment 1, further comprising a first junction attaching a first wire of the two or more wires to a second wire of the two or more wires proximate the first open end, the first junction being the only attached junction between the first wire and the second wire. (3) A stent as described in embodiment 1, wherein a first wire of the two or more wires crosses below and above an adjacent second wire of the two or more wires within one vibration period of the waveform of the first wire. (4) The stent of embodiment 1, wherein each of the two or more wires is formed independently of every other of the two or more wires. (5) a first end structure positioned adjacent to the first open end and extending between the first open end and the vibrating portion; 2. The stent of embodiment 1, further comprising a second end structure positioned adjacent to the second open end and extending between the second open end and the vibration portion.

[0045] (6) The stent of embodiment 5, wherein the first end structure and the second end structure each include an atraumatic shape. (7) The stent of embodiment 1, wherein each of the two or more wires is joined to a circumferentially adjacent one of the two or more wires at one or more locations. (8) The stent of embodiment 1, wherein the two or more wires have a width that varies along the length of the stent. (9) A stent comprising: a length measured parallel to the z-axis from the first open end to the second open end; With the surroundings, two or more wires, each wire including a three-dimensional waveform; each waveform oscillates circumferentially in an arc about the z-axis; each corrugation extends parallel to the z-axis for a majority of the length of the stent; each corrugation maintains a substantially constant radial distance from the z-axis; each of the two or more wires being positioned circumferentially adjacent one another around the perimeter; A stent wherein each of the two or more wires is movable along the majority of the length of the stent independently of all others of the two or more wires. (10) A tubular stent, With the surroundings, A length from a first end to a second end; a plurality of wires positioned around the periphery; Each wire is independently formed; each wire circumferentially undulating to form a wave pattern extending across a majority of the length of the tubular stent; each wire passes under and over adjacent wires of the plurality of wires in a repetitive manner while maintaining an adjacent position relative to adjacent wires of the plurality of wires over the majority of the length of the tubular stent; A tubular stent, wherein the plurality of wires are circumferentially intertwined to form the tubular stent.

[0046] (11) The stent of embodiment 10, wherein each of the plurality of wires comprises a shape memory material that configures a predetermined three-dimensional shape curved along an arc, the three-dimensional shape comprising the wave pattern that undulates within the arc. (12) A stent comprising a tubular structure including circumferentially positioned undulating wires extending through a majority of the length of the stent, the wires each including circumferentially oscillating undulations, the undulations of each of the wires being circumferentially recessed within the undulations of a circumferentially adjacent wire such that the circumferential positioning of the undulating wires solely defines a circumference of the stent. (13) A method for manufacturing a stent, comprising the steps of: Providing a resilient tubing; cutting the tubing to form a plurality of substantially similar wave patterns, each wave pattern comprising: an amplitude extending circumferentially over an arc within the circumference of the tubing; an axis along which the wave pattern repeats, the axis extending along at least a portion of the length of the tubing; a curved inner surface cut from a luminal surface of the tubing; separating each of the plurality of wave patterns from the tubing; positioning each wave pattern to extend across a majority of the length of the stent; aligning the curved inner surfaces of any wave patterns to collectively form a circumference of the stent; forming a majority of a tubular stent body from said plurality of wave patterns. 14. The method of claim 13, further comprising interlacing each wave pattern with a clockwise adjacent wave pattern in the plurality of wave patterns and a counterclockwise adjacent wave pattern in the plurality of wave patterns. 15. The method of claim 13, further comprising joining a first wave pattern of the plurality of wave patterns to a second wave pattern of the plurality of wave patterns proximate an end of the tubular stent body.

[0047] 16. The method of claim 13, wherein the elastic tubing comprises a shape memory metal. (17) cutting the tubing to form a plurality of bends, each bend joining two adjacent wave patterns of the plurality of wave patterns; 14. The method of claim 13, further comprising the step of: positioning each of the plurality of bends such that each is positioned adjacent to a first end of the tubular stent body or a second end of the tubular stent body. (18) The method of embodiment 17, wherein each bend has an atraumatic shape. (19) A method for manufacturing a stent, comprising the steps of: Providing a resilient tubing comprising a circumference and a length; cutting individual wires from the tubing such that each wire includes a peak-to-peak oscillating wave pattern across a portion of the circumference; and c. weaving the wires to form a tubular shape. (20) The method of claim 19, wherein the step of cutting individual wires from the tubing further comprises the step of separating the wires from the tubing such that the individual wires are separated from one another.

[0048] 21. The method of claim 19, further comprising joining a first one of the individual wires to a second one of the individual wires at one or more locations. (22) A stent having a tubular structure, the tubular structure comprising: circumferentially positioned undulating wire segments extending across a majority of the length of the stent, the wire segments each including circumferentially oscillating undulations, the undulations of each of the wire segments being circumferentially recessed within the undulations of circumferentially adjacent wire segments such that the circumferential positioning of the undulating wires solely defines a circumference of the stent; atraumatic wire segment positioned proximate a first end or a second end of the stent, respectively, the atraumatic wire segment joining circumferentially adjacent wire segments. (23) The stent of embodiment 22, wherein the combination of the undulating wire segment and the atraumatic wire segment forms a continuous structure. (24) The stent of embodiment 22, wherein the combination of the undulating wire segment and the atraumatic wire segment forms a continuous wire. (25) The stent of embodiment 22, wherein the undulating wire segments and the atraumatic wire segments are positioned in an alternating manner to form a continuous wire that meanders both longitudinally along the length of the stent and circumferentially forming the circumference of the stent.

[0049] (26) The stent of embodiment 25, further comprising a first atraumatic end structure positioned proximate a first end of the continuous wire and a second atraumatic end structure positioned proximate a second end of the continuous wire.

Claims

1. 1. A stent comprising: Three or more wires; Each of the three or more wires includes a three-dimensional vibration portion and a pair of end structures connected to both ends of the three-dimensional vibration portion; the three-dimensional oscillating portion comprises a curved portion that extends circumferentially around the stent over an arc of less than 360° about the z-axis, the curved portion maintaining a substantially constant radius from the z-axis over a oscillating portion length of the three-dimensional oscillating portion measured parallel to the z-axis; the curved portion includes corrugations that oscillate in the circumferential direction, that are confined within the arc of the curved portion, and that extend across the length of the oscillating portion; a length of the stent is measured from a first open end to a second open end; the vibration portion length is a length obtained by subtracting the length of the pair of end structures from the length of the stent, At least a portion of the three-dimensional vibration portion of each of the three or more wires is movable independently of all other three-dimensional vibration portions of the three or more wires; a first location in the three-dimensional vibration portion of a first wire of the three or more wires is fixed to a second location in the three-dimensional vibration portion of a second wire of the three or more wires to form a first fixed portion, a third location in the three-dimensional vibration portion of the second wire is fixed to a fourth location in the three-dimensional vibration portion of a third wire of the three or more wires to form a second fixed portion, the second location and the third location being different locations from each other in the three-dimensional vibration portion of the second wire, A stent, the shape of which can be changed from a folded state to an expanded state, wherein the stent in the folded state has a greater length in the longitudinal direction of the stent and a smaller length in the width direction of the stent perpendicular to the longitudinal direction of the stent than the stent in the expanded state.

2. A stent as described in claim 1, wherein the first wire crosses the lower and upper parts of the second wire within one vibration period of the waveform of the first wire.

3. a first end structure positioned adjacent the first open end and extending between the first open end and the vibrating portion; The stent of claim 1 , further comprising a second end structure positioned adjacent the second open end and extending between the second open end and the vibrating portion.

4. The stent of claim 3 , wherein the first end structure and the second end structure each include an atraumatic shape.

5. The stent of claim 1 , wherein at least one of the three or more wires has a width thereof that varies along the length of the stent.

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