Hybrid stent

Abstract

The present invention relates to a stent comprising a stent body formed by braiding a plurality of wire segments into a first tubular shape. The braided wire segments create a series of first cells composed solely of wire segments made from a first wire material, which are arranged adjacent to each other to form one or more first composite cell areas. Additionally, the braided wire segments create a series of second cells composed solely of wire segments made from a second wire material, which are also arranged adjacent to each other to form one or more second composite cell areas. This unique configuration allows for improved structural integrity and enhanced functionality of the stent.

Description

HYBRID STENTRELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63 / 559,584 filed February 29, 2024 entitled Hybrid Stent, which is hereby incorporated herein by reference in its entirety.BACKGROUND

[0002] Previous approaches for stent design have primarily focused on using a single wire material throughout the stent body. These stents typically consist of a tubular structure formed by interweaving or braiding wire segments made from a single wire material. The wire material used in these stents is typically selected based on its mechanical properties, such as flexibility, radial strength, ability to impart a self-expanding secondary shape, and biocompatibility. However, the use of a single wire material limits the ability to tailor the stent's properties to specific requirements.

[0003] Some approaches have explored the use of coatings or surface treatments to enhance the properties of stents. These coatings or treatments are typically applied to the entire stent body and aim to improve biocompatibility, reduce thrombogenicity, or promote drug delivery. While these approaches have shown some benefits, they do not address the limitations associated with using a single wire material throughout the stent body.SUMMARY

[0004] In some aspects, the techniques described herein relate to a stent, including: a stent body having a first plurality of wire segments with a first property, and a second plurality of wire segments with a second property; wherein the first property is exclusive to the first plurality of wire segments and wherein the second property is exclusive to the second plurality of wire segments; the first plurality of wire segments forming a pluralityof first cells being positioned adjacent to each other to form one or more first composite cell areas.

[0005] In some aspects, the techniques described herein relate to a stent, wherein the second plurality of wire segments form one or more second composite cell areas.

[0006] In some aspects, the techniques described herein relate to a stent, wherein the first plurality of wire segments are braided into a first tubular shape.

[0007] In some aspects, the techniques described herein relate to a stent, wherein the first property includes a diameter of a first dimension and the second property includes a diameter of a second dimension, different than the first dimension.

[0008] In some aspects, the techniques described herein relate to a stent, wherein the first property is a first wire material and the second property is a second wire material, different than the first wire material.

[0009] In some aspects, the techniques described herein relate to a stent, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells including wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area.

[0010] In some aspects, the techniques described herein relate to a stent, wherein the first wire material includes drawn filled tubing.

[0011] In some aspects, the techniques described herein relate to a stent, wherein the drawn filled tubing includes an outer layer of a shape memory alloy and an inner core of a radiopaque material.

[0012] In some aspects, the techniques described herein relate to a stent, wherein the first plurality of wire segments and the second plurality of wire segments are part of a single wire or are part of a plurality of discrete wires.

[0013] In some aspects, the techniques described herein relate to a stent, wherein each of the first plurality of wire segments and the second plurality of wire segments extend between a proximal end and a distal end of the stent body, and wherein the plurality of wire segments includes 12, 16, 20, or 14 wire segments.

[0014] In some aspects, the techniques described herein relate to a stent, wherein the first plurality of wire segments and the second plurality of wire segments include a first wire including the first wire material and a second wire including the second wire material.

[0015] In some aspects, the techniques described herein relate to a stent, wherein the plurality first cells are a parallelogram shape, diamond shape, rhombus shape, square shape, or rectangular shape.

[0016] In some aspects, the techniques described herein relate to a stent, wherein the plurality first composite cell areas are a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, circumferential tube, or a helical shape.

[0017] In some aspects, the techniques described herein relate to a stent, wherein the one or more first composite cell areas are positioned adjacent to the one or more second composite cells areas along a length of the first tubular shape.

[0018] In some aspects, the techniques described herein relate to a stent, wherein the one or more first composite cell areas and the one or more second composite cell areas form an alternating pattern in a linear shape along the length of the first tubular shape.

[0019] In some aspects, the techniques described herein relate to a stent, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells including wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area; and wherein the plurality of third composite cell areas include a plurality of third composite cell areas that form a linear shape along the length of the tubular shape.

[0020] In some aspects, the techniques described herein relate to a stent, wherein the wire segments of the first wire material have a different diameter than the wire segments of the second wire material.

[0021] In some aspects, the techniques described herein relate to a stent, further including a second tubular shape extending along a portion of the first tubular shape and on either an inside or an outside of the first tubular shape; wherein the second tubular shape has a porosity that is less than or greater than the first tubular shape.

[0022] In some aspects, the techniques described herein relate to a stent, wherein the one or more first composite cell areas and the one or more second composite cells areas are positioned apart from each other by the plurality of third cells.

[0023] In some aspects, the techniques described herein relate to a stent, wherein the plurality of third cells completely surround the plurality of first cells and the plurality of second cells.

[0024] In some aspects, the techniques described herein relate to a stent, wherein the plurality of first cells are entirely bounded by some of the first plurality of wire segments of the first wire material, where the plurality of second cells are entirely bounded by some of the second plurality of wire segments of the second wire material, and where the plurality of third cells are entirely bounded by some of the first plurality of wire segments and of the second plurality of wire segments.

[0025] In some aspects, the techniques described herein relate to a stent, including: at least a first wire including a first wire material and a plurality of first wire segments; at least a second wire including a second wire material and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and theplurality of second cells are positioned adjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.

[0026] In some aspects, the techniques described herein relate to a stent, wherein the first wire material is composed of drawn filled tube wire and wherein the at least second wire segment is composed of a shape memory alloy.

[0027] In some aspects, the techniques described herein relate to a stent, including: a stent body means forming one or more first cells including only wire segments of a first wire material; and, one or more second cells including only wire segments of a second wire material.

[0028] In some aspects, the techniques described herein relate to a method of creating a stent, including: providing one or more wires, wherein each of the one or more wires includes at least one of a first wire segment of a first wire material and a second wire segment of a second material; and, braiding the one or more wires on a mandrel to create a tubular shape having one or more first cells including only a plurality of the first wire segments braided together, and one or more second cells including only a plurality of the second wire segments braided together.

[0029] In some aspects, the techniques described herein relate to a method of braiding a stent, including: loading a stent braiding machine having a plurality of pins with a plurality of wires, wherein the each of the plurality of pins is loaded with one or more of the plurality of wires, wherein a first series of consecutive pins is loaded with wires from the plurality of wires including a first material, wherein a second series of consecutive pins is loaded with wires from the plurality of wires including a second material, and wherein a third series of one or more consecutive pins is loaded with at least one of the plurality of wires including the first material and at least one of the plurality of wires including the second material; braiding the plurality of wires to form at least a portion of the stent.

[0030] In some aspects, the techniques described herein relate to a stent, including: at least a first wire including a first wire diameter and a plurality of first wire segments; at least a second wire including a second wire diameter and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and the plurality of second cells are positioned adjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The following figures are included to illustrate certain example aspects of the present disclosure and should not be viewed as exclusive or limiting. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. The present disclosure references the drawings as follows:

[0032] Fig. 1 illustrates a side view of a stent according to one example.

[0033] Fig. 2 illustrates a side view of the stent of Fig. 1 according to one example.

[0034] Fig. 3 illustrates a representation of two wires braided between pins of a mandrel for the stent of Fig. 1 according to one example.

[0035] Fig. 4 illustrates a side view of only one of the wires of the stent of Fig. 1 braided on the mandrel between its pins, according to one example.

[0036] Fig. 5 illustrates a side view of another example stent according to one example.

[0037] Fig. 6 illustrates a view of the stent of Fig. 5 split open to show both sides simultaneously according to one example.

[0038] Fig. 7 illustrates a representation of two wires braided between pins of a mandrel for the stent of Fig. 5 according to one example.

[0039] Fig. 8 illustrates a side view of the two wires of the stent of Fig. 5 braided on the mandrel between its pins according to one example.

[0040] Fig. 9 illustrates a view of another example stent split open to show both sides simultaneously according to one example.

[0041] Fig. 10 illustrates a side view of the two wires of the stent of Fig. 9 braided on the mandrel between its pins according to one example.

[0042] Fig. 11 illustrates a view of another example stent split open to show both sides simultaneously according to one example.

[0043] Fig. 12 illustrates a side view of the two wires of the stent of Fig. 11 braided on the mandrel between its pins according to one example.DETAILED DESCRIPTION

[0044] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0045] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used and brought together in any combination. In other words, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of thisdisclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0046] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings are not to scale. Unless otherwise noted, the term “about” is defined to mean plus-or-minus 5% of a stated value.

[0047] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician / clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician / clinician or handle / hub of a device).

[0048] The present disclosure is generally directed to stents, methods of making stents, and methods of using stents. More specifically, this disclosure is generally directed to stents braided with wires in which a first group of the wires / segments have a first feature and a second group of wires / segments have a second feature (alternatively referred to as a first and second characteristic or property). These first and second features are different from each other and are non-overlapping with between the first and second groups (i.e. , exclusive to the first group and second group respectively). In some examples, the first and second features may be at least two different materials or may be two different sized wire diameters.

[0049] In examples of different wire materials, a first wire material may have relatively better recovery, resilience, shape retention, and / or ability to be crimped, while a second wire material may be relatively softer than the first wire material but may have other valuable properties, such as being partially or fully radiopaque. Such a combination of wire material may provide a stent with improved or additionally beneficial properties that may otherwise not be possible by using only wires of a single material alone. Additionally, the wires of two different materials may be braided into specific patterns that may provideadditional beneficial properties, such as improved radiopaque visibility, radial strength, and / or shape retention.

[0050] In one specific example, stents woven solely from one or more Nitinol wires tend to have relatively better recovery, resilience, shape retention, and / or ability to be crimped as compared with stents woven solely from one or more DFT wires. Hence, stents woven from one or more DFT wires may not expand (e.g., open up upon delivery) and otherwise be delivered as well as their Nitinol counterparts. However, since DFT wires may be partially composed of radiopaque materials, DFT stents may be better visualized (e.g., fluoroscopy) during a procedure. By combining one or more Nitinol wires with one or more DFT wires in the various examples disclosed in this specification, such a stent may exhibit improved delivery and expansion characteristics versus a DFT-only stent while also improving visualization. These DFT / Nitinol improvements may be further increased by creating certain braiding patterns, as discussed in greater detail in this specification.

[0051] The stents and methods of use and manufacture thereof that are discussed in this disclosure may be generally directed to stents comprising two or more wires that are braided together to form a generally tubular shape. One or a plurality of first wires comprise a first wire material and one or a plurality of second wires comprise a second material. Third, fourth, fifth, or more wires (or plurality of wires), each with their own distinct wire materials, may also be braided together with the first wire(s) and second wire(s). Put another way, while two different material wires may be braided together to form an example stent, three, four, five, or more different material wires may also be used, resulting in a stent with several different types / com positions of wires.

[0052] In some examples, a stent body comprises a plurality of wire segments braided into a first tubular shape. The term “wire segments” may mean regions, lengths, or portions of a single wire or may mean a single, entire wire. In other words, the term “wire segment” is intended to be inclusive of both smaller portions of a wire and a single wire in its entirety. Hence, a stent body may be formed from a single wire with a plurality ofwire segments or two or more wires with a plurality of wire segments. In some examples, a wire segment may mean a length of wire that extends between a proximal end and a distal end of a stent. In the example of a single wire, the single wire may have a plurality of different wire material segments connected together, such as alternating regions of nitinol wire segments and DFT wire segments.

[0053] The plurality of wire segments of the stent body may form one or more first cells including only wire segments of a first wire material and, the plurality of braided wire segments may form one or more second cells including only wire segments of a second wire material.

[0054] In this disclosure, the term “cell” is intended to mean a space, area, or region bounded by a plurality of braided wire segments and the terms space, area, or region may also be used interchangeably with “cell” within this specification. In other words, the plurality of wire segments is braided to create a plurality of cells or openings, and the term “cell” includes the space within a cell or region that is defined by the plurality of wire segments in addition to the wires making of the cell.

[0055] The cells created by the plurality of wire segments may form a variety of different shapes. For example, the cells may have a polygon shape, such as a parallelogram, square, rectangle, diamond, rhombus, triangle, pentagon, or other multisided shapes. Note, these cell shapes are generally described as if the pattern of the stent body is flattened. When the stent body is in an expanded configuration, the cell shapes may also have a curved component along the circumferential curve of the tubular shape of the stent body.

[0056] In some examples, the plurality of braided wire segments may form one or more third cells including wire segments of the first wire material and the second wire material. The one or more third cells may be bounded or defined by different configuration of wire comprising wire segments of a first wire material and wire segments of a second wire material. For example, two sides may each comprise a wire segment of the first wire material and two sides may each comprise a wire segment of the second wire material.In another example, one side may comprise a wire segment of the first wire material and three sides may each comprise a wire segment of the second wire material (and vise versa).

[0057] In one example, one or more first wires or segments may comprise a shapememory or super elastic material, such as Nitinol, and one or more second wires or segments may comprise a metal that is softer than a shape-memory or super elastic material such as Nitinol. In one specific example, one or more first wires or segments may comprise Nitinol and one or more second wires or segments may comprise a radiopaque metal such as tantalum or platinum.

[0058] In another example, one or more of the wires or segments may comprise a drawn filled tube wire (DFT wire). In one specific example, one or more first wires or segments may comprise non-DFT wires and one or more second wires or segments may comprise DFT wires.

[0059] The non-DFT wires or segments may be composed of any material typically used for medical devices, including shape memory alloys (e.g., Nitinol), stainless steel, cobalt-chromium, polymers, or other materials. Shape memory alloys, and especially Nitinol, may be preferable in some examples. These non-DFT wires are generally composed of a single material through its cross section, though coatings and similar features are also possible.

[0060] The DFT wires or segments may be composed of a variety of different materials with different cross-sectional thicknesses. For example, a DFT wire or segments may comprise an inner core composed of a first material and an outer jacket or tube composed of a second material. In another example, the outer jacket may alternately be composed of multiple layers of different material (e.g., two or more layers over inner core). Either the inner core and the outer jacket may be composed of radiopaque materials (such as platinum, gold, tantalum, palladium, or similar known radiopaque materials). Either the inner core and the outer jacket may be composed of non-radiopaque materials (i.e., materials with a relatively low or no radiopaque properties). Such non-radiopaquematerials may include, e.g., stainless steel, cobalt-chromium, or shape memory alloys such as Nitinol. In one example, the inner core may be composed of radiopaque material(s) and the outer jacket may be composed of non-radiopaque materials. In another example, the inner core may be composed of non-radiopaque materials and the outer jacket may be composed of non-radiopaque materials.

[0061] In one example, the inner core may be composed of a radiopaque material and the outer jacket may be composed of a shape memory alloy such as Nitinol. The radiopaque material promotes visualization of the DFT wire, while the outer jacket allows for good pliability and the ability to have a memorized shape (e.g., via being heat-set). In another example, the inner core may be composed of platinum or tantalum, while the outer jacket may be composed of Nitinol-1 or Nitinol-2.

[0062] The inner core may have a cross-sectional shape that is circular, elliptical, or ovular, though a variety of other shapes can be used, such as rectangular, triangular, or the like. The outer jacket may be tubular in shape with an inner diameter that closely matches the outer diameter of the inner core. Put differently, the outer jacket may include an internal lumen through which the inner core extends.

[0063] Additionally, DFT wires may sometimes exhibit a higher degree of bendability and reduced stiffness than a single-metal shape memory wire once heat treatment / heat- setting occurs. This may be generally unexpected since inclusion of a radiopaque material in the inner core (depending on which particular material is used) can generally be stiffer in comparison to the metallic shape memory outer jacket. However, the inclusion of two separate materials in creating a single wire can alter the material characteristics of the combined wire shape. Due to these characteristics, when DFT wires or segments are used in a stent, design aspects of the stent may need to compensate for this increased flexibility, especially to promote proper deployment and proper apposition of the DFT stent at the treatment site to prevent stent migration.

[0064] The outer diameter of the DFT wire or segment may have a wide range of diameters, depending on its use within a stent. For example, the DFT wire or segmentmay have a diameter within an inclusive range of about 0.001 inch to 0.004 inch, or about 0.0025 inch to about 0.003 inch. The inner core and outer jacket of the DFT wire or segment may be composed of different percentages of the cross section of the DFT wire or segment based on cross-sectional width or diameter. For example, the inner core may be within an inclusive range of 5% to 30% of the cross-sectional width or diameter of the DFT wire or segment with the remaining percentage being the outer jacket (i.e., 95% to 70%). In a more specific example, the ration may be 10% inner core cross-sectional width or diameter and 90% outer jacket cross-sectional width or diameter.

[0065] In some examples, the total cross-sectional width or diameter of the DFT wire or segment is within an inclusive range of about 0.0018 inch to about 0.0022 inch. In some examples, the inner core (e.g., composed of a radiopaque material) has a width or diameter within an inclusive range of about 0.0005 inch to about 0.001 inch, or an inclusive range of about 0.0008 inch to about 0.0009 inch.

[0066] Any of the wires used in a stent of this disclosure may be functionalized, for example with poly (MEA-co-APMA).

[0067] In some examples, the plurality of braided wire segments, some of which comprise at least a first wire material and some of which comprise a second wire material, are part of a single wire. For example, wire segments of a first wire material and segments of a second wire material may be attached to each other, at or near their ends, to form a single, elongated wire. That single elongated wire may then be braided on a mandrel with itself, there by forming different bounded cells, as previously described.

[0068] In other examples, the plurality of braided wire segments may comprise a plurality of discrete wires. Some of the plurality of discrete wires may be comprised of a first wire material while other wires of the plurality of discrete wires may be comprised of a second wire material, both of which are discussed elsewhere in this specification. In some examples, the plurality of discrete wires may further comprise one or more wires that may be comprised of a third wire material. In some examples, the plurality of discrete wires may further comprise one or more wires that may be comprised of a fourth wirematerial. In some examples, the plurality of discrete wires may further comprise one or more wires that may be comprised of a fifth wire material. In other words, the plurality of discrete wires may include at least two different types / com positions of wires, but as many as 3, 4, 5, 6, 7, 8, 9, or more types / com positions of wires.

[0069] In some examples, the plurality of wire segments comprising a stent body may include 12, 16, 20, 24, 28, 32, 36, 40, and 44 wire segments, though any number of segments are possible. In this context, a wire segment means a portion of wire generally extending between a proximal end and a distal end of the body of the stent. In that respect, a single wire may form the necessary segments by being braided back and forth between the proximal and distal ends of the stent body. A plurality of discrete wires may also form each of the necessary segments by being braided with each other. For example, a stent body braided to have 12 wire segments may be composed of 2 or 12 discrete wires, though, between 2-12 wires may also be possible.

[0070] Where two or more wires are braided to form a stent body, one end of a first wire may be welded or otherwise attached near another end of a second wire. This pattern may be continued with all wires that make up the stent body such that no free wires ends are left unattached. In one example, this may include overlapping the ends of each wire and creating multiple weld locations along the overlapping length of the two wires. In another example, this may include overlapping the ends of each wire and placing a wire coil, ring, tube or similar structure around both of the wires.

[0071] In some examples, the stent body may be braided such that several first cells that comprise or are bounded by only wire segments of a first wire material are located near or adjacent to each other to form larger composite cell areas. A total of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, or more first cells may be positioned adjacent to each other and may further share a wire segment in comment that bounds each area. In this respect, several first cells may be located adjacent to each other to form one or more larger composite cell areas in a variety of different configurations. For example, several first cells may comprise one or more larger composite cell areas in the shape of a square,rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, circumferential tube, a helical shape, or any other possible shape.

[0072] In some further examples, the stent body may be braided such that several second cells that comprise or are bounded by only wire segments of a second wire material, are located near or adjacent to each other to form larger composite cell areas. A total of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, or more second cells may be positioned adjacent to each other and may further share a wire segment in comment that bounds each area. In this respect, several second cells may be located adjacent to each other to form one or more larger composite cell areas in a variety of different configurations. For example, several second cells may comprise one or more larger composite cell areas in the shape of a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape (alone or alternating with the first larger composite cell areas), circumferential tube, a helical shape, or any other possible shape.

[0073] Hence, a stent body may comprise one or more larger composite cell areas formed by a plurality of first cells and one or more larger composite cell areas formed by a plurality of second cells. Different patterns may be achieved with the larger composite cell areas, such as by alternating the larger composite cell areas along a length of the stent body between those comprising a plurality of first cells and those comprising a plurality of second cells. Another possible example pattern may include larger composite cell areas of only the same type repeating linearly between a proximal and a distal end of the stent. Several different patterns of the larger composite cell areas may be included at various circumferential positions of the stent (e.g., at about 0 degrees, 90 degrees, 180 degrees, and 270 degrees).

[0074] While a stent body of this example may only include first cells and second cells, the stent body may also include a plurality of third cells that are bounded or defined by some wire segments of the first wire material and some wire segments of the second wire material.

[0075] In some further examples, the stent body may be braided such that several third cells that comprise or are bounded by wire segments of the first wire material and wire segments of the second wire material, are located near or adjacent to each other to form larger composite cell areas. A total of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, or more third cells may be positioned adjacent to each other and may further share a wire segment in comment that bounds each area. In this respect, several third cells may be located adjacent to each other to form one or more larger composite cell areas in a variety of different configurations. For example, several first cells may comprise one or more larger composite cell areas in the shape of a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, circumferential tube, a helical shape, or any other possible shape.

[0076] In some examples, a larger composite cell area of third cells comprises only third cells with a certain number of wire segments comprising a first wire material and the second wire material. In a specific example, two sides of a third cell may be bounded by wire segments of a first wire material while two sides of the third cell may also be bounded by wire segments of a second wire material. In another specific example, one side of a third cell may be bounded by a wire segment of a first wire material while three sides of the third cell may also be bounded by wire segments of a second wire material. The inclusion of cells of both of the prior examples may also be possible.

[0077] In a further example, a stent body may comprise one or more larger composite cell areas formed by a plurality of first cells, a plurality of larger composite cell areas formed by a plurality of second cells, and a plurality of larger composite cell areas formed by a plurality of third cells. In another example, a stent body may comprise one or more larger composite cell areas formed by a plurality of first cells, a plurality of larger composite cell areas formed by a plurality of second cells, and a plurality of third cells that partially or fully surround the one or more larger composite cell areas formed by a plurality of first cells and the plurality of larger composite cell areas formed by a plurality of second cells.

[0078] Any of the larger composite cell areas may be sized, shaped, and positioned at various locations on the stent body. For example, a plurality of larger composite areas may be positioned at locations along the length of the stent body, such as in a linear configuration, helical configuration, or in an alternating pattern along the length of the stent body. Alternatively or additionally, a plurality of composite areas may be positioned at uniform locations around the circumference of the stent body, such as 2, 3, 4, 5, 6, 7,8, or more larger composite areas locate at different circumferential locations but at about the same longitudinal locations of the stent body.

[0079] These patterns of larger composite cell areas may have several different benefits to the stent. In a first example, if one or more large composite cell areas are composed only of wire segments of a relatively stronger, resilient, shape memory material such as Nitinol, those larger composite cell areas may help increase the radial expansion strength or force of the stent body when deployed in a patient, particularly relative to a stent body with wire segments of multiple wire materials that are not arranged in the larger composite cell areas. In other words, the inclusion of these larger composite cell areas may provide further strength and radial expansion force compared with the shape not otherwise being formed, but the stent body being composed of similar wire segments. In a specific example, Since DFT wires may sometimes exhibit a relatively higher degree of bendability as previously discussed, the inclusion of Nitinol wires in one or more large composite cell areas may help the stent open up with greater force than it otherwise might with only DFT wires or with a combination of DFT and Nitinol wires that do not create one or more large composite cell areas.

[0080] In a second example, if a large composite cell area is composed only of wire segments of a relatively radiopaque material (e.g., DFT wires or tantalum wire), those large composite cell areas may be better visualized to a clinician during a procedure and therefore the clinician may better understand the position of the stent.

[0081] In a further example, such larger composite cell areas of wire segments of relatively radiopaque material may be further arranged and located in a manner to conveydistance to a clinician viewing it. For example, when the stent body is radially expanded, each larger composite cell area may be sized to a known length (e.g., 1 mm). The clinician may compare the large composite cell area relative to a radiopaque marker at the end of the stent delivery device to better determine how far out a stent has been deployed. In such an example, a plurality of large composite areas may be linearly arranged along the length of the stent body and may have uniform sizes or may have sizes that increase or decrease between a distal end and a proximal end of the stent body to better convey deployment. Additionally, several linear arrangements may be located along different sides of the stent body (e.g., generally at 90-degree increments around the circumference of the stent body).

[0082] In some examples, the wire segments of the first wire material may have a different diameter than the wire segments of the second wire material. For example, the first wire material may have a wire diameter that is larger than the second wire material. In a specific example, wire diameters of a first wire material and a second wire material may be selected from and inclusive range of about 0.0015 inch to about 0.0050 inch, such as about 0.0015, 0.0020, 0.0025, 0.0030, 0.0035, 0.0040, 0.0045, and 0.0050 inch. The larger diameter wire segments may create more space adjacent to the smaller diameter wire throughout the braid of the stent. In some examples, the larger diameter wire may allow for the inclusion of a larger amount of radiopaque material. For example, a larger diameter DFT wire with a relatively greater amount of platinum (versus diameters of all the same size) may provide improved visualization during a procedure.

[0083] While the plurality of first cells and the plurality of second cells (and possibly additional areas) that each may comprise larger composite areas have been primarily described as each being composed of wire segments of different wire materials, these areas may alternatively be composed of wire segments of the same wire materials but that have different wire diameters. For example, a stent body may have larger composite areas formed from first cells and second cell with wire segments composed of the same material, however, wire segments comprising the first cells may have a first diameter and wire segments of the second cells may have a second diameter that is larger than thefirst diameter. In other words, some larger composite areas comprise wire segments with a larger diameter than other larger composite areas with smaller diameters, but with the same wire materials. In some examples, the same number of larger diameter wire segments and smaller diameter wires segments may be used or braided together. In other example, different numbers of the two diameter wires may be used. For example, additional smaller diameter wire segments may be used relative to the larger diameter wire segments or vice versa (e.g., 2 to 1 , 3 to 1 , or 4 to 1 ratios in either combination).

[0084] In some examples, the stent or stent body may have a single layer or may have multiple layers. For example, the stent body may comprise a first tubular shape with the previously described “area” features, and a second tubular shape extending along at least a portion of the first tubular shape, the entire length of the first tubular shape, or beyond the proximal and / or distal end of the first tubular shape. The second tubular shape may be located within the first tubular shape or on an outside of the first tubular shape. The first tubular shape and the second tubular shape may have one or more connecting elements, such as rings, tubes, coils, or wire woven between the first tubular shape and the second tubular shape. The second tubular shape may also be braided in a manner similar to the examples set forth in this specification (e.g., creating areas of wire segments with the same wire material) or the second tubular shape may be braided with one or more wires that are all composed of the same wire material. The second tubular shape may have a porosity that is greater than the first tubular shape or less than the first tubular shape. Additionally, the second tubular shape may be braided with one or more wires that have a larger or smaller diameter. In one specific example, the second tubular shape is a flow diverter layer that may have less porosity than the first tubular shape and may be composed of one or more wires with a smaller diameter than those of the first tubular shape. Examples of multilayer stents and other stent aspects can be found in U.S. Pat. No. 9,439,791 , the content of which is hereby incorporated herein by reference. It is specifically contemplated that the stents and teachings of this patent may be used with the example stents and methods disclosed in this specification.

[0085] Any of the example stents, stent bodies, or tubular shapes may be created, in one example, by providing one or more wires, wherein each of the one or more wires includes at least one of a first wire segment of a first wire material and a second wire segment of a second material; and, braiding the one or more wires on a mandrel to create a tubular shape having one or more first cells including only a plurality of the first wire segments braided together, and one or more second cells including only a plurality of the second wire segments braided together.

[0086] Depending on the desired braid pattern, the mandrel may include a plurality of pins that the one or more wires are positioned around. Typically, a greater number of pins increases the pick-per-inch of a braided pattern and decreases its porosity (e.g., smaller cell sizes).

[0087] Typically, stent bodies, or tubular shapes may be braided on a mandrel by hand (i.e., a human hand braids a pattern) or is machine braided by a braiding machine, as is known in the art.

[0088] In that respect, any of the example stents, stent bodies, or tubular shapes may be created, in one example, by loading a stent braiding machine having a plurality of pins with a one or more wires, wherein the each of the plurality of pins is loaded with one or more of the plurality of wires, wherein a first series of consecutive pins is loaded with wires from the plurality of wires including a first material, wherein a second series of consecutive pins is loaded with wires from the plurality of wires including a second material, and wherein a third series of one or more consecutive pins is loaded with at least one of the plurality of wires including the first material and at least one of the plurality of wires including the second material; braiding the plurality of wires to form at least a portion of the stent.

[0089] Specific examples will now be discussed as shown in the figures. These specific examples primarily illustrate stents comprising only first wire segments comprising a first wire material and second wire segments comprising a second wire material. However, the features, properties, or characteristics of these stents may bemodified in a manner previously discussed in this specification. For example, third wire segments comprising a third wire material may be included, the first wire segments and second wire segments may be of different sizes and either the same wire material or different wire material, and / or the stents may further include a second stent layer (e.g., a flow diverter layer).

[0090] Figs. 1 and 2 illustrate various aspects of a stent 100 composed of first wire segments 102 and second wire segments 104. Fig. 1 illustrates a side view of the stent 100 at a first rotational position and Fig. 2 illustrates a side view of the stent 100 at a second rotational position that is about 90 degrees relative to the position of Fig. 1 .

[0091] In the present example, the first wire segments 102 and second wire segments 104 may comprise about 12 wire segments total that extend from a first end of the stent 100 to a second end of the stent 100. In one example, the stent 100 comprises about 6 of the first wire segments 102 and about 6 of the second wire segments 104, though other combinations and wire numbers are possible. In one example, two wires can be braided together to form these 12 wire segments, though any number of individual wires may also be used, such as 12 individual wires. In the present example, the first wire segments 102 are composed of DFT wires and the second wire segments 104 are composed of Nitinol wires, though any of the wire materials discussed in this specification are also possible.

[0092] As seen in Figs. 1 and 2, the first wire segments 102 and second wire segments 104 may be braided together to form a plurality of cells. In the present example stent 100, the first wire segments 102 may form one or a plurality of first cells 106 that may be bounded or defined on all its sides by the first wire segments 102. In other words, each of the plurality of first cells 106 may be only composed at its outer perimeter by the first wire segments 102 while otherwise having no further wires within each of the plurality of first cells 106.

[0093] In the present example stent 100, the second wire segments 104 may form one or a plurality of second cells 108 that may be bounded or defined on all its sides by the second wire segments 104. In other words, each of the plurality of second cells 108 maybe only composed at its outer perimeter by the second wire segments 104 while otherwise having no further wires within each of the plurality of second cells 108.

[0094] In the present example stent 100, the first wire segments 102 and the second wire segments 104 may form one or a plurality of third cells 110 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of third cells 110 may be comprised of about 50% of first wire segments 102 and about 50% of second wire segments 104 (e g., two wire segments of each).

[0095] In the present example stent 100, the first wire segments 102 and the second wire segments 104 may form one or a plurality of fourth cells 111 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of fourth cells 111 may be comprised of unequal portions of the first wire segments 102 and the second wire segments 104. For example, about 25% of first wire segments 102 and about 75% of second wire segments 104 or vice versa (e.g., one wire segment of one type and three wire segments of another type).

[0096] In the present example of the stent 100, the plurality of first cells 106, the plurality of second cells 108, the plurality of third cells 110, and plurality of fourth cells 111 may all form generally square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, or other shapes disclosed in this specification.

[0097] In the present example of the stent 100, at least the plurality of first cells 106, the plurality of second cells 108, and the plurality of third cells 110 may be arranged directly next to each other or adjacent to each other to form one or more larger composite cell areas. In one example, next to each other or adjacent to each other may mean that adjacent cells share a wire segment in common. In other words, a length or portion of a wire may define two different cells on opposite sides.

[0098] In the present example of the stent 100, a first larger composite cell area 103 may be formed from a plurality of first cells 106 that are adjacent to each other, a second larger composite cell area 105 may be formed from a plurality of second cells 108 that are adjacent to each other, and a third larger composite cell area 107 may be formed from a plurality of third cells 110 that are adjacent to each other. In the present example of stent 100, the plurality of fourth cells 111 are positioned in between the first larger composite cell area 103, second larger composite cell area 105, and third larger composite cell area 107 (e.g., one row of a plurality of fourth cells 111 between the cell areas). These rows of the plurality of fourth cells 111 may be considered a larger composite cell area or may be considered cells spaced in between the other larger composite cell areas.

[0099] In the present example of the stent 100, the first larger composite cell area 103 may form a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, a circumferential tube, a helical shape, or other shapes described in this specification.

[0100] In the present example of the stent 100, the stent 100 may be braided such that the first larger composite cell areas 103 and the second larger composite cell areas 105 form an alternating pattern along a length of the stent 100 but spaced apart from each other by a plurality of fourth cells 111 (see Fig. 1 ). The stent 100 may also be braided such that a plurality of the third larger composite cell areas 107 are positioned along a length of the stent 100 (see Fig. 2). Hence, in this example, two opposites sides of the stent 100 may include the alternating pattern of the first larger composite cell areas 103 and the second larger composite cell areas 105, while generally perpendicular two opposites sides may include the repeating pattern of the third larger composite cell area 107. Alternatively, the first larger composite cell areas 103 and / or the second larger composite cell areas 105 may form a single repeating pattern similar to the third larger composite cell areas 107 in Fig. 2.

[0101] Again, the size, pattern, shape, and position of these larger composite cell areas may vary on the stent 100 in any manner described in this specification and any combination of these variations is also contemplated.

[0102] In the present example of the stent 100, the first wire segments 102 may comprise a first wire material and the second wire segments 104 may comprise a second wire material. For example, the first wire segments 102 may comprise a radiopaque wire such as DFT wire and the second wire segments 104 may comprise a nonradiopaque shape memory wire such as Nitinol wire. However, any of the wires discussed in this specification may be alternatively used in any combination. In the present example, the first wire segments 102 and the second wire segments 104 may have about the same diameter (e.g., .0025 inch) or different diameters. Alternatively, the first wire segments 102 and the second wire segments 104 may comprise the same wire material but may have different diameters.

[0103] These patterns of larger composite cell areas may have several different benefits to the stent 100. In a first example, if second larger composite cell areas 105 are composed only of second wire segments 104 of a relatively stronger, resilient, shape memory material such as Nitinol, those larger composite cell areas may help increase the radial expansion strength or force of the stent body when deployed in a patient, particularly relative to a stent body with wire segments of multiple wire materials that are not arranged in the second larger composite cell areas 105. In other words, the inclusion of these second larger composite cell areas 105 may provide further strength and radial expansion force compared with the shape not otherwise being formed, but the stent 100 being composed of similar wire segments.

[0104] In a second example, if first larger composite cell areas 103 are composed only of first wire segments 102 of a relatively radiopaque material (e.g., DFT wires or tantalum wire), those first larger composite cell areas 103 areas may be better visualized to a clinician during a procedure and therefore the clinician may better understand the position of the stent 100.

[0105] In a further example, such first larger composite cell areas 103 of wire segments first wire segments 102 of relatively radiopaque material may be further arranged and located in a manner to convey distance to a clinician viewing it. For example, when the stent body is radially expanded, each larger composite cell area may be sized to a known length (e.g., 1 mm) and / or spaced apart at a known length. The clinician may compare the first larger composite cell areas 103 relative to a radiopaque marker at the end of the stent delivery device (or other marker) to better determine how far out a stent 100 has been deployed. In such an example, a plurality of first larger composite cell areas 103 may be linearly arranged along the length of the stent 100 and may have uniform sizes or may have sizes that increase or decrease between a distal end and a proximal end of the stent 100 to better convey deployment. Additionally, several linear arrangements of the first larger composite cell areas 103 may be located along different sides of the stent body (e.g., generally at 90 or 180-degree increments around the circumference of the stent body).

[0106] Fig. 3 illustrates a representation of two wires braided between pins of a mandrel 101 for the stent 100 of Fig. 1. Fig. 4 illustrates a side view of only one of the wires braided on the mandrel 101 between its pins. In the example of the present stent 100, the first wire segments 102 may comprise a single wire and the second wire segments 104 may comprise a second single wire. However, a plurality of wires may be used for each of the first wire segments 102 and the second wire segments 104.

[0107] The mandrel 101 includes a plurality of pins that the wires are wrapped around during the braiding process. These pins are represented by numbers in each of the Figs. 1 -4. In the present example, the stent 100 is formed on a mandrel 101 with 12 pins. In the present example, the pins are longitudinally staggered in an alternating pattern, which causes the wires to form alternating patterns of larger loops 114 and smaller loops 112 at each end of the stent 100. However, different loop patterns are possible, such as each end being entirely composed of only larger loops 114 or smaller loops 112. Alternatively, no loops may be included. The braiding pattern may achieve a wide range of picks-per- inch (PPI), depending on the use of the stent (e.g., between 15-250 PPI).

[0108] Since the stent 100 of the present example comprises two wires, these wires may be connected together. Fig. 3 illustrates one example of such a connection in which the wire for the first wire segments 102 and the wire for the second wire segments 104 may overlap with each other. In one example, the two wires overlap each other between the length of two pins at opposite ends of the mandrel 101 . For example, the wire of the first wire segments 102 terminates at or near pin 1 at one end and pin 8 at another end, while the wire of second wire segments second wire segments 104 terminates at or near pin 2 at one end and pin 7 at another end. The two wires may be connected only at their terminal end points (e.g., via welding, coils, or other attachment mechanisms known or described in this specification) or the two wires may be connected at a plurality of locations along the overlapping portions (e.g., a plurality of weld locations).

[0109] In one example, the stent 100 may be wound manually by hand on the mandrel 101 or with the aid of a braiding machine, which is known in the art. Hence, the present disclosure includes a method of braiding the stent 100, comprising braiding at least a first wire and a second wire on a mandrel between a plurality of pins at each end of the mandrel; wherein the braiding forms a tubular shape comprising a plurality of first cells 106 and a plurality of second cells 108. The plurality of first cells 106 may be arranged to create one or more first larger composite cell areas 103 and the plurality of second cells 108 may be arranged to create one or more second larger composite cell areas 105. The tubular shape may further comprise a plurality of third cells 110 that may be arranged to create one or more third larger composite cell area 107.

[0110] In the example of a braiding machine, a method of braiding the stent 100 may include loading a stent braiding machine with a first wire and a second wire; positioning the first wire around a first plurality of pins and positioning the second wire around a second plurality of pins while braiding the first wire and the second wire, wherein the braiding forms a tubular shape comprising a plurality of first cells 106 and a plurality of second cells 108. The plurality of first cells 106 may be arranged to create one or more first larger composite cell areas 103 and the plurality of second cells 108 may be arranged to create one or more second larger composite cell areas 105. The tubular shape mayfurther comprise a plurality of third cells 110 that may be arranged to create one or more third larger composite cell area 107.

[0111] Fig. 5 illustrates a side view of another example stent 120 and Fig. 6 illustrates a view of the stent 120 split in half so that both halves of the stent 120 are visible to the viewer.

[0112] The stent 120 is generally similar to the previously described stent 100 but may comprise about 16 total wires segments that extend from a first end of the stent 120 to a second end of the stent 120. Unless otherwise discussed, the description of stent 100 and other portions of this specification are also applicable to stent 120, as well as other stents of this specification, and therefore some description of stent 120 (or other stents) may not be specifically discussed to avoid repetition but is otherwise contemplated. In one example, the stent 120 may comprise about 8 of the first wire segments 102 and about 8 of the second wire segments 104, though other combinations and wire numbers are possible. In one example, two wires can be braided together to form these 16 wire segments, though any number of individual wires may also be used, such as 16 individual wires. In the present example, the first wire segments 102 are composed of DFT wires and the second wire segments 104 are composed of Nitinol wires, though any of the wire materials discussed in this specification are also possible.

[0113] As with stent 100, first wire segments 102 and second wire segments 104 of stent 120 may be braided together to form a plurality of cells. In the present example stent 120, the first wire segments 102 may form one or a plurality of first cells 106 that may be bounded or defined on all its sides by the first wire segments 102. In other words, each of the plurality of first cells 106 may be only composed or defined by the first wire segments 102 at the cell’s outer perimeter while otherwise having no further wires within each of the plurality of first cells 106.

[0114] In the present example stent 120, the second wire segments 104 may form one or a plurality of second cells 108 that may be bounded or defined on all its sides by the second wire segments 104. In other words, each of the plurality of second cells 108 maybe only composed or defined at its outer perimeter by the second wire segments 104 while otherwise having no further wires within each of the plurality of second cells 108.

[0115] In the present example stent 120, the first wire segments 102 and the second wire segments 104 may form one or a plurality of third cells 110 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of third cells 110 may be comprised of about 50% of first wire segments 102 and about 50% of second wire segments 104 (e g., two wire segments of each).

[0116] In the present example stent 120, the first wire segments 102 and the second wire segments 104 may form one or a plurality of fourth cells 111 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of fourth cells 111 may be comprised of unequal portions of the first wire segments 102 and the second wire segments 104. For example, about 25% of first wire segments 102 and about 75% of second wire segments 104 or vice versa (e.g., one wire segment of one type and three wire segments of another type).

[0117] As with the previously described stent 100, the stent 120 may include one or more of a first larger composite cell area 103 that may be formed from a plurality of first cells 106 that are adjacent to each other, a second larger composite cell area 105 that may be formed from a plurality of second cells 108 that are adjacent to each other, and a third larger composite cell area 107 that may be formed from a plurality of third cells 110 that are adjacent to each other.

[0118] Since the stent 120 may have a larger number of cells per area than stent 100 due to the greater number of wire segments or picks-per-inch, the larger composite cell areas may either have a larger number of adjacent cells or the stent 120 may have a greater number of larger composite cell areas. Each approach may provide different benefits. For example, including a larger number of adjacent cells within larger composite cell areas, such as larger composite cell area 103, may result in shapes with moreradiopaque material per area (e.g., a greater amount of picks-per-inch of radiopaque wire in certain areas that produces better visibility when imaging during a procedure). In another example, including a greater number of larger composite cell areas, such as first larger composite cell areas 103, may result in a stent 120 with a more uniform image during a procedure since the grouping of radiopaque wires are spread out more uniformly throughout the stent 120.

[0119] Fig. 7 illustrates a representation of two wires braided between pins of a mandrel 101. Fig. 8 illustrates a side view of the two wires braided on the mandrel 121 between its pins. In the example of the present stent 120, the first wire segments 102 may comprise a single wire and the second wire segments 104 may comprise a second single wire. However, a plurality of wires may be used for each of the first wire segments 102 and the second wire segments 104.

[0120] The mandrel 121 may include a plurality of pins that the wires are wrapped around during the braiding process and is generally similar to mandrel 101 only it has a greater number of pins. These pins are represented by numbers in each of the Figs. 5- 7. In the present example, the stent 100 is formed on a mandrel 121 with 12 pins. In the present example, the pins are longitudinally staggered in an alternating pattern, which causes the wires to form alternating patterns of larger loops 114 and smaller loops 112 at each end of the stent 120. However, different loop patterns are possible, such as each end being entirely composed of only larger loops 114 or smaller loops 112. Alternatively, no loops may be included. The braiding pattern may achieve a wide range of picks-per- inch (PPI), depending on the use of the stent (e.g., between 15-250 PPI).

[0121] The braiding process of the stent 120 on the mandrel 121 may be performed in a similar manner as described for the stent 100, except with additional pins and therefore additional first wire segments 102 and second wire segments 104 which may create a higher picks-per-inch.

[0122] Fig. 9 illustrates a view of another example stent 130 split in half so that both halves of the stent 130 are visible to the viewer. The stent 130 is generally similar to thepreviously described stent 100 and stent 120 but may comprise about 20 total wire segments that extend from a first end of the stent 130 to a second end of the stent 130. In one example, the stent 130 may comprise about 10 of the first wire segments 102 and about 10 of the second wire segments 104, though other combinations and wire numbers are possible.

[0123] As with stent 100 and stent 120, the first wire segments 102 and second wire segments 104 of stent 130 may be braided together to form a plurality of cells. In the present example stent 130, the first wire segments 102 may form one or a plurality of first cells 106 that may be bounded or defined on all its sides by the first wire segments 102. In other words, each of the plurality of first cells 106 may be only composed by the first wire segments 102 at the cell’s outer perimeter while otherwise having no further wires within each of the plurality of first cells 106.

[0124] In the present example stent 130, the second wire segments 104 may form one or a plurality of second cells 108 that may be bounded or defined on all its sides by the second wire segments 104. In other words, each of the plurality of second cells 108 may be only composed at its outer perimeter by the second wire segments 104 while otherwise having no further wires within each of the plurality of second cells 108.

[0125] In the present example stent 130, the first wire segments 102 and the second wire segments 104 may form one or a plurality of third cells 110 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of third cells 110 may be comprised of about 50% of first wire segments 102 and about 50% of second wire segments 104 (e.g., two wire segments of each).

[0126] In the present example stent 130, the first wire segments 102 and the second wire segments 104 may form one or a plurality of fourth cells 111 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of plurality of fourth cells 111 may be comprised of unequal portions of the first wire segments 102 and the second wiresegments 104. For example, about 25% of first wire segments 102 and about 75% of second wire segments 104 or vice versa (e.g., one wire segment of one type and three wire segments of another type).

[0127] As with the previously described stent 100 and stent 120, the stent 130 may include one or more of a first larger composite cell area 103 may be formed from a plurality of first cells 106 that are adjacent to each other, a second larger composite cell area 105 may be formed from a plurality of second cells 108 that are adjacent to each other, and a third larger composite cell area 107 may be formed from a plurality of third cells 110 that are adjacent to each other.

[0128] Since the stent 130 may have a larger number of cells per area than stent 100 or stent 120 due to the greater number of wire segments or picks-per-inch, the larger composite cell areas may either have a larger number of adjacent cells or the stent 130 may have a greater number of larger composite cell areas. Each approach may provide different benefits. For example, including a larger number of adjacent cells within larger composite cell areas, such as larger composite cell area 103, may result in shapes with more radiopaque material per area (e.g., a greater amount of picks-per-inch of radiopaque wire in certain areas that produces better visibility when imaging during a procedure. In another example, including a greater number of larger composite cell areas, such as first larger composite cell areas 103, may result in a stent 130 with a more uniform image during a procedure since the grouping of radiopaque wires are spread out more uniformly throughout the stent 130.

[0129] Fig. 10 illustrates a representation of two wires braided between pins of a mandrel 101 (not shown). In the example of the present stent 130, the first wire segments 102 may comprise a single wire and the second wire segments second wire segments 104 may comprise a second single wire. However, a plurality of wires may be used for each of the first wire segments 102 and the second wire segments 104.

[0130] The mandrel 101 may include a plurality of pins that the wires are wrapped around during the braiding process. These pins are represented by numbers in each ofthe Figs. 9 and 10. In the present example, the stent 100 is formed on a mandrel 101 with 12 pins. In the present example, the pins are longitudinally staggered in an alternating pattern, which causes the wires to form alternating patterns of larger loops 114 and smaller loops 112 at each end of the stent 130. However, different loop patterns are possible, such as each end being entirely composed of only larger loops 114 or smaller loops 112. Alternatively, no loops may be included. The braiding pattern may achieve a wide range of picks-per-inch (PPI), depending on the use of the stent (e.g., between 15-250 PPI).

[0131] The braiding process of the stent 130 on the mandrel 101 may be performed in a similar manner as described for the stent 100 and stent 120, except with additional pins and therefore additional first wire segments 102 and second wire segments 104 which may create a higher picks-per-inch.

[0132] Fig. 11 illustrates a view of another example stent 140 split in half so that both halves of the stent 140 are visible to the viewer. The stent 140 is generally similar to the previously described stent 100, stent 120, and stent 130 but may comprise about 24 total wire segments that extend from a first end of the stent 130 to a second end of the stent 130. In one example, the stent 140 may comprise about 12 of the first wire segments 102 and about 12 of the second wire segments 104, though other combinations and wire numbers are possible.

[0133] As with stent 100, stent 120, and stent 130, the first wire segments 102 and second wire segments 104 of stent 130 may be braided together to form a plurality of cells. In the present example stent 140, the first wire segments 102 may form one or a plurality of first cells 106 that may be bounded or defined on all its sides by the first wire segments 102. In other words, each of the plurality of first cells 106 may be only composed by the first wire segments 102 at the cell’s outer perimeter while otherwise having no further wires within each of the plurality of first cells 106.

[0134] In the present example stent 140, the second wire segments 104 may form one or a plurality of second cells 108 that may be bounded or defined on all its sides by thesecond wire segments 104. In other words, each of the plurality of second cells 108 may be only composed at its outer perimeter by the second wire segments 104 while otherwise having no further wires within each of the plurality of second cells 108.

[0135] In the present example stent 140, the first wire segments 102 and the second wire segments 104 may form one or a plurality of third cells 110 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of third cells 110 may be comprised of about 50% of first wire segments 102 and about 50% of second wire segments 104 (e.g., two wire segments of each).

[0136] In the present example stent 140, the first wire segments 102 and the second wire segments 104 may form one or a plurality of fourth cells 111 that may be bounded or defined on all its sides by the first wire segments 102 and the second wire segments 104. In one example, each cell of the plurality of plurality of fourth cells 111 may be comprised of unequal portions of the first wire segments 102 and the second wire segments 104. For example, about 25% of first wire segments 102 and about 75% of second wire segments 104 or vice versa (e.g., one wire segment of one type and three wire segments of another type).

[0137] As with the previously described stent 100, stent 120, and stent 130, the stent 140 may include one or more of a first larger composite cell area 103 may be formed from a plurality of first cells 106 that are adjacent to each other, a second larger composite cell area 105 may be formed from a plurality of second cells 108 that are adjacent to each other, and a third larger composite cell area 107 may be formed from a plurality of third cells 110 that are adjacent to each other.

[0138] Since the stent 140 may have a larger number of cells per area than stent 100 or stent 120 due to the greater number of wire segments or picks-per-inch, the larger composite cell areas may either have a larger number of adjacent cells or the stent 140 may have a greater number of larger composite cell areas. Each approach may provide different benefits. For example, including a larger number of adjacent cells within largercomposite cell areas, such as larger composite cell area 103, may result in shapes with more radiopaque material per area (e.g., a greater amount of picks-per-inch of radiopaque wire in certain areas that produces better visibility when imaging during a procedure. In another example, including a greater number of larger composite cell areas, such as first larger composite cell areas 103, may result in a stent 140 with a more uniform image during a procedure since the grouping of radiopaque wires are spread out more uniformly throughout the stent 140.

[0139] Fig. 12 illustrates a representation of two wires braided between pins of a mandrel 101 (not shown). In the example of the present stent 140, the first wire segments 102 may comprise a single wire and the second wire segments second wire segments 104 may comprise a second single wire. However, a plurality of wires may be used for each of the first wire segments 102 and the second wire segments 104.

[0140] The mandrel 101 may include a plurality of pins that the wires are wrapped around during the braiding process. These pins are represented by numbers in each of the Figs. 11 and 12. In the present example, the stent 100 is formed on a mandrel 101 with 12 pins. In the present example, the pins are longitudinally staggered in an alternating pattern, which causes the wires to form alternating patterns of larger loops 114 and smaller loops 112 at each end of the stent 130. However, different loop patterns are possible, such as each end being entirely composed of only larger loops 114 or smaller loops 112. Alternatively, no loops may be included. The braiding pattern may achieve a wide range of picks-per-inch (PPI), depending on the use of the stent (e.g., between 15-250 PPI).

[0141] The braiding process of the stent 140 on the mandrel 101 may be performed in a similar manner as described for the stent 100, stent 120, and stent 130, except with additional pins and therefore additional first wire segments 102 and second wire segments 104 which may create a higher picks-per-inch.

[0142] Claim Bank

[0143] Clause 1. A stent, comprising: a stent body having a first plurality of wire segments with a first property, and a second plurality of wire segments with a second property; wherein the first property is exclusive to the first plurality of wire segments and wherein the second property is exclusive to the second plurality of wire segments; the first plurality of wire segments forming a plurality of first cells being positioned adjacent to each other to form one or more first composite cell areas.

[0144] Clause 2. The stent of clause 1 , wherein the second plurality of wire segments form one or more second composite cell areas.

[0145] Clause 3. The stent of clause 2, wherein the first plurality of wire segments are braided into a first tubular shape.

[0146] Clause 4. The stent of clause 3, wherein the first property comprises a diameter of a first dimension and the second property comprises a diameter of a second dimension, different than the first dimension.

[0147] Clause 5. The stent of clause 3, wherein the first property is a first wire material and the second property is a second wire material, different than the first wire material.

[0148] Clause 6. The stent of clause 5, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells comprising wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area.

[0149] Clause 7. The stent of clause 5, wherein the first wire material comprises drawn filled tubing.

[0150] Clause 8. The stent of clause 7, wherein the drawn filled tubing comprises an outer layer of a shape memory alloy and an inner core of a radiopaque material.

[0151] Clause 9. The stent of clause 5, wherein the first plurality of wire segments and the second plurality of wire segments are part of a single wire or are part of a plurality of discrete wires.

[0152] Clause 10. The stent of clause 5, wherein each of the first plurality of wire segments and the second plurality of wire segments extend between a proximal end and a distal end of the stent body, and wherein the plurality of wire segments comprises 12, 16, 20, or 14 wire segments.

[0153] Clause 11 . The stent of clause 10, wherein the first plurality of wire segments and the second plurality of wire segments comprise a first wire comprising the first wire material and a second wire comprising the second wire material.

[0154] Clause 12. The stent of clause 5, wherein the plurality first cells are a parallelogram shape, diamond shape, rhombus shape, square shape, or rectangular shape.

[0155] Clause 13. The stent of clause 5, wherein the plurality first composite cell areas are a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, circumferential tube, or a helical shape.

[0156] Clause 14. The stent of clause 5, wherein the one or more first composite cell areas are positioned adjacent to the one or more second composite cells areas along a length of the first tubular shape.

[0157] Clause 15. The stent of clause 14, wherein the one or more first composite cell areas and the one or more second composite cell areas form an alternating pattern in a linear shape along the length of the first tubular shape.

[0158] Clause 16. The stent of clause 15, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells comprising wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area; and whereinthe plurality of third composite cell areas comprise a plurality of third composite cell areas that form a linear shape along the length of the tubular shape.

[0159] Clause 17. The stent of clause 5, wherein the wire segments of the first wire material have a different diameter than the wire segments of the second wire material.

[0160] Clause 18. The stent of clause 5, further comprising a second tubular shape extending along a portion of the first tubular shape and on either an inside or an outside of the first tubular shape; wherein the second tubular shape has a porosity that is less than or greater than the first tubular shape.

[0161] Clause 19. The stent of clause 6, wherein the one or more first composite cell areas and the one or more second composite cells areas are positioned apart from each other by the plurality of third cells.

[0162] Clause 20. The stent of clause 6, wherein the plurality of third cells completely surround the plurality of first cells and the plurality of second cells.

[0163] Clause 21 . The stent of clause 6, wherein the plurality of first cells are entirely bounded by some of the first plurality of wire segments of the first wire material, where the plurality of second cells are entirely bounded by some of the second plurality of wire segments of the second wire material, and where the plurality of third cells are entirely bounded by some of the first plurality of wire segments and of the second plurality of wire segments.

[0164] Clause 22. A stent, comprising: at least a first wire comprising a first wire material and a plurality of first wire segments; at least a second wire comprising a second wire material and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and the plurality of second cells are positionedadjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.

[0165] Clause 23. The stent of clause 22, wherein the first wire material is composed of drawn filled tube wire and wherein the at least second wire segment is composed of a shape memory alloy.

[0166] Clause 24. A stent, comprising: a stent body means forming one or more first cells comprising only wire segments of a first wire material; and, one or more second cells comprising only wire segments of a second wire material.

[0167] Clause 25. A method of creating a stent, comprising: providing one or more wires, wherein each of the one or more wires comprises at least one of a first wire segment of a first wire material and a second wire segment of a second material; and, braiding the one or more wires on a mandrel to create a tubular shape having one or more first cells comprising only a plurality of the first wire segments braided together, and one or more second cells comprising only a plurality of the second wire segments braided together.

[0168] Clause 26. A method of braiding a stent, comprising: loading a stent braiding machine having a plurality of pins with a plurality of wires, wherein the each of the plurality of pins is loaded with one or more of the plurality of wires, wherein a first series of consecutive pins is loaded with wires from the plurality of wires comprising a first material, wherein a second series of consecutive pins is loaded with wires from the plurality of wires comprising a second material, and wherein a third series of one or more consecutive pins is loaded with at least one of the plurality of wires comprising the first material and at least one of the plurality of wires comprising the second material; braiding the plurality of wires to form at least a portion of the stent.

[0169] Clause 27. A stent, comprising: at least a first wire comprising a first wire diameter and a plurality of first wire segments; at least a second wire comprising a secondwire diameter and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and the plurality of second cells are positioned adjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.

Claims

What is claimed is:

1. A stent, comprising: a stent body having a first plurality of wire segments with a first property, and a second plurality of wire segments with a second property; wherein the first property is exclusive to the first plurality of wire segments and wherein the second property is exclusive to the second plurality of wire segments; the first plurality of wire segments forming a plurality of first cells being positioned adjacent to each other to form one or more first composite cell areas.

2. The stent of claim 1 , wherein the second plurality of wire segments form one or more second composite cell areas.

3. The stent of claim 2, wherein the first plurality of wire segments are braided into a first tubular shape.

4. The stent of claim 3, wherein the first property comprises a diameter of a first dimension and the second property comprises a diameter of a second dimension, different than the first dimension.

5. The stent of claim 3, wherein the first property is a first wire material and the second property is a second wire material, different than the first wire material.

6. The stent of claim 5, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells comprising wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area.

7. The stent of claim 5, wherein the first wire material comprises drawn filled tubing.

8. The stent of claim 7, wherein the drawn filled tubing comprises an outer layer of a shape memory alloy and an inner core of a radiopaque material.

9. The stent of claim 5, wherein the first plurality of wire segments and the second plurality of wire segments are part of a single wire or are part of a plurality of discrete wires.

10. The stent of claim 5, wherein each of the first plurality of wire segments and the second plurality of wire segments extend between a proximal end and a distal end of the stent body, and wherein the plurality of wire segments comprises 12, 16, 20, or 14 wire segments.

11. The stent of claim 10, wherein the first plurality of wire segments and the second plurality of wire segments comprise a first wire comprising the first wire material and a second wire comprising the second wire material.

12. The stent of claim 5, wherein the plurality first cells are a parallelogram shape, diamond shape, rhombus shape, square shape, or rectangular shape.

13. The stent of claim 5, wherein the plurality first composite cell areas are a square, rectangle, triangle, diamond, parallelogram, rhombus, circle, oval, a generally linear shape, circumferential tube, or a helical shape.

14. The stent of claim 5, wherein the one or more first composite cell areas are positioned adjacent to the one or more second composite cells areas along a length of the first tubular shape.

15. The stent of claim 14, wherein the one or more first composite cell areas and the one or more second composite cell areas form an alternating pattern in a linear shape along the length of the first tubular shape.

16. The stent of claim 15, wherein the first plurality of wire segments and the second plurality of wire segments form a plurality of third cells comprising wire segments of the first wire material and the second wire material; the plurality of third cells being positioned adjacent to each other to form a third composite cell area; and wherein the plurality of third composite cell areas comprise a plurality of third composite cell areas that form a linear shape along the length of the tubular shape.

17. The stent of claim 5, wherein the wire segments of the first wire material have a different diameter than the wire segments of the second wire material.

18. The stent of claim 5, further comprising a second tubular shape extending along a portion of the first tubular shape and on either an inside or an outside of the first tubular shape; wherein the second tubular shape has a porosity that is less than or greater than the first tubular shape.

19. The stent of claim 6, wherein the one or more first composite cell areas and the one or more second composite cells areas are positioned apart from each other by the plurality of third cells.

20. The stent of claim 6, wherein the plurality of third cells completely surround the plurality of first cells and the plurality of second cells.

21. The stent of claim 6, wherein the plurality of first cells are entirely bounded by some of the first plurality of wire segments of the first wire material, where the plurality of second cells are entirely bounded by some of the second plurality of wire segments of the second wire material, and where the plurality of third cells are entirely bounded by some of the first plurality of wire segments and of the second plurality of wire segments.

22. A stent, comprising: at least a first wire comprising a first wire material and a plurality of first wire segments;at least a second wire comprising a second wire material and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and the plurality of second cells are positioned adjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.

23. The stent of claim 22, wherein the first wire material is composed of drawn filled tube wire and wherein the at least second wire segment is composed of a shape memory alloy.

24. A stent, comprising: a stent body means forming one or more first cells comprising only wire segments of a first wire material; and, one or more second cells comprising only wire segments of a second wire material.

25. A method of creating a stent, comprising: providing one or more wires, wherein each of the one or more wires comprises at least one of a first wire segment of a first wire material and a second wire segment of a second material; and, braiding the one or more wires on a mandrel to create a tubular shape having one or more first cells comprising only a plurality of the first wire segments braided together, and one or more second cells comprising only a plurality of the second wire segments braided together.

26. A method of braiding a stent, comprising: loading a stent braiding machine having a plurality of pins with a plurality of wires, wherein the each of the plurality of pins is loaded with one or more of the plurality of wires, wherein a first series of consecutive pins is loaded with wires from the plurality of wires comprising a first material, wherein a second series of consecutive pins is loaded with wires from the plurality of wires comprising a second material, and wherein a third series of one or more consecutive pins is loaded with at least one of the plurality of wires comprising the first material and at least one of the plurality of wires comprising the second material; braiding the plurality of wires to form at least a portion of the stent.

27. A stent, comprising: at least a first wire comprising a first wire diameter and a plurality of first wire segments; at least a second wire comprising a second wire diameter and a plurality of second wire segments; wherein the plurality of first wire segments and the plurality of second wire segments are braided together to form a plurality of first cells bounded only by some of the plurality of first wire segments and a plurality of second cells bounded only by some of the plurality of second wire segments; wherein some of the plurality of first cells are positioned adjacent to each other to form a plurality of first composite cell areas and the plurality of second cells are positioned adjacent to each other to form a plurality of second composite cell areas; and, wherein the plurality of first composite cell areas and the plurality of second composite cell areas form a pattern along a length of the stent.

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