Medical stents

Abstract

The implantable stent may include a braided tubular member comprised of braided wires, including radially outer segments that intersect above and radially outward of the radially inner segments at a plurality of intersection points. Furthermore, the radially outer segments may be coated with a coating, and the radially inner segments may be uncoated and free of coating.

Description

[0001] (Division of case 201880066803.3)

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 545,179, filed on August 14, 2017, which is hereby incorporated by reference in its entirety. Technical Field

[0004] The present disclosure relates to medical devices and methods for making and / or using medical devices. More specifically, the present disclosure relates to medical stents and methods for making and / or using medical stents. Background Art

[0005] In medicine, a stent is a tube made of metal, plastic, or other materials, or a combination thereof, that is inserted into a lumen or passageway of an anatomical body cavity to maintain its patency. There are a wide variety of stents used for different purposes, ranging from stents that expand coronary arteries, blood vessels, esophagus, trachea, colon, and bile ducts to stents that allow urine to flow between the kidneys and bladder. Known medical stents each have certain advantages and disadvantages. There is a continuing need to provide alternative medical stents and alternative methods for making and using medical stents. Summary of the Invention

[0006] The present disclosure provides design, material, manufacturing methods, and use alternatives for medical devices, including delivery devices.

[0007] In a first example, an implantable stent may include a braided tubular member comprised of a plurality of braided wires, the braided tubular member including a plurality of radially outer segments that cross over a plurality of radially inner segments and are radially outward of the plurality of radially inner segments at a plurality of intersection points. The radially outer segments may be coated with a coating, and the radially inner segments may be uncoated or may be uncoated.

[0008] Alternatively or in addition to any of the above examples, in another example, each braided wire of the plurality of braided wires may include radially outer wire segments alternating with radially inner wire segments.

[0009] Alternatively or in addition to any of the above examples, in another example, the radially outer segments can be configured to pivot relative to the plurality of radially inner segments at the intersection point as the braided tubular member radially expands and radially contracts.

[0010] Alternatively or in addition to any of the above examples, in another example, a plurality of braided wires may define open cells therebetween, and the coating may not extend across the open cells between adjacent wires.

[0011] Alternatively or in addition to any of the above examples, in another example, when the braided tubular member is in a nominally expanded state, the uncoated length of the radially inner segment can be greater than the length of the radially inner segment contacting the radially outer segment at the intersection.

[0012] Alternatively or in addition to any of the above examples, in another example, the braided tubular member can be radially compressed from a nominally expanded state to a radially contracted state. When the braided tubular member is in the nominally expanded state, the length of the radially inner segment that contacts the radially outer segment at the intersection in the radially contracted state can be greater than the length of the radially inner segment that contacts the radially outer segment at the intersection.

[0013] Alternatively or in addition to any of the above examples, in another example, the radially contracted state can be determined based on a pivot angle between adjacent line segments at an intersection point.

[0014] Alternatively or in addition to any of the above examples, in another example, the pivot angle may have a value between 0° and 45°.

[0015] Alternatively or in addition to any of the above examples, in another example, the uncoated length of the radially inner segment can be greater than the diameter of the radially outer segment at the intersection point.

[0016] In another example, an implantable stent may include a tubular member, the tubular member may be composed of a plurality of braided wires forming a braid pattern including a plurality of intersections, and a first segment and a second segment of the braided wires may intersect at each intersection such that the first segment intersects above and radially outward of the second segment and the second segment intersects below and radially inward of the first segment. A coating may be provided only on the first segment, the first segment intersects above and radially outward of the second segment, and the second segment intersects below and radially inward of the uncoated first segment.

[0017] Alternatively or in addition to any of the above examples, in another example, each braided wire of the plurality of braided wires may include a plurality of first wire segments that may include a coating alternating with a plurality of second wire segments that may be uncoated along the length of the wire.

[0018] Alternatively or in addition to any of the above examples, in another example, the plurality of braided wires may include a first wire, a second wire, a third wire, and a fourth wire, and the first and second wires may extend parallel to each other in a first helical direction, and the third and fourth wires may extend parallel to each other in an opposite, second helical direction. The first wire may cross the third wire at a first intersection, above and radially outward from the third wire, and may cross the fourth wire at a second intersection, below and radially inward from the fourth wire. The second wire may cross the third wire at a third intersection, below and radially inward from the third wire, and may cross the fourth wire at a fourth intersection, above and radially outward from the fourth wire. A first portion of the first wire may form a first wire segment coated with a coating, and a second portion of the first wire may form a second wire segment uncoated. A first portion of the second wire may form a first wire segment coated with a coating, and a second portion of the second wire may form a second wire segment uncoated. A first portion of the third wire may form a first wire segment coated with a coating, and a second portion of the third wire may form a second wire segment uncoated. A first portion of the fourth wire may form a first wire segment coated with a coating, and a second portion of the fourth wire may form a second wire segment uncoated.

[0019] Alternatively or in addition to any of the above examples, in another example, the first thread, the second thread, the third thread, and the fourth thread can define open cells therebetween, and the coating can not extend across the open cells.

[0020] Alternatively or in addition to any of the above examples, in another example, the first, second, third, and fourth wires can be configured to pivot and expand axially at the first, second, third, and fourth intersection points and can geometrically change the appearance of the open cell.

[0021] Alternatively or in addition to any of the above examples, in another example, the first line and the third line may not slide relative to each other at the first intersection, the first line and the fourth line may not slide relative to each other at the second intersection, the second line and the third line may not slide relative to each other at the third intersection, and the second line and the fourth line may not slide relative to each other at the fourth intersection.

[0022] Alternatively or in addition to any of the above examples, in another example, the coating can include a therapeutic agent.

[0023] In another example, a method for selectively coating portions of an expandable stent may include applying an axial force to a braided tubular member to change the axial length of the braided tubular member from the length of the braided tubular member in a nominally expanded state, wherein the braided tubular member may include radially outer segments that intersect above and radially outward of radially inner segments of the braided tubular member at a plurality of intersection points. Applying the axial force may change the angle between the radially outer and radially inner segments of the braided tubular member at the intersection points. Thereafter, coating the radially outer segments while avoiding coating the radially inner segments.

[0024] Alternatively or in addition to any of the above examples, in another example, when in the nominally deployed state, the uncoated length of the radially inner segment can be greater than the length of the radially inner segment that contacts the radially outer segment at the intersection point.

[0025] Alternatively or in addition to any of the above examples, in another example, the braided tubular member can include a plurality of braided wires, and each braided wire of the plurality of braided wires can include radially outer wire segments alternating with radially inner wire segments.

[0026] Alternatively or in addition to any of the above examples, in another example, the coating may be applied when the pivot angle has a value between 5° and 45° or between 150° and 175°. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure may be more fully understood based on the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1A An exemplary stent comprising a braided tubular member comprised of braided wires is shown in a nominally deployed state.

[0029] Figure 1B Shown Figure 1A A magnified view of a portion of the braided tubular member of the stent.

[0030] Figure 2 Shown Figure 1A An example of the radially expandable / contractible function of the braided tubular member of a stent.

[0031] Figure 3A Shown in an axially elongated state Figure 1A An exemplary stent is provided.

[0032] Figure 3B Shown in nominal deployed state, Figure 1A Magnified view of the braided tubular members of the stent.

[0033] Figure 3C Shown in an axially elongated state, Figure 1A Magnified view of the braided tubular members of the stent.

[0034] Figure 3D is an enlarged view of the intersection of the intersection lines of the braided tubular member illustrating the movement of the intersection lines between a nominally expanded state (dashed lines) and an axially elongated state (solid lines).

[0035] Figure 3E Shown along Figure 3A The line 3E-3E intercepts Figure 1A Cross-sectional view of a braided tubular member of a stent.

[0036] Figure 4A Shown in axial contraction state Figure 1A An exemplary stent is provided.

[0037] Figure 4B Shown in the axial contraction state, Figure 1A Magnified view of the braided tubular members of the stent.

[0038] Figure 4C is an enlarged view of the intersection of the intersection lines of the braided tubular member illustrating the movement of the intersection lines between a nominally expanded state (dashed lines) and an axially contracted state (solid lines).

[0039] Figure 4D Shown along Figure 4A The line 4D-4D intercepts Figure 1A Cross-sectional view of a braided tubular member of a stent.

[0040] Figure 5 The coating is applied to the Figure 1A bracket.

[0041] Figures 6A to 6C The braided tubular member of the stent is shown in various states after application of the coating.

[0042] Figures 7A to 7C The braided tubular member of the stent is shown in various states after application of the coating using an alternative coating process.

[0043] Figures 8A to 8D Alternative braid patterns for exemplary stents are shown.

[0044] Figure 9 is a block flow diagram of an illustrative method.

[0045] While the present disclosure is susceptible to various modifications and alternative forms, details thereof have been disclosed by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the present disclosure is not intended to limit the present disclosure to the specific embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0046] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0047] All numerical values ​​herein are assumed to be modified by the term "about", whether or not expressly indicated otherwise. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0048] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0049] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0050] It should be noted that references in this specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such references do not necessarily imply that all embodiments include the particular features, structures, and / or characteristics. Furthermore, when particular features, structures, and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures, and / or characteristics may also be used in other embodiments, regardless of whether such features, structures, and / or characteristics are explicitly described, unless otherwise expressly stated.

[0051] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are labeled with the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the present disclosure.

[0052] Figure 1AAn exemplary stent 10 is shown, which includes a braided tubular member 100 composed of braided wires 102 in a nominal expanded state (i.e., a state of equilibrium in the absence of external forces acting on the stent). In some cases, in the nominal expanded state, the braided tubular member 100 may have a diameter D1 and a length L1. In some embodiments, the braided wire 102 may have a first group of line segments extending parallel to each other in a first helical direction and a second group of line segments extending parallel to each other in a second helical direction opposite to the first helical direction. In this way, the line segments of the first group and the line segments of the second group may cross or intersect multiple times at intersections to form a braided pattern. In some cases, the braided pattern may be uneven or inconsistent because the spacing between each line segment and the line segments of any group may change or the angle at which the line segments cross may change. In some cases, the braided pattern may be in a one-on-one braided configuration, wherein a single line segment extending in the first helical direction intersects a single line segment extending in the second helical direction at each intersection. In an over-under braiding configuration, a wire segment from the first group of wire segments may be positioned above (radially outward from) a first wire segment from the second group of wire segments at a first intersection (i.e., intersection), then below a second wire segment from the second group of wire segments at a second intersection (i.e., intersection), and then above a third wire segment from the second group of wire segments at a third intersection (i.e., intersection), continuing in this alternating pattern from the first end 104 of the braided tubular member 100 to the second end 106 of the braided tubular member 100. Furthermore, other wires from the braided wire 102 may also be braided in this alternating pattern from the first end 104 to the second end 106. Furthermore, each wire of the braided wire 102 may be viewed as a plurality of wire segments. Thus, in the over-under braiding configuration, each wire may be comprised of alternating radially outward wire segments (i.e., wire segments that extend radially outward from the other wire at the intersection) and radially inward wire segments (i.e., wire segments that extend radially inward from the other wire at the intersection). Thus, the radially outward segment may be radially outward of the radially inward segment at the intersection point.

[0053] Steering Figure 1B, shows an enlarged view of a cutout portion 108 of a braided tubular member 100. Cutout portion 108 may include lines 110, 112, 114, 116, 118, and 120. As shown, line 110 crosses above line 116 at intersection 122, crosses below line 118 at intersection 124, and crosses above line 120 at intersection 126. Thus, line 110 includes radially outer segments 140A and 140C and a radially inner segment 140B between radially outer segments 140A and 140C. Line 112 crosses below line 116 at intersection 128, crosses above line 118 at intersection 130, and crosses below line 120 at intersection 132. Thus, line 112 includes radially inner segments 142A and 142C and a radially outer segment 142B between radially inner segments 142A and 142C. Line 116 intersects line 110 below at intersection 122 and above line 112 at intersection 128. Thus, line 116 includes radially outer segments 146A and 146C and a radially inner segment 146B between radially outer segments 146A and 146C. Furthermore, line 118 intersects line 110 above at intersection 124 and below line 112 at intersection 130. Thus, line 118 includes radially outer segments 148A and 148C and a radially outer segment 148B between radially outer segments 148A and 148C. Finally, line 120 crosses above line 112 at intersection 132 and below line 110 at intersection 126. Thus, line 120 includes a radially outer segment 150A and a radially inner segment 150B. Thus, braided tubular member 100 may include or be comprised of a plurality of radially outer segments (e.g., radially outer segments 140A, 140C, 142B, 146A, 146C, 148A, 148C, and 150A) that cross above and radially outward of a plurality of radially inner segments (e.g., radially inner segments 140B, 142A, 142C, 146B, 148B, and 150B) at a plurality of intersections (e.g., intersections 122-132). In various embodiments, the over-under configuration of wires 110-120 can define a plurality of open cells (e.g., open cells 152). Open cells 152 can be openings through the tubular wall of braided tubular member 100 from the outer surface to the inner surface of braided tubular member 100. Open cells 152 can have a parallelogram shape, having an upper vertex, a lower vertex, and side vertices formed by intersections (e.g., intersections 122-132).

[0054] Braided tubular member 100 is not limited to a one-up-one-down configuration. In some alternative configurations, wires 102 can be braided in a two-down-two-up pattern. Other braiding patterns known in the art can also be appropriately adopted. In addition, in some cases, wires 102 can be paired with each other and braided in a one-up-one-down pattern using each wire pair. These wire pairs can be the same or can be different (e.g., can have the same or different sizes, shapes and / or manufacturing materials). In addition, these wire pairs can be appropriately braided in other braiding patterns (e.g., but not limited to, a pattern with two wires below and two wires above).

[0055] According to various embodiments, the wire 102 can be made of any suitable implantable material, including but not limited to nickel-titanium alloys (e.g., Nitinol), stainless steel, cobalt-based alloys such as Platinum, gold, titanium, tantalum, niobium, polymer materials and combinations thereof. Useful polymer materials may include, for example, polyesters (including polyethylene terephthalate (PET)), polypropylenes, polyethylenes, polyurethanes, polyolefins, vinyl polymers, polymethyl acetates, polyamides, naphthalene dicarboxylate derivatives, silk, polyvinyl chloride, polytetrafluoroethylene, including expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylate derivatives (such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and polytrimethylene naphthalate), polyurethanes, polyureas, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers (such as fully or partially halogenated polyethers), and copolymers and combinations thereof. In addition, useful non-limiting examples of polymeric stent materials include poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolide (PGA), L-lactide-D,L-lactide copolymer (PLLA / PLA), L-lactide-glycolide copolymer (PLLA / PGA), D,L-lactide-glycolide copolymer (PLA / PGA), glycolide-trimethylene carbonate copolymer (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), polyphosphazene-D,L-lactide-caprolactone copolymer (PLA / PCL), glycolide-caprolactone copolymer (PGA / PCL), polyphosphates, and the like. Threads made of polymeric materials may also include radiopaque materials, such as metal-based powders, microparticles, or pastes, that can be incorporated into the polymeric material. For example, the radiopaque material can be mixed with the polymer composition comprising the polymeric thread and then fabricated into a stent, as described herein. Alternatively, a radiopaque material may be coated onto the surface of a metal or polymer stent. In either embodiment, a variety of radiopaque materials and their derivatives may be used, including but not limited to bismuth, barium and its derivatives such as barium sulfate, tantalum, tungsten, gold, platinum, and titanium. Other useful radiopaque materials can be found in U.S. Patent No. 6,626,936, the entire contents of which are incorporated herein by reference. Metal complexes that can be used as radiopaque materials are also contemplated. Depending on the desired end product and application, the braided tubular member 100 can be selectively made radiopaque in predetermined areas along the wire, or can be completely radiopaque. Furthermore, the wire 102 may have an inner core of tantalum, gold, platinum, iridium, or a combination thereof, and an outer member or layer of nitinol, to provide a composite wire for improved radiopacity or visibility. In some cases, the inner core may be platinum and the outer layer may be nitinol. In some cases, the platinum inner core may comprise at least approximately 10% of the wire, based on the total cutout percentage.Additionally, Nitinol that has not been processed for shape memory purposes (e.g., by heating, forming, and cooling the Nitinol in its martensite and austenite phases) can also be used as the outer layer. Further details of such composite wires can be found in U.S. Patent No. 7,101,392, the contents of which are incorporated herein by reference.

[0056] Figure 2 An example of the radially expandable / contractible function of the braided tubular member 100 of the stent 10 is shown. As can be seen in the figure, Figure 2 A cut-away portion of a braided tubular member 100 is shown in an over-under configuration. Figure 2 The cutout shown in Figure 1B However, in other examples, Figure 2 The cut-out portion shown in FIG. 1 may be another cut-out portion of the braided tubular member 100 .

[0057] As described above, the braided wires 102 may be connected to each other at the intersections (e.g., Figure 1B These intersections may also function as pivot points (e.g., pivot points 202a-202k), and when a force is applied to the stent 10 such that the braided tubular member 100 is axially stretched or axially contracted, the radially outer segments (e.g., Figure 1B The radially outer line segment) can be relative to the radially inner line segment (for example, Figure 1B For example, an axial force (i.e., a force that causes axial elongation or axial contraction of the braided tubular member 100) can be applied to the braided tubular member 100. In some cases, the axial force can be applied to the first end 104 and the second end 106 (shown in FIG. Figure 1A When an axial force is applied, the braided wire 102 can pivot around the pivot points 202a-202k and change the pivot angles α1-α 11 In some cases, as shown in the figure, the pivot angles α1 to α 11 It can be a measured angle that is equally divided by the longitudinal axis X of the braided tubular member 100 (or a straight line segment parallel to the longitudinal axis X). In some embodiments, when the braided tubular member 100 is in the nominal expanded state, the measured angles α1 to α 11The angles α1 to α20 may be within a range of about 75° to about 135°, about 80° to about 120°, about 90° to about 110°, or about 90°, about 100°, or about 110°. In addition, the pivoting of the braided wire 102 at the pivot points 202a to 202k may change the shape of the open cell 152. In some examples, the force applied to axially elongate the braided tubular member 100 and thereby move the first end 104 and the second end 106 apart may reduce the pivot angles α1 to α20. 11 In this regard, by reducing the pivot angle α1 to α 11 , the diameter D1 of the braided tubular member 100 ( Figure 1A ) can be radially contracted and the length L1 of the braided tubular member 100 ( Figure 1A ) can be axially stretched from its nominal expanded state to an axially stretched state (also known as a radially contracted state). In certain embodiments, when the braided tubular member 100 is in the axially stretched state, the angles α1 to α 11 It can be less than or equal to 45°, less than or equal to 35°, or less than or equal to 25°. In some cases, the angles α1 to α 11 The pivot angle α1 may be within a range of about 0° to less than or equal to 45°, about 0° to less than or equal to 35°, about 0° to less than or equal to 25°, about 5° to less than or equal to 45°, about 5° to less than or equal to 35°, or about 5° to less than or equal to 25°. In some examples, the force applied to axially contract the braided tubular member 100 and thereby move the first end 104 and the second end 106 closer together may increase the pivot angle α1 to α1. 11 In this regard, by increasing the pivot angle α1 to α 11 , the diameter D1 can be radially expanded and the length L1 can be axially contracted from its nominal expanded state to an axially contracted state (also referred to as a radially expanded state). In certain embodiments, when the braided tubular member 100 is in the axially contracted state, the angles α1 to α 11 It can be greater than or equal to 150°, greater than or equal to 155°, or greater than or equal to 160°. In some cases, the angles α1 to α 11 It can range from greater than or equal to 150° to about 180°, from greater than or equal to 155° to about 180°, from greater than or equal to 160° to about 180°, from greater than or equal to 150° to about 175°, from greater than or equal to 155° to about 175°, or from greater than or equal to 160° to about 175°.

[0058] Alternatively and in addition, reference may be made to the pivot angles β1 to β 11 The effect of the applied axial force can be seen. 11 It can be the pivot angle α1~α 11In some cases, as shown in the figure, the pivot angles β1 to β 11 β1-β2 may be measured relative to the circumference of the braided tubular member 100 (or a straight line segment perpendicular to the longitudinal axis X). In addition, the pivoting of the braided wire 102 at the pivot points 202a-202k may again change the shape of the open cell 152. In certain embodiments, when the braided tubular member 100 is in the nominally expanded state, the angles β1-β2 may be measured relative to the circumference of the braided tubular member 100 (or a straight line segment perpendicular to the longitudinal axis X). 11 The pivot angle β1 to β2 may be in the range of about 45° to about 105°, about 60° to about 100°, about 70° to about 90°, or about 70°, about 80°, or about 90°. In some examples, the force applied to axially elongate the braided tubular member 100 and thereby move the first end 104 and the second end 106 away from each other may increase the pivot angle β1 to β2. 11 In this regard, by increasing the pivot angle β1 to β 11 , the diameter D1 of the braided tubular member 100 can be radially contracted and the length L1 of the braided tubular member 100 can be axially elongated from its nominal expanded state to an axially elongated state (or radially contracted state). In certain embodiments, when the braided tubular member 100 is in the axially elongated state, the angles β1 to β 11 It can be greater than or equal to 135°, greater than or equal to 145°, or greater than or equal to 155°. In some cases, the angles β1 to β 11 The pivot angle β1-β2 may be within a range of from greater than or equal to 135° to about 180°, from greater than or equal to 145° to about 180°, from greater than or equal to 155° to about 180°, from greater than or equal to 135° to about 175°, from greater than or equal to 145° to about 175°, or from greater than or equal to 155° to about 175°. In some examples, the force applied to axially contract the braided tubular member 100 and thereby move the first end 104 and the second end 106 closer together may increase the pivot angle β1-β2. 11 In this regard, by reducing the pivot angle β1 to β 11 , the diameter D1 can be radially expanded and the length L1 can be axially contracted from its nominal expanded state to an axially contracted state (or radially expanded state). In certain embodiments, when the braided tubular member 100 is in the axially contracted state, the angles β1 to β 11 It can be less than or equal to 30°, less than or equal to 25°, or less than or equal to 20°. In some cases, the angles β1 to β 11 It can range from about 0° to less than or equal to 30°, from about 0° to less than or equal to 25°, from about 0° to less than or equal to 20°, from about 5° to less than or equal to 30°, from about 5° to less than or equal to 25° to about 175°, from about 5° to less than or equal to 20°.

[0059] In certain embodiments, the braided tubular member 100 can maintain structural integrity even when axial forces are applied and the braided tubular member 100 undergoes geometric changes. In certain cases, when the braided tubular member 100 undergoes these geometric changes, by maintaining structural integrity, the braided wires 102 can be configured to exhibit pivotal motion about the pivot points 202a-202k without sliding, shifting, or deflecting along the intersection line 102. This allows the radially outer segments to remain substantially constant relative to the radially inner segments, where the radially outer segments intersect at their respective intersection points. Maintaining the intersection points at a constant position along the length of the segments can prevent selective coatings that can be provided on the braided tubular member 100, as described herein. In certain cases, the braided wires 102 can be braided in a non-interlocking configuration. This non-interlocking braid configuration can eliminate intertwining, encircling, or interengaging at the intersection points. However, in certain cases, the braided wires 102 can be braided in an interlocking manner.

[0060] Figure 3A Shown is an exemplary braided tubular member 100 of the stent 10 in an axially elongated state (or radially contracted state). In some cases, the braided tubular member 100 is adjusted to the axially elongated state by utilizing the applied force that makes the first end 104 and the second end 106 move axially away from. The applied force moves the braided tubular member 100 from its nominal expanded state (that is, the equilibrium state under the condition of no external applied force) to the axially elongated state. As shown in the figure, the braided tubular member 100 has contracted radially and the diameter of the braided tubular member 100 has been reduced to the diameter D2 in the axially elongated state from the diameter D1 in the nominal expanded state, and the length of the braided tubular member 100 has been increased to the L2 in the axially elongated state from the length L1 in the nominal expanded state.

[0061] Figure 3B As shown in Figure 1A 1 is an enlarged view of a portion of the braided tubular member 100 in a nominally expanded state as depicted in FIG. Figure 3C As shown in Figure 3A FIG. 1 is an enlarged view of a portion of the braided tubular member 100 in an axially elongated state. As shown in the figure, the pivot angles α1 to α3 have been changed from Figure 3B Their nominal deployed state measurements are reduced to Figure 3C In addition, the pivot angles β1 to β3 have been changed from Figure 3B Their nominal deployed state measurements are reduced to Figure 3C Measured values ​​of their axially elongated state.

[0062] Figure 3D30 is an enlarged view of the intersection of the intersection lines of the braided tubular member 100, which illustrates the movement of the intersection line 102 between the nominal expanded state (dashed line) and the axially elongated state (solid line). View 304 (dashed line) shows the braided tubular member 100 in the nominal expanded state, and view 306 (solid line) shows the braided tubular member 100 in the axially elongated state. As shown in the figure, view 304 is superimposed (shown in dashed line) on view 306 and has a common pivot point at the intersection 322 of the radially outer line segment 308 of line 102 and the radially inner line segment 310 of line 102. In addition, Figure 3D 304, the radially outer segment 308 covers, crosses, is above, and / or radially outward of the radially inner segment 310 by a length X1, and contacts the radially inner segment 310 by a length X1. However, in the axially elongated state shown in view 306, the radially outer segment 308 covers, crosses, is above, and / or radially outward of the radially inner segment 310 by a length X2, and contacts the radially inner segment 310 by a length X2. As can be seen in the figure, the length X2 of the radially inner segment 310 that contacts the radially outer segment 308 in the axially elongated state can be greater than the length X1 of the radially inner segment 310 that contacts the radially outer segment 308 in the nominally deployed state. As described in more detail below, the uncoated portions of the wire (e.g., segments of each wire that are uncoated and therefore have no coating) may have a length greater than or equal to the length X2 of the radially outer wire segment 308 in contact with the radially inner wire segment 310 in the axially elongated state to ensure that the outward wire segment 308 does not contact or rub through the coating on the coated portions of the wire that form the inward wire segment 310 on either side of the intersection.

[0063] Figure 3E Shown along Figure 3A 3E~3E, and is a cross-sectional view of the braided tubular member 100 in an axially elongated state. As described above, the radially outer line segment 308 can be located radially outside the radially inner line segment 310 at each intersection. Figure 3E, selected portions of the braided tubular member 100 can be coated with a coating 314 applied directly thereto. For example, the radially outer segments 308 can be coated with the coating 314 using techniques such as roll coating, dot-matrix printing, electrospinning, and spray coating, for example, while leaving uncoated lengths of the inward segments 310 at each intersection 122. In certain embodiments, when the coating 314 is applied to the braided tubular member 100, the radially outer segments 308 can cover or pass over the radially inner segments 310, and the radially inner segments 310 can be uncoated and free of the coating 314, and / or the radially outer segments 308 can extend radially outward from the radially inner segments 310 such that the coating 314 only covers portions of the radially outer segments 308 while not contacting the radially inner segments 310, thereby leaving the radially inner segments 310 uncoated or free of the coating 314. Furthermore, if the coating 314 is applied when the braided tubular member 100 is in the nominally expanded state, the uncoated length of the radially inner segment 310 (i.e., X2) can be greater than the uncoated length of the radially inner segment 310 (i.e., X1) because the braided tubular member 100 is in an axially elongated state when the coating 314 is applied. In some cases, the coating 314 can extend less than the entire circumference of the radially outer segment 308 at the intersection 122. For example, the coating 314 can extend only partially around the circumference of the radially outer segment 308, such that the radially outer segment 308 faces and / or contacts the portion of the radially inner segment 310 that is uncoated.

[0064] Figure 4A The exemplary braided tubular member 100 of the stent in axial contraction state (or radial expansion state) is shown. In some cases, the applied force that makes the first end 104 and the second end 106 move axially and approach can be utilized to adjust the braided tubular member 100 to the axial contraction state. The applied force moves the braided tubular member 100 from its nominal expanded state (that is, the equilibrium state under the condition of no external applied force) to the axial contraction state. As shown in the figure, the braided tubular member 100 has expanded radially, and the diameter of the braided tubular member 100 has increased to the diameter D3 in the axial contraction state from the diameter D1 in the nominal expanded state, and the length of the braided tubular member 100 has been reduced to the L3 in the axial contraction state from the length L1 in the nominal expanded state.

[0065] Figure 4B Shown as Figure 4A FIG. 1 is an enlarged view of a portion of the braided tubular member 100 in an axially contracted state. As shown in the figure, the pivot angles α1 to α3 have been changed from Figure 3B Their nominal expansion measurements increase to Figure 4BIn addition, the pivot angles β1 to β3 have been changed from Figure 3B Their nominal expansion measurements are reduced to Figure 4B The values ​​of their axial contraction state are measured in .

[0066] Figure 4C 304 is an enlarged view of the intersection of the intersection lines of the braided tubular member 100 illustrating the movement of the intersection lines between the nominal expanded state (dashed line) and the axially contracted state (solid line). View 304 (dashed line) shows the braided tubular member 100 in the nominal expanded state, and view 406 (solid line) shows the braided tubular member 100 in the axially contracted state. As shown in the figure, view 304 is superimposed (indicated by the dashed line) on view 406 and has a common pivot point at the intersection 322 of the radially outer line segment 308 of line 102 and the radially inner line segment 310 of line 102. In addition, Figure 4C 304 , radially outer segment 308 covers, passes over, is above, and / or is radially outside of, and contacts radially inner segment 310 by a length X1. In the axially contracted state shown in view 406 , radially outer segment 308 covers, passes over, is above, and / or is radially outside of, and contacts radially inner segment 310 by a length X3. As can be seen in the figure, the length X3 of radially inner segment 310 that contacts radially outer segment 308 in the axially contracted state may be greater than the length X1 of radially inner segment 310 that contacts radially outer segment 308 in the nominally deployed state. As described in more detail below, the uncoated portions of the wire (e.g., the uncoated and therefore uncoated sections of each wire) may have a length greater than or equal to length X3 such that the radially inner wire segment 310 contacts the radially outer wire segment 308 in an axially contracted state to ensure that the outward wire segment 308 does not contact or rub past the coating on the coated portions of the wire comprising the inward wire segment 310 on either side of the intersection.

[0067] Figure 4D Shown along Figure 4A 4D-4D, in a cross-sectional view of the braided tubular member 100 in an axially contracted state. As described above, the radially outer line segment 308 can be located radially outward of the radially inner line segment 310 at each intersection. Figure 4DAs shown in , selected portions of the braided tubular member 100 can be coated with a coating applied directly thereto. For example, the radially outer segments 308 can be coated with the coating 314 using techniques such as roll coating, dot matrix printing coating, and spray coating, for example, while leaving uncoated lengths of the inward segments 310 at each intersection. In certain embodiments, when the coating 314 is applied to the braided tubular member 100, the radially outer segments 308 can cover and / or pass over the radially inner segments 310, which can be uncoated and without the coating 314, and / or the radially outer segments 308 can extend radially outward from the radially inner segments 310 such that the coating 314 only covers the radially outer segments 308 while not contacting the radially inner segments 310, thereby leaving the radially inner segments 308 uncoated or without the coating 314. Furthermore, if the coating 314 is applied when the braided tubular member 100 is in the nominally expanded state, the uncoated length of the radially inner segment 310 (i.e., X3) can be greater than the uncoated length of the radially inner segment 310 (i.e., X1) because the braided tubular member 100 is in the axially contracted state when the coating 314 is applied. In some cases, the coating 314 can extend less than the entire circumference of the radially outer segment 308 at the intersection 122. For example, the coating 314 can extend only partially around the circumference of the radially outer segment 308, leaving the portion of the radially outer segment 308 that faces and / or contacts the radially inner segment 310 free of the coating 314.

[0068] Figure 5 Schematically, a coating material 500 is applied to the braided tubular member 100 using a roller coating technique to form a coating 314. According to various embodiments, when the coating material 500 is applied to the braided tubular member, the braided tubular member 100 can be in an axially elongated state or an axially contracted state. An automated placement device (not shown) can be used to place the braided tubular member 100 in a basin 502 containing the coating material 500. In this embodiment, the braided tubular member 100 can be placed in the basin 502 near the first end 504 of the basin and advanced toward the second end 506 of the basin 502. When the braided tubular member 100 is advanced through the basin 502, the braided tubular member 100 can be moved about a longitudinal axis (e.g., Figure 2204) rolls along the longitudinal axis 204 of the basin 502. In some cases, the rolling can be due to the friction between the bottom 508 of the basin 502 and the radially outer segment (e.g., the radially outer segment 308). For example, the radially outer segment can be in contact with the bottom 508, and the friction can push the radially outer segment in the direction opposite to the direction in which the braided tubular member 100 is advanced. In response, the braided tubular member 100 can be rotated and another radially outer segment can be placed in the coating 500, contact the bottom 508 of the basin 502, and continue the rotation of the braided tubular member 100 until the surface of the braided tubular member 100 is coated with the coating material 500 as required to form the coating 314. In another example, an automatic placement device can rotate the braided tubular member 100 itself through the coating material 500 and the braided tubular member 100 can be advanced through or without the basin 502. Regardless of the direction of rotation, according to various embodiments, because the braided tubular member 100 is in an axially elongated state or an axially contracted state during the application of the coating material 500 to form the coating 314 on the braided tubular member 100, the radially outer segment (e.g., the radially outer segment 308) can be radially outward of the radially inner segment (e.g., the radially inner segment 310). In addition, the braided tubular member 100 can be immersed in the coating material 50 in the basin 502 to a depth (i.e., Y) less than the diameter d of the radially outer segment 308. Because the radially inner segment 310 is located radially inward of the radially outer segment 308 and the immersion depth Y into the coating material 500 is less than the diameter d of the radially outer segment 308, the coating material 500 can be applied to the surface of the radially outer segment 308 without the coating material 500 contacting the surface of the radially inner segment 310 (i.e., the radially inner segment 310 avoids entering or being immersed in the coating material 500). As such, during the coating process for applying the coating 314 to the radially outer segment 308, the radially inner segment 310 can remain uncoated and free of the coating material 500. Furthermore, because the braided tubular member 100 is in an axially elongated state or an axially contracted state while being rolled through the coating material 500 or undergoing the coating process, the uncoated length of the radially inner segment 310 of the wire 102 can be greater than the length of the radially inner segment 310 that is in contact with the radially outer segment 308 at the intersection 322 when in the nominally deployed state.

[0069] Coating 314 can be any suitable biologically acceptable coating. In some cases, coating 314 can contain a therapeutic agent, such as a non-genetic therapeutic agent, a biomolecule, a small molecule, or a cell.

[0070] Exemplary non-gene therapy agents include: antithrombotic agents such as heparin, heparin derivatives, prostaglandins (including micellar prostaglandin E1), urokinase, and PPack (dextrorotatory phenylalanine-proline-arginine chloromethyl ketone); antiproliferative agents such as enoxaparin, angiostatin, sirolimus (rapamycin), tacrolimus, everolimus, zotarolimus, biolimus, monoclonal antibodies capable of preventing smooth muscle cell proliferation, hirudin, and acetylsalicylic acid; anti-inflammatory agents such as dexamethasone, rosiglitazone, prednisolone, corticosterone, budesonide, estrogen, estradiol, sulfasalazine, acetylsalicylic acid, mycophenolic acid, and mesalamine; antitumor / antiproliferative / antimitotic agents such as paclitaxel, epothilone, cladribine, 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, cyclosporin, cisplatin, vinblastine, vincristine, epothilone, endostatin, trapidil, halofuginone, and angiostatin; anticancer agents, such as antisense inhibitors of the c-myc-oncogene; antimicrobial agents, such as triclosan, cephalosporins, aminoglycosides, nitrofurantoin, silver ions, compounds, or salts; biofilm synthesis inhibitors, such as nonsteroidal anti-inflammatory agents, and chelating agents, such as ethylenediaminetetraacetic acid, O,O'-bis(2- aminoethyl)ethylene glycol-N,N,N',N'-tetraacetic acid and mixtures thereof; antibiotics such as gentamicin, rifampicin, minocycline, and ciprofloxacin; antibodies, including chimeric antibodies and antibody fragments; anesthetics such as lidocaine, bupivacaine, and ropivacaine; nitric oxide; nitric oxide (NO) donors such as linsidomide, molsidomide, L-arginine, NO-carbohydrate adducts, high molecular weight or oligomeric NO adducts; anticoagulants such as D-Phe-Pr o-Arg chloromethyl ketone, complexes containing RGD peptides, heparin, antithrombin compounds (including antithrombin antibodies), platelet receptor antagonists, antiplatelet receptor antibodies, enoxaparin, hirudin, warfarin sodium, dicoumarol, aspirin, prostaglandin inhibitors, platelet aggregation inhibitors such as cilostazol and tick antiplatelet factor; vascular cell growth promoters such as growth factors, transcription activators, and translation promoters; vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, and bifunctional molecules consisting of an antibody and a cytotoxin; cholesterol-lowering agents; vasodilators; agents that block endogenous vasoactive mechanisms; heat shock protein inhibitors such as geldanamycin; angiotensin-converting enzyme (ACE) inhibitors; beta-blockers; beta-AR kinase (βSARK) Inhibitors; phospholamban inhibitors; protein-bound particle drugs, such as ABRAXANE TM ; and any combination and prodrugs of the above.

[0071] Exemplary biomolecules include: peptides, polypeptides, and proteins; oligonucleotides; nucleic acids such as double-stranded or single-stranded DNA (including naked DNA and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), and ribozymes; genes; carbohydrates; angiogenic factors (including growth factors); cell cycle inhibitors; and anti-restenotic agents. Nucleic acids can be incorporated into delivery systems such as vectors (including viral vectors), plasmids, or liposomes.

[0072] Non-limiting examples of proteins include SERCA2 protein, monocyte chemoattractant protein ("MCP-1"), and bone morphogenetic proteins ("BMPs"), such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (VGR-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, and BMP-15. Preferred BMPs are any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, and BMP-7. These BMPs can be provided as homodimers, heterodimers, or combinations thereof, alone or in combination with other molecules. Alternatively or in addition, molecules capable of inducing upstream or downstream effects of BMPs can be provided. Such molecules include any of the "hedgehog" proteins or DNA encoding the "hedgehog" proteins. Non-limiting examples of genes include survival genes that prevent cell death, such as anti-apoptotic Bcl-2 family factors and Akt kinase; the SERCA2 gene; and combinations thereof. Non-limiting examples of angiogenic factors include acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factor α and β, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor α, hepatocyte growth factor, and insulin-like growth factor. A non-limiting example of a cell cycle inhibitor is a cathepsin D (CD) inhibitor. Non-limiting examples of anti-restenotic agents include p15, p16, p18, p19, p21, p2′7, p53, p57, Rb, nFkB, and E2F decoys, thymidine kinase, and combinations thereof, as well as other agents that can be used to inhibit cell proliferation.

[0073] Exemplary small molecules include hormones, nucleotides, amino acids, sugars, and lipids, and compounds with a molecular weight of less than 100 kD.

[0074] Exemplary cells include: stem cells, progenitor cells, endothelial cells, adult cardiomyocytes, and smooth muscle cells. Cells can be of human origin (autologous or allogeneic) or from animal sources (xenogeneic), or genetically engineered. Non-limiting examples of cells include: side population (SP) cells, lineage negative (Lin - ) cells (including Lin - CD34 - 、Lin - CD34 + 、Lin - c Kit + , mesenchymal stem cells (including mesenchymal stem cells induced with 5-azacytidine), umbilical cord blood cells, stem cells derived from cardiac tissue or other tissues, whole bone marrow, bone marrow mononuclear cells, endothelial progenitor cells, skeletal muscle myoblasts or satellite cells, myogenic cells, GO cells, endothelial cells, adult cardiomyocytes, fibroblasts, smooth muscle cells, adult cardiac fibroblasts + 5-azacytidine, genetically modified cells, tissue engineered grafts, MyoD scar fibroblasts, pacemaker cells, embryonic stem cell clones, embryonic stem cells, fetal or neonatal cells, immune shielded cells, and teratoma-derived cells.

[0075] Any therapeutic agents may be combined to the extent that the combination is biocompatible.

[0076] In some cases, coating 314 can be a polymeric coating including any of the above-described therapeutic agents, which can be incorporated into the polymeric coating on selected portions of braided tubular member 100. The polymer of the polymeric coating can be biodegradable or non-biodegradable. Non-limiting examples of suitable non-biodegradable polymers include: polystyrene; polystyrene-maleic anhydride copolymers; polyisobutylene copolymers, such as styrene-isobutylene-styrene block copolymers (SIBS) and styrene-ethylene / butylene-styrene (SEBS) block copolymers; polyvinyl pyrrolidone (including cross-linked polyvinyl pyrrolidone); polyvinyl alcohols, copolymers of vinyl monomers, such as EVA; polyvinyl ethers; polyvinyl aromatic hydrocarbons; polyethylene oxides; polyesters, including polyethylene terephthalate; polyamides; polymethacrylamides, including (methyl methacrylate-butyl acetate-methyl methacrylate) block copolymers; polyethers, including polyethersulfones; polyalkylenes, including polypropylene, polyethylene and high molecular weight polyethylene; polyurethanes; polycarbonates, silicones; siloxane polymers; cellulosic polymers, such as cellulose acetate; polymer dispersions, such as polyurethane dispersions Squalene emulsion; and mixtures and copolymers of any of the foregoing.

[0077] Non-limiting examples of suitable biodegradable polymers include: polycarboxylic acids, polyanhydrides (including maleic anhydride polymers); polyorthoesters; polyamino acids; polyethylene oxide; polyphosphazenes; polylactic acid, polyglycolic acid, and copolymers and mixtures thereof, such as poly (L-lactic acid) (PLLA), poly (D, L-lactide), lactic acid-glycolic acid copolymer, 50 / 50 DL-lactide-glycolide copolymer; polydioxanone; polypropylene fumarate; polyester peptides; polycaprolactone and copolymers and mixtures thereof, such as D, L-lactide- Caprolactone copolymers and caprolactone-butyl acrylate copolymers; polyhydroxybutyrate valerate and blends; polycarbonates, such as tyrosine-derived polycarbonates and acrylates, polyiminocarbonates, and polydimethyltrimethylcarbonate; cyanoacrylates; calcium phosphates; polyglycosaminoglycans; macromolecules, such as polysaccharides (including hyaluronic acid; cellulose, and hydroxypropyl methylcellulose); gelatin; starches; dextran; alginates and their derivatives, proteins, and polypeptides; and mixtures and copolymers of any of the foregoing. The biodegradable polymer may also be a surface-erodible polymer, such as polyhydroxybutyrate and its copolymers, polycaprolactone, polyanhydrides (crystalline and amorphous), maleic anhydride copolymers, and zinc calcium phosphate.

[0078] Such coatings can be formed using any method known to those skilled in the art. For example, an initial polymer / solvent mixture can be formed and the therapeutic agent is then added to the polymer / solvent mixture. Alternatively, the polymer, solvent, and therapeutic agent can be added simultaneously to form the mixture. The polymer / solvent / therapeutic agent mixture can be a dispersion, a suspension, or a solution. The therapeutic agent can also be mixed with the polymer in the absence of a solvent. The therapeutic agent can be dissolved in the polymer / solvent mixture or in the polymer in a true solution with the mixture or polymer, dispersed into fine particles or micronized particles in the mixture or polymer, suspended in the mixture or polymer based on its solubility characteristics, or combined with a micelle-forming compound (such as a surfactant) or adsorbed onto small carrier particles to form a suspension in the mixture or polymer. The coating can contain multiple polymers and / or multiple therapeutic agents.

[0079] Figure 6AAn exemplary cut-away portion 600 of the braided tubular member 100 is shown in an axially elongated state after application of the coating 314 as described above. As shown, the radially outwardly exposed surface portion of the braided wire 102 has been coated with the coating 314. However, the remaining portion of the braided wire 102 and the open cells 152 are uncoated. The uncoated portion includes the radially inner segment 310 of the wire 102 at the intersection 322. Furthermore, as described above, the uncoated length of the radially inner segment 310 can be greater than the diameter of the wire 102 at the radially outer segment 308 at the intersection 322. In some cases, as the braided tubular member 100 is compressed and elongated back and forth between the axially elongated state, the nominally expanded state, and the axially contracted state, the uncoated length of the uncoated radially inner segment 310 can enable the radially outer segment 308 to pivot relative to the radially inner segment 310 at the intersection 322 without the radially outer segment 308 contacting the coating 314 on the coated portion of the braided wire 102. In other words, the radially outer segments 308 can be unencumbered by the coating 314 and can have an unconstrained range of motion as they pivot back and forth between the axially elongated state, the nominally expanded state, and the axially contracted state at the intersection 322. In this way, the coating 314 is not damaged as the radially outer segment 308 pivots relative to the radially inner segment 310 at the intersection 322 when moving between the axially elongated state, the nominally expanded state, and the axially contracted state.

[0080] Figure 6B An exemplary cut-out portion 600 of the braided tubular member 100 is shown in an axially contracted state after application of the coating 314, as described above. Figure 6A , because the coating 314 is applied when the braided tubular member 100 is in either the axially elongated state or the axially contracted state, the length of the uncoated radially inner segment 310 can allow the radially outer segment 308 to pivot at the intersection 322 without contacting the coating 314 on the coated portion of the braided wire 102. Thus, the range of pivotal motion of the radially outer segment 308 at the intersection 322 can be unconstrained as the radially outer segment 308 pivots relative to the radially inner segment 310 at the intersection 322 when moving between the axially elongated state, the nominally deployed state, and the axially contracted state.

[0081] Figure 6C An exemplary cut-out portion 600 of the braided tubular member 100 is shown in a nominally expanded state after application of the coating 314 using the roll coating technique described above. Figure 6A-6BAs depicted in FIG, because the coating 314 is applied while the braided tubular member 100 is in an axially elongated or axially contracted state, the length of the uncoated radially inner segments 310 allows the radially outer segments 308 to pivot at the intersection 322 without contacting the coating 314 on the coated portions of the intersecting braided wires 102 at the intersection 322. As a result of the coating process, each of the plurality of braided wires 102 includes radially outer segments 308 having the coating 312 alternating with a plurality of uncoated radially inner segments 310 along the length of the wire 102. The length of each uncoated radially inner segment 310 and the length of each coated radially outer segment 308 along each wire 102 can be different or equal. For example, the length of each uncoated radially inner segment 310 along each wire 102 can be less than the length of each coated radially outer segment 308.

[0082] Figure 7A Shown is the exemplary cut-out portion 600 of the braided tubular member 100 in axially elongated state after utilizing dot matrix coating technology coating 314.In dot matrix coating technology, can be selectively opened and closed one group (array) coating element by controller.The quantity and position of coating element can be described as the matrix with M possible positions in row and N possible positions (these can be considered to cell together) in column.In some cases, utilize wherein coating 314 with discrete position towards the technology of braided tubular member 100 advancement, coating element can be coated with independent coating point 700 and on the selected portion of braided tubular member 100, form coating 314.Independent coating point 700 is illustrated as being spaced apart from each other, and it is contemplated herein that each coating point 700 can contact or overlap to form coating 314 with each successive coating point 700 of the coated portion along line 102. In some cases, the coating 314 can be transferred from a ribbon filled with the coating 314 to the braided tubular member 100 by causing an element (e.g., a wire) to compress the coated ribbon, thereby transferring the coating 314 from the coated ribbon to the braided tubular member 100. These are just a few of the dot-matrix coating techniques. Exemplary dot-matrix coating techniques are described in European Patent No. EP2045019B1, entitled "Method and Apparatus for Coating Stents," the contents of which are incorporated herein by reference. In other cases, another dot-matrix coating technique known in the art can be used.

[0083] As in Figure 7AAs shown in FIG, coating points 700 have been positioned on radially outwardly exposed surfaces of portions of the braided wire 102. However, other portions of the braided wire 102 and the open cells 152 remain uncoated. The uncoated portions include the radially inner segments 310 of the wire 102, which are covered by the radially outer segments 308 during coating at coating points 700. Furthermore, as described above, the length of the uncoated portion of the wire 102 defining the radially inner segments 310 may be greater than the diameter of the radially outer segments 308 at the intersection 322. In some cases, as the braided tubular member 100 is compressed and elongated back and forth between the axially elongated state, the nominally expanded state, and the axially contracted state, the uncoated length of the radially inner segments 310 may enable the radially outer segments 308 to pivot relative to the radially inner segments 310 at the intersection 322 without contacting the coating 314 on the coated portions of the braided wire 102. In other words, the radially outer segments 308 may be unencumbered by the coating 314 and may have an unconstrained range of motion as they pivot back and forth between the axially elongated state, the nominally deployed state, and the axially contracted state at the intersection 322. Thus, the coating 314 may not be damaged as the radially outer segments 308 pivot relative to the radially inward segments 310 at the intersection 322 when moving between the axially elongated state, the nominally deployed state, and the axially contracted state.

[0084] Figure 7B An exemplary cut-out portion 600 of the braided tubular member 100 is shown in an axially contracted state after application of the coating 314 using the dot matrix coating technique described above. Figure 7A , because the coating point 700 forming the coating 314 is coated when the braided tubular member 100 is in either the axially elongated state or the axially contracted state, the length of the uncoated radially inner segment 310 can allow the radially outer segment 308 to pivot at the intersection 322 without contacting the coating 314 on the coated portion of the braided wire 102. Therefore, when moving between the axially elongated state, the nominally deployed state, and the axially contracted state, as the radially outer segment 308 pivots relative to the radially inner segment 310 at the intersection 322, the range of pivotal motion of the radially outer segment 308 at the intersection 322 can be unconstrained.

[0085] Figure 7C An exemplary cut-out portion 600 of the braided tubular member 100 is shown in a nominally expanded state after application of the coating 314 using the dot matrix coating technique described above. Figures 7A and 7B, because the coating point 700 forming the coating 314 is applied while the braided tubular member 100 is in an axially elongated or axially contracted state, the length of the uncoated radially inner segments 310 allows the radially outer segments 308 to pivot at the intersection 322 without contacting the coating 314 on the coated portion of the intersecting braided wires 102 at the intersection 322. As a result of the coating process, each of the plurality of braided wires 102 includes radially outer segments 308 having the coating 312 alternating with a plurality of uncoated radially inner segments 310 along the length of the wire 102. The length of each uncoated radially inner segment 310 along each wire 102 can be different from or equal to the length of each coated radially outer segment 308. For example, the length of each uncoated radially inner segment 310 along each wire 102 can be less than the length of each coated radially outer segment 308.

[0086] Roll coating techniques and dot-matrix coating techniques are just a few coating techniques that can be used to apply a coating to a braided tubular member (e.g., braided tubular member 100) in an axially elongated or axially contracted state, thereby causing radially outer segments 308 comprising coating 312 to intersect with radially inner segments 310 that are uncoated along the length and around the circumference of the braided tubular member 100 at intersection points 322. Thus, the coated stent 10 can be comprised of a plurality of interwoven strands 102, wherein each interwoven strand 102 includes radially outer segments 308 comprising coating 312 that alternate with a plurality of radially inner segments 310 that are uncoated along the length of the strand 102. In some cases, other techniques known in the art or combinations of coating techniques can be employed.

[0087] Figures 8A to 8D Exemplary braid patterns are shown for stents that may have braided tubular members for application of coatings as described herein. Figures 8A to 8D The stent shown in is shown in the nominal deployed state. Figure 8A , a braided tubular member 800 is illustrated having a braid pattern using paired wires (wire pairs) 802 that intersect to define open cells 812 therebetween. The braided tubular member 800 is relatively symmetrical, and the axial displacement of the wire pairs 802 is relatively symmetrical. As described above, the wire pairs 802 can be identical or different (e.g., made of different materials).

[0088] Steering Figure 8B, the braided tubular member 804 is illustrated having a braid pattern with open cells 820 defined between intersection lines 806. The braided wires 806 are also relatively asymmetrically displaced axially, thereby providing a variety of sizes of open cells 820. The braided wires 806 can be the same or can be different (e.g., can have the same or different structural sizes, shapes, and / or materials).

[0089] Steering Figure 8C , the braided tubular member 808 is shown having another braid pattern. The braided tubular member 808 may be constructed similarly to the braided tubular member 800 ( Figure 8A ), however, the open chamber 810 may have a similar configuration to the open chamber 812 (shown in FIG. Figure 8A This is because the wire pair 814 is wound more tightly than the wire pair 802.

[0090] Steering Figure 8D , the braided tubular member 816 is shown having another braid pattern. The braided tubular member 816 can be constructed similarly to the braided tubular member 804 ( Figure 8B ), however, the open chamber 818 may have a similar configuration to the open chamber 820 (shown in FIG. Figure 8B This is because the braided wire 822 is more tightly wound than the braided wire 806.

[0091] Figure 9Shown is an illustrative flow chart of a method 900 for selectively coating an expandable stent. In an example, the braided tubular member of the stent can be in a nominal expanded state, and method 900 can begin at step 902, wherein an axial force can be applied to the braided tubular member so as to change the axial length of the braided tubular member from the nominal expanded state. The length after the change of the braided tubular member can be less than or greater than the length of the braided tubular member in the nominal expanded state. As described in this article, the braided tubular member can have a line that is woven and forms a radially outer line segment, and these radially outer line segments are located at the radially outer side of the radially inner line segment along the braided tubular member and around the intersection of the braided tubular member. In addition, these lines can cross each other at the intersection many times. These intersections can also play the role of pivot points, and wherein at each intersection, the radially outer line segment can pivot relative to the radially inner line segment that intersects. For example, when applying axial force, the line can pivot around the pivot point and change the pivot angle between the intersecting line segments. In some cases, the pivot angle can be a measured angle relative to the longitudinal axis (or a line segment parallel to the longitudinal axis) of the braided tubular member. In some instances, the axial force can be a compressive force 904 applied to the braided tubular member. When the compressive force is applied, the pivot angle increases, the diameter of the braided tubular member increases, and the length of the braided tubular member decreases, thereby changing the braided tubular member from a nominal expanded state to a radially contracted state. In some instances, the axial force can be a tensile force 906 applied to the braided tubular member. When the tensile force is applied, the pivot angle decreases, the diameter of the braided tubular member decreases, and the length of the braided tubular member increases, thereby changing the braided tubular member from a nominal expanded state to an axially elongated state.

[0092] Once the braided tubular member is in an axially contracted state or an axially elongated state, the coating can be applied to the braided tubular member in step 906. In some instances, a roller coating technique 908 can be utilized to apply the coating. In some instances, a dot matrix coating technique 910 can be utilized to apply the coating. In some instances, a spraying technique 912 can be utilized to apply the coating. In some instances, other coating techniques 914 can be adopted, such as electrospinning technology. When applying the coating, some parts of the braided wire can be coated with the coating while the other parts of the braided wire are in an uncoated state. The uncoated portion can be the radially inner segment at the intersection. In addition, the uncoated length of the radially inner segment that crosses below the radially outer segment at the intersection can be greater than the diameter of the radially outer segment at the intersection, thereby allowing the radially outer segment to pivot at the intersection and not contact the coating on the coated portion of the braided wire at the intersection. As a result of the coating process, each braided wire of the plurality of braided wires includes radially outer wire segments having the coating that alternate along the length of the wire with a plurality of radially inner wire segments that are uncoated.

[0093] At step 916, it may be determined whether the braided tubular member has been adequately coated. If it is determined that the braided tubular member has not been adequately coated, step 906 may be repeated. If it is determined that the braided tubular member has been adequately coated, the method 900 may end.

[0094] It should be understood that this disclosure is in many respects illustrative only. Changes may be made in the details, particularly in shape, size, and arrangement of steps, without departing from the scope of this disclosure. This may include, to the extent appropriate, incorporating any feature of one exemplary embodiment into other embodiments. The scope of the present invention is, of course, defined by the terms in which the appended claims are expressed.

Claims

1. An implantable stent comprising: a braided tubular member comprised of a plurality of braided wires, the braided tubular member including a plurality of radially outer wire segments that cross over and radially outward of a plurality of radially inner wire segments at a plurality of intersection points; The radially outer segment is coated with a coating, and the radially inner segment includes an uncoated length without a coating at the intersection, the uncoated length being at least an overlapping length where the radially inner segment contacts the radially outer segment when the braided tubular member is in a radially compressed state, wherein the overlapping length when the braided tubular member is in a radially expanded state is less than the overlapping length when it is in a radially compressed state. 2 . The implantable stent according to claim 1 , wherein the uncovered length is greater than an overlapping length of the radially inner segment in contact with the radially outer segment when the braided tubular member is in a radially compressed state.

3. The implantable stent according to claim 1 or 2, wherein the radially outer segment is configured to pivot relative to the radially inner segment at the intersection as the braided tubular member is radially expanded and radially contracted. 4 . The implantable stent according to claim 1 , wherein each braid of the plurality of braids comprises radially outer segments alternating with radially inner segments.

5. The implantable stent of claim 1 or 2, wherein the plurality of braided wires define open cells therebetween, wherein the coating does not extend across the open cells between adjacent wires. 6 . The implantable stent according to claim 1 , wherein at the intersection, the uncovered length of the radially inner segment is greater than the diameter of the radially outer segment.

7. The implantable stent according to claim 1 or 2, wherein the plurality of intersections remain in a constant position along the length of the braided wire.

8. The implantable stent according to claim 1 or 2, wherein said braided tubular member is radially compressible from said radially expanded state to a radially contracted state; and wherein a length by which the radially inner segment contacts the radially outer segment at the intersection in the radially contracted state is greater than a length by which the radially inner segment contacts the radially outer segment at the intersection when the braided tubular member is in the radially expanded state.

9. The implantable stent of claim 8, wherein the radially contracted state is determined based on a pivot angle between adjacent line segments at the intersection.

10. The implantable stent according to the preceding claim 9, wherein the pivot angle has a value between 0 and 45 degrees.

11. The implantable stent of claim 1 or 2, wherein the uncovered length has a coating that extends only partially around the circumference of the radially inner segment at the intersection.

12. A method of selectively coating portions of an expandable stent, comprising: applying an axial force to a braided tubular member to change the axial length of the braided tubular member from a length of the braided tubular member in a nominally expanded state, wherein the braided tubular member includes a radially outer segment that intersects above and radially outward of a radially inner segment of the braided tubular member at a plurality of intersection points; wherein applying the axial force changes the angle between the radially outer segment and the radially inner segment of the braided tubular member at the intersection, wherein an overlap length of contact between the radially inner segment and the radially outer segment when the braided tubular member is in an expanded state is less than an overlap length when the braided tubular member is in a compressed state; Thereafter, a coating is applied to the radially outer segments while avoiding coating the radially inner segments at the intersection points. 13 . The method of claim 12 , wherein the uncovered length of the radially inner segment is greater than the length at which the radially inner segment contacts the radially outer segment at the intersection when in the nominal deployed state.

14. The method of claim 12 or 13, wherein the braided tubular member comprises a plurality of braided wires, wherein each braided wire of the plurality of braided wires comprises radially outer wire segments alternating with radially inner wire segments. 15 . The method according to claim 14 , wherein the coating is applied when the angle has a value between 5° and 45° or between 150° and 175°.

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