Stent delivery device and method of manufacturing the same

Abstract

An improved stent delivery device is configured to have radiopaque characteristics without sacrificing the structural integrity or functionality of the device itself. In at least one embodiment, the stent delivery device provides a plurality of individual strands that are woven together to form a self-expanding stent delivery structure having a proximal end and an opposing distal end, the delivery structure forming an elongated initial shape capable of being inserted into a catheter. At least one radiopaque marker is coaxially disposed within and secured to a circumferential inner surface of the delivery structure. Thus, the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

Description

[0001] Related applications

[0002] not applicable. Technical Field

[0003] The subject matter of this patent application relates generally to stents and, more particularly, to an improved stent delivery device and related methods of manufacture. Background Art

[0004] Applicants incorporate by reference any and all patents and published patent applications cited or mentioned in this application.

[0005] As background, stents are tubular devices that are delivered to a patient's vascular system via a catheter or similar delivery device for the treatment of a variety of conditions, including stenosis and aneurysms. Stent delivery is typically simple when the stent is deployed in a generally straight portion of a vessel. For example, the distal end of the delivery catheter is advanced to the vicinity of the desired delivery location, and the outer sheath is withdrawn, allowing the stent to expand within the vessel. However, even in the case of these straight vessels, stent delivery remains challenging due to variables such as stent size, delivery catheter size, and vessel size. Typically, self-expanding stents can be difficult to deploy correctly when the stent must be deployed near or at a twisted or severely curved portion of a vessel.

[0006] To aid in accurate stent placement, it is useful to visualize the stent as it is passed through the vessel. Figure 1 As shown, some prior art stent delivery devices 20 include one or more radiopaque marker bands 22 disposed circumferentially around an outer surface 24 of the stent delivery device 20. As used herein, the term "radiopaque" is used in its standard meaning of being radiopaque, i.e., formed from one or more materials (e.g., platinum, chromium, cobalt, tantalum, tungsten, nitinol, gold, silver, stainless steel, or alloys thereof) that inhibit the passage of electromagnetic radiation and thereby increase visibility during imaging. However, because such prior art marker bands 22 are disposed circumferentially around the outer surface 24 of the stent delivery device 20, the stent delivery device 20 has a relatively large outer diameter at the location of each marker band 22. Furthermore, each opposing end 26 of each marker band 22 (i.e., the location where the diameter of the stent delivery device 20 changes due to the marker band 22) forms a rigid shoulder that may catch on a deployed stent, catheter, vessel, or other component when the stent delivery device 20 is pushed or pulled. Another disadvantage of the prior art marker band 22 disposed circumferentially about the outer surface 24 of the stent delivery device 20 is that such an arrangement limits the potential shapes and configurations of the marker band 22 .

[0007] Therefore, there remains a need for an improved stent delivery device having radiopaque properties without sacrificing the structural integrity or functionality of the stent delivery system and the stent itself. Aspects of the present invention satisfy these needs and provide other related advantages as described in the following summary of the invention.

[0008] It should be noted that the above background description includes information that may be helpful in understanding various aspects of the present invention. This does not constitute an admission that any information provided herein is prior art or relevant to the presently claimed invention, nor does it constitute an admission that any publication explicitly or implicitly referenced herein is prior art. Summary of the Invention

[0009] Various aspects of the present invention provide certain advantages in construction and use, resulting in the exemplary advantages described below.

[0010] The present invention solves the aforementioned problems by providing an improved stent delivery device configured to have radiopaque properties without sacrificing the structural integrity or functionality of the device itself. In at least one embodiment, the stent delivery device provides a plurality of individual strands braided together to form a self-expanding stent delivery structure having a proximal end and an opposing distal end, the delivery structure forming an elongated initial shape capable of insertion into a catheter. At least one radiopaque marker is coaxially disposed within and secured to a circumferential inner surface of the delivery structure. Thus, the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

[0011] Other features and advantages of various aspects of the invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of various aspects of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings illustrate various aspects of the present invention. In these drawings:

[0013] Figure 1 is a partial side view of an exemplary prior art stent delivery device;

[0014] Figure 2 is a partial side view of an exemplary improved stent delivery device according to at least one embodiment;

[0015] Figure 3 is an end view according to at least one embodiment;

[0016] Figure 4 is a partial side view of another exemplary improved stent delivery device according to at least one embodiment;

[0017] Figure 5 isFigure 4 detail view of the portion defined by line 5 in

[0018] Figure 6 is a perspective view according to at least one embodiment;

[0019] Figure 7 is an end view according to at least one embodiment;

[0020] Figure 8 is a perspective view of another exemplary stent delivery device according to at least one embodiment; Figure 4 is another partial side view of the stent delivery device in

[0021] Figure 9 is a partial side view of yet another exemplary stent delivery device according to at least one embodiment, wherein the delivery structure of the device is omitted for illustrative purposes;

[0022] Figure 10 is an end view according to at least one embodiment; and

[0023] Figure 11 and Figure 12 is a perspective view of other exemplary markers according to at least one embodiment.

[0024] The above figures show various aspects of the present application in at least one of its exemplary embodiments, which will be further defined in the following description, according to one or more embodiments. According to one or more embodiments, features, elements and aspects of the present application indicated by the same reference numbers in different figures represent the same, equivalent or similar features, elements or aspects. DETAILED DESCRIPTION

[0025] Turning now to Figure 2 wherein a partial side view of one exemplary embodiment of an improved stent delivery device 30 is shown. In at least one embodiment, the device 30 provides a plurality of individual strands 32 that are woven together to form a self-expanding stent delivery structure 34 having an elongated initial shape (as shown in Figure 4134,954, the contents of which are incorporated herein by reference. In at least one embodiment, the end caps are constructed of one or more radiopaque materials to facilitate positioning of the delivery structure 34 at a desired location within a blood vessel or at another target area within the patient's vascular system (hereinafter generally referred to as the "target site" for simplicity). In at least one alternative embodiment, one or both of the proximal and distal ends of the delivery structure 34 are simply closed, sealed, or otherwise terminated to maintain the braided arrangement of the strands 32.

[0026] In at least one embodiment, given that the delivery structure 34 is comprised of multiple strands 32 braided together, the properties of the delivery structure 34 can be selectively adjusted to suit the requirements of the medical procedure in which the device 30 will be used. For example, in at least one embodiment, one or more individual strands 32 can be comprised of a different material than the other strands 32 of the delivery structure 34. In at least one such embodiment, at least one strand 32 is comprised of one or more radiopaque materials, while the remaining strands 32 are comprised of one or more non-radiopaque materials (e.g., fibers, plastics, polymers, multi-layer composites, or other biocompatible materials). In this way, the radiopacity of the delivery structure 34 can be selectively adjusted (by including fewer or more radiopaque strands 32) while also maintaining the necessary structural integrity to maintain the desired shape, as discussed further below. In at least one further embodiment, one or more individual strands 32 can be comprised of both radiopaque and non-radiopaque materials. In at least one further embodiment, one or more individual strands 32 can be comprised of a drawn filler tube bi-material or composite bimetal. Those skilled in the art will appreciate that other suitable biocompatible materials may be used, provided they possess suitable mechanical properties. It should also be noted that the specific braid patterns shown in the accompanying drawings are exemplary only and are shown and described for illustrative purposes only. In further embodiments, the strands 32 of the delivery structure 34 may be braided using any braid, knit, or weave pattern currently known or later developed (for simplicity, the terms "braid" and "woven" as used herein are intended to include all patterns), including but not limited to 1-upper-1-lower-1, 1-upper-2-lower-2, 2-upper-2-lower-2, etc., so long as the device 30 is capable of substantially achieving the functions described herein. Furthermore, the braid density and braid gaps depicted in the accompanying drawings are also exemplary only. In further embodiments, the delivery structure 34 may employ any other braid density, and any braid gaps may employ any other size, shape, number, dimension, or pattern currently known or later developed, so long as the device 30 is capable of substantially achieving the functions described herein. Similarly, the strands 32 themselves can each have any other size, number, or dimensions currently known or developed in the future, so long as the device 30 can substantially function as described herein. For example, in at least one embodiment, one or more strands 32 can have a cross-section that is circular, flat, square, hexagonal, oval, ribbon-like, hollow / tubular, or the like.

[0027] In at least one embodiment, the elongated initial shape of the delivery structure 34 is suitable for insertion into the vascular system via a catheter with minimal discomfort to the patient. In at least one such embodiment, when in the initial shape, the delivery structure 34 has the shape of an elongated bundle of braided strands 32, as described above. Once the delivery structure 34 reaches the target site, with the stent (not shown) still coaxially disposed on the outer surface 52 of the delivery structure 34, the delivery structure 34 expands to a predetermined secondary shape (at Figure 8 Thus, the size, shape and dimensions of each of the primary and secondary shapes depicted in the figures are merely exemplary and are shown for illustrative purposes.

[0028] In at least one embodiment, Figure 2 and Figure 3 As best shown in FIG, the device 30 provides at least one radiopaque marker 36 coaxially disposed within the delivery structure 34. In at least one such embodiment, the device 30 provides a plurality of markers 36 coaxially disposed within the delivery structure 34 and longitudinally spaced apart from one another along the length of the delivery structure 34. In at least one embodiment, each of the at least one marker 36 is affixed to a circumferential inner surface 38 of the delivery structure 34. Thus, in at least one such embodiment, the outer diameter 40 of the at least one marker 36 is relatively smaller than the initial inner diameter 42 of the delivery structure 34 (i.e., the inner diameter of the delivery structure 34 when the delivery structure 34 is in its elongated initial shape, e.g., as shown in FIG. Figure 4 ). In at least one embodiment, the outer diameter 40 of the at least one marker 36 is proximate to the initial inner diameter 42 of the delivery structure 34. In at least one embodiment, the circumferential outer surface 44 of the at least one marker 36 is permanently affixed to the inner surface 38 of the delivery structure 34 using welding, adhesives, or any other material or technique (now known or later developed) capable of forming a permanent bond between the outer surface 44 of the at least one marker 36 and the inner surface 38 of the delivery structure 34. Thus, with the at least one marker 36 disposed within the delivery structure 34, the initial outer diameter 46 of the delivery structure 34 (i.e., the outer diameter of the delivery structure 34 when the delivery structure 34 is in its elongated initial shape, e.g., Figure 4 ) remains constant such that initial outer diameter 46 is substantially uniform along the entire length of delivery structure 34. In other words, unlike the known prior art stent 20 described above, the at least one internally disposed marker 36 does not form any rigid outer edge or shoulder that could snag a deployed stent, catheter, vessel, or other component when delivery structure 34 is pushed or pulled.

[0029] In at least one embodiment, the at least one marker 36 is comprised of one or more radiopaque materials to facilitate positioning the delivery structure 34 at a desired location within a blood vessel relative to a target site. In at least one such embodiment, the at least one marker 36 is comprised of a tungsten-loaded polymer. In further embodiments, the at least one marker 36 can be comprised of platinum, chromium, cobalt, tantalum, nitinol, gold, silver, bismuth subcarbonate, barium sulfate, bismuth oxychloride, bismuth trioxide, stainless steel, or alloys thereof, or any other radiopaque material (or combination of materials) currently known or later developed. In at least one alternative embodiment, the at least one marker 36 is comprised of one or more non-radiopaque materials, wherein an adhesive material (e.g., glue or epoxy) containing a radiopaque material is used instead to permanently secure the at least one marker 36 to the inner surface 38 of the delivery structure 34. Therefore, as used herein, the term "radiopaque marker" is intended to include embodiments in which the at least one marker 36 itself is comprised of one or more radiopaque materials, as well as embodiments in which the at least one marker 36 itself is comprised of a non-radiopaque material, but the adhesive used to secure the at least one marker 36 to the inner surface of the delivery structure 34 contains a radiopaque material. In at least one embodiment, at least one marker 36 is substantially tubular in structure (i.e., hollow). In at least one such embodiment, Figure 3 As best shown in FIG, at least one marker 36 has a substantially cylindrical shape. In at least one such alternative embodiment, as Figure 9 and Figure 10 As best shown in FIG, at least one marker 36 has a substantially coil / spiral shape, thereby increasing the flexibility of the at least one marker 36. In at least one such embodiment, as Figure 9 As best shown in FIG, where the at least one marker 36 is substantially tubular in structure, the device 30 further provides at least one elongated guide wire 48 coaxially disposed and extending longitudinally from within the at least one marker 36 and the delivery structure 34. In at least one alternative embodiment, as Figure 11 and Figure 12 As best shown in FIG. 1 , at least one marker 36 is solid (i.e., not substantially tubular in structure). In further embodiments, the at least one marker 36 can take on any other size, shape, dimensions, configuration, number, and / or relative position now known or later developed (depending at least in part on the specific environment in which the device 30 will be used), so long as the device 30 is capable of substantially performing the functions described herein. In at least one embodiment, when the device 30 provides a plurality of markers 36, each marker 36 has the same size, shape, and dimensions. In at least one alternative embodiment, when the device 30 provides a plurality of markers 36, one or more markers 36 can have different sizes, shapes, and / or dimensions.

[0030] In at least one embodiment, Figures 4 to 8 As best shown in FIG. 1 , the device 30 further provides at least one substantially tubular protective outer barrier 50 circumferentially engaged about an outer surface 52 of the delivery structure 34 at substantially the same location as the at least one marker 36, such that the at least one outer barrier 50, the delivery structure 34, and the at least one marker 36 are concentrically disposed. In at least one such embodiment, the at least one outer barrier 50 has a barrier length L1 ( Figure 5 ), which is greater than or equal to the corresponding at least one mark 36 ( Figure 2 ) of the marking length L2 such that the at least one outer barrier 50 substantially covers the markings 36 (and the corresponding length of the transport structure 34 sandwiched therebetween). In at least one alternative embodiment, the barrier length L1 of the at least one outer barrier 50 is less than the marking length L2 of the corresponding at least one marking 36. In at least one embodiment, the at least one outer barrier 50 is permanently affixed to the outer surface 52 of the transport structure 34 using welding, adhesives, or any other material or technique (now known or later developed) capable of forming a permanent bond between the at least one outer barrier 50 and the outer surface 52 of the transport structure 34. In at least one embodiment, the at least one outer barrier 50 is constructed of a heat shrink material (e.g., PET or PEBAX). However, in further embodiments, the at least one outer barrier 50 can be constructed of any other material (or combination of materials) now known or later developed (depending at least in part on the specific environment in which the device 30 will be used), so long as the device 30 is capable of substantially performing the functions described herein. In at least one embodiment, the opposing barrier ends 54 of the at least one outer barrier 50 are tapered to help prevent the device 30 from snagging on a catheter, blood vessel, or other components when the delivery structure 34 is pushed or pulled, which could damage the components or even the delivery structure 34 itself. In further embodiments, the at least one outer barrier 50 can take on any other size, shape, dimensions, configuration, number, and / or relative position now known or later developed (depending at least in part on the specific environment in which the device 30 will be used), so long as the device 30 is able to substantially perform the functions described herein.

[0031] In at least one embodiment, the device 30 is manufactured by temporarily placing at least one marker 36 on an elongated support wire and then coaxially moving the at least one marker 36 (via the support wire) through the delivery structure 34 until the at least one marker 36 is in the desired position within the delivery structure 34. The outer surface 44 of the at least one marker 36 is then affixed to the inner surface 38 of the stent delivery structure 34 as described above, and the support wire is detached from the marker 36. In at least one alternative embodiment, the support wire is left in place and affixed to the marker 36 using welding, adhesive, or any other material or technique (now known or later developed) capable of forming a bond between the support wire and the marker 36. In at least one embodiment, an outer barrier 50 is then positioned over the at least one marker 36 and the corresponding length of the delivery structure 34 and then affixed to the outer surface 52 of the delivery structure 34 as described above. In at least one embodiment, these steps are repeated for each of the at least one marker 36. In at least one alternative embodiment, when the device 30 provides a plurality of markers 36, two or more of the markers 36 are simultaneously provided on the support wire at a desired distance from one another (based on the distance the markers 36 will be spaced apart when engaged with the delivery structure 34), thereby allowing the above steps to be performed simultaneously for a plurality of markers 36. In further alternative embodiments, any other method for manufacturing the device 30 (either currently known or developed in the future) may be employed, so long as the device 30 is capable of substantially performing the functions described herein.

[0032] Aspects of this specification may also be described as follows:

[0033] 1. A stent delivery device comprising: a plurality of individual strands braided together to form a self-expanding stent delivery structure having a proximal end and an opposite distal end, the delivery structure forming an elongated initial shape capable of being inserted into a catheter; and at least one radiopaque marker coaxially disposed within and secured to a circumferential inner surface of the delivery structure; whereby the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

[0034] 2. The stent delivery device according to embodiment 1, wherein the proximal end of the delivery structure can be removably engaged with the delivery mechanism for selectively moving the delivery structure through the catheter.

[0035] 3. The stent delivery device according to embodiments 1-2, wherein an end cap is provided at the distal end of the delivery structure for maintaining the braided arrangement of the strands of the delivery structure.

[0036] 4. The stent delivery device of embodiments 1-3, wherein the end cap is comprised of at least one radiopaque material.

[0037] 5. The stent delivery device of embodiments 1-4, wherein at least one of the strands of the delivery structure is composed of at least one material that is different from the other strands of the delivery structure.

[0038] 6. The stent delivery device of embodiments 1-5, wherein at least one of the strands of the delivery structure is comprised of at least one radiopaque material.

[0039] 7. The stent delivery device of embodiments 1-6, wherein at least one of the strands of the delivery structure is comprised of at least one non-radiopaque material.

[0040] 8. The stent delivery device of embodiments 1-7, wherein at least one of the strands of the delivery structure is comprised of a radiopaque material and a non-radiopaque material.

[0041] 9. The stent delivery device according to embodiments 1-8 further includes: a plurality of markers coaxially arranged within the delivery structure and longitudinally spaced apart from each other along the length of the delivery structure.

[0042] 10. The stent delivery device of embodiments 1-9, wherein the outer diameter of at least one marker is relatively smaller than the initial inner diameter of the delivery structure.

[0043] 11. The stent delivery device of embodiments 1-10, wherein the outer diameter of at least one marker is close to the initial inner diameter of the delivery structure.

[0044] 12. The stent delivery device of embodiments 1-11, wherein the circumferential outer surface of at least one marker is permanently affixed to the inner surface of the delivery structure.

[0045] 13. The stent delivery device of embodiments 1-12, wherein at least one marker is comprised of at least one radiopaque material.

[0046] 14. The stent delivery device of embodiments 1-13, wherein at least one marker is substantially tubular in structure.

[0047] 15. The stent delivery device of embodiments 1-14, wherein at least one marker has a substantially cylindrical shape.

[0048] 16. The stent delivery device of embodiments 1-15, wherein at least one marker has a substantially coil-shaped shape.

[0049] 17. The stent delivery device according to embodiments 1-16 further includes: at least one slender guide wire, coaxially arranged and extending longitudinally from the interior through at least one marker and delivery structure.

[0050] 18. The stent delivery device of embodiments 1-17, wherein at least one marker is non-tubular in structure.

[0051] 19. The stent delivery device according to embodiments 1-18 further includes: at least one substantially tubular protective outer barrier, which is circumferentially engaged around the outer surface of the delivery structure at substantially the same position as the at least one marker, so that the at least one outer barrier, the delivery structure and the at least one marker are concentrically arranged.

[0052] 20. The stent delivery device of embodiments 1-19, wherein each of at least one outer barrier has a barrier length greater than or equal to a marking length of a corresponding at least one marking on which the outer barrier is located, such that the outer barrier substantially covers the marking.

[0053] 21. The stent delivery device of embodiments 1-20, wherein at least one outer barrier is permanently affixed to an outer surface of the delivery structure.

[0054] 22. The stent delivery device of embodiments 1-21, wherein at least one outer barrier is comprised of a heat shrink material.

[0055] 23. The stent delivery device of embodiments 1-22, wherein opposite ends of at least one outer barrier are tapered.

[0056] 24. A stent delivery device comprising: a plurality of individual strands braided together to form a self-expanding stent delivery structure having a proximal end and an opposite distal end, the delivery structure forming an elongated initial shape capable of being inserted into a catheter; and at least one substantially coil-shaped radiopaque marker coaxially disposed within the delivery structure, the at least one marker having a circumferential outer surface that is permanently affixed to a circumferential inner surface of the delivery structure; whereby the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

[0057] 25. A stent delivery device comprising: a plurality of individual strands braided together to form a self-expanding delivery structure having a proximal end and a relative distal end, the delivery structure forming an elongated initial shape capable of being inserted into a catheter; at least one radiopaque marker coaxially disposed within and secured to a circumferential inner surface of the delivery structure; and at least one substantially tubular protective outer barrier circumferentially engaged around the outer surface of the delivery structure at substantially the same position as the at least one marker, such that the at least one outer barrier, the delivery structure, and the at least one marker are concentrically disposed; whereby the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

[0058] Finally, with respect to the exemplary embodiments of the present invention as shown and described herein, it will be appreciated that an improved stent delivery device and related methods of manufacture are disclosed that are constructed to have radiopaque properties without sacrificing the structural integrity or functionality of the device itself. Because the principles of the present invention can be practiced in a variety of configurations other than those shown and described, it will be understood that the present invention is not limited in any way to the exemplary embodiments, but is generally directed to stent delivery devices and is capable of taking a variety of forms without departing from the spirit and scope of the present invention. It will also be appreciated by those skilled in the art that the present invention is not limited to the specific geometries and materials of construction disclosed, but rather that other functionally equivalent structures or materials, now known or developed in the future, may be substituted without departing from the spirit and scope of the present invention.

[0059] Certain embodiments of the present invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations of these described embodiments will become apparent to those of ordinary skill in the art upon reading the above description. The inventors anticipate that a skilled person will appropriately employ such variations, and the inventors intend that the present invention be implemented in a manner other than as specifically described herein. Therefore, the present invention includes all variations and equivalents of the subject matter described in the appended claims as permitted by applicable law. In addition, the present invention encompasses any combination of the above-described embodiments in all their possible variations, unless otherwise indicated herein or clearly contradicted by the context.

[0060] The grouping of alternative embodiments, elements or steps of the present invention should not be construed as limiting. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is contemplated that, for reasons of convenience and / or patentability, one or more members of a group may be included in or deleted from the group. When any such inclusion or deletion occurs, the present specification is deemed to include the group as modified, thereby satisfying the written description of all Markush groups used in the appended claims.

[0061] Unless otherwise indicated, all numbers used in this specification and claims to represent features, items, quantities, parameters, characteristics, terms, etc. should be understood as being modified by the terms "about" and "approximately" in all cases. As used herein, the terms "about" and "approximately" mean that the defined feature, item, quantity, parameter, characteristic, or term covers a range of plus or minus ten percent above and below the value of the feature, item, quantity, parameter, characteristic, or term. Therefore, unless otherwise indicated, the numerical parameters set forth in this specification and the appended claims are approximate values ​​that may vary. At the very least, and without attempting to limit the application of the doctrine of equivalents within the scope of the claims, each numerical indication should at least be interpreted in light of the number of reported significant digits and by applying ordinary rounding techniques. Although the numerical ranges and values ​​setting forth the broad scope of the present invention are approximate, the numerical ranges and values ​​set forth in the specific examples should be reported as precisely as possible. However, any numerical range or value inherently contains certain errors, which are inevitably caused by the standard deviation in their corresponding test measurements. The description of numerical ranges herein is intended merely as a shorthand method for individually referring to each individual value falling within that range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into this specification as if it were individually recited herein. Similarly, as used herein, unless indicated to the contrary, the term "substantially" is a term of degree intended to indicate the degree of approximation of the defined feature, item, quantity, parameter, characteristic, or term, encompassing a range that can be understood and interpreted by one of ordinary skill in the art, or at least encompassing a range of plus or minus ten percent above and below the value of the feature, item, quantity, parameter, characteristic, or term.

[0062] The terms "may" or "can" used with respect to an embodiment or an aspect of an embodiment also carry the alternative meanings of "may not" or "cannot." Thus, if this specification discloses that an embodiment or an aspect of an embodiment may or can be included as part of the present subject matter, a negative limitation or exclusive proviso is also expressly intended to mean that an embodiment or an aspect of an embodiment may not or cannot be included as part of the present subject matter. In a similar manner, the term "optionally" used with respect to an embodiment or an aspect of an embodiment means that the embodiment or aspect of the embodiment may or may not be included as part of the present subject matter. Whether such a negative limitation or exclusive proviso applies will depend on whether the negative limitation or exclusive proviso is recited in the claimed subject matter.

[0063] There is no quantifier before the element used in the context of describing the present invention (especially in the context of the appended claims) and should be interpreted as including both singular and plural forms, unless otherwise specified in this article or there is obvious contradiction in the context. In addition, the ordinal designator (such as "first", "second", "third", etc.) for identifying the element is used to distinguish the elements, but does not indicate or imply the required or limited quantity of these elements, nor does it indicate the specific position or order of these elements, unless otherwise specified. Unless otherwise specified herein or there is obvious contradiction with the context, all methods described herein can be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (such as, "such as") provided herein is only to better illustrate the present invention, and is not intended to limit the scope of the present invention. Any language in this manual should not be interpreted as representing any unclaimed element that is essential to the implementation of the present invention.

[0064] When used in a claim, whether as filed or added by amendment, the open transition term "comprising" (and its equivalent open transition phrases such as "including," "containing," and "having") encompasses all expressly recited elements, limitations, steps, and / or features, either alone or in combination with unrecited subject matter; the named elements, limitations, and / or features are required, but other unnamed elements, limitations, and / or features may be added and still form a structure within the scope of the claim. The closed transition phrases "consisting of" or "consisting essentially of" may be used in the claim in place of "comprising" or as an amendment to "comprising" to further limit the specific embodiments disclosed herein. When used in a claim, whether as filed or added by amendment, the closed transition phrase "consisting of" excludes any element, limitation, step, or feature not expressly recited in the claim. The closed transition phrase “consisting essentially of” limits the scope of a claim to the explicitly enumerated elements, limitations, steps, and / or features and any other elements, limitations, steps, and / or features that do not materially affect one or more of the basic and novel characteristics of the claimed subject matter. Thus, the open transition phrase “comprising” is defined to include all of the specifically enumerated elements, limitations, steps, and / or features and any optional additional unspecified elements, limitations, steps, and / or features. The closed transition phrase “comprising” is defined to include only those elements, limitations, steps, and / or features that are specifically enumerated in the claim, while the closed transition phrase “consisting essentially of” is defined to include only those elements, limitations, steps, and / or features that are specifically enumerated in the claim and any other elements, limitations, steps, and / or features that do not materially affect one or more of the basic and novel characteristics of the claimed subject matter. Thus, as a limitation, the open transition phrase “comprising” (and its equivalent open transition phrases) includes within its meaning the claimed subject matter specified by the closed transition phrase “consisting of” or “consisting essentially of.” Thus, with respect to the phrases "consisting essentially of and "consisting of," the embodiments described herein or claimed with the phrase "comprising" are expressly or fundamentally described, enabled, and supported herein.

[0065] Any claim intended to be invoked under 35 U.S.C. § 112(f) will begin with the words "a means / method for...", but use of the term "for" in any other context is not intended to invoke a discussion under 35 U.S.C. § 112(f). Accordingly, applicants reserve the right to pursue additional claims in this or a continuation application after the filing of this application.

[0066] It should be understood that any method disclosed herein and the order of executing the various elements of any such method are merely exemplary. Depending on the implementation, they can be executed in any order or in parallel, unless otherwise specified in the present invention.

[0067] The entire contents of all patents, patent publications and other publications cited and identified in this specification are individually and expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the compositions and methods described in these publications that can be used in conjunction with the present invention. These publications are provided solely for the purpose of disclosing them prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to advance such disclosure due to prior invention or for any other reason. All statements about dates or statements about the contents of these documents are based on information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

[0068] While the various aspects of the present invention have been described in conjunction with at least one exemplary embodiment, it should be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention should be construed solely in conjunction with the appended claims, and it is expressly intended that the inventors believe that the claimed subject matter is the present invention.

Claims

1. A stent delivery device, comprising: a plurality of individual strands braided together to form a self-expanding stent delivery structure having a proximal end and an opposite distal end, the delivery structure forming an elongated initial shape capable of insertion into a catheter; as well as at least one radiopaque marker coaxially disposed within the delivery structure, the at least one radiopaque marker having a circumferential outer surface secured to a circumferential inner surface of the delivery structure; at least one protective outer barrier circumferentially engaged about an outer surface of the delivery structure at substantially the same location as the at least one radiopaque marker such that the at least one outer barrier, the delivery structure, and the at least one radiopaque marker are concentrically disposed; the protective outer barrier being substantially tubular; Whereby, the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure; The at least one radiopaque marker may have a substantially cylindrical shape in structure, which may be hollow or solid; or the at least one radiopaque marker may have a substantially coil-shaped shape in structure.

2. The stent delivery device according to claim 1, wherein: An end cap is provided at the distal end of the delivery structure for maintaining the braided arrangement of the strands of the delivery structure.

3. The stent delivery device according to claim 2, wherein: The end cap is constructed from at least one radiopaque material.

4. The stent delivery device according to claim 1, wherein: At least one of the strands of the delivery structure is composed of at least one radiopaque material.

5. The stent delivery device of claim 1, the at least one radiopaque marker being a plurality of radiopaque markers coaxially disposed within the delivery structure and longitudinally spaced apart from one another along a length of the delivery structure. The stent delivery device according to claim 1 , wherein: The at least one radiopaque marker has an outer diameter that is relatively smaller than an initial inner diameter of the delivery structure.

7. The stent delivery device according to claim 1, wherein: The at least one radiopaque marker has an outer diameter approximating an initial inner diameter of the delivery structure.

8. The stent delivery device according to claim 1, wherein: The circumferential outer surface of the at least one radiopaque marker is permanently affixed to the inner surface of the delivery structure.

9. The stent delivery device according to claim 1, further comprising: At least one elongated guidewire is coaxially disposed and extends longitudinally from within the at least one radiopaque marker and the delivery structure.

10. The stent delivery device according to claim 1, wherein: Each of the at least one outer barrier has a barrier length that is greater than or equal to a marking length of the corresponding at least one radiopaque marking on which the outer barrier is located, such that the outer barrier substantially covers the marking.

11. The stent delivery device according to claim 1, wherein: The at least one external barrier is permanently affixed to an outer surface of the conveying structure.

12. The stent delivery device according to claim 1, wherein: The at least one outer barrier is constructed from a heat shrink material.

13. The stent delivery device according to claim 1, wherein: Opposite ends of the at least one outer barrier are tapered.

14. A stent delivery device comprising: a plurality of individual strands braided together to form a self-expanding stent delivery structure having a proximal end and an opposite distal end, the delivery structure forming an elongated initial shape capable of insertion into a catheter; as well as at least one radiopaque marker coaxially disposed within the delivery structure, the at least one radiopaque marker having a circumferential outer surface permanently affixed to a circumferential inner surface of the delivery structure; the radiopaque marker being substantially coil-shaped; at least one protective outer barrier circumferentially engaged about an outer surface of the delivery structure at substantially the same location as the at least one radiopaque marker such that the at least one protective outer barrier, the delivery structure, and the at least one radiopaque marker are concentrically disposed; the protective outer barrier being substantially tubular; Thereby, the delivery structure has an initial outer diameter that is substantially uniform along the entire length of the delivery structure.

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