US20110190873A1 - Stent - Google Patents

Abstract

A stent with strut bands and connectors, wherein the strut bands have long and short struts with a junction positioned between the short struts. Each junction defines a reservoir, wherein the reservoirs of a strut band are substantially circumferentially aligned. The connectors each have arms, wherein each arm includes an opposing U-shaped link. The opposing links have a shared portion disposed between a peak on one strut band and a longitudinally adjacent trough of an adjacent strut band.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This Application is a continuation of U.S. patent application Ser. No. 12/783,781, Published as 2010/0222868, and filed on May 20, 2010, which is a division of U.S. patent application Ser. No. 11/960,333, filed on Dec. 19, 2007 and issued as U.S. Pat. No. 7,722,661, both of which are herein incorporated by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
• Not Applicable
FIELD OF THE INVENTION
• This invention relates to an endoprosthesis device for implantation within a body vessel, typically a blood vessel. More specifically, it relates to a tubular expandable stent having improved structural aspects as well as improved drug retention/delivery capabilities.
BACKGROUND OF THE INVENTION
• Stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and similar implantable medical devices, collectively referred to hereinafter as stents, are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously. Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, fallopian tubes, coronary vessels, secondary vessels, etc. Stents may be used to support body vessels and to prevent restenosis following angioplasty in the vascular system. They may be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and balloon expandable (hybrid expandable).
• Stents may be created by methods including cutting or etching a design from a tubular stock, from a flat sheet which is cut or etched and which is subsequently rolled, and/or from one or more interwoven wires or braids.
• Known construction materials for use in stents include polymers, organic fabrics, and biocompatible metals. Metals and/or alloys of such metals that have been used in the construction of stents and/or their components include but are not limited to: stainless steel, gold, silver, tantalum, titanium, chromium, cobalt and shape memory alloys such as Nitinol.
• In an effort to combat vessel restenosis, as well as other medical conditions, stents have been employed to delivery a variety of therapeutic agents directly to the site of stent deployment. Some stents employ a variety of structural features, such as slots, grooves, holes, chambers, etc, to act as reservoirs for a therapeutic agent and/or other substances.
• There remains a need for drug delivery stents that have improved structural performance characteristics, such as improved flexibility, structural integrity, compression resistance, etc. There also remains a need to provide such stents with a more desirable drug delivery profile.
• The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists.
• All U.S. patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
• Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
• A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.
BRIEF SUMMARY OF THE INVENTION
• Embodiments of the present invention are directed to stent structures, which when used for the delivery of therapeutic agents such as drugs, provide improved drug delivery characteristics. The unique arrangement and configuration of drug delivery reservoirs throughout the stent structure provide improved drug delivery characteristics without compromise to the stent's performance characteristics.
• Embodiments of the present invention include stents, which have improved flexibility, but also sufficient structural strength to permit the stents to traverse the tortuous confines of mammalian anatomy. In some embodiments the stent of the present invention are provided with strut bands of long and short struts, wherein pairs of short struts are connected to one another at junctions. The junctions provide a circumferential offset within the strut band.
• In some embodiments the stents are provided with connectors between the strut bands, which have opposingly oriented U-shaped links, wherein each link extends from a junction of adjacent strut bands.
• The combination of the structural features provided in the stents of the present invention provide a structurally improved, highly flexible stent.
• An additional goal of the present invention however, is to provide stents with improved drug delivery characteristics as well. This goal is achieved by providing stents with drug delivery reservoirs that are positioned in and defined by the strut band junctions, as well as the connectors, and in some cases the struts as well. In some embodiments at least some of the reservoirs are provided in circumferentially aligned columns about the stent.
• Reservoirs can be any type of surface feature suitable for containing a defined amount of therapeutic agent(s) such as a drug or drug/polymer matrix. In some embodiments one or more of the reservoirs extend only partially through the thickness of the stent with only a single opening on either the inner surface (luminal) or outer surface (abluminal) of the stent. In some embodiments, one or more of the reservoirs is a through-hole which extends entirely through the thickness of the stent body. Each reservoir can have a constant or varied cross-sectional area throughout its thicknesses. Each reservoir opening can have any of a variety of sizes or shapes.
• These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for further understanding of the invention, its advantages and objectives obtained by its use, reference can be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described a embodiments of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
• A detailed description of the invention is hereafter described with specific reference being made to the drawings.
• FIG. 1 shows a flat pattern view of an embodiment of the invention.
• FIG. 2 shows a flat pattern view of an embodiment of the invention.
• FIG. 3 shows a flat pattern view of an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
• While this invention may be embodied in many different forms, there are described in detail herein specific embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
• For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.
• At least one embodiment of the present invention is directed to astent10, an example of which is illustrated inFIG. 1. The structure ofstent10 is comprised of a plurality ofstrut bands20 andconnectors40.
• Eachstrut band20 forms a closed path ofalternating peaks22 andtroughs24.Strut bands20 that are adjacent one another are connected by at least oneconnector40.
• Eachstrut band20 comprises a plurality oflong struts30, a plurality of firstshort struts32 and secondshort struts34, and a plurality ofjunctions36. Eachjunction36 is positioned between and connects a firstshort strut32 and a secondshort strut34. In the embodiments depicted inFIGS. 1-3, within eachstrut band20 each firstshort strut32 is longitudinally and circumferentially offset from each secondshort strut34. Eachlong strut30 is connected to a firstshort strut32 at apeak22 and to a secondshort strut34 at atrough24.
• In the various embodiments shown inFIGS. 1-3 eachjunction36 defines asingle junction reservoir12, wherein all of thejunction reservoirs12 of a givenstrut band20 are substantially circumferentially aligned. In some embodiments however, a junction defines a plurality, such as 1, 2, 3, 4 or more junction reservoirs.
• In some embodiments, theconnectors40 comprise afirst arm42 which extends from ajunction36 on onestrut band20 and asecond arm46 which extends from ajunction36 on anadjacent strut band20. At least a portion of thefirst arm42 comprises a firstU-shaped link44 and at least a portion of thesecond arm46 comprises a secondU-shaped link48. Each firstU-shaped link44 opens in a first direction and each secondU-shaped link48 opens in a second direction substantially opposite the first direction. Though the specific orientation of the opening of the links can be varied and in any direction, in the embodiments shown inFIG. 1-3, eachlink44 and48 opens in a substantially circumferential direction or substantially perpendicular to a longitudinal axis of thestent10.
• At least a portion of the firstU-shaped link44 and at least a portion of the secondU-shaped link48 have a sharedportion50. The sharedportion50 of eachconnector40 is disposed between one of thepeaks22 on onestrut band20 and a longitudinallyadjacent trough24 of anadjacent strut band20. In embodiments where thestent10 includes a plurality ofconnectors40 betweenadjacent strut bands20, the sharedportions50 between any twostrut bands20 are substantially circumferentially aligned.
• If desired thestrut bands20 or a single continuous can be angled relative to a longitudinal axis of the stent to provide the band(s) with a helical or helical-like configuration. In such an embodiment the sharedportions50 ofconnectors40 between a given pair ofstrut bands40 can likewise be slanted or angled relative to the longitudinal axis.
• In the embodiment depicted inFIG. 2 eachlong strut30 defines at least onestrut reservoir14. In some embodiments, one or more of thelong struts30 define a plurality ofstrut reservoirs14. The number ofstrut reservoirs14 on a givenlong strut30 can be varied from one to about twelve, depending on the length of thelong strut30. In some embodiments the number ofstrut reservoirs14 is between at least three to nine. In the embodiment depicted inFIG. 2, in eachlong strut30 one of thestrut reservoirs14 is in substantial circumferential alignment with thejunction reservoirs12 of a givenstrut band20. Where there is a plurality ofstrut reservoirs14 on along strut30, preferably theadditional reservoirs14 are spaced equidistantly from one another and are distributed evenly on either side of the central reservoir in circumferential alignment with thejunction reservoirs12.
• The various components of a stent (struts, connectors, reservoirs, etc.) can have a variety of physical characteristics, such as length, width, thickness, etc, of which each can also be varied. In the embodiments depicted inFIG. 2 however, eachlong strut30 has a long strut width,31 and each first and secondshort strut32/34 has ashort strut width33. Thelong strut width31 is greater than theshort strut width33. Alternatively, in the embodiment shown inFIGS. 1 & 3long strut width31 is substantially the same as theshort strut width33.
• In some embodiments, such as those shown inFIGS. 1 and 2, eacharm42 and46 of theconnectors40 have anarm width45. The arm width is less than either thelong strut width31 or theshort strut width33. In at least one embodiment, such as is depicted inFIG. 3, thewidth45 of thearms42 and46 can vary along their lengths, particularly if the presence ofconnector reservoirs16 necessitate agreater width region47 in order to accommodate the desired cross-sectional area of thereservoirs16.
• In some embodiments, such as for example those depicted inFIGS. 1-2 the sharedportion50 of eachconnector40 defines asingle connector reservoir16. As can be seen in the illustrations, thecross-sectional area51 of a givenconnector reservoir16 is greater than thecross-sectional area53 ofjunction reservoir12 or thecross-sectional area55 of a strut reservoir14 (areas51,53, and55 are depicted shaded).
• In some embodiments such as in thestent10 depicted inFIG. 3, at least a portion of the firstU-shaped link44, adjacent to the sharedportion50, defines at least oneconnector reservoir16 and at least a portion of the secondU-shaped link48, adjacent to the sharedportion50, defines at least oneconnector reservoir16. In the embodiment shown, thearea51 of each connector reservoir is less than or substantially equal to thearea53 of eachjunction reservoir12.
• In the embodiment depicted inFIG. 3 the firstU-shaped link44 and the secondU-shaped link48 each define a plurality offirst connector reservoirs16a.A region of thefirst arm42 adjacent the firstU-shaped link44 and a region of thesecond arm46 adjacent the secondU-shaped link48 each define a second plurality ofconnector reservoirs16b.Thefirst plurality16ais greater than thesecond plurality16b.
• The particular configuration and arrangement of theconnector reservoirs16 is not limited to only those configurations/patterns shown inFIGS. 1-3. The distribution, size, shape and configuration of the connector reservoirs (as well as the junction reservoirs and strut reservoirs) can be modified, in order to provide desired distribution/elution characteristics of one or more drugs or other therapeutic agents.
• A therapeutic agent may be a drug or other pharmaceutical product such as non-genetic agents, genetic agents, cellular material, etc. Some examples of suitable non-genetic therapeutic agents include but are not limited to: anti-thrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc. Where an agent includes a genetic therapeutic agent, such a genetic agent may include but is not limited to: DNA, RNA and their respective derivatives and/or components; hedgehog proteins, etc. Where a therapeutic agent includes cellular material, the cellular material may include but is not limited to: cells of human origin and/or non-human origin as well as their respective components and/or derivatives thereof. Where the therapeutic agent includes a polymer agent, the polymer agent may be a polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and/or any other suitable substrate.
• Thestent10 shown and described herein may be made from any suitable biocompatible materials including one or more polymers, one or more metals or combinations of polymer(s) and metal(s). Examples of suitable materials include biodegradable materials that are also biocompatible. By biodegradable is meant that a material will undergo breakdown or decomposition into harmless compounds as part of a normal biological process. Suitable biodegradable materials include polylactic acid, polyglycolic acid (PGA), collagen or other connective proteins or natural materials, polycaprolactone, hylauric acid, adhesive proteins, co-polymers of these materials as well as composites and combinations thereof and combinations of other biodegradable polymers. Other polymers that may be used include polyester and polycarbonate copolymers. Examples of suitable metals include, but are not limited to, stainless steel, titanium, tantalum, platinum, tungsten, gold and alloys of any of the above-mentioned metals. Examples of suitable alloys include, but are not limited to: platinum-iridium alloys, cobalt-chromium alloys, including Elgiloy and Phynox, MP35N alloy and nickel-titanium alloys, for example, Nitinol.
• Thestent10 may be made of shape memory materials such as superelastic Nitinol or spring steel, or may be made of materials which are plastically deformable. In the case of shape memory materials, the stent may be provided with a memorized shape and then deformed to a reduced diameter shape. Thestent10 may restore itself to its memorized shape upon being heated to a transition temperature and having any restraints removed therefrom.
• Thestent10 may be manufactures by methods including cutting or etching a design from a tubular stock, from a flat sheet which is cut or etched and which is subsequently rolled or from one or more interwoven wires or braids. Any other suitable technique which is known in the art or which is subsequently developed may also be used to manufacture thestent10 disclosed herein.
• In some embodiments thestent10, or its delivery system, may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc. In some embodiments at least a portion of the stent is at least partially radiopaque.
• The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. The various elements shown in the individual figures and described above may be combined or modified for combination as desired. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”.
• Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.
• This completes the description of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.

Claims (13)

1. A stent comprising:

a cylindrical body comprising a plurality of strut pairs having a first lateral side and a second lateral side, the first lateral side comprising a first straight strut segment and the second lateral side comprising a second straight strut segment, the first straight strut segment being circumferentially offset from the second straight strut segment; and

a plurality of connectors, the connectors connecting longitudinally adjacent strut pairs one to another, wherein the connectors have a first end and a second end, the first end being connected to the first straight strut segment and the second end being connected to the first straight strut segment of a longitudinally adjacent strut pair, the first end being longitudinally and circumferentially offset from the second end;

the first straight strut segment and the second straight strut segment each comprise at least one reservoir, the first straight strut segments having a different number of reservoirs than the second straight strut segments and the reservoirs having therein a therapeutic agent;

wherein the strut pairs include first strut pairs and second strut pairs, first strut pairs being longitudinally offset from second strut pairs, first lateral sides of the first strut pairs being circumferentially aligned with second lateral sides of second strut pairs.

2. The stent ofclaim 1, wherein the connectors have a connector width that is less than the width of the first straight strut segment.

3. The stent ofclaim 1, wherein the therapeutic agent includes a polymeric material and a drug.

4. The stent ofclaim 1, wherein the second straight strut segment has between one and twelve reservoirs.

5. The stent ofclaim 1, wherein the stent is metallic.

6. The stent ofclaim 1, wherein the connectors comprise at least one curved portion.

7. The stent ofclaim 1, wherein the first straight strut segment is connected to the second straight strut segment via a curved segment.

8. The stent ofclaim 7, wherein circumferentially adjacent strut pairs are connected to one another via a curved segment.

9. The stent ofclaim 1, wherein the at least one band comprises a serpentine pattern.

10. A stent comprising:

a band comprising a plurality of strut pairs having a first strut segment and a second strut segment, the first strut segments being circumferentially offset from the second strut segments;

a plurality of connectors, the connectors connecting longitudinally adjacent strut pairs to one another, wherein the connectors have first ends and second ends, the first ends being connected to a first strut segment and the second ends being connected to a first strut segment, the first end being contralateral to the second end;

wherein the first strut segment and the second strut segment each comprise at least one reservoir, the first strut segments having a different number of reservoirs than the second strut segments and the reservoirs having therein a therapeutic agent.

11. The stent ofclaim 10, the strut pairs comprise first strut pairs and second strut pairs, the first strut pairs being longitudinally offset from the second strut pairs, wherein each of the first and second strut pairs comprises a first lateral side and a second lateral side, the first lateral side of the first strut pair being circumferentially aligned with the second lateral side of the longitudinally adjacent second strut pair.

12. The stent ofclaim 11, wherein the stent is metallic.

13. The stent ofclaim 10, wherein the band is helical.

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