Stent coating

• US 8,114,152 B2
• Filed: 11/10/2008
• Issued: 02/14/2012
• Est. Priority Date: 04/15/1998
• Status: Expired due to Term

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/267,651
• Publication Number:
  US 20090062904A1
• Time in Patent Office: 1,191 Days
• Field of Search: 623/1.13, 623/1.42, 623/1.43, 623/1.44, 623/1.45, 623/1.46, 606/191, 606/194, 606/195, 606/198, 606/108
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An expandable stent for use within a body passageway having a body member with two ends and a wall surface disposed between the ends. The body member has a first diameter to permit delivery of the body member into a body passageway and a second expanded diameter. The surface of the stent is coated with a biological agent and a polymer which controls the release of the biological agent.

Claims

1. An expandable intraluminal graft for use within a body passageway including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said body member having a first cross-sectional shape having a first cross-sectional area which permits intraluminal delivery of said body member into the body cavity, and a second expanded cross-sectional shape having a second cross-sectional area which is greater than said first cross-sectional area, said biological agent at least partially secured to said body member, said biological agent including one or more agents selected from the group consisting of Trapidil, GM-CSF, Trapidil derivative and GM-CSF derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including one or more compounds selected from the group consisting of a polymer and copolymer, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, between said body member and said intermediate compound, or combinations thereof, said intermediate compound at least partially delays delivery of said biological agent into said body passageway, said biological agent is at least partially releasably coated on said graft, said intermediate compound having a coating thickness of about 5,000 to 250,000 Å

, said biological agent present in an amount of at least 1 μ

g and up to about 10 mg.

2. The expandable intraluminal graft as defined in claim 1, wherein said intermediate compound includes one or more compounds selected from the group consisting ofparylene, parylene derivative, polytetrafluoroethylene, polyethylene, poly(hydroxyethly methacrylate), poly(vinyl alcohol), polycaprolactone, poly(D, L-lactic acid), poly(L-lactic acid), poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(glycolic acid-cotrimethylene cabonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, aliphatic polycarbonates, polyethylene oxide, polyethylene gylcol, poly(propylene oxide), polyacrylamides, polyacrylic acid polymethacrylic acid, poly(N-vinyl-2-pyrollidone), polyurethanes, poly(aminoacid), cellulosic polymers, collagens, carrageenan, alginate, starch, dextrin, gelatins, poly(lactide), poly(glycolide), polydioxanone, polycaprolactone, polyhydroxybutyrate, poly(phospazazene), poly(phosphate ester), poly(lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(glycolide-co-caprolactone), polyanhydrides, polyamides, polyesters, polyethers, polyketones, polyether elastomers, parylene, polyether amide elastomers, polyacrylate-based elastomers, polyethylene and polypropylene.

3. The expandable intraluminal graft as defined in claim 2, wherein said biological agent includes two or more agents selected from the group consisting of Trapidil and/or derivatives thereof;

GM-CSF and/or derivatives thereof;

taxol and/or derivatives thereof;

5-Fluorouracil and/or derivatives thereof;

Beta-Estradiol and/or derivatives thereof;

Tranilast and/or derivatives thereof;

Probucol and/or derivatives thereof;

Angiopeptin and/or derivatives thereof;

paclitaxel and/or derivatives thereof;

cytochalasin and/or derivatives thereof;

aspirin and/or derivatives thereof;

dipyridamoles and/or derivatives thereof;

argatroban and/or derivatives thereof;

forskolin and/or derivatives thereof;

vapiprost and/or derivatives thereof;

prostacyclin and prostacyclin and/or derivatives thereof;

glycoprotein IIb/IIIa platelet membrane receptor antibody;

colchicine and/or derivatives thereof;

dexamethazone and/or derivatives thereof;

dipyridamoles and/or derivatives thereof; and

/or heparin and/or derivatives thereof;

glucocorticoids and/or derivatives thereof;

hirudin and/or derivatives thereof;

coumadin and/or derivatives thereof;

prostacyclenes and/or derivatives thereof;

antithrombogenic agents;

steroids;

seramin and/or derivatives thereof;

thioprotese inhibitors;

nitric oxide;

ibuprofen;

antimicrobials;

antibiotics;

tissue plasma activators;

rifamycin and/or derivatives thereof;

monoclonal antibodies;

antifibrosis compounds;

cyclosporine;

hyaluronate;

protamine and/or derivatives thereof;

tocopherol and/or derivatives thereof;

angiopeptin and/or derivatives thereof;

tick anticoagulant protein and/or derivatives thereof;

methotrexate and/or derivatives thereof;

azathioprine and/or derivatives thereof;

vincristine and/or derivatives thereof;

vinblastine and/or derivatives thereof;

fluorouracil and/or derivatives thereof;

adriamycin and/or derivatives thereof;

mutamycin and/or derivatives thereof;

Anti-Invasive Factor;

Cartilage-Derived Inhibitor;

retinoic acids and/or derivatives thereof, Suramin;

Tissue Inhibitor of Metalloproteinase-1 and/or derivatives thereof;

Tissue Inhibitor of Metalloproteinase-2 and/or derivatives thereof;

Plasminogen Activator Inhibitor-1 and/or derivatives thereof;

Plasminogen Activator Inhibitor-2 and/or derivatives thereof;

estramustine and/or derivatives thereof;

methotrexate and/or derivatives thereof, curacin-A and/or derivatives thereof;

epothilone and/or derivatives thereof;

vinblastine and/or derivatives thereof;

tBCEV and/or derivatives thereof;

lighter “

d group”

transition metals;

Platelet Factor 4;

growth factors;

Protamine Sulphate;

Sulphated Chitin Derivatives;

Sulphated Polysaccharide Peptidoglycan Complex;

Staurosporine;

proline analogs;

cishydroxyproine;

d,L-3,4-dehydroproline;

Thiaproline;

alpha-dipyridyl;

beta aminopropionitrile fumarate;

4-propyl-5-(4-pyridinyl)-2(3H)-oxazolone;

Methotrexate Mitoxantrone;

Interferons;

alpha 2 Macroglobulin;

ChIMP-3;

Chymostatin;

beta-Cyclodextrin Tetradecasulfate;

Eponemycin;

Camptothecin;

Fumagillin;

Gold Sodium Thiomalate;

D-Penicillamine;

beta-1-anticollagenase;

alpha 2-antiplasmin;

Bisantrene;

Lobenzarit disodium (N-(2)-carboxyphenyl-4-chloroanthronilic acid disodium;

Thalidomide;

Angiostatic steroid;

AGM-1470;

carboxynaminolmidazole;

penicillins;

cephalosporins;

aminoglycosides sulfonamides;

rapamycin, metronidazole;

prednisone;

prednisolone;

hydrocortisone;

adrenocorticotropic hormone;

sulfasalazine;

naproxen;

fenoprofen;

indomethacin;

phenylbutazone;

acyclovir;

ganciclovir;

zidovudine;

nystatin;

ketoconazole;

griseofulvin;

flucytosine;

miconazole;

clotrimazole;

pentamidine isethionate;

quinine;

chloroquine;

mefloquine;

thyroid hormone;

estrogen;

progesterone;

cortisone;

growth hormone;

insulin;

T.sub.H 1;

T.sub.H 2;

estramustine;

epothilone;

curacin-A;

colchicine;

methotrexate;

vinblastine;

4-tert-butyl→

3-(2-chloroethyl)ureido!benzene;

alpha-adrenergic blocking agents;

angiotensin II receptor antagonists;

receptor antagonists for histamine;

serotonin;

serotonin blockers;

endothelin;

inhibitors of the sodium/hydrogen antiporter;

agents that modulate intracellular Ca.sup.2+ transport such as L-type or T-type Ca.sup.2+ channel blockers;

calmodulin antagonists;

inhibitors of the sodium/calcium antiporter;

ap-1 inhibitors;

anti-depressants;

cytokine and/or growth factors;

GM-CSF;

G-CSF;

epidermal growth factor;

transforming growth factors alpha and beta;

TNF;

antagonists of vascular epithelial growth factor;

endothelial growth factor;

acidic or basic fibroblast growth factors;

platelet derived growth factor;

inhibitors of the IP₃ receptor;

protease;

collagenase inhibitors;

nitrovasodilators;

anti-mitotic agents;

immunosuppressive agents;

sense or antisense oligonucleotides;

inhibitors of transcription factor activity;

anti-neoplastic compounds;

chemotherapeutic compounds, radioactive agents;

7E-3B;

CAPTOPRIL;

CILAZAPRIL;

LISINOPRIL;

LOVASTATIN;

nitroprusside;

phosphodiesterase inhibitors;

prostaglandin inhibitors;

thioprotesase inhibitors;

triazolopyrimidine and/or derivatives thereof;

calcium channel blockers;

toxins;

metalloproteinase inhibitors;

ACE inhibitors;

growth factors;

oligonucleotides;

antiplatlet compounds;

antitabolite compounds;

anti-inflammatory compounds;

anticoagulent compounds;

antimitotic compounds;

antioxidants;

antimetabolite compounds;

anti-migratory agents;

anti-matrix compounds;

protein kinase inhibitors;

anti-vital compounds, anti-proliferatives, anti-fungal compounds and anti-protozoal compounds.

4. The expandable intraluminal graft as defined in claim 3, wherein said biological agent includes at least three different biological agents.

5. The expandable intraluminal graft as defined in claim 4, wherein said intermediate compound is at least partially formed of a biodegradable material.

6. A graft for use in repairing a body passageway, said graft including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said biological agent at least partially secured to said body member, said biological agent including two or more agents selected form the group consisting of Trapidil, GM-CSF, Trapidil derivative, and GM-CSF derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including one or more compounds selected from the group consisting of parylene and parylene derivative, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, at least partially encapsulating at least a portion of said biological agent between said body member and said intermediate compound, or combinations thereof.

7. The graft as defined in claim 6, wherein said biological agent is at least partially releasably secured to said graft.

8. The graft as defined in claim 6, wherein said biological agent further includes one or more agents selected from the group consisting of paclitaxel, rapamycin, paclitaxel derivative, and rapamycin derivative.

9. The graft as defined in claim 6, wherein said intermediate compound is at least partially formed of a biodegradable material.

10. The graft as defined in claim 8, wherein at least a portion of said body member is at least partially formed of a biodegradable material.

11. A graft for use in repairing a body passageway, said graft including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said biological agent at least partially secured to said body member, said biological agent including a first compound selected from the group consisting of Trapidil, GM-CSF, Trapidil derivative and GM-CSF derivative and a second compound selected form the group consisting of paclitaxel, rapamycin, paclitaxel derivative and rapamycin derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including one or more compounds selected from the group consisting of parylene and parylene derivative, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, at least partially encapsulating at least a portion of said biological agent between said body member and said intermediate compound, or combinations thereof, said intermediate compound at least partially delays delivery of said biological agent into said body passageway, said biological agent is at least partially releasably coated on said graft, said intermediate compound having a coating thickness of about 5,000 to 250,000 Å

, said biological agent present in an amount of at least 1 μ

g and up to about 10 mg.

12. The graft as defined in claim 11, wherein said biological agent includes Trapidil, Trapidil derivative, and mixtures thereof.

13. The expandable intraluminal graft as defined in claim 12, wherein said biological agent includes at least three different biological agents.

14. The expandable intraluminal graft as defined in claim 11, wherein said biological agent includes at least three different biological agents.

15. A graft for use in repairing a body passageway, said graft including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said biological agent at least partially secured to said body member, said biological agent including a first compound selected from the group consisting of Trapidil, GM-CSF, Trapidil derivative and GM-CSF derivative and a second compound selected from the group consisting of paclitaxel, rapamycin, paclitaxel derivative and rapamycin derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including one or more compounds selected from the group consisting of parylene and parylene derivative, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, at least partially encapsulating at least a portion of said biological agent between said body member and said intermediate compound, or combinations thereof, said biological agent includes Trapidil, Trapidil derivative, and mixtures thereof, said biological agent includes GM-CSF, GM-CSF derivative, and mixtures thereof.

16. The graft as defined in claim 15, wherein said biological agent further includes one or more agents selected from the group consisting of paclitaxel, rapamycin, paclitaxel derivative and rapamycin derivative.

17. A graft for use in repairing a body passageway, said graft including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said biological agent at least partially secured to said body member, said biological agent including a first compound selected from the group consisting of Trapidil, Trapidil derivative, or mixtures thereof and a second compound selected form the group consisting of GM-CSF, GM-CSF derivative, paclitaxel, paclitaxel derivative, rapamycin and rapamycin derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including parylene, parylene derivative or mixtures thereof, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, at least partially encapsulating at least a portion of said biological agent between said body member and said intermediate compound, or combinations thereof, said intermediate compound at least partially delays delivery of said biological agent into said body passageway, said biological agent is at least partially releasably coated on said graft, said intermediate compound having a coating thickness of about 5,000 to 250,000 Å

, said biological agent present in an amount of at least 1 μ

g and up to about 10 mg.

18. The graft as defined in claim 17, wherein said biological agent includes one or more agents selected from the group consisting of paclitaxel, paclitaxel derivative, rapamycin and rapamycin derivative.

19. The expandable intraluminal graft as defined in claim 18, wherein said biological agent includes at least three different biological agents.

20. The expandable intraluminal graft as defined in claim 17, wherein said biological agent includes at least three different biological agents.

21. A graft for use in repairing a body passageway, said graft including a body member, intermediate compound, and biological agent, said body member having first and second ends and a wall surface disposed between said first and second ends defining a longitudinal axis of said body member, said biological agent at least partially secured to said body member, said biological agent including a first compound selected from the group consisting of Trapidil, Trapidil derivative, or mixtures thereof and a second compound selected from h group consisting of GM-CSF, GM-CSF derivative, paclitaxel, paclitaxel derivative, rapamycin and rapamycin derivative, said intermediate compound at least partially securing said biological agent to said body member, said intermediate compound including parylene, parylene derivative or mixtures thereof, said intermediate compound at least partially encapsulating at least a portion of said biological agent in said intermediate compound, at least partially encapsulating at least a portion of said biological agent between said body member and said intermediate compound, or combinations thereof, said second compound includes GM-CSF, GM-CSF derivative, and mixtures thereof.

22. The graft as defined in claim 21, wherein said biological agent further includes one or more agents selected from the group consisting of paclitaxel, rapamycin, paclitaxel derivative and rapamycin derivative.