Granted Patent B2

US 8,287,590 · App. 12/828,512 · Granted Oct 16, 2012

Abstract

Claims (18)

1. A stent having a coating comprising: (a) a primer layer having a polymer composition of two or more polymers, and (b) a single outermost drug reservoir layer having a polymer composition comprising a polymeric alloy mixture of two or more polymers, the primer layer polymer composition being distinct from the drug reservoir layer polymer composition, the drug reservoir layer further comprising one or more active agents, the coating having sufficient adhesion and flexibility to remain intact upon stent expansion and during a sustained period thereafter, and releasing efficacious amounts of the active agent at the site of stent expansion;

wherein the primer layer comprises one or more polymers selected from the group consisting of acrylate polymer/copolymer, acrylate carboxyl or hydroxyl copolymer, olefin acrylic acid copolymer, ethylene acrylic acid copolymer, a polyamide polymer/copolymer, a polyimide polymer/copolymer, polyvinylpyrrolidone/vinyl acetate copolymer (PVP/VA), polyethylene glycol, polyethylene oxide, ethylene vinylacetate copolymer, epoxy polymer, polyurethane, polycarbonate urethane, silicone urethane, a polyvinylpyridine polymer, a polyvinylpyridine copolymer, and polyether sulfones.

2. The stent of claim 1 , further comprising an intermediate layer between the primer layer and the drug reservoir layer, the intermediate layer comprising a polymer composition distinct from the primer layer polymer composition and the drug reservoir layer polymer composition.

3. The stent of claim 2 , wherein the intermediate layer comprises one or more polymers selected from the group consisting of acrylate polymer/copolymer, acrylate carboxyl and/or hydroxyl copolymer, polycarbonate polyurethane, polyvinylpyrrolidone/vinyl acetate copolymer (PVP/VA), polyurethane, silicone urethane polymer, polycarbonate urethane polymer, polyvinylbutyral, and epoxy polymers.

4. The stent of claim 1 , further comprising one or more image enhancing materials in one of the layers, or in one or more separate layers, the image enhancing material being capable of enhancing visibility in ultra sound, magnetic resonance imaging, or X ray imaging.

5. The stent of claim 1 , wherein the primer layer polymer composition comprises an anchoring polymer.

6. The stent of claim 1 , wherein the drug reservoir polymer composition comprises a drug stabilizing polymer and a toughening polymer.

7. The stent of claim 6 , wherein the drug stabilizing polymer is a cellulose ester, a cellulose ether, an acrylic polymer, an acrylic copolymer or combinations thereof.

8. The stent of claim 6 , wherein the toughening polymer is a polyurethane.

9. The stent of claim 1 , wherein the drug reservoir layer comprises one or more polymers selected from the group consisting of hydroxyethyl methacrylate (HEMA), copolymers of HEMA with acrylate, copolymers of HEMA with polymethylmethacrylate (PMMA), polyvinyl pyrrolidone, polyvinylpyrrolidone/vinyl acetate copolymer (PVP/VA), a polyethylene glycol, acrylate polymer/copolymer, acrylate/carboxyl polymer, acrylate hydroxyl and/or carboxyl copolymer, a cellulose ester, a polyurethane, polycarbonate-urethane polymer, a silicone-urethane polymer, an epoxy polymer, cellulose nitrate, polytetramethylene ether glycol urethane, polymethylmethacrylate-2-hydroxyethylmethacrylate copolymer, polyethylmethacrylate-2-hydroxyethylmethacrylate copolymer, polypropylmethacrylate-2-hydroxyethylmethacrylate copolymer, polybutylmethacrylate-2-hydroxyethylmethacrylate copolymer, polymethylacrylate-2-hydroxyethylmethacrylate copolymer, polyethylacrylate-2-hydroxyethylmethacrylate copolymer, polypropylacrylate-2-hydroxymethacrylate copolymer, polybutylacrylate-2-hydroxyethylmethacrylate copolymer, copolymermethylvinylether maleicanhydride copolymer, poly (2-hydroxyethyl methacrylate) and a polyethylene oxide.

10. The stent of claim 1 , wherein the active agent is selected from the group consisting of plasmin, streptokinase, single chain urokinase, urokinase, t-PA (tissue type plasminogen activator), aminocaproic acid, aspirin, monoclonal antibodies, peptides, ReoPro, Cilastagel, eptifibatide, tirofiban, ticlopidine, Vapiprost, dipyridamole, forskolin, angiopeptin, argatroban, dextan, heparin, LMW heparin, a heparin complex, Enoxaparin, Dalteparin, hirudin, recombinant hirudin, anti-thrombin, a synthetic antithrombin, a thrombin inhibitor, Warfarin, a coumarin, vincristine, vinblastine, paclitaxel, a paclitaxel analogue, methotrexate, cisplatin, fluorouracil, rapamycin, azathioprine, cyclophosphamide, mycophenolic acid, a corticosteroid, colchicine, nitroprusside, angiostatin, endostatin, genetic material, an oligonucleotide, Cilazapril, Lisinopril, Captopril, VEGF, FGF, Probucol, Tocopherol, nifedipine, Molsidomine, angiopeptin, prednisolone, a glucocorticoid, dexamethasone, rifamycin, Re-188, Re-186, 1-125, Y-90, celecoxib, Vioxx, theophylline, tacrolimus, everolimus, sirolimus and combinations.

11. The stent of claim 1 , wherein the active agent comprises heparin together with an antirestenotic drug selected from the group consisting of paclitaxel, rapamycin, sirolimus, everolimus, tacrolimus, and combinations.

12. The stent of claim 1 , wherein the active agents are benzalkonium heparinate and paclitaxel.

13. The stent of claim 1 , wherein the primer layer comprises an ethylene acrylic acid copolymer and an epoxy polymer, and wherein the ethylene acrylic acid copolymer is one or more of PRIMACOR™ 5989 and 5990 and the epoxy is one or more of EPOTUF™ 38-505, EPOTUF™ 37-618, and EPON™ 1001.

14. The stent of claim 1 , wherein the drug reservoir layer comprises a polyurethane and a cellulose nitrate.

15. The stent of claim 14 , wherein the polyurethane is polytetramethylene ether glycol urethane, polycarbonate urethane or combinations thereof.

16. The stent of claim 14 , wherein the polyurethane is selected from the group consisting of CHRONOFLEX® AR, CHRONOFLEX® AL, CHRONOFLEX® C and BIONATE® 80A.

17. The stent of claim 1 , wherein the primer layer comprises an ethylene acrylic acid copolymer and an epoxy polymer and the drug reservoir layer comprises a polyurethane and a cellulose ester.

Assignments (6)