Claims for Patent: 7,901,453

Summary for Patent: 7,901,453

Title:	Coated implantable medical device
Abstract:	A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of an immunosuppressive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of immunosuppressive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of immunosuppressive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a coronary stent. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative which is deposited without solvents, heat or catalysts, but rather by condensation of a monomer vapor.
Inventor(s):	Ragheb; Anthony O. (West Lafayette, IN), Fearnot; Neal E. (West Lafayette, IN), Voorhees, III; William D. (West Lafayette, IN), Kozma; Thomas G. (Canton, GA), Bates; Brian L. (Bloomington, IN), Osborne; Thomas A. (Bloomington, IN)
Assignee:	Cook Incorporated (Bloomington, IN) MED Institute, Inc. (West Lafayette, IN)
Application Number:	11/932,113
Patent Claims:	1. A medical stent device comprising: a stent adapted for introduction into a patient, the stent having at least one surface, the stent made from a metal comprising tungsten; a two-layer coating system on the stent, the two-layer coating system including: (i) a first layer, the first layer in contact with the surface of the stent, the first layer including a polymer of n-butyl methacrylate; (ii) a second layer, the second layer in contact with the first layer and providing an outermost layer over the stent, the second layer comprising an immunosuppressive agent and a polymer comprising polyvinylidene halide. 2. The device of claim 1, wherein the immunosuppressive agent comprises azathioprine, azathioprine sodium, basiliximab, cyclosporine, daclizumab, glatiramer, glatiramer acetate, muromonab-CD3, mycophenolate, mycophenolate mofetil, mycophenolate, morpholinoethyl, mycophenolic acid, tacrolimus, anhydrous tacrolimus, tacrolimus monohydrate, sirolimus, interferon alfa-2a, antilymphocyte immunoglobulin, antithymocyte immunoglobulin, anti-lymphocyte serum, antithymocyte serum, lymphocytic antiserum, thymitic antiserum, brequinar, brequinar sodium, cyclophosphamide, cyclophosphamide monohydrate, anhydrous cyclophosphamide, dactinomycin, actinomycin C, actinomycin D, meractinomycin, daunorubicin, daunorubicin hydrochloride, daunomycin hydrochloride, rubidomycin hydrochloride, doxorubicin, doxorubicin hydrochloride, adriamycin, adriamycin hydrochloride, fluorouracil, gusperimus, gusperimus hydrochloride, inolimomab, leflunomide, mercaptopurine, mercaptopurine monohydrate, purinethiol, anhydrous mercaptopurine, methotrexate, methotrexate sodium, methotrexate disodium, alpha-methopterin, amethopterin, mustine, mustine hydrochloride, chlormethine hydrochloride, chlorethazine hydrochloride, mechlorethamine hydrochloride, nitrogen mustard, mizoribine, vinblastine, vinblastine sulfate, or vinca-leukoblastine sulphate, a pharmacologically acceptable salt of any of the agents, a physiologically acceptable salt of any of the agents, a pharmacologically acceptable mixture of any two or more of the agents, or a physiologically acceptable mixture of any two or more of the agents. 3. The device of claim 1, wherein the immunosuppressive agent comprises capecitabine, carmofur, epirubicin, epirubicin hydrochloride, idarubicin, idarubicin hydrochloride, mafosfamide, menogaril, mitozantrone, mitozantrone hydro-chloride, mitoxantrone hydrochloride, pirarubicin, tepirubicin, piroxantrone, piroxantrone hydrochloride, anthrapyrazole hydrochloride, oxantrazole hydrochloride, teloxantrone, teloxantrone hydrochloride, thioguanine, anhydrous thioguanine, thiguanine hemihydrate, tioguanine, trofosfamide, trilophosphamide, trophosphamide, uramustine, uracil mustard, vincristine, vincristine sulphate, leurocristine sulphate, vindesine, vindesine sulfate, desacetyl vinblastine amide sulfate, vinorelbine, vinorelbine tartrate, vinorelbine ditartrate, zorubicin, zorubicin hydrochloride, a pharmacologically acceptable salt of any of the agents, a physiologically acceptable salt of any of the agents, a pharmacologically acceptable mixture of any two or more of the agents, or a physiologically acceptable mixture of any two or more of the agents. 4. The device of claim 1, wherein the stent is a vascular stent. 5. The device of claim 4, wherein the stent is a coronary stent. 6. The device of claim 1, wherein the stent is made from an alloy including tungsten. 7. The device of claim 6, wherein the immunosuppressive agent is present at a level of about 0.1 to about 4 milligrams per square centimeter of the gross surface area of the stent. 8. The device of claim 7, wherein the immunosuppressive agent is present at a level of about 0.1 milligram per square centimeter of the gross surface area of the stent. 9. The device of claim 1, wherein the immunosuppressive agent comprises sirolimus. 10. The device of claim 7, wherein the polymer comprising polyvinylidene halide is a polymer comprising polyvinylidene fluoride. 11. The device of claim 7, wherein the polymer comprising polyvinylidene halide is a polymer comprising polyvinylidene chloride.

Details for Patent 7,901,453

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Centocor Ortho Biotech Products, L.p.	ORTHOCLONE OKT3	muromanab-cd3	Injection	103463	09/14/1992		2016-05-16
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2016-05-16
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	05/12/1998		2016-05-16
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	01/02/2003		2016-05-16
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2016-05-16
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2016-05-16