Coated implantable medical device

• US 7,901,453 B2
• Filed: 10/31/2007
• Issued: 03/08/2011
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Bates, Brian L., Fearnot, Neal E., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D. III, Osborne, Thomas A.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/932,113
• Publication Number:
  US 20080145399A1
• Time in Patent Office: 1,224 Days
• Field of Search: 623 142- 146, 604264-265, 604/891.1, 604/892.1
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• 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 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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: A61L 33/022 Metal or alloys
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 65/04 : Polyxylenes

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.

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.