Drug eluting implantable medical device

• US 20070134290A1
• Filed: 07/26/2006
• Published: 06/14/2007
• Est. Priority Date: 05/20/2002
• Status: Abandoned Application

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: OrbusNeich Medical Pte Ltd
• Inventors: Rowland, Stephen, Cottone, Robert, Camp, David, Juman, Ike
• Application Number:
  US11/494,801
• Publication Number:
  US 20070134290A1
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/604 Biodegradation
• 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: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device, such as a stent, vascular, or synthetic graft comprises a coating consisting of a controlled-release matrix of a bioabsorbable, biocompatible, bioerodible, biodegradable, nontoxic material, such as a Poly(DL-Lactide-co-Glycolide) polymer, and at least one pharmaceutical substance, or bioactive agent incorporated within the matrix or layered within layers of matrix. In particular, the drug eluting medical device when implanted into a patient, delivers the drugs or bioactive agents within the matrix to adjacent tissues in a controlled and desired rate depending on the drug and site of implantation.

Claims

1. A medical device comprising a coating for controlled release of one or more pharmaceutical substances to adjacent tissue for inhibiting restenosis, wherein the coating comprises a bioabsorbable matrix, one or more pharmaceutical substances and a nonabsorbable polymer selected from ethylene vinyl acetate and methylmethacrylate.

2. The medical device of claim 1, wherein the device is structured and configured to be implanted in a patient, and wherein at least one surface of the device comprises one or more base materials.

3. The medical device of claim 1, wherein the medical device is a stent, a vascular or other synthetic graft, or a stent in combination with a synthetic graft.

4. The medical device of claim 1, wherein the medical device is a vascular stent.

5. The medical device of claim 2, wherein the one or more base materials is/are biocompatible.

6. The medical device of claim 2, wherein the one or more base materials is/are selected from the group consisting of stainless steel, Nitinol, MP35N, gold, tantalum, platinum, platinum iridium, carbon fiber, cellulose acetate, cellulose nitrate, silicone, cross-linked polyvinyl acetate (PVA) hydrogel, cross-linked PVA hydrogel foam, polyurethane, polyamide, styrene isobutylene-styrene block copolymer (Kraton), polyethylene terephthalate, polyester, polyorthoester, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polyesters of polylactic acid, polyglycolic acid, copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, extracellular matrix components, proteins, collagen, fibrin, and mixtures thereof.

7. The medical device of claim 1, wherein the bioabsorbable matrix comprises one or more polymers or oligomers which is/are selected from the group consisting of poly(lactide-co-glycolide), polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, and mixtures or copolymers thereof.

8. The medical device of claim 1, wherein the coating comprises poly(DL-lactide-co-glycolide).

9. The medical device of claim 7, wherein the bio-absorbable matrix comprises poly(DL-lactide).

10. The medical device of claim 1, wherein the one or more pharmaceutical substances is/are selected from the group consisting of antibiotics/antimicrobials, antiproliferatives, antineoplastics, antioxidants, endothelial cell growth factors, thrombin inhibitors, immunosuppressants, anti-platelet aggregation agents, collagen synthesis inhibitors, therapeutic antibodies, nitric oxide donors, wound-healing agents, therapeutic gene transfer constructs, extracellular matrix components, vasodilators, thrombolytics, anti-metabolites, growth factor agonists, antimitotics, steroidal and nonsteroidal antiinflammatory agents, angiotensin converting enzyme (ACE) inhibitors, free radical scavengers, and anti-cancer chemotherapeutic agents.

11. The medical device of claim 10, wherein the one or more pharmaceutical substances is/are selected from the group consisting of paclitaxel, cyclosporin A, mycophenolic acid, mycophenolate mofetil acid, rapamycin, azathioprene, tacrolimus, tranilast, dexamethasone, another corticosteroid, everolimus, retinoic acid, vitamin E, a statin, and probucol.

12. The medical device of claim 11, wherein the one or more pharmaceutical substances is/are cyclosporin A and/or mycophenolic acid.

13. The medical device of claim 11, wherein the one or more pharmaceutical substances is/are mycophenolic acid and/or vitamin E.

14. The medical device of claim 8, wherein the poly(DL-lactide-co-glycolide) comprises from about 50 to 99% of the polymer in the coating.

15. The medical device of claim 8, wherein the poly(DL-lactide-co-glycolide) polymer comprises from about 50 to 85% lactide polymer and from about 15 to 50% glycolide polymer.

16. The medical device of claim 1, wherein the pharmaceutical substance comprises from about 1 to about 50% (w/w) of the composition

17. The medical device of claim 11, wherein the one or more pharmaceutical substances is/are paclitaxel and/or cyclosporin A.

20. The medical device of claim 1, wherein the ethylene vinyl acetate is ethylene vinyl acetate 25.

21. The medical device of claim 1, wherein the coating comprises a single homogeneous layer comprising poly(DL-lactide-co-glycolide) and the pharmaceutical substances.

22. The medical device of claim 1, wherein the coating comprises multiple layers of the poly(DL-lactide-co-glycolide) polymer and the pharmaceutical substances.

23. The medical device of claim 1, wherein the coating comprises multiple layers of the pharmaceutical substances and multiple layers of poly(DL-lactide-co-glycolide) polymer.

26. A method of treating vascular disease, comprising implanting the medical device of any one of claims 1-17 and 20-23 into a patient in need of such treatment.

27. The medical device of claim 2, wherein the ethylene vinyl acetate is ethylene vinyl acetate 25.

28. A method of treating vascular disease, comprising implanting the medical device of claim 27 into a patient in need of such treatment.

18. (canceled)

19. (canceled)

24. (canceled)

25. (canceled)