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08/23/07 | 91 views | #20070198080 | Prev - Next | USPTO Class 623 | About this Page  623 rss/xml feed  monitor keywords

Coatings including an antioxidant

USPTO Application #: 20070198080
Title: Coatings including an antioxidant
Abstract: A coating including an antioxidant or a combination of antioxidant and another bioactive agent on a medical device is described. (end of abstract)
Agent: Squire, Sanders & Dempsey L.L.P. - San Francisco, CA, US
Inventors: Ni Ding, Leslie Coleman
USPTO Applicaton #: 20070198080 - Class: 623001380 (USPTO)
Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Absorbable In Natural Tissue
The Patent Description & Claims data below is from USPTO Patent Application 20070198080.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This is a continuation-in-part application of U.S. application Ser. No. 11/189,216, filed on Jul. 25, 2005, the teachings of which are incorporated hereto by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention generally relates to a method of providing an antioxidant to a coating on a medical device such as a drug-delivery stent.

[0004] 2. Description of the Background

[0005] Blood vessel occlusions are commonly treated by mechanically enhancing blood flow in the affected vessels, such as by employing a stent. Stents are used not only for mechanical intervention but also as vehicles for providing biological therapy. To effect a controlled delivery of an active agent in stent medication, the stent can be coated with a biocompatible polymeric coating. The biocompatible polymeric coating can function either as a permeable layer or a carrier to allow a controlled delivery of the agent.

[0006] Although stents work well mechanically, the chronic issues of restenosis and, to a lesser extent, stent thrombosis remain. Pharmacological therapy in the form of a drug delivery stent appears to be a feasible means to tackle these issues. Subacute thrombosis and neointimal hyperplasia are considered to be the leading complications after stenting. Various factors are believed to be involved in the process. Methods for reducing thrombosis and restenosis have been previously proposed. However, those methods are less satisfactory for reducing thrombosis or restenosis associated with stenting.

[0007] The embodiments disclosed herein address the above described problems.

SUMMARY OF THE INVENTION

[0008] Provided herein is a coating that includes an antioxidant for a medical device. The coating includes a polymer matrix, an antioxidant, and optionally heparin or a bioactive agent. In some embodiments, the coating can include a biobeneficial material. The coating can be biodegradable or nondegradable. In some embodiments, the medical device can be a stent. In some embodiments, the stent, itself, can be a polymeric biodegradable, bioerodable or bioabsorbable stent, terms which are used interchangeably unless specifically indicated, which can include the bioactive agent embedded in the body of the stent or coating in the stent.

[0009] In some embodiments, the antioxidant can be embedded within the coating of the body of the medical device. In some embodiments, the antioxidant can be attached to the surface of the coating or surface of the medical device.

[0010] In some embodiments, a coating or device can include two ore more antioxidants, at least one of the antioxidant can be butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), Vitamin E, a super-oxide dismutase mimetic (SODm), or combinations thereof.

[0011] Some examples of the bioactive agent that can be included in the coating or medical device include, but are not limited to, paclitaxel, docetaxel, estradiol, nitric oxide donors, super oxide dismutases, super oxide dismutases mimics, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), tacrolimus, dexamethasone, rapamycin, rapamycin derivatives, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, and 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), pimecrolimus, imatinib mesylate, midostaurin, clobetasol, mometasone, CD-34 antibody, abciximab (REOPRO), progenitor cell capturing antibody, prohealing drugs, prodrugs thereof, co-drugs thereof, or a combination thereof.

[0012] The medical device having the features described herein can be used for treating, preventing, or ameliorating a medical condition such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation (for vein and artificial grafts), bile duct obstruction, ureter obstruction, tumor obstruction, or combinations of these.

DETAILED DESCRIPTION

[0013] Provided herein is a coating that includes an antioxidant for a medical device. The coating includes a polymer matrix, an antioxidant, and optionally heparin or a bioactive agent. In some embodiments, the coating can include a biobeneficial material. The coating can be biodegradable or nondegradable. In some embodiments, the medical device can be a stent. In some embodiments, the stent, itself, can be a polymeric biodegradable, bioerodable or bioabsorbable stent, terms which are used interchangeably unless specifically indicated, which can include the bioactive agent embedded in the body of the stent or coating in the stent.

[0014] In some embodiments, the antioxidant can be embedded within the coating of the body of the medical device. In some embodiments, the antioxidant can be attached to the surface of the coating or surface of the medical device.

[0015] In some embodiments, a coating or device can include two ore more antioxidants, at least one of the antioxidant can be BHT, BHA, Vitamin E, a SODm, or combinations thereof.

[0016] Some examples of the bioactive agent that can be included in the coating or medical device include, but are not limited to, paclitaxel, docetaxel, estradiol, nitric oxide donors, super oxide dismutases, super oxide dismutases mimics, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), tacrolimus, dexamethasone, rapamycin, rapamycin derivatives, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, and 40-O-tetrazole-rapamycin, 40-epi-(N1-tetrazolyl)-rapamycin (ABT-578), pimecrolimus, imatinib mesylate, midostaurin, clobetasol, mometasone, CD-34 antibody, abciximab (REOPRO), progenitor cell capturing antibody, prohealing drugs, prodrugs thereof, co-drugs thereof, or a combination thereof.

[0017] The medical device having the features described herein can be used for treating, preventing, or ameliorating a medical condition such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation (for vein and artificial grafts), bile duct obstruction, ureter obstruction, tumor obstruction, or combinations of these.

Antioxidants

[0018] As used herein, the term "antioxidant" refers to a substance that is capable of inhibiting, preventing, reducing or ameliorating oxidative reactions on another substance (e.g., a polymer, a bioactive agent or a therapeutic substance) when the antioxidant is used in a system (e.g., coating) that includes such other substances. An example of such "antioxidant" is oxygen scavenger.

[0019] The antioxidant useful in the present invention can be any volatile or non-volatile antioxidant, which can be natural or synthetic. Natural antioxidant refers to an antioxidant derived from a natural source, with or without modification. Synthetic antioxidant refers to any antioxidant that is not a natural antioxidant. For example, ascorbic acid (Vitamin C) can be a natural antioxidant. BHT, BHA, or a SODm can be a synthetic antioxidant.

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Sectional crimped graft
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Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

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