Coatings for Medical Devices Comprising a Therapeutic Agent and a Metallic Material

Abstract

The invention relates generally to an implantable medical device for delivering a therapeutic agent to the body tissue of a patient, and a method for making such a medical device. In particular, the invention pertains to an implantable medical device, such as an intravascular stent, having a coating comprising a first coating composition comprising a therapeutic agent and, optionally, a polymer; and a second coating composition comprising a metallic material.

Description

FIELD OF THE INVENTION[0001]The invention relates generally to implantable medical devices for delivering a therapeutic agent to the body tissue of a patient, and methods for making such medical devices. In particular, the invention pertains to implantable medical devices, such as intravascular stents, having a coating comprising a first coating composition comprising a therapeutic agent and a second coating composition comprising a metallic material.BACKGROUND OF THE INVENTION[0002]Medical devices have been used to deliver therapeutic agents locally to the body tissue of a patient. For example, intravascular stents comprising a therapeutic agent have been used to locally deliver therapeutic agents to a blood vessel. Often such therapeutic agents have been used to prevent restenosis. Examples of stents comprising a therapeutic agent include stents that comprise a coating containing a therapeutic agent for delivery to a blood vessel. Studies have shown that stents having a coating wi...

AI Technical Summary

Benefits of technology

[0006]These and other objectives are accomplished by the present invention. The present invention provides a medical device, such as an implantable, intravascular stent comprising a coating. The coating is designed to eliminate or at least reduce the amount of polymer contact with the body tissue, such as a body lumen, while still providing a suitable release rate of the therapeutic agent. The coating comprises a first coating composition comprising a therapeutic agent and a second coating composition comprising a metallic material. Optionally, the first coating composition can further comprise a polymer.

[0007]The coating can comprise a first coating composition comprising a therapeutic agent, disposed on the surface of a medical device; and a second coating composition, which comprises a metallic material and which is substantially free of any polymer, disposed on at least a portion of the first coating composition. Metallic materials are materials containing a metal including but not limited to, metals alloys and oxides. As used herein and unless otherwise defined the phrase “substantially free of any polymer” means having less than or equal to 50% of polymer by volume of the composition. With such coatings, polymer contact with the body lumen is reduced or eliminated.

Problems solved by technology

However, the use of polymers in medical device coatings can also have some disadvantages.

For example, depending on the type of polymer used to coat the medical device, some polymers can cause inflammation of the body lumen, offsetting the effects of the therapeutic agent.

Additionally, some polymers may also cause thrombosis.

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