Biocompatible medical devices

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S272000

Reexamination Certificate

active

06663606

ABSTRACT:

FIELD OF THE INVENTION
The present application relates to medical devices for delivery of pharmaceutically active materials. More specifically, the present invention relates to methods and compositions effective to prevent reduction in the activity of pharmaceutically active materials arising from contact with metallic or polymeric components of medical devices.
BACKGROUND OF THE INVENTION
Medical devices having metallic and polymeric components are used extensively in the medical field. In many cases the medical device is used for delivery of a pharmaceutically active material, and the pharmaceutically active material comes into contact with the metallic or polymeric component during the course of delivery of the pharmaceutically active material.
For example, metallic lumens are frequently used to carry pharmaceutically active materials to various bodily tissues. As another example, metallic stents having a drug delivery polymer coating thereon are used for delivery of pharmaceutically active materials. In both examples, the pharmaceutically active material contacts the metallic component. Metallic components such as stainless steel and nickel-titanium superelastic alloys (e.g., nitinol), cobalt based alloys and super-alloys are commonly used for this purpose as they are formable, have desirable mechanical properties and are commonly believed to be substantially inert.
Moreover, polymeric materials such as polycarbonate, polyimide, acrylonitrile/butadiene/styrene resins (ABS), poly ether ether ketone (PEEK), epoxy and nylon also commonly contact pharmaceutically active materials in connection with their use as catheters, stents, manifolds, stop-cocks, needle materials, and so forth.
The present inventors, however, have found that such materials are relatively incompatible with certain pharmaceutically active materials. As a result, there is at present a need in the art to overcome this incompatibility.


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