Coated implantable medical device

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure

Reexamination Certificate

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Details

C623S001430, C623S001460, C623S023740, C623S023760

Reexamination Certificate

active

06918927

ABSTRACT:
A medical device (10) includes a structure (12) adapted for introduction into a patient, the structure (12) being formed of a preferably non-porous base material (14) having a roughened or textured surface (16). The structure (12) is conveniently configured as a vascular stent with a base material (14) of stainless steel, nitinol or another suitable material. The medical device (10) also includes a layer (18) of a bioactive material posited directly upon the roughened or textured surface (16) of the base material (14) of the structure (12). The surface (16) of the base material (14) is roughened or textured by etching or by abrasion with sodium bicarbonate or another suitable grit. A preferred roughened or textured surface (16) is thought to have a mean surface roughness of about 10 μin. (about 250 nm) and a surface roughness range between about 1 μin. and about 100 μin. (about 25 nm and about 2.5 μm). The particularly preferred use of sodium bicarbonate as the abrasive to provide roughness or texture to the surface (16) of the base material (14) of the structure (12) is additionally advantageous in the low toxicity of the sodium bicarbonate to production workers, the ease of product and waste cleanup, and the biocompatibility of any residual sodium bicarbonate.

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