主权项 |
1. A method of delivering a bioactive to a point of treatment within a body vessel, the method comprising the steps of:
positioning a balloon catheter at said point of treatment within said body vessel, the balloon catheter including a catheter shaft having an inflation lumen and a fluid delivery lumen, a deflated inner balloon mounted on the catheter shaft and in communication with the inflation lumen, a compressed outer balloon mounted around at least a portion of the inner balloon, the outer balloon including a plurality of apertures and the inner balloon not including any apertures, the inner balloon and the outer balloon being configured and oriented such that an annular lumen is defined between the inner and outer balloons when the inner balloon is in an inflated configuration and the outer balloon is in an expanded configuration, the annular lumen being in communication with the fluid delivery lumen and the plurality of apertures; and a first composition comprising a bioactive disposed on a portion of a surface of at least one of the outer balloon and the inner balloon; inflating the inner balloon to the inflated configuration to place the outer balloon in contact with a wall of said body vessel; introducing a second composition comprising a carrier that enhances the elution rate of the bioactive compared to saline for a time period of 2 to 10 minutes, wherein the carrier is a diagnostic x-ray contrast medium, the second composition being introduced through the fluid delivery lumen and the annular lumen to move the outer balloon to the expanded configuration at a pressure effective to deliver the second composition to said body vessel wall through the apertures of the outer balloon; and maintaining contact of the outer balloon with said body vessel wall for a time sufficient to deliver a therapeutically effective amount of bioactive to said treatment site within said body vessel wall.
|