Patent ID: 8241249

Claim:
A balloon catheter for delivering a therapeutic agent to a target site of a blood vessel, the balloon catheter comprising: a coating layer overlying an exterior surface of a balloon, wherein: the coating layer comprises an initial drug load of a hydrophobic therapeutic agent, and a combination of a water-soluble first additive and a water-soluble second additive; the coating layer does not include an iodine covalent-bonded contrast agent, a dye, an oil, or a lipid; the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel, paclitaxel analogues, rapamycin, rapamycin analogues, and combinations thereof; the hydrophobic therapeutic agent is not enclosed in micelles or liposomes and is not encapsulated in polymer particles; the water-soluble first additive is a surfactant selected from the group consisting of PEG sorbitan monolaurates, PEG sorbitan monooleates, and combinations thereof; the water-soluble second additive is a chemical compound having at least four hydroxyl groups, the chemical compound being selected from the group consisting of sorbitol, sorbitan, xylitol, gluconolactone, and combinations thereof, whereby the combination of the water-soluble first additive and the water-soluble second additive promotes a rapid release of the hydrophobic therapeutic agent from the balloon, and whereby the rapid release comprises a residual drug amount of the hydrophobic therapeutic agent remaining on the balloon after the balloon is inflated at the target site of the blood vessel for an inflation period of from about 0.1 minutes to 10 minutes and subsequently removed from the blood vessel.