Drug-coated balloon catheters for body lumens

A method for treating a body lumen stricture, the method comprising:

• flushing the body lumen stricture with water, saline solution, or a water solution comprising at least one water soluble additive, wherein the body lumen stricture is a urethral stricture, a ureteral stricture, or a benign prostatic hyperplasia (BPH) stricture;
• inserting a balloon catheter into a target site in the body lumen stricture prior to, during, or after the flushing of the body lumen stricture, the balloon catheter comprising
• an elongated balloon having a main diameter, wherein the elongated balloon has a length of about 20 mm to about 160 mm, and
• a coating layer overlying an exterior surface of the balloon, wherein the coating layer comprises one or more water-soluble additives and an initial drug load of a therapeutic agent, wherein
• the one or more water-soluble additives in the drug coating comprise pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4),
• the therapeutic agent comprises paclitaxel, and
• in the coating layer a mass ratio of the paclitaxel to the pentaerythritol ethoxylate (15/4) and the pentaerythritol ethoxylate (3/4) is 1:5.5 to 10:1 and a mass ratio of the pentaerythritol ethoxylate (15/4) to the pentaerythritol ethoxylate (3/4) is 1:40 to 7.5:1;
• inflating the balloon until the coating layer contacts walls of the body lumen at the target site and the balloon achieves an inflated balloon diameter for an inflation period, wherein
• a) the inflating comprises inflating the balloon to a pressure equal to or greater than a nominal pressure of the balloon catheter, or
• b) the inflating comprises inflating to a pressure greater than the nominal pressure of the balloon catheter, and the nominal diameter of the balloon catheter is less than the inflated balloon diameter, or
• c) any combination of (a) and (b);
• deflating the balloon after the inflation period;
• and
• withdrawing the balloon catheter from the body lumen.