Drug-coated balloon catheters for body lumens

A method of splitting an enlarged prostate or creating a commissurotomy for treating benign prostatic hyperplasia comprising:

• inserting a scope and a drug coated balloon catheter into the prostatic urethra prior to, during, or after the flushing of the prostatic urethra with water, wherein the drug coated balloon catheter comprises a balloon catheter with a drug coating, the balloon catheter comprising an elongated balloon having a main diameter, the elongated balloon comprising a proximal waist, a distal waist, and at least one neck section, the balloon comprising a first main section and a second main section on opposite sides of the neck section, wherein the drug coating is on the first main section and the neck, the drug coating comprising one or more water-soluble additives and an initial drug load of a therapeutic agent, and wherein
• the therapeutic agent comprises paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, sirolirnus, a sirolimus analogue, everolimus, an everolimus analogue, tacrolimus, a tacrolimus analogue, mammalian target of rapamycin (mTOR) inhibitors;
• an mTOR inhibitor analogue, or a combination thereof;
• flushing the prostatic urethra with water;
• saline solution, or a water solution comprising at least one water soluble additive;
• putting the scope and balloon catheter near the external sphincter;
• inflating the balloon in the prostatic urethra such that the first main section of the balloon catheter is in the prostatic urethra, the second main section of the balloon catheter is in the bladder, and the neck section is in the bladder neck, until the pressure drops, prostatic urethra tissue yields, and the commissurotomy is created, wherein the at least one neck section comprises an inflated diameter that is smaller than the main diameter when the balloon is inflated, during the inflating the inflated diameter of the neck section is the smallest diameter of the balloon catheter between the first main section and the second main section, during the inflating the inflated diameter of the neck section is greater than a diameter of the neck section prior to the inflation, and the at least one neck section comprises an area of reduced compliance during inflation relative to the first main section and the second main section;
• increasing the pressure further to dilate the prostatic urethra more;
• keeping the balloon inflated for 1 minute to 7 days to release the therapeutic agent into tissue;
• deflating the balloon catheter;
• and
• withdrawing the scope and balloon catheter from the prostatic urethra, 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).

A method of splitting an enlarged prostate or creating a commissurotomy for treating benign prostate hyperplasia comprising:

• inserting a scope and an uncoated balloon catheter into the prostatic urethra;
• inflating the balloon in the prostatic urethra until the pressure drops, prostatic urethra tissue yields, and the commissurotomy is created;
• increasing the pressure further to dilate the prostatic urethra more;
• keeping the balloon inflated for 1 minute to 7 days;
• deflating the uncoated balloon catheter;
• withdrawing the uncoated balloon catheter from the body prostatic urethra;
• flushing the prostatic urethra with water, saline solution, or a water solution comprising at least one water soluble additive;
• inserting a drug coated balloon catheter into the prostatic urethra prior to, during, or after the flushing of the prostatic urethra, wherein the drug coated balloon catheter comprises a balloon catheter with a drug coating, the balloon catheter comprising an elongated balloon having a main diameter, the elongated balloon comprising a proximal waist, a distal waist, and at least one neck section, the balloon comprising a first main section and a second main section on opposite sides of the neck section, wherein the drug coating is on the first main section and the neck, the drug coating comprising one or more water-soluble additives and an initial drug load of a therapeutic agent, the at least one neck section comprising a reinforcing material around a circumference of the neck section to reduce compliance of the neck section during the inflation, wherein the inflating comprises inflating the the first main section, the neck, and the second main section of the balloon simultaneously via a single inflation lumen, and wherein
• the therapeutic agent comprises paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, sirolimus, a sirolimus analogue, everolimus, an everolimus analogue;
• tacrolimus, a tacrolimus analogue, mammalian target of rapamycin (mTOR) inhibitors, an mTOR inhibitor analogue, or a combination thereof;
• positioning the scope and drug coated balloon catheter near the external sphincter;
• inflating such that the first main section of the balloon catheter is in the prostatic urethra;
• the second main section of the balloon catheter is in the bladder, and the neck section is in the bladder neck, to dilate the prostate;
• wherein the at least one neck section comprises an inflated diameter that is smaller than the main diameter when the balloon is inflated, during the inflating the inflated diameter of the neck section is the smallest diameter of the balloon catheter between the first main section and the second main section, and during the inflating the inflated diameter of the neck section is greater than a diameter of the neck section prior to the inflation;
• and
• keeping the balloon inflated for 1 minute to 7 days to release the therapeutic agent into tissue, 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).