BALLOON CATHETERS FOR BODY LUMENS

1 . A system comprising:

a balloon catheter in a stricture or stenosis of a body lumen, the balloon catheter comprising

an elongated balloon; and

a coating layer overlying external surfaces of the balloon, the coating layer comprising at least one additive and a therapeutic agent;

wherein the balloon is being inflated to contact the coating layer with the stricture or stenosis; and

a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope;

wherein the inflation of the balloon to contact the coating layer with the stricture or stenosis is visualizable via the scope.

2 . The system of claim 1 , wherein the balloon catheter and the scope are positioned side-by-side.

3 . The system of claim 1 , wherein the balloon catheter is loaded into the scope.

4 . The system of claim 1 , wherein the scope comprises an endoscope, enteroscope, colonoscope, sigmoidoscope, rectoscope, anoscope, rhinoscope, bronchoscope, or a cystoscope.

5 . The system of claim 1 , wherein the stricture or stenosis is in the esophagus, airways, sinus, trachea, colon, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, rectum, large intestine, urinary tract, prostatic urethra, urethra, or ureter.

6 . The system of claim 1 , wherein the one or more additives in the coating layer comprise N-acetylglucosamine, N-octyl-D-gluconamide, N-nonanoyl-N-methylglycamine, N-octanoyl-N-methyl glutamine, C6-ceramide, dihydro-C6-ceramide, cerabroside, sphingomyelin, galaclocerebrosides, lactocerebrosides, N-acetyl-D-sphingosine, N-hexanoyl-D-sphingosine, N-octonoyl-D-sphingosine, N-lauroyl-D-sphingosine, N-palmitoyl-D-sphingosine, N-oleoyl-D-sphingosine, PEG caprylic/capric diglycerides, PEG8 caprylic/capric glycerides, PEG caprylate, PEG8 caprylate, PEG caprate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, monolaurin, monocaprin, monocaprylin, monomyristin, monopalmitolein, monoolein, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthosine, xanthosine monophosphate, caffeine, allantoin, (2-hydroxyethyl)urea, N,N′-bis(hydroxymethyl)urea, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, or combinations thereof.

7 . The system of claim 1 , wherein the one or more additives in the coating layer comprises pentaerythritol ethoxylate (15/4), pentaerythritol ethoxylate (¾), or a combination thereof.

8 . The system of claim 1 , 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.

9 . The system of claim 1 , wherein the coating layer is hydrated.

10 . The system of claim 9 , wherein the coating layer is soaked or flushed with a solution comprising water or saline to form the hydrated coating layer.

11 . A system comprising:

a balloon catheter in a stricture or stenosis of a body lumen, the balloon catheter comprising an elongated balloon, wherein the balloon is in a deflated state after inflation to contact a coating layer overlaying external surfaces of the inflated balloon with the stricture or stenosis, the coating layer on the inflated balloon comprising at least one additive and an initial drug load of a therapeutic agent; and

a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope;

wherein the therapeutic agent that deposited during the inflation of the balloon from the external surfaces of the balloon onto the stricture or stenosis during the inflating is visualizable via the scope.

12 . The system of claim 9 , wherein the balloon catheter and the scope are positioned side-by-side.

13 . The system of claim 9 , wherein the balloon catheter is loaded into the scope.

14 . The system of claim 9 , wherein the stricture or stenosis comprises is in the esophagus, airways, sinus, trachea, colon, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, rectum, large intestine, urinary tract, prostatic urethra, urethra, or ureter.

15 . The system of claim 9 , wherein the one or more additives in the coating layer comprise N-acetylglucosamine, N-octyl-D-gluconamide, N-nonanoyl-N-methylglycamine, N-octanoyl-N-methyl glutamine, C6-ceramide, dihydro-C6-ceramide, cerabroside, sphingomyelin, galaclocerebrosides, lactocerebrosides, N-acetyl-D-sphingosine, N-hexanoyl-D-sphingosine, N-octonoyl-D-sphingosine, N-lauroyl-D-sphingosine, N-palmitoyl-D-sphingosine, N-oleoyl-D-sphingosine, PEG caprylic/capric diglycerides, PEG8 caprylic/capric glycerides, PEG caprylate, PEG8 caprylate, PEG caprate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, monolaurin, monocaprin, monocaprylin, monomyristin, monopalmitolein, monoolein, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthosine, xanthosine monophosphate, caffeine, allantoin, (2-hydroxyethyl)urea, N,N′-bis(hydroxymethyl)urea, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, or combinations thereof.

16 . The system of claim 9 , wherein the one or more additives in the coating layer comprises pentaerythritol ethoxylate (15/4), pentaerythritol ethoxylate (¾), or a combination thereof.

17 . The system of claim 9 , 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.

18 . The system of claim 9 , wherein the contacting of the coating layer and the stricture or stenosis is sufficient to release 37% to 97% of the initial drug load

19 . The system of claim 9 , wherein the coating layer is hydrated.

20 . The system of claim 19 , wherein the coating layer is soaked or flushed with a solution comprising water or saline to form the hydrated coating