Drug-coated balloon catheters for body lumens

1. 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 or a benign prostatic hyperplasia (BPH) stricture;

inserting a balloon catheter with a drug coating comprising an initial drug load of a therapeutic agent into a body lumen such that the balloon catheter is in the body lumen stricture, the balloon catheter comprising an elongated balloon having a main diameter, the elongated balloon comprising at least one neck section, the balloon comprising a first main section and a second main section on opposite sides of the neck section;

inflating the balloon catheter 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 stricture in the body lumen is dilated to a desired diameter, 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;

keeping the balloon inflated to release the therapeutic agent into tissue;

deflating the balloon catheter; and

withdrawing the balloon catheter from the body lumen.

2. The method of claim 1 , wherein the body lumen stricture is the urethral stricture.

3. The method of claim 1 , wherein the body lumen stricture is the benign prostatic hyperplasia stricture.

4. The method of claim 1 , wherein the drug coating is on the first main section and the neck.

5. The method of claim 1 , wherein the inserting is prior to, during, or after the flushing of the body lumen stricture.

6. The method of claim 1 , wherein the flushing is prior to the inserting of the balloon catheter into the body lumen stricture.

7. The method 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.

8. The method of claim 1 , wherein the drug coating further comprises one or more water-soluble additives.

9. The method of claim 1 , wherein the water-soluble additive comprises pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, 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, polyethylene glycol (PEG) caprylic/capric diglycerides, PEG-8 caprylic/capric glycerides, PEG caprylate, PEG-8 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, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, or combinations thereof.

10. The method of claim 1 , further comprising, prior to the step of inserting the balloon catheter with a drug coating,

inserting an uncoated balloon catheter into the body lumen stricture;

inflating the uncoated balloon catheter until the balloon contacts the walls of the body lumen stricture;

deflating the uncoated balloon; and

withdrawing the uncoated balloon from the body lumen.

11. The method of claim 1 , wherein the inflating of the balloon and the increasing of the pressure in the balloon until the lumen is dilated to the desired diameter comprises:

inflating the balloon catheter to an initial pressure and maintaining the initial pressure until the pressure no longer drops;

inflating to a next higher pressure above the initial pressure and maintaining the next higher pressure until the pressure inside the balloon no longer drops; and

repeating the inflating to the next higher pressure and the maintaining until the lumen is dilated to the desired diameter.

12. The method of claim 1 , wherein the balloon catheter has a ratio of inflated balloon diameter to normative body lumen diameter at the stricture of 1.31 to 10.

13. The method of claim 1 , wherein the balloon catheter has a stretch ratio of the nominal balloon diameter to the normative body lumen diameter at the stricture of 1.31 to 10, or a combination thereof.

14. The method of claim 1 , wherein the inflating comprises inflating the first section, the second section, and the neck section of the balloon simultaneously via a single inflation lumen.

15. The method of claim 1 , wherein the at least one neck section comprises a reinforcing material around a circumference of the neck section to reduce compliance of the neck section during the inflation, the reinforcing material comprising a suture, monofilament, or multifilament, wherein the reinforcing material comprises nylon, a polyamide, an aromatic polyamide, ultra high molecular weight polyethylene (UHMWPE), a polyester, an aromatic polyester, polyethylene terephthalate (PET), or a combination thereof.

16. The method of claim 1 , wherein the method is a method of increasing Q max , wherein the method increases Q max to a minimum of 15 mL/s.

17. The method of claim 1 , wherein the method is a method decreasing International Prostate Symptom Score (IPSS), wherein the method decreases the IPSS to 14 or less.

18. The method of claim 1 , wherein the method is a method for treating benign prostatic hyperplasia, wherein:

the body lumen stricture is the benign prostatic hyperplasia stricture,

the method splits the prostatic urethra and prostate,

prostatic urethra diameter after dilation is at least 12 mm, and

the inflated diameter of the balloon catheter is at least 25 mm.

19. The method of claim 1 , wherein the method is a method for treating a urethral stricture, wherein:

the body lumen stricture is the urethral structure,

the urethra diameter after dilation is at least 6.7 mm, and

the inflated diameter of the balloon catheter is at least 7 mm.

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

inserting a drug coated balloon catheter into 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 at least one neck section, the balloon comprising a first main section and a second main section on opposite sides of the neck section, the drug coating comprising an initial drug load of a therapeutic agent;

flushing the prostatic urethra with water, saline solution, or a water solution comprising at least one water soluble additive;

putting the 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 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;

keeping the balloon inflated to release the therapeutic agent into tissue;

deflating the balloon catheter; and

withdrawing the balloon catheter from the prostatic urethra.

21. The method of claim 20 , 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).

22. The method of claim 20 , wherein the drug coating is on the first main section and the neck.

23. The method of claim 20 , 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.

24. The method of claim 20 , wherein the drug coating further comprises one or more water-soluble additives.

25. The method of claim 24 , wherein the one or more water-soluble additives comprise pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, 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, polyethylene glycol (PEG) caprylic/capric diglycerides, PEG-8 caprylic/capric glycerides, PEG caprylate, PEG-8 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, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, or combinations thereof.

26. The method of claim 20 , wherein the at least one neck section comprises a reinforcing material around a circumference of the neck section to reduce compliance of the neck section during the inflation.

27. The method of claim 26 , wherein the reinforcing material comprising a suture, monofilament, or multifilament, wherein the reinforcing material comprises nylon, a polyamide, an aromatic polyamide, ultra high molecular weight polyethylene (UHMWPE), a polyester, an aromatic polyester, polyethylene terephthalate (PET), or a combination thereof.

28. The method of claim 20 , wherein the inflating comprises inflating the first main section, the neck, and the second main section of the balloon simultaneously via a single inflation lumen.

29. The method of claim 20 , further comprising, prior to the step of inserting the balloon catheter with a drug coating,

inserting an uncoated balloon catheter into the prostatic urethra;

inflating the uncoated balloon catheter until the balloon contacts the walls of the prostatic urethra;

deflating the uncoated balloon; and

withdrawing the uncoated balloon from the prostatic urethra.

30. A method for treating benign prostatic hyperplasia (BPH), the method comprising:

flushing a prostatic urethra with water, saline solution, or a water solution comprising at least one water soluble additive;

inserting a balloon catheter with a drug coating comprising an initial drug load of a therapeutic agent into the prostatic urethra, the balloon catheter comprising an elongated balloon having a main diameter, the elongated balloon comprising at least one neck section, the balloon comprising a first main section and a second main section on opposite sides of the neck section;

inflating the balloon catheter 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 prostatic urethra is dilated to a desired diameter, 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;

keeping the balloon inflated to release the therapeutic agent into tissue;

deflating the balloon catheter; and

withdrawing the balloon catheter from the prostatic urethra.