Drug coated balloon catheters for nonvascular strictures

• US 10,675,386 B2
• Filed: 02/05/2019
• Issued: 06/09/2020
• Est. Priority Date: 10/26/2012
• Status: Active Grant

• Current Assignee: Urotronic Inc
• Original Assignee: Urotronic Inc
• Inventors: Wang, Lixiao
• Primary Examiner(s): Azpuru, Carlos A
• Assistant Examiner(s): Hagopian, Casey S
• Application Number:
  US16/267,434
• Publication Number:
  US 20190167854A1
• Time in Patent Office: 490 Days
• Field of Search: None
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Embodiments of the present invention provide a method for treatment of nonvascular body lumen strictures such as benign prostatic hyperplasia (BPH), urethral strictures, ureteral strictures, prostate cancer, esophageal strictures, sinus strictures, biliary tract strictures, asthma and chronic obstructive pulmonary disease (COPD). The method involves delivering, preferably via drug coated balloon catheters, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues) and one or more additives.

Claims

1. A method for treating sinusitis, a sinus stricture, or a nasal lumen, the method comprising:

inserting a balloon catheter into a target site, wherein the target site is the sinus stricture or the nasal lumen, the balloon catheter comprising

a coating layer overlying an exterior surface of a balloon that is inflatably expandable, the coating layer comprising

an initial drug load comprising a therapeutic agent chosen from rapamycin, a rapamycin analogue, and a combination thereof, wherein the initial drug load has a density of the therapeutic agent in the coating layer of 1 to 20 μ

g per mm² of the exterior surface of the balloon, and

an additive comprising

a water-soluble first additive that comprises more than one hydroxyl group, wherein the water-soluble first additive has a molecular weight of 50 to 750; and

a water-soluble second additive that is different than the first water-soluble additive and that comprises more than one hydroxyl group, wherein the water-soluble second additive has a molecular weight of 750 to 1,000;

inflating the balloon at least until the coating layer contacts walls of the target site to transfer at least some of the coating layer to the walls of the target site, wherein the coating layer contacts the walls of the target site for an inflation period that is from 0.1 minutes to 30 minutes;

deflating the balloon at completion of the inflation period; and

withdrawing the balloon catheter from the target site, wherein after the withdrawing of the balloon catheter from the target site the balloon has thereon a residual drug amount that is less than or equal to 45% of the initial drug load, and after the inflation period the walls of the target site comprise an amount of the therapeutic agent that is 0.1% to 25% of the initial drug load.

2. The method of claim 1, wherein after the withdrawing of the balloon catheter from the target site the balloon has thereon a residual drug amount that 2 to 45% of the initial drug load, and wherein after the inflation period the walls of the target site comprise an amount of the therapeutic agent that is 2% to 25% of the initial drug load.

3. The method of claim 1, wherein during the transferring of the coating layer to the walls of the target site, the coating layer makes uniform direct pressure contact with the walls of the target site.

4. The method of claim 1, wherein the additive further comprises an excipient, a natural product or derivative thereof, an oligomer, a surfactant, or a combination thereof.

5. The method of claim 1, wherein the additive further comprises a polysorbate, polyethylene glycol, polypropylene glycol, polyvinyl pyrrolidinone, a glycerol fatty acid ester, a fatty acid, a poloxamer, 2-hydroxypropyl cyclodextrin, sucrose monopalmitate, sucrose monolaurate, glycerol, an alcohol, a propylene glycol fatty acid ester, cellulose, polycaprolactone, a polyester, a polyurethane, a polylactic acid-polyethylene oxide copolymer, or a combination thereof.

6. The method of claim 1, wherein the additive further comprises a polysorbate, polyethylene glycol, polyvinyl pyrrolidinone, a glycerol fatty acid ester, or a combination thereof.

7. The method of claim 1, wherein the additive further comprises polyvinyl pyrrolidone.

8. The method of claim 1, wherein the additive further comprises a polysorbate.

9. The method of claim 8, wherein the polysorbate is a PEG sorbitan fatty ester, a PEG sorbitan monolaurate, a PEG sorbitan monopalmitate, a PEG sorbitan monooleate, a PEG sorbitan monostearate, PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monooleate, PEG-20 sorbitan monostearate, or a combination thereof.

10. The method of claim 1, wherein the additive further comprises a glycerol fatty acid ester.

11. The method of claim 1, wherein the additive further comprises a polysorbate and polyethylene glycol.

12. The method of claim 1, wherein a ratio of the additive to the initial drug load in the coating layer by weight is 20:

1 to 0.05;

1.

13. The method of claim 1, wherein a ratio of the additive to the initial drug load in the coating layer by weight is 10:

1 to 0.5;

1.

14. The method of claim 1, wherein the ratio of the additive to the initial drug load in the coating layer by weight is 5:

1 to 0.8;

1.

15. The method of claim 1, wherein the initial drug load has a density of the therapeutic agent in the coating layer of 2 to 10 μ

g per mm² of the exterior surface of the balloon.

16. The method of claim 1, wherein the initial drug load has a density of the therapeutic agent in the coating layer of 2 to 6 μ

g per mm² of the exterior surface of the balloon.

17. The method of claim 1, wherein the coating layer has a uniform thickness.

18. The method of claim 1, wherein the balloon has a uniform circular cross-section perpendicular to a longitudinal direction of the balloon.

19. The method of claim 1, wherein the target site is the sinus stricture.

20. The method of claim 1, wherein the method is a method for treating sinusitis.

21. The method of claim 1, wherein the method is a method of treating a nasal lumen, wherein the target site is the nasal lumen.