Drug releasing coatings for medical devices

• US 9,737,640 B2
• Filed: 05/13/2016
• Issued: 08/22/2017
• Est. Priority Date: 11/20/2006
• Status: Active Grant

• Current Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Inventors: Wang, Lixiao
• Primary Examiner(s): ZISKA, SUZANNE E
• Application Number:
  US15/154,570
• Publication Number:
  US 20160250388A1
• Time in Patent Office: 466 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61L 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• 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 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• 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: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

Medical device are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

Claims

1. A balloon catheter for delivering a therapeutic agent to a target site of a body lumen chosen from an esophagus, an airway, a sinus, a trachea, a colon, a biliary tract, a urinary tract, or a prostate, the balloon catheter comprising a balloon and a coating layer overlying external surfaces of the balloon, wherein:

the coating layer consists essentially of a water-soluble first additive, a water soluble second additive, and a hydrophobic therapeutic agent;

the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, everolimus, docetaxel, daunorubicin, doxorubicin, beta-lapachone, biologically active vitamin D, and combinations thereof;

the water-soluble first additive is selected from the group consisting of gluconolactone, PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates; and

the water-soluble second additive is selected from the group consisting of sorbitol, sorbitan, xylitol, lactobionic acid, and combinations thereof.

2. The balloon catheter of claim 1, wherein the water-soluble first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate.

3. The balloon catheter of claim 1, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is selected from the group consisting of PEG-20 sorbitan monolaurate and PEG-20 sorbitan monooleate.

4. The balloon catheter of claim 1, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is gluconolactone.

5. The balloon catheter of claim 1, wherein:

the water-soluble first additive is selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates.

6. The balloon catheter of claim 5, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is PEG-20 sorbitan monooleate; and

the water-soluble second additive is sorbitol.

7. A method for treating a diseased body lumen, the method comprising:

inserting a balloon catheter into a diseased body lumen to a target site in the diseased body lumen, the diseased body lumen chosen from an esophagus, an airway, a sinus, a trachea, a colon, a biliary tract, a urinary tract, or a prostate, the balloon catheter comprising a balloon and a coating layer overlying external surfaces of the balloon, wherein;

the coating layer consists essentially of a water-soluble first additive, a water soluble second additive, and a hydrophobic therapeutic agent;

the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, everolimus, docetaxel, daunorubicin, doxorubicin, beta-lapachone, biologically active vitamin D, and combinations thereof; and

the water-soluble first additive is selected from the group consisting of gluconolactone, PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates; and

the water-soluble second additive is selected from the group consisting of sorbitol, sorbitan, xylitol, lactobionic acid, and combinations thereof;

inflating the balloon catheter until the coating layer contacts walls of the diseased body lumen at the target site and releases therapeutic agent to the walls of the diseased body lumen;

deflating the balloon catheter; and

withdrawing the balloon catheter from the diseased body lumen.

8. The method of claim 7, wherein the diseased body lumen is a urinary tract.

9. The method of claim 8, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is gluconolactone.

10. The method of claim 8, wherein:

the water-soluble first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate.

11. The method of claim 8, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is PEG-20 sorbitan monooleate; and

the water-soluble second additive is sorbitol.

12. The method of claim 7, wherein the diseased body lumen is a lumen of a prostate.

13. The method of claim 12, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is gluconolactone.

14. The method of claim 12, wherein:

the water-soluble first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate.

15. The method of claim 12, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is PEG-20 sorbitan monooleate; and

the water-soluble second additive is sorbitol.

16. The method of claim 7, wherein the diseased body lumen is an airway or a sinus.

17. The method of claim 16, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is gluconolactone.

18. The method of claim 16, wherein:

the water-soluble first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate.

19. The method of claim 16, wherein:

the hydrophobic therapeutic agent is paclitaxel; and

the water-soluble first additive is PEG-20 sorbitan monooleate; and

the water-soluble second additive is sorbitol.