Drug releasing coatings for balloon catheters

• US 9,737,691 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:
  US15/154,669
• Publication Number:
  US 20160250453A1
• Time in Patent Office: 466 Days
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2300/416 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 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 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

Abstract

Balloon catheters, methods for preparing balloon catheters, and uses of balloon catheters are disclosed. The balloon catheter includes an elongate member, an expandable balloon, and a coating layer overlying an exterior surface of the expandable balloon. The coating layer includes a total drug load of a hydrophobic therapeutic agent and a combination of additives including a first additive and a second additive. The hydrophobic therapeutic agent is paclitaxel, rapamycin, or paclitaxel and rapamycin. The first additive is a surfactant. The second additive is a chemical compound having one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide, or ester groups.

Claims

1. A balloon catheter for delivering a therapeutic agent to a blood vessel while the balloon catheter is deployed at a target site of the blood vessel, the balloon catheter comprising:

an elongate member having a lumen and a distal end,

an expandable balloon attached to the distal end of the elongate member and in fluidic communication with the lumen; and

a dried coating layer overlying an exterior surface of the expandable balloon,

wherein;

the dried coating layer comprises a total drug load of a hydrophobic therapeutic agent and a combination of additives comprising a first additive and a second additive;

the hydrophobic therapeutic agent is one of paclitaxel, rapamycin, or combinations thereof;

the first additive is one of PEG sorbitan monolaurates, PEG sorbitan monooleates, or combinations thereof; and

the second additive is one of sorbitol, sorbitan, xylitol, gluconolactone, lactobionic acid, or combinations thereof.

2. The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is paclitaxel.

3. The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is rapamycin.

4. The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is uniformly distributed in the dried coating layer.

5. The balloon catheter of claim 1, wherein the total drug load of the hydrophobic therapeutic agent is from 1 μ

g to 20 μ

g per square millimeter of the expandable balloon.

6. The balloon catheter of claim 1, wherein the total drug load of the hydrophobic therapeutic agent is from 2.5 μ

g to 6 μ

g per square millimeter of the expandable balloon.

7. The balloon catheter of claim 1, wherein the first additive is a PEG sorbitan monolaurate.

8. The balloon catheter of claim 7, wherein the PEG sorbitan monolaurate is PEG-20 sorbitan monolaurate.

9. The balloon catheter of claim 1, wherein the first additive is a PEG sorbitan monooleate.

10. The balloon catheter of claim 9, wherein the PEG sorbitan monooleate is PEG-20 sorbitan monooleate.

11. The balloon catheter of claim 1, wherein the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof.

12. The balloon catheter of claim 1, wherein the second additive is one of sorbitol, gluconolactone, or combinations thereof.

13. The balloon catheter of claim 1, wherein the second additive is sorbitol.

14. The balloon catheter of claim 1, wherein the second additive is gluconolactone.

15. The balloon catheter of claim 1, wherein the ratio by weight of the combination of additives in the dried coating layer to the hydrophobic therapeutic agent in the dried coating layer is about 10 to 0.5.

16. The balloon catheter of claim 1, wherein:

the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive;

the hydrophobic therapeutic agent is paclitaxel;

the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof; and

the second additive is one of sorbitol, gluconolactone, or combinations thereof.

17. The balloon catheter of claim 1, wherein:

the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive;

the hydrophobic therapeutic agent is paclitaxel;

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is sorbitol.

18. The balloon catheter of claim 1, wherein:

the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive;

the hydrophobic therapeutic agent is paclitaxel;

the second additive is gluconolactone; and

the total drug load of the hydrophobic therapeutic agent is from 2 μ

g to 6 μ

g per square millimeter of the expandable balloon.

19. The balloon catheter of claim 1, wherein the dried coating layer has a thickness of from about 0.1 μ

m to 15 μ

m.

20. A balloon catheter for delivering a therapeutic agent to a blood vessel while the balloon catheter is deployed at a target site of the blood vessel, the balloon catheter comprising:

an elongate member having a lumen and a distal end,

an expandable balloon attached to the distal end of the elongate member and in fluid communication with the lumen; and

a dried coating layer overlying an exterior surface of the expandable balloon,

wherein;

the dried coating layer comprises a total drug load of a hydrophobic therapeutic agent and a combination of additives comprising a first additive and a second additive;

the total drug load of the hydrophobic therapeutic agent is from 2.5 μ

g to 6 μ

g per square millimeter of the expandable balloon;

the hydrophobic therapeutic agent is one of paclitaxel, rapamycin, or combinations thereof;

the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof;

the second additive is one of sorbitol, gluconolactone, or combinations thereof; and

the ratio by weight of the combination of additives in the dried coating layer to the hydrophobic therapeutic agent in the dried coating layer is about 10 to 0.5.