Multiple drug delivery from a balloon and a prosthesis

• US 8,431,145 B2
• Filed: 02/13/2009
• Issued: 04/30/2013
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Toner, John L., Burke, Sandra E., Cromack, Keith R., Oepen, Randolf von
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/371,422
• Publication Number:
  US 20100023108A1
• Time in Patent Office: 1,537 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2300/606 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 31/10 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

Disclosed is an interventional device for delivery of therapeutic agents from an angioplasty balloon and from a prosthesis such as an intraluminal stent. The invention also relates to the method of loading the beneficial agents onto the balloon and the device, as well as the method of delivery of the agents from separate surfaces. The invention also relates to an interventional device having a prosthesis surface that is loaded with a first beneficial agent, and a balloon surface loaded with a second beneficial agent. The invention also relates to a method of loading multiple beneficial agents onto the prosthesis surfaces and the balloon surfaces, and to a method of manufacturing an interventional device for the delivery of a first beneficial agent and a second beneficial agent from separate surfaces.

Claims

1. A system for treating vascular disease comprising:

a balloon having an outer surface for temporary contact with a vessel wall when in an expanded state;

a prosthesis mounted on the balloon; and

a coating disposed on at least a portion of the outer surface of the balloon, the coating including an initial amount of zotarolimus, the coating being capable of maintaining a therapeutically effective amount of zotarolimus on the outer surface of the balloon for delivery to a vessel wall, the coating further being capable of retaining between about 4.9% to about 23% of the initial amount of zotarolimus on the outer surface after delivery of the therapeutically effective amount of zotarolimus to the vessel wall.

2. The system of claim 1, wherein the zotarolimus is disposed on the outer surface at a concentration of from about 3.7 μ

g/mm² to about 7.0 μ

g/mm².

3. The system of claim 1, wherein the coating further comprises binders, polymers, solvents, or combinations thereof.

4. The system of claim 1, wherein the coating further comprises ethanol, Iopromide and acetone.

5. The system of claim 1, wherein the prosthesis is a stent.

6. The system of claim 5, wherein the therapeutically effective amount of zotarolimus is effective to maintain at least about 35.7% of a vessel lumen diameter after delivery of the therapeutically effective amount of zotarolimus.

7. The system of claim 5, wherein the stent is crimped onto the expandable member.

8. The system of claim 5, wherein the stent is a self-expanding stent.

9. The system of claim 3, wherein the binder is selected from the group consisting of complex sugars, starches, collagens, and polymeric materials.

10. The system of claim 1, wherein the coating includes a second beneficial agent.

11. The system of claim 1, wherein the therapeutically effective amount of the zotarolimus is effective to reduce neointimal formation after delivery of the zotarolimus to the vessel wall.

12. The system of claim 1, wherein the therapeutically effective amount of the zotarolimus is delivered within about 60 seconds of contact between the expandable member in an expanded condition and the vessel wall.