MULTIPLE DRUG DELIVERY FROM A BALLOON AND A PROSTHESIS

• US 20130013048A1
• Filed: 09/14/2012
• Published: 01/10/2013
• 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
• Granted Patent: US 8,501,213 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 method for treating vascular disease comprising:

providing an expandable member having an outer surface and a coating disposed on at least a portion of the outer surface, the coating including an initial amount of a cytostatic agent selected from the group consisting of Zotarolimus, rapamycin, everolimus, tacrolimus, pimecrolimus, and a combination thereof, the coating being capable of maintaining a therapeutically effective amount of the cytostatic agent on the outer surface for delivery to a vessel wall;

positioning the expandable member at a lesion site along the vessel wall; and

expanding the expandable member for temporary contact of the outer surface with the vessel wall to deliver the therapeutically effective amount of the cytostatic agent to the vessel wall at the lesion site, wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall.

2. The method of claim 1, wherein the cytostatic agent is Zotarolimus.

3. The method of claim 2, wherein the Zotarolimus is disposed on the outer surface at a concentration of between about 3.7 μ

g/mm² to about 7.0 μ

g/mm².

4. The method of claim 3, wherein about 4.9% to about 23% of the Zotarolimus remains disposed on the outer surface after delivery of the therapeutically effective amount of Zotarolimus to the vessel wall.

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

6. The method of claim 2, wherein the coating further comprises ethanol, Iopromide and acetone.

7. The method of claim 1, wherein the expandable member is an angioplasty balloon.

8. The method of claim 1, further comprising deploying a prosthesis at the lesion site.

9. The method of claim 8, wherein the prosthesis is a stent.

10. The method of claim 9, wherein the cytostatic agent is Zotarolimus, and 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.

11. The method of claim 9, wherein the stent is crimped onto the expandable member, the stent being deployed by expansion of the expandable member.

12. The method of claim 9, wherein the stent is a self-expanding stent.

13. The method of claim 5, wherein the binder is selected from the group consisting of complex sugars, starches, collagens, and polymeric materials.

14. The method of claim 1, wherein the coating includes a second beneficial agent.