Multiple drug delivery from a balloon and prosthesis

• US 8,956,639 B2
• Filed: 07/03/2013
• Issued: 02/17/2015
• Est. Priority Date: 03/19/2004
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Toner, John L., Burke, Sandra E., Cromack, Keith R., von Oepen, Randolf
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US13/935,025
• Publication Number:
  US 20130297000A1
• Time in Patent Office: 594 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

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 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 (ABT578), everolimus, 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, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall, and optionally, a stent disposed on the balloon.

Claims

1. A kit for treating vascular disease comprising:

a balloon having an outer surface for temporary contact with a vessel wall at a target site when in an expanded state, 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 (ABT578), everolimus, 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 the vessel wall, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall; and

a stent for deployment proximate the target site.

2. The kit of claim 1, wherein the cytostatic agent is zotarolimus.

3. The kit of claim 2, 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.

4. The kit of claim 2, wherein the coating further comprises ethanol, Iopromide and acetone.

5. The kit of claim 2, 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.

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

7. The kit of claim 6, wherein the binder is selected from the group consisting of complex sugars, starches, collagens, and polymeric materials.

8. The kit of claim 1, wherein the stent is crimped onto the balloon.

9. The kit of claim 1, wherein the stent is a self-expanding stent.

10. The kit of claim 1, wherein the coating includes an additional beneficial agent.

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

12. The kit of claim 1, wherein the therapeutically effective amount of the cytostatic agent is delivered within about 60 seconds of contact between the balloon in an expanded condition and the vessel wall.