40-O-(2-hydroxy)ethyl-rapamycin coated stent

• US 8,173,199 B2
• Filed: 09/26/2006
• Issued: 05/08/2012
• Est. Priority Date: 03/27/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Hossainy, Syed F. A., Stewart, Gordon, Williams, Mark A., Royal, Jeff, Consigny, Paul M., Scheinpflug, Kurt, Hu, Ty, Happ, Dorrie M.
• Primary Examiner(s): Meeks, Timothy
• Assistant Examiner(s): SELLMAN, CACHET I
• Application Number:
  US11/527,893
• Publication Number:
  US 20070020381A1
• Time in Patent Office: 2,051 Days
• Field of Search: 427/2.1, 427/2.24
• US Class Current: 427/2.24
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A method and coating for reducing the release rate of an active agent from an implantable device, such as a stent, is disclosed.

Claims

1. A method of treating a coating, including a polymer, on a stent to reduce the rate of release of 40-O-(2-hydroxy)ethyl-rapamycin from the coating, comprising:

exposing the coating to a temperature, between the glass transition temperature and the melting temperature of the polymer, that causes modifications in the structure of the polymer which allows for the reduction of the release rate of the 40-O-(2-hydroxy)ethyl-rapamycin through the polymer, wherein the amount of the 40-O-(2-hydroxy)ethyl-rapamycin-released in 24 hours after the implantation of the stent in a blood vessel of a human being is less than about 50% of the total amount of 40-O-(2-hydroxy)ethyl-rapamycin contained in the coating; and

maintaining the peak purity of the 40-O-(2-hydroxy)ethyl-rapamycin to greater than 90%.

2. The method of claim 1, wherein the coating includes an additive for shifting the glass transition temperature and/or the melting temperature of the polymer to a temperature different than the glass transition temperature or the melting temperature of the polymer without the additive.

3. The method of claim 2, wherein the additive is dioctyl phthalate.

4. The method of claim 2, wherein the amount of the additive included in the coating shifts the polymer glass transition temperature and/or the polymer melting temperature thus allowing for the temperature exposure without degradation of the 40-O-(2-hydroxy)ethyl-rapamycin or the polymer.