Method of coating a stent with a release polymer for 40-O-(2-hydroxy)ethyl-rapamycin

• US 8,961,588 B2
• Filed: 09/26/2006
• Issued: 02/24/2015
• 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., Happ, Dorie M., Scheinpflug, Kurt, Hu, Ty
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US11/527,971
• Publication Number:
  US 20070020382A1
• Time in Patent Office: 3,073 Days
• Field of Search: 623/1.42, 623/1.46, 623/901, 623/920, 623/921, 427/2.24, 427/2.25, 523/112
• US Class Current: 623/1.42
• 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 of coating a stent is presented such that less than 50% of the total amount of 40-O-(2-hydroxyl)ethyl-rapamycin, or an analog or derivative thereof, is released in vivo in a 24 hour period, wherein the method comprises exposing the coating to sufficient temperature to modify the structure of the polymer.

Claims

1. A method of providing drug delivery capability for a stent, comprising:

coating a stent with a composition comprising a polymer and 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin; and

exposing the coating to a sufficient temperature to cause modification to the polymer so as to reduce the rate of release of the drug;

wherein

the coating releases less than 50% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in a first 24 hour period following an implantation procedure.

2. The method of claim 1, wherein the coating releases about 40% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

3. The method of claim 1, wherein the coating releases about 30% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

4. The method of claim 1, wherein the coating releases about 20% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

5. The method of claim 1, wherein the coating releases about 10% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

6. A method of providing drug delivery capability for a stent, comprising:

coating a stent with a composition comprising a polymer and 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin;

wherein

the coating releases less than 50% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in a first 24 hour period following an implantation procedure.

7. The method of claim 6, wherein the coating releases about 40% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

8. The method of claim 6, wherein the coating releases about 30% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

9. The method of claim 6, wherein the coating releases about 20% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

10. The method of claim 6, wherein the coating releases about 10% of the total amount of the 40-O-(2-hydroxyl)ethyl-rapamycin, 40-O-(3-hydroxyl)propyl-rapamycin or 40-O-[2-(2-hydroxyl)ethoxy]ethyl-rapamycin in vivo in the first 24 hour period following the implantation procedure.

11. The method of claim 6, wherein the coating includes a reservoir layer and optionally one or a combination of a primer layer and a barrier layer, wherein a polymer included in each layer can be the same or different.