Methods, devices, and coatings for controlled active agent release

• US 7,709,049 B2
• Filed: 09/09/2005
• Issued: 05/04/2010
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Chappa, Ralph A.
• Primary Examiner(s): Richter; Johann R
• Assistant Examiner(s): FISHER, ABIGAIL L
• Application Number:
  US11/223,811
• Publication Number:
  US 20060057277A1
• Time in Patent Office: 1,698 Days
• Field of Search: 427/2.24, 427/2.25, 427/2.3, 427/427.4, 424/423, 424/426
• US Class Current: 427/2.24
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 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

Abstract

The present invention relates to methods, devices, and coatings, wherein active agent release is determined by deposition rate of a coating or material. In an embodiment, the invention includes a method for coating a medical device, including identifying active agent elution rates for a coating composition applied to substrates at a plurality of coating deposition rates, selecting one of the coating deposition rates, and applying the coating composition to the medical device at the selected deposition rate. In an embodiment, the invention includes a combination including a medical device and a composition for coating the surface of a medical device with an active agent in a manner that permits the coated surface to release the active agent over time when implanted in vivo.

Claims

1. A method for coating a medical device, comprising:

identifying active agent elution rates for a coating composition applied to substrates at a plurality of coating deposition rates, the coating composition comprising an active agent and a polymer;

selecting one of the plurality of coating deposition rates with a desired active agent elution rate, wherein the selected deposition rate is faster if a faster elution rate is desired and slower if a slower elution rate is desired, and

applying the coating composition to the medical device at the selected deposition rate.

2. The method of claim 1, wherein the coating composition comprises a polyalkyl(meth)acrylate.

3. The method of claim 1, wherein the coating composition comprises poly(n-butyl methacrylate).

4. The method of claim 1, the coating composition comprising at least two different polymers.

5. The method of claim 4, wherein the coating composition comprises poly(ethylene-co-vinyl acetate) and poly(n-butyl methacrylate).

6. The method of claim 1, wherein the coating composition comprises polybutadiene and poly(n-butyl methacrylate).

7. The method of claim 1, wherein the total concentration of polymer in the coating composition is between about 0.25% and about 70% by weight, and the active agent is dissolved or suspended in the coating composition at a concentration of 0.01% to 90% by weight.

8. The method of claim 1, wherein the coating composition comprises a solvent.

9. The method of claim 8, wherein the solvent comprises one or more of an alcohol, an alkane, an amide, an ether, an ester, or an aromatic compound.

10. The method of claim 8, wherein the solvent is one or more of tetrahydrofuran, chloroform, or methanol.

11. The method of claim 1, wherein the medical device is a stent.

12. The method of claim 1, wherein the active agent comprises one or more of triamcinolone acetonide, dexamethasone, and paclitaxel.

13. The method of claim 1, wherein coating at least one medical device is conducted under a controlled level of relative humidity of between about 0% and about 95%.

14. The method of claim 1, wherein coating at least one medical device is conducted under a controlled level of relative humidity of between about 20% and about 40% relative humidity.

15. A method for coating a medical device comprising:

applying an amount of a coating composition to a test substrate at a plurality of deposition rates, the coating composition including an active agent and at least one polymer;

determining an active agent release rate for at least one of the deposition rates;

identifying a deposition rate that provides a desired active agent release rate, wherein the identified deposition rate is faster if a faster elution rate is desired and slower if a slower elution rate is desired; and

coating at least one medical device with the composition at the identified deposition rate.

16. The method of claim 15, the coating composition comprising at least two different polymers.

17. The method of claim 16, wherein the coating composition comprises poly(ethylene-co-vinyl acetate) and poly(n-butyl methacrylate).

18. The method of claim 16, wherein the coating composition comprises polybutadiene and poly(n-butyl methacrylate).