Poly(butylmethacrylate) and rapamycin coated stent

• US 7,691,401 B2
• Filed: 05/17/2005
• Issued: 04/06/2010
• Est. Priority Date: 09/28/2000
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Castro, Daniel, Pacetti, Stephen D.
• Primary Examiner(s): Azpuru; Carlos A
• Application Number:
  US11/132,048
• Publication Number:
  US 20050208098A1
• Time in Patent Office: 1,785 Days
• Field of Search: None
• US Class Current: 424/426
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2300/416 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 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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: C08L 31/04 Homopolymers or copolymers of vinyl acetate
• CPC Class Codes: C08L 33/10 Homopolymers or copolymers of methacrylic acid esters

Abstract

An implantable medical device, such as a stent, is disclosed. The device includes a substrate and a polymeric layer including poly(methylmethacrylate) or poly(butylmethacrylate) supported by the substrate. The polymeric layer contains rapamycin. A barrier is over at least a portion of the polymeric layer to reduce the rate of release of rapamycin from the implantable medical device. The polymeric layer can additionally include poly(ethylene co-vinyl acetate).

Claims

1. An implantable medical device, comprising:

a substrate adapted to be implanted at a site in need of therapy;

a polymeric layer comprising poly(methylmethacrylate) or poly(butylmethacrylate) supported by the substrate, the polymeric layer containing rapamycin for administering rapamycin to the site in need of therapy by diffusing through the polymeric layer to the site; and

a barrier over at least a portion of the polymeric layer to reduce the rate of release of rapamycin from the implantable medical device.

2. The implantable medical device of claim 1, wherein the barrier degrades.

3. The implantable medical device of claim 1, wherein the polymeric layer additionally includes poly(ethylene co-vinyl acetate).

4. The implantable medical device of claim 1, wherein the device is a stent.

8. The implantable medical device of claim 1, wherein the barrier comprises a polymer.

9. The implantable medical device of claim 1, wherein the barrier comprises an inorganic material.

10. The implantable medical device of claim 3, wherein the barrier comprises a polymer and wherein the polymeric layer includes poly(butylmethacrylate).

11. The implantable medical device of claim 10, wherein the device is a stent.

12. The implantable medical device of claim 10, wherein the barrier is a homogeneous layer.

13. The implantable medical device of claim 1, wherein the barrier comprises a polymer;

wherein the polymeric layer consists of poly(butylmethacrylate), poly(ethylene co-vinyl acetate), and rapamycin; and

wherein the device is a stent.

14. The implantable medical device of claim 1, wherein the barrier comprises a metallic material.

5. A method of making an implantable medical device, the method comprising:

forming a coating on the device, wherein the coating comprises poly(butyl methacrylate), rapamycin and poly(ethylene co-vinyl acetate); and

forming a barrier layer for reducing a rate of release of rapamycin after implantation of the device into a body of a patient.

6. The method of claim 5, wherein the coating is formed by applying a plurality of layers of poly(butyl methacrylate), rapamycin and poly(ethylene co-vinyl acetate) to the device.

7. The method of claim 5, wherein the device is a stent.

15. The method of claim 5, wherein the barrier layer comprises a polymer.

16. The method of claim 5, wherein the barrier layer comprises a polymer and the device is a stent.

17. The method of claim 16, wherein the barrier layer is blended into the coating.

18. The method of claim 5, wherein the barrier layer comprises an inorganic material.