Drug release coated stent

• US 20060088654A1
• Filed: 12/06/2005
• Published: 04/27/2006
• Est. Priority Date: 04/19/1995
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Ding, Ni, Helmus, Michael
• Application Number:
  US11/296,765
• Publication Number:
  US 20060088654A1
• Time in Patent Office: Days
• US Class Current: 427/2.210
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

The present invention is directed to an expandable stent for implantation in a patient comprising a tubular metal body having open ends and a sidewall structure having openings therein and a coating disposed on a surface of said sidewall structure, said coating comprising a hydrophobic biostable elastomeric material and a biologically active material, wherein said coating continuously conforms to said structure in a manner that preserves said openings.

Claims

1. A method of making a balloon-expandable stent comprising:

providing a metallic intravascular balloon-expandable open lattice sidewall stent structure designed for permanent implantation into a blood vessel of a patient;

applying a first polymer composition to at least a portion of the open lattice sidewall stent structure in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the first polymer composition comprises a first polymer and a biologically active material; and

applying a second polymer composition conforming to at least a portion of the first polymer composition in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the second polymer composition comprises a second polymer that is different from the first polymer, and wherein the second polymer composition is substantially free of any biologically active material when applied to the portion of the first polymer composition.

2. The method of claim 1, wherein when in use, the biologically active material is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same biologically active material from the stent had the second polymer composition not been applied to the first polymer composition.

3. The method of claim 1, wherein the stent comprises stainless steel.

4. The method of claim 1, wherein the first polymer is a biostable polymer.

5. The method of claim 1, wherein the first polymer comprises a hydrophobic biostable elastomeric material.

6. The method of claim 1, wherein the first polymer comprises an ethylene vinyl acetate copolymer material.

7. The method of claim 1, wherein the biologically active material is an agent that inhibits restenosis.

8. The method of claim 7, wherein the agent that inhibits restenosis is a smooth muscle cell inhibitor.

9. The method of claim 1, wherein the biologically active material is an anti-proliferative agent.

10. The method of claim 1, wherein the stent releases the biologically active material over a period of time.

11. A method of making a balloon-expandable stent comprising:

providing a metallic intravascular balloon-expandable open lattice sidewall stent structure designed for permanent implantation into a blood vessel of a patient;

applying a first polymer composition to at least a portion of the open lattice sidewall stent structure in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the first polymer composition comprises a first biostable polymer and an agent that inhibits restenosis; and

applying a second polymer composition to at least a portion of the first polymer composition in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the second polymer composition comprises a second biostable polymer that is different from the second biostable polymer, and wherein the second polymer composition is substantially free of any biologically active material when applied to the portion of the first polymer composition.

12. The method of claim 11, wherein when in use, the agent that inhibits restenosis is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same agent that inhibits restenosis from the stent had the second polymer composition not been applied to the first polymer composition.

13. The method of claim 11, wherein the stent comprises stainless steel.

14. The method of claim 11, wherein the first biostable polymer comprises a hydrophobic elastomeric material.

15. The method of claim 11, wherein the first biostable polymer comprises an ethylene vinyl acetate copolymer material.

16. The method of claim 11, wherein the agent that inhibits restenosis is a smooth muscle cell inhibitor.

17. The method of claim 11, wherein the stent releases the agent that inhibits restenosis over a period of time.

18. A method of making a balloon-expandable stent comprising:

providing a metallic intravascular balloon-expandable open lattice sidewall stent structure designed for permanent implantation into a blood vessel of a patient;

applying a first polymer composition to at least a portion of the open lattice sidewall stent structure in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the first polymer composition comprises an ethylene vinyl acetate copolymer material and an agent that inhibits restenosis; and

applying a second polymer composition to at least a portion of the first polymer composition in a conforming manner so as to preserve the open lattice sidewall stent structure, wherein the second polymer composition comprises a biostable polymer that is different from the ethylene vinyl acetate copolymer material of the first polymer composition, and wherein the second polymer composition is substantially free of any biologically active material when applied to the portion of the first polymer composition.

19. The method of claim 18, wherein when in use, the agent that inhibits restenosis is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same agent that inhibits restenosis from the stent had the second polymer composition not been applied to the first polymer composition.

20. The method of claim 18, wherein the stent comprises stainless steel.

21. The method of claim 18, wherein the agent that inhibits restenosis is a smooth muscle cell inhibitor.

22. The method of claim 18, wherein the stent releases the agent that inhibits restenosis over a period of time.