Laminated drug-polymer coated stent with dipped and cured layers

• US 8,227,016 B2
• Filed: 05/18/2010
• Issued: 07/24/2012
• Est. Priority Date: 09/29/2003
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Thornton, Ronan, Dolan, Finbar
• Primary Examiner(s): Yuan, Dah-Wei
• Assistant Examiner(s): Bowman, Andrew
• Application Number:
  US12/782,286
• Publication Number:
  US 20100228342A1
• Time in Patent Office: 798 Days
• Field of Search: 428/447, 525/60, 604/265, 427/2.1
• US Class Current: 427/2.1
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane

Abstract

The present invention provides a method of applying a drug-polymer coating on a stent. A stent framework is dipped into a first polymeric solution including a first polymer, a first therapeutic agent, and a first solvent. The polymeric solution is dried and the first polymer is cured to form a thin drug-polymer layer on the stent framework. The steps of dipping the stent framework into the first polymeric solution, drying the first polymeric solution, and curing the first polymer are repeated until a target drug-polymer coating thickness is disposed on the stent framework. A drug-polymer coated stent including a stent framework and a laminated drug-polymer coated stent, a system for treating a vascular condition, and a method of treating a vascular condition are also disclosed.

Claims

1. A method of applying a drug-polymer coating on a stent, comprising:

dipping a stent framework into a first polymeric solution, wherein the first polymeric solution comprises a first polymer, a first therapeutic agent, and a first solvent, the first polymeric solution further comprising a first monomer including acrylic acid, a second monomer including vinyl pyrollidone, and an initiator;

partially drying the first polymeric solution on the stent framework to partially remove the first solvent;

curing the partially dried first polymeric solution to form a thin drug-polymer layer on the stent framework; and

repeating the steps of dipping the stent framework into the first polymeric solution, partially drying the first polymeric solution on the stent framework, and curing the partially dried first polymeric solution until a target thickness of the drug-polymer coating with the thin drug-polymer layers is disposed on the stent framework.

2. The method of claim 1 wherein the initiator comprises benzophenone.

3. The method of claim 1 wherein the first polymeric solution comprises between 0.05 percent and 3.0 percent total solids by weight of the first polymer.

4. The method of claim 1 wherein the first therapeutic agent is selected from the group consisting of rapamycin, a rapamycin derivative, a rapamycin analogue, camptothecin, dexamethasone, 5-fluorouracil, a bioactive agent, a pharmaceutical drug, a therapeutic substance, and a combination thereof.

5. The method of claim 1 wherein forming the thin drug-polymer layer comprises drying the first polymeric solution and curing the first polymer with ultraviolet light.

6. The method of claim 1 wherein forming the thin drug-polymer layer comprises drying the first polymeric solution and curing the first polymer with one of thermal activation, electrical activation, or ionizing irradiation.

7. The method of claim 1 further comprising:

adding an ultraviolet-sensitive catalyst into the first polymeric solution prior to dipping the stent framework into the first polymeric solution.

8. The method of claim 1 further comprising:

adding one of the initiator or a crosslinking agent into the first polymeric solution prior to dipping the stent framework into the first polymeric solution.

9. The method of claim 1 further comprising:

dipping the stent framework including the formed thin drug-polymer layer into a second polymeric solution, wherein the second polymeric solution comprises a second polymer and a second solvent;

forming a thin barrier layer on the formed thin drug-polymer layer, wherein the second polymeric solution is dried and wherein the second polymer is cured; and

repeating the steps of dipping the stent framework into the first polymeric solution and forming an additional thin drug-polymer layer, and dipping the stent framework including the additional thin drug-polymer layer and forming the thin barrier on the thin drug polymer layer, until a target thickness of the drug-polymer coating with the thin drug-polymer layers and the thin barrier layers is disposed on the stent framework.

10. The method of claim 9 wherein the second polymeric solution comprises a second therapeutic agent.

11. The method of claim 10 wherein the second therapeutic agent is selected from the group consisting of rapamycin, a rapamycin derivative, a rapamycin analogue, camptothecin, dexamethasone, 5-fluorouracil, a bioactive agent, a pharmaceutical drug, a therapeutic substance, and a combination thereof.

12. The method of claim 1 further comprising:

modulating a concentration of the first therapeutic agent in the thin drug-polymer layers to provide a predetermined drug-release profile.

13. A method of applying a drug-polymer coating on a stent, comprising:

dipping a stent framework into a first polymeric solution, wherein the first polymeric solution comprises a first polymer, a first therapeutic agent, and a first solvent, the first polymeric solution further comprising a first monomer including acrylic acid, a second monomer including vinyl pyrollidone, and an initiator;

forming a first thin drug-polymer layer on the stent framework, wherein the first polymeric solution is dried and wherein the first polymer is cured;

repeating the dipping the stent framework and the forming the first thin drug-polymer layer to form a first drug-polymer coating having a first drug-polymer coating target thickness disposed on the stent framework, the first drug-polymer coating including the first thin drug-polymer layer;

dipping the stent framework including the first drug-polymer coating into a second polymeric solution, wherein the second polymeric solution comprises a second polymer and a second solvent;

forming a thin barrier layer on the first drug-polymer coating, wherein the second polymeric solution is dried and wherein the second polymer is cured;

repeating the dipping the stent framework including the first drug-polymer coating and the forming the thin barrier layer to form a barrier coating having a barrier target thickness disposed on the first drug-polymer coating, the barrier coating including the thin barrier layer;

dipping the stent framework including the barrier coating into a third polymeric solution, wherein the third polymeric solution comprises a third polymer, a third therapeutic agent, and a third solvent;

forming a second thin drug-polymer layer on the barrier coating, wherein the third polymeric solution is dried and wherein the third polymer is cured; and

repeating the dipping the stent framework including the barrier coating and the forming the second thin drug-polymer layer to form a second drug-polymer coating having a second drug-polymer coating target thickness disposed on the stent framework, the second drug-polymer coating including the second thin drug-polymer layer;

wherein the cured second polymer excludes drug interaction between the first thin drug-polymer layer adjacent the barrier coating and the second thin drug-polymer layer adjacent the barrier coating.

14. The method of claim 13 further comprising:

modulating at least one of a concentration of the first therapeutic agent in the first thin drug-polymer layers and a concentration of the second therapeutic agent in the second thin drug-polymer layers to provide a predetermined drug-release profile.