Stent coating

• US 6,258,121 B1
• Filed: 07/02/1999
• Issued: 07/10/2001
• Est. Priority Date: 07/02/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Wang, Lixiao, Smith, Scott R., Yang, Dachuan, Stanslaski, Joel L.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/346,975
• Time in Patent Office: 739 Days
• Field of Search: 623/1-6-, 623/1.16, 623/1.42, 623/1.43, 623/1.38, 623/1.39, 623/1.4, 427/2.3
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• 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 2300/608 having 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: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A stent having a polymeric coating for controllably releasing an included active agent. The polymeric coating includes a blend of a first polymeric material, which if alone, would release the agent at a first, higher rate, and a second polymeric material, which if alone would release the agent at a second, lower rate over a longer time period. One stent coating utilizes a faster releasing hydrophilic polymeric material and a slower releasing hydrophobic material. One stent coating includes a blend of a faster releasing PLA-PEO copolymer and a slower releasing PLA-PCL copolymer. One active agent is Taxol. One use of the Taxol delivering stent is to inhibit restenosis following angioplasty.

Claims

1. A stent comprising:

a stent body;

a coating disposed over at least a portion of said body; and

a biologically active agent dispersed in said coating, wherein said coating includes a mixture of a first co-polymer and a second co-polymer, wherein said first co-polymer releases said agent at a first rate and said second co-polymer release said agent at a second rate, wherein said second rate is slower than said first rate, such that said agent is released from said coating at a rate slower than said first rate and faster than said second rate.

2. A stent as recited in claim 1, wherein said first co-polymer is hydrophilic.

3. A stent as recited in claim 1, wherein said second co-polymer is hydrophobic.

4. A stent as recited in claim 1, wherein said first co-polymer is hydrophilic and said second co-polymer is hydrophobic.

5. A stent as recited in claim 1, wherein said first co-polymer include s PLA-PEO.

6. A stent as recited in claim 1, where said second co-polymer includes PLA-PCL.

7. A stent as recited in claim 1, wherein said first co-polymer includes PLA-PEO and said second co-polymer includes PLA-PCL.

8. A stent as recited in claim 7, wherein said agent includes an agent selected from the group consisting of paclitaxel, paclitaxel analogues, paclitaxel derivatives, and combinations thereof.

9. A stent for controllably releasing a biologically active agent over a long time period comprising:

a stent body;

a biologically active agent; and

means for adhering said agent to said stent body and controllably releasing said agent from said stent body over time, wherein said means for controllably releasing said agent includes an admixture of a first means for releasing said agent at a first rate over a first time period and second means for releasing said agent at a second rate over a second time period, wherein said first rate is faster than said second rate and said first period is shorter than said second period.

10. A stent as recited in claim 9, wherein said first means for releasing includes a bioabsorbable polymeric material and second means for releasing includes a bioabsorbable polymeric material, wherein said first means is absorbed faster than said second means.

11. A stent for releasing a biologically active agent inside the human body comprising:

a stent body;

a polymeric coating disposed over at least a part of said stent body; and

a biologically active material admixed with said polymeric coating, wherein said polymeric coating includes a blend of a PLA-PEO copolymer and a PLA-PCL copolymer.

12. A stent as recited in claim 11, wherein said biologically active agent includes an agent selected from the group consisting of paclitaxel, paclitaxel analogues, paclitaxel derivatives, and combinations thereof.

13. A method for inhibiting restenosis comprising the steps of:

providing a stent including a coating having a blend of a PLA-PEO copolymer and a PLA-PCL copolymer, wherein said coating includes a restenosis inhibiting agent selected from the group consisting of paclitaxel, paclitaxel analogues, paclitaxel derivatives, and combinations thereof mixed therein, such that said agent is released over a time period longer than would be released by said PLA-PEO copolymer alone, and released over a time period shorter than would be released PLA-PCL copolymer alone.