Methods and devices for delivering therapeutic agents to target vessels

• US 7,666,222 B2
• Filed: 11/01/2006
• Issued: 02/23/2010
• Est. Priority Date: 04/18/1997
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Rakos, Ronald, King, Kristen, Wright, Carol, Llanos, Gerard H.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/555,420
• Publication Number:
  US 20070100436A1
• Time in Patent Office: 1,210 Days
• Field of Search: 623 111- 148, 514/530
• US Class Current: 623/1.42
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/606 Coatings
• 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 9/00 Drugs for disorders of the cardiovascular system

Abstract

Methods of preparing intravascular stents with a polymeric coating containing macrocyclic lactone (such as rapamycin or its analogs), stents and stent graphs with such coatings, and methods of treating a coronary artery with such devices. The macrocyclic lactone-based polymeric coating facilitates the performance of such devices in inhibiting restenosis.

Claims

1. A method of delivering at least one therapeutic agent to a target vessel in a mammal, comprising contacting an outer surface of the target vessel with a device comprising a polymer and said at least one therapeutic agent, wherein said at least one therapeutic agent comprises rapamycin or a macrocyclic lactone analog thereof, and wherein said device is a sheet having a thickness of about 10 μ

m to about 1000 μ

m.

2. The method of claim 1 wherein the contacting step comprises positioning at least a portion of said sheet proximate at least a portion of the target vessel.

3. The method of claim 1 wherein the contacting step comprises wrapping the target vessel or a portion thereof perivascularly with said sheet.

8. The method of any one of claims 1, 4, or 5 wherein the device comprises about 0.001 weight percent to about 30 weight percent of the at least one therapeutic agent.

9. The method of any one of claims 1, 4, or 5 wherein the polymer is degradable.

10. The method of any one of claims 1, 4, or 5 wherein the polymer is non-degradable.

4. A method of delivering at least one therapeutic agent to a target vessel in a mammal, comprising contacting an outer surface of the target vessel with a device comprising a polymer having a melting temperature above 37°

C. and said at least one therapeutic agent, wherein said at least one therapeutic agent comprises rapamycin or a macrocyclic lactone analog thereof.

5. A method of delivering at least one therapeutic agent to a target vessel in a mammal, comprising contacting an outer surface of the target vessel with a device comprising a molten mass comprising a polymer and said at least one therapeutic agent, wherein said at least one therapeutic agent comprises rapamycin or a macrocyclic lactone analog thereof.

6. The method of claim 5, comprising the step of permitting the molten mass to conform to the outside of the target vessel.

7. The method of claim 5, comprising the step of permitting the molten mass to cool and congeal while in contact with the outside of the target vessel.