System and device for preventing restenosis in body vessels

• US 6,682,545 B1
• Filed: 10/05/2000
• Issued: 01/27/2004
• Est. Priority Date: 10/06/1999
• Status: Expired due to Fees

• Current Assignee: Penn State Research Foundation (Pennsylvania State University)
• Original Assignee: Penn State Research Foundation (Pennsylvania State University)
• Inventors: Kester, Mark
• Primary Examiner(s): Lindsey, Rodney M.
• Application Number:
  US09/679,715
• Time in Patent Office: 1,209 Days
• Field of Search: 606/191, 606/108, 606/192, 606/194, 623/1.42, 623/1.46, 604/103.01, 604/103.02, 604/891.1, 604/28, 604/265, 604/266
• US Class Current: 606/191
• CPC Class Codes: A61K 31/133 having hydroxy groups, e.g. sphingosine
• CPC Class Codes: A61K 31/164 of a carboxylic acid with an aminoalcohol, e.g. ceramides
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• 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 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention relates to a system and device for preventing stenosis and/or restenosis after an invasive procedure in a body vessel or cavity having an inner wall surface, the system comprising inserting a device coated with a growth arresting, lipid-derived, bioactive substance at a desired location along the inner wall surface of the body vessel or cavity.

Claims

1. A method for preventing restenosis after an invasive procedure in a body vessel or cavity having an inner wall surface, said method comprising:

inserting a device along the inner wall surface of the body vessel or cavity, said device combined with a growth-arresting, lipid-derived bioactive compound selected from the group consisting of ceramide or derivatives thereof, dimethyl sphingosine, ether-linked diglycerides, ether-linked phosphatidic acids and sphinganines; and

delivering said growth-arresting, lipid-derived bioactive compound to the inner wall surface.

2. The method as recited in claim 1, wherein said device is a catheter, a balloon catheter, and/or a stent.

3. The method of claim 1, wherein said growth-arresting, lipid-derived bioactive compound is coated onto said device.

4. The method of claim 1, wherein said body vessel is a blood vessel.

5. The method as recited in claim 1, wherein said growth-arresting, lipid-derived bioactive compound is ceramide or a derivative thereof, that contains a 2-10 carbon short-chain fatty acid at SN-2 position.

6. The method as recited in claim 5, wherein the ceramide or derivative thereof is a C₆-ceramide.

7. The method as recited in claim 1, wherein said growth-arresting, lipid-derived bioactive compound is delivered through an infusion port(s) of said device.

8. The method as recited in claim 1, wherein said growth-arresting, lipid-derived bioactive compound is delivered at a dose sufficient to reduce neointimal hyperplasia induced by said invasive procedure.

9. The method as recited in claim 8, wherein said growth-arresting, lipid-derived bioactive compound reduces neointimal hyperplasia by diminishing the percentage of vascular smooth muscle cells that are proliferating and/or migrating, without inducing significant apoptosis.

10. The method as recited in claim 8, wherein said growth-arresting, lipid-derived bioactive compound reduces neointimal hyperplasia by diminishing the percentage of vascular smooth muscle cells that enter the cell cycle.

11. A combination for preventing stenosis and restenosis in a body vessel or cavity having an inner wall surface, said combination comprising a device and a growth-arresting, lipid-derived, bioactive compound selected from the group consisting of ceramide or derivatives thereof, dimethyl sphingosine, ether-linked diglycerides, ether-linked phosphatidic acids and sphinganines.

12. The combination as recited in claim 11, wherein said growth-arresting, lipid-derived bioactive compound is ceramide or a derivative thereof, that contains a 2-10 carbon short-chain fatty acid at SN-2 position.

13. The combination as recited in claim 12, wherein the ceramide or derivative thereof is a C₆-ceramide.

14. The combination of claim 11,wherein said growth-arresting, lipid-derived bioactive compound is in solution.

15. The device of claim 14, further comprising a port(s) adapted for delivery of said growth-arresting, lipid-derived bioactive compound in solution via systemic infusion.

16. The combination of claim 11, wherein said growth-arresting, lipid-derived bioactive compound is coated onto said device.