Lubricious coating for a medical device

• US 6,866,656 B2
• Filed: 01/24/2002
• Issued: 03/15/2005
• Est. Priority Date: 01/24/2001
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Johnson, Steven W., Orr, Douglas P., Lee, Min-Shiu, Tingey, Kevin, Purdy, E. Robert
• Primary Examiner(s): McAvoy, Ellen M.
• Application Number:
  US10/056,417
• Publication Number:
  US 20020168530A1
• Time in Patent Office: 1,146 Days
• Field of Search: 604/265
• US Class Current: 604/265
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 65/04 Polyxylenes
• CPC Class Codes: Y10T 428/266 of base or substrate
• CPC Class Codes: Y10T 428/3154 Of fluorinated addition polymer from unsaturated monomers

Abstract

A lubrication system is disclosed which minimizes friction and that is useful for application on the surface of a flexible portion of a medical device. Such a lubrication system includes a lubricant that is able to move when the flexible portion of the medical device flexes and is biocompatible and is not degraded by the application of alcohol or other conventional medical sterilizing and cleaning agents. The lubricant is bonded to the surface of the flexible portion of the medical device. The lubrication system may be used on an elastomeric septum, such as a silicone rubber elastomer. The lubricant coating may be any type of coating that can be chemically bonded to the elastomer, such as di-paraxylene, poly-(p-xylene), polytetrafluoroethylene, or polyvinylpyrrolidone.

Claims

1. A lubricious coating for a medical device having a flexible surface, the coating comprising a substantially continuous layer of polymeric material on the flexible surface of the medical device, the layer having a thickness between 0.5 microns and 0.9 microns, wherein the polymeric material is polymerized by vapor deposition and wherein the polymeric material is parylene-N.

2. The lubricious coating of claim 1 wherein the medical device is an elastomeric septum and wherein the coating completely covers the exterior surface of the septum.

3. The lubricious coating of claim 1 wherein the medical device is a septum and wherein the coating covers only a top surface of the septum.

4. A lubricious coating for a medical device having a flexible surface comprising a layer of polymeric material on the flexible surface of the medical device having a thickness between 0.2 and 1.0 microns.

5. The lubricious coating of claim 4 wherein the polymeric material is hydrophobic, hydrophilic, aliphatic or aromatic.

6. The lubricious coating of claim 5 wherein the polymeric material has a thickness between 0.5 and 0.9 microns.

7. The lubricious coating of claim 6 wherein the polymeric material has a thickness of about 0.79 microns.

8. The lubricious coating of claim 6 wherein the polymeric material is polymerized by vapor deposition.

9. The lubricious coating of claim 8 wherein the polymeric material is one of the group of di-paraxylene, poly-(p-xylene), polyvinylpyrrolidone, and polytetrafluoroethylene.

10. The lubricious coating of claim 4 wherein the polymeric material is parylene-N.

11. The lubricious coating of claim 4 wherein the polymeric material is one of the group of parylene-C or parylene-D.

12. The lubricious coating of claim 4 wherein the polymeric material is one of the group of a fluorocarbon or a pyrolized polymer film.

13. A lubricious coating for a septum used in a needleless luer access connector, the septum having at least one flexible surface, the coating comprising a substantially continuous layer of polymeric material on the at least one flexible surface of the medical device, the layer having a thickness between 0.2 and 1.0 microns, and wherein the polymeric material is one of the group of di-paraxylene, poly-(p-xylene), polyvinylpyrrolidone, and polytetrafluoroethylene.

14. The lubricious coating of claim 13 wherein the coating covers the entire exterior surface of the septum and wherein the septum is unslit.

15. The lubricious coating of claim 13 wherein the septum has a top surface and the coating covers only the top surface.

16. The lubricious coating of claim 13 wherein the layer has a thickness between 0.5 and 0.9 microns.

17. The lubricious coating of claim 13 wherein the material is parylene-N.

18. The lubricious coating of claim 16 wherein the material is parylene-N.

19. The lubricious coating of claim 17 wherein the coating covers the entire exterior surface of the septum.

20. The lubricious coating of claim 13 wherein the material is parylene-N, the layer has a thickness about 0.79 microns, the coating covers the entire exterior surface of the septum and the septum is unslit.