Vascular prosthesis having fluorinated coating with varying F/C ratio

• US 4,718,907 A
• Filed: 06/20/1985
• Issued: 01/12/1988
• Est. Priority Date: 06/20/1985
• Status: Expired due to Term

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Karwoski, Theodore, Matsuzawa, Yasuo
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Cannon, Alan W.
• Application Number:
  US06/747,034
• Time in Patent Office: 936 Days
• Field of Search: 427/2, 427/255.5, 427/296, 427/255.6, 427/39, 427/40, 623/1, 623/11, 623/12, 623/66, 128/334 R, 128/DIG. 14, 428/394, 428/395, 428/409, 428/422, 428/420, 428/421, 204/158 HA, 204/158.19, 204/169, 66/178 A, 66/194-197, 139/421-423
• US Class Current: 623/23.71
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 33/0088 by grafting of a monomer onto the substrate
• CPC Class Codes: B29C 59/142 of profiled articles, e.g. hollow or tubular articles
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 428/2969 Polyamide, polyimide or polyester
• CPC Class Codes: Y10T 428/3154 Of fluorinated addition polymer from unsaturated monomers

Abstract

Disclosed is a method of producing implantable prosthetic devices, e.g., tubular vascular prostheses having a substantially non-thrombogenic inside surface and a biocompatible outside surface. The method involves deposition onto an elongate substrate, e.g., a porous tubular substrate, of a fluorine-containing coating by inducing glow discharge progressively along the length of a tubular reaction vessel. A polymerizable fluorine-containing gas is flowed through the tubular substrate and a portion of the gas migrates radially to traverse the pores of the substrate. An RF field is applied to successive volumes of the gas within the vessel and tube. A substantially non-thrombogenic fluorinated coating with a first fluorine to carbon ratio deposits and bonds to the inside surface of the substrate, and a fluorinated biocompatible cross-linked coating with a lower F/C atomic ratio than the inside coating deposits and bonds to the outside surface of the substrate. The method of the invention can produce uniform coatings containing fluorine over the surface of elongated substrates. The coatings can be engineered to have a very low surface energy and to be essentially non-thrombogenic.

Claims

1. An implantable device comprising a hollow porous tubular substrate having a non-thrombogenic inside surface and a biocompatible outside surface, said inside surface comprising a first cross-linked substantially uniform coating of a fluorine-containing polymer bonded to said substrate and characterized by a first F/C ratio greater than 1.5, said outside surface comprising a second cross-linked coating of a fluorine-containing polymer bonded to said substrate and characterized by an F/C ratio lower than said first ratio.

2. The device of claim 1 wherein said first coating has a substantially uniform F/C ratio across said inside surface.

3. The device of claim 1 wherein said first and second coatings are contiguous and define an F/C ratio gradient through a wall of said substrate.

4. The device of claim 1 wherein said tubular substrate comprises a fabric.

5. The device of claim 4 wherein said fabric comprises threads composed of fibers having a diameter of less than approximately 15 microns.

6. The device of claim 4 wherein said fabric comprises polyethylene terephthalate.

7. The device of claim 1 wherein said substrate has a wall thickness less than 0.60 mm.

8. The device of claim 4 wherein said fabric comprises a microporous tube having a longitudinal axis, said tube comprising a multiplicity of circumferentially oriented fill threads interwoven with a multiplicity of axially oriented substantially non-elastic warp threads, individual ones of said axially oriented warp threads defining loops extending radially outwardly between adjacent circumferential fill threads, said loops being set to return to a loop configuration upon release of tension applied axially to said tube, said tube defining an outer macroscopically smooth porous surface.

9. The device of claim 1 wherein said substrate is elastic.

10. An implantable device comprising a tubular substrate having a non-thrombogenic interior surface greater than about 15 centimeters long in at least one dimension, said surface comprising a first cross-linked coating of a fluorine-containing polymer bonded to said substrate and characterized by an F/C ratio greater than 1.5.

11. The device of claim 10 wherein said coating is characterized by an F/C ratio greater than 1.7.

12. The device of claim 10 wherein said substrate comprises a fabric.

13. The device of claim 10 wherein said substitute comprises polyethylene terephthalate.

14. The device of claim 10 wherein said substrate defines a wall defining pores and having a thickness no greater than about 0.60 mm.

15. The device of claim 10 wherein said substrate comprises fibers less than approxmately 15 microns in diameter.