Non-thromogenic vascular prosthesis

• US 5,383,927 A
• Filed: 04/15/1993
• Issued: 01/24/1995
• Est. Priority Date: 05/07/1992
• Status: Expired due to Term

• Current Assignee: InterVascular, Inc. (Getinge AB)
• Original Assignee: InterVascular, Inc. (Getinge AB)
• Inventors: Hudson, John O., De Goicoechea, George L.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Brittingham, Debra s.
• Application Number:
  US08/047,799
• Time in Patent Office: 649 Days
• Field of Search: 623/1, 623/11, 623/12, 128/DIG. 8, 600/36
• US Class Current: 623/1.43
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 33/0017 using a surface active agent
• CPC Class Codes: C08L 5/10 Heparin; Derivatives thereof
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

The present invention provides vascular prostheses free of any substance that counteracts an anticoagulant comprising a base material, the base material having inner and outer surfaces, wherein the outer surface has a layer of a material capable of reducing the porosity of said prosthesis to blood or body fluid and a coating of compounded heparin bound thereon, and the inner surface has a coating of compounded heparin bound thereon, the compounded heparin comprising heparin and a cationic surfactant. The present invention also provides a method for forming a vascular prosthesis. The vascular prostheses of the present invention exhibit low porosity at the time of implantation of the prosthesis thereby obviating the need for pre-clotting the prosthesis to avoid leakage or hemorrhaging of blood through the prosthesis. The compounded heparin coating of the vascular prostheses of the invention prevents or slows down blood clotting which leads to the build up of natural tissue within the interstitial spaces of the prosthesis and the build-up of a thin, even, well-defined and well-adhered pseudo-intima on the inner surface of the prosthesis.

Claims

1. A vascular prosthesis, comprising

a base material having inner and outer surfaces and a degree of porosity,

an outer coating of compounded heparin bound to said outer surface of said base material and an inner coating of compounded heparin bound to said inner surface of said base material, said compounded heparin including heparin and a cationic surfactant, and

a layer of a material capable of reducing said degree of porosity of said base material formed on said outer coating of compounded heparin, said layer of material being free of any substance that counteracts an anti-coagulant.

2. The vascular prosthesis as claimed in claim 1, wherein said material capable of reducing said degree of porosity of said base material is a biodegradable material.

3. The vascular prosthesis as claimed in claim 2, wherein said biodegradable material is collagen.

4. The vascular prosthesis as claimed in claim 1, wherein said material capable of reducing said degree of porosity of said base material is a non-biodegradable material.

5. The vascular prosthesis as claimed in claim 4, wherein said non-biodegradable material is a silicon-based polymer.

6. The vascular prosthesis as claimed in claim 1, wherein said base material is a bio-compatible polymeric material.

7. The vascular prosthesis as claimed in claim 6, wherein said bio-compatible polymeric material is polyethylene terephthalate.

8. The vascular prosthesis as claimed in claim 7, wherein said polyethylene terephthalate is woven.

9. The vascular prosthesis as claimed in claim 7, wherein said polyethylene terephthalate is knitted.

10. The vascular prosthesis as claimed in claim 1, wherein said base material has a tubular shape.

11. The vascular prosthesis as claimed in claim 10, wherein said tubular shape is radially supported by a synthetic polymer.

12. The vascular prosthesis as claimed in claim 11, wherein said synthetic polymer includes a polypropylene monofilament spirally wound along a length of said tubular shape.

13. The vascular prosthesis as claimed in claim 1, wherein said base material has a bifurcated tubular shape.

14. The vascular prosthesis as claimed in claim 13, wherein said bifurcated tubular shape is radially supported by a synthetic polymer.

15. The vascular prosthesis as claimed in claim 14, wherein said synthetic polymer includes a polypropylene monofilament spirally wound along a length of said tubular shape.

16. The vascular prosthesis as claimed in claim 1, wherein said base material has a planar shape.

17. The vascular prosthesis as claimed in claim 16, wherein said base material comprises a narrow strip having selvedged edges.

18. The vascular prosthesis as claimed in claim 1, wherein said compounded heparin includes heparin ionically bonded with tridodecylmethylammonium chloride.

19. The vascular prosthesis as claimed in claim 1, wherein said compounded heparin includes heparin ionically bonded with benzalkonium chloride.

20. A method of forming a vascular prosthesis, comprising the steps of:

providing a base material having inner and outer surfaces and a degree of porosity;

applying a compounded heparin coating to said inner surface of said base material,

applying a compounded heparin coating to said outer surface of said base material, and

applying to said outer surface of said base material overlying said compounded heparin coating a layer of a material capable of reducing said degree of porosity of said base material, said layer of material being free of any substance that counteracts an anti-coagulant, wherein said compounded heparin includes heparin and a cationic surfactant.