Vascular prosthesis

• US 4,687,482 A
• Filed: 04/27/1984
• Issued: 08/18/1987
• Est. Priority Date: 04/27/1984
• Status: Expired due to Term

• Current Assignee: Stephen Hanson
• Original Assignee: Scripps Clinic & Research Foundation (Scripps Health)
• Inventors: Hanson, Stephen R.
• Primary Examiner(s): Kight, John
• Assistant Examiner(s): SANDERS, KRIELLION ANTIONETTE
• Application Number:
  US06/604,996
• Time in Patent Office: 1,208 Days
• Field of Search: 3/1.4, 623/1, 623/9, 623/12
• US Class Current: 623/1.49
• 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 33/06 Use of macromolecular materials grafting of a monomer onto the substrate A61L33/0088
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/08 from polyethers
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10S 534/02 Azo compounds containing chains of eight or more carbon atoms not provided for elsewhere in this class

Abstract

A vascular prosthesis for implantation in a living mammalian body and a method for producing same are disclosed. The vascular prosthesis has a hydrophobic polymeric layer on its luminal surface defining a substantially non-thrombogenic flow surface. The polymeric material of the layer defining the flow surface exhibits a rate of platelet consumption of less than about 20×10⁸ platelets/cm² ·day.

Claims

1. A vascular prosthesis for implantation in a living mamalian body comprising (a) an elongated tubular segment, said tubular segment having a substantially foraminous, non-complaint, hollow body portion open at both ends, said hollow body portion having a luminal surface defining a confined-flow passageway, and (b) a hydrophobic, physiologically compatible lining constituted by a polymeric material on said luminal surface and defining a thormbus-resistant flow surface that prevents platelet deposition and is free from surface irregularities greater than about 5 microns in height, depth or width, said polymeric material exhibiting a rate of platelet consumption of less than about 20×

10⁸ platelets/cm². day.

2. The vascular prosthesis of claim 1 wherein said flow surface is thrombus-resistant at an arterial blood flow rate of at least about 50 millimeters/minute.

3. The vascular prosthesis of claim 1 wherein said polymeric material is made up of a polymer principally constituted by repeating units of a polyether-based polyurethane.

4. The vascular prosthesis of claim 3 wherein said polyether-based polyurethane is derived from a polytetramethylene ether glycol and a mixture of methylene diisocyanate and a diamine coupler.

5. The vascular prosthesis of claim 1 wherein said polymeric material is made up of a silicone elastomer.

7. The vascular prosthesis of claim 1 wherein said lining is constituted by a plurality of discrete, substantially coextensive polymeric layers.

8. The vascular prosthesis of claim 7 wherein the outermost polymeric layer of said lining is made up of a polymer principally constituted by repeating units of tetrafluoroethylene.

9. The vascular prosthesis of claim 7 wherein the outermost polymeric layer is made up of a polymer principally constituted by repeating units of hexafluoroethane.

10. The vascular prosthesis of claim 1 wherein said rate of platelet consumption is in a range of about 2.0×

10⁸ platelets/cm² ·

day to about 20×

10⁸ platelets/cm² ·

day.

11. The vascular prosthesis of claim 1 wherein said rate of platelet consumption is in a range of about 1.2×

10⁸ platelets/cm² ·

day to about 1.8×

10⁸ platelets/cm² ·

day.

12. A vascular prosthesis of claim 1 wherein said lining has a thickness of at least about 100 nanometers and less than about 1.1 millimeters.

13. The vascular prosthesis of claim 12 wherein said lining has a thickness of at least about 1 micrometer and less than about 1 millimeter

14. The vascular prosthesis of claim 12 wherein said lining has a thickness of at least about 100 nanometers and less than about 1 micrometer.

15. A method of producing a vascular prothesis having a luminal surface, comprising the steps of:

(a) depositing a hydrophobic, physiologically compatible polymeric material exhibiting a rate of platelet consumption of less than about 20×

10⁸ platelets/cm² ·

day onto said luminal surface as a layer having a thickness of at least about 100 nanometers to less than about 1.1 millimeters; and

,

(b) further polymerizing the deposited polymeric material to form a substantially smooth hydrophobic lining on said luminal surface free from surface irregularites greater than about 5 microns in height, depth or width.

6. The vascular prosthesis of claim 15 wherein said silicone elastomer is principally constituted by repeating units of polydimethylsiloxane-methylvinylsiloxane copolymer.

16. The method of claim 15 wherein:

(a) said polymeric material is dissolved in a compatible solvent to produce a solution having a polymeric material concentration in the range of about 1 percent by weight to about 20 percent by weight based on the weight of the solvent;

(b) said solution is deposited onto said luminal surface;

(c) said solvent is removed by evaporation from said deposited solution to form a polymeric residue; and

(d) said polymeric residue is cured to form a substantially smooth hydrophobic lining on said luminal surface free from surface irregularities greater than about 5 microns in height, depth or width.

17. The method of claim 16 wherein said lining is derived from a silicone elastomer.

18. The method of claim 17 wherein said silicone elastomer is principally constituted by repeating units of polydimethylsiloxane.

19. The method of claim 16 wherein said solution has a concentration of from about 1 percent to about 20 percent by weight of said polymeric material in said solvent.

20. The method of claim 16 wherein said solvent is an inert, organic, non-polar solvent.

21. The method of claim 20 wherein said solvent is hexane.

22. The method of claim 16 wherein said steps (b)-(d) are repeated successively to form a plurality of discrete polymeric layers.

23. The method of claim 16 including the further step of depositing a polymeric layer defining a flow surface by glow discharge polymerization.

24. The method of claim 23 wherein said polymeric layer is derived from tetrafluoroethylene.

25. The method of claim 23 wherein said polymeric layer is derived from hexafluoroethane.

26. The method of claim 15 further including the steps of:

(a) depositing a preparation containing said polymeric material in a liquid vehicle onto said luminal surface;

(b) removing said liquid vehicle by evaporation from said preparation to form a polymeric residue; and

,

(c) polymerizing further said polymeric residue to form a hydrophobic lining on said luminal surface.

27. The method of claim 26 wherein said lining is derived from a polymeric material made up of a polymer principally constituted by repeating units of a polyether-based polyurethane.

28. The method of claim 27 wherein said polyether-based polyurethane is derived from a polytetramethylene ether glycol and a mixture of methylene diisocyanate and a diamine coupler.

29. The method of claim 26 wherein said steps (a)-(c) are repeated succesively to form a plurality of discrete polymeric layers.

30. The method of claim 26 including the further step of depositing a polymeric layer defining a flow surface by glow discharge polymerization.

31. The method of claim 30 wherein said polymeric layer is derived from tetrafluoroethylene.

32. The method of claim 30 wherein said polymeric layer is derived from hexafluoroethane.