Coated vascular grafts and methods of use

• US 6,939,377 B2
• Filed: 08/20/2001
• Issued: 09/06/2005
• Est. Priority Date: 08/23/2000
• Status: Expired due to Fees

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Thoratec LLC
• Inventors: Jayaraman, Ramesh B., Christoforou, Christofer T.
• Primary Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/933,256
• Publication Number:
  US 20020065552A1
• Time in Patent Office: 1,478 Days
• Field of Search: 623 144- 153
• US Class Current: 623/1.46
• 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: C08L 75/04 Polyurethanes

Abstract

A vascular graft, such as an AAA stent graft, includes a core zone of PET fabric with a non-porous coating comprising a polyurethane, such as Thoralon®, disposed on at least one surface. The coating provides a barrier to prevent short and long term leakage of fluids through the pores of the PET fabric core zone. A method for sealing the pores of a porous PET graft includes the step of coating at least one surface of said graft with at least one polyurethane, or mixtures and combinations thereof. Preferably, the coating is Thoralon®. A method for making a vascular prosthesis includes the steps of providing a core zone of PET fabric, and coating at least one surface of the core zone with at least one polyurethane, or mixtures and combinations thereof, such as Thoralon®. Finally, a method of repairing or treating a defective vessel includes the step of reinforcing or replacing the defective vessel with a graft according to the invention.

Claims

1. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein the coating comprises a polyurethane urea, wherein said first coating has a thickness of about 12 μ

m.

2. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein the coating comprises a polyetherurethane urea blended with a siloxane containing a surface modifying additive, wherein said first coating has a thickness of about 12 μ

m.

3. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein said at least one polyurethane comprises a soft segment and a hard segment, wherein said first coating has a thickness of about 12 μ

m.

4. The graft of claim 3 wherein the soft segment has a molecular weight of about 2,000 g/mole.

5. The graft of claim 3 wherein the soft segment comprises one or more compounds selected from the group consisting of polyethylene oxide, polypropylene oxide, polytetramethylene oxide, polycarbonate, polyolefin, polysiloxane, polyether soft segments made from higher homologous series of diols, and mixtures and combinations thereof.

6. The graft of claim 3 wherein the hard segment comprises one or more compounds selected from the group consisting of 4,4′

-diphenylmethane diisocyanate, tetramethylene diisocyanate, hexamethylene diisocyanate, trimethyhexamethylene diisocyanate, tetramethylxylylene diisocyanate, 4,4′

-decyclohexylmethane diisocyanate, dimer acid diisocyanate, isophorone diisocyanate, metaxylene diisocyanate, diethylbenzene diisocyanate, decamethylene 1,10 diisocyanate, cyclohexylene 1,2-diisocyanate, 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, xylene diisocyanate, m-phenylene diisocyanate, hexahydrotolylene diisocyanate (and isomers), naphthylene-1,5-diisocyanate, 1-methoxyphenyl2,4-diisocyanate, 4,4′

-biphenylene diisocyanate, 3,3-dimethoxy-4,4′

-biphenyl diisocyanate, ethylene diamine, propane diamines, butanediamines, hexanediamines, pentane diamines, heptane diamines, octane diamines, m-xylylene diamine, 1,4-cyclohexane diamine, 2-methypentamethylene diamine, 4,4′

-methylene dianiline, alkanol amines and diamines, ethylene glycol, diethylene glycol, triethylene glycol, 1,4-butanediol, neopentyl alcohol, 1,6-hexanediol, 1,8-octanediol, propylene glycols, 2,3-butylene glycol, dipropylene glycol, dibutylene glycol, glycerol, and mixtures and combinations thereof.

7. The graft of claim 3 wherein said coating comprises a polyether urethane urea, and wherein said soft segment comprises polytetramethylene oxide (PTMO) and said hard segment comprises 4,4′

-diphenylmethane diisocyanate (MDI) and ethylene diamine.

8. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein the coating comprises a polyurethane urea, wherein said first coating has a thickness in a range of about 4 μ

m to about 5 μ

m.

9. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein the coating comprises a polvetherurethane urea blended with a siloxane containing a surface modifying additive, wherein said first coating has a thickness in a range of about 4 μ

m to about 5 μ

m.

10. A vascular graft comprising:

a core zone comprising a PET fabric, said core zone having a first surface and a second surface opposing said first surface, wherein the first surface is a blood interface surface; and

a first non-porous coating disposed on said first surface and permeating into at least a portion of said core zone, such that said at least one portion of said core zone is impermeable, wherein said first coating comprises at least one polyurethane;

wherein said at least one polyurethane comprises a soft segment and a hard segment, wherein said first coating has a thickness in a range of about 4 μ

m to about 5 μ

m.

11. The graft of claim 10 wherein the soft segment has a molecular weight of about 2000 g/mole.

12. The graft of claim 10 wherein the soft segment comprises one or more compounds selected from the group consisting of polyethylene oxide, polypropylene oxide, polytetramethylene oxide, polycarbonate, polyolefin, polysiloxane, polyether soft segments made from higher homologous series of diols, and mixtures and combinations thereof.

13. The graft of claim 10 wherein the hard segment comprises one or more compounds selected from the group consisting of 4,4′

-diphenylmethane diisocyanate, tetramethylene diisocyanate, hexamethylene diisocyanate, trimethyhexamethylene diisocyanate, tetramethylxylylene diisocyanate, 4,4′

-decyclohexylmethane diisocyanate, dimer acid diisocyanate, isophorone diisocyanate, metaxylene diisocyanate, diethylbenzene diisocyanate, decamethylene 1,10 diisocyanate, cyclohexylene 1,2-diisocyanate, 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, xylene diisocyanate, m-phenylene diisocyanate, hexahydrotolylene diisocyanate (and isomers), naphthylene-1,5-diisocyanate, 1-methoxyphenyl2,4-diisocyanate, 4,4′

-biphenylene diisocyanate, 3,3-dimethoxy-4,4′

-biphenyl diisocyanate, ethylene diamine, propane diamines, butanediamines, hexanediamines, pentane diamines, heptane diamines, octane diamines, m-xylylene diamine, 1,4-cyclohexane diamine, 2-methypentamethylene diamine, 4,4′

-methylene dianiline, alkanol amines and diamines, ethylene glycol, diethylene glycol, triethylene glycol, 1,4-butanediol, neopentyl alcohol, 1,6-hexanediol, 1,8-octanediol, propylene glycols, 2,3-butylene glycol, dipropylene glycol, dibutylene glycol, glycerol, and mixtures and combinations thereof.