Antimicrobial fabric and medical graft of the fabric

• US 6,296,863 B1
• Filed: 11/23/1998
• Issued: 10/02/2001
• Est. Priority Date: 11/23/1998
• Status: Expired due to Term

• Current Assignee: Sciessent, LLC
• Original Assignee: AgION Technologies, LLC
• Inventors: Trogolo, Jeffrey A., Holley, Steven, Barry, John E.
• Primary Examiner(s): Dodson, Shelley A.
• Application Number:
  US09/197,809
• Time in Patent Office: 1,044 Days
• Field of Search: 424/400, 424/402, 424/404, 623/1, 623/12, 427/2, 427/2.1
• US Class Current: 424/404
• CPC Class Codes: A61L 2300/10 containing or releasing inorganic materials
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• 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 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: D06M 16/00 Biochemical treatment of fibres, threads, yarns, fabrics, or fibrous goods made from such materials, e.g. enzymatic

Abstract

A medical graft, such as a vascular graft, made of a fabric containing an inorganic antimicrobial agent. The fabric has a coating material with the inorganic antimicrobial agent bonded to it, the agent preferably being a zeolite. The fabric can be porous so as to permit tissue to grow on it with the fabric pores providing attachment sites for the tissue. Alternatively, the fabric can be coated with a tissue biocompatible material, such as collagen. A porous fabric applicable for the graft, and for other medical uses, and a method of manufacturing the porous fabric having a coating thereon to which is bonded an antimicrobial agent, such as a zeolite, also is provided. The fabric is antimicrobial, remains pliable, and is also porous.

Claims

1. A porous, flexible, medical graft comprising:

(a) fabric material in a generally tubular shape; and

(b) ceramic particles bound to the fabric material, the particles comprising antimicrobial metal cations ion-exchanged thereon, wherein some or all of the ceramic particles are exteriorly exposed to permit entry into the particles of water and cations, thereby effecting an ion exchange reaction, which releases antibiotic cations from the ceramic particles in an antimicrobially effective amount.

2. The medical graft of claim 1 wherein the ceramic particles are bound to the graft by a polymeric coating material.

3. The medical graft of claim 1 wherein the ceramic particles comprise zeolite particles dispersed on the coating material and wherein the zeolite constitutes between 0.5 and 20% of the weight of the graft, exclusive of the fabric.

4. The graft of claim 2 wherein the coating material comprises an elastomeric material selected from the group consisting of acrylic, polyurethane, silicone, latex, polyglycolic lactic acid, a biodegradable polymer, a hydrophilic biodegradable polymer, and a non-degrading polymer.

5. The graft of claim 2 wherein the coating material comprises a hydrophilic polyurethane.

6. The graft of claim 1 wherein said ceramic particles comprise zeolite particles.

7. The graft of claim 4 wherein the ceramic particles have a size between 0.8 and 10 microns.

8. The graft of claim 1 wherein the fibers of the fabric comprise a polymer selected from the group consisting of cotton, nylon, polyester, PTFE, e-PTFE and blends of these materials.

9. The graft of claim 1 further comprising a coating of a tissue compatible material on at least an exterior surface of the graft.

10. A method of making a medical graft comprising:

(a) providing porous fabric treated with ceramic particles bound to the fabric material, the particles comprising antimicrobial metal cations ion-exchanged thereon, wherein the process results in some or all of the ceramic particles being exteriorly exposed to permit entry of water and cations into the ceramic particles, thereby effecting an ion exchange reaction, which releases antibiotic cations from the ceramic particles in an antimicrobially effective amount; and

(b) forming said fabric piece into a generally tubular shape to form said graft with said antibiotic agent.

11. The method of claim 10 further comprising the step of coating at least the outer surface of said graft with a tissue compatible material.

12. The method of claim 10 wherein step (a) comprises applying a coating material containing said antimicrobial agent to cover the fabric piece and removing matter from the fabric pores.

13. The method of claim 12 wherein said applying step comprises first applying a wet coating material to the fabric and then applying the ceramic particles in powdered form to the wet coating material.

14. The method of claim 12 wherein said applying step comprises applying a mixture of the coating material and the ceramic particles to said fabric.

15. The method of claim 12 wherein said removing step comprises applying a gas under pressure to said fabric.

16. The method of claim 12 wherein said fabric is held under tension during the application of said coating material.

17. The method of claim 13 wherein said fabric piece is held under tension during application of said coating material and removing of said matter in said fabric pores.

18. A method of producing a porous, pliable antimicrobial fabric comprising:

(a) providing a porous fabric; and

(b) applying to said fabric ceramic particles while leaving pores of said fabric open, wherein;

(i) the ceramic particles bound to the fabric comprise antimicrobial metal cations ion-exchanged thereon; and

(ii) some or all of the ceramic particles are exteriorly exposed to permit entry of water and cations into the ceramic particles, thereby effecting an ion exchange reaction, which releases antibiotic cations from the ceramic particles in an antibiotically effective amount.

19. The method of claim 18 wherein said applying step comprises applying a coating material and the ceramic particles to cover the fabric piece and removing matter from the fabric pores.

20. The method of claim 19 wherein said applying step comprises first applying a wet coating material to the fabric and then applying the ceramic particles in powdered form to the wet coating material.

21. The method of claim 19 wherein said applying step comprises applying a mixture of the coating material and the ceramic particles to the fabric.

22. The method of claim 19 wherein the removing step comprises applying a gas under pressure to the fabric.

23. The method of claim 19 wherein the fabric is held under tension during the application of the coating material.

24. The method of claim 19 wherein the fabric piece is held under tension during application of the coating material and during removing of the matter from said fabric pores.

25. The method of claim 19 wherein fibers of the fabric are of a type having voids, and the step of applying comprises placing said antimicrobial agent into said voids.

26. A pliable antimicrobial fabric comprising a porous fabric comprising an antimicrobial metal ion-generating inorganic antimicrobial agent on fibers of the fabric, with the pores of the fabric left open.

27. The fabric of claim 26 wherein said antimicrobial agent is in a coating on the fibers of said fabric piece.

28. A porous, flexible medical graft comprising fabric material formed in a generally tubular shape, wherein at least a portion of the fabric material is coated with a polymeric coating material incorporating inorganic ceramic particles, such that some or all of the ceramic particles are exteriorly exposed to release antibiotic metal cations in an antimicrobially effective amount when the medical graft is implanted in vivo.

29. A non-porous medical graft, the graft comprising fabric material formed in a generally tubular shape, wherein:

(a) the fabric material comprises a first coating comprising a polymeric coating material incorporating inorganic ceramic particles; and

(b) the fabric comprises a second coating comprising a tissue growth-promoting material;

such that some or all of the ceramic particles are exteriorly exposed to release antibiotic metal cations in an antimicrobially effective amount when the medical graft is implanted in vivo.