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1. WO2013163577 - COMPOSITIONS AND METHODS FOR COATING IMPLANT SURFACES TO INHIBIT SURGICAL INFECTIONS

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[ EN ]

CLAIMS

What is claimed is:

1. An infection-inhibiting composition for application to the surface of an implantable medical device, comprising an antimicrobial agent in a waxy matrix operable to deposit the anti-infective when rubbed on a surface of the device.

2. The infection-inhibiting composition according to Claim 1, wherein the composition comprises a lipid selected from the group consisting of fatty acids, triacylglyerols, diacyl glycerols, glycerophospholipids, and mixtures thereof.

3. The infection-inhibiting composition according to Claim 2, wherein the waxy matrix comprises about 90% or more, by weight of the matrix, of pho sphatidylcholine .

4. The infection-inhibiting composition according to Claim 1, wherein the antimicrobial agent is present at a level of from about 0.1% to about 35% by weight.

5. The infection-inhibiting composition according to Claim 1, wherein the antimicrobial agent is selected from the group consisting of antibiotics, antimicrobial peptides, synthetic mimics of antimicrobial peptides, disinfectants, and antimicrobial metal ions, epsilon polylysine, sugar alcohols, essential oils, and mixtures thereof.

6. The infection-inhibiting composition according to Claim 5, wherein the antimicrobial agent is selected from the group consisting of fosfomycin, rifampin, tetracyclines, aminoglycosides, quinolones, glycopeptides, and mixtures thereof.

7. The infection-inhibiting composition according to Claim 6, wherein the antimicrobial agent comprises rifampin and minocycline.

8. The infection-inhibiting composition according to Claim 1, having a cone penetration test hardness of at least 1.5 lbf.

9. The infection-inhibiting composition according to Claim 8, having a cone penetration test hardness of from about 5 to about 15 lbf.

10. An infection-inhibiting delivery system for application of an anti-infective coating to a surface of an implantable medical device, comprising:

a) infection-inhibiting composition having a waxy matrix comprising an infection-inhibiting material selected from the group consisting of a lipid, an antimicrobial agent, and mixtures thereof, wherein the waxy carrier is operable to deposit the infection-inhibiting material when rubbed on a surface of the device; and b) an applicator containing the infection-inhibiting composition.

11. The infection-inhibiting delivery system according to Claim 10, wherein the applicator comprises a substantially cylindrical tube having an open end and an advancing mechanism at the end of the tube opposite to the open end, wherein the infection-inhibiting composition is contained within the tube, and the advancing mechanism is operable to move the composition along the axis of the tube so as to extend a surface of the infection-inhibiting composition at the open end of the tube.

12. A method for inhibiting infection at the site of implantation of an orthopedic device in a human or animal subject, comprising rubbing a surface of the device, prior to implantation, with an infection-inhibiting composition having a waxy matrix comprising an infection-inhibiting material selected from the group consisting of a lipid, an antimicrobial agent, and mixtures thereof, wherein a thin layer of the infection-inhibiting material is deposited on the surface of the device.

13. The method for inhibiting infection according to Claim 12, wherein the waxy matrix comprises a lipid selected from the group consisting of fatty acids, triacylglyerols, diacyl glycerols, glycerophospholipids, and mixtures thereof..

14. The method for inhibiting infection according to Claim 13, wherein the composition wherein the waxy matrix comprises about 90% or more, by weight of the matrix, of phosphatidylcholine.

15. The infection-inhibiting composition according to Claim 1, comprising an antimicrobial agent selected from the group consisting of antibiotics, antimicrobial peptides, synthetic mimics of antimicrobial peptides, disinfectants, and antimicrobial metal ions, epsilon polylysine, sugar alcohols, essential oils, and mixtures thereof.

16. The method for inhibiting infection according to Claim 15, wherein the antimicrobial agent is selected from the group consisting of fosfomycin, rifampin, tetracyclines, aminoglycosides, quinolones, glycopeptides, and mixtures thereof.

17. The method for inhibiting infection according to Claim 12, wherein the composition has a cone penetration test hardness from about 5 to about 15 lbf.

18. The method for inhibiting infection according to Claim 14, wherein the orthopedic device is a hip implant, a knee implant, an elbow implant, a prosthetic frame, bone plate, a bone prosthesis, a small joint prosthesis, a rod, a pin, a hook, an intramedullary nail or other nail, a bone screw, a spacer or a cage.

19. The method for inhibiting infection according to Claim 12, wherein the surface is textured.

20 The method for inhibiting infection according to Claim 12, wherein the sterile medical device is coated with the infection-inhibiting composition in the operating room prior to implantation in a patient.