Coated surgical mesh

• US 8,574,627 B2
• Filed: 10/30/2007
• Issued: 11/05/2013
• Est. Priority Date: 11/06/2006
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Martakos, Paul, Herweck, Steve A., Prowse, Jocelyn, Horton, Anthony Richard, Faucher, Keith M., Ferraro, Joseph
• Primary Examiner(s): FORD, ALLISON M
• Application Number:
  US11/978,840
• Publication Number:
  US 20080118550A1
• Time in Patent Office: 2,198 Days
• Field of Search: None
• US Class Current: 424/484
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

A surgical mesh is formed of a biocompatible mesh structure with a coating that provides anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a implantation in a patient. The coating is generally formed of a fish oil, can include vitamin E, and may be at least partially cured. In addition, the coating can include a therapeutic agent component, such as a drug or other therapeutic agent.

Claims

1. A coated surgical mesh comprising:

a biocompatible mesh structure composed of a plurality of inter-coupled strands forming a plurality of interstices therebetween, wherein the mesh structure is not a stent; and

a non-polymeric coating formed from one or more of fatty acids, glycerides or combinations thereof, wherein the one or more of fatty acids, glycerides or combinations thereof are cross-linked in a substantially random configuration, wherein the coating encapsulates the strands while maintaining the plurality of interstices uncoated.

2. The mesh of claim 1, wherein the coating further comprises vitamin E.

3. The mesh of claim 2, wherein the source of the one or more of fatty acids, glycerides or combinations thereof is fish oil, wherein the coating further comprises at least one therapeutic agent, and wherein a ratio of the fish oil to the vitamin E is variable prior to coating to increase the solubility of the therapeutic agent.

4. The mesh of claim 3, wherein the ratio of the fish oil to the vitamin E is at least about 80:

20 by weight.

5. The mesh of claim 1, wherein the coating further comprises at least one therapeutic agent.

6. The mesh of claim 5, wherein the therapeutic agent is selected from the group consisting of antioxidants, anti-inflammatory agents, anti-coagulant agents, drugs to alter lipid metabolism, anti-proliferatives, anti-neoplastics, tissue growth stimulants, functional protein/factor delivery agents, anti-infective agents, imaging agents, anesthetic agents, chemotherapeutic agents, tissue absorption enhancers, anti-adhesion agents, germicides, analgesics, prodrugs and antiseptics.

7. The mesh of claim 5, wherein the coating is formulated to release the therapeutic agent in a controlled manner after implantation of the mesh in a subject.

8. The mesh of claim 1, wherein the coating is in at least a partially cured state prior to application of the coating on the mesh.

9. The mesh of claim 1, wherein the coating is subjected to curing conditions subsequent to application of the coating on the mesh, such that the coating is resident on the mesh in at least a partially cured state.

10. A method of making a coated surgical mesh, the method comprising:

providing a biocompatible mesh structure composed of a plurality of inter-coupled strands forming a plurality of interstices therebetween, wherein the mesh structure is not a stent;

preparing a coating formed from one or more of fatty acids, glycerides or combinations thereof, wherein the one or more of fatty acids, glycerides or combinations thereof are cross-linked in a substantially random configuration; and

applying the coating to the biocompatible mesh structure, wherein the coating encapsulates the strands while maintaining the plurality of interstices uncoated.

11. The method of claim 10, wherein the coating further comprises vitamin E.

12. The method of claim 10, wherein the source of the one or more of fatty acids, glycerides or combinations thereof is fish oil, and wherein the coating is prepared by mixing about 80% by weight of the fish oil with about 20% by weight vitamin E.

13. The method of claim 12, wherein the method further comprises the step of dissolving one or more therapeutic agents in the coating prior to application of the coating to the biocompatible mesh structure.

14. The method of claim 10, wherein the method further comprises the step of coating the biocompatible mesh structure with one or more therapeutic agents dissolved in a solvent.

15. The method of claim 10, wherein the coating further comprises between about 0.1 and 50% by weight of a therapeutic agent.

16. The method of claim 10, wherein the coating further comprises between about 6% and 7% by weight of a therapeutic agent.

17. The method of claim 10, wherein the coating is dispersed on the biocompatible mesh structure in the amount of about 15 mg/in².

18. The method of claim 10, wherein the method further comprises the step of treating the biocompatible mesh structure prior to application of the coating.

19. The method of claim 18, wherein the step of treating the biocompatible mesh structure prior to coating improves the adhesive forces between the coating and the mesh, diminishes coating flow and pooling and provides a more continuous coating.

20. The method of claim 10, wherein said coating is in at least a partially cured state prior to application of the coating on the mesh.

21. The method of claim 20, wherein curing comprises applying a curing mechanism selected from the group of curing mechanisms comprising heat, UV light, chemical means and reactive gasses.

22. The method of claim 10, further comprising the step of partially curing the coating after application of the coating to the biocompatible mesh structure.

23. The method of claim 22, wherein the step of partially curing comprises applying a curing mechanism selected from the group of curing mechanisms comprising heat, UV light, chemical means and reactive gasses.

24. The method of claim 10, wherein the method further comprises the step of packaging and sterilizing the biocompatible mesh structure and the coating.

25. The method of claim 24, wherein the step of sterilizing is performed by vaporized hydrogen peroxide, ethylene oxide (ETO) gas, radiation using gamma or electron-beam radiation, steam and gas plasma.