SOLVATING SYSTEM AND SEALANT FOR MEDICAL USE IN THE SINUSES AND NASAL PASSAGES

• US 20070264342A1
• Filed: 04/24/2007
• Published: 11/15/2007
• Est. Priority Date: 05/10/2006
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Myntti, Matthew F., Lewis, Cecil O., Hissong, James Britton, Oliver, Dana A., Gonzalez Lopez, Maria Nieves, Tijsma, Edze Jan
• Granted Patent: US 7,993,675 B2
• Time in Patent Office: Days
• US Class Current: 424/486
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 31/04 Antibacterial agents

Abstract

Chronic rhinosinusitis and other bacterial sinus conditions may be treated by applying a solvating system containing a surfactant to a bacterial biofilm in a nasal or sinus cavity, disrupting the biofilm, and applying a protective layer of a polymeric film-forming medical sealant.

Claims

1. A method for treating rhinosinusitis and other bacterial sinus conditions, which method comprises:

a) applying a solvating system comprising a surfactant to a treatment site comprising a bacterial biofilm attached or adhered to a surface within a nasal or sinus cavity,

b) detaching, removing or otherwise disrupting at least a part of the biofilm, and

c) applying to the treatment site a protective layer of a polymeric film-forming medical sealant.

2. A method according to claim 1 wherein the treatment site is in a nasal cavity.

3. A method according to claim 1 wherein the treatment site is in a sinus cavity.

4. A method according to claim 1 comprising applying the solvating system by spraying, lavage, misting, mopping, wicking or dripping and further comprising removing the solvating system from the treatment site by flushing, rinsing, draining or absorption.

5. A method according to claim 1 comprising applying the sealant by spraying, lavage, misting, mopping, wicking or dripping.

6. A method according to claim 1 comprising applying the sealant as a film or conformal coating.

7. A method according to claim 1 wherein the surfactant comprises an anionic surfactant, nonionic surfactant, cationic surfactant, zwitterionic surfactant or mixture thereof.

8. A method according to claim 1 wherein the surfactant comprises an alkyl sulfate, alkyl sulfonate or aryl sulfonate.

9. A method according to claim 1 wherein the surfactant is at least about 0.2% of the solvating system.

10. A method according to claim 1 wherein the surfactant is about 0.3% to about 30% of the solvating system.

11. A method according to claim 1 wherein the surfactant is about 0.5% to about 25% of the solvating system.

12. A method according to claim 1 wherein the solvating system further comprises a metal ion sequestering agent.

13. A method according to claim 12 wherein the metal ion sequestering agent comprises a sequestering agent for sodium, calcium or iron.

14. A method according to claim 12 wherein the metal ion sequestering agent comprises citric acid.

15. A method according to claim 12 wherein the metal ion sequestering agent is present at a concentration of about 0.01 to about 0.5 M.

16. A method according to claim 1 wherein the solvating system further comprises water and has a pH of about 5 to about 8.5.

17. A method according to claim 16 wherein the solvating system further comprises a buffer.

18. A method according to claim 1 wherein the solvating system further comprises an antimicrobial agent.

19. A method according to claim 1 wherein the sealant is viscoelastic.

20. A method according to claim 1 wherein the sealant hardens after application.

21. A method according to claim 1 wherein the sealant comprises a polysaccharide.

22. A method according to claim 21 wherein the sealant comprises cellulose, chitin, chitosan, dextran, glycogen, glycosaminoglycan, gum, pectin, starch, or a derivative thereof.

23. A method according to claim 1 wherein the sealant comprises hyaluronan.

24. A method according to claim 1 wherein the sealant comprises carboxymethyl cellulose.

25. A method according to claim 1 wherein the sealant comprises a lipid or polypeptide.

26. A method according to claim 1 wherein the solvating system or sealant further comprises an antimicrobial agent.

27. A method according to claim 26 wherein the antimicrobial agent comprises gallium acetoacetonate, gallium bromide, gallium chloride, gallium fluoride, gallium iodide, gallium maltolate, gallium nitrate, gallium nitride, gallium percolate, gallium phosphite, gallium sulfate or mixture thereof.

28. A method according to claim 1 further comprising applying an antimicrobial agent after application of the solvating system and before application of the sealant.

29. A method according to claim 1 wherein the same steps performed in vitro will cause greater than a 1-log order reduction in a population of one or more of Staphylococcus aureus, Pseudomonas aeruginosa, S. pneumonia, Haemophilus influenzae or Moraxella catarrhalis bacteria.

30. A method according to claim 1 wherein the same steps performed in vitro will cause greater than a 2-log order reduction in a population of one or more of Staphylococcus aureus, Pseudomonas aeruginosa, S. pneumonia, Haemophilus influenzae or Moraxella catarrhalis bacteria.

31. A method according to claim 1 wherein the same steps performed in vitro will cause greater than a 3-log order reduction in a population of one or more of Staphylococcus aureus, Pseudomonas aeruginosa, S. pneumonia, Haemophilus influenzae or Moraxella catarrhalis bacteria.

32. A method according to claim 1 wherein the sealant further comprises an anti-fungal agent, antihistamine, steroidal or non-steroidal anti-inflammatory agent, anti-parasitic agent, antiviral agent, chemotherapeutic/antineoplastic agent, decongestant or mucolytic.

33. A composition for discouraging bacterial recolonization and biofilm reformation on tissue from which a biofilm has been removed, the composition comprising a polymeric film-forming medical sealant and an antimicrobial agent comprising a gallium-containing compound.

34. A composition according to claim 33, wherein the sealant comprises a synthetic polymer, natural polymer or synthetically-modified natural polymer.

35. A composition according to claim 33, wherein the sealant comprises polyethylene glycol.

36. A composition according to claim 33, wherein the sealant comprises a polysaccharide, lipid or polypeptide.

37. A composition according to claim 33 wherein the sealant comprises carboxymethyl cellulose.

38. A composition according to claim 33, wherein the sealant comprises a chitin.

39. A composition according to claim 33 wherein the sealant comprises hyaluronan.

40. A composition according to claim 33, wherein the sealant comprises a collagen.

41. A composition according to claim 33, wherein the sealant comprises a polypeptide reacted with an aldehyde.

42. A composition according to claim 33, wherein the gallium-containing compound comprises gallium acetoacetonate, gallium bromide, gallium chloride, gallium fluoride, gallium iodide, gallium maltolate, gallium nitrate, gallium nitride, gallium percolate, gallium phosphite, gallium sulfate or mixture thereof.