Solvating system and sealant for medical use in the sinuses and nasal passages

• US 7,993,675 B2
• Filed: 04/24/2007
• Issued: 08/09/2011
• Est. Priority Date: 05/10/2006
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Gonzalez Lopez, Maria Nieves, Tijsma, Edze Jan, Myntti, Matthew F., Lewis, Cecil O., Hissong, James Britton, Oliver, Dana A.
• Primary Examiner(s): Blanchard; David J
• Assistant Examiner(s): ZISKA, SUZANNE E
• Application Number:
  US11/739,480
• Publication Number:
  US 20070264342A1
• Time in Patent Office: 1,568 Days
• Field of Search: None
• 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 an aqueous solvating system comprising a metal ion sequestering agent and a surfactant to a treatment site comprising a bacterial biofilm comprising an extracellular polysaccharide matrix 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 by solvating the extracellular polysaccharide matrix so as to provide greater than a 1-log order reduction in one or more of Staphylococcus aureus, Pseudomonas aeruginosa, S. pneumonia, Haemophilus influenzae or Moraxella catarrhalis bacteria, and then

c) applying to the treatment site a protective layer of a polymeric film-forming 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 after applying the solvating system and before applying the sealant.

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 conformal coating.

7. A method according to claim 1 wherein the surfactant comprises a cationic surfactant.

8. A method according to claim 1 wherein the surfactant comprises a zwitterionic surfactant.

9. A method according to claim 1 wherein the surfactant is at least 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 metal ion sequestering agent comprises a sequestering agent for sodium, calcium or iron.

13. A method according to claim 1 wherein the metal ion sequestering agent comprises citric acid.

14. A method according to claim 1 wherein the metal ion sequestering agent is present at a concentration of about 0.01 to about 0.5 M.

15. A method according to claim 1 wherein the solvating system has a pH of about 5 to about 8.5.

16. A method according to claim 15 wherein the solvating system further comprises a buffer.

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

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

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

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

21. A method according to claim 20 wherein the sealant comprises cellulose, chitin, chitosan, dextran, glycogen, glycosaminoglycan, gum, pectin, starch, or a derivative thereof.

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

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

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

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

26. A method according to claim 25 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.

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

28. 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 Staphylococcus aureus.

29. 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.

30. 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.

31. 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.