Method for treating the ear, nose, sinus or throat

• US 9,333,220 B2
• Filed: 11/13/2013
• Issued: 05/10/2016
• Est. Priority Date: 04/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gonzalez, Maria Nieves, Tijsma, Edze Jan, TenBroek, Erica M., Schaffhausen, Nancy
• Primary Examiner(s): Berry, Layla
• Application Number:
  US14/079,378
• Publication Number:
  US 20140073601A1
• Time in Patent Office: 909 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/718 Starch or degraded starch, e.g. amylose, amylopectin
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 26/0052 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 26/009 Materials resorbable by the body
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

Bodily tissue and structures may be protected using a fluid layer containing a mixture of chitosan and oxidized polysaccharide. The mixture forms a protective gel layer via in situ crosslinking. Compared to crosslinking using a low molecular weight aldehyde such as glutaraldehyde or genipin, oxidized polysaccharides appear to provide faster gelation while avoiding the use of potentially less bioacceptable low molecular weight aldehydes.

Claims

1. A method for treating bodily tissue or structure in the ear, nose, sinus or throat, which method comprises:

a) applying to such ear, nose, sinus or throat tissue or structure a fluid layer containing a mixture of (i) chitosan having a number average molecular weight before sterilization of at least about 50 kDa and (ii) an oxidized polysaccharide, and

b) allowing the mixture to crosslink in situ to form a protective gel layer that remains exposed to air or other nearby gases, reduces adhesions to anatomy, and has a residence time of one day to four weeks.

2. A method according to claim 1 comprising applying the fluid layer to a nasal or sinus cavity.

3. A method according to claim 1 comprising applying the fluid layer to a middle or inner ear.

4. A method according to claim 1 comprising applying the fluid layer to throat tissue.

5. A method according to claim 1 comprising applying the fluid layer to mucosal tissue.

6. A method according to claim 1 comprising applying the fluid layer from a multiple-barrel syringe.

7. A method according to claim 1 comprising applying the fluid layer by spraying.

8. A method according to claim 1 wherein the chitosan is an unmodified chitosan or a chitosan salt.

9. A method according to claim 1 wherein the chitosan is a chitosan derivative.

10. A method according to claim 1 wherein the oxidized polysaccharide comprises oxidized starch.

11. A method according to claim 1 wherein the oxidized polysaccharide comprises oxidized cellulose.

12. A method according to claim 1 wherein the oxidized polysaccharide comprises oxidized chitin, oxidized chitosan, oxidized chondroitin sulfate, oxidized dextran, oxidized glycogen or oxidized hyaluronic acid.

13. A method according to claim 1 wherein the chitosan and oxidized polysaccharide are combined in a ratio of about 10:

1 to about 1;

20.

14. A method according to claim 1 wherein the chitosan and oxidized polysaccharide are combined in a ratio of about 3:

1 to about 1;

5.

15. A method according to claim 1 wherein the chitosan is a low molecular weight material having a number average molecular weight of about 50 to about 200 kDa.

16. A method according to claim 1 wherein the chitosan is a medium molecular weight material having a number average molecular weight of about 200 to about 500 kDa.

17. A method according to claim 1 wherein the chitosan is a high molecular weight material having a number average molecular weight greater than about 500 kDa.

18. A method according to claim 1 wherein the fluid layer remains a gel during biodegradation or bioresorbtion.

19. A method according to claim 1 wherein the protective gel layer is biodegradable or bioresorbable without shedding large solid chunks.

20. A method according to claim 1 wherein the fluid layer contains chitosan and oxidized polysaccharide in a combined amount of about 1 to about 10 wt. % of the fluid layer.

21. A method according to claim 1 wherein the fluid layer consists essentially of chitosan, oxidized polysaccharide, a solvent selected from water and alcohols, and an optional buffering agent.