Claims for Patent: 7,951,130

Summary for Patent: 7,951,130

Title:	Sinus delivery of sustained release therapeutics
Abstract:	The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.
Inventor(s):	Eaton; Donald J. (Los Altos, CA), Moran; Mary L. (Woodside, CA), Brenneman; Rodney A. (San Juan Capistrano, CA)
Assignee:	Intersect ENT, Inc. (Palo Alto, CA)
Application Number:	12/883,059
Patent Claims:	1. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising: a) loading one or more drug-releasing implants into a conduit having a distal portion; b) creating access to the paranasal sinus cavity with the loaded conduit while using a visualization technique such that at least a portion of the loaded conduit is advanced into the paranasal sinus cavity; and c) delivering the one or more drug-releasing implants through an opening in the distal portion of the conduit into the paranasal sinus cavity, wherein the one or more drug-releasing implants comprise a therapeutic amount of an active agent for the treatment of sinusitis. 2. The method of claim 1 wherein the drug-releasing implant is delivered through a sinus ostium. 3. The method of claim 1 wherein the drug-releasing implant is delivered through a sinus wall. 4. The method of claim 1 wherein the implant has a diameter of about 5 millimeters while in the conduit. 5. The method of claim 1 wherein delivering the drug-releasing implant comprises delivering the drug-releasing implant with a pusher. 6. The method of claim 1 wherein delivering the drug-releasing implant comprises delivering the drug-releasing implant with a pressurized gas. 7. The method of claim 1 wherein the drug-releasing implant is a biodegradable polymeric implant. 8. The method of claim 1 wherein the conduit is sharp-tipped. 9. The method of claim 1 wherein the distal portion of the conduit is angulated. 10. The method of claim 9 wherein the distal portion of the conduit is angulated at an angle between about zero degrees to about 135 degrees. 11. The method of claim 1 wherein the distal opening is located at a tip of the conduit. 12. The method of claim 1 wherein the distal opening is located in a side wall of the conduit. 13. The method of claim 1 wherein the drug-releasing implant comprises a series of predetermined fracture lines. 14. The method of claim 1 wherein the drug-releasing implant comprises a therapeutic amount of an anti-inflammatory active agent. 15. The method of claim 14 wherein the anti-inflammatory active agent comprises mometasone furoate. 16. The method of claim 14 wherein the anti-inflammatory active agent comprises budesonide. 17. The method of claim 14 wherein the anti-inflammatory active agent comprises fluticasone propionate. 18. The method of claim 14 wherein the anti-inflammatory active agent comprises triamcinolone acetonide. 19. The method of claim 1 wherein the visualization technique comprises endoscopy. 20. The method of claim 1 wherein the visualization technique comprises computer image-guidance. 21. The method of claim 1 wherein the one or more drug-releasing implants comprises a biodegradable matrix. 22. The method of claim 21 wherein the biodegradable matrix comprises a biodegradable polymer matrix. 23. The method of claim 22 wherein the biodegradable polymer matrix comprises a mucoadhesive polymer. 24. The method of claim 22 wherein the biodegradable polymer matrix comprises a poly(lactic-co-glycolic)acid (PLGA) copolymer. 25. The method of claim 22 wherein the biodegradable polymer matrix comprises lactic acid. 26. The method of claim 22 wherein the biodegradable polymer matrix comprises glycolic acid. 27. The method of claim 1 wherein the active agent is released over a treatment period of about one week to about three months. 28. The method of claim 1 wherein the active agent is released over a treatment period of about two weeks to about four weeks. 29. The method of claim 1 wherein the active agent is released over a treatment period of at least about one week. 30. The method of claim 1 wherein the active agent is released over a treatment period of at least about two weeks. 31. The method of claim 1 wherein the one or more drug-releasing implants comprises an active agent in an amount between about 5% and about 90% by weight of the one or more drug-releasing implants. 32. The method of claim 1 wherein the one or more drug-releasing implants is a rod, pellet, bead, strip, or microparticle. 33. The method of claim 1 wherein the one or more drug-releasing implants comprises a gel. 34. The method of claim 1 wherein the one or more drug-releasing implants comprises a semi-solid. 35. The method of claim 1 wherein the one or more drug-releasing implants has a diameter of less than about 5 millimeters while in the conduit. 36. The method of claim 1 wherein the one or more drug-releasing implants has a diameter of about 2 millimeters while in the conduit. 37. The method of claim 1 wherein the one or more drug-releasing implants has a diameter between about 0.05 millimeters and about 5 millimeters while in the conduit. 38. The method of claim 1 wherein the one or more drug-releasing implants comprises hyaluronic acid. 39. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising: a) loading one or more drug-releasing implants into a conduit having a distal portion; b) creating access to the paranasal sinus cavity with the loaded conduit such that at least a portion of the loaded conduit is advanced into the paranasal sinus cavity; and c) delivering the one or more drug-releasing implants through an opening in the distal portion of the conduit into the paranasal sinus cavity while using a visualization technique, wherein the one or more drug-releasing implants comprise a therapeutic amount of an active agent for the treatment of sinusitis. 40. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising: a) loading one or more drug-releasing implants into a conduit having a distal portion; b) creating access to the paranasal sinus cavity with the loaded conduit such that at least a portion of the loaded conduit is advanced into the paranasal sinus cavity; and c) delivering the one or more drug-releasing implants through an opening in the distal portion of the conduit into the paranasal sinus cavity while using a visualization technique, wherein the one or more drug-releasing implants comprise a therapeutic amount of an active agent for the reduction of inflammation. 41. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising: a) loading one or more drug-releasing implants into a conduit having a distal portion; b) creating access to the paranasal sinus cavity with the loaded conduit while using a visualization technique such that at least a portion of the loaded conduit is advanced into the paranasal sinus cavity; and c) delivering the one or more drug-releasing implants through an opening in the distal portion of the conduit into the paranasal sinus cavity, wherein the one or more drug-releasing implants comprise a therapeutic amount of an active agent for the reduction of inflammation.