Sinus delivery of sustained release therapeutics
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.
1. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising:
a) loading a delivery device with one or more drug-releasing implants;
b) creating access to the paranasal sinus cavity with the loaded delivery device such that at least a portion of the delivery device is advanced into the paranasal sinus cavity; and
c) delivering the one or more drug-releasing implants from the delivery device-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 one or more drug-releasing implants is a solid implant having a first delivery form for facilitating delivery into the sinus cavity and a second form, different from the first form, the second form having a shape that substantially prevents clearance of the implant from the sinus cavity.
3. The method of claim 1 wherein the one or more drug-releasing implants has a diameter of about 5 millimeters while in the conduit.
4. The method of claim 1 wherein delivering the one or more drug-releasing implants comprises delivering the one or more drug-releasing implants with a pusher.
5. The method of claim 1 wherein delivering the one or more drug-releasing implants comprises delivering the one or more drug-releasing implants with a pressurized gas.
6. The method of claim 1 wherein the one or more drug-releasing implants is a biodegradable polymeric implant.
7. The method of claim 1 wherein the delivery device Comprises a conduit.
8. The method of claim 1 wherein a distal portion of the delivery device is angulated.
9. The method of claim 8 wherein the distal portion of the delivery device is angulated at an angle between about zero degrees to about 135 degrees.
10. The method of claim 7 wherein the conduit comprises a distal opening at a tip of the conduit.
11. The method of claim 7 wherein the conduit comprises a distal opening in a side wall of the conduit.
12. The method of claim 1 wherein the one or more drug-releasing implants comprises a series of predetermined fracture lines.
13. The method of claim 1 wherein the one or more drug-releasing implants comprises a therapeutic amount of an anti-inflammatory active agent.
14. The method of claim 13 wherein the anti-inflammatory active agent comprises mometasone furoate.
15. The method of claim 13 wherein the anti-inflammatory active agent comprises budesonide.
16. The method of claim 13 wherein the anti-inflammatory active agent comprises fluticasone propionate.
17. The method of claim 13 wherein the anti-inflammatory active agent comprises triamcinolone acetonide.
18. The method of claim 1 wherein the one or more drug-releasing implants comprises a biodegradable matrix.
19. The method of claim 18 wherein the biodegradable matrix comprises a biodegradable polymer matrix.
20. The method of claim 19 wherein the biodegradable polymer matrix comprises a mucoadhesive polymer.
21. The method of claim 19 wherein the biodegradable polymer matrix comprises a poly(lactic-co-glycolic)acid (PLGA) copolymer.
22. The method of claim 19 wherein the biodegradable polymer matrix comprises lactic acid.
23. The method of claim 19 wherein the biodegradable polymer matrix comprises glycolic acid.
24. The method of claim 1 wherein the active agent is released over a treatment period of about one week to about three months.
25. The method of claim 1 wherein the active agent is released over a treatment period of about two weeks to about four weeks.
26. The method of claim 1 wherein the active agent is released over a treatment period of at least about one week.
27. The method of claim 1 wherein the active agent is released over a treatment period of at least about two weeks.
28. 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.
29. The method of claim 1 wherein the one or more drug-releasing implants is a rod, pellet, bead, strip, or microparticle.
30. The method of claim 1 wherein creating access to the paranasal sinus cavity comprises puncturing a sinus wall of the paranasal sinus.
31. A method for delivering a drug-releasing implant into a paranasal sinus cavity comprising:
a) loading a delivery device with one or more drug-releasing implants;
b) creating access to the paranasal sinus cavity with the loaded delivery device such that at least a portion of the delivery device is advanced into the paranasal sinus cavity; and
c) delivering the one or more drug-releasing implants from the delivery device-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.
32. The method of claim 31 wherein creating access to the paranasal sinus cavity comprises puncturing a sinus wall of the paranasal sinus.