Sinus delivery of sustained release therapeutics

• US 7,951,135 B2
• Filed: 09/15/2010
• Issued: 05/31/2011
• Est. Priority Date: 03/14/2003
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Brenneman, Rodney A., Eaton, Donald J., Moran, Mary L.
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Witczak; Catherine N
• Application Number:
  US12/883,090
• Publication Number:
  US 20110004196A1
• Time in Patent Office: 258 Days
• Field of Search: 604/93.01, 604/891.1, 604/57, 604 59- 64, 604/510, 604/514, 604/506, 424/434, 606/196
• US Class Current: 604/514
• CPC Class Codes: A61K 31/43 Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula , e.g. penicillins, penems
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants

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.

Claims

1. A method for delivering at least a portion of a drug-releasing implant into a paranasal sinus having a paranasal sinus cavity comprising:

a) enlarging an ostium of the paranasal sinus;

b) subsequently accessing the paranasal sinus cavity through the enlarged ostium with a delivery device loaded with the drug-releasing implant; and

c) delivering at least a portion of the drug-releasing implant into the paranasal sinus cavity,

wherein the drug-releasing implant comprises a therapeutic amount of an active agent.

2. The method of claim 1 wherein delivering at least a portion of the drug-releasing implant into the paranasal sinus cavity comprises delivering the drug-releasing implant through an opening in a distal portion of a conduit.

3. The method of claim 2 wherein the drug-releasing implant has a diameter of about 5 millimeters while in the conduit.

4. The method of claim 2 wherein delivering the drug-releasing implant comprises delivering the drug-releasing implant with a pusher.

5. The method of claim 2 wherein delivering the drug-releasing implant comprises delivering the drug-releasing implant with a pressurized gas.

6. The method of claim 1 wherein the drug-releasing implant is a biodegradable polymeric implant.

7. The method of claim 2 wherein the conduit is sharp-tipped.

8. The method of claim 2 wherein the distal portion of the conduit is angulated.

9. The method of claim 8 wherein the distal portion of the conduit is angulated at an angle up to about 90 degrees.

10. The method of claim 8 wherein the distal portion of the conduit is angulated at an angle up to about 135 degrees.

11. The method of claim 8 wherein the distal portion of the conduit is angulated at an angle up to about 175 degrees.

12. The method of claim 2 wherein the distal opening is located at a tip of the conduit.

13. The method of claim 2 wherein the distal opening is located in a side wall of the conduit.

14. The method of claim 1 wherein the drug-releasing implant comprises a series of predetermined fracture lines.

15. The method of claim 1 wherein the drug-releasing implant comprises a therapeutic amount of an anti-inflammatory active agent.

16. The method of claim 15 wherein the anti-inflammatory active agent comprises mometasone furoate.

17. The method of claim 15 wherein the anti-inflammatory active agent comprises budesonide.

18. The method of claim 15 wherein the anti-inflammatory active agent comprises fluticasone propionate.

19. The method of claim 15 wherein the anti-inflammatory active agent comprises triamcinolone acetonide.

20. The method of claim 1 wherein the drug-releasing implant comprises a biodegradable matrix.

21. The method of claim 20 wherein the biodegradable matrix comprises a biodegradable polymer matrix.

22. The method of claim 21 wherein the biodegradable polymer matrix comprises a mucoadhesive polymer.

23. The method of claim 21 wherein the biodegradable polymer matrix comprises a poly(lactic-co-glycolic)acid (PLGA) copolymer.

24. The method of claim 21 wherein the biodegradable polymer matrix comprises lactic acid.

25. The method of claim 21 wherein the biodegradable polymer matrix comprises glycolic acid.

26. The method of claim 1 wherein the active agent is released over a treatment period of about one week to about three months.

27. The method of claim 1 wherein the active agent is released over a treatment period of about two weeks to about four weeks.

28. The method of claim 1 wherein the active agent is released over a treatment period of at least about one week.

29. The method of claim 1 wherein the active agent is released over a treatment period of at least about two weeks.

30. The method of claim 1 wherein the drug-releasing implant comprises an active agent in an amount between about 5% and about 90% by weight of the drug-releasing implant.

31. The method of claim 1 wherein the drug-releasing implant is a rod, pellet, bead, strip, or microp article.

32. The method of claim 1 wherein the drug-releasing implant comprises a gel.

33. The method of claim 1 wherein the drug-releasing implant comprises a semi-solid.

34. The method of claim 2 wherein the drug-releasing implant has a diameter of less than about 5 millimeters while in the conduit.

35. The method of claim 2 wherein the drug-releasing implant has a diameter of about 2 millimeters while in the conduit.

36. The method of claim 2 wherein the drug-releasing implant has a diameter between about 0.05 millimeters and about 5 millimeters while in the conduit.

37. The method of claim 1 wherein delivering the drug-releasing implant comprises using a visualization technique.

38. The method of claim 37 wherein the visualization technique comprises endoscopy.

39. The method of claim 37 wherein the visualization technique comprises computer image-guidance.

40. The method of claim 1 wherein the drug-releasing implant is a solid implant having a first delivery form for facilitating delivery into the paranasal 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 paranasal sinus cavity.

41. A method for delivering a drug-releasing implant into a paranasal sinus having a paranasal sinus cavity comprising:

a) enlarging an ostium of the paranasal sinus;

b) subsequently accessing the paranasal sinus cavity through the enlarged ostium with a delivery device loaded with the drug-releasing implant; and

c) delivering the drug-releasing implant into the paranasal sinus cavity,

wherein the drug-releasing implant comprises a therapeutic amount of an active agent for the treatment of sinusitis.

42. A method for delivering a drug-releasing implant into a paranasal sinus having a paranasal sinus cavity comprising:

a) enlarging an ostium of the paranasal sinus;

b) subsequently accessing the paranasal sinus cavity through the enlarged ostium with a delivery device loaded with the drug-releasing implant; and

c) delivering the drug-releasing implant into the paranasal sinus cavity,

wherein the drug-releasing implant comprises a therapeutic amount of an active agent for the reduction of inflammation.