Sinus delivery of sustained release therapeutics

• US 7,951,133 B2
• Filed: 10/24/2008
• 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 Lynn
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Witczak; Catherine N
• Application Number:
  US12/258,282
• Publication Number:
  US 20090047327A1
• Time in Patent Office: 949 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 treating a sinus condition comprising:

a) creating access to a paranasal sinus cavity with a delivery device loaded with a biodegradable implant; and

b) delivering the biodegradable implant to the paranasal sinus cavity,

wherein the biodegradable 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, and wherein the biodegradable implant comprises a therapeutic amount of an active agent.

2. The method of claim 1 wherein the biodegradable implant is delivered through a sinus ostium.

3. The method of claim 1 wherein the biodegradable implant is delivered through a sinus wall.

4. The method of claim 1 wherein delivering the biodegradable implant comprises delivering the biodegradable implant with a pusher.

5. The method of claim 1 wherein delivering the biodegradable implant comprises delivering the biodegradable implant with a pressurized gas.

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

7. The method of claim 1 wherein the delivery device is a sharp-tipped conduit.

8. The method of claim 1 wherein the delivery device is an angulated conduit.

9. The method of claim 8 wherein a distal portion of the conduit is angulated at an angle between about zero degrees to about 135 degrees.

10. The method of claim 1 wherein the delivery device comprises a conduit with a distal opening located at the tip of the conduit.

11. The method of claim 1 wherein the delivery device comprises a conduit with a distal opening located in a side wall of the conduit.

12. The method of claim 1 wherein the biodegradable implant comprises a series of predetermined fracture lines.

13. The method of claim 1 wherein the biodegradable implant 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.