Sinus delivery of sustained release therapeutics

• US 8,109,918 B2
• Filed: 06/06/2009
• Issued: 02/07/2012
• Est. Priority Date: 03/14/2003
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Eaton, Donald J., Moran, Mary L., Brenneman, Rodney
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US12/479,794
• Publication Number:
  US 20090238859A1
• Time in Patent Office: 976 Days
• Field of Search: 604/93.01, 604/891.1, 604/890.1, 604/57, 604 59- 64, 604/510, 604/514, 604/506, 128/204.12, 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 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,

wherein the one or more drug-releasing implants comprise an active agent.

2. The method of claim 1 wherein the active agent comprises mometasone furoate.

3. The method of claim 1 wherein the one or more drug-releasing implants comprise a biodegradable polymer.

4. The method of claim 1 wherein the conduit is angulated.

5. 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 an active agent.

6. The method of claim 5 wherein the active agent comprises mometasone furoate.

7. The method of claim 5 wherein the one or more drug-releasing implants comprise a biodegradable polymer.

8. The method of claim 7 wherein the biodegradable polymer comprises a poly(lactic-co-glycolic)acid (PLGA) copolymer.

9. A method for delivering a biodegradable implant into a paranasal sinus cavity comprising:

a) loading one or more biodegradable implants into a conduit having a distal portion;

b) creating access to the paranasal sinus cavity with the loaded conduit; and

c) delivering the one or more biodegradable implants through an opening in the distal portion of the conduit into the paranasal sinus cavity,

wherein the one or more biodegradable implants comprise an active agent.

10. The method of claim 9 wherein the active agent comprises an anti-inflammatory active agent.

11. The method of claim 10 wherein the anti-inflammatory active agent comprises mometasone furoate.

12. The method of claim 9 wherein the conduit is angulated.

13. A method for delivering a biodegradable implant into a paranasal sinus cavity comprising:

a) loading a delivery device with one or more biodegradable implants;

b) creating access to the paranasal sinus cavity with the loaded delivery device; and

c) delivering the one or more biodegradable implants from the delivery device into the paranasal sinus cavity,

wherein the one or more biodegradable implants comprise an active agent.

14. The method of claim 13 wherein the active agent comprises 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 13 wherein the one or more biodegradable implants comprises a biodegradable polymer.

17. The method of claim 16 wherein the biodegradable polymer comprises a poly(lactic-co-glycolic)acid (PLGA) copolymer.