Device and methods for treating paranasal sinus conditions

Abstract

Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

1 . A paranasal sinus device comprising
 a cavity member having an expanded configuration and a collapsed configuration, and a body sized to fit within a paranasal sinus cavity, the body comprising a plurality of filaments comprising one or more biodegradable polymers and configured as a mesh having diamond-shaped apertures, wherein the expandable device is configured to release an active agent for at least about six months.   
     
     
         2 . The paranasal sinus device of  claim 1 , wherein the one or more biodegradable polymers comprises poly(lactide-co-glycolide). 
     
     
         3 . The paranasal sinus device of  claim 1 , wherein the one or more biodegradable polymers comprises poly(lactide-co-caprolactone). 
     
     
         4 . The paranasal sinus device of  claim 1 , wherein the plurality of filaments comprises a coating containing the active agent. 
     
     
         5 . The paranasal sinus device of  claim 1 , wherein the active agent comprises one or more of an anticholinergic agent, an antihistamine, an anti-infective agent, an anti-inflammatory agent, an anti-scarring agent, an anti-proliferative agent, a chemotherapeutic agent, an antineoplastic agent, a cytokine, a decongestant, a healing promotion agent, a vitamin, a hyperosmolar agent, an immunomodulator, and an immunosuppressive agent. 
     
     
         6 . The paranasal sinus device of  claim 1 , wherein the active agent comprises one or more anti-inflammatory agents selected from the group consisting of 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, derivatives thereof, and combinations thereof. 
     
     
         7 . The paranasal sinus device of  claim 6 , wherein the active agent comprises mometasone furoate. 
     
     
         8 . The paranasal sinus device of  claim 1 , wherein the body of the cavity member comprises a tubular structure. 
     
     
         9 . The paranasal sinus device of  claim 8 , wherein the tubular structure has a diameter between about 1 cm to about 5 cm. 
     
     
         10 . The paranasal sinus device of  claim 1 , wherein the mesh is a woven mesh. 
     
     
         11 . The paranasal sinus device of  claim 1 , wherein the cavity member is configured to self-expand to the expanded configuration. 
     
     
         12 . A method of treating a patient comprising:
 delivering an expandable device in a collapsed configuration to a paranasal sinus, a paranasal sinus ostium, or a portion of a nasal cavity of the patient, the expandable device comprising an active agent and a plurality of biodegradable polymer filaments, wherein the plurality of biodegradable polymer filaments are configured as a mesh having diamond-shaped apertures;   expanding the expandable device to an expanded configuration in the paranasal sinus, the paranasal sinus ostium, or the portion of the nasal cavity; and   releasing the active agent from the expandable device for at least about six months.   
     
     
         13 . The method of  claim 12 , wherein the portion of the nasal cavity is the middle meatus. 
     
     
         14 . The method of  claim 12 , wherein the paranasal sinus is a frontal sinus, a maxillary sinus, a sphenoid sinus, or an ethmoid sinus. 
     
     
         15 . The method of  claim 12 , wherein the paranasal sinus ostium is a frontal sinus ostium, a maxillary sinus ostium, a sphenoid sinus ostium, or an ethmoid sinus ostium. 
     
     
         16 . The method of  claim 12 , wherein the active agent is coated onto at least a portion of the plurality of biodegradable polymer filaments. 
     
     
         17 . The method of  claim 12 , wherein the active agent comprises mometasone furoate. 
     
     
         18 . The method of  claim 12 , wherein the expandable device comprises a tubular structure. 
     
     
         19 . The method of  claim 12 , wherein the expandable device is used to treat rhinosinusitis. 
     
     
         20 . The method of  claim 12 , wherein delivering is accomplished using a sinus inserter. 
     
     
         21 . The method of  claim 20 , wherein one or more expandable devices are preloaded into the sinus inserter.