Medical item for prevention and treatment of ear infection

Abstract

Methods of preventing and treating an ear infection comprising insertion of a tympanostomy tube comprised of a least one anti-biotic agent

What is claimed: 
     
         1 . A method of preventing an ear infection, said method comprising insertion of a tympanostomy tube in an ear drum by myringotomy, said tympanostomy tube being comprised of a solid, non-porous composite comprised of:
 a) a melt blend of:
 (i) an ethylene-vinyl acetate copolymer having a melt index less than about 50 g/10 min. as measured by ASTM D1238 and comprising 10 to 50 percent by weight of vinyl acetate, 
 (ii) polyethylene glycol having a weight average molecular weight of from about 2,000 to about 20,000 Daltons; and 
   b) one or more bioactive agents comprising at least ciprofloxacin antibiotic dispersed uniformly throughout said polymer material; said bioactive agents comprising about 1 to about 60 percent by weight of said polymer plus bioactive agents;    wherein said ciprofloxacin is present in said polymer material as:
 i) a solid solution phase with said polymer material comprised of from about 0.1 to about 30 percent by weight of said ciprofloxacin; and 
 ii) a solid solution phase with said polymer material comprised of from about 95 to about 99.99 percent by weight of said ciprofloxacin; and 
 iii) a phase selected from a supersaturated solution, essentially pure ciprofloxacin, a solid solution comprised of ciprofloxacin and their combination. 
   
     
     
         2 . The method of preventing an ear infection as in  claim 1  wherein said ciprofloaxacin before dispersion in said polymer material has a particle size distribution best described by a Weibull function with an index of determination of at least about 0.90, said distribution having a characteristic size of from about 5 to about 100 micrometers and a shape factor from about 1.1 to about 5. 
     
     
         3 . The method of preventing an ear infection as in  claim 1  or  2  wherein said composite comprises one or more bioactive agents selected from the group consisting of carbapenems, cephalosporins, penicillins, lincosamides, tetracyclins, macrolides, glycopeptides, quinolones, oxazolidinones, aminoclycosides, gyrase inhibitors, and their combination. 
     
     
         4 . The method of preventing an ear infection as in  claim 3 , wherein said composite includes a bioactive anti-inflammatory glucocorticoid. 
     
     
         5 . The method of preventing an ear infection as in  claim 4 , wherein the bioactive anti-inflammatory agent is selected from the group consisting of dexamethasone dispropionate, clobefasol propionate and hydrocortisone. 
     
     
         6 . The method of preventing an ear infection as in  claim 3 , wherein said tympanostomy tube is highly resistant to biofilm formation. 
     
     
         7 . The method preventing an ear infection as in  claim 3  wherein biofilm growth is prevented in the middle ear. 
     
     
         8 . The method of preventing an ear infection as in  claim 3 , wherein said antibiotic is selected from the group consisting of beta lactam, meropenem, ceftazidime, amoxicillin, clindamycin, tetracycline, erythromycin, vancomycin, ciprofloxacin, ciprofloxacin hydrochloride linezolid, usnic acid, sodium usnate, polyhexamethylene biguanide, and their combination. 
     
     
         9 . A method of treating an ear infection, said method comprising insertion of a tympanostomy tube in an ear drum by myrangotomy, said tympanostomy tube being comprised of a solid, non-porous composite comprised of:
 a) a melt blend of:
 (i) an ethylene-vinyl acetate copolymer having a melt index less than about 50 g/10 min. as measured by ASTM D1238 and comprising 10 to 50 percent by weight of vinyl acetate, 
 (ii) polyethylene glycol having a weight average molecular weight of from about 2,000 to about 20,000 Daltons; and 
   b) one or more bioactive agents comprising at least ciprofloxacin antibiotic dispersed uniformly throughout said polymer material; said bioactive agents comprising about 1 to about 60 percent by weight of said polymer plus bioactive agents;    wherein said ciprofloxacin is present in said polymer material as:
 i) a solid solution phase with said polymer material comprised of from about 0.1 to about 30 percent by weight of said ciprofloxacin; and 
 ii) a solid solution phase with said polymer material comprised of from about 95 to about 99.99 percent by weight of said ciprofloxacin; and 
 iii) a phase selected from a supersaturated solution, essentially pure ciprofloxacin, a solid solution comprised of ciprofloxacin and their combination. 
   
     
     
         10 . The method of treating an ear infection as in  claim 9 , wherein said ciprofloaxacin before dispersion in said polymer material has a particle size distribution best described by a Weibull function with an index of determination of at least about 0.90, said distribution having a characteristic size of from about 5 to about 100 micrometers and a shape factor from about 1.1 to about 5. 
     
     
         11 . The method of treating an ear infection as in  claim 9  or  10 , wherein said composite comprises one or more bioactive antibiotics selected from the group consisting of carbapenems, cephalosporins, penicillins, lincosamides, tetracyclins, macrolides, glycopeptides, quinolones, oxazolidinones, aminoclycosides, gyrase inhibitors, and their combination. 
     
     
         12 . The method of treating an ear infection as in  claim 9  or  10  wherein said tympanostomy tube is highly resistant to biofilm formation. 
     
     
         13 . The method of treating an ear infection as in  claim 9  or  10 , wherein growth of biofilm-forming organisms are highly suppressed in the middle ear. 
     
     
         14 . The method of treating an ear infection as in  claim 9  or  10 , wherein said composite includes a bioactive anti-inflammatory agent. 
     
     
         15 . The method treating an ear infection as in  claim 14 , wherein said composite includes a bioactive anti-inflammatory glucocorticoid. 
     
     
         16 . The method treating an ear infection as in  claim 14 , wherein the bioactive anti-inflammatory agent is selected from the group consisting of dexamethasone dispropionate, clobetasol propionate and hydrocortisone, 9 or 10 
     
     
         17 . The method of treating an ear infection as described in  claim 9  or  10 , wherein said antibiotic is selected from the group consisting of beta lactam, meropenem, ceftazidime, amoxicillin, clindamycin, tetracycline, erythromycin, vancomycin, ciprofloxacin, ciprofloxacin hydrochloride linezolid, usnic acid, sodium usnate, polyhexamethylene biguanide, and their combination.