Drug-releasing device usable in mucosal body cavities

Abstract

A tympanostomy tube containing a polymeric material and a drug is described. The polymeric material may comprise a non-resorbable polymer and a water-soluble polymer. The drug may be released when the device is contacted by an aqueous liquid such as middle ear exudate during otitis media. The implant may contain sufficient drug to treat multiple episodes of otitis media or to catch subsequent episodes in their early stages as a prophylactic. The device may be hydrophilic and further may contain a surfactant. The implant may be porous. The implant may have enhanced surface area at places exposed to middle ear liquid and may have enlarged mass so as to contain an increased total amount of drug. Intentional reorientation of the patient's head may aid in moving drug-containing liquid around the middle ear cavity. Similar implants can be used in other mucosal cavities.

1 - 49 . (canceled) 
     
     
         50 . A tympanostomy tube, comprising:
 a hollow tube having a long direction; and   at least one enlarged region at a respective end of said hollow tube,   wherein said tympanostomy tube is made of a material that contains a polymeric material and contains a drug that is releasable to an aqueous liquid when a surface of said first enlarged region is exposed to said aqueous liquid,   wherein said first enlarged region has an enveloping surface area and said first enlarged region has an actual exposed surface area, and said actual exposed surface area is greater than said enveloping surface area.   
     
     
         51 . The tympanostomy tube of  claim 50 , wherein said first enlarged region has a surface that contains surface features selected from the group consisting of grooves, ridges, rings, recesses, projections, holes, roughness of between 2 and 250 microinches root-mean-square, and texturing. 
     
     
         52 . The tympanostomy tube of  claim 50 , wherein said first enlarged region has a surface that contains grooves that have a groove-to-groove dimension of less than 0.2 mm. 
     
     
         53 . The tympanostomy tube of  claim 50 , wherein said second enlarged region has a mass that is more than two times a mass of said first enlarged region. 
     
     
         54 . The tympanostomy tube of  claim 50 , wherein said tympanostomy tube is porous. 
     
     
         55 . The tympanostomy tube of  claim 50 , wherein said second enlarged region has a flat surface facing said first enlarged region, and said flat surface is non-perpendicular to said long direction. 
     
     
         56 . An implant for use in a mucosal cavity of a patient, comprising:
 an article comprising a blend of a polymer and an active pharmaceutical ingredient, said active pharmaceutical ingredient being releasable when an aqueous liquid contacts a surface of said article,   wherein at least a portion of said surface contains a surface feature selected from the group consisting of grooves, ridges, rings, projections, recesses, roughness and texturing.   
     
     
         57 . The implant of  claim 56 , wherein said implant is porous. 
     
     
         58 . The implant of  claim 56 , wherein said implant has an actual surface area that is at least 30% greater than an enveloping surface area. 
     
     
         59 . The implant of  claim 56 , wherein said implant has an actual surface area that is at least 50% greater than an enveloping surface area. 
     
     
         60 . The implant of  claim 56 , wherein said implant has an actual surface area that is at least 100% greater than an enveloping surface area. 
     
     
         61 . A tympanostomy tube, comprising:
 a hollow tube having a long direction; and   at least one enlarged region at a respective end of said hollow tube,   wherein said tympanostomy tube comprises a composite of a polymeric material and an active pharmaceutical ingredient, and   wherein said first enlarged region has a mass that is more than two times a mass of said second enlarged region.   
     
     
         62 . The tympanostomy tube of  claim 61 , wherein said polymeric material comprises a blend of a non-resorbable copolymer and a water-soluble polymer. 
     
     
         63 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube is porous. 
     
     
         64 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube is porous having at least some interconnected pores. 
     
     
         65 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube is porous having a porosity of at least 20%. 
     
     
         66 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube is porous having a porosity of at least 50%. 
     
     
         67 . The tympanostomy tube of  claim 61 , wherein said hollow tube has a wall cross-sectional area, in a cross-section taken perpendicular to said long direction, of at least 1.4 mm 2 . 
     
     
         68 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube has a first enlarged region and a second enlarged region, wherein said first enlarged region has a first surface facing said second enlarged region and said second enlarged region has a second surface facing said first enlarged region, and wherein a minimum distance between said first surface and said second surface is not more than 0.3 mm. 
     
     
         69 . The tympanostomy tube of  claim 61 , wherein said implant is formed by a process selected from the group consisting of extrusion, compression or injection molding. 
     
     
         70 . The tympanostomy tube of  claim 61 , wherein said active pharmaceutical ingredient comprises ciprofloxacin. 
     
     
         71 . The tympanostomy tube of  claim 61 , wherein said tympanostomy tube has a first enlarged region and a second enlarged region, wherein said second enlarged region has a flat surface facing said first enlarged region, and said flat surface is non-perpendicular to said long direction. 
     
     
         72 . The tympanostomy tube of  claim 61 , wherein said first enlarged region contains enough of said active pharmaceutical ingredient to create a concentration of said active pharmaceutical ingredient at least 10 times a Minimum Inhibitory Concentration for 30 or more instances of treating an otitis media infection with otorrhea. 
     
     
         73 - 103 . (canceled)