Biodegradable silk ear tubes

Abstract

In some embodiments, the present invention provides methods for making resorbable ear tubes including the steps of providing a silk fibroin solution, and forming a silk ear tube from the silk fibroin solution, wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbable. In some embodiments, the present invention also provides methods for treating otitis media including the step of introducing a silk ear tube into the ear canal of a subject, wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbed by the subject.

1 . A method for making resorbable ear tubes comprising
 providing a silk fibroin solution; and   forming a silk ear tube from the silk fibroin solution,   
       wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbable. 
     
     
         2 . The method of  claim 1 , wherein the silk ear tube is formed via gel spinning or gel deposition. 
     
     
         3 . The method of  claim 1 , wherein the silk ear tube is formed via dip coating or solution deposition. 
     
     
         4 . The method of  claim 1 , wherein the silk ear tube is formed via micromolding. 
     
     
         5 . The method of  claim 1 , wherein the method further comprises introducing a plurality of pores into the silk ear tube. 
     
     
         6 . The method of  claim 5 , wherein the pores are introduced by associating a porogen with the silk fibroin solution prior to forming the silk ear tube. 
     
     
         7 . The method of  claim 6 , wherein the porogen is selected from polyethylene oxide, NaCl, alkali metals, alkali earth metal halides, phosphates, sulfates, sugar crystals, water-soluble microspheres, polysaccharides, protein microspheres, wax particles, and synthetic polymer particles. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein the silk ear tube comprises at least two layers. 
     
     
         9 . The method of  claim 1 , further comprising associating at least one therapeutic agent with the silk fibroin solution prior to or during formation of the silk ear tube. 
     
     
         10 . The method of  claim 9 , wherein the at least one therapeutic agent is selected from the group consisting of antibiotics, pain relievers, and steroids. 
     
     
         11 . The method of any one of  claims 1 - 10 , wherein the silk fibroin solution contains between 1%-30% wt silk fibroin. 
     
     
         12 . The method of any one of the above claims, wherein the silk ear tube has a resorption rate of between one day and one week, inclusive. 
     
     
         13 . The method of any one of the above claims, wherein the silk ear tube has a resorption rate of between eight days and 2 years, inclusive. 
     
     
         14 . The method of any one of  claims 1 - 13 , wherein the silk ear tube comprises beta-sheet content between 1-60%. 
     
     
         15 . The method of  claim 14 , wherein the substantial beta sheet content is introduced by at least one of autoclaving, water vapor annealing and treatment with methanol. 
     
     
         16 . A method for treating otitis media comprising
 introducing a silk ear tube into the ear canal of a subject, wherein the silk ear tube is less than 2 mm in length and has an outer diameter of less than 1.5 mm, and wherein the silk ear tube is resorbed by the subject.   
     
     
         17 . The method of  claim 16 , further comprising administering at least one therapeutic agent to the subject prior to introduction of the silk ear tube. 
     
     
         18 . The method of  claim 16 , further comprising administering at least one therapeutic agent to the subject subsequent to introduction of the silk ear tube. 
     
     
         19 . The method of  claim 16 , further comprising administering at least one therapeutic agent to the subject prior substantially concurrently with introduction of the silk ear tube. 
     
     
         20 . The method of any one of  claims 16 - 19 , wherein the at least one therapeutic agent is an antibiotic, a pain reliever, or a steroid. 
     
     
         21 . The method of any one of  claims 16 - 20 , wherein the otitis media is acute otitis media, otitis media with effusion, or chronic suppurative otitis media. 
     
     
         22 . The method of any one of  claims 16 - 21 , wherein the silk ear tube is resorbed over a period of time of between one day and one week, inclusive. 
     
     
         23 . The method of any one of  claims 16 - 21 , wherein the silk ear tube is resorbed over a period of time of between eight days and 2 years, inclusive. 
     
     
         24 . The method of any one of  claims 16 - 22 , wherein the silk ear tube comprises beta-sheet content between 1-60%. 
     
     
         25 . The method of  claim 24 , wherein the substantial beta sheet content is introduced by at least one of autoclaving, water vapor annealing and treatment with methanol. 
     
     
         26 . The method of any one of  claims 16 - 25 , wherein the silk ear tube comprises at least two layers. 
     
     
         27 . The method of  claim 26 , wherein the silk ear tube comprises at least one porous layer. 
     
     
         28 . The method of any one of the above claims, wherein the silk fibroin is selected from the group consisting of spider silk, silkworm silk, and recombinant silk.