Dissolvable nasal sinus sponge

Abstract

An implantable article comprising a dissolvable sponge derived from the mixture of chitosan, a first polysaccharide and a second polysaccharides. The polysaccharides have different number average molecular weight characteristics to enable the control of the mechanical features of the sponge.

1 . An article comprising a dissolvable sponge derived from a mixture of chitosan, a first polysaccharide having a number average molecular weight of 1.3 million or greater, and a second polysaccharide having a number average molecular weight of 500,000 to less than 1.3 million, wherein the first polysaccharide and the second polysaccharide are distinct from chitosan and the dissolvable sponge exhibits one or more of a wet compression strength or a dry compression strength of at least 20 grams according to the Compression Test. 
     
     
         2 . An article according to  claim 1 , wherein the dissolvable sponge when at least partially hydrated is mucoadhesive. 
     
     
         3 . An article according to  claim 2 , wherein the dissolvable sponge exhibits a mucoadhesive force of at least 20 grams or greater according to the Adhesive Force Test. 
     
     
         4 . An article according to  claim 1 , wherein the dissolvable sponge begins to dissolve upon hydration. 
     
     
         5 . An article according to  claim 1 , wherein the dissolvable sponge exhibits one or more of a wet compression strength or a dry compression strength of at least 100 grams according to the Compression Test, or a dissolution rate of greater than or equal to 1 day according to the Dissolution Test. 
     
     
         6 . An article according to  claim 1 , wherein the dissolvable sponge when at least partially hydrated possesses an antibacterial effectiveness from time 24 hours through 14 days of at least a log reduction of 4 according to the Log Reduction Test. 
     
     
         7 . An article according to  claim 1 , wherein first polysaccharide, the second polysaccharide, or both comprise cellulose, agar, alginate, carrageenan, chitin, chondroitin sulfate, dextran, galactomannan, glycogen, hyaluronic acid, starch or a combination thereof. 
     
     
         8 . An article according to  claim 7 , wherein the cellulose comprises hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, or carboxymethyl cellulose. 
     
     
         9 . An article according to  claim 1 , wherein the first polysaccharide and the second polysaccharide comprise hydroxyethyl cellulose. 
     
     
         10 . An article according to  claim 1 , wherein the dissolvable sponge is an anatomical stent or a nasal stent. 
     
     
         11 . An article according to  claim 10 , wherein the nasal stent prevents adhesion of tissue in the sinus cavity. 
     
     
         12 . An article according to  claim 1 , wherein the chitosan is chitosan hydrochloride. 
     
     
         13 . An article according to  claim 12 , wherein the dissolvable sponge is antimicrobial. 
     
     
         14 . An article according to  claim 1 , wherein the dissolvable sponge degrades by mechanical dissolution or chemical dissolution. 
     
     
         15 . An article according to  claim 1 , further comprising an adjuvant selected from the group consisting of non-aqueous solvents, acids, bases, buffering agents, antimicrobial and therapeutic agents. 
     
     
         16 . An article according to  claim 15 , wherein at least a portion of the therapeutic agent is present in the dissolvable sponge over time until the dissolvable sponge exhibits no compressive strength, as determined in accordance with the Dissolution and Compression Test. 
     
     
         17 . An article according to  claim 1 , wherein the dissolvable sponge is sterilized by ionizing radiation. 
     
     
         18 . An article according to  claim 1 , wherein the dissolvable sponge exhibits one or more of a complete hydration in water under 30 seconds, or a fluid absorption of greater than 10 times its initial dry weight in accordance with the Fluid Absorption Test. 
     
     
         19 . An article according to  claim 1 , wherein the sponge possesses a pH value in the range of about 4 to about 6. 
     
     
         20 . A method comprising:
 (a) mixing chitosan, a first polysaccharide and a second polysaccharide to form a solution, wherein the first polysaccharide has a number average molecular weight of 1.3 million or greater and the second polysaccharide has a number average molecular weight of 500,000 to less than 1.3 million, and wherein the first polysaccharide and the second polysaccharide are distinct from chitosan, and the solution has a viscosity of at least 0.05 Pa/s at 225 l/s and at 25 ° C.,   (b) freezing the solution, and   (c) lyophilizing the frozen solution to form a sponge, wherein the sponge exhibits one or more of a wet compression strength or a dry compressive strength of at least 20 grams according to the Compression Test.   
     
     
         21 . A method according to  claim 20 , further comprising packaging the sponge in a sealed package, and sterilizing the sponge in the package using ionizing radiation. 
     
     
         22 . A method according to  claim 20 , further comprising adjusting the pH of the solution to a pH in the range of about 4 to about 6 prior to freezing. 
     
     
         23 . A method according to  claim 20 , wherein the first polysaccharide and the second polysaccharide comprise hydroxyethyl cellulose. 
     
     
         24 . A method according to  claim 21 , wherein the ionizing radiation comprises gamma radiation, ultraviolet light, X-rays or E-Beam radiation. 
     
     
         25 . A method according to  claim 21 , further comprising removing the sponge from the package and hydrating the sponge to form a pliable sponge that is mucoadhesive. 
     
     
         26 . A method according to  claim 25 , wherein the sponge exhibits a mucoadhesive force of at least 20 grams or greater according to the Adhesive Force Test. 
     
     
         27 . A method according to  claim 25 , wherein the sponge is dissolvable upon hydration. 
     
     
         28 . A method according to  claim 20 , wherein the solution has a solids content of 0.5% by weight or greater. 
     
     
         29 . An article produced by the method of  claim 20 . 
     
     
         30 . A method for treating mucosal tissue comprising applying thereto the dissolvable sponge of  claim 1 .