Soft Tissue Filler and Methods

Abstract

A malleable polysaccharide soft tissue filler for filling tissue cavities or voids such as those resulting from tumor removal or other tissue resection. The soft tissue filler includes a first cross-linking polysaccharide, preferably a beta-D glucan, and a second cross-linking polysaccharide. The soft tissue filler is both porous and malleable and can be formed to accommodate the tissue cavity or void. The soft tissue filler can include an embedded marker for locating on medical imaging. Methods of making the soft tissue filler including lyophilizing an aqueous polysaccharide suspension are disclosed. The second cross-linking polysaccharide provides for increased structural integrity in a high-porosity and malleable soft tissue filler in which the respective cross-linking polysaccharides synergistically provide structural scaffolding for one another. Methods of use are also disclosed.

What is claimed is: 
     
         1 . A method of making a malleable soft tissue filler for use to fill a body cavity in the body of a mammal in which soft tissue has been removed to create the body cavity; the method of making a malleable soft tissue filler comprising the steps of:
 mixing from about 0.5 percent by weight to about 2 percent by weight of a first cross-linking polysaccharide material and from about 0.01 percent by weight to about 0.3 percent by weight of a second cross-linking polysaccharide material with water for a sufficient time to form an aqueous suspension of both the first cross-linking polysaccharide material and the second cross-linking polysaccharide material; wherein the first cross-linking polysaccharide material is a beta-D-glucan material and wherein the second cross-linking polysaccharide material is selected from the group consisting of chitin, chitosan, agarose, cellulose, pectin, xanthan gum, dextran, and hyaluronic acid; and   lyophilizing the aqueous suspension.   
     
     
         2 . The method of making a malleable soft tissue filler of  claim 1 , wherein the step of lyophilizing the aqueous suspension includes first freezing the aqueous suspension to form a frozen aqueous suspension and then desiccating the frozen aqueous suspension to make the malleable soft tissue filler. 
     
     
         3 . The method of making a malleable soft tissue filler of  claim 1 ; wherein the beta-D-glucan material is selected from the group consisting of (1-3), (1-4) beta-D-glucan and (1-3),(1-6) beta-D-glucan. 
     
     
         4 . The method of making a malleable soft tissue filler of  claim 3 ; wherein the beta-D-glucan material is selected from the group consisting of oat-derived (1-3), (1-4) beta-D-glucan; yeast-derived (1-3),(1-6) beta-glucan; and mushroom-derived (1-3),(1-6) beta-glucan. 
     
     
         5 . The method of making a malleable soft tissue filler of  claim 2 ; wherein the beta-D-glucan material is (1-3), (1-4) beta-D-glucan. 
     
     
         6 . The method of making a malleable soft tissue filler of  claim 2 ; wherein the second cross-linking polysaccharide material is selected from the group consisting of chitosan, agarose, cellulose, pectin, xanthan gum, dextran, and hyaluronic acid. 
     
     
         7 . The method of making a malleable soft tissue filler of  claim 5 ; wherein the first beta-D-glucan material is oat-derived (1-3), (1-4) beta-D-glucan and the second cross-linking polysaccharide material is selected from the group consisting of chitosan, agarose, cellulose, pectin, xanthan gum, dextran, and hyaluronic acid. 
     
     
         8 . The method of making a malleable soft tissue filler of  claim 1 ; wherein the malleable soft tissue filler includes from about 50.0 to about 99.9 percent by weight of the first cross-linking polysaccharide material and from about 0.03 percent by weight to about 50.0 percent by weight of a second cross-linking polysaccharide material and the density of the malleable soft tissue filler is from about 5.0 to about 300 mg/cubic centimeters (mg/cc). 
     
     
         9 . A malleable soft tissue filler, comprising:
 from about 50.0 to about 99.9 percent by weight of a first cross-linking polysaccharide material and from about 0.03 percent by weight to about 50.0 percent by weight of a second cross-linking polysaccharide material;   wherein the density of the malleable soft tissue filler is from about 5.0 to about 300 mg/cubic centimeters (mg/cc); and   wherein the first cross-linking polysaccharide material is a beta-D-glucan material and wherein the second cross-linking polysaccharide material is selected from the group consisting of chitin, chitosan, agarose, cellulose, pectin, xanthan gum, dextran, and hyaluronic acid.   
     
     
         10 . The malleable soft tissue filler of  claim 9 , wherein the beta-D-glucan material is selected from the group consisting of (1-3), (1-4) beta-D-glucan and (1-3),(1-6) beta-D-glucan. 
     
     
         11 . The malleable soft tissue filler of  claim 10 , wherein the beta-D-glucan material is oat-derived (1-3), (1-4) beta-D-glucan. 
     
     
         12 . The malleable soft tissue filler of  claim 9 , wherein the second cross-linking polysaccharide material is selected from the group consisting of chitosan, agarose, cellulose, pectin, xanthan gum, dextran, and hyaluronic acid. 
     
     
         13 . The malleable soft tissue filler of  claim 12 , wherein the malleable soft tissue filler includes at least one marker that is distinguishable from surrounding soft tissue using common medical imaging technologies.