Tissue Augmentation Material And Method

Abstract

A permanent, biocompatible material for soft tissue augmentation. The biocompatible material comprises a matrix of smooth, round, finely divided, substantially spherical particles of a biocompatible ceramic material, close to or in contact with each other, which provide a scaffold or lattice for autogenous, three dimensional, randomly oriented, non-scar soft tissue growth at the augmentation site. The augmentation material can be homogeneously suspended in a biocompatible, resorbable lubricious gel carrier comprising a polysaccharide. This serves to improve the delivery of the augmentation material by injection to the tissue site where augmentation is desired. The augmentation material is especially suitable for urethral sphincter augmentation, for treatment of incontinence, for filling soft tissue voids, for creating soft tissue blebs, for the treatment of unilateral vocal cord paralysis, and for mammary implants. It can be injected intradermally, subcutaneously or can be implanted.

1 . A method of implanting a biocompatible material in a patient, comprising:
 providing a polysaccharide gel having characteristic elastic properties when implanted;   manipulating the polysaccharide gel without loss of its elastic properties;   
       and
 implanting the polysaccharide gel into the patient with the gel recovering its elastic properties within several seconds of implantation. 
 
     
     
         2 . The method of  claim 1 , wherein the polysaccharide gel is selected from the group consisting of (i) nonionic polysaccharides, (ii) anionic polysaccharides, and (iii) cationic polysaccharides and combinations thereof. 
     
     
         3 . The method of  claim 1 , wherein the polysaccharide gel is selected from the group consisting of sodium carboxymethylcellulose, starch, chitin, chitosan, hyaluronic acid, alginic acid, sodium alginate, carrageenans, guar, dextrin, agar, agarose, agar methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, microcrystalline cellulose, oxidized cellulose and xanthan gum. 
     
     
         4 . The method of  claim 1 , wherein the biocompatible material further comprises glycerin. 
     
     
         5 . The method of  claim 1 , wherein the gel is implanted intradermally. 
     
     
         6 . The method of  claim 1 , wherein the gel is implanted subdermally. 
     
     
         7 . The method of  claim 1 , wherein the viscosity of the gel ranges from about 20,000 to about 350,000 centipoise. 
     
     
         8 . The method of  claim 3 , wherein the carboxymethylcellulose has a viscosity ranging from about 1000 to about 4000 centipoise. 
     
     
         9 . The method of  claim 1 , wherein the polysaccharide gel comprises hyaluronic acid and sodium alginate. 
     
     
         10 . The method of  claim 1 , wherein the biocompatible material further comprises substantially spherical particles. 
     
     
         11 . The method of  claim 10 , wherein the particles are constructed of a material selected from the group consisting of calcium hydroxylapatite, polystyrene, polymethylmethacrylate, glass, and stainless steel. 
     
     
         12 . The method of  claim 10 , wherein the particles range in size from 35 microns to 150 microns. 
     
     
         13 . The method of  claim 10 , wherein the biocompatible material further comprises glycerin.