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.

What is claimed:  
     
         1 . A tissue augmentation composition, comprising: 
 a biomaterial for augmenting a desired tissue site;    a biocompatible, resorbable, lubricous carrier for homogeneously suspending the biomaterial both prior to and during the introduction of the composition to the desired tissue site; and    a pharmaceutically active agent disposed in the carrier, wherein the carrier comprises a polysaccharide gel having a viscosity between about 20,000 centipoise and about 350,000 centipoise.    
     
     
         2 . The tissue augmentation composition of  claim 1 , wherein the carrier comprises a polysaccharide gel having a viscosity between about 150,000 centipoise to about 250,000 centipoise.  
     
     
         3 . The tissue augmentation composition of  claim 2 , wherein the carrier comprises a polysaccharide gel having a viscosity between about 200,000 centipoise to about 250,000 centipoise.  
     
     
         4 . The tissue augmentation composition of  claim 1 , wherein the pharmaceutically active agent comprises a growth factor.  
     
     
         5 . The tissue augmentation composition of  claim 1 , wherein the pharmaceutically active agent comprises an antibiotic.  
     
     
         6 . The tissue augmentation composition of  claim 1 , wherein the pharmaceutically active agent comprises an analgesic.  
     
     
         7 . The tissue augmentation composition of  claim 1 , further comprising an additive.  
     
     
         8 . The tissue augmentation composition of  claim 7 , wherein the additive comprises at least one of a surfactant, a stabilizer, and a pH buffer.  
     
     
         9 . The tissue augmentation composition of  claim 1 , wherein the biomaterial comprises a material selected from the group consisting of a ceramic, polymethylmethacrylate, glass, a metal, silicone and mixtures thereof.  
     
     
         10 . The tissue augmentation composition of  claim 9 , wherein the metal comprises titanium.  
     
     
         11 . The tissue augmentation composition of  claim 1 , wherein the desired tissue site is a soft tissue site.  
     
     
         12 . The tissue augmentation composition of  claim 1 , wherein the composition is implantable into the human body, and wherein carrier maintains its viscous and elastic properties after implantation.  
     
     
         13 . The tissue augmentation composition of  claim 1 , wherein the desired tissue site is a hard tissue site.  
     
     
         14 . The tissue augmentation composition according to  claim 14 , wherein the desired tissue site is an osseous site.  
     
     
         15 . The tissue augmentation composition according to  claim 15 , wherein the desired tissue site is an osseous site in a state of osteoporosis.  
     
     
         16 . The tissue augmentation composition according to  claim 1 , wherein the carrier maintains its elastic characteristics after the forming of the composition.  
     
     
         17 . The tissue augmentation composition of  claim 1 , wherein the polysaccharide gel comprises a polysaccharide selected from the group consisting of a cellulose polysaccharide, starch, chitin, chitosan, hyaluronic acid, hydrophobe modified polysaccharide, an alginate, a carrageenan, agar, agarose, an intramolecular complex of a polysaccharide, an oligosaccharide and a macrocylic polysaccharide.  
     
     
         18 . A composition for homogeneously suspending a biomaterial prior and during introduction of the biomaterial to a desired tissue site, the composition comprising: 
 a biocompatible, resorbable, lubricous carrier including a polysaccharide gel having a viscosity between about 20,000 centipoise and about 350,000 centipoise; and    a pharmaceutically active agent disposed in the carrier.    
     
     
         19 . The composition of  claim 18 , wherein the carrier comprises a polysaccharide gel having a viscosity between about 150,000 centipoise to about 250,000 centipoise.  
     
     
         20 . The composition of  claim 18 , wherein the pharmaceutically active agent is selected from the group consisting of a growth factor, an antibiotic and an alalgesic.  
     
     
         21 . The tissue augmentation composition of  claim 18 , further comprising an additive.  
     
     
         22 . The composition of  claim 18 , wherein the biomaterial comprises a material selected from the group consisting of a ceramic, polymethylmethacrylate, glass, a metal, silicone and mixtures thereof.  
     
     
         23 . The composition of  claim 18 , wherein the desired tissue site is a hard tissue site.  
     
     
         24 . The composition of  claim 18 , wherein the desired tissue site is a soft tissue site.  
     
     
         25 . In a biocompatible composition for augmenting tissue, the composition comprising a biomaterial for augmenting tissue and a biocompatible, resorbable, lubricous carrier, the improvement comprising a polysaccharide gel carrier having a viscosity between about 20,000 centipoise to about 350,000 centipoise and further including a pharmaceutically active agent disposed in the carrier, the carrier also homogeneously suspending the biomaterial in the composition prior to and during the introduction of the composition to a desired tissue site.  
     
     
         26 . The composition of  claim 26 , wherein the carrier comprises a polysaccharide gel having a viscosity between about 200,000 centipoise to about 250,000 centipoise.  
     
     
         27 . The composition of  claim 26 , further comprising an additive.  
     
     
         28 . The composition of  claim 28 , wherein the additive comprises at least one of a surfactant, a stabilizer, and a pH buffer.  
     
     
         29 . The composition of  claim 26 , wherein the pharmaceutically active agent comprises at least one of a analgesic, an antibiotic and a growth factor.  
     
     
         30 . The composition of  claim 26 , wherein the biomaterial comprises a material selected from the group consisting of a ceramic, polymethylmethacrylate, glass, a metal, silicone and mixtures thereof.  
     
     
         31 . The composition of  claim 26 , wherein the composition is implantable into the human body, and wherein carrier maintains its viscous and elastic properties after implantation.  
     
     
         32 . The composition of  claim 26 , wherein the desired tissue site is a hard tissue site.  
     
     
         33 . The composition of  claim 26 , wherein the desired tissue site is a soft tissue site.  
     
     
         34 . A substantially dehydrated biocompatible tissue augmentation composition, comprising: 
 a biomaterial for augmenting a desired tissue site;    a dehydrated, biocompatible, resorbable, suspending medium; and    a pharmaceutically active agent,    wherein the suspending medium includes a dehydrated polysaccharide gel for maintaining the biomaterial suspended in the composition.    
     
     
         35 . The composition of  claim 35 , wherein the pharmaceutically active agent comprises at least one of a growth factor, an antibiotic and an analgesic.  
     
     
         36 . The composition of  claim 35 , wherein the biomaterial is selected from the group consisting of a ceramic, a plastic, and a metal.  
     
     
         37 . The composition of  claim 37 , wherein the biomaterial comprises rounded, substantially spherical, biocompatible, substantially nonresorbable, finely divided ceramic particles.  
     
     
         38 . The composition of  claim 38 , wherein the ceramic particles are selected from the group consisting of calcium phosphate particles, calcium silicate particles, calcium carbonate particles and alumina particles.  
     
     
         39 . The composition of  claim 35 , further comprising an additive.  
     
     
         40 . The composition of  claim 35 , wherein the composition is capable cut or shaped.