Gel suitable for implantation and delivery system

Abstract

The invention concerns a dried form of a porous polymer gel material which may be rehydrated and placed under pressure or compression to induce solvation, thereby forming a high concentration gel, in the form of an injectable viscous putty or dough, which may be implantated in the body.

1 . An implantable gel material, said implantable gel material formed from a pressure solubilized dried gel, wherein said dried gel is hydrated by the addition of a solvating fluid, then said dried gel and solvating fluid form said implantable gel material upon the application of a pressurizing force.  
     
     
         2 . The implant of  claim 1  wherein said implantable gel material further comprises at least one biologically active agent.  
     
     
         3 . The implant of  claim 1  wherein said solvating fluid further comprises at least one biologically active agent.  
     
     
         4 . The implant of  claim 1  wherein said dried gel material further comprises at least one biologically active agent.  
     
     
         5 . The implant of  claim 1  wherein said solvating fluid comprises a biologically active agent.  
     
     
         6 . The implant of  claim 1  wherein said implantable gel material further comprises at least one filler material.  
     
     
         7 . The implant of  claim 1  wherein said solvating fluid further comprises at least one filler material.  
     
     
         8 . The implant of  claim 1  wherein said dried gel material further comprises at least one filler material.  
     
     
         9 . The implant of  claim 1  wherein said implantable gel material comprises at least one polymer.  
     
     
         10 . The implant of  claim 9  wherein said polymer comprises at least one natural polymer.  
     
     
         11 . The implant of  claim 9  wherein said polymer comprises at least one synthetic polymer.  
     
     
         12 . An implantable biomaterial comprising a high surface area, fluid soluble material hydrated by a fluid and then solvated by a pressure solubilization process, wherein said implantable biomaterial becomes malleable.  
     
     
         13 . The biomaterial of  claim 12 , wherein said rehydration step comprises adding less fluid than was removed during a dehydration step.  
     
     
         14 . The biomaterial of  claim 13 , wherein said pressure solubilization process causes solubilization at a faster rate than occurs by capillary rehydration and stagnant salvation.  
     
     
         15 . A process for manufacturing an implantable gel material comprising the steps of: 
 a. providing a biomaterial having a large surface area, and a fluid;    b. combining said biomaterial and fluid, wherein said surface area of said biomaterial becomes coated with said fluid; and    c. applying a pressurizing force to said combined fluid and biomaterial wherein said biomaterial collapses into a malleable gel.    
     
     
         16 . The process of  claim 15 , wherein said implantable gel material further comprises at least one biologically active agent.  
     
     
         17 . The process of  claim 15 , wherein said fluid further comprises at least one biologically active agent.  
     
     
         18 . The process of  claim 15 , wherein said biomaterial further comprises at least one biologically active agent.  
     
     
         19 . The process of  claim 15 , wherein said fluid comprises a biologically active agent.  
     
     
         20 . The process of  claim 15 , wherein said biomaterial further comprises at least one filler material.  
     
     
         21 . The process of  claim 15 , wherein said fluid further comprises at least one filler material.  
     
     
         22 . The process of  claim 15 , wherein said biomaterial further comprises at least one filler material.  
     
     
         23 . The process of  claim 15 , wherein said implantable gel material comprises at least one polymer.  
     
     
         24 . The process of  claim 3 , wherein said polymer comprises at least one natural polymer.  
     
     
         25 . The process of  claim 3 , wherein said polymer comprises at least one synthetic polymer.  
     
     
         26 . A process for manufacturing an implantable gel material comprising the steps of: 
 a. removing a fluid from a biomaterial solution or suspension having a first viscosity to leave a dry porous body presenting a large amount of surface area;    b. rehydrating said biomaterial with a volume of fluid less than the amount removed during step a;    c. allowing said surface area of said biomaterial to become coated with said fluid; and applying a pressurizing force to the combined fluid and biomaterial, wherein said biomaterial collapses into a malleable gel having a second viscosity, wherein said second viscosity is greater than said first viscosity.    
     
     
         27 . The process of  claim 26 , wherein said implantable gel material further comprises at least one biologically active agent.  
     
     
         28 . The process of  claim 26 , wherein said fluid further comprises at least one biologically active agent.  
     
     
         29 . The process of  claim 26 , wherein said biomaterial further comprises at least one biologically active agent.  
     
     
         30 . The process of  claim 26 , wherein said fluid comprises a biologically active agent.  
     
     
         31 . The process of  claim 26 , wherein said biomaterial further comprises at least one filler material.  
     
     
         32 . The process of  claim 26 , wherein said fluid further comprises at least one filler material.  
     
     
         33 . The process of  claim 26 , wherein said biomaterial further comprises at least one filler material.  
     
     
         34 . The process of  claim 26 , wherein said implantable gel material comprises at least one polymer.  
     
     
         35 . The process of  claim 34 , wherein said polymer comprises at least one natural polymer.  
     
     
         36 . The process of  claim 34 , wherein said polymer comprises at least one synthetic polymer.  
     
     
         37 . An implantable gel material, said implantable gel material formed by the process comprising the steps of: 
 a. providing a biomaterial having a large surface area, and a fluid;    b. combining said biomaterial and fluid, wherein said surface area of said biomaterial becomes coated with said fluid; and    c. applying a pressurizing force to said combined fluid and biomaterial wherein said biomaterial collapses into a malleable gel.    
     
     
         38 . The implantable gel material of  claim 37 , wherein said implantable gel material further comprises at least one biologically active agent.  
     
     
         39 . The implantable gel material of  claim 37 , wherein said fluid further comprises at least one biologically active agent.  
     
     
         40 . The implantable gel material of  claim 37 , wherein said biomaterial further comprises at least one biologically active agent.  
     
     
         41 . The implantable gel material of  claim 37 , wherein said fluid comprises a biologically active agent.  
     
     
         42 . The implantable gel material of  claim 37 , wherein said biomaterial further comprises at least one filler material.  
     
     
         43 . The implantable gel material of  claim 37 , wherein said fluid further comprises at least one filler material.  
     
     
         44 . The implantable gel material of  claim 37 , wherein said biomaterial further comprises at least one filler material.  
     
     
         45 . The implantable gel material of  claim 37 , wherein said implantable gel material comprises at least one polymer.  
     
     
         46 . The implantable gel material of  claim 45 , wherein said polymer comprises at least one natural polymer.  
     
     
         47 . The implantable gel material of  claim 45 , wherein said polymer comprises at least one synthetic polymer.  
     
     
         48 . An implantable gel material, said implantable gel material formed by the process comprising the steps of: 
 a. removing a fluid from a biomaterial solution or suspension having a first viscosity to leave a dry porous body presenting a large amount of surface area;    b. rehydrating said biomaterial with a volume of fluid less than the amount removed during step a;    c. allowing said surface area of said biomaterial to become coated with said fluid; and    d. applying a pressurizing force to the combined fluid and biomaterial, wherein said biomaterial collapses into a malleable gel having a second viscosity, wherein said second viscosity is greater than said first viscosity.    
     
     
         49 . The implantable gel material of  claim 48 , wherein said implantable gel material further comprises at least one biologically active agent.  
     
     
         50 . The implantable gel material of  claim 48 , wherein said fluid further comprises at least one biologically active agent.  
     
     
         51 . The implantable gel material of  claim 48 , wherein said biomaterial further comprises at least one biologically active agent.  
     
     
         52 . The implantable gel material of  claim 48 , wherein said fluid comprises a biologically active agent.  
     
     
         53 . The implantable gel material of  claim 48 , wherein said biomaterial further comprises at least one filler material.  
     
     
         54 . The implantable gel material of  claim 48 , wherein said fluid further comprises at least one filler material.  
     
     
         55 . The implantable gel material of  claim 48 , wherein said biomaterial further comprises at least one filler material.  
     
     
         56 . The implantable gel material of  claim 48 , wherein said implantable gel material comprises at least one polymer.  
     
     
         57 . The implantable gel material of  claim 56 , wherein said polymer comprises at least one natural polymer.  
     
     
         58 . The implantable gel material of  claim 56 , wherein said polymer comprises at least one synthetic polymer.  
     
     
         59 . An implantable collagen gel material, said implantable gel material formed from a pressure solubilized dried gel containing a particulate ceramic filler, wherein said dried gel is hydrated by the addition of a solvating fluid, then said dried gel and solvating fluid form said implantable gel material with suspended ceramic particulate upon the application of a pressurizing force.  
     
     
         60 . The implantable gel material of  claim 59  further comprising an insoluble collagen fiber filler.