Inflatable prostheses and methods of making same

Abstract

An inflatable tissue expander, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

1 . A method of making an inflatable device suitable for implantation in a mammal, the method comprising:
 providing a mesh;   positioning the mesh on a curved molding surface;   applying a fluid elastomeric material to the molding surface with the mesh positioned thereon; and   allowing the elastomeric material to set to form a flexible shell having an open end, the shell including the mesh embedded within the set elastomer, and the shell being useful as a component of an inflatable prosthesis.   
     
     
         2 . The method of  claim 1  wherein the mesh comprises a mesh sock. 
     
     
         3 . The method of  claim 1  wherein the step of positioning comprises positioning overlapping mesh segments on the curved molding surface. 
     
     
         4 . The method of  claim 1  further comprising providing a puncture resistant member and sealing the puncture resistant member to the open end of the elastomeric shell to form an inflatable prosthesis having a self-sealing anterior portion and a puncture resistant posterior portion. 
     
     
         5 . The method of  claim 4  wherein the puncture resistant member comprises a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion,
 the first composite guard and the second composite guard being positioned such that the arrangement of puncture resistant members of the second composite guard are misaligned with the arrangement of puncture resistant members of the first composite guard, and 
 a intermediate layer disposed between and connecting the first composite guard with the second composite guard. 
 
     
     
         6 . The method of  claim 1  wherein the inflatable prosthesis is an inflatable tissue expander. 
     
     
         7 . An inflatable prosthesis made by the method of  claim 5 . 
     
     
         8 . An inflatable prosthesis comprising:
 a self-sealing inflatable anterior portion comprising a silicone-based elastomer material and defining a fillable cavity; and   a posterior portion substantially opposing the anterior portion and comprising a needle guard assembly including
 a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion, 
 the first composite guard and the second composite guard being positioned such that the arrangement of puncture resistant members of the second composite guard are misaligned with the arrangement of puncture resistant members of the first composite guard, and 
 a intermediate layer disposed between and connecting the first composite guard with the second composite guard. 
   
     
     
         9 . The prosthesis of  claim 8  wherein the anterior portion comprises an elastomer having a mesh embedded therein. 
     
     
         10 . The prosthesis of  claim 8  wherein the anterior portion comprises
 an interior shell, 
 an exterior shell comprising a silicone-based elastomer material having a mesh embedded therein, and 
 a gel separating the interior shell and the exterior shell. 
 
     
     
         11 . The prosthesis of  claim 8  wherein the needle guard assembly further comprising a third composite guard wherein the arrangement of puncture resistant members of the third composite guard are misaligned with the arrangement of puncture resistant members of the second composite guard. 
     
     
         12 . The prosthesis of  claim 8  wherein the puncture resistant members are dome shaped. 
     
     
         13 . The prosthesis of  claim 8  wherein the puncture resistant members are generally dome shaped with a flat surface area. 
     
     
         14 . The prosthesis of  claim 8  wherein the puncture resistant members have a thickness of between about 0.1 mm and about 1.0 mM. 
     
     
         15 . The prosthesis of  claim 8  wherein the puncture resistant members have a spacing of between about 0.1 mm and about 1.0 mm 
     
     
         16 . The prosthesis of  claim 8  wherein the puncture resistant members have a diameter of between about 0.5 mm and about 2.0 mm. 
     
     
         17 . An inflatable prosthesis suitable for implantation in a breast, the tissue expander comprising:
 a puncturable, self-sealing inflatable anterior portion comprising
 an interior shell defining a fillable cavity, 
 an exterior shell comprising a silicone-based elastomer material having a mesh embedded therein, 
 a gel separating the interior shell and the exterior shell; and 
   a needle guard assembly substantially opposing the self-sealing inflatable portion and comprising
 a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion, 
 the first composite guard and the second composite guard being positioned such that the arrangement of puncture resistant members of the second composite guard are misaligned with the arrangement of puncture resistant members of the first composite guard, and 
 a intermediate layer disposed between and connecting the first composite guard with the second composite guard. 
   
     
     
         18 . The prosthesis of  claim 17  wherein the puncture resistant members have a thickness of between about 0.1 mm and about 1.0 mM. 
     
     
         19 . The prosthesis of  claim 17  wherein the puncture resistant members have a spacing of between about 0.1 mm and about 1.0 mm. 
     
     
         20 . The prosthesis of  claim 17  wherein the puncture resistant members have a have a diameter of between about 0.5 mm and about 2.0 mm. 
     
     
         21 . The prosthesis of  claim 17  wherein the puncture resistant members have a thickness of between about 0.1 mm and about 1.0 mm, a spacing of between about 0.1 mm and about 1.0 mm and a diameter of between about 0.5 mm and about 2.0 mm. 
     
     
         22 . The prosthesis of  claim 17  wherein the total volume of the prosthesis is adjustable by introduction and removal of fluid into and from the fillable cavity.