Inflatable prostheses and methods of making same

Abstract

An inflatable tissue expander or more permanent prosthesis, 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.

What is claimed is: 
     
         1 . An inflatable breast 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 
 an intermediate layer disposed between and bonding the first composite guard with the second composite guard, the intermediate layer comprising an elastomeric material. 
   
     
     
         2 . The prosthesis of  claim 1  wherein the intermediate layer comprises a silicone elastomer. 
     
     
         3 . The prosthesis of  claim 1  wherein the intermediate layer comprises a silicone elastomer that is sealed to the first and second composite guards and adhered to the puncture resistant members. 
     
     
         4 . The prosthesis of  claim 1  wherein the intermediate layer encapsulates the first and second composite guards. 
     
     
         5 . The prosthesis of  claim 4  wherein the intermediate layer comprises a silicone elastomer. 
     
     
         6 . The prosthesis of  claim 4  wherein the intermediate layer comprises a silicone elastomer that is sealed to the first and second composite guards and adhered to the puncture resistant members. 
     
     
         7 . The prosthesis of  claim 1  wherein the intermediate layer is a low durometer silicone elastomer that has been cured in place between the first and second composite guards. 
     
     
         8 . An inflatable breast 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, a second composite guard, and a third 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, second and third composite guards 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 each adjacent composite guard, and 
 an elastomeric material disposed between and bonding the first composite guard with the second composite guard, and the second composite guard with the third composite guard. 
   
     
     
         9 . The prosthesis of  claim 8  wherein the elastomeric material comprises a silicone elastomer. 
     
     
         10 . The prosthesis of  claim 8  wherein the elastomeric material comprises a silicone elastomer that is sealed to the first, second and third composite guards and adhered to the puncture resistant members. 
     
     
         11 . The prosthesis of  claim 8  wherein the elastomeric material encapsulates the first, second and third composite guards. 
     
     
         12 . The prosthesis of  claim 11  wherein the elastomeric material comprises a silicone elastomer. 
     
     
         13 . The prosthesis of  claim 11  wherein the elastomeric material comprises a silicone elastomer that is sealed to the first and second composite guards and adhered to the puncture resistant members. 
     
     
         14 . The prosthesis of  claim 11  wherein the elastomeric material is a low durometer silicone elastomer that has been cured in place between the first, second and third composite guards.