Inflatable prostheses and methods of making same

Abstract

A prosthesis can include a shell and a needle guard coupled to a posterior portion of the shell. The shell can include a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough. The needle guard can include a plurality of offset layers of offset, puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature. The needle guard can have a shape memory characteristic for urging the prosthesis toward the expanded state.

What is claimed is: 
     
         1 . A flexible, fillable prosthesis, the prosthesis comprising:
 a shell having an anterior portion and a posterior portion, the shell comprising a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough; and   a needle guard coupled to the posterior portion of the shell and comprising a plurality of offset layers of offset, puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature, the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state.   
     
     
         2 . The prosthesis according to  claim 1 , wherein the intermediate layer comprises Nusil MED 6350. 
     
     
         3 . The prosthesis according to  claim 1 , wherein the plurality of offset layers comprises slat members. 
     
     
         4 . The prosthesis according to  claim 1 , wherein the plurality of offset layers comprises dome-shaped members. 
     
     
         5 . The prosthesis according to  claim 1 , wherein the plurality of offset layers comprises three layers. 
     
     
         6 . The prosthesis according to  claim 1 , wherein the plurality of offset layers comprises members having a thickness between 0.1 mm and 1.0 mm and a spacing of between 0.2 mm and 0.5 mm. 
     
     
         7 . The prosthesis according to  claim 1 , wherein an interior surface of the base layer forms an inflatable cavity, and the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer. 
     
     
         8 . A flexible, fillable prosthesis, the prosthesis comprising:
 a shell having an anterior portion and a posterior portion; and   a needle guard coupled to the posterior portion of the shell and comprising a plurality of offset layers of offset, puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature, the needle guard having a shape memory characteristic for urging the prosthesis toward the expanded state.   
     
     
         9 . The prosthesis according to  claim 8 , wherein the plurality of offset layers comprises slat members. 
     
     
         10 . The prosthesis according to  claim 8 , wherein the plurality of offset layers comprises dome-shaped members. 
     
     
         11 . The prosthesis according to  claim 8 , wherein the plurality of offset layers comprises three layers. 
     
     
         12 . The prosthesis according to  claim 8 , wherein the plurality of offset layers comprises members having a thickness between 0.1 mm and 1.0 mm and a spacing of between 0.2 mm and 0.5 mm. 
     
     
         13 . The prosthesis according to  claim 8 , wherein the shell comprises a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough. 
     
     
         14 . The prosthesis according to  claim 13 , wherein an interior surface of the base layer forms an inflatable cavity, and the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer. 
     
     
         15 . A method of making a flexible, fillable prosthesis, the prosthesis comprising:
 providing first and second layers of puncture-resistance structures;   bonding the first layer of puncture-resistance structures to the second layer of puncture-resistance structures to form a needle guard, such that (i) the structures of the first layer of puncture-resistance structures is offset relative to the structures of the second layer of puncture-resistance structures, and (ii) in an expanded state, the first layer of puncture-resistance structures collectively form a concave shape; and   coupling the needle guard to a posterior portion of shell, wherein the shell further comprises an anterior portion;   wherein the a posterior portion of the prosthesis comprises a concave exterior surface configured to approximate a human anatomical feature, and the needle guard comprises a shape memory characteristic for urging the prosthesis toward the expanded state.   
     
     
         16 . The method of  claim 15 , further comprising providing an intermediate layer between the first layer of puncture-resistance structures. 
     
     
         17 . The method of  claim 15 , further comprising:
 providing a third layer of puncture-resistance structures between the first and second layers of puncture-resistance structures; and   positioning the structures of the third layer of puncture-resistance structures to be offset relative to the structure of at least one of the first and second layers of puncture-resistance structures.   
     
     
         18 . The method of  claim 17 , further comprising bonding the third layer of puncture-resistance structures to at least one of the first and second layers of puncture-resistance structures. 
     
     
         19 . The method of  claim 15 , wherein the shell comprises a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough. 
     
     
         20 . The method of  claim 19 , wherein an interior surface of the base layer forms an inflatable cavity, and the soft silicone gel intermediate layer is disposed between an outer surface of the base layer and an interior surface of the top layer.