Three Layer Breast Prosthesis

Abstract

A breast prosthesis that includes an outer first layer, a middle second layer and an inner third layer. The outer first layer includes a first material that has a first firmness. The first firmness allows for a 20 mm to a 25 mm penetration by a cone penetrometer. The first layer has a shape corresponding to a shape of a breast form. The middle second layer is disposed adjacent to the first layer and includes a second material that has a second firmness that is greater than the first firmness. The inner third layer is disposed adjacent to the second layer opposite from the first layer and includes a third material that has a third firmness that is less than the second firmness.

What is claimed is: 
     
         1 . A method of making a breast prosthesis, comprising the steps of:
 (a) welding together four flexible films with a single weld so as to form a breast form envelope, the breast form envelope including a first chamber, a second chamber and a third chamber, each chamber having a shape of a breast form footprint;   (b) placing the breast form envelope into a mold having a shape that is complementary in shape to a breast form;   (c) injecting a first material into the first chamber, the first material having a first firmness that allows for a  20  mm to a  25  mm penetration by a cone penetrometer when cured;   (d) injecting a second material into the second chamber, the second material having a second firmness when cured, the second firmness being greater than the first firmness;   (e) injecting a third material into the third chamber, the third material having a third firmness when cured, the third firmness being less than the second firmness; and   (f) heating the mold, the breast form envelope, the first material, the second material and the third material to a temperature sufficient to cure the first material to the first firmness, the second material to the second firmness and the third material to the third firmness.   
     
     
         2 . The method of  claim 1 , wherein the firmness of the second material is such that the second material allows for a 10 mm to a 13 mm penetration by a cone penetrometer. 
     
     
         3 . The method of  claim 1 , wherein the firmness of the third material is such that the third material allows for a 22 mm to a 26 mm penetration by a cone penetrometer. 
     
     
         4 . The method of  claim 1 , wherein the first material comprises silicone gel with a first concentration of a cross-linker, the second material comprises silicone gel with a second concentration of cross-linker, and the third material comprises silicone gel with a third concentration of cross-linker, wherein the second concentration is greater that both the first concentration and the third concentration. 
     
     
         5 . The method of  claim 4 , wherein the cross-linker comprises a methyl hydrosiloxane polymer. 
     
     
         6 . The method of  claim 1 , further comprising the step of adding micro-spheres to at least one of the first material, the second material and the third material so as to reduce the weight of the breast prosthesis.