Method for forming a breast prothesis

Abstract

A method for forming the outer surface of a breast prosthesis is disclosed. A digital, three-dimensional image is formed of a patient's breast using a computerized scanner. A computer-controlled milling machine utilizes the image to form a solid model of the breast. A sheet of flexible, moldable material having a uniform, precise thickness is then vacuum-formed over the breast model. A hard, two-piece mold is cast from the flexible sheet. A soft, curable material is then either poured or injected between the two pieces of the mold to form the breast prosthesis outer surface. The breast prosthesis outer surface is then turned inside out to form a shape that is a mirror image of the patient's breast.

1. A method for forming a breast prosthesis comprising the method steps of:
 (a) producing a three-dimensional image of a breast by performing a computerized scan of the breast;  
 (b) producing a positive model of the breast based on said three-dimensional image;  
 (c) vacuum-forming a uniformly flat flexible sheet having a consistent thickness over said positive model such that said flexible sheet is molded into the shape of said positive model thereby forming an interior side and exterior side;  
 (d) casting a two-piece solid mold from said flexible sheet, said two piece mold comprising a first piece formed over the exterior side of said flexible sheet, and said second piece formed within the interior side of said flexible sheet;  
 (e) introducing a curable material into said mold between said first piece and said second piece to form a breast prosthesis having an inner surface and an outer surface and having a consistent thickness; and  
 (f) turning said breast prosthesis inside out such that said inner surface becomes the outer surface of said breast prosthesis to form a precise mirror image of the breast.  
 
     
     
       2. The method of  claim 1 , wherein said thickness of said flexible sheet is about 1.9 millimeters. 
     
     
       3. The method of  claim 2 , wherein said flexible sheet comprises vinyl. 
     
     
       4. The method of  claim 1 , wherein the breast is held in a support garment during step (a). 
     
     
       5. The method of  claim 4 , wherein said support garment comprises a half-cup fitted underneath the breast. 
     
     
       6. The method of  claim 1 , wherein said curable material is silicone material. 
     
     
       7. The method of  claim 1 , wherein step (a) is performed using a camera on a 180° mount. 
     
     
       8. The method of  claim 1 , wherein step (b) is performed using a computer-controlled milling machine. 
     
     
       9. A method of forming a breast prosthesis, comprising:
 ( a )  scanning the breast to create two - dimensional images of the breast from two or more angles, wherein the breast is held in a support garment during scanning of the breast, the support garment being at least partially altered such that an upper portion of the breast is uncovered for scanning;      ( b )  using the two - dimensional images of the breast to create a three - dimensional image;      ( c )  using the three - dimensional image of the breast to produce a positive model of the breast; and      ( d )  using the positive model to produce a breast prosthesis.     
     
     
       10. The method of  claim 9 , wherein the breast is scanned by a camera at various angles as the camera moves around the breast. 
     
     
       11. The method of  claim 9 , wherein the breast is scanned by a camera mounted on a support that allows the camera to move around the breast. 
     
     
       12. The method of  claim 11 , wherein the support allows the camera to rotate about  180 ° around the breast. 
     
     
       13. The method of  claim 11 , wherein the support allows the camera to move in an arc. 
     
     
       14. The method of  claim 9 , further comprising transmitting the three- dimensional image to a production facility.   
     
     
       15. The method of  claim 9 , wherein a milling machine is used to perform step ( c ). 
     
     
       16. The method of  claim 9 , further comprising modifying the three- dimensional image to reduce irregularities in the three - dimensional image caused by the support garment.   
     
     
       17. A method for forming a breast prosthesis, comprising:
 ( a )  producing a three - dimensional image of a breast by performing a computerized scan of the breast;      ( b )  producing a positive model of the breast based on said three - dimensional image;      ( c )  vacuum - forming a flexible sheet having a consistent thickness over said positive model such that said flexible sheet is molded into the shape of said positive model thereby forming an interior side and exterior side;      ( d )  casting a two - piece solid mold from said flexible sheet, said two - piece solid mold comprising a first piece formed over the exterior side of said flexible sheet, and said second piece formed within the interior side of said flexible sheet;      ( e )  injecting or pouring a curable material into said mold between said first piece and said second piece to form a breast prosthesis having an inner surface and an outer surface and having a consistent thickness; and      ( f )  turning said breast prosthesis inside out such that said inner surface becomes the outer surface of said breast prosthesis to form a mirror image of the breast.     
     
     
       18. A method of forming a breast prosthesis, comprising:
 ( a )  scanning the breast to create at least one two - dimensional image of the breast;      ( b )  using one or more of the two - dimensional images of the breast to create a three - dimensional image; and      ( c )  using the three - dimensional image of the breast to produce a positive model of the breast;      ( d )  vacuum - forming a flexible sheet having a consistent thickness over said positive model such that said flexible sheet is molded into the shape of said positive model thereby forming an interior side and exterior side;      ( e )  casting a two - piece solid mold from said flexible sheet, said two - piece solid mold comprising a first piece formed over the exterior side of said flexible sheet, and said second piece formed within the interior side of said flexible sheet; and      ( f )  injecting or pouring a curable material into said mold between said first piece and said second piece to form a breast prosthesis having an inner surface and an outer surface and having a consistent thickness.     
     
     
       19. The method of  claim 18 , wherein step ( a )  is performed using a camera mounted on a support that allows the camera to move in an arc around the breast.   
     
     
       20. The method of  claim 18 , further comprising storing the three- dimensional image on a computer storage medium.   
     
     
       21. The method of  claim 18 , wherein a milling machine is used to performed step ( c ). 
     
     
       22. The method of  claim 18 , wherein the breast is held in a support garment during step ( a ). 
     
     
       23. The method of  claim 22 , further comprising modifying the three- dimensional image to reduce irregularities in the three - dimensional image caused by the support garment.   
     
     
       24. The method of  claim 9 , wherein the support garment only covers the lower portion of the breast.