Implant identification by radiographic means

Abstract

A breast implant includes a flexible shell having an anterior face including an outer surface and an inner surface, and a marker attached to the inner surface of the anterior face of the shell. The marker includes a first layer of material having a radiopaque surface with readable characters for identifying a characteristic of the breast implant while in vivo, and a second layer of non-radiopaque material laminated onto the radiopaque surface. The readable characters defined by an outline formed from an absence of at least a portion of material of the radiopaque surface. The first layer of material with the readable characters is interposed between the inner surface of the anterior face of the shell and the second layer, and the readable characters are viewable in vivo using conventional imaging techniques.

1 - 10 . (canceled) 
     
     
         11 . A method of manufacturing a radiopaque identifier for a breast implant, the method comprising:
 providing a first layer of material, the first layer of material having a radiopaque material;   attaching a second layer of non-radiopaque material to the first layer of material, wherein the radiopaque material is interposed between an outer surface of the first layer and the second layer; and   removing at least a portion of the radiopaque material to form the radiopaque identifier including readable characters defined by the removed portion of radiopaque material, wherein the readable characters are viewable in vivo using X-ray imaging techniques.   
     
     
         12 . The method of  claim 11 , wherein the attaching the second layer of non-radiopaque material to the first layer of material comprises laminating the second layer of non-radiopaque material to the first layer of material. 
     
     
         13 . The method of  claim 11 , wherein the removing at least a portion of the radiopaque material comprises controllably marking and cutting out the portion of the radiopaque material of the first layer with a laser. 
     
     
         14 . The method of  claim 11 , wherein providing the first layer of material comprises incorporating barium sulfate into a silicone sheet. 
     
     
         15 . The method of  claim 14 , wherein the first layer of material comprises silicone incorporating barium sulfate, and the attaching a second layer of non-radiopaque material comprises attaching a clear silicone sheet to the first layer of silicone incorporating the barium sulfate. 
     
     
         16 . A method of manufacturing a breast implant, comprising:
 forming a breast implant marker having readable characters for identifying a characteristic of the breast implant while in vivo, the forming comprising:
 providing a first layer of material having an inner surface and an outer surface with a radiopaque material incorporated between the inner and outer surfaces; 
 attaching a second layer of non-radiopaque material to the inner surface of the first layer of material; and 
 removing at least a portion of the radiopaque material from the first layer of material to form readable characters defined by absence of the portion of radiopaque material; 
 providing a shell having an anterior face; and 
 attaching the breast implant marker to the anterior face of the shell, 
 wherein the first layer of material having the readable characters is interposed between the anterior face of the shell and the second layer of non-radiopaque material, and the readable characters are viewable in vivo using conventional imaging techniques. 
   
     
     
         17 . The method of  claim 16 , wherein the anterior face further includes an upper pole region and a lower pole region, and a midline of the shell extends from the upper pole region to the lower pole region, the method further comprising positioning the marker on the midline to indicate orientation of the breast implant during surgery. 
     
     
         18 . The method of  claim 16 , wherein the attaching the breast implant marker to the anterior face of the shell comprises attaching the breast implant marker to an inner surface of the anterior face of the shell. 
     
     
         19 . The method of  claim 18 , wherein the attaching the marker to the inner surface of the anterior face of the shell comprises silicone vulcanizing the marker to the inner surface of the anterior face of the shell. 
     
     
         20 . The method of  claim 16 , wherein the attaching the second layer of non-radiopaque material to the first layer of material comprises laminating the second layer of non-radiopaque material to the first layer of material. 
     
     
         21 . The method of  claim 16 , wherein the removing at least a portion of the radiopaque material comprises controllably marking and cutting out the portion of the radiopaque material from the first layer of material with a laser. 
     
     
         22 . The method of  claim 16 , wherein:
 the providing a first layer of material comprises incorporating barium sulfate into a silicone sheet; and   the attaching a second layer of non-radiopaque material comprises attaching a clear silicone sheet to the silicone sheet having the barium sulfate.   
     
     
         23 . The method of  claim 16 , wherein the attaching the breast implant marker to the anterior face of the shell comprises attaching the breast implant marker to an outer surface of the anterior face of the shell. 
     
     
         24 . The method of  claim 23 , wherein the attaching the marker to the outer surface of the anterior face of the shell comprises silicone vulcanizing the marker to the outer surface of the anterior face of the shell.