Implants with symmetric shape

Abstract

Implants having symmetry are described. The implant may comprise a biocompatible material and have at least two planes of symmetry, including symmetry about an equator of the implant. The implant may be a body contouring implant, wherein a posterior side of the implant is symmetric about the equator to an anterior side of the implant.

We claim: 
     
         1 . A medical implant comprising a biocompatible material and having at least two planes of symmetry, wherein one of the at least two planes of symmetry corresponds to an equator of the implant. 
     
     
         2 . The implant of  claim 1 , wherein the implant has three planes of symmetry. 
     
     
         3 . The implant of  claim 1  or  2 , wherein the implant is a body contouring implant chosen from a breast implant or a gluteal implant, a tissue expander, a sizer, or a tissue dissector, a posterior side of the implant being symmetric about the equator to an anterior side of the implant. 
     
     
         4 . The implant of any of the preceding claims, wherein the implant has a round shape, an oval shape, or a teardrop shape. 
     
     
         5 . The implant of any of the preceding claims, wherein the implant includes a shell and a filler, the shell having a patch affixed thereto. 
     
     
         6 . The implant of any of the preceding claims, wherein the implant has a first side and a second side symmetric about the equator, the implant including a patch located between an apex of the first side and the equator, or between an apex of the second side and the equator, optionally wherein the patch is located less than or equal to 20 mm from the equator, less than or equal to 18.9 mm from the equator, less than or equal to 15 mm from the equator, less than or equal to 10 mm from the equator, less than or equal to 7.5 mm from the equator, less than or equal to 5.5 mm from the equator, less than or equal to 5 mm from the equator, optionally wherein at least a portion of the patch is located at the equator. 
     
     
         7 . The implant of any of the preceding claims, wherein the implant includes a patch having a diameter less than or equal to 30 mm, such as less than or equal to 27 mm, less than or equal to 25 mm, less than or equal to 20 mm, or less than or equal to 19 mm. 
     
     
         8 . The implant of any of the preceding claims, wherein the implant includes a label imprinted thereon for identifying the implant, optionally wherein the label includes a name and/or location of a manufacturer, an implant model number, one or more size dimensions, a date of manufacture, or a combination thereof. 
     
     
         9 . The implant of any of the preceding claims, wherein the implant includes a transponder, optionally wherein the transponder is disposed in a filler proximate an apex of the implant. 
     
     
         10 . The implant of any of the preceding claims, wherein the implant is a breast implant comprising a gel filler that has a viscosity or penetration value suitable for simulating movement of natural breast tissue. 
     
     
         11 . The implant of any of the preceding claims, wherein at least a portion of an outer surface or the entire outer surface of the implant is texturized with surface features on the order of nanometers to micrometers, optionally wherein the implant comprises a shell that includes a patch, the outer surface of the patch being texturized with surface features on the order of nanometers to micrometers. 
     
     
         12 . Use of the implant of any of the preceding claims in a minimally-invasive implantation procedure. 
     
     
         13 . A method of manufacturing the implant of any of  claims 1 - 11 . 
     
     
         14 . A method of manufacturing an implant comprising a biocompatible material, wherein the implant comprises a shell that includes exactly one low diffusion barrier the forms an outermost surface of the shell. 
     
     
         15 . The method of  claim 13  or  14 , wherein preparing a shell of the implant comprises:
 applying a first silicone dispersion to a surface of a mold to form at least one first layer of the shell; and 
 applying a second silicone dispersion to the at least one first layer to form at least one second layer; 
 wherein the first silicone dispersion or the second silicone dispersion comprises a colored silicone elastomer that includes a dye or a pigment, and the other of the first silicone dispersion or the second silicone dispersion does not include a dye or a pigment. 
 
     
     
         16 . The method of  claim 15 , wherein the second silicone dispersion comprises the colored silicone elastomer, the at least one second layer being a low diffusion barrier layer, optionally wherein the second silicone dispersion comprises from about 0.01% to about 0.05% by weight of the blue silicone elastomer, with respect to the total weight of the second silicone dispersion. 
     
     
         17 . The method of  claim 15  or  16 , wherein the colored silicone elastomer is blue, green, yellow, pink, orange, or purple. 
     
     
         18 . The method of any of  claims 15 - 17 , wherein the method includes applying 2, 3, 4, or 5 first layers, and then applying only one second layer over the first layers. 
     
     
         19 . The method of any of  claims 15 - 18 , wherein the method includes applying exactly 6 layers, the shell optionally having a total thickness ranging from about 0.010 inches to about 0.040 inches before and/or after curing the shell. 
     
     
         20 . The method of any of  claims 15 - 19 , further comprising curing the shell, optionally wherein the curing is performed at a temperature ranging from about 115.0° C. to about 135.0° C. 
     
     
         21 . The method of any of  claims 15 - 20 , further comprising removing the shell from the mold and inverting the shell, optionally wherein a surface of the mold is texturized with surface features on the order of nanometers to micrometers, such that an outermost surface of the shell, when inverted, is texturized. 
     
     
         22 . The method of any of  claims 15 - 21 , further comprising introducing a gel into a cavity of the shell, optionally wherein the gel has a penetration value ( 1/10 mm) between 10 and 60. 
     
     
         23 . The method of any of  claims 15 - 22 , further comprising applying a patch to a hole of the shell and sealing the patch to the shell. 
     
     
         24 . The method of  claim 23 , wherein the patch includes a transponder incorporated between layers of the patch or attached to an inner surface of the patch. 
     
     
         25 . The method of any of  claims 15 - 23 , further comprising introducing a transponder into a cavity of the shell. 
     
     
         26 . The method of  claim 25 , wherein the transponder is introduced into the cavity before or after introducing a gel into the cavity, the micro-transponder being (a) disposed within the gel and unattached to an inner surface of the shell, or (b) attached to an inner surface of the shell or incorporated into a portion of the shell. 
     
     
         27 . The method of  claim 25  or  26 , wherein the transponder is introduced into the cavity before or after applying a patch to a hole of the shell. 
     
     
         28 . The method of any of  claims 15 - 27 , further comprising heating the implant to cure a gel disposed inside a cavity of the shell, wherein the implant is placed in a substrate, such as in a cavity of a substrate, during the heating to maintain a symmetrical shape of the implant. 
     
     
         29 . The mold used in the method of any of  claims 15 - 27  to manufacture the implant, wherein the mold is a mandrel comprising a head and a handle, the head having a symmetric shape having at least two planes of symmetry corresponding to the at least two planes of symmetry of the implant, optionally wherein the head has a textured surface. 
     
     
         30 . The mold of  claim 29 , wherein the head is centered relative to the handle. 
     
     
         31 . The mold of  claim 29 , wherein the head is offset relative to the handle.