Pyramid-shaped breast implant for augmentation, reconstruction, or lift and methods of use and production of the same

Abstract

The disclosure describes a breast implant device product that mimics the natural pectoral fat of the breast and is characterized by an incomplete pyramid with isosceles triangular base and wedge-shaped edges and sloping faces that meet at acute angles with variable degree located medially, laterally, and on the top and a footprint characterized by a semi-circular lower portion and an oval paraboloid upper portion and a center of gravity located closer to the footprint than to the profile, the said footprint is advantageously converging and moving towards the underlying surface as the chest wall with a method of manufacturing and a method of use of the said implant including a breast pyramid sizing system.

What is claimed is: 
     
         1 . A breast implant device that mimics the physical characteristics and configuration of natural fatty tissue of the breast comprising:
 a body comprising a volume between a footprint and a front surface, the body having an upper portion and a lower portion,   wherein the upper portion of the body comprises a truncated triangular isosceles pyramid sculptured to the shape of the breast above the horizontal level of the nipple,   wherein a perimeter of the footprint defined by an edge of the upper portion of the body has an oval paraboloid shape,   wherein the front surface has a straight slope,   wherein the footprint intersects the front surface to form a wedge-shaped edge,   wherein an angle between the footprint and front surface at the edge is acute,   wherein the body vertical height is unlinked to its width,   wherein the upper portion of the body fills the breast upper pole,   wherein the lower portion of the body is a segment of a sphere that fills the lower pole of the breast,   wherein a perimeter defined by the edge of the lower portion of the body has a semi-circular shape,   wherein the footprint is configured to lie on a chest wall, and   wherein a center of gravity of the body is located at the junction of the upper and lower portion of the body closer to the footprint than the front surface.   
     
     
         2 . The breast implant device of  claim 1  wherein a medial cleavage angle is variable with a range from 20 to 89 degrees. 
     
     
         3 . The breast implant device of  claim 1 , wherein the center of gravity of the body is positioned closer to the footprint than to the front surface, located at the meridian point of the breast triangle. 
     
     
         4 . The breast implant device of  claim 1  having selective implant fill distribution,
 wherein a volume of a central palm area of the body is about 55% of a total fill volume of the implant body, 
 wherein a volume of the upper extension is about 25% of the total fill volume of the implant body, and 
 wherein a remaining fill volume of the total is distributed on a medial and lateral wings. 
 
     
     
         5 . The breast implant device of  claim 1  having an alternative implant fill distribution wherein 45% of the total fill volume is located above an implant profile line and 55% of the total fill volume is located below the implant profile line. 
     
     
         6 . A method of making a breast implant device that mimics the natural breast fatty tissue, the method comprising:
 forming a three dimensional solid mandrel in the shape of a breast implant device, wherein the mold comprises:
 a base surface approximating an isosceles triangle in shape, 
 a front surface,
 wherein the base surface intersects the front surface to form a wedge-shaped edge, 
 wherein the angle between the base surface and front surface at the edge is acute, and 
 
 a body comprising a volume between the base surface and the front surface, the body having an upper portion and a lower portion, 
 wherein the mold is attached to a handle, 
 wherein the handle is attached to a rotating machine; 
   casting a shell of the breast implant device using the mold,
 wherein the shell has internal septa resulting in multiple interior compartments, 
 wherein the compartments are adapted to receive saline solution or silicone gel fill material; 
   providing a fill port on the shell; and   creating fixation holes on the edge of the shell, wherein the fixation holes are adapted to receive surgical fixation, thereby allowing the shell to be affixed to underlying or overlying tissues.   
     
     
         7 . The breast implant device of  claim 1  wherein the body comprises a solid pliable silicone gel without a shell. 
     
     
         8 . The method of  claim 6 , further comprising:
 making a pre-operative breast implant sizer that mimics the breast implant device.   
     
     
         9 . A method of pre-operative sizing a breast implant device comprising:
 determining an upper volume of a breast above a nipple-line;   determining a lower volume of a breast below the nipple-line;   selecting an implant size and fill volume distribution so that a combined upper volume comprising the upper volume of a breast and an upper volume of the device above a profile line of the device is about 45% of a total volume and a combined lower volume comprising the lower breast volume and a lower volume of the device below the profile line of the device is about 55% of the total volume,   wherein the total volume is a volume of the device and a volume of the breast.   
     
     
         10 . A method of using a breast implant device that mimics the natural breast fatty tissue, the method comprising:
 forming a surgical pocket that extends upwards to the upper boundaries of the natural breast footprint,   non-invasively placing the breast implant device with limited release of the pectoralis major muscle,   pushing the medial cleavage wedge-shaped edge to a point under the pectoralis major origin on the medial side, and   placing the breast implant device center of gravity behind the nipple.   
     
     
         11 . The method of  claim 10 , further comprising:
 anchoring the breast implant device to the chest wall by surgical fixation using fixation holes.   
     
     
         12 . The method of  claim 10  further comprising:
 using intra-operative breast implant sizers to further evaluate the suitability of the selected breast implant size to a particular patient anatomy and desire. 
 
     
     
         13 . An implant device for use in humans in need for augmentation of other parts of the body including the gluteal area, cheeks, chin, calf and others having the physical characteristics and configuration of a truncated triangular pyramid comprising wedge shaped edges, acute lateral and upper angles, and a footprint diverging towards an underlying support surface.