GRAVITY SENSITIVE SILICONE BREAST IMPLANTS
A gravity sensitive silicone breast implant is provided which, in various embodiments, has a soft, natural feel and adapts shape after implantation responsive to gravity, according to movements of the patient.
1 - 11 . (canceled)
12 . A gravity-sensitive breast implant comprising:
a flexible shell comprising a plurality of silicone layers including at least one low diffusion barrier layer, wherein the shell reaches at least 50% elongation at forces of about 1.8 N to about 2.2 N when tested in accordance with ASTM D412; and
a cohesive silicone gel filler, wherein the silicone gel filler reaches about 2 mm to about 29 mm protrusion in a cone cohesion test without detaching when tested in accordance with ASTM F703;
wherein the breast implant is configured to shift its maximum point of projection when subjected to gravity to simulate natural breast tissue, the silicone gel filler having a high elasticity and a low viscosity.
13 . The breast implant of claim 12 , wherein the shell reaches at least 25% elongation at forces of about 1.4 N to about 1.9 N.
14 . The breast implant of claim 12 , wherein an outermost surface of the shell has nanoscale features.
15 . The breast implant of claim 12 , wherein an outermost surface of the shell has microscale features.
16 . The breast implant of claim 12 , wherein the low diffusion barrier layer forms an innermost layer of the shell.
17 . The breast implant of claim 12 , wherein the low diffusion barrier layer has a color different from the other layer or layers of the shell.
18 . The breast implant of claim 12 , wherein the shell has a thickness of about 0.008 inches to about 0.030 inches.
19 . The breast implant of claim 12 , wherein the low diffusion barrier layer comprises a polysiloxane backbone having at least 10 mole percent of a pendant chemical group that retards permeation of the silicone gel filler through the low diffusion barrier layer.
20 . The breast implant of claim 19 , wherein the pendant chemical group comprises a phenyl group or a fluorine group.
21 . The breast implant of claim 19 , wherein the pendant chemical group comprises a diphenyl group, a methylphenyl group, a trifluoropropyl group, or a mixture thereof.
22 . The breast implant of claim 12 , wherein the breast implant has a round base or an oval base.