Soft prosthesis shell texturing method
First Claim
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1. A soft prosthetic breast implant, formed by a process comprising:
- forming a flexible shell of silicone elastomer, the silicone elastomer having a thickness;
adhering on the exterior of the flexible shell an even distribution of round particles;
curing the flexible shell with the round particles adhered thereto; and
removing the round particles thereby forming an open-pored structure on the exterior of the flexible shell such that the exterior of the flexible shell exhibits an undulating topography, the open pored-structure comprising round open cavities defined by impressions of the round particles;
processing the flexible shell such that it forms a closed envelope;
wherein the flexible shell formed by the process has at least one of the physical properties of ultimate break force, ultimate elongation, or ultimate tensile strength that is superior to such physical property of an identical flexible shell made using the same process and same materials except for angular particles instead of round particles;
wherein the round particles have a substantially uniform particle size within a particle size range selected from a group of ranges consisting of (1) a range between 180 microns and 425 microns, (2) a range between 425 microns and 850 microns, and (3) a range between 850 microns and 1450 microns; and
wherein the open-pored structure does not extend through the entire thickness of the silicone elastomer.
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Abstract
A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.
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Citations
12 Claims
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1. A soft prosthetic breast implant, formed by a process comprising:
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forming a flexible shell of silicone elastomer, the silicone elastomer having a thickness; adhering on the exterior of the flexible shell an even distribution of round particles; curing the flexible shell with the round particles adhered thereto; and removing the round particles thereby forming an open-pored structure on the exterior of the flexible shell such that the exterior of the flexible shell exhibits an undulating topography, the open pored-structure comprising round open cavities defined by impressions of the round particles; processing the flexible shell such that it forms a closed envelope; wherein the flexible shell formed by the process has at least one of the physical properties of ultimate break force, ultimate elongation, or ultimate tensile strength that is superior to such physical property of an identical flexible shell made using the same process and same materials except for angular particles instead of round particles; wherein the round particles have a substantially uniform particle size within a particle size range selected from a group of ranges consisting of (1) a range between 180 microns and 425 microns, (2) a range between 425 microns and 850 microns, and (3) a range between 850 microns and 1450 microns; and wherein the open-pored structure does not extend through the entire thickness of the silicone elastomer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification