Textured surfaces for breast implants
AssigneeEstablishment Labs S.A.
InventorsArdeshir Bayat, Ernie Hill, Daniel Kyle, Antonios Oikonomou
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Abstract
The invention provides new devices for implantation in a patient having irregular textured surfaces, which devices show significantly improved cellular response compared to conventional smooth and textured implants, indicating that significantly improved biocompatibility would be achieved in vivo. Methods for making such new devices and surface textures are also disclosed.
Claims20
A breast implant comprising a textured surface having, at an area scale of 1 mm×1 mm:
- a mean surface roughness Sa value of from 5 μm to 7 μm;
- a root mean square height Sq value of from 5 μm to 10 μm;
- a mean surface skewness Ssk value of from −0.4 to +0.4;
- and
- a mean excess kurtosis value (Sku minus 3) of from −0.7 to +0.7;
- wherein the surface comprises a biocompatible polymer.
A breast implant comprising a biocompatible polymer material that forms an outermost surface of the breast implant, wherein the surface is textured and has, at an area scale of 1 mm×1 mm:
- a mean surface roughness Sa value of from 3 μm to 9 μm;
- a root mean square height Sq value of from 5 μm to 10 μm;
- a mean excess kurtosis value (Sku minus 3) of from −0.7 to +0.7;
- and
- a maximum peak height to trough depth Sz value from 10 μm to 80 μm.
A breast implant comprising a biocompatible polymer material that forms an outermost surface of the breast implant, wherein the surface is textured and has, at an area scale of 1 mm×1 mm:
- a mean surface roughness Sa value of from 5 μm to 7 μm;
- a root mean square height Sq value of from 4 μm to 15 μm;
- a mean surface skewness Ssk value of from −0.4 to +0.4;
- and
- a mean excess kurtosis value (Sku minus 3) of from −0.7 to +0.7;
- wherein the textured surface is an irregular textured surface.
Dependencies are inferred from the claim text.