US Pat. No. 10,111,744

METHOD OF MAKING A PROSTHESIS DEVICE

Establishment Labs S.A., ...

1. A method of making a prosthesis device comprising a flexible shell and a filling material, said method comprising:forming a plurality of first layers by coating a mold with a first silicone material, wherein the plurality of first layers has a first thickness and a first color;
forming one or more second layers by coating the plurality of first layers with a second silicone material, comprising:
a polydimethylsiloxane polymer having at least 10 mole percent of a pendant chemical group chosen from a diphenyl group, a methylphenyl group, a trifluoropropyl group, or a combination thereof;
a vinyldimethyl-terminated polydimethylsiloxane polymer; and
a pigment,
the one or more second layers providing a diffusion barrier to impede passage of the filling material through the shell, wherein the one or more second layers has a second thickness and a second color different from the first color of the plurality of first layers;
forming a plurality of third layers by coating the one or more second layers with the first silicone material, wherein the plurality of third layers has a third thickness greater than the second thickness and the same color as the first color of the plurality of first layers, and wherein a total thickness of the shell, comprising the first thickness, the second thickness, and the third thickness, ranges from 0.33 mm to 1.00 mm; and
verifying the presence of the one or more second layers in the shell by visual observation of the second color in the shell, the one or more second layers being visually distinguishable through the plurality of first layers without the use of an optical comparator, specialized equipment, or destructive tests.

US Pat. No. 10,176,412

TRANSPONDERS AND SENSORS FOR IMPLANTABLE MEDICAL DEVICES AND METHODS OF USE THEREOF

Establishment Labs S.A., ...

1. A transponder, comprising:a coil comprised of a wire, wherein
a length of the transponder measures between about 5 mm and about 30 mm;
a width of the transponder measures between about 2 mm and about 5 mm and is less than the length of the transponder;
the transponder does not include a ferromagnetic material; and
the wire is wound along the length of the transponder.

US Pat. No. 10,595,979

TEXTURED SURFACES FOR BREAST IMPLANTS

Establishment Labs S.A., ...

1. An implant comprising a textured surface having:at an area scale of 1 mm×1 mm:
a mean surface roughness Sa value of from 2 ?m to 12 ?m; and
a maximum peak height to trough depth Sz value of 20 ?m to 60 ?m; and
at an area scale of 90 ?m×90 ?m:
a mean surface roughness Sa value of from 0.1 ?m to 5 ?m;
wherein the surface comprises a biocompatible polymer.

US Pat. No. 11,109,956

GRAVITY SENSITIVE SILICONE BREAST IMPLANTS

Establishment Labs S.A., ...


1. A gravity sensitive silicone breast implant, comprising a flexible multilayer shell and a cohesive silicone gel filler with a high elasticity and a low viscosity, the breast implant being configured to shift its maximum point of projection when subjected to gravity, wherein the flexible multilayer shell reaches at least 25% elongation at forces of about 1.4 N to about 1.9 N and at least 50% elongation at forces of about 1.8 N to about 2.2 N when tested in accordance with ASTM D412, and 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.

US Pat. No. 10,905,466

APPARATUSES FOR THE IMPLANTATION OF MEDICAL DEVICES AND METHODS OF USE THEREOF

Establishment Labs S.A., ...

1. A medical device for delivering a breast implant to a subject, comprising:a shaft extending between a proximal end and a distal end, the shaft including a lumen therein, the distal end including a tapered nozzle, wherein the shaft is configured to compress the breast implant has an inner diameter ranging from about 2-3 inches;
a handle detachably coupled to the proximal end of the shaft and including a valve mechanism and an actuator; and
a tubing assembly extending from a distal end of the handle and configured to transfer a fluid between a compressed fluid source and the shaft, the tubing assembly including a pressure line extending through a body of the handle;
wherein the actuator is configured to engage the valve mechanism to control fluid flow to the shaft through the pressure line so as to impart a positive pressure in the at least a portion of the lumen.

US Pat. No. 11,045,307

MEDICAL IMPLANTS AND METHODS OF PREPARATION THEREOF

Establishment Labs S.A., ...


1. A breast implant, comprising:a shell comprising a biocompatible material and having an outer surface configured to contact tissue and an inner surface facing a cavity defined by the shell;wherein the outer surface of the shell includes a plurality of peaks distributed at a density ranging from about 20,000 peaks/cm2 to about 65,000 peaks/cm2, the outer surface having an average roughness ranging from about 3.0 ?m to about 5.0 ?m and a kurtosis value ranging from about 3.0 to about 7.0; and
wherein the inner surface of the shell has an average roughness that is higher than the average roughness of the outer surface of the shell.


US Pat. No. 11,026,775

TEXTURED SURFACES FOR BREAST IMPLANTS

Establishment Labs S.A., ...

1. 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 ?m to 7 ?m;
a root mean square height Sq value of from 5 ?m to 10 ?m;
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.

US Pat. No. 10,912,636

TEXTURED SURFACES FOR BREAST IMPLANTS

Establishment Labs S.A., ...

1. A breast implant comprising a textured surface having:a mean surface roughness Sa value of from 2 ?m to 12 ?m at an area scale of 1 mm×1 mm;
a mean surface skewness Ssk value of from ?0.7 to +0.7 at an area scale of 1 mm×1 mm;
a mean excess kurtosis value (Sku minus 3) of ?1.0 to +1.0 at an area scale of 1 mm×1 mm; and
a maximum peak height to trough depth Sz value from 10 ?m to 80 ?m at an area scale of 1 mm×1 mm;
wherein the textured surface comprises silicone.

US Pat. No. 10,824,925

TRANSPONDERS AND SENSORS FOR IMPLANTABLE MEDICAL DEVICES AND METHODS OF USE THEREOF

Establishment Labs S.A., ...

1. An integrated port assembly, comprising:a chamber configured to receive a fluid;
a wire coil, the wire coil sharing a central axis with the chamber; and
a port dome covering an opening into the chamber, wherein the port dome is penetrable by an injection device and self-sealing upon removal of the injection device.