# US 2019/0167414 A1 · Gravity sensitive silicone breast implants

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- Number: US 2019/0167414 A1
- Document ID: US20190167414A1
- Status: Published application
- Kind: A1
- Application number: 16/027,726
- Filed: 2018-07-05
- Published: 2019-06-06
- Earliest claimed: 2014-04-04
- Assignees: Establishment Labs S.A.
- Applicants: Establishment Labs S.A.
- Inventors: Juan Jose Chacon Quiros; Salvador Dada; Olivier Tourniaire; Luis M. Gutierrez
- Web page: https://patentgrep.com/patent/US20190167414A1

## CPC

- A61F 2/12: Mammary prostheses
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2230/0076: ellipsoidal or ovoid
- A61F 2230/008: paraboloidal
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

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.

## Claims

### Claim 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, and 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 and will not detach from the cone when tested in accordance with ASTM F703.

### Claim 2 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the flexible multilayer shell has a nano-textured outer surface.

### Claim 3 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the flexible multilayer shell has a micro-textured outer surface.

### Claim 4 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the flexible multilayer shell has a thickness of about 0.008 in to about 0.030 in.

### Claim 5 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the flexible multilayer shell includes at least one low diffusion barrier layer.

### Claim 6 (depends on 5)

The gravity sensitive silicone breast implant of claim 5, 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 silicone gel through the low diffusion barrier layer.

### Claim 7 (depends on 5)

The gravity sensitive silicone breast implant of claim 5, wherein the low diffusion barrier layer comprises a polydimethylsiloxane backbone having at least 10 mole percent of a pendant chemical group comprising at least one of a phenyl group and a fluorine group.

### Claim 8 (depends on 5)

The gravity sensitive silicone breast implant of claim 5, wherein the low diffusion barrier layer comprises a polydimethylsiloxane backbone having at least 10 mole percent of a pendant chemical group comprising at least one of a diphenyl group, a methylphenyl group, a trifluoropropyl group, and mixtures thereof.

### Claim 9 (depends on 5)

The gravity sensitive silicone breast implant of claim 5, wherein the low diffusion barrier layer has a color.

### Claim 10 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the implant has a round base.

### Claim 11 (depends on 1)

The gravity sensitive silicone breast implant of claim 1, wherein the implant has an oval base.