# US 11,026,775 B2 · Textured surfaces for breast implants

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- Number: US 11,026,775 B2
- Document ID: US11026775B2
- Status: Granted
- Kind: B2
- Application number: 16/784,479
- Filed: 2020-02-07
- Published: 2020-06-18
- Granted: 2021-06-08
- Earliest claimed: 2014-02-17
- Assignees: Establishment Labs S.A.
- Applicants: Establishment Labs S.A.
- Inventors: Ardeshir Bayat; Ernie Hill; Daniel Kyle; Antonios Oikonomou
- Web page: https://patentgrep.com/patent/US11026775B2

## CPC

- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/12: Mammary prostheses
- G03F 7/0037: {Production of three-dimensional images}
- H01J 37/3056: {for microworking, e. g. etching of gratings or trimming of electrical components}
- A61F 2002/0081: {directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence)}
- A61F 2002/0086: {for preferentially controlling or promoting the growth of specific types of cells or tissues}
- A61F 2240/004: Using a positive or negative model, e.g. moulds
- B29C 64/112: using individual droplets, e.g. from jetting heads
- B29K 2083/00: Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
- B29L 2031/7532: {Artificial members, protheses}
- B33Y 10/00: Processes of additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- H01J 2237/3174: Etching microareas
- 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)
- G03F: PHOTOMECHANICAL PRODUCTION OF TEXTURED OR PATTERNED SURFACES, e.g. FOR PRINTING, FOR PROCESSING OF SEMICONDUCTOR DEVICES; MATERIALS THEREFOR; ORIGINALS THEREFOR; APPARATUS SPECIALLY ADAPTED THEREFOR; (phototypographic composing devices B41B; photosensitive materials or processes for photographic purposes G03C; electrophotography, sensitive layers or processes therefor G03G)
- H01J: ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS (spark-gaps H01T; electric arc lamps H05B31/00; particle accelerators H05H)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## 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.

## Claims

### Claim 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 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.

### Claim 2 (depends on 1)

The breast implant of claim 1, wherein a maximum peak height to trough depth Sz value of the surface at an area scale of 1 mm×1 mm ranges from 10 μm to 80 μm.

### Claim 3 (depends on 1)

The breast implant of claim 1, wherein a maximum peak height to trough depth Sz value of the surface at an area scale of 1 mm×1 mm ranges from 10 μm to 80 μm.

### Claim 4 (depends on 1)

The breast implant of claim 1, wherein the mean surface skewness Ssk value ranges from −0.3 to +0.3.

### Claim 5 (depends on 1)

The breast implant of claim 1, wherein the mean excess kurtosis value (Sku minus 3) ranges from −0.5 to +0.5.

### Claim 6 (depends on 1)

The breast implant of claim 1, wherein the biocompatible polymer comprises polydimethylsiloxane.

### Claim 7 (depends on 1)

The breast implant of claim 1, wherein the surface has, at an area scale of 90 μm×90 μm, a mean surface roughness Sa value of from 0.1 μm to 5 μm.

### Claim 8

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.

### Claim 9 (depends on 8)

The breast implant of claim 8, wherein a ratio of average peak height to average trough depth of the surface ranges from 2:3 to 3:2.

### Claim 10 (depends on 8)

The breast implant of claim 8, wherein the mean surface roughness Sa value ranges from 5 μm to 7 μm.

### Claim 11 (depends on 8)

The breast implant of claim 8, wherein a mean surface skewness Ssk value of the surface ranges from −0.4 to +0.4.

### Claim 12 (depends on 8)

The breast implant of claim 8, wherein the surface is an irregular textured surface.

### Claim 13 (depends on 8)

The breast implant of claim 8, wherein the surface forms at least 90% of a total tissue-contacting surface of the breast implant.

### Claim 14 (depends on 8)

The breast implant of claim 8, wherein the biocompatible polymer material is polydimethylsiloxane.

### Claim 15 (depends on 8)

The breast implant of claim 8, wherein the surface has, at an area scale of 90 μm×90 μm, a mean surface roughness Sa value of from 0.1 μm to 5 μm.

### Claim 16

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.

### Claim 17 (depends on 16)

The breast implant of claim 16, wherein the root mean square height Sq value ranges from 5 μm to 10 μm, and wherein the surface has a maximum peak height to trough depth Sz value from 10 μm to 80 μm at an area scale of 1 mm×1 mm.

### Claim 18 (depends on 16)

The breast implant of claim 16, wherein a ratio of average peak height to average trough depth of the surface ranges from 2:3 to 3:2.

### Claim 19 (depends on 16)

The breast implant of claim 16, wherein the surface has, at an area scale of 90 μm×90 μm, a mean surface roughness Sa value of from 0.1 μm to 5 μm.

### Claim 20 (depends on 16)

The breast implant of claim 16, wherein the surface has, at an area scale of 90 μm×90 μm, a mean surface skewness Ssk value of −0.9 to +0.9 and a mean excess kurtosis value (Sku minus 3) of from −1.5 to +1.5.