Porous materials, methods of making and uses

• US 9,138,309 B2
• Filed: 09/24/2012
• Issued: 09/22/2015
• Est. Priority Date: 02/05/2010
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Liu, Futian, Manesis, Nicholas J., Goraltchouk, Alexei, Stroumpoulis, Dimitrios
• Primary Examiner(s): DANIELS, MATTHEW J
• Application Number:
  US13/625,159
• Publication Number:
  US 20130023987A1
• Time in Patent Office: 1,093 Days
• Field of Search: 264/305, 264/307
• US Class Current: 1/1
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: B05D 2400/00 Indexing scheme for single layers or multilayers
• CPC Class Codes: B05D 2518/00 Other type of polymers
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

The present specification discloses porous materials, methods of forming such porous materials, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.

Claims

1. A method for forming a textured implant shell, the method comprising the steps of:

(a) coating a base shell with a first layer of an elastomer, the elastomer comprising a silicone base and a solvent;

(b) applying porogens to the first layer of elastomer to form a first porogen-coated elastomer layer;

(c) applying a second layer of the elastomer to the first porogen-coated elastomer layer;

(d) applying porogens to the second layer of elastomer to form a second porogen-coated elastomer layer;

(f) applying a third layer of the elastomer to the second porogen-coated elastomer layer to thereby form a multilayered porogen/elastomer coating on the base shell;

(g) treating the multilayered porogen/elastomer coating on the base shell such that during the treatment the porogens become fused to one another while the uncured elastomer layers become cured, thereby forming a fused porogen scaffold surrounded by cured elastomer; and

(h) removing the porogen scaffold from the cured elastomer, wherein the removing the porogen scaffold results in an interconnected open-cell textured implant shell;

wherein the porogens comprise PLGA.

2. The method of claim 1, wherein the porogens comprise a material having a melting temperature (Tm) from about 30°

C. to about 100°

C.

3. The method of claim 1 wherein the step of treating the multilayered porogen/elastomer coating by subjecting the multilayered porogen/elastomer coating to heat in the range of about 110°

C. to about 135°

C. for about 60 minutes to about 90 minutes.

4. The method of claim 1 wherein the porogens are porogens having a mean particle diameter of between about 300 μ

m to about 600 μ

m.

5. The method of claim 1 wherein the porogens are porogens having a mean particle diameter of about 400 μ

m to about 500 μ

m.

6. A method for forming a breast implant with porous material, the method comprising the steps of:

(a) coating a breast implant shell with an uncured elastomer base to form an elastomer coated breast implant shell wherein the uncured elastomer base comprises a silicon-based elastomer and a solvent;

(b) devolitalizing the solvent;

(c) coating the elastomer coated breast implant shell with porogens to form an elastomer coated porogen mixture;

(d) devolitalizing the solvent;

(e) repeating step (a);

(f) devolitalizing the solvent;

(g) repeating step (c);

(h) devolitalizing the solvent;

(i) repeating step (a);

(j) devolitalizing the solvent;

(k) repeating step (c);

(l) devolitalizing the solvent;

(m) treating the elastomer coated porogen mixture such that the porogens are fused to form a porogen scaffold and the uncured elastomer base is cured; and

(n) removing the porogen scaffold, wherein the removing the porogen scaffold results in the breast implant with porous material;

wherein the porogens comprise PLGA.

7. The method of claim 6, wherein steps (a)-(l) are conducted at about 20°

C. to about 25°

C., and step (m) is conducted in the range of about 110°

C. to about 135°

C. for about 60 minutes to about 90 minutes.

8. The method of claim 6, wherein step (m) is conducted at 126°

C. for 85 minutes.

9. The method of claim 6, wherein step (b) is for about 18 minutes to about 22 minutes.

10. The method of claim 6, wherein step (d), step (f) and/or step (j) is for about 3 minutes to about 6 minutes.

11. The method of claim 6, wherein step (h) is for about 25 minutes to about 35 minutes.

12. The method of claim 6, wherein step (l) is for at least 45 minutes.