Processes for making porous implantable materials

• US 8,697,763 B2
• Filed: 03/27/2013
• Issued: 04/15/2014
• Est. Priority Date: 01/28/2010
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Goraltchouk, Alexei, Thompson, Jordan, Van Epps, Dennis
• Primary Examiner(s): Gulakowski, Randy
• Assistant Examiner(s): WALES, CHRISTINA H
• Application Number:
  US13/851,877
• Publication Number:
  US 20130209661A1
• Time in Patent Office: 384 Days
• Field of Search: 521/62, 508/208, 508/209, 508/211, 508/214
• US Class Current: 521/86
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B32B 5/16 characterised by features of a layer formed of particles, e.g. chips, powder or granules layer formed of natural mineral particles B32B19/00; layer being formed of wood fibres, chips or particles B32B21/02
• CPC Class Codes: B32B 5/18 characterised by features of a layer of foamed material
• CPC Class Codes: C08J 2201/046 Elimination of a polymeric phase
• CPC Class Codes: C08J 2201/0502 the liquid phase being organic
• CPC Class Codes: C08J 2205/05 Open cells, i.e. more than 50% of the pores are open
• CPC Class Codes: C08J 2207/10 Medical applications, e.g. biocompatible scaffolds
• CPC Class Codes: C08J 2383/04 Polysiloxanes
• CPC Class Codes: C08J 9/26 by elimination of a solid phase from a macromolecular composition or article, e.g. leaching out
• CPC Class Codes: C08J 9/28 by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/249921 Web or sheet containing structurally defined element or component
• CPC Class Codes: Y10T 428/268 Monolayer with structurally defined element

Abstract

Described herein are methods of making open celled foams including a matrix of interconnected spheres. The open celled foams are silicone based materials and can be used to coat implants, such as breast implants, and function to encourage tissue ingrowth and reduce capsular formation.

Claims

1. A process for forming an open celled foam suitable for implantation, the process comprising the steps of:

combining a first composition comprising a first organic solvent and at least one extractable agent, and a second composition comprising a second organic solvent and at least one silicone matrix agent thereby forming a mixture, wherein said at least one matrix agent is less than about 40% of said mixture;

agitating said mixture thereby forming an emulsion; and

curing said emulsion thereby forming said open celled foam including a matrix of interconnected spheres;

wherein said silicone matrix agent is a high temperature vulcanizing (HTV) silicone.

2. The process according to claim 1 wherein said matrix of interconnected spheres has a theoretical void space of about 50% to about 99%.

3. The process according to claim 1 wherein said matrix of interconnected spheres has a physical void space of about 50% to about 70%.

4. The process according to claim 1 wherein said first organic solvent and said second organic solvent are selected from the group consisting of dichloromethane, water, xylene, acetone, methanol, methyl acetate, hexane, benzene toluene, and isopropyl alcohol.

5. The process according to claim 1 wherein said at least one extractable agent is a polymer selected from the group consisting of poly siloxane, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, and combinations thereof.

6. The process according to claim 1 wherein said curing step further comprises heating said emulsion.

7. The process according to claim 1 further comprising the step of casting said emulsion before said curing step.

8. The process according to claim 1 further comprising the step of dipping an implant into said emulsion before said curing step.

9. A process for forming an open celled foam suitable for implantation, the process comprising the steps of:

combining a first composition comprising a first organic solvent and at least one extractable agent, and a second composition comprising a second organic solvent and at least one silicone matrix agent thereby forming a mixture, wherein said at least one matrix agent is less than about 40% of said mixture;

agitating said mixture thereby forming an emulsion; and

curing said emulsion thereby forming said open celled foam including a matrix of interconnected spheres;

wherein said at least one extractable agent is a polymer selected from the group consisting of poly siloxane, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, and combinations thereof.

10. The process according to claim 9 wherein said matrix of interconnected spheres has a theoretical void space of about 50% to about 99%.

11. The process according to claim 9 wherein said matrix of interconnected spheres has a physical void space of about 50% to about 70%.

12. The process according to claim 9 wherein said first organic solvent and said second organic solvent are selected from the group consisting of dichloromethane, water, xylene, acetone, methanol, methyl acetate, hexane, benzene toluene, and isopropyl alcohol.

13. The process according to claim 9 wherein said silicone matrix agent is a room temperature vulcanizing silicone (RTV).

14. The process according to claim 9 wherein said curing step further comprises heating said emulsion.

15. The process according to claim 9 further comprising the step of casting said emulsion before said curing step.

16. The process according to claim 9 further comprising the step of dipping an implant into said emulsion before said curing step.

17. A process for forming an open celled foam suitable for implantation, the process comprising the steps of:

combining a first composition comprising a first organic solvent and at least one extractable agent, and a second composition comprising a second organic solvent and at least one silicone matrix agent thereby forming a mixture, wherein said at least one matrix agent is less than about 40% of said mixture;

agitating said mixture thereby forming an emulsion;

curing said emulsion thereby forming said open celled foam including a matrix of interconnected spheres; and

dipping an implant into said emulsion before said curing step.

18. The process according to claim 17 wherein said matrix of interconnected spheres has a theoretical void space of about 50% to about 99%.

19. The process according to claim 17 wherein said matrix of interconnected spheres has a physical void space of about 50% to about 70%.

20. The process according to claim 17 wherein said first organic solvent and said second organic solvent are selected from the group consisting of dichloromethane, water, xylene, acetone, methanol, methyl acetate, hexane, benzene toluene, and isopropyl alcohol.

21. The process according to claim 17 wherein said silicone matrix agent is a room temperature vulcanizing silicone (RTV).

22. The process according to claim 17 wherein said curing step further comprises heating said emulsion.