Implantable prosthesis with open cell textured surface and method for forming same

• US 5,545,220 A
• Filed: 11/04/1993
• Issued: 08/13/1996
• Est. Priority Date: 11/04/1993
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Lipomatrix, Inc.
• Inventors: Nelson, David, Novy, Richard W., Andrews, Winston A.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/147,737
• Time in Patent Office: 1,013 Days
• Field of Search: 623/7, 623/8, 623/11, 623/12, 623/16, 623/66, 427/2.24, 427/202, 427/205, 427/224, 427/245, 427/264, 427/387, 427/412.1
• US Class Current: 623/8
• 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 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08J 2201/044 Elimination of an inorganic solid phase
• CPC Class Codes: C08J 2203/02 CO2-releasing, e.g. NaHCO3 and citric acid
• 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: C08L 83/04 Polysiloxanes

Abstract

A method for forming an open cell texturized surface in a silicone elastomer layer of a breast implant, or other medical implant, is created by forming a layer of uncured silicone elastomer, applying a coating of particles to the surface thereof, and curing the layer by heating it at an elevated temperature which also volatilizes the particles such that their constituent gases boil through the surface of the layer and create the texturing.

Claims

1. A method for forming a layer of silicone elastomer with an open cell structure, said method comprising the steps of:

forming a layer of silicone elastomer, said layer having a tacky surface;

applying a coating of particles to said surface; and

volatilizing said particles as said layer is cured, said particles thereby producing products of volatilization which render said surface into an open cell structure as said layer is cured.

2. The method of claim 1 wherein the step of volatilizing includes the step of curing said layer by heating.

3. The method of claim 2 wherein said curing step includes the step of heating said layer at about 150°

C. for about 120 minutes.

4. The method of claim 1 wherein the particles are made of ammonium carbonate.

5. The method of claim 4 wherein said particles are between about 350 microns and about 800 microns in diameter.

6. The method of claim 1 wherein the forming step includes the step of dipping a surface into a silicone elastomer dispersion.

7. The method of claim 1 wherein said layer is a laminate of at least two layers, one of said layers being a base layer and the other of said layers being a barrier layer, and the method is applied to the base layer to thereby apply an open cell structure thereto.

8. The method of claim 1 wherein said method creates open cells ranging from about 300 microns to about 900 microns in diameter and with a depth from about 250 microns to about 900 microns.

9. The method of claim 1 wherein said elastomer is a shell for an implantable prosthesis, and said method is applied to the exterior surface of said prosthesis.

10. A method for forming a layer of silicone elastomer with an open cell structure, said method comprising the steps of:

forming a layer of silicone elastomer, said layer having a tacky surface;

applying a coating of particles to said surface; and

curing said layer to thereby volatilize the particles and create said open cell structure.

11. The method of claim 10 wherein the curing step includes the step of heating the layer to an elevated temperature for a period of time.

12. The method of claim 11 wherein the applying step includes the step of applying a coating of particles having a temperature of volatilization substantially less than the curing temperature of said layer of elastomer.

13. The method of claim 12 wherein the forming step includes the steps of:

forming a layer of silicone elastomer laminate comprising a barrier layer and a base layer;

cross-linking said base layer; and

dipping the laminate into a silicone elastomer dispersion to thereby form an external layer with a tacky surface.

14. The method of claim 13 wherein the forming step includes the step of evaporating any excess solvent from said external layer.

15. The method of claim 14 wherein the heating step includes heating the layer to a temperature of about 150°

C. for about 120 minutes.

16. A method for making an implantable prosthesis having an external layer of silicone elastomer, at least a portion of which has an open cell structure, said method comprising the steps of:

forming said layer of silicone elastomer, said layer having a tacky surface;

applying a coating of particles to said surface; and

curing said layer to thereby volatilize the particles and create said open cell structure therein.

17. The method of claim 16 wherein the curing step includes the step of heating the layer to an elevated temperature for a period of time.

18. The method of claim 17 wherein the applying step includes the step of applying a coating of particles having a temperature of volatilization substantially less than the curing temperature of said layer of elastomer.

19. The method of claim 18 wherein the forming step includes the steps of:

forming a layer of silicone elastomer laminate comprising a barrier layer and a base layer;

cross-linking said base layer; and

dipping the laminate into a silicone elastomer dispersion to thereby form an external layer with a tacky surface.

20. The method of claim 19 wherein the forming step includes the step of evaporating any excess solvent from said external layer.

21. The method of claim 20 wherein the heating step includes heating the layer to a temperature of about 150°

C. for about 120 minutes.

22. An implantable prosthesis having an external layer of silicone elastomer, said layer of silicone elastomer having an external surface with at least a portion thereof of open cell irregularly shaped structure, said implantable prosthesis being made by the method comprising the steps of:

forming a layer of silicone elastomer, said layer having a tacky surface;

applying a coating of particles to said surface; and

curing said layer to thereby volatilize the particles and create said open cell structure.

23. The implantable prosthesis of claim 22 wherein substantially the entirety of the external surface has an open cell structure.

24. The implantable prosthesis of claim 23 wherein the cells in the open cell structure have a diameter from about 300 microns to about 900 microns, and a depth from about 250 microns to about 900 microns.

25. The implantable prosthesis of claim 24 wherein said implantable prosthesis is a breast implant, said breast implant including a shell filled with a fill material, said shell having said external layer of silicone elastomer.

26. The implantable prosthesis of claim 25 wherein said shell is a laminate comprised of a fluorosilicone barrier layer approximately 0.002 inches thick and a polydimethylsiloxane base approximately 0.012 inches thick, said base layer being partially cross-linked for structural integrity, said base layer forming the exterior surface.

27. A method for forming an open cell structure in an external surface of a medically implantable prosthesis, said method comprising the steps of applying a coating of particles to said surface and volatilizing said particles as said surface is finally cured, said particles thereby producing products of volatilization so that products of said volatilization shape said surface as it cures.