TEXTURED PROSTHESIS WITH REDUCED CAPSULAR CONTRACTURE RESPONSE

• US 20140005783A1
• Filed: 06/20/2013
• Published: 01/02/2014
• Est. Priority Date: 06/29/2012
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Van Epps, Dennis E., Nofrey, Barbara, Thompson, Jordan
• Application Number:
  US13/923,227
• Publication Number:
  US 20140005783A1
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• 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: C08L 83/04 Polysiloxanes

Abstract

Biocompatible materials are provided which include various textured surfaces, which when such materials are implanted in a human being, for example, as a component of a breast prosthesis, provide for tissue integration, reduce the linear alignment of collagen fibers around the implant and reduce or eliminate the potential for capsular contracture.

Claims

1. A non-resorbable, open cell material that, when an identical material is implanted subcutaneously in a Sprague Dawley rat using standard procedures, periprosthetic tissue forms adjacent the material, and at least six weeks following the subcutaneous implantation, the periprosthetic tissue has a characteristic that at least 22% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

2. The material of claim 1 wherein said periprosthetic tissue, at the period of time of about six weeks from the implanting step, has the characteristic that at least 25% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

3. The material of claim 1 wherein said periprosthetic tissue, at the period of time of about six weeks from the implanting step, has the characteristic that at least 50% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

4. The material of claim 1 wherein said periprosthetic tissue, at the period of time of about six weeks from the implanting step, has the characteristic that at least 56% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

5. A soft implant comprising the material of claim 1.

6. A breast implant comprising the material of claim 1.

11. The material of claim 1 made substantially entirely of elastomeric silicone.

13. The material of claim 1 having an average pore size of between about 200 microns and about 600 microns.

14. The material of claim 1 having an average pore size of between about 300 microns and about 550 microns.

15. The material of claim 1 having an average pore size of about 450 microns.

16. The material of claim 1 wherein the material is a porous elastomeric silicone having an average pore size of about 470 microns.

21. A breast implant comprising an outer surface consisting of the material of claim 1.

7. An open cell material that, when implanted subcutaneously in a Sprague Dawley rat using standard procedures, periprosthetic tissue forms adjacent the material, and at least six weeks following the subcutaneous implantation, the periprosthetic tissue has an adherence force of at least 6 Newtons.

8. The material of claim 7 wherein said periprosthetic tissue, at the period of time of about six weeks from the implanting step, has the further characteristic that at least 56% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

9. A soft implant comprising the material of claim 7.

10. A breast implant comprising the material of claim 7.

12. The material of claim 7 made substantially entirely of elastomeric silicone.

17. A material useful as a component of a mammary prosthesis:

the material being non-bioresorbable and comprising a textured surface having an open cell structure with an average pore size of between about 300 microns to about 550 microns, and

wherein, when an identical material is implanted subcutaneously in a Sprague Dawley rat using standard procedures, periprosthetic tissue forms adjacent the material, and at least six weeks following the subcutaneous implantation, the periprosthetic tissue has a characteristic that at least 22% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

18. A material useful as a component of a mammary prosthesis,

the material comprising a textured surface having an open cell structure with an average pore size of between about 300 microns to about 550 microns, and

wherein, when implanted subcutaneously in a Sprague Dawley rat using standard procedures, periprosthetic tissue forms adjacent the material, and at least six weeks following the subcutaneous implantation, the periprosthetic tissue has an adhesion force of at least 6 Newtons.

19. The material of claim 18 wherein said periprosthetic tissue, at the period of time of about six weeks from the implanting step, has the further characteristic that at least 56% of collagen fibers of the periprosthetic tissue are non-aligned with respect to a major planar surface defined by the material.

20. The material of claim 18 wherein the material is a porous elastomeric silicone.

22. A breast implant comprising an outer surface consisting of the material of claim 18.