Controlled porosity 3-D fabric breast prosthesis

• US 6,432,138 B1
• Filed: 03/07/2000
• Issued: 08/13/2002
• Est. Priority Date: 03/07/2000
• Status: Expired due to Fees

• Current Assignee: ProMatrix Inc.
• Original Assignee: ProMatrix Inc.
• Inventors: Koch, Durmus, Offray, Denise Ann, Mortensen, John
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/521,081
• Time in Patent Office: 889 Days
• Field of Search: 623/7, 623/8
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants

Abstract

A biocompatable nonbiodegradable breast prosthesis comprises a generally conical shell filled with a resilient mass comprised of a multiplicity of layers of resiliently compressible fabric. The shell fabric provides a pore size in the range of from about 2 to 15 microns, 5 microns being preferred.

The filler fabric layers define a void content from 70 to 90% or more and are resilient when subjected to compressive forces in both wet and dry conditions. The layers preferably are a honeycomb weave and are formed of monofilament yarns.

Claims

1. A biocompatible breast prosthesis implant comprising a fabric shell in the general configuration of a cone and having a base and an apex, a plurality of fabric layers in mutually engaging stacked array within said shell, the perimeters of said layers being disposed proximate interior surfaces of said shell, the transverse dimension of said layers becoming progressively smaller in the direction of said apex, said layers being comprised of monofilament yarns formed into a resilient 3-D fabric and said shell being porous, the pore size of said shell being in the range of, about 2 to 15 microns.

2. The implant of claim 1 wherein the void volume within said shell is from about 70 to 90% of the total enclosed volume of said shell.

3. An implant in accordance with claim 2 wherein said implant may be compressed to a third or more of its initial unstressed volume and will return to its initial configuration responsive to removal of said stress under wet and dry conditions.

4. A bio compatible non-biodegradable breast prosthesis comprising a generally conical shell, a resilient filler within said shell, said shell comprising a pervious fabric having pore size of from about 2 to 15 microns, said filler comprising a plurality of stacked mutually engaging layers of 3-D fabric, said 3-D fabric comprising a monofilament, said filler providing a void content of at least about 80%.

5. A prosthesis in accordance with claim 4 wherein said stacked layers of 3-D fabric are in the general configuration of a cone, said stack characterized in that the same will return to its unstressed shape following application and release of compressive forces which reduce the height of said cone to one eighth of its unstressed height under wet or dry conditions.

6. A prosthesis in accordance with claim 4 wherein the engaging surfaces of adjacent said layers are partially internested whereby relative lateral movement of adjacent layers is impeded.

7. A bio compatible non-biodegradable breast prosthesis comprising a generally conical shell, a resilient filler within said shell, said shell comprising a pervious fabric having a pore size of about 5 microns, said filler comprising a plurality of stacked 3-D fabric layers, said stacked layers including edge portions engaging the interior of said shell, said 3-D fabric comprising a monofilament in a honeycomb weave, said filler providing a void content of at least about 80%.