Breast prosthesis with improved biocompatibility and method of making the same

• US 4,772,284 A
• Filed: 03/27/1986
• Issued: 09/20/1988
• Est. Priority Date: 03/27/1986
• Status: Expired due to Term

• Current Assignee: Isotis Orthobiologics, Inc. (Orthofix Medical Inc.)
• Original Assignee: Collagenix Corporation
• Inventors: Jefferies, Steven R., Spence, Robert J.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/845,125
• Time in Patent Office: 908 Days
• Field of Search: 623/4-8, 623/66, 128/DIG. 8
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 77/04 Polyamides derived from alpha-amino carboxylic acids C08L77/10 takes precedence
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10S 128/08 Collagen

Abstract

A single lumen implantable and biocompatible breast prosthesis composed of an outer membrane of silastic, medical grade silicone, and an inner filling material selected from the group consisting of purified reconstituted collagen gel and a purified gel of poly-alpha amino acid homopolymers or random copolymers having a molecular weight of from 5,000 to 400,000. The purified reconstituted collagen gel has a collagen concentration of from 20 to 100 milligrams per milliliter of gel.

Claims

1. A single lumen biocompatible implantable breast prosthesis composed of an outer membrane of silastic, medical-grade silicone, and an inner filling material selected from the group consisting of (a) purified, reconstituted collagen gel, wherein said collagen has a concentration of from 20 to 100 milligrams per millimeter of gel, and (b) a purified gel of poly-alpha amino acid homopolymers or random copolymers having a molecular weight of from 5,000 to 400,000 whereby the outer membrane, when filled with the inner filling material takes on the configuration of a natural human female breast.

2. The prosthesis of claim 1, wherein said collagen gel is crosslinked with glutaraldehyde or hemamethylene diisocyanate at a concentration of from 0.005% to 5% by volume.

3. The prosthesis of claim 1, wherein the gel in (b) is crosslined with a chemical crosslinking agent.