EB matrix production from fetal tissues and its use for tissue repair

Abstract

A method of forming and preserving a bioremodelable, biopolymer scaffold material by subjecting animal tissue to chemical and mechanical processing. In addition to skin tissue, another source of EBM is a blood vessel. EBM may be used for hernia repair, colon, rectal, vaginal and or urethral prolapse treatment; pelvic floor reconstruction; muscle flap reinforcement; lung tissue support; rotator cuff repair or replacement; periosteum replacement; dura repair; pericardial membrane repair; soft tissue augmentation; intervertebral disk repair; and periodontal repair. EBM may also be used as a urethral sling, laminectomy barrier or spinal fusion device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part application of U.S. application Ser. No. 09 / 871,518, filed May 31, 2001, the entire contents of which are herein incorporated by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to the field of tissue engineering, and in particular to animal-derived, bioremodelable, biopolymer scaffold materials used to repair animal tissue. The term “bioremodelable” or “bioremodelability” refers to a material that lends itself to the breakdown by cells that occupy it and use it as a template for creating a replacement made up mainly of newly synthesized components secreted by the cells. [0004] Rebuilding the human body is a significant industry. Human tissue banks and synthetic polymers do not meet the need for repair or replacement of body parts. High on the list of alternative sources of material used to meet this need are animal tissues prepared in new way...

AI Technical Summary

Benefits of technology

[0011] EBM is a bioremodelable, biopolymer scaffold material derived from fetal, neo-natal or post-natal animal tissue. EBM is processed in a way that preserves its tissue strength without reducing its intrinsic biological properties or compromising the ability of cells that occupy the tissue to remodel it.

[0012] Upon processing EBM, binding sites for cells and cell-secreted products that make up the extracellular matrix surrounding cells that occupy it are preserved. Undesirable tissue components of EBM (e.g., DNA, RNA) are solubilized and expressed mechanically from the tissue, and delipidyzing organic solvents are used to reduce the presence of cell and nuclear membranes.

Problems solved by technology

However, aldehydic processing effectively destroys any biological activity, such as cell binding sites, associated with the original tissue and greatly reduces or eliminates the ability of cells to attach to it.

Collagen-based devices that are animal-derived and fixed with glutaraldehyde or a similar agent can not be remodeled since they are highly resistant to metalloproteinase enzymes.

The methods suggested in U.S. Pat. No. 4,801,299 and U.S. Pat. No. 5,916,265 include the use of glutaraldehyde or a similar agent for the fixation of tissue derived from a post-natal animal source; the resulting products can not be faithfully remodeled.