Materials for soft and hard tissue repair

Abstract

Biomaterials and methods and uses for repair or augmentation of tissues are provided. In particular, the invention provides a multi-layered, naturally occurring multi-axial oriented biomaterial comprising predominately type I collagen fibers. The invention further provides methods and uses for repair or augmentation of tissues using biomaterials of the invention.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of priority Application Ser. No. 61 / 446,956, filed on Feb. 25, 2011, and Application Ser. No. 61 / 515,803, filed on Aug. 5, 2011, both of which applications are expressly incorporated herein by reference in their entirety.FIELD[0002]The invention relates to biomaterials and methods and uses for tissue repair or augmentation.INTRODUCTION[0003]Collagen rich, naturally derived tissue has been used to repair hernias and large abdominal wall defects for many years. The use of autologous human fascia lata to repair hernia defects was reported by Kirschner in 1913. Fascia lata, a dense layer of collagen rich connective tissue, was taken from a donor site on the lateral (outside) aspect of the thigh along with the accompanying blood vessels, and transplanted to the defect. This type transplant, with the patient being both the donor and recipient, is known as an autologous transplant. If there are no blood vessel...

AI Technical Summary

Problems solved by technology

A major disadvantage to this type of procedure however, in addition to the large surgical procedure required to harvest the tissue, is the risk donor site morbidity such as lateral knee instability.

Indeed, studies indicate that this procedure has a high post operative complication rate in the range of 10% to 40%.

One possible reason for the failure in this technique is that autologous tissues, especially if not vascularized, can be readily resorbed.

These products are not without their problems, which include infection, scar formation and pain, adhesion formation with viscera leading to bowel obstruction and fistula.

These problems have lead to the development of a variety of synthetic and biologic materials for repair of soft tissue defects, weaknesses, hernias or inadequacies.

The drawbacks associated with the synthetic meshes (both heavyweight and lightweight) have lead to the development of “biologic” meshes.

However, once in widespread use, the biologics have been shown to have their own drawbacks: namely laxity and recurrence of hernia over time.

Over the past few years, the problems with these materials have become apparent and re-operation for secondary repair has been required in some cases.

While CST may be used alone to achieve closure, it also may be used in conjunction with synthetic or natural prosthetic patch materials to not only increase the ability to close large defects, but also to reduce tension on the closure, leading to decreased risk for recurrence.

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