Biomaterials with enhanced properties and devices made therefrom

Abstract

Biomaterials with enhanced properties such as improved strength, flexibility, durability and reduced thickness are useful in the fabrication of biomedical devices, particularly those subjected to continuous or non-continuous loads where repeated flexibility and long-term durability are required. These enhanced properties can be attributed to elevated levels of elastin, altered collagen types, and other biochemical changes which contribute to these enhanced properties. Examples of devices which would be improved by use of such tissue include heart valves, including percutaneous heart valves, and vascular grafts, patches and the like. Such enhanced materials can be sourced from specific populations of animals, such as neonatal calves, or in range-fed adult cattle, or can be fabricated or created from cell populations exhibiting such properties. In one embodiment, glutaraldehyde-fixed neonatal pericardial tissue is used to create leaflets in a percutaneous heart valve, and may be used without chemical fixation, with or without processes to remove residual cellular membranes, and utilized as a scaffold material for tissue engineering.

Description

[0001]This application claims the benefit of PCT application No. PCT / US2011 / 049027 filed Aug. 24, 2011, which claims the benefit of U.S. Provisional Application No. 61 / 376,627 filed Aug. 24, 2010, which applications are incorporated herein by reference.FIELD[0002]The subject matter described herein relates generally to new biomaterials with enhanced properties, such as improved strength, flexibility, durability and reduced thickness, where these enhanced properties enable the creation of new and improved medical devices, such as small-profile percutaneous heart valves, thin, flexible patches for repair, and tissue engineering scaffolds with enhanced elasticity and durability. These enhanced properties are due to compositional differences between the embodiments described herein and the prior art, including elevated elastin levels, altered collagen types, and other biochemical differences which contribute to enhanced strength, flexibility, durability and reduced thickness.BACKGROUND[...

AI Technical Summary

Benefits of technology

The patent text describes a new biomaterial that can be used to create improved medical devices. These materials have enhanced strength, durability, flexibility, and reduced thickness, which can be achieved by identifying and selecting tissues with elevated elastin content. The elastin-rich tissues can be crosslinked and sterilized for use in various medical applications. The new biomaterials can be fabricated from natural sources of tissue or in the laboratory. The use of these materials can lead to reduced fatigue-related failure, better durability, and improved healing and reduced scar formation compared to current devices. The patent also discusses the use of altered collagen types and reduced crosslinking to further enhance the properties of the biomaterials.

Problems solved by technology

As these tissues are composed primarily of collagen, the degradation of collagen with time is the primary mode of failure.

The authors summarize that mechanical stresses initiate calcification by damaging the structural integrity of the leaflet tissue.

While the industry has focused on modification of designs as a means to reduce stresses on the tissue, and chemical treatments to inhibit calcification, no one has examined the possibility of reducing functional stresses through special selection of tissue properties and combinations throughout.

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