Biomaterials with enhanced properties and devices made therefrom

摘要

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.

主权项

1. A method to process calf pericardium tissue for human implantation comprising:
excising a portion of calf pericardium tissue from an animal less than 12 months old, sizing the tissue to be fashioned into a construct for implantation in a human patient, testing the tissue to measure an elastin content of greater than 326 micrograms per milligram dry weight, testing the tissue to measure a ratio of hydroxyproline to proline greater than 1.0, selecting tissue portions having the elastin content greater than 326 micrograms per milligram dry weight and the ratio of hydroxyproline to proline greater than 1.0 for use in human implantation as a dural patch or component of a prosthetic heart valve, and wherein the selected tissue portions are chemically treated to synthetically cross-link amino acid residues in the tissue portions to reduce immunogenicity.