(Dr. David Ku, advisor)

"Design Verification for Tissue Engineered Vascular Grafts"

Abstract

A shortage of adequate vascular grafts limits the surgical treatment of coronary artery disease.  Various new vascular grafts, such as tissue engineered vascular grafts (TEVG), are being developed to meet this challenge.  Mechanical strength and physiologic functions are important parameters in evaluating TEVG.  Some of these attributes may be evaluated with less expensive bench-top methods before proceeding to in vivo testing.  Currently, there is no set of standard tests available for evaluation of TEVG.

In this study, eight bench-top tests were developed for evaluation of TEVG.  Baseline data on normal carotid arteries were obtained for validation of the eight tests, and also for comparison with TEVG.  Minimum standards for TEVG were established from data on natural arteries, such as compliance of at least 1 MPa-1 at a lumen pressure of 13.3 kPa (100 mmHg), burst pressure of at least 413.7 kPa (3108 mmHg), and suture retention strength of at least 3.7 N.  The results validated that the bench-top tests developed in this study can be used as standard tests for evaluating TEVG, and the data obtained from natural arteries can serve as a baseline for comparison.  Bench-top verification test results may be useful for design optimization studies, and may also serve as data in support of an FDA submission.