Composite Vascular Graft Production System

The Composite Graft Production System fully automates the graft sealing process. The System's hardtware and algorithm control temperature, flow rates and pressure of the protein composites (with or without medication) in the reactive chamber, acquire data from the pressure and temperature sensors, configure the network of pinch valves to establish the appropriate flow direction for different steps of the process, implement the optimal control algorithm, system test and calibration procedures, and provide production quality tracking with hard copy and magnetic history of each production run. The System grants the high production rate for both bifurcated and straight grafts of maximum length with a rejection rate of less than 5%.

The permeability of Bionit2™ and DeBekey™ Soft Woven grafts sealed using our technology (top two figures on the picture) demonstrated very low water permeability under the high pressure. The figure on the bottom of the picture illustrates water permeability of the Microvel with Hemashield™ grafts made by Meadox Co.

These results were published in our paper Kaplan A, Sauvage LR, Kaplan S, Marcoe KF, Mungin D, Wu HD, Walker MW. A new method for measuring permeability of bio-impregnated textile grafts. J Applied Biomaterials 1990; 1:127-136.

Vascular grafts sealed using our process consistently demonstrated good handling characteristics and zero water permeability at pressure more than 200 mm Hg with low production cost.

The handling characteristics of grafts sealed by our method are reported in the paper Patel M, Kaplan A, Sauvage LR, Wu HD, Kaplan S, Usui Y, Walker MW. Comparative evaluation of the elasticity and flexibility of bioimpregnated knitted grafts. Ann Vasc Surg 1992; 6:127-33.

The biocompatibility and toxicity tests were provided on our grafts by an independent organization. Test results confirmed that grafts sealed by our method are biocompatible and nontoxic.

The excelent quality of our grafts has been unequivocally demonstrated by experimental implantation results.