The unique product described in this proposal has the potential to greatly improve the current procedures used to obtain hemostasis and control trauma during invasive surgery. It is estimated that by 1998 there will be in excess of 1.5 million surgical procedures that will use some type of hemostatic device. Currently, there are no products on the market that adequately address all the surgeon's needs. The major complaint is that present devices cannot be effectively sutured or stapled in place. This is due to the low tensile strength and poor tear resistance of the materials. It is the objective of this program to prepare bioresorbable laminated structures that can be sutured in place and provide a high degree of support to traumatized organs and tissues. The program will involve an initial screening of bioresorbable polymers as well as a preliminary investigation into the best methods of attaching the reinforcing polymer film to the rather delicate collagen hemostat. Once this screening process is completed the best candidates will be tested in vivo under surgical conditions. If the Phase I study is funded, Kensey Nash Corporation will be able to move to Phase II which will include an evaluation of polymer structures and collagen pore sizes (lyophilization technique) relative to the overall tensile strength of the device.
