Surgery of the colon or rectum is often required in patients presenting with penetrating trauma, colorectal cancer, and inflammatory bowel disease. While advances in surgical techniques have improved outcomes in colorectal anastomosis over the years, one of the most severe and life-threatening complications that can occur is anastomotic leakage, which occurs at a rate ranging up to 20 percent, and which is associated with a mortality rate ranging between 6 and 22 percent. Rehospitalization on patients presenting with post-operative complications due to colonic anastomotic leakage incurred costs averaging at least $14,000. Rocky Mountain Biosystems, Inc., and its partner Rose Biomedical Development Corporation, propose developing and testing a new technology to allow surgeons to seal over a colorectal anastomosis staple line to ensure an enduring leak-proof bond. This technology works by inductively heating a proteinaceous fusion compound, which effects a tissue bond upon cooling. While the device will initially be used to seal staple lines, in the long run it is being developed to replace staples and sutures. In Phase I, using the existing power source and a modification of the existing fusion formulation, a new applicator will be designed and systematically tested to confirm it meets design specifications. Finally, the procedure will be tested by sealing the staple line of ex-vivo colonic anastomoses, with the goal of realizing a reduced leak rate while not compromising the tissue bursting and tensile strength.
