Colorectal Anastomosis Suture/Staple Line Sealing

描述（由申请人提供）：对于出现穿透性创伤、结直肠癌和炎症性肠病的患者，通常需要结肠或直肠手术。虽然多年来外科技术的进步改善了结直肠吻合术的结果，但可能发生的最严重和危及生命的并发症之一是吻合口漏，发生率高达20%，死亡率在6%至22%之间。因结肠吻合口漏而出现术后并发症的患者再次住院的费用平均至少为14,000美元。

DESCRIPTION (provided by applicant): 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.