Colorectal Anastomosis Suture/Staple Line Sealing

描述（由申请人提供）：患有穿透性创伤、结直肠癌和炎症性肠病的患者通常需要进行结肠或直肠手术。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，其发生率高达20%，并且与6%至22%的死亡率相关。因结肠吻合口瘘而出现术后并发症的患者再住院平均费用至少为14，000美元。 落基山生物系统公司，和它的合作伙伴Rose生物医学发展公司，提议开发和测试一种新技术，使外科医生能够密封结直肠吻合吻合钉线，以确保持久的防漏粘合。该技术通过感应加热蛋白质融合化合物来工作，其在冷却时影响组织粘合。虽然该器械最初将用于密封缝钉线，但从长远来看，它将被开发用于替代斯台普斯和缝线。 在第一阶段，使用现有的电源和现有融合配方的修改，将设计一种新的施用器并进行系统测试，以确认其符合设计规范。最后，将通过密封离体结肠息肉的缝钉线对手术进行测试，目的是降低泄漏率，同时不影响组织爆破和拉伸强度。

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.