Colorectal Anastomosis Suture/Staple Line Sealing

描述(申请人提供)：穿透性创伤、结直肠癌和炎症性肠病患者通常需要进行结肠或直肠手术。尽管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威胁生命的并发症之一是吻合口漏，发生率高达20%，死亡率在6%到22%之间。对于因结肠吻合口漏而出现术后并发症的患者，再住院的平均费用至少为14,000美元。 洛基山生物系统公司及其合作伙伴Rose Biomedical Development Corporation建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口缝合线，以确保持久的防泄漏粘合。这项技术的工作原理是感应加热蛋白质类融合化合物，在冷却时影响组织粘结。虽然该设备最初将用于密封缝合线，但从长远来看，它正在开发以取代缝合器和缝合线。 在第一阶段，利用现有的电源和对现有聚变配方的改进，将设计一种新的喷涂器，并进行系统测试，以确保其符合设计规格。最后，将通过密封体外结肠吻合口的缝合线来测试该程序，目的是在不影响组织破裂和拉伸强度的情况下实现减少渗漏率。

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.