Colorectal Anastomosis Suture/Staple Line Sealing

结直肠吻合缝合/缝合线密封

• 批准号: 6791827
• 负责人: Kevin Marchitto
• 金额: $ 13.14万
• 依托单位: ROCKY MOUNTAIN BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2005-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6791827
• 关键词: animal tissue; biomaterial development /preparation; colon surgery; surgery material /equipment; surgical wound; technology /technique development; wound healing

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.

描述（由申请人提供）：在患有穿透性创伤，结直肠癌和炎症性肠病的患者中通常需要进行结肠或直肠手术。尽管多年来，手术技术的进步已经改善了结直肠吻合的预后，但可能发生的最严重和危及生命的并发症之一是吻合式泄漏，其发生率高达20％，与6％至22％的死亡率相关。因结肠吻合泄漏引起的术后并发症的患者的重新住院，费用至少为14,000美元。 Rocky Mountain Biosystems，Inc。及其合作伙伴Rose Biomedical Development Corporation提出了开发和测试新技术，以允许外科医生密封结直肠吻合的主食线索，以确保持久的防漏粘合。该技术通过电感加热蛋白质融合化合物而起作用，该化合物会在冷却时影响组织键。虽然该设备最初将用于密封主食线，但从长远来看，它正在开发以取代主食和缝合线。 在第一阶段，使用现有的电源和现有融合配方的修改，将设计并系统地测试新的涂抹器，以确认其符合设计规格。最后，将通过密封前体内结肠吻合的主食来测试该过程，目的是实现降低的泄漏速率，同时不损害组织爆发和拉伸强度。