SBIR Phase I: Intraoperative monitoring device to detect bowel injuries during laparoscopic surgical procedures

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力将是使腹腔镜和机器人辅助腹部手术对患者更安全，并降低医疗保健系统的成本。尽管这是一种比较罕见的并发症，但在每年进行的1500多万例腹腔镜手术中，不慎造成的肠道损伤可能会给患者带来灾难性的后果，导致延长住院时间、多次矫正手术、终身医学并发症，甚至在超过5%的病例中死亡。此外，考虑到患者所受损害的性质，与这种并发症相关的直接成本可能是巨大的，包括重症监护康复和潜在的诉讼。术中检测手术中的肠道损伤提供了一种简单而优雅的解决方案，能够立即修复并避免负面结果。该项目的商业潜力包括在49,000多个操作套房中提供服务，以及每年7.5亿美元的潜在市场。这项拟议的创新将显著提高患者的安全性，降低与矫正护理相关的成本，并从美国的制造中产生收入。这项小型企业创新研究(SBIR)第一阶段项目旨在通过识别通常隔离在胃肠道内部的气体来实现术中肠道损伤的检测。要做到这一点，这些目标气体必须与腹腔镜或机器人手术中通常存在的背景气体和其他试剂有足够的区分性。这种背景试剂提出了一个有意义的技术挑战，因为它们存在假阳性检测结果的可能性。所有可能存在的药物的特征将完成，以便它们能够与目标胃肠道气体充分区分。高精度的气相色谱系统和定制的模拟手术条件的气室，包括温度、压力、湿度和气体流速，将被用来准确地识别和区分所有潜在的现有气体。一旦确定了所有潜在的交叉反应气体的特征，将使用物理过滤和算法信号处理相结合的方法来确保正确区分/识别气体种类，并避免潜在的假阳性结果。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to make laparoscopic and robotic assisted abdominal surgery safer for patients, and less costly for the healthcare system. Though a somewhat rare complication, inadvertent bowel injury during the more than 15 million laparoscopic procedures performed annually can be catastrophic for patients resulting in extended hospitalization, multiple corrective surgeries, lifelong medical complications, and, in more than 5% of cases, death. In addition, the direct costs associated with this complication can be substantial including intensive care convalescence and the potential for litigation given the nature of damages suffered by patients. Intraoperative detection of bowel injuries during surgery provides a simple, yet elegant solution enabling immediate repair and avoidance of negative outcomes. This project’s commercial potential includes availability in more than 49,000 operating suites and an addressable market of $750 million per annum. The proposed innovation will significantly enhance patient safety, reduce costs associated of corrective care, and generate revenue from U.S. based manufacturing.This Small Business Innovation Research (SBIR) Phase I project aims to enable intraoperative detection of bowel injuries by identifying gases typically sequestered to the interior of the gastrointestinal tract. To accomplish this, these target gases must be sufficiently differentiable from background gases and other agents typically present during laparoscopic or robotic surgery. Such background agents present a meaningful technical challenge in that they present the potential for false positive detection results. Characterization of all potentially present agents will be completed such that they can be sufficiently differentiated from target gastrointestinal gases. A high precision gas chromatography system and custom fabricated chamber replicating surgical conditions including temperature, pressure, humidity and gas flow rate will be used to precisely identify and distinguish all potentially present gases. Once all potentially cross-reactive gases are characterized, a combination of physical filtration and algorithmic signal processing will be used to ensure proper differentiation/recognition of gas species and avoidance of potential false positive results.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.