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

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将使腹腔镜和机器人辅助腹部手术对患者更安全，对医疗保健系统成本更低。 虽然是一种罕见的并发症，但每年进行的1500多万例腹腔镜手术中的意外肠损伤可能对患者造成灾难性的后果，导致住院时间延长，多次矫正手术，终身医疗并发症，以及超过5%的病例死亡。 此外，与这种并发症相关的直接费用可能是巨大的，包括重症监护恢复期和考虑到患者所遭受损害的性质的诉讼的可能性。手术期间肠损伤的术中检测提供了一种简单而优雅的解决方案，可以立即修复并避免负面结果。该项目的商业潜力包括提供超过49，000个手术室和每年7.5亿美元的潜在市场。拟议的创新将大大提高病人的安全性，降低相关的成本矫正护理，并产生来自美国的制造业的收入。这个小企业创新研究（SBIR）第一阶段项目的目的是使术中检测肠损伤，通过识别气体通常隔离到胃肠道的内部。为了实现这一点，这些目标气体必须与背景气体和腹腔镜或机器人手术期间通常存在的其他试剂充分区分。这样的背景试剂提出了有意义的技术挑战，因为它们存在假阳性检测结果的可能性。将完成对所有潜在存在试剂的表征，以便充分区分它们与目标胃肠道气体。将使用高精度气相色谱系统和定制制造的腔室复制手术条件，包括温度、压力、湿度和气体流速，以精确识别和区分所有可能存在的气体。一旦所有潜在的交叉反应气体的特征，物理过滤和算法信号处理的组合将被用来确保正确的区分/识别的气体种类，并避免潜在的假阳性结果。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.