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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/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。虽然这是一种罕见的并发症，但在每年超过1500万例腹腔镜手术中，无意的肠道损伤对患者来说可能是灾难性的，导致延长住院时间、多次矫正手术、终身医疗并发症，在超过5%的病例中，死亡。此外，与这种并发症相关的直接费用可能是巨大的，包括重症监护康复和考虑到患者所遭受损害的性质而可能发生的诉讼。术中检测手术中肠损伤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49,000多个操作套房和每年7.5亿美元的潜在市场。拟议的创新将显著提高患者安全性，降低与矫正护理相关的成本，并从美国制造中产生收入。这项小企业创新研究（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，实现术中肠损伤的检测。要做到这一点，这些目标气体必须与背景气体和其他在腹腔镜或机器人手术中通常存在的物质充分区分。这样的背景剂提出了一个有意义的技术挑战，因为它们有可能出现假阳性检测结果。所有可能存在的试剂的特征将被完成，这样它们就可以与目标胃肠道气体充分区分开来。高精度气相色谱系统和定制制造的可复制手术条件（包括温度、压力、湿度和气体流速）的腔室将用于精确识别和区分所有可能存在的气体。一旦对所有潜在的交叉反应气体进行了表征，将使用物理过滤和算法信号处理相结合的方法来确保气体种类的适当区分/识别，并避免潜在的假阳性结果。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.