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

SBIR一期项目的更广泛的影响/商业潜力是通过解决机器人辅助和标准腹腔镜手术中最具破坏性和最昂贵的风险——未被发现的肠道穿孔，来提高患者的安全性。每年进行的此类手术超过1500万例，包括子宫切除术、胆囊切除术、疝修补术、前列腺切除术、卵巢切除术等。虽然未被发现的肠穿孔发生率相对较低，为0.3 - 1.0%，但每年有超过4万名患者的后果是严重的，而且照顾这些患者的增量成本很大。在最初的手术中发现无意的肠道穿孔将使外科医生能够在当时进行修复，避免不必要的患者痛苦，数十亿美元的相关费用和5%的死亡率。那些没有死亡的病人经历了多次矫正手术、广泛的抗生素治疗和可能长期的重症监护康复。考虑到患者的安全问题，以及每位患者的矫正治疗成本很容易超过10万美元，因此需要一种低成本的解决方案。拟议的项目将推进肠穿孔术中检测的发展，允许立即修复和避免不良后果。这可以通过检测肠道穿孔时释放的气体并提醒外科医生穿孔的存在来实现。这一创新将适用于美国49,000多套运营套房，并代表着每年7.5亿美元的潜在市场。拟议的SBIR一期项目将推进肠穿孔术中检测的发展，包括：1)与气体种类选择和检测方法/模式相关的实验；2)检测距离的确定与优化；3)制定控制措施，确保不出现假阳性和假阴性结果。提出了台式和体内测试，以确定设备功效的可重复性和可靠性。潜在失效模式影响分析（PFMEA）将用于突出技术风险。该项目还将探索性价比交易空间，在腹腔镜和机器人手术中创造一种新的患者安全措施。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。

This broader impacts/commercial potential of this SBIR Phase I project is to enhance patient safety by addressing the most devastating and costly risk associated with robotic-assisted and standard laparoscopic surgical procedures – undetected bowel perforation. More than 15 million such procedures, including hysterectomy, cholecystectomy, hernia repair, prostatectomy, oophorectomy and others, are performed annually. While the incidence of undetected bowel perforation is relatively low at 0.3 – 1.0%, the consequences for more than 40,000 patients annually are severe, and the incremental costs of caring for those patients substantial. Detection of inadvertent bowel perforation during the initial surgery would enable surgeons to effect repair at that time, avoiding unnecessary patient suffering, billions in associated costs and a 5% mortality rate. Those patients who do not die are subjected to multiple corrective surgeries, extensive antibiotic treatment and potentially lengthy intensive care convalescence. Patient safety concerns and the significant cost of corrective care, which can easily exceed $100,000 per patient, dictate the need for a low-cost solution. The proposed project will advance the development of intraoperative detection of bowel perforation, allowing for immediate repair and avoidance of negative outcomes. This can be accomplished by the detection of gases released from the bowel when it is perforated and alerting the surgeon to the presence of the perforation. This innovation would be applicable to more than 49,000 operating suites in the U.S. and represent a potential addressable market of $750 million annually. The proposed SBIR Phase I project will be to advance the development of an intraoperative detection of bowel perforation, including: 1) experimentation relative to gas species selection and detection methodology / modality; 2) identification and optimization of detection ranges; 3) development of controls to ensure against false positive and negative results. Benchtop and in-vivo testing is proposed to determine repeatability and reliability regarding device efficacy. A Potential Failure Modes Effects Analysis (PFMEA) will be utilized to highlight technical risks. The project will also explore the cost-performance trade space to create a new patient safety measure in laparoscopic and robotic procedures.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.