Wireless Pulse Oximetry (WiPOX) for Diagnosing Intra-Operative Ischemia

描述（由申请人提供）：组织缺血是导致伤口裂开或吻合口漏的主要原因，发病率和死亡率很高，发生率为15%至25%。虽然通过手指脉搏血氧仪测量全身血液氧合状态是每位住院患者的强制性要求，但在手术室进行复杂的手术切除和重建后，没有可用的设备或方法来测量组织氧合。越来越多的外科手术采用微创技术，这增加了问题的复杂性，因为外科医生没有机会直接触摸、感觉或可视化器官。在纽约城市学院（CCNY）生物工程设计团队和纪念斯隆-凯特琳癌症中心（MSKCC）外科医生的合作下，我们成功地设计、制造和测试了一种新型的无线手持式术中氧饱和度仪（WiPOX），它提供实时、准确和方便的术中组织氧合监测，从而确保组织活力，从而改善手术结果，降低死亡率。患者住院及相关费用。在这个R03提案中，基于正在进行的临床试验的反馈，我们将通过两项进一步的创新来提高设备的性能和准确性：结合板载压力传感器以实现可靠的组织接触，以及通过与系统脉搏血氧仪的无线集成来提高S/N。临床前和临床试验的管道已经到位。这些创新的改进对于外科医生采取该设备实用的下一步至关重要-修改基于组织氧合的手术程序。

DESCRIPTION (provided by applicant): Tissue ischemia is a major cause of wound dehiscence or anastomotic leakage resulting in significant morbidity and mortality and occurs at a rate of 15 to 25%. Although measurement of systemic blood oxygenation status by pulse oximetry on the finger is a mandatory requirement for every single patient while in the hospital, there are no devices or methods available to measure tissue oxygenation following complex surgical resections and reconstructions in the operating room. Increasingly, surgical procedures are performed by minimally invasive techniques, which add complexity to the problem, as surgeons do not have the opportunity to directly touch, feel or visualize the organs. In a collaboration between The City College of New York (CCNY) bioengineering design team and Memorial Sloan-Kettering Cancer Center (MSKCC) surgeons, we have successfully designed, constructed and tested a novel wireless, handheld intraoperative oximetry (WiPOX) device, which provides real-time, accurate, and convenient intraoperative monitoring of the tissue oxygenation ensuring tissue viability thereby improving surgical outcomes, decreasing mortality, patient hospitalization and the associated costs. In this R03 proposal, based on the feedback from the ongoing clinical trial, we will enhance device performance and accuracy through two further innovations: incorporation of onboard pressure sensors to allow reliable tissue contact and enhancement of S/N through wireless integration with a systemic pulse oximeter. A pipeline for preclinical and clinical testing is in place. These innovative modifications are crucial for surgeons to take the next step of this device utility - to modify the surgical procedure based on tissue oxygenation.