SBIR Phase I: Gastrointestinal Therapeutic Device for Alleviating Postoperative Ileus

这个小企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是为患者提供一种新的胃肠治疗设备，用于缓解术后肠梗阻(POI)和恢复胃肠动力。POI是一种胃肠动力障碍，通常发生在腹部手术后，会给患者及其家人带来严重的不适和并存。现有的以管理战略和药物疗法为基础的预防或治疗POI的解决方案疗效有限，而且鲜为人知。临床医生也没有有效的方法来定量监测POI的严重程度和解决情况。该项目是有价值的和及时的，它代表着对现状的重大改变。该项目的成功不仅将使腹部手术患者及其家人受益，还将通过缩短住院时间和相关的医疗资源，显著减少美国的医疗支出。所开发的技术可进一步作为各种生物医学应用的研究工具，以探索潜在的生物学机制和针对不同疾病的新治疗方法的可行性研究。拟议的项目是开发并演示一种无线腔外闭环胃肠调节装置，能够同时对胃肠道进行神经调节，并无线记录胃肠运动，以缓解POI，从而增强胃肠运动。POI每年为其医疗系统花费超过15亿美元。安全地将这一停留时间缩短一天将产生巨大的红利，导致每年超过7亿美元的市场规模。拟议的项目不仅将涉及生物电子设备的设计和优化，还将涉及无线胃肠道治疗设备的集成化和微型化。将进行动物实验，以验证该设备在调节和无线记录胃肠运动方面的有效性，以及其安全性和可靠性。如果成功，这一结果将导致一种新的生物电子药物，促进POI的治疗，并有可能扩展到其他医疗应用。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide patients with a new gastrointestinal therapeutic device for the alleviation of postoperative ileus (POI) and the restoration of gastrointestinal motility. POI is an impairment of gastrointestinal motility that often develops following abdominal surgery and causes significant discomfort and comorbidities to both patients and their families. Existing solutions in the prevention or treatment of POI based on management strategies and pharmaceutical therapies have limited efficacy and are highly anecdotal. There is also no effective way for clinicians to quantitatively monitor the severity and resolution of POI. The project is valuable and timely, and it represents a significant departure from the status quo. The success of this project would not only benefit the patients undergoing abdominal surgery and their families, but also would significantly reduce the health care expenditure in the United States by shortening the hospitalization stay as well as the associated medical resources. The developed technologies can be further served as research tools for various biomedical applications to investigate underlying biological mechanisms and the feasibility study of novel treatment method for different diseases.The proposed project is to develop and demonstrate a wireless extra-luminal closed-loop gastrointestinal modulation device, capable of simultaneously neuromodulating the gastrointestinal tract and recording gastrointestinal motility wirelessly for alleviating POI, resulting in enhancing gastrointestinal motility. POI costs over US $1.5 billion annually to its healthcare system. Safely shortening this length of stay by one day would produce significant dividends, leading to a market size of more than $700 million annually. The proposed project will address not only the design and optimization of a bioelectronic device, but also the integration and miniaturization of the wireless gastrointestinal therapeutic device. Animal study is to be conducted to validate the efficacy of the device in modulating and wirelessly recording of gastrointestinal motility, and its safety and reliability. If successful, the outcome will lead to a new bioelectronics medicine that advances the treatment of POI, and can be potentially expanded to other medical applications.