SBIR Phase I: Gastrointestinal Therapeutic Device for Alleviating Postoperative Ileus

这个小企业创新研究（SBIR）一期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道治疗设备，以缓解术后肠梗阻（POI）和恢复胃肠道运动。POI是一种胃肠道运动障碍，通常在腹部手术后发生，对患者及其家属造成严重不适和合并症。现有的基于管理策略和药物治疗的预防或治疗POI的解决方案疗效有限，而且非常轶事。临床医生也没有有效的方法来定量监测POI的严重程度和消退。该项目是有价值的和及时的，它代表了对现状的重大背离。该项目的成功不仅有利于腹部手术患者及其家属，而且通过缩短住院时间和相关医疗资源，将大大减少美国的医疗保健支出。所开发的技术可以进一步作为各种生物医学应用的研究工具，以探讨潜在的生物学机制和研究不同疾病的新治疗方法的可行性。本项目拟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每年给其医疗保健系统造成的损失超过15亿美元。安全地缩短一天的停留时间将产生可观的红利，导致每年超过7亿美元的市场规模。该项目不仅将解决生物电子设备的设计和优化问题，还将解决无线胃肠道治疗设备的集成和小型化问题。为了验证该装置在胃肠运动调节和无线记录方面的有效性，以及其安全性和可靠性，我们将进行动物实验。如果取得成功，这一成果将导致一种新的生物电子药物，可以推进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.