SBIR Phase II: An Ingestible, Intraluminal, Bioelectronic Capsule (IBC) for Closed-Loop Diagnosis and Treatment of Gastrointestinal Disorders

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力集中于支持多模式胃肠道测量和术后并发症治疗的新型胃肠道治疗器械。美国每年有超过30万名患者接受腹部切除手术。这些患者通常会出现严重的并发症，如术后肠梗阻、胃肠道出血和吻合口瘘，这些严重影响生活质量。这一项目的成功不仅将使接受腹部手术的病人及其家属受益，而且还将通过缩短住院时间和减少相关的医疗资源来大大减少保健支出。此外，这种跨学科的研究汇集了来自不同专业领域的学术合作者。该项目为神经接口设计和医疗设备实验领域的工程师和科学家提供了独特的经验和培训，弥合了工程和医学界之间的差距，以及促进和培养未来的神经工程师，专注于开发新兴/未满足的诊断和治疗设备，以改善人类健康。第二阶段项目开发并展示了一种无线、小型化、腔内生物电子胶囊，能够对胃肠道进行按需神经调节和多模态传感，支持闭环神经调节。该器械将在台架上以及通过猪模型进行测试和表征，以证明其治疗和监测术后并发症的潜力。诊断和治疗术后并发症的漫长过程大大增加了医疗保健成本。仅术后肠梗阻的住院费用每天就超过2 000美元。 由于住院时间延长而造成的额外费用每年超过15亿美元。快速检测和治疗这些并发症可以减少住院时间，加速康复，实现闭环治疗，并提高患者的生活质量。该项目的成功有可能给目前以药物为基础的手术后管理和治疗带来颠覆性的影响和革命。此外，在该项目中开发的技术可能有助于治疗其他慢性疾病和药物无法治愈的损伤。 该技术可用作研究不同疾病的生物机制和新疗法的研究工具。该奖项反映了NSF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 II project focuses on a new gastrointestinal therapeutic device supporting multi-modal gastrointestinal measurements and treatment of post-surgical complications. Over 300,000 patients in the US undergo abdominal resection surgery each year. These patients often experience serious complications, such as post-operative ileus, gastrointestinal hemorrhage, and anastomotic leakage, that significantly impact quality of life. The success of this project would not only benefit patients undergoing abdominal surgery and their families, but also would significantly reduce health care expenditures by decreasing the length of hospitalization as well as associated medical resources. Furthermore, this interdisciplinary research brings together academic collaborators from different fields of expertise. The project provides a unique experience and training for engineers and scientists in the fields of neural interface design and medical device experiments, bridging the gap between the engineering and medical communities, as well as promoting and cultivating future neural engineers to focus on developing emerging/unmet diagnostic and therapeutic devices for improving human health.This Small Business Innovation Research (SBIR) Phase II project develops and demonstrates a wireless, miniaturized, intraluminal bioelectronic capsule capable of performing on-demand neuromodulation and multi-modality sensing on the gastrointestinal tract, supporting closed-loop neuromodulation. The device will be tested and characterized on benchtop and also through porcine models to demonstrate its potential for treating and monitoring post-surgical complications. The lengthy process of diagnosing and treating post-surgical complications significantly increases healthcare costs. Costs from hospitalization time alone exceed $2,000 per day for post-operative ileus alone. Additional costs due to prolonged hospitalization time exceed $1.5 billion annually. Rapid detection and treatment of these complications could reduce hospitalization time, accelerate recovery, enable closed-loop therapies, and increase quality of life for patients. The success of this project has the potential to bring disruptive impact and revolution to the current pharmaceutical-based post-surgical management and treatment. In addition, the technology developed during this project may be useful to treat other chronic diseases and injuries that are incurable pharmaceutically. The technique may be used as research tools for investigating the biological mechanisms and new therapeutics for different diseases.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.