I-Corps: An Implantable, Bioresorbable Medical Device to Regenerate A Damaged Esophagus

严重受损的食管（为胃提供食物的器官）需要进行最后的外科手术，称为食管切除术。这种手术涉及切除食管的受损部分（即肿瘤），然后替换缺失的食管组织，使胃旁路（即胃上拉）。这导致患者的生活质量非常低，因为胃不是食管的合适替代品，通常需要患者在其生存时间内依赖饲管。此外，术后并发症发生率高达80%，5年生存率不到20%。为了避免胃上拉手术并保留胃，该I-Corps团队旨在将申报的可吸收医疗器械植入切除的食管受损部分，促进体内功能性食管组织再生。最终，这将提高患者的生活质量和生存率，同时与标准食管切除术相比，大大降低了可报销的医疗费用。该设备将用于治疗晚期Barrett食管（慢性胃酸反流）、食管癌、食管先天缺陷以及因腐蚀性摄入毒物而导致的食管损伤。I-Corps团队正在开发一种可植入的生物可吸收医疗设备，用于功能性再生受损食管。 总体而言，该器械具有抗炎性、生物相容性/非免疫原性、生物可吸收性、易于包装（至少1年有效期），并且可随时“现货”供胸外科医生在临床中使用。该团队计划在I-Corps项目期间与胸外科医生、麻醉师和胃肠病学家进行客户访谈。 该团队希望启动一项大型猪研究，以证明所提出的设备能够再生人类受损的食管。在I-Corps项目结束时，一项更实用的概念验证研究正在小鼠模型中证明拟议器械的生物相容性、生物降解性和免疫耐受性。 这将为团队成功申请其他赠款（如NSF SBIR第一阶段）提供重要信息。

A severely impaired esophagus (organ providing food to the stomach) requires a last resort surgical procedure called an esophagectomy. This surgery involves cutting out a damaged portion of an esophagus (i.e. a tumor) and then replacing the missing esophageal tissue bypulling up the stomach (i.e. gastric pull-up). This causes a very low quality of life for the patient because the stomach is not a suitable replacement for an esophagus, often requiring patients to rely on feeding tubes for the length of their survival. Furthermore, post-operative complication rates are as high as 80% and the 5-year survival rate is less than 20%. In order to avoid a gastric pull-up surgery and spare the stomach, this I-Corps team aims to implant the proposed absorbable medical device into the excised damaged portion of the esophagus, promoting functional esophageal tissue regeneration within the body. Ultimately, this will improve the quality of life and survival of the patients, while substantially decreasing reimbursable medical costs than compared to a standard esophagectomy procedure. The proposed device will treat patients that suffer from advanced Barrett's Esophagus (chronic regurgitation of stomach acid), esophageal cancer, esophageal birth defects, and injury to the esophagus due to caustic ingestion of poisons.This I-Corps team is developing an implantable, bioresorbable medical device to functionally regenerate a damaged esophagus. Overall the device is anti-inflammatory, biocompatible/non-immunogenic, bioresorbable, easily packaged (a minimum one year shelf life), and readily available "off the shelf" to be used in the clinic by the thoracic surgeon. This team plans to conduct customer interviews with thoracic surgeons, anesthesiologists, and gastroenterologists during the I-Corps program. The team would like to initiate a large pig study, yielding proof-of-concept that the proposed device is capable of regenerating a damaged esophagus in humans. A more pragmatic proof-of-concept study at the end of the I-Corps project is demonstrating biocompatibility, biodegradability, and immune tolerance of the proposed device in mouse models. This would provide the team significant information to successfully apply for other grants such as the NSF SBIR Phase I.