Pediatric Gastrojejunal Feeding Tube (GJ-tube) Cleaner

描述（由申请人提供）：长期肠内营养，通过饲管，通常提供给儿科患者的胃肠道功能正常，但有营养不良的风险，因为他们不能正确地口服摄入营养。肠内喂养可以通过手术植入经皮喂食管来实现，该管可通往胃、小肠或两者。肠管闭塞是常见的并发症，特别是通往小肠的长而直径小的肠管（J-管或gj -管）。细菌和真菌沿着管壁生长是另一个严重的问题，可以加速管的降解和显着减少管的寿命。当常规方法（注射器冲洗和/或化学治疗）不能恢复通畅时，儿童必须住院，通过手术取出管子并换上新的管子。这种营养中断对儿童和护理人员来说是非常耗时、昂贵和痛苦的经历。在这个NIH SBIR项目中，压电共振创新公司（PRII）将开发并进行Pedi-GJ tube - cleartm的安全性和有效性的初步测试，Pedi-GJ tube - cleartm是一种活性儿科胃空肠喂食管（GJ-tube）清洁器，当管道留在患者体内时，它可以有效地进行原位清洁。该设备将被设计用于打破喂食管堵塞，恢复通畅，清洁管壁-迅速为生病的孩子重建营养和药物支持。在第一阶段，PRII将探索微驱动技术来优化Pedi-GJ Tube-ClearTM原型。然后临床医生将对原型的功效进行评估。在为期9个月的项目即将结束时，还将在猪模型中进行设备安全性的初步评估。小儿饲管清洁器将延长植入饲管的使用寿命，改善患者的舒适度和健康状况，同时让家长和护理人员更加安心。第一阶段假设：Pedi-GJ tube - cleartm原型将消除90%的模拟阻塞并恢复通畅，而不会导致管道移位或损坏。具体目标：1；构建可插入临床gj管的Pedi-GJ Tube-ClearTM原型。2. 通过体外模型证明Pedi-GJ Tube-ClearTM原型可以清除障碍物并清洁内壁，而不会损坏或移位gj管。3. 通过内窥镜观察和组织学分析，证明该装置可以在体内操作，不会造成管移位或肠胃壁损伤。预期结果：验证Pedi-GJ Tube-ClearTM装置在清除10Fr gj管内阻塞方面安全有效的试验数据（体外和体内）。PRII将在其位于宾夕法尼亚州Bellefonte的符合FDA标准的ISO 13485认证工厂生产该设备。PRII正在与肠内喂养市场的三个潜在战略合作伙伴讨论销售/营销/分销。

DESCRIPTION (provided by applicant): Long-term enteral nutrition, via a feeding tube, is often provided to pediatric patients who have a functioning gastrointestinal tract but are at risk of malnutrition due to their inability to properly ingest nutrients orally. Enteral feeding can be accomplished by surgically implanting a percutaneous feeding tube that provides access to the stomach, small intestine, or both. Occlusion of the tubes is a regular complication, particularly with the long, small diameter tubes that access the small intestine (J- or GJ-tubes). Bacterial and fungus growth along the tube wall is another serious issue that can accelerate tube degradation and significantly reduce tube life. When patency cannot be restored by conventional means (syringe flush and/or chemical treatments), the child must be admitted to a hospital to have the tube surgically removed and replaced with a new one. This disruption of nutrition is a very time-consuming, expensive and agonizing experience for the child and caregivers. In this NIH SBIR program, Piezo Resonance Innovations Inc. (PRII) will develop and conduct preliminary testing for safety and efficacy of the Pedi-GJ Tube-ClearTM, an active pediatric gastrojejunal feeding tube (GJ-tube) cleaner that cleans efficiently while the tube remains in the patient, in-situ. The device will be designed to break up feeding tube clogs, restore patency, and clean walls - reestablishing nutrition and medication support quickly to an ill child. In Phase I, PRII will explore micro-actuation technologies in optimizing the Pedi-GJ Tube-ClearTM prototype. The efficacy of the prototype will then be evaluated by clinicians. A preliminary evaluation of device safety will also be performed in a porcine model near the end of the 9-month project. The pediatric feeding tube cleaner will extend the life of implanted feeding tubes, improving patient comfort and health while providing parents and nursing staff greater peace of mind. Phase I Hypothesis: The Pedi-GJ Tube-ClearTM prototype will remove 90% of simulated obstructions and restore patency without causing dislodgement or damage to the tube. Specific Aims: 1. Build a Pedi-GJ Tube-ClearTM prototype that can be inserted into clinical GJ-tubes. 2. Demonstrate that the Pedi-GJ Tube-ClearTM prototype can remove obstructions and clean the inner wall without damage or dislodgement of the GJ-tube with in vitro model. 3. Demonstrate the device can be operated in vivo without causing tube dislodgement or damage to the intestinal or stomach walls via endoscopic observation and histological analysis. Expected Outcomes: Test data (in-vitro and in vivo) that verifies that the Pedi-GJ Tube-ClearTM device is safe and effective in clearing obstructions in 10Fr GJ-tubes. PRII will manufacture the device in its FDA compliant, ISO 13485-certified facility in Bellefonte, PA. PRII is in discussions with three potential strategic partners in the enteral feeding market for sales/marketing/distribution. PUBLIC HEALTH RELEVANCE: Long-term feeding tubes are needed to provide nutrition to children who cannot digest food orally. For gastrojejunostomy (GJ) tubes, specifically designed to access the small intestine, clogging rates as high 35% occur. Long term degradation due to bacteria and fungus colonization in the feeding tube is also a major concern. If a clog cannot be removed by conventional approaches, the tube must be surgically removed and replaced - a very time-consuming, expensive and agonizing experience for the child and parents. The goal of this project is a simple, non-surgical intervention option for reestablishing and maintaining patency and cleanliness in pediatric GJ feeding tubes while the tube remains in the patient.