Pediatric Gastrojejunal Feeding Tube (GJ-tube) Cleaner

描述(申请人提供)：长期肠内营养，通过饲管，通常提供给胃肠道功能正常，但由于不能适当地口服营养物质而有营养不良风险的儿科患者。肠内喂养可以通过外科手术植入经皮喂养管来实现，该管提供通向胃、小肠或两者的通道。输卵管阻塞是一种常见的并发症，尤其是进入小肠的细长管子(J管或GJ管)。沿着管壁生长的细菌和真菌是另一个严重的问题，可能会加速管子的降解并显著降低管子的寿命。如果无法通过常规方法(注射器冲洗和/或化学治疗)恢复通畅，则必须将儿童送入医院，通过手术拔除导管并换上新的导管。对于孩子和照顾者来说，这种营养中断是一种非常耗时、昂贵和痛苦的经历。在NIH的SBIR项目中，Piezo Resonance Innovation Inc.(PRI)将开发Pedi-GJ Tube-ClearTM，并对其安全性和有效性进行初步测试。Pedi-GJ Tube-ClearTM是一种活性的儿科胃空肠喂养管(GJ-tube)清洁剂，可在患者留在患者体内的情况下高效地进行清洁。该设备的设计将打破喂养管堵塞，恢复通畅，并清洁墙壁-快速重建营养和药物支持，以帮助患病的儿童。在第一阶段，Prii将探索微驱动技术，以优化Pedi-GJ Tube-ClearTM原型。然后，临床医生将评估该原型的疗效。在这个为期9个月的项目接近尾声时，还将在猪模型上进行设备安全性的初步评估。儿科喂养管清洁剂将延长植入的喂养管的寿命，改善患者的舒适度和健康，同时为父母和护理人员提供更大的安心。第一阶段假设：Pedi-GJ Tube-ClearTM原型将消除90%的模拟障碍物，恢复通畅，而不会导致管子移位或损坏。具体目标：1.建立可插入临床GJ管的Pedi-GJ Tube-ClearTM样机。2.通过体外模型验证了Pedi-GJ Tube-ClearTM样机可以清除障碍物，清洁内壁，而不会造成GJ管的损伤或移位。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，而不会导致管子移位或对肠壁或胃壁造成损害。预期结果：(体外和体内)测试数据证实PEDI-GJ Tube-ClearTM装置在清除10Fr GJ管中的障碍物方面是安全有效的。Prii将在其位于宾夕法尼亚州贝尔方特的符合食品和药物管理局标准、获得国际标准化组织13485认证的工厂生产该设备。Prii正在与肠内喂养市场的三个潜在战略合作伙伴进行谈判，以进行销售/营销/分销。 公共卫生相关性：需要长期的喂养管，为不能口服消化食物的儿童提供营养。对于胃空肠吻合术(GJ)管，专门设计用于访问小肠，堵塞发生率高达35%。由于细菌和真菌在喂养管中的定植而导致的长期降解也是一个主要问题。如果传统方法无法清除堵塞，必须通过手术移除并更换导管-对于孩子和父母来说，这是一种非常耗时、昂贵和痛苦的经历。这个项目的目标是一种简单的非手术干预方案，用于重建和维持儿童GJ喂养管的通畅性和清洁度，同时管子仍留在患者体内。

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.