Pediatric Gastrojejunal Feeding Tube (GJ-tube) Cleaner

描述（由申请方提供）：通过饲管进行的长期肠内营养通常提供给胃肠道功能正常但由于无法正确口服摄入营养而存在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饲管来实现，该饲管提供进入胃、小肠或两者的入口。输卵管阻塞是一种常见的并发症，特别是进入小肠的长而小直径的管道（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，会加速管的降解并显著缩短管的寿命。当通过常规方法（注射器冲洗和/或化学治疗）无法恢复通畅时，儿童必须住院，通过手术取出插管并更换新的插管。这种营养中断对儿童和照顾者来说是一种非常耗时、昂贵和痛苦的经历。在这个NIH SBIR计划中，Piezo Resonance Innovations Inc.（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是一种主动式小儿胃空肠饲管（GJ管）清洁器，可在管留在患者体内时进行有效清洁。该设备将被设计为打破喂养管堵塞，恢复通畅，清洁墙壁-重建营养和药物支持迅速生病的孩子。在第一阶段，PRII将探索微驱动技术，优化Pedi-GJ Tube-ClearTM原型。然后，临床医生将对原型的疗效进行评估。在9个月项目接近结束时，还将在猪模型中进行器械安全性的初步评价。儿科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，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原型将清除90%的模拟阻塞物并恢复通畅性，而不会导致管路移位或损坏。具体目标：1。构建可插入临床GJ管的Pedi-GJ Tube-ClearTM原型。 2.证明Pedi-GJ Tube-ClearTM原型可以在体外模型中清除阻塞物并清洁内壁，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器械可在体内操作，而不会导致管路移位或对肠壁或胃壁造成损伤。预期结果：验证Pedi-GJ Tube-ClearTM器械在清除10 Fr GJ管中阻塞物时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贝莱丰特的FDA合规、ISO 13485认证工厂生产该器械。PRII正在与肠内营养市场的三个潜在战略合作伙伴进行销售/营销/分销讨论。 公共卫生相关性：需要长期喂食管为无法口服消化食物的儿童提供营养。对于专门设计用于进入小肠的胃空肠吻合（GJ）管，堵塞率高达35%。由于饲管中的细菌和真菌定植而导致的长期降解也是主要问题。如果无法通过常规方法清除堵塞物，则必须通过手术取出并更换管道-这对儿童和父母来说是非常耗时，昂贵和痛苦的经历。本项目的目标是提供一种简单的非手术干预选择，用于在儿科GJ饲管保留在患者体内时重建并保持其通畅性和清洁度。

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.