Pediatric Gastrojejunal Feeding Tube (GJ-tube) Cleaner

儿科胃空肠饲管（GJ 管）清洁器

• 批准号: 8056982
• 负责人: Ryan S Clement
• 金额: $ 29.01万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8056982
• 关键词: Bacteria; Caliber; Caregivers; Catheters; Chemicals; Child; Childhood; Clinical; Coca; Complication; Creation of jejunostomy; Cystic Fibrosis; Data; Dehydration; Device Safety; Device or Instrument Development; Devices; Ensure; Enteral; Enteral Feeding; Enteral Nutrition; Enzymes; Evaluation; Failure to Thrive; Family suidae; Flushing; Food; Functional disorder; Gastrointestinal tract structure; Gastrostomy; Genus Cola; Goals; Growth; Health; Home environment; Hospitals; Human; Human Resources; Implant; In Situ; In Vitro; Infant; Intervention; Intestines; Knowledge; Length; Licensing; Life; Lower Gastrointestinal Tract; Malnutrition; Manuals; Manufacturer Name; Marketing; Meat; Medical Device; Metabolic; Methods; Mind; Modeling; Motor; Nursing Protocols; Nursing Staff; Nutrient; Obstruction; Operative Surgical Procedures; Outcome; Parents; Patients; Pharmaceutical Preparations; Phase; Process; Protocols documentation; Reporting; Risk; Safety; Sales; Simulate; Small Business Innovation Research Grant; Small Intestines; Staff Development; Stomach; Syringes; Techniques; Technology; Testing; Time; Tissues; Tube; Ultrasonics; United States National Institutes of Health; Water; base; cancer therapy; cohort; commercialization; congenital heart disorder; cost; design; exhaust; experience; feeding; fungus; gastrointestinal; gastrojejunostomy; improved; in vitro Model; in vivo; innovation; manufacturing scale-up; miniaturize; nervous system disorder; nutrition; peace; premature; programs; prototype; safety testing; tube feeding; uptake; verification and validation

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.

描述（由申请人提供）：通常通过饲管向胃肠道功能正常但由于无法正确口服营养物质而面临营养不良风险的儿科患者提供长期肠内营养。肠内喂养可以通过手术植入经皮饲管来实现，该饲管可进入胃、小肠或两者。管阻塞是一种常见的并发症，特别是对于进入小肠的长而小直径的管（J 管或 GJ 管）。细菌和真菌沿着管壁生长是另一个严重问题，它会加速管的降解并显着缩短管的寿命。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，必须将孩子送入医院，通过手术取出插管并更换新插管。对于儿童和护理人员来说，这种营养破坏是一种非常耗时、昂贵且痛苦的经历。在这个 NIH SBIR 计划中，Piezo Resonance Innovations Inc. (PRII) 将开发并进行 Pedi-GJ Tube-ClearTM 的安全性和功效初步测试，这是一种主动儿科胃空肠饲管 (GJ-tube) 清洁器，可在管留在患者体内原位。该设备的设计目的是打破饲管堵塞、恢复通畅和清洁墙壁——为生病的孩子快速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。然后临床医生将评估原型的功效。在为期 9 个月的项目即将结束时，还将在猪模型中对设备安全性进行初步评估。儿科饲管清洁器将延长植入饲管的使用寿命，提高患者的舒适度和健康，同时让父母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% 的模拟障碍物并恢复通畅，而不会导致管移位或损坏。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，而不会损坏或移动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，不会引起管移位或肠壁或胃壁损伤。预期结果：测试数据（体外和体内）验证 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 FDA 标准、通过 ISO 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销售/营销/分销方面的讨论。 公共卫生相关性：需要长期饲管来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造口 (GJ) 管，堵塞率高达 35%。由于细菌和真菌在饲管中定植而导致的长期降解也是一个主要问题。如果无法通过传统方法清除堵塞物，则必须通过手术取出并更换管子，这对于儿童和家长来说是非常耗时、昂贵且痛苦的经历。该项目的目标是提供一种简单的非手术干预方案，用于在儿童 GJ 饲管保留在患者体内时重建并保持其通畅和清洁。