In-Patient Pediatric Gastrojejunal Tube Cleaner Eliminating Surgical Intervention

描述（由申请人提供）：在NIH SBIR II期中，Actuated Medical, Inc.将完成pedii - gj - cleartm装置的开发，用于清除闭塞并原位恢复儿科胃空肠喂养管（GJ-tubes）的通畅，从而无需手术更换堵塞的管道。公共卫生问题：肠内营养是为下消化道功能正常但不能口服营养物质并有营养不良风险的患者提供的。需要长期肠内营养的情况包括早产、胃肠功能障碍、癌症治疗、神经系统疾病、心脏病和先天性代谢异常。当需要长期肠内通路时，可采用经皮胃造口术、空肠造口术或胃空肠管。据报道，GJ和j型管的堵塞率高达35%，这主要是由于井径小、长度长、布置几何形状复杂。由于真菌生长导致的管的降解是另一个主要问题。此外，年轻的儿科患者往往会很快耗尽能量储备，并且极易受到脱水、低血糖和高血糖的影响，这些都可能由管道堵塞引起。在美国，有3000到5000名婴儿和儿童依赖于狭窄的喂食管。该Pedi-GJ-Clear可靠地清除闭塞和维持喂食管通畅，而管仍在儿童。Pedi-GJ-Clear在长而窄的管道中绕紧曲线工作，不会对肠组织、管道移位或管道完整性造成风险。这款正在申请专利的导管装置在光滑的导管中使用了一根柔性导线，以及一种经过优化的冲洗机制，可以快速清除障碍物，恢复通畅并清洁内壁。该项目的目标是为小儿gj管梗阻重建通畅提供一种成本低、易于操作的非手术干预选择。例行维护清洁最终将包括在患者护理中，以保持壁面清洁并减少由于真菌和细菌生长而导致的管降解。其他存在堵塞和恶化的留置管将成为基础平台技术开发和商业化的后续目标。I期试验证明Pedi-GJ-Clear清除闭塞的可行性，达到了具体目标。实践临床医生的评价非常积极，并已用于指导II期Beta原型设计要求。II期假设：Pedi-GJ Clear将在一项中试人体临床试验（n = 30）中安全地恢复闭塞的gj管的通畅，成功率至少为0.95（95%）。此外，猪试验（30例）证实了安全性和有效性，成功率为0.95。具体目标：1)整合最终设计的特点，包括灌溉

DESCRIPTION (provided by applicant): In this Phase II NIH SBIR, Actuated Medical, Inc. will complete the development of the Pedi-GJ-ClearTM device for clearing occlusions and restoring patency in-situ to pediatric gastrojejunal feeding tubes (GJ-tubes) - eliminating the need to surgically replace clogged tubes. Public Health Problem: Enteral nutrition is provided for patients that have a functioning lower gastrointestinal tract, but are unable to orally ingest nutrients, and are at risk of malnutrition. Conditions necessitating long-term enteral nutrition include prematurity, gastrointestinal dysfunction, cancer treatment, neurological disorders, heart disease, and congenital metabolic abnormalities. When long-term enteral access is needed, percutaneous gastrostomy, jejunostomy or gastrojejunal tubes can be surgically placed. Reported clogging rates of GJ and J-tubes have been as high as 35%, mainly due to the small bore, considerable length, and convoluted geometries for placement. Degradation of the tube due to fungal growth is another major issue. Furthermore, young pediatric patients tend to exhaust energy reserves very quickly and are highly susceptible to the dehydration, and hypo- and hyper-glycemia that can result from a clogged tube. In the U.S. 3,000 - 5,000 infants and children are dependent on narrow bore feeding tubes. The Pedi-GJ-Clear reliably clears occlusions and maintains feeding tube patency while the tube remains in the child. The Pedi-GJ-Clear operates around tight curves in long, narrow tubing without risk to bowel tissue, tube dislodgement, or tube integrity. The patent-pending catheter-based device employs a flexible wire in a smooth catheter, and an irrigation mechanism, optimized to clear obstructions quickly, restoring patency and cleaning inner-walls. The project goal is a non-surgical intervention option for patency re-establishment in obstructed pediatric GJ-tubes that is low cost and easy to operate. A routine maintenance cleaning will ultimately be included in patient care to maintain wall cleanliness and reduce tube degradation due to fungus and bacteria growth. Other indwelling tubes that suffer from occlusions and deterioration will be later targets for development and commercialization with the base platform technology. Phase I proved feasibility of the Pedi-GJ-Clear to clear occlusions and met the Specific Aims. Reviews by practicing clinicians were extremely positive and have been used to guide the Phase II Beta prototype design requirements. Phase II Hypothesis: The Pedi-GJ Clear will safely restore patency to occluded GJ-tubes in- patient with a success rate of at least 0.95 (95%) in a pilot human clinical trial (n = 30). Additionally, porcine testing (n e 30) confirms safety and efficacy t a success rate e 0.95. Specific Aims: 1) Integration of final design features, including irrigation and electronics, 2) Fabrication and Design Verification 3) Design Validation and 4) Pilot Human Clinical Evaluation.