In-Patient Pediatric Gastrojejunal Tube Cleaner Eliminating Surgical Intervention

住院小儿胃空肠管清洁器消除手术干预

基本信息

批准号：
8453735
负责人：
Ryan S Clement
金额：
$ 86.27万
依托单位：
ACTUATED MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-04-01 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8453735
关键词：
Adult Americas Anatomic Models Bacteria Boxing Caring Catheters Characteristics Child Childhood China Chronic Clinical Trials Contractor Creation of jejunostomy Cystic Fibrosis Dehydration Deterioration Development Devices Doctor of Philosophy Effectiveness Electronics Enteral Enteral Feeding Enteral Nutrition Failure to Thrive Family suidae Feedback Focus Groups Functional disorder Funding Gastrostomy Goals Growth Home environment Hong Kong Human In Situ Infant Intervention Intestines Irrigation Legal patent Length Licensing Life Lower Gastrointestinal Tract Maintenance Malnutrition Marketing Medical Medical Device Metabolic Modeling Motion Nutrient Obstruction Operative Surgical Procedures Outcome Parents Patient Care Patients Performance Pharmaceutical Preparations Phase Public Health Reporting Risk Safety Sales Secure Small Business Innovation Research Grant Stomach Taiwan Technology Testing Tissues Tube United States United States National Institutes of Health Validation base cancer therapy cohort commercialization congenital heart disorder cost design exhaust experience flexibility fungus gastrointestinal improved meetings nervous system disorder nutrition premature programs prototype public health relevance research clinical testing stem success tube feeding uptake

项目摘要

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.

描述（由申请人提供）：在 NIH SBIR 第二阶段中，Actuated Medical, Inc. 将完成 Pedi-GJ-ClearTM 设备的开发，用于清除闭塞并恢复儿科胃空肠饲管（GJ 管）原位通畅- 无需通过手术更换堵塞的管道。公共卫生问题：肠内营养是为下胃肠道功能正常但无法口服营养物质且有营养不良风险的患者提供的。需要长期肠内营养的疾病包括早产、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，可以通过手术放置经皮胃造口术、空肠造口术或胃空肠管。据报道，GJ 和 J 形管的堵塞率高达 35%，这主要是由于孔径小、长度较长以及放置时的复杂几何形状造成的。由于真菌生长而导致的管子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，并且非常容易出现脱水以及因导管堵塞而导致的低血糖和高血糖。在美国，有 3,000 - 5,000 名婴儿和儿童依赖窄孔饲管。 Pedi-GJ-Clear 能够可靠地清除堵塞物，并在饲管留在孩子体内时保持饲管通畅。 Pedi-GJ-Clear 在又长又窄的管道中围绕紧曲线运行，不会对肠组织、管道移位或管道完整性造成风险。这种基于导管的设备正在申请专利，在光滑的导管中采用柔性线，以及冲洗机制，经过优化可以快速清除障碍物，恢复通畅并清洁内壁。该项目的目标是为阻塞的儿科 GJ 管重建通畅提供一种非手术干预方案，成本低且易于操作。例行维护清洁最终将包含在患者护理中，以保持管壁清洁并减少由于真菌和细菌生长而导致的管道退化。其他遭受闭塞和恶化的留置管将成为后续利用基础平台技术进行开发和商业化的目标。第一阶段证明了 Pedi-GJ-Clear 清除闭塞物的可行性并达到了特定目标。执业临床医生的评论非常积极，并已用于指导第二阶段 Beta 原型设计要求。 II 期假设：Pedi-GJ Clear 将安全地恢复闭塞 GJ 管的住院患者的通畅，在试点人体临床试验 (n = 30) 中成功率至少为 0.95 (95%)。此外，猪试验（n e 30）证实了安全性和有效性，成功率 e 0.95。具体目标： 1) 整合最终设计功能，包括灌溉和电子学，2) 制造和设计验证 3) 设计验证和 4) 试点人体临床评估。