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）：在此阶段II NIH SBIR中，Actiet Medical，Inc。将完成PEDI-GJ-CLEALTM设备的开发，用于清除闭塞并恢复对儿科胃肠道胃喂养管（GJ管）（GJ管）（GJ管）（GJ-tubes）的现场通报 - 消除了需要进行策略更换凝结的块状水管。公共卫生问题：为胃肠道较低但无法口服营养且有营养不良的患者提供肠内营养。需要长期肠内营养的状况包括早产，胃肠道功能障碍，癌症治疗，神经系统疾病，心脏病和先天性代谢异常。如果需要长期的肠内进入，则可以通过手术放置经皮胃造口术，空肠造口术或胃管。据报道，GJ和J管的堵塞率高达35％，这主要是由于孔较小，长度相当长，并且要备份的几何形状用于放置。由于真菌增长而导致的管子降解是另一个主要问题。此外，年轻的小儿患者倾向于迅速耗尽能量储量，并且非常容易受到脱水的影响，并且可能由堵塞的管子引起的低血糖。在美国，有3,000-5,000名婴儿和儿童取决于狭窄的孔喂养管。 Pedi-GJ清除可靠地清除闭塞并保持喂食管的通畅性，而管子保留在儿童中。 Pedi-gj清晰的曲线在长而狭窄的管道中围绕紧密的曲线运行，没有肠组织，管道脱位或管完整性的风险。基于申请的专利导管设备在光滑的导管中采用柔性电线和一种灌溉机制，可快速清除障碍物，恢复通畅和清洁内壁。项目目标是一种非手术干预选择，用于在障碍的小儿GJ管中重新建立通报，这是低成本且易于操作的。常规维护清洁最终将包括在患者护理中，以维持墙壁清洁度并减少由于真菌和细菌生长而导致的管降解。其他被遮挡和恶化的留置管将是以后使用基本平台技术开发和商业化的目标。第一阶段证明了Pedi-GJ清除以清除遮挡并达到了具体目的的可行性。执业临床医生的评论非常积极，已用于指导II期Beta原型设计要求。 II阶段假设：Pedi-GJ Clear将安全恢复在一项试验人类临床试验（n = 30）中，成功率至少为0.95（95％）的闭塞GJ管IN患者的通用性至少为0.95（95％）。此外，猪测试（N E 30）证实了成功率E 0.95的安全性和功效。具体目的：1）最终设计特征的整合，包括灌溉和电子产品，2）制造和设计验证3）设计验证和4）试验人类临床评估。