In-Patient Pediatric Gastrojejunal Tube Cleaner Eliminating Surgical Intervention

描述（由申请人提供）：在本II期NIH SBIR中，Actuated Medical，Inc.将完成Pedi-GJ-ClearTM装置的开发，用于清除阻塞并原位恢复小儿胃空肠饲管（GJ管）的通畅性-无需通过手术更换堵塞的管。公共卫生问题：肠内营养提供给下胃肠道功能正常，但不能口服摄入营养物质，并有营养不良风险的患者。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。当需要长期的肠内通路时，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管和J管的堵塞率高达35%，这主要是由于小孔、相当长的长度和用于放置的回旋几何形状。由于真菌生长而导致的管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，并且非常容易脱水，以及可能由堵塞的管道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口径喂养管。Pedi-GJ-Clear能够可靠地清除阻塞，并在饲管留在儿童体内时保持饲管通畅。Pedi-GJ-Clear可在长而窄的管路中围绕紧密的弯曲进行操作，不会对肠组织、管路移位或管路完整性造成风险。正在申请专利的基于导管的设备采用光滑导管中的柔性金属丝和冲洗机制，优化以快速清除阻塞物，恢复通畅性和清洁内壁。该项目的目标是提供一种非手术干预选择，用于在阻塞的儿科GJ管中重建通畅性，该选择成本低且易于操作。常规维护清洁最终将包括在患者护理中，以保持管壁清洁并减少由于真菌和细菌生长而导致的管降解。其他遭受阻塞和退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期研究证明了Pedi-GJ-Clear清除闭塞的可行性，并符合特定目标。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。第二阶段假设：在初步人体临床试验（n = 30）中，Pedi-GJ Clear将安全地恢复患者体内堵塞GJ管的通畅性，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）集成最终设计功能，包括灌溉 和电子学，2）制造和设计验证，3）设计确认和4）初步人体临床评价。

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.