Percutaneous Ultrasound Gastrostomy (PUG): Engineering and Feasibility Assessment of a Pediatric Device

经皮超声胃造口术 (PUG)：儿科设备的工程和可行性评估

• 批准号: 9909329
• 负责人: Howard Carolan
• 金额: $ 22.46万
• 依托单位: COAPTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2020-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909329
• 关键词: Abdomen; Acute; Adult; Adverse event; Advocate; Air; Anatomy; Animal Model; Animals; Bypass; Caliber; Canis familiaris; Catheters; Child; Childhood; Client satisfaction; Clinical; Complex; Complication; Confined Spaces; Devices; Diagnostic; Dimensions; Endoscopes; Engineering; Enteral Feeding; Enteral Nutrition; Environment; Esophageal; Esophagus; Failure; Family; Funding; Gastrostomy; Goals; Hospitals; Human; Image; Imagery; Imaging Device; Infant; Infection; Legal patent; Liquid substance; Lung; Magnetism; Medical Device; Methods; Modeling; Operative Surgical Procedures; Oral cavity; Organ; Oryctolagus cuniculus; Outcome; Pathway interactions; Patients; Perforation; Peritonitis; Pharyngeal structure; Phase; Physicians; Physics; Pilot Projects; Procedures; Provider; Puncture procedure; Radiology Specialty; Risk; Safety; Seeds; Sepsis; Small Business Innovation Research Grant; Specialist; Sterility; Stomach; System; Techniques; Testing; Time; Tube; Ultrasonography; United States; Work; base; cost; design; experimental study; hazard; image guided; improved; medical specialties; migration; minimally invasive; models and simulation; novel; nutrition; off-patent; pediatric patients; pediatrician; point of care; prototype; success

The goal of this project is to test a potentially safer, more accessible method for placement of gastrostomy feeding tubes in pediatric patients. Millions of patients worldwide require enteral nutrition, and hundreds of thousands of gastrostomy (feeding tube placement) procedures are performed annually in the United States alone, over 10,000 of which are in children. The current standard of practice for placement of nearly all feeding tubes worldwide is called the Percutaneous Endoscopic Gastrostomy (PEG) method. PEG is costly, complex, and potentially risky to perform, as it is performed in a surgical suite about 85% of the time, requiring specialty providers and sophisticated imaging instruments. Open surgical gastrostomy is another alternative, but is more invasive. We have invented a new device and method, using magnets and low-cost, non-invasive ultrasound, called the Point-of-Care Ultrasound Magnet Aligned Gastrostomy (PUMA-G) device, which will improve and simplify the gastrostomy procedure on many dimensions. The PUMA-G device is applied using the Percutaneous Ultrasound Gastrostomy (PUG) procedure. The most important difference between our method and PEG, is that the PUMA-G device will eliminate several safety risks of PEG while also allowing up to 80% of all gastrostomy procedures to be performed at the patient’s bedside - without specialist consultants, expensive imaging, and surgical suite time (for the remaining 20% of cases, the PUMA-G device will be contraindicated, and a conventional PEG or open surgical gastrostomy may be performed). Migration of methods from the surgical theatre to the patient bedside has successfully occurred for many different specialty procedures over the previous two decades, and in each instance has led to substantially reduced cost and improved patient satisfaction, with comparable or better safety outcomes. PUMA-G has been designed, built, and tested successfully in adults, with over 15 successful live canine experiments and 6 live human patient cases to date. Recently, many world-class pediatricians who have seen the PUMA-G device have recognized it as a superior method for use in children, and have requested a PUMA-G device be built which is sized and designed for use in smaller patients. This project will design, test, and validate in a live rabbit model a smaller PUMA-G device for safer and less costly ultrasound gastrostomy in children.

该项目的目标是测试一种可能更安全、更易于使用的方法来放置 全球数以百万计的儿科患者需要进行胃造口饲管。 营养，以及数十万次胃造口术（饲管放置）程序 仅在美国每年就有超过 10,000 例儿童参与。 全球几乎所有饲管放置的实践标准被称为 经皮内窥镜胃造口术 (PEG) 方法成本高、复杂且潜在风险大。 执行有风险，因为大约 85% 的时间是在手术室中执行，需要专业知识 开放式胃造口术是另一种方法。 替代方案，但更具侵入性，我们发明了一种使用磁铁的新设备和方法。 低成本、非侵入性超声，称为床旁超声磁体对齐 胃造口术 (PUMA-G) 设备，将改善和简化胃造口术程序 PUMA-G 装置采用经皮超声技术。 我们的方法和 PEG 之间最重要的区别是胃造口术 (PUG) 程序。 PUMA-G 设备将消除 PEG 的多项安全风险，同时还允许高达 80% 所有胃造口手术均在患者床边进行 - 无需专家 顾问、昂贵的成像和手术套件时间（对于其余 20% 的病例， PUMA-G 装置将是禁忌的，并且传统的 PEG 或开放式胃造口术 方法从手术室转移到患者床边 在过去的二十年里，许多不同的专业手术都成功进行了，并且 在每种情况下都大大降低了成本并提高了患者满意度 PUMA-G 已成功设计、制造和测试。 迄今为止，已在成人中进行了超过 15 例成功的活体犬实验和 6 例活体人类患者病例。 最近，许多见过PUMA-G设备的世界级儿科医生都认可了它 作为一种在儿童中使用的优越方法，并要求构建 PUMA-G 设备，该设备 该项目将在现场进行设计、测试和验证。 兔子模型更小的 PUMA-G 装置，用于更安全且成本更低的超声胃造口术 孩子们。