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

该项目的目标是测试一种潜在的更安全，更容易获得的方法， 儿科患者的胃造口饲管。全球数百万患者需要肠内 营养，以及成千上万的胃造口术（饲管放置）程序， 每年仅在美国就有超过10，000例是儿童。当前 全世界几乎所有饲管放置的实践标准被称为 经皮内镜胃造口术（PEG）方法。PEG是昂贵的，复杂的，并且可能 执行风险，因为大约85%的时间在手术室中执行，需要专业知识 供应商和先进的成像仪器。开放式胃造口术是另一种 替代，但更具侵入性。我们发明了一种新的装置和方法， 和低成本的非侵入性超声，称为床旁超声磁体对准 胃造口术（PUMA-G）装置，这将改善和简化胃造口术程序， 多维度。PUMA-G器械使用经皮超声 胃造口术（PUG）手术。我们的方法和PEG之间最重要的区别是 PUMA-G装置将消除PEG的几个安全风险，同时还允许高达80%的 所有胃造口术手术均应在患者床边进行-无需专科医生 顾问，昂贵的成像和手术室时间（对于其余20%的病例， PUMA-G器械将是禁忌症，常规PEG或开放式外科胃造口术 可以执行）。从手术室到患者床边的方法迁移 在过去的二十年中，许多不同的专业手术都成功地进行了， 在每种情况下都导致了成本的大幅降低和患者满意度的提高， 具有可比性或更好的安全性结果。PUMA-G已成功设计、制造和测试 在成人中，迄今已有超过15个成功的活体犬实验和6个活体人类患者病例。 近日，不少看过PUMA-G设备的世界级儿科医生都认可了它 作为一种用于儿童的上级方法，并要求制造一种PUMA-G装置， 尺寸和设计适用于较小的患者。该项目将设计，测试，并在现场验证 一种更小的PUMA-G装置，用于更安全，更便宜的超声胃造口术， 孩子

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.