Grainger College of Engineering, University of Illinois Urbana-Champaign, Urbana, IL, United States of America.
Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, Urbana, IL, United States of America.
PLoS One. 2020 Dec 30;15(12):e0244963. doi: 10.1371/journal.pone.0244963. eCollection 2020.
The COVID-19 pandemic disrupted the world in 2020 by spreading at unprecedented rates and causing tens of thousands of fatalities within a few months. The number of deaths dramatically increased in regions where the number of patients in need of hospital care exceeded the availability of care. Many COVID-19 patients experience Acute Respiratory Distress Syndrome (ARDS), a condition that can be treated with mechanical ventilation. In response to the need for mechanical ventilators, designed and tested an emergency ventilator (EV) that can control a patient's peak inspiratory pressure (PIP) and breathing rate, while keeping a positive end expiratory pressure (PEEP). This article describes the rapid design, prototyping, and testing of the EV. The development process was enabled by rapid design iterations using additive manufacturing (AM). In the initial design phase, iterations between design, AM, and testing enabled a working prototype within one week. The designs of the 16 different components of the ventilator were locked by additively manufacturing and testing a total of 283 parts having parametrically varied dimensions. In the second stage, AM was used to produce 75 functional prototypes to support engineering evaluation and animal testing. The devices were tested over more than two million cycles. We also developed an electronic monitoring system and with automatic alarm to provide for safe operation, along with training materials and user guides. The final designs are available online under a free license. The designs have been transferred to more than 70 organizations in 15 countries. This project demonstrates the potential for ultra-fast product design, engineering, and testing of medical devices needed for COVID-19 emergency response.
2020 年，COVID-19 疫情以空前的速度传播，在短短几个月内造成数万人死亡，使全球陷入混乱。在需要住院治疗的患者数量超过可用医疗资源的地区，死亡人数大幅增加。许多 COVID-19 患者患有急性呼吸窘迫综合征（ARDS），这种疾病可以通过机械通气来治疗。为了应对对机械呼吸机的需求，我们设计并测试了一种紧急呼吸机（EV），它可以控制患者的吸气峰压（PIP）和呼吸频率，同时保持呼气末正压（PEEP）。本文介绍了 EV 的快速设计、原型制作和测试。增材制造（AM）的快速设计迭代使开发过程成为可能。在初始设计阶段，设计、AM 和测试之间的迭代使一个工作原型在一周内得以实现。通过对呼吸机的 16 个不同部件进行增材制造和总计 283 个具有参数化变化尺寸的部件的测试，完成了通气设备的设计。在第二阶段，使用 AM 生产了 75 个功能原型，以支持工程评估和动物测试。这些设备经过了超过两百万次的测试。我们还开发了一个电子监测系统和自动报警系统，以确保安全操作，并提供培训材料和用户指南。最终的设计可以在网上免费获得许可证。这些设计已经转移到 15 个国家的 70 多个组织。该项目展示了 COVID-19 应急响应所需的医疗设备的超快速产品设计、工程和测试的潜力。
