ABSTRACT
In the first quarter of 2020, SARs-CoV-2 (COVID-19) infections began to grow at an alarming rate despite drastic measures to reduce infection rates. Severe COVID-19 cases required mechanical ventilation, resulting in ventilator shortages worldwide. To address the ventilator shortages, the authors developed the CoreVent 2020, an emergency-use ventilator for adult patients that was designed, built, and tested in ten days. The CoreVent 2020 is a pressure-cycled, time-limited ventilator with a breath-assist mode that operates on standard pressurized oxygen and medical air. It provides adjustable peak inspiratory pressure (PIP) and positive end-expiratory pressure (PEEP). A medical-grade commercially available breathing circuit is used to minimize non-medical component requirements. The CoreVent 2020 was fabricated in-house at Stony Brook University Hospital and tested on three mechanical lung simulators in which the operating modes and alarm features were demonstrated. Animal studies were also performed in both normal breathing mode and breath-assisted modes. Arterial blood gas measurements confirmed that the ventilator provided satisfactory ventilation for the test subjects. The COVID-19 pandemic presented unique constraints on the design and innovation process not normally encountered in typical practice. Design decisions such as component choice, delivery time, and ease of high-volume, rapid manufacturing influenced all aspects of the design process. This aspect of the design/innovation process is also discussed, as well as an introductory discussion on how training and simulations can be developed so that innovation can occur efficiently in future crises situations.
ABSTRACT
The novel Coronavirus can easily be transmitted from one person to another via respiratory droplets or direct contact with infected surfaces. Human beings have several common and shared objects that they touch daily. Door handles are among the most commonly touched surfaces. In this work, novel manufacturing solutions are developed for several hands-free door handles that were designed to reduce the COVID-19 disease vectors. In tandem with the design optimization activities, a rapid and low-cost tooling solution was developed leveraging additive manufacturing, ‘design for additive manufacturing’, and conventional design for assembly strategies. This rapid tooling approach is capable of molding high temperature thermoplastics as well as of introducing highly complex internal channels that can aid the cooling performance of the mold and component. For the case study, the mold is built in less than one week. The part geometry varied between 1 – 3% from the CAD model. The production time for a part is reduced from 3 hours to less than 2 minutes per piece. The material price per piece was significantly dropped. This solution introduces new design and manufacturing options to the engineering community. The case study highlights the merit of these approaches. © 2022 CAD Solutions, LLC.
ABSTRACT
Development of emergency use ventilators has attracted significant attention and resources during the COVID-19 pandemic. To facilitate mass collaboration and accelerate progress, many groups have adopted open-source development models, inspired by the long history of open-source development in software. According to the Open-source Hardware Association (OSHWA), Open-source Hardware (OSH) is a term for tangible artifacts - machines, devices, or other physical things - whose design has been released to the public in such a way that anyone can make, modify, and use them. One major obstacle to translating the growing body of work on open-source ventilators into clinical practice is compliance with regulations and conformance with mandated technical standards for effective performance and device safety. This is exacerbated by the inherent complexity of the regulatory process, which is tailored to traditional centralized development models, as well as the rapid changes and alternative pathways that have emerged during the pandemic. As a step in addressing this challenge, this paper provides developers, evaluators, and potential users of emergency ventilators with the first iteration of a pragmatic, open-source assessment framework that incorporates existing regulatory guidelines from Australia, Canada, UK and USA. We also provide an example evaluation for one open-source emergency ventilator design. The evaluation process has been divided into three levels: 1. Adequacy of open-source project documentation; 2. Clinical performance requirements, and 3. Conformance with technical standards.
ABSTRACT
COVID-19, which is rampant around the world, has seriously disrupted people's normal work and living. To respond to public urgent needs such as COVID-19, emergency supplies are essential. However, due to the special requirements of supplies, when an emergency occurs, the supply reserve mostly cannot cope with the high demand. Given the importance of emergency supplies in public emergencies, rapid response manufacturing of emergency supplies is a necessity. The faster emergency supplies and facilities are manufactured, the more likely the pandemic can be controlled and the more human lives are saved. Besides, new generation information technology represented by cloud computing, IoT, big data, AI, etc. is rapidly developing and can be widely used to address such situations. Therefore, rapid response manufacturing enabled by New IT is presented to quickly meet emergency demands. And some policy suggestions are presented.