Background and problem statement
The novel coronavirus (SARS-CoV-2) swept around the world, infecting millions of people in nearly every country in the world. The disease it causes, COVID-19, has a range of impacts on its victims, with the most serious cases suffering from severe pneumonia and lung damage.
These most severe cases require clinical intervention to keep patients alive, with a primary means initially being the use of continuous positive airway pressure (CPAP) machines and ultimately invasive ventilation to ensure the patient receives enough oxygen, and is able to breathe despite associated edema. Although it is only a small percentage of patients that require these extreme measures, the rapid rate of transmission of the virus has created situations whereby ICU and ventilator capacities that would normally be adequate for a given population size are overwhelmed and patients cannot get access to this life-saving therapy.
Because modern ventilators are complex, highly-regulated and expensive devices, their manufacture cannot be quickly scaled to meet this demand in time to be effective, especially if the production is centralised and controlled by several key market players who compete using incremental technological improvements. This creates problems of accessibility of available products. Equally problematic is that the component parts of these systems are themselves in short supply as the entire medical supply chain has been stretched by the epidemic. There are also intellectual property, distributorship, repair and other legal impediments to scaling the manufacture of ventilators or their component parts.
The community response has been for students, tech companies, and others to develop ‘ad-hoc’ ventilators to try and bridge the gap. In addition, to help solve the problem, special regulatory provisions were introduced to ease the minimal standards for “pandemic ventilators”. To date, none have been widely adopted for several reasons. First, many use ambu-bags and other equipment sourced from the same stretched medical supply chain and thus are unable to get parts. Second, clinical data has shown that patients with severe COVID-19 pneumonia have very fragile lungs, and improper ventilation can cause significant additional damage, actually worsening the outcome for the patient than if they had not received ventilation at all. Most of the ad-hoc ventilators proposed to date lack the fine control, measurement and feedback systems required to ensure they are not injurious to patients and have thus not been adopted by the medical community.
In response to the urgent need for ventilators, the PolyVent project was formed. The core team is composed entirely of volunteers from the engineering, technology, medical device and clinical industries, as well students and entrepreneurs.
Current challenges that inspired us:
- Global shortage of ventilators due to the COVID-19 pandemic is causing preventable loss of life.
- Limited ventilator supply as the existing clinical ventilators are too complicated to manufacture, and improvised ones do not conform to the minimal clinical standards.
- Most of the ad-hoc ventilator designs do not meet the minimal standards or are non-scalable.
- We need alt-routes for acquiring ventilator components as the medical device manufacturers and supply chains are strained and broken at many places.
- We are facing an unprecedented crisis of our lifetime. We need to revise our production strategy to solve the logistical imbalance.
- Lack of timely delivery due to entrenched bureaucracy, IP and distributor/repair issues.
- Difficulties in global R&D aggregation and adoption into production.
PolyVent operates like a bridging initiative between multiple semi-autonomous geographical clusters, centred around one adaptable design blueprint. The idea is to allow creation of locally tailored variants of the ventilator, to increase chances of it getting to actual patients.
To join our team as a volunteer or a partner, please reach out to us here: https://www.polyvent.org/join-our-team-1
Our primary goal is to design a ventilator that:
- Meets patient safety standards in terms of monitoring, durability and resilience.
- Provides appropriate levels of clinical control to maximize therapeutic value and minimise risks to patients.
- Is easy to use and intuitive for experienced users as well as non-experts (thus freeing up expert clinicians for more demanding tasks), but also offers the ability to control advanced parameters to maximize patient benefit.
- Enables integration of a wide range of widely-available parts, components, materials and their manufacturing methods. For example: 3D printed or machined parts wherever possible to enable small-scale production, avoid supply chain bottlenecks, IP and licensing issues, and leverage under-utilized industrial manufacturing capacity.
- Has a modular design to simplify manufacturing and maintenance, and permit modules to be locally improvised based on part availability while still interfacing with the rest of the machine.
- Is based on a fully digital model, such that the impacts of utilizing alternate parts can be modeled and compensated for in the operating software without compromising performance.
- Can be manufactured at large scales using injection molding, stamping, casting, and other mass production methodologies.
- Has a robust digital control system, with the potential for remote monitoring as well as cloud-based data aggregation for performance and maintenance analytics, as well as collecting anonymized clinical data to provide large-scale cross-sectional and longitudinal data on patient outcomes.
- Is entirely open-source (software and hardware), with designs freely available worldwide.
To ensure the design becomes a reality, our secondary objectives are:
- To build supporting systems for design implementation, validation and monitoring.
- To create a scalable worldwide community platform to identify shortages, support the creation and dissemination of ventilator-related R&D, and to channel human and other resources. Such an international community will cut through the existing economic, social and political barriers and help innovators around the world to work together to address this problem effectively.
PolyVent ventilator specifications
PolyVent is a robust mechanical ventilator design formula for an emergency production scenario, which provides needed functionality, flexibility and adaptability based on the regional production and supply chain capabilities. A central mathematical blueprint provides a known degree of flexibility within the functional limits of the design. Highly modifiable, the basic design includes two independently-controlled air-pumping bellows driven by linear actuators. The system includes a multi-functional Venturi-based pressure/flow/volume sensor, an air-mixing and filtering system, an O2 concentrator integration possibility an electronics interface with optional GUI controls. Suitable for mass-production, PolyVent is a multi-modular concept, aiming to ease the pressure on the healthcare supply chain, and aid in repair and replacement needs. Parts can be ordered from existing suppliers outside the healthcare chain, manufactured from a variety of materials and with a wide range of methods. The design aims to avoid IP issues and to allow unrestricted global access and implementation.
Designed for respiratory support modes: Synchronised intermittent mandatory ventilation (SIMV) Volume control ventilation (VCV) Continuous positive airway pressure (CPAP)
Current and Incoming Collaborations & Ventures
As one of the winners of the EUvsVirus Hackathon we have now moved on to the matchmaking process. We have received a significant number of interests and offers from Institutional entities. We are in the process of solidifying our stance and direction of PolyVent prototyping, validation and production. We list here our ongoing progress with our partners:
State University of New York, Canton: Agreed to prototyping and validation
Netherlands Enterprise Agency: Offered support with project funding consultations
Grand Garage, Austria and the City of Linz: Discussions on hosting the European cluster of the project
Engineers Without Borders, Netherlands: Agreed to provide organisational structure for our group under their umbrella
Engineers Without Borders, USA: Discussions on partnership
COSYLAB Switzerland: Agreed to support with R&D and certification consultations
SIRIUS Global: Agreed to support in establishment of academic partnerships and other contacts
Cardiff University, UK: Agreed to do the flow simulations of the system
Fonly LLC: Agreed to provide a unified electronics manufacturing blueprint for the control system
CEU InnovationsLab, Hungary: Discussion on networking possibilities
NYU STERN BERKLEY Innovation Lab, New York: Discussion on organisational structure
Inter University Centre for Astronomy and Astrophysics, Pune: Pledged for infrastructure and startup facility
Wrike, Netherlands: Provided free access to their project management software