Charged Concepts:

Collaborating to Combat COVID-19

The Call to Action

Turbulent and uncertain times can lead to standstills, but sometimes also lead to the best in humanity working together, integrating technologies, and expediently arriving at innovative and impactful solutions. To contribute to the fight against the global pandemic, we at Charged Concepts began in March by organizing a volunteer- and donation-based program to sew and distribute cloth face masks to healthcare workers, first responders, and essential service workers nationwide. We additionally recognized that we could apply our collective expertise in medical device design towards developing some much-needed hospital equipment for treating COVID-19 patients.

After deciding to take action, however, our team was faced with a challenge: What type of technology would be most useful in fighting the virus?

Planning Our Move and Exploring Alternatives

In the early months of the pandemic, it was widely believed that traditional mechanical ventilator machines, requiring patients to be sedated and intubated, were the key to fighting the virus. In response to a nationwide shortage of such devices, many companies immediately shifted development and manufacturing focuses towards the production of parts to create more mechanical ventilator machines. While Charged Concepts initially considered making ventilators as well, we decided to get some first hand feedback before beginning development, in order to confirm that our efforts would not be misplaced. We reached out to doctors and nurses working in the frontlines at Jacobi-Montefiore Hospital and North Central Bronx Hospital in New York City, who urged us to explore non-invasive helmet-based ventilation systems, rather than develop more standard ventilators, which had shown an alarming mortality rate as high as 88% in a study of some New York City hospitals during early interventions.

Non-Invasive Helmet-Based Ventilation: How it Works

While preliminary findings indicated that COVID-19 primarily affected the respiratory system, some of the medical community now recognize that the Coronavirus can affect patients’ blood by inhibiting hemoglobin’s ability to bind to oxygen, limiting the quantity of oxygen delivered to the brain and other vital organs. Lack of oxygen produces respiratory distress and blood clots, which can lead to organ failure, strokes, heart attacks, death, or long-term impairments even if patients survive.

Non-invasive (NIV) helmet-based ventilation systems address the core of the oxygenation problem by pumping oxygen-rich air to COVID-19 patients through “bubble helmets” at elevated pressures, without the need for sedation or intubation. The oxygen-rich environment ensures that the patient gets the oxygen they need to help their body heal naturally, while the helmet itself additionally serves as a small quarantine zone, limiting the spread of the virus to surrounding areas. Patients receiving this type of treatment typically recover within 2 weeks, showing few to no side effects.

The NIV helmets have been subject to a three-year study at the University of Chicago, and have been utilized for decades in Italy for other conditions. While these treatments are promising, widespread awareness and adoption have still been limited.  Click here to learn more about Helmet-Based Ventilation.

Clarifying Project Needs through Expert Feedback

Aurika Savickaite, MSN, RN, an expert in NIV helmets who worked on the University of Chicago study, told us that, while many manufacturers are beginning to produce these bubble helmets, many medical professionals are reluctant to utilize this type of medical intervention without the monitoring and alarm systems they are accustomed to. The currently-available bubble helmets lack integrated monitoring technology, requiring overloaded nurses and doctors to frequently check patients, analyze their conditions inside the helmet, and make changes to their treatment.

Concerns for how quickly some of these patients could destabilize if conditions were not properly maintained are also a barrier for adoption.

Our team sat down with Aurika and helmetbasedventilation.com to discuss the project. See the interview here.

Establishing Project Aims

Having established a defined need, we began development work, while also amassing additional subject matter experts and collaborating organizations. We set out to architect a monitoring and alarm system for NIV helmets that would achieve the following aims:

  1. Increase safety and efficacy
  2. Make monitoring and treatment of patients easier for healthcare professionals
  3. Increase access to and adoption of NIV helmet ventilation systems in both developed and developing countries
  4. Securely archive treatment data for iteration of treatment protocol as well as retrospective studies 
  5. Serve as a flexible architecture to control additional NIV helmet functions and peripherals, such as proning pillows
  6. Decrease treatment cost and resource use

Concept designs for “proning pillows” to be used with the NIV helmets

Communication & Collaboration: Helium Systems

Recognizing that communication and data transfer were both critical components of this system, we reached out to Helium Systems. Upon hearing about our plans in the fight against COVID-19, Mark Phillips, VP of Business Development at Helium, pledged to have Helium Systems help the Charged Concepts team in whatever ways they could, by leveraging their LoRaWAN communication and transmission technology.

LoRaWAN’s low bandwidth, frequency, and power consumption, coupled with its end-to-end encryption and long-range transmission ability made it an ideal solution for networked systems in both RF-unfriendly environments such as steel and concrete hospitals with heavy electronics noise as well as in rural pop-up hospitals lacking infrastructure in continents such as Africa and South America. Importantly, because the Helium Network has rapidly grown over a short period of time, it can be put to ready use with our system and will be a strong indicator of the rapid deployment and scalability of the technology.

Click here to learn more about Helium and how we are partnering.

Prototyping the System

Since partnering with Helium Systems, our team, with the help of Helium Developer Growth Lead Travis Teague, has created working prototypes of the end-to-end monitoring and alarm suite that can be retrofitted to the generic NIV helmets from various manufacturers. The system utilizes sensors to monitor flow rates, oxygen levels, pressure, temperature, and carbon dioxide concentrations. Data and alarms on the unit are passed to healthcare workers via central monitoring stations and mobile devices and archived for further processing or study.

The prototype sensor and alarm suite in its current form

Charged Concepts Chief Medical Officer Dr. Dave Altobelli tests out the prototype system

A CAD model of the next-generation prototype

Interested in Helping Out?

Charged Concepts is currently seeking funding and additional strategic partners to translate the concept demonstrators into commercial products, perform clinical testing, obtain FDA Emergency Use Authorization, and manufacture in volume.

If you would like more information or can help, please contact the Charged Concepts team at info@chargedconcepts.com  

Charged Concepts and Helium Systems would like to acknowledge and thank the following organizations for their contributions to this project: Helmet Based Ventilation, SparkFun Electronics, ReSound Clinical and Regulatory Consulting, VFX Lab, Saigon South International School, Integron, Sgnl24, Cantina Films, Companies of Nassal, and NASA.

“It is truly humbling and inspiring to be working with exceptional individuals and companies across the U.S. and as far-reaching as Vietnam. We know that the time, energy, and investment put forth now will be rewarded with lives saved, advancements to science and technology, and enduring containment and treatment solutions for COVID-19 and future illnesses that we may face. Charged Concepts is proud to be the first to deliver medical technology incorporating Helium, and we are excited about the expansive possibilities and our future family of solutions built in collaboration with Helium Systems.”

Wayne Penn

Founder and CEO, Charged Concepts