Unique Negative Pressure Ventilator System to Advance into Production and Clinical Trials

Positive pressure ventilators (PPV) are commonly used in healthcare, but they have limitations that could potentially be addressed by negative pressure ventilators (NPV). NPVs have a long history of effectiveness in treating various conditions like acute respiratory failure and neuromuscular disorders, but they've been largely overlooked since the 1960s due to the rise of more compact PPV devices. Recent research suggests that modern NPVs, especially those that cover only the torso, could offer a more comfortable alternative to Continuous Positive Airway Pressure systems (CPAP), which typically require a mask. Now, a novel NPV system that was initially proposed and designed by a team of anesthetists, critical care consultants, medical clinicians, and engineers in response to the COVID-19 crisis is all set to advance into initial production and first clinical trials.

Portsmouth Aviation (Hampshire, UK) has appointed 42 Technology (42T, Cambridgeshire, UK) as a strategic development partner to help roll out its unique Exovent NPV system. 42T has been tasked with designing and developing the control unit, monitoring, and alarm system for the new ventilator, including system hardware, firmware, and strict regulatory compliance. Medical device engineers from 42T will then collaborate with Portsmouth Aviation and clinicians from the Exovent charity to integrate the control system into the ventilator.

Unlike PPVs which often require patients to be sedated and undergo intubation or a tracheostomy to bypass the oral-nasal route for breathing, NPVs may offer a more 'natural' form of breathing. This could translate to clinical advantages, such as minimizing the risks of lowered cardiac output, hypotension, or lung injuries related to ventilator use. An NPV system could even potentially prevent the worsening of a patient's condition, thus eliminating the need for invasive methods like intubation and PPV mechanical ventilation.

The Exovent NPV system in development is a lightweight device that encloses a patient's torso from the neck to the hips. The device allows patients to eat, drink, and converse while receiving ventilation, unlike PPV systems where patients generally have to be sedated and intubated or wear a mask. 42T's involvement with Portsmouth Aviation builds upon a prior project in which the consultancy had reviewed and suggested improvements to the Exovent NPV control system. These enhancements focused on the segregation of the monitoring/alarm system, main controller, pump assembly and user interface (HMI) into separate components. This new approach aims to reduce dependency on safety-critical software, cut down on developmen risks, and expedite the product's development, all while maintaining safety and security.

“42 Technology will play a pivotal role in developing the control system for the Exovent ventilator, and their medical device engineering and regulatory experience will be essential in helping us to advance it into initial production and first clinical trials,” said Simon Escott, managing director of Portsmouth Aviation. “42 Technology’s appointment follows a complete review of the development program and series of improvements that we decided to make to the initial designs for the new ventilator. We have worked closely with the team at Exovent to improve key aspects including the usability and aesthetics of the patient enclosure, noise levels and the seals around the patient. We have also modified the design so units can be more easily and cost-effectively manufactured using our existing in-house production technologies and teams.”

Related Links:
Portsmouth Aviation 
42 Technology