The PORSAV project, an initiative developing new technology to protect surgeons and patients from COVID-19, has received 2.4m euro in support from the European Commission. The rapid 18-month effort is being led by Irish SMEs Palliare Ltd and Pintail Ltd, in collaboration with University College Dublin, as well as Polish medical device manufacturer SteriPack and IRCAD, a leading French institution for surgical training.
When surgeons perform laparoscopic (‘keyhole’) surgery, they operate through a small hole in the body. Surgical instruments and cameras are operated through a tube (the ‘trocar’) that holds the incision open. The patient’s body is inflated with carbon dioxide gas, to give the surgeon room to see and to operate. However, small amounts of this gas can escape around the edges of the trocar and be released into the air of the operating room.
In the time of COVID-19, these aerosols can contain viral particles, endangering surgeons and depositing the virus on operating room surfaces. The threat of these viral aerosols has a huge impact on the frequency and availability of surgery, appropriate safety protocols, and the time it takes to clean the operating room between procedures.
With the aid of the critical new EU funding, the PORSAV project will address this problem through a new technological solution, by bringing together the expertise of European leaders in medical device manufacturing, and academic leaders in digital surgery and engineering research and innovation.
Palliare has developed a vacuum ring, the LeakTrapTM, which captures stray air leaks that occur around the edge of the tube or the incision, and pipes potentially infectious air away for correct disposal. A similar device (the EndoTrapTM) protects gastroenterologists performing endoscopies from the breath, coughing or sneezing of their patients. The PORSAV project will produce thousands of LeakTraps and EndoTraps, and will see them used in operating rooms around the world.
UCD researchers will carry out extensive clinical validation of the new product. Dr Kevin Nolan from UCD School of Mechanical and Materials Engineering brings optical expertise to develop portable, innovative imaging technology for the operating room, to accurately characterise and measure the potentially hazardous invisible gas leaks. The UCD team – at the UCD Digital Surgery unit, led by Professor Ronan Cahill – will then carry out clinical trials in conjunction with the Mater Hospital to test Palliare’s new devices in real time.
Investigators Prof Bernard Dallemagne and Prof Silvana Perretta will direct a second trial at IRCAD and will use the new technology and information to train surgeons around the world on how to reduce the risks of COVID-19 in the operating room. SteriPack will mass-produce the disposable tubing in Poland, while the vacuum technology is manufactured by Palliare in Galway. Pintail will provide project management and administrative support.
Palliare co-founder, John O’Dea said: “For several months after the pandemic started, surgical procedures stopped due to concerns around risks to hospital staff from aerosolized virus. We are delighted to have assembled such an outstanding multi-disciplinary team and are grateful to the European Commission for the support to conduct this research and development project aiming to make surgery safer during this and future pandemics. Surgery can’t stop!”
“Our experience in Med Tech innovation has always been that the progress of any significant medical device hinges on the collaboration of passionate clinicians and passionate engineers. Palliare has found such a passion for clinical innovation in surgery and for active publication in Professor Ronan Cahill at UCD and Professors Perretta and Dallemagne at IRCAD in Strasbourg. We are excited about moving forward in researching and trialling new surgical devices with these innovative physicians.”