For patients that require mechanical ventilation, the closed ventilator circuit is used to maintain a normal respiratory-metabolic function. Endotracheal suctioning is an essential component of intubated patient care and 'closed suction‘ systems enable saline lavage and the removal of airway secretions without disconnecting the patient from the ventilator circuit.
However, deep suctioning, bronchoscopy, some drug delivery, lung measurement studies and manual ventilation/resuscitation procedures require the circuit to be opened. This ventilator circuit break carries several critical risks for the patient, including desaturation of oxygen levels, potential loss of positive-end respiratory pressure that may lead to lung collapse and infection/cross contamination. The healthcare provider is also at risk from infection when the ventilator connection is removed, as moisture from within the tube may spray out onto the provider. By far, the major risk associated with mechanical ventilation is the development of ventilator-associated pneumonia.
The Baywin Valve maintains a closed ventilator circuit to accommodate deep suctioning, medical procedures, lung measurement studies and manual ventilation without the need to open the circuit. It allows for a seamless transition between mechanical and manual ventilation. Two issued US patents (6,886,561; 8,656,925) and corresponding patents in Europe and Canada cover key features of the design. Innovation Lab has also filed an international patent application to protect recent design improvements.
The product has not been cleared by U.S. FDA.
Neil Winthrop has witnessed the consequences for both the patient and caregiver that result from having to regularly open the ventilator circuit. His desire to protect patients from the risk of airborne infections, cross contamination, loss of PEEP and oxygenation - issues that can be catastrophic in these vulnerable patients - led him to design the Baywin Valve in collaboration with Harry Bayron. Neil and Harry also wished to protect the caregiver from the risk of infection they run upon opening of the ventilator circuit. Often, due to the high pressure within the circuit, secretions that have built up in the system are catapulted into the air upon opening and result in the spread of infection to the healthcare provider and contamination of the space around the patient. Together, they designed the Baywin Valve to overcome these problems and to provide an improved device for better patient outcomes and a safer working environment.
Approximately 40%, or 1.65 million ICU patients are mechanically ventilated in the US each year. Closed suctioning systems are widely adopted, and closed suction catheter market has an estimated value of over $44m and a CAGR of 2%.
About the Innovators
Harry Bayron, M.D. is a Pediatric Cardiologist and a Pediatrician. He completed a Pediatric Cardiology fellowship at the University of Miami and Pediatric Training at the University of Connecticut. He established the first ever Pediatric Cardiology practice in Palm Beach County, Florida and expanded the practice to three adjacent counties. Dr. Bayron is now retired, but continues his involvement in medicine as a consultant and a medical director. His passion for innovation began when he was a Pediatric Cardiology fellow. Dr. Bayron continues to innovate new devices for the advancement of medicine and improvement of medical care.
Mr. Neil Winthrop is a Registered Respiratory Therapist (RRT), Pediatric Perinatal Specialist, and Certified Hyperbaric Technologist. He currently works at St Mary’s Hospital, West Palm Beach, FL where he utilizes his clinical skills in all areas of the hospital as well as for air and ground transport and hyperbaric medicine in a multi-place dive chamber. His passion for patient care and inventing comes from an injury when he was young - the reminder of the care and compassion he received then led him to design his first invention over 20 years ago a CPAP device to help patients in neonatal intensive care. Neil Winthrop is married to his best friend Kimberly and they have three sons Max, Jake and Philip.