Inventors Create BayWin Closed Circuit Valve to Protect Patients and Caregivers

For two decades, Dr. Harry Bayron and Neil Winthrop worked to reimagine a safer ventilator valve so providers could easily treat patients and protect everyone in the room. Then came a chance online mention of the Innovation Lab – and the novel coronavirus pandemic.

Bayron, a retired pediatric cardiologist, and Winthrop, a respiratory therapist, had long tinkered with this invention, but had shelved the idea after an earlier licensing partner dropped them upon the arrival of a new CEO. After a few years, the Florida-based duo reassessed their arsenal of pending ideas to improve healthcare delivery. What stood out as the product with the best go-to-market viability: the BayWin Closed Circuit Valve.

COVID-19 upped the ante on risks with infected aerosols released into the air when caring for patients on respirators. Providers often need to suction airways or move ventilated patients to other areas of the hospital for treatment. With common valves used today, each treatment or movement means the patient’s ventilator circuit must be broken. Some treatments require patients to cough, with contaminated particles ejected at up to 150 miles per hour. Each action creates risks for caregivers, evidenced by 1,700 front-line health worker deaths in the pandemic’s first six months.

Bayron and Winthrop developed the BayWin Valve with a series of ports that can be easily opened and closed when new devices are attached. Those include a resuscitation bag port to transition to manual ventilation. An elbow adapter with an integrated suction/bronchoscopy port allows for medication delivery and pulmonary function tests without disconnecting the ventilatory circuit.

The two inventors hold five patents on their design. Before COVID-19, 40% of ICU patients required mechanical ventilation. As patient volumes escalated during the pandemic, the Lab was instrumental in securing emergency U.S. Food and Drug Administration approval on the valve.

While the pandemic delivered a valuable kickstart to production, Bayron and Winthrop initially developed their device to eliminate multiple circuit disconnections associated with conventional valves. Beyond the risk of exposure to patients and staff to airborne contaminants, those breaks release air pressure that is critical to preventing respiratory infections, which nearly half of these patients experience, requiring longer hospital stays. Maintaining pressure while delivering treatment could help shorten recovery time.

As a follow-up to Winthrop presenting the BayWin Closed Circuit Value at the Lab’s Online Technology Showcase in early October, the inventors recently shared their experiences in bringing their idea off the drawing board and partnering with the Innovation Lab. Here are highlights of our conversation.

How did you come up with this idea?

Bayron: I was caring for a newborn in the Neonatal ICU with pulmonary hypertension. The patient was extremely unstable, which made treatment difficult to carry out without exposing him to sudden decompensation. The intermittent drops in PEEP and the ensuing drop in oxygen saturation during this necessary treatment were creating the perfect storm.

I had given instructions to the respiratory therapist not to suction the baby and to keep him well oxygenated. The team got increasingly nervous because the patient developed a substantial amount of secretions in his airways. A decision was made by the team to suction the patient. The procedure destabilized the patient, and his oxygenation dropped abruptly. I was called back to the unit, and we did everything we could to bring the patient back. Unfortunately, all efforts were unsuccessful.

I started thinking about a closed-suction system where we could treat a patient without having to open the respiratory circuit. Soon after, I met Neil. Both of us had lots of ideas, and we combined our independent expertise. I suggested the concept of a valve with multiple ports. He initially came up with this version of the valve design, and we worked from there to develop something useful and easy to operate. We wanted it to be able to be manufactured with relative ease and built it so its aftermarket price could be reasonable. Our primary goal continues to be to deliver safe treatment to patients and to protect providers.

How did you get from this concept to something tangible?

Winthrop: From the first initial idea to create a concept, it took about nine months. We were constantly looking at all options and possibilities. And the first idea that we came up with, it honestly wasn’t the best.

Bayron: We realized that it wasn’t safe. And we came to another one that was a little bit safer. And the third version – that was definitely safer. We said, “This is what we want. Now, what do we need to do to make this unique?” From that point to producing working prototypes took another five or six years. This involved not only designing, but talking to and finding the right people who could make a capital investment.

What makes the BayWin Valve so revolutionary?

Bayron: There’s a company that currently markets a closed circuit system, and it’s extremely simple. That’s the industry leader. Then one day, I was in our patent lawyer’s office. He looked at me and said: “You don’t realize that you’re pioneers in this area.” He searched everything regarding this line of product. With that existing product, you still have to open the system to perform several procedures. What’s revolutionary about our device is that it’s the first true closed-suction system.

Winthrop: When you have a device like this, it’s connected to a breathing tube that’s connected to a ventilator. So when you want to do certain procedures, such as a suction maneuver while giving positive pressure ventilation with a resuscitation bag, this mimics a cough effect when a patient is on a ventilator. When a forceful exhalation is produced, it brings the mucus up from their chest and you can suction it with the catheter. You never break the circuit, and it’s a truly sealed system. You can disconnect the device, and no one in the room is going to get contaminated.

COVID-19 brought a lot of attention to risks with respiratory therapy and ventilators. How did that expedite your development?

Winthrop: As a clinician, I still work at the bedside, taking care of sick patients. Right when COVID-19 came up, we were already in discussions with the Innovation Lab. Leaders there recognized problems with cross-contamination and that we had to get to the marketplace quickly. Because of all of our work over the year, we had everything in their hands to make prototype molds.

Tell us about your experience with the Innovation Lab. How did you make your initial connection?

Bayron: I was doing some computer work, and the Innovation Lab name popped up. I started to research them, and I looked at and liked their model. After calling Neil, I called the Lab and explained what we were doing. The Lab team said they’d never received an invention so advanced in research and development as ours.

We had a lot of information to share regarding the mechanical and physiological effects of the valve. In addition, we had a significant amount of information obtained from several meetings with focus groups. Their assessments of the valve inspired us to keep moving forward. We also sent our one remaining functioning prototype to the Innovation Lab for evaluation. They were amazed that we’d done all this by ourselves.

The Lab has built a comprehensive idea-to-commercialization process. What’s the most important thing you gained from working with the team?

Bayron: It’s a challenge sometimes to explain to somebody who isn’t a physician or an engineer what you’re trying to do. That wasn’t a challenge at the Lab. I loved talking to different people who were giving their input into how to make our idea better. And talking with engineers helped me understand how they think about the world – that there are multiple pieces in this puzzle.

Winthrop: Being a bedside clinician, I worked to help the engineers understand the many bells and whistles we wanted on this device – and to fit them with industry standards. For example, this device has an elbow. But if you notice, the elbow can only go on one way. By adhering to ISO standards, we take out the risk of providers connecting different devices in the wrong way and creating other issues. It was nice to work with people who listened to us and who shared our commitment to make sure that by the time we got this in the hands of other clinicians, it was safe, intuitive and ready to go.

Patient pilot studies with this device continue, and the Lab is filling five hospital orders. What feedback have you received from the front line?

Bayron: What we hear from most respiratory therapists – and especially those in COVID wards – is they don’t want a ventilator set up without this device on it because they feel that there’s so much more protection. A lot of nurses told us that when they suction a patient, they have to break a circuit on existing systems to clear out the mucus. In doing so, everybody in the room runs the risk of contamination. Now we have clinicians who are using our valve and teaching nurses how to bag and suction a patient without ever having to break the circuit. That makes them more comfortable and reduces the chance of someone else in their hospital getting sick.

Winthrop: After the first batch was distributed, we learned that a piston sometimes didn’t pop back up completely – maybe it only goes to 90% open as we put someone back on a breathing machine. That didn’t put the patient at any risk, but we needed to solve for that. We mentioned it to the Innovation Lab, which immediately modified the spring-loaded system, and we haven’t heard any issues with that second generation.

You’re both “idea men,” looking for ways to improve healthcare. What is one tip you would offer to someone who might think they have a great idea – and to someone who doesn’t think they could invent anything new?

Bayron: Whatever you create becomes the best thing after sliced bread for you. And sometimes, if you don’t check your ideas and your own emotions, you can become the worst obstacle and bring a bad invention to market. You feel like what you create is the best and no improvement can be done and you’re simply at the end. And to the other part of the question, people encounter problems every day in life and they’re figuring out ways to them. You might not have a huge invention at first, but if you do that regularly, you can create bigger things.

Winthrop: An inventor that I became close with over the years created the nebulizer “T” adapter. The first thing he said to me when I wanted to present this invention to his company was, “Give me your name and address so I can send you a confidentiality letter.” As an inventor himself, he realized how important it was to have a non-disclosure agreement (NDA), and he wanted to protect me, which was greatly appreciated. It’s very important for anyone to have when working on a new product and with others to protect your idea.

Would you recommend that other idea people reach out to the Lab?

Bayron: The beauty of the Lab is they have a team that works with you and your concept. As part of the Innovation Institute, they work with seven different hospital systems at a minimum, so they have providers that they can bring products to for evaluation. With teams for marketing, research development, engineering, testing, clinical trials, FDA approval – they offer everything you need.

 

Interested in submitting your idea on changing healthcare? Contact the Innovation Lab to learn more and speak to someone from our team.