A hospital’s Intensive Care Unit is often a harrowing environment, particularly when it involves patient care following a complicated brain surgery.
Patients who suffer severe head trauma, aneurysms, strokes, or brain tumors often undergo some form of neurosurgery, and the most common procedure therein is the ventriculostomy. Essentially, physicians create a small hole in a person’s skull to allow an external catheter, or tube, to be fitted and cerebrospinal fluid to be drained using an External Ventricular Drain (EVD). Typically, a healthy person produces and reabsorbs about a pint of cerebrospinal fluid a day, but that’s not the case for these patients, and this temporary medical device is enlisted to facilitate the process while the patient recovers. A ventriculostomy aims to relieve intracranial pressure and prevent hydrocephalus, or the atypical buildup of fluid on the brain. It also can prevent secondary brain injury or death. If you are familiar with the term “water on the brain” or have seen disturbing images of infants and small children with enlarged heads suffering from the condition, then you are familiar with hydrocephalus.
For the procedure to work properly, patients must remain in one position (lying down, typically) and immobile while they recover. If they sit up, roll over, or move in any other way, fluid levels must be adjusted by moving the EVD up and down along an IV stand to accommodate for the change in cranial pressure. Even a patient’s cough can alter fluid levels and create a dangerous situation if the device isn’t releveled.
This form of patient care requires supervision on a nearly 24-hour basis as nurses and physicians monitor the situation to make sure pressure readings are accurate and fluids are properly draining on an hour-to-hour basis. It is also susceptible to human error. And limiting a patient’s mobility likely increases other health maladies, such as pneumonia or deep vein thrombosis.
Dr. Samuel R. Browd is familiar with this scenario. It’s a particular challenge for some of the youngest patients, a demographic he treats every day as a pediatric neurosurgeon at Seattle Children’s Hospital.
“Kids are pretty hard to keep still,” said Browd. “Kids want to move around. It becomes a situation where we are sedating the kids or really having to do one-to-one nursing to really be able to manage the kids. It really creates a friction for the family and the nursing staff.”
What’s more, the device used to monitor and drain the patient’s cerebral spinal fluid was invented 60 years ago. A stand-mounted laser level was added 15 years ago to help calibrate pressure readings, but it did nothing to increase patient mobility or decrease the level of one-to-one patient care. For the most part, the device’s circa-1950s technology remains the same today.
Browd and a team of researchers, physicians, and engineers are determined to change this.
Seven years ago, Browd began a discussion with Dr. Barry Lutz, then an assistant professor at the University of Washington, to determine how this situation could be improved, and in 2013, Browd and Lutz partnered with Tom Clement, an expert in the field of biotech medical devices, to form Aqueduct Critical Care and start to build a better, smarter, and automated device that would improve the quality of care for patients who undergo ventriculostomies.
Folding Clement’s business acumen and connections into the equation was key, according to Browd.
“(Tom is a good) business guy who can make the science real,” said Browd.
“That trifecta of getting a physician with an engineer, and then partnering with a business guy, is a very powerful thing.”
Clement’s career in the field dates back to the early 1980s, when he was a graduate student at the University of Washington and working under the advice and mentorship of electrical engineering professor David Auth. Auth encouraged his students to move their best engineering ideas from the classroom to the real world and develop practical solutions that could be brought to market in order to serve the broader public.
Clement went on to help develop eight products over the past three decades that have helped doctors, nurses, and patients in the fields of interventional cardiology, radiology, gastroenterology, vascular surgery, and neurosurgery. Most notably, Clement, who earned a master’s degree in electrical engineering from the University of Washington in 1982, was hired by Auth to help build Heart Technologies. The Redmond-based company developed the patented Rotablator — a tiny, high-speed, diamond-tipped drill that clears plaque-choked arteries without damaging healthy tissue.
“It was really interesting for me as a young person to watch the process,” said Clement. “The day I walked in, I was the second employee and there was a room about 1,000 square feet with six tables. David (Auth) walked in, handed me a bunch of catalogs, and said, ‘Start buying stuff.’ We had nothing in the room. It was all from scratch. But we knew the concept, and David had already developed a proof of concept prototype and filed patents on the concept. We just had to get the right tools to build it and test it.”
Over the course of 13 years, Heart Technologies grew to employ 550 people, occupy a 200,000-square-foot manufacturing facility, and generate $100 million in annual sales. It was purchased by Boston Scientific Corporation in 1995.
Three years later, Clement co-founded Pathway Medical Technologies and was the company’s CEO while it developed a more high-tech and innovative expandable drill to clear arteries in legs. The company was purchased by Bayer in 2011.
By then, Clement was the director of new ventures for life sciences at the University of Washington Center for Commercialization. His job was to look at some of the biotech ideas coming out of the university and see which ones could be viable in the marketplace. Clement was essentially scouting for university-based biotech startups.
It was in that environment that Clement met Browd and Lutz, who described the problem associated with the outdated external drain, and how a new device was needed.
“I heard the story, I liked these guys a lot, and I loved their vision and the way they worked together. I offered to join them,” said Clement one recent weekday morning in his office at Aqueduct Critical Care’s Bothell headquarters, which resembles many bootstrapped startups. The company started out with three employees crammed into a 500-square-foot office. Today, Aqueduct Critical Care is still lean — recently, Clement and his team of engineers were pleased to score office furniture for cheap — but now occupies 4,000 square feet in an office park along North Creek Parkway. Most of that space is devoted to manufacturing in clean rooms and testing facilities.
“We think we are going to have a dramatic impact on the safety of the most commonly done thing in neurosurgery.”
How does the new device compare to the existing EVD currently used in hospitals?
Clement answered that question by pointing at one of the devices currently used in hospitals, which was leaning against a wall just inside his office door. It was an odd-looking, rudimentary contraption that resembled a draftsman’s T-square outfitted with hoses and a collection bag. It looked like it belonged in a medical museum instead of hospital ICUs.
Aqueduct Critical Care’s Smart External Drain is a reusable console that sits firmly on an IV stand; measures 18 inches wide and 6 inches tall; and resembles a small, white microwave oven. It might look like a small box, but it’s doing the work of a team of nurses. The device features touch-screen programming, automatic controls, and high-technology sensors that continuously monitor a patient’s cerebrospinal fluid levels and make adjustments as needed. A single-use, disposable cartridge connects the console to a tube that exits the patient’s head.
Strict immobility is no longer required. Instead, a patient can turn over, sit up, or even engage in physical therapy while the machine adjusts the fluid levels automatically and accordingly.
“With our Smart External Drain, if a patient is otherwise healthy, if they are not tied down to another machine, they can stand up and walk with their IV stand, exercise, or even go to the bathroom on their own without a nurse having to relevel their drain or shut it off,” said Clement.
The machine can also signal an alarm that alerts doctors and nurses if there are any unusual fluid level changes or activities.
Aqueduct Critical Care employs 13 people and has raised nearly $9 million through angel investors and a major medical device manufacturer. Clement expects it will cost an additional $6 million to $7 million to bring the Smart External Drain to market. The company has already received one level of FDA approval, and is poised to begin its first human-based studies this year.
Clement and Browd hope to see the device in hospitals by the end of this year.
“It’s a nice opportunity to use the technology that we are developing for a very common thing that has huge benefits to the patient,” said Browd. “We think we are going to have a dramatic impact on the safety of the most commonly done thing in neurosurgery. The opportunity here is very broad.”