A modified catheter invented by a Sanford Health physician to reduce pullout injuries has been licensed by a company whose founder co-invented technologies for the angioplasty balloon and coronary stent.
Bruce Gardner, M.D., a radiologist at Sanford Health in Bismarck, North Dakota, developed the investigational catheter after numerous attempts. It’s designed to allow for the retention balloon inside a person’s bladder to deflate nearly instantaneously when tension is applied to the external tubing. He calls his invention the Safety Foley Urinary Catheter.
InnoCare Urologics LLC has agreed to develop, manufacture and sell Gardner’s device.
“It’s amazing,” he said. “It’s exciting to see it come to this point and now on the road to being used by patients and benefiting patients. That’s what the goal was from the beginning.”
Millions of people use Foley catheters. Dislodgment usually occurs when someone is confused or because of discomfort. It can also happen when patients trip or step on the bag or hose and when transferring patients from one location to another, such as during surgery.
Damage to the body can include blood in the urine, lacerations to mucous membranes, urethral disruption or obstruction that requires surgery, permanent urinary incontinence and even death. Bleeding from lacerations also allows bacteria to get in the bloodstream and increases the risk of infection. In women, damage may include a prolapse in which the bladder is pulled out of the body. In men, dislodgment can damage the prostate or penis and result in permanent erectile dysfunction.
A family of entrepreneurs
Gardner said he’s honored to have his invention picked up by a company founded by Leonard Pinchuk, Ph.D.,who won the prestigious Russ Prize in 2019 for his invention of the angioplasty balloon. He has more than 40 years of experience working with medical devices, with 130 issued patents and 100 publications. He has also cofounded 10 companies.
Pinchuk’s wife, Diane Pinchuk, and their son, Bryan Pinchuk, also have the entrepreneurial bug and are co-founders of InnoCare Urologics. She has practiced as an attorney since 1980 and provides in-house counsel to the various medical device companies. Bryan Pinchuk has over 10 years of experience as a medical device engineer with a concentration in catheters and as CEO is responsible for development, manufacturing, regulatory matters and the quality system at InnoCare Urologics.
”It’s been a fantastic experience to work with Dr. Gardner and the Pinchuk family. It’s apparent that they all share the same spirit of innovation, entrepreneurship and solving practical problems to benefit patients,” said Braden Bills, a member of Sanford Health’s commercialization team that helps doctors, researchers and other employees determine if their idea to improve patient care has commercial merit.
Common catheter problem
Gardner has seen his share of what can go wrong with generic urinary catheters when a patient mistakenly pulls it out.
“It was a bloody mess,” he recalled of the first time he saw it. “I thought that seems like a very unsafe device if it can be just ripped out.”
Another mishap involved a man in his 80s who was admitted overnight for a urinary tract infection. As the patient was being discharged from the hospital, he accidentally pulled out his catheter. Because the man was on a blood thinner for a heart valve, he bled profusely, required several blood transfusions and extended his hospital stay at least two weeks.
Learn more: Innovations at Sanford Health
“I saw those incidents and thought, ‘What can we do about this?’” Gardner said. “Patients’ lives are at stake. I’m driven to get this device approved if for no other reason than to try to reduce the number of these injuries.”
Gardner grew up on a small farm in rural Missouri with five siblings and not a lot of money, so they got creative.
“We were always working on stuff. I just got that mechanical itch to play with things. We were always tearing apart our toys and modifying them. My parents probably hated that,” he said. “I like to work with my hands, problem solve and basically tinker with things to make them work better.”
Which is why those early episodes of seeing a dislodged urinary catheter stuck with him. Catheters have been around for centuries. But urologist Frederic Foley invented the modern version in the 1930s that uses a balloon to anchor it in place and allows the bladder to drain through a tube that catches urine in a bag that’s attached to the person’s leg.
“The device really hadn’t changed since the 1930s. Every other medical device has been modified in some way to make it safer. However, the only thing that has really changed with the Foley catheter are the materials that are used,” Gardner said.
He initially experimented and tested multiple different designs but ultimately ended up using a very simple solution.
“My modification utilizes a microfilament with a plug and the elastic properties of the catheter which when stretched acts as a mechanical valve and opens up a drainage channel for the balloon to rapidly deflate,” Gardner said.
Normal movements allow for 2-3 pounds of force without causing trouble. “Above about 5 pounds of force on the catheter is where you get injury,” Gardner said. “If the investigational safety catheter is pulled with sufficient tension, the novel safety mechanism will activate to deflate the balloon, which may prevent injury. It’s a one-time use, but the person has averted a potentially life-threatening event.”
He initially worked on the invention on his own, which was costly and time-consuming, but eventually connected with Sanford Health’s commercialization team.
“The team’s been great,” Gardner said. “This started out as a project of just tinkering around with things. And to be able to get the catheter now to the point where it’s getting developed, commercialized and then being on the road to distribution and actually helping patients, like I said, it’s an exciting process.”
Sanford Health values the ideas and problem-solving ability of its physicians, researchers, clinical workers and support staff. Any employee with an idea for a device, therapy, software, tool or other method that helps patients is encouraged to contact the commercialization team and join the dozens of people at Sanford Health who are already inventing.
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