A urinary catheter intended to reduce damage from accidental pullout injuries, which was invented by a Sanford Health doctor, should be ready for a first-in-human clinical study this year.
InnoCare Urologics LLC licensed the technology from Sanford Health. It has finalized the design with a manufacturer and completed the necessary testing. The next step is submission to the U.S. Food and Drug Administration, which could grant clearance in early 2022.
Bruce Gardner, M.D., invented the investigational urinary catheter after numerous prototypes. He then partnered with fellow Sanford Health radiologist David Swanson, M.D., and brother Jeff Gardner to patent the technology.
“The device is quite simple,” Dr. Gardner said.
It’s designed to help minimize injury from accidental or inadvertent catheter dislodgement by allowing for the retention balloon inside a person’s bladder to deflate nearly instantaneously when excess tension is applied to the external tubing. He calls his invention the “Safety Foley” urinary catheter but is unsure as to what the final name will be when the device is made available to medical providers and patients.
InnoCare Urologics agreed to develop, manufacture and sell the novel safety device. The company’s founder co-invented technologies for the angioplasty balloon and coronary stent and has successfully developed many additional medical devices throughout his career, benefiting and saving countless lives.
“They had also recognized the shortcomings of the standard Foley catheter and need for a safer alternative and were already working on a similar solution, so the partnership was perfect,” Dr. Gardner said. “They’ve worked out nearly all of the kinks with the design. Hopefully once we get our initial pilot study done we’ll be able to test this in a larger group of patients and show efficacy so it can do its thing and start helping patients.”
Catheter injury and death
Up to 100 million Foley catheters are used annually worldwide. Inadvertent dislodgment typically occurs when patients are delirious, demented or confused and end up ripping their catheter out with the retention balloon still inflated. It also can 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 significantly increases the risk for potentially life-threatening infection. In women, damage may include a prolapse in which the bladder is pulled out of the body. In men, dislodgment can damage the penis, prostate or nerves and could result in permanent erectile dysfunction.
A family of entrepreneurs
Dr. 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 innovation and commercialization team that helps nurses, doctors, researchers and other employees commercialize their ideas to improve patient care.
Common catheter problem
Dr. Gardner has seen his share of what can go wrong with standard Foley urinary catheters when patients mistakenly or inadvertently pull 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 and cause all that damage.”
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. They ultimately had to hold his blood thinners, significantly increasing his risk of stroke.
“I saw those incidents and thought, ‘What can we do about this?’” Dr. 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 potentially life-threatening injuries.”
He 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,” Dr. Gardner said. “I like to work with my hands, problem solve and basically tinker with things to make them work better.”
Catheter design largely unchanged
Which is why those early episodes of seeing a dislodged urinary catheter stuck with him.
Catheters have been around for centuries. Urologist Frederic Foley invented the modern version in the 1930s that uses a balloon to anchor it in place. It 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,” Dr. Gardner said.
He initially experimented and tested multiple different designs but ultimately ended up using a very simple solution.
“My modification utilizes a microfilament tether with a plug and the elastic properties of the catheter, which when stretched acts as a mechanical valve and opens up an accessory drainage channel for the balloon to rapidly deflate, thereby helping to minimize injury,” Dr. 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 start to get injury,” he said. “If the investigational safety catheter is pulled with sufficient tension, the novel safety mechanism will activate to rapidly deflate the balloon, which should help to minimize injury. It’s a one-time use, but the person has averted a potentially life-threatening event.”
Sanford Health values the ideas and problem-solving ability of its nurses, providers, 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 innovation and commercialization team and join the dozens of people at Sanford Health who already are inventing.
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