Bruce Gardner has seen his share of what can go wrong with today’s generic urinary catheters when a patient mistakenly pulls it out.
“It was a bloody mess,” Gardner, M.D., a radiologist at Sanford Health in Bismarck, North Dakota, 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.
“I saw those incidents and thought, ‘What can we do about this?'” Gardner said.
Learn more: Innovations at Sanford Health
The self-proclaimed lifelong tinkerer ordered a bunch of catheters and started looking for a way to modify the device. After multiple attempts, he developed a modification that would allow for the retention balloon within the bladder to deflate nearly instantaneously when tension was applied to the external portion of the investigational catheter. He calls his invention the Safety Foley Urinary Catheter.
“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 said.
The personal and financial costs of the problem are significant, Gardner said:
- More than 100 million Foley catheters are used worldwide annually, including 33 million in the U.S. each year.
- Up to 25 percent of hospital patients receives a urinary catheter during their stay and about 7 percent of nursing home patients have a catheter long-term.
- Up to 33 percent of patients with long-term catheter use (30 days or longer) experience accidental dislodgment.
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.
Dislodgment usually occurs when a patient 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.
‘Tinker with things’
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, so the catheter releases without injury. It’s a one-time use, but the person has averted a potentially life-threatening event.”
Part of an innovation team
Gardner eventually connected with Pat Kelly, M.D., a Sanford Health vascular surgeon who is developing multiple inventions himself.
They are among more than 100 inventors working with the Sanford Health’s commercialization team that helps doctors, researchers and other employees determine if their idea to improve patient care has commercial merit.
Those inventors have made 140 disclosures outlining their idea: 54 from the Sioux Falls region, 43 from the Fargo, North Dakota, area, five from Bismarck and six from Bemidji, Minnesota. The inventions include devices, software, therapy or drugs, research tools and other innovations.
“Sanford Health employees are on the front lines of health care and are in a great position to spot solutions to problems,” Kelly said.
“I initially worked on this invention on my own, which required a lot of time, effort and resources,” Gardner said. “The Sanford commercialization department can definitely expedite innovation, as they bring an entire team of knowledge, experience and expertise, which are invaluable for projects like this.”
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