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 radiologistDavid Swanson, M.D.,and brother Jeff Gardner to patent the technology.
“这种设备非常简单，”加德纳博士说。
它的设计是为了帮助最大限度地减少意外或无意的导管脱臼的伤害，通过允许一个人的膀胱内的滞留气球瘪几乎瞬间时，多余的张力应用到外部管道。他称自己的发明为“安全福利”导尿管，但不确定当这种设备被提供给医疗提供者和患者时，它的最终名称会是什么。
InnoCare Urologicsagreed 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.
加德纳博士说:“他们也认识到标准弗利导尿管的缺点，以及需要更安全的替代品，并已经在研究类似的解决方案，所以这次合作是完美的。”“他们已经解决了几乎所有的设计问题。希望一旦我们完成了最初的试点研究，我们就能在更大的患者群体中测试它，并显示其疗效，这样它就能发挥作用，开始帮助患者。”
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 byLeonard 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’sinnovation and commercialization team这有助于护士、医生、研究人员和其他员工将他们改善病人护理的想法商业化。
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 tocontact the innovation and commercialization teamand join the dozens of people at Sanford Health who already are inventing.
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Posted InBismarck,Digestive Health,Imaging,Innovations,Physicians and APPs,Sanford Stories
