Gordon Atkinson survived prostate surgery, but his most frustrating hurdle was having to use a catheter and bag following the procedure. The bag was difficult to conceal and was awkward when wearing shorts (he lived in Florida at the time) and engaging in leisure activities.
"He was incredibly uncomfortable with the catheter," Jeff Hale, of Link-It Medical (Hickory, North Carolina) told Medical Device Daily. "He couldn't sleep at night or wear shorts. The catheter bag would slide down and it would just be awkward."
"I love to fish and sail, but the catheter and bag made it difficult for me to feel comfortable doing those things," Atkinson said. I had all this tubing hanging on my leg, and I had to be careful not to snag it on anything. I definitely couldn't wear shorts. If the tubing disconnects, which can easily happen, urine runs down your leg and soils your pants. I knew there had to be a better way."
With a background in fluid dynamics, Atkinson began tinkering away to make the device easier to use. He then teamed up with his doctor Mutch Yadven MD, to patent and make improvements to the concept.
"When I showed it to Mitch, he said, 'Do you know what you've done?'" Atkinson said. "I think we both knew this valve could have life-changing potential."
The duo then teamed up with Hale's company Link-It Medical and selected neophyte med-tech company ProtekMed (Hickory, North Carolina) to manufacture the device, which has been named the Tru-Flo urinary catheter valve.
The company reported launching the device earlier this week. It's a Class I device and it's considered a urinary accessory, so there is no need for a 510(k) or PMA according to the company.
"What this valve does is, it allows the patient to have control over the drainage of urine," Hale told MDD. "This is the first of its kind in the U.S. market. Interestingly enough there have been quite a few valves in Europe that have attempted to accomplish what we're doing with Tru-Flo. But [ProtekMed] is looking at European market which is much more mature, but our primary focus is in the U.S."
The device itself is being touted as a huge game changer in the quality of life for catheter patients.
Designed to be used in place of a bag, the valve connects to the end of the catheter tube and slides open and closed easily with one hand. With a secure, leak-free seal, a Tru-flo-equipped catheter can be drained directly into a commode at the convenience of the patient. The valve universally adapts to all Foley and Supra-pubic catheter systems.
By eliminating the bag and utilizing shorter catheter tubing, the entire catheter system is easily concealed thanks to Tru-flo - helping to restore patient comfort and dignity. And with no recessed or undercut external surfaces that can harbor bacteria, the Tru-flo valve has important design features for infection prevention.
The company said that for patients utilizing the valve, the device should be opened every three-to-four hours initially. Some patients may have the urge to void and should open the valve as this occurs. The valve can be used safely overnight, or a bedside drainage bag may be attached before bed, reducing nocturia, and the valve replaced in the morning.
Patient indications for use of the Tru-flo valve include the following:
• Conditions of chronic urinary retention;
• Conditions of acute urinary retention;
• Other medical conditions requiring in-dwelling catheters.
Contraindications include a high-pressure neurogenic bladder, a history of autonomic dysreflexia, a febrile UTI, and situations following any procedure or trauma where there is a possibility for urinary extravasation and urinary drainage is needed for optimal tissue repair, such as TURBT, bladder repair or trauma, or radical prostatectomy. Relative contraindications are gross hematuria with clot.
"There has been a lot of interest with this device," Hale told MDD. "We've got orders for [Tru-Flo] that have been booked and we look to have our first sales of the device [in the near future]."
Omar Ford, 404-262-5546;