New double-balloon catheter receives Canadian patent

Medical University of South Carolina radiologist assistant Cephus E. Simmons Sr., Ph.D., realized that catheters on the market were not optimal for providing the needed diagnostic yield during radiology procedures. He thus created a double-balloon catheter, the Cephus Catheter, for use in prognostic and diagnostic radiology procedures. He founded the company SealCath, LLC, of which he is CEO, to create the product and make it available commercially.

His invention improves radiologists' ability to evaluate post-surgical patients with more precision, allowing for the early detection of complications and thus leads to faster patient recovery. The product is already available in the U.S. and has just been patented in Canada.

Simmons clearly remembers the day that he realized a better catheter was needed. He was on the care team of a pediatric patient in need of radiology-driven bowel obstruction therapy. For that treatment, a Foley catheter was used. The catheter is a sterile tube with a spherical balloon that enters the bowel. The catheter fills the bowel with air to relieve the obstruction.

Half the air would leak around the Foley catheter's balloon, and it made it very difficult to treat the child."

Cephus E. Simmons Sr., Ph.D., Radiologist Assistant, MUSC

As air entered the catheter, the bowel would dilate as intended. However, that also caused the balloon that was at maximum inflation capacity to float, breaking the seal at the rectum. This prolonged the procedure, and in turn, increased the patient's and medical staff's radiation exposure.

"It bothered me so much that I went to my office after the procedure to see if there was any product out there that we could use to improve the process, and I could not find anything," said Simmons.

That same night, Simmons sketched possible catheters that could fix the problem. One year later, in 2013, Simmons started his own company, SealCath LLC, in an effort to get the product on the market.

"Getting the company up and running was challenging," he said.

His team created a business plan and received several grants that allowed him to fund the company. However, Simmons still needed to rely on personal funds and investments from family and friends until the product was on the market.

Simmons initially tested out prototypes, with different balloon shapes on the catheter, searching for the one that worked best.

"We used my garage," said Simmons. "Once I got something I thought would work, I got a lab project going." The final project was funded by a grant from the National Institutes of Health.

A study Simmons conducted in 2018 identified the best balloon shape, enabling the creation of a prototype and initiation of the FDA approval process.

"In 2018, we finalized the prototype that was going to work for clinical application, and then we took it to a manufacturer, which was Bard," explained Simmons. "In July 2019, we went on the market."

The catheter's balloon shape was designed specific to the bowel to allow efficient and effective procedural performance. Another innovative feature of the catheter is the presence of two balloons instead of one. As with other catheters, the first balloon is spherical and enters the rectum, a portion of the bowel. In this case, it fits perfectly for colorectal procedures. The second balloon is pear-shaped and acts as both a seal on the surface of the skin and as an anchor for the spherical balloon.

"By having a double-balloon catheter, we can keep the balloons from floating upstream and breaking the seal," explained Simmons.

The new catheter is now used in some hospitals across the U.S., including pediatric hospitals. It is intended to increase diagnostic precision and decrease complications of colorectal radiology procedures, including colon cancer screening, post-surgical bowel evaluation and the reduction of intussusception, or the sliding of one part of the bowel over another, in children.

"The most rewarding part is just seeing that it helps," said Simmons. "I've been in health care for over 30 years, and my goal the whole time has been to treat patients and help them get better. The Cephus Catheter has definitely identified why I love medicine. I have been involved in several medical studies in the past, but this one identifies me."

The catheter was recently awarded a Canadian patent. Simmons decided to apply for a patent after Canadian doctors at a radiology conference expressed interest in using the product.

Simmons is pleased to make the catheter available to more radiologists because he believes it will improve the early diagnosis of complications, leading to a reduced patient recovery time.

"This is an innovative product that will increase the diagnostic yield of various colorectal procedures within radiology," he explained.

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