Advancing the Science

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December 17, 2019

Mayo Clinic innovator inspired by patients, surgical experience to improve medical devices

By Advancing the Science contributor

By Sandy Shortridge

Like so many Mayo Clinic staff members, Kenneth Dye has been inspired by Mayo Clinic patients throughout his career.

In Dye's case, conversations with two prolific inventors — while they were patients at Mayo Clinic — sparked his interest in finding ways to improve medical devices. The inventors encouraged Dye to pursue his interest and emphasized that where others see a problem, he should look for opportunities. He took those words to heart. Now with several patents and three inventions to his name, Dye views innovation as an inherent part of his job.

During his 26-year career as a physician assistant in Cardiothoracic Surgery, Dye has worked as a first assistant to surgeons in the operating room. His perspective from this vantage point has generated the ideas for his inventions, each conceived to solve a problem or correct a flaw.

"My inventions were driven by an opportunity to make medical devices clinically safer for our patients," he says. "It's my hope that all my ideas will translate to improved patient care and outcomes."

Kenneth Dye on left, clipping white sheet to a pole, across from another pair of hands attaching the other side of the sheet to another pole. Sheet drapes across operating table.
Kenneth Dye, a physician's assistant in Cardiothoracic Surgery at Mayo Clinic in Florida, and a health care innovator, demonstrating use of his portal drape to maintain sterility during surgery.

Portal drape expands access to surgical field

graphic illustration of a surgical drape with various pieces of equipment in pockets, ready to be selected to cover with sterile sleeve and put through hole in drape to use on patient during surgery
Artist's rendering of drape staged for surgery.

Among Dye's inventions is a portal drape that allows items that have not been sterilized, such as ultrasound probes, to access surgical areas without compromising sterility.

Items that cannot be sterilized can't be used in surgery unless they are sheathed by a sterile probe cover. Dye had the idea to build the probe cover directly into surgical drapes, which are used to cover patients in operating rooms, allowing instruments such as ultrasound probes access to areas where they previously weren't used due to infection risk.

He worked with Neil Feinglass, M.D., Anesthesiology, to develop the drape, which has proven to save time and decrease the risk of complications associated with invasive procedures such as open heart surgery, where breaches in sterility can have serious consequences.

surgical tool emerging from hole in drape across operating table, encased in plastic sleeve to maintain sterility

With the new drape, ultrasound guidance can be used to safely place central lines, arterial lines and peripherally inserted central catheter lines.

Once the idea was conceived and solidified, the portal drape was developed quickly. After proof of concept and preliminary testing were completed, Mayo Clinic Ventures helped secure a commercial license, and the drape became available in 2016. Dye and Dr. Feinglass continue to promote and expand its utility. Dye holds a U.S. patent and several European patents for the portal drape.

Vessel dissector to reduce risks during bypass surgery

Dye also drew on his experience with coronary bypass and minimally invasive surgeries to work on a minimally invasive endoscopic vessel dissector and harvesting system to reduce the risk of vessel compression during bypass procedures. A coronary bypass involves taking a healthy blood vessel from a patient's leg, arm or chest, and connecting it beyond the blocked arteries in the heart.Traditional dissectors cause compression because they are rigid, and the vessel is soft and compliant, according to Dye. The device is intended to reduce the compression and minimize internal trauma within the vessel.

Dye secured a U.S. patent for the endoscopic vessel dissector and has proceeded with initial testing. The device shows great promise, and may offer improved outcomes and vein quality during bypass surgery, Dye says.

Improving safety for artificial heart implants

black and white drawing of device inserted into heart

Ever the innovator, Dye currently is developing a device to be used during artificial heart implants to maintain full priming of the artificial heart pump.

The artificial heart inflow cannula apparatus would be used during implants to maintain full priming of the pump circuit prior to the insertion of the artificial heart, keeping the inside of the heart, device and pump tubing free of air. This will reduce the risk of air embolization — obstruction of blood vessel by air bubbles — when the device is being implanted.Since air typically travels with the flow of blood, a device that can be submerged, fully primed and exhausted of all free air prior to insertion will minimize the chance of air traveling to organs such as the brain, where negative outcomes could occur. Dye holds his third U.S. patent for the apparatus, and work is in progress to advance this technology.

Both the vessel dissector and the artificial heart inflow cannula apparatus are technical inventions that require engineering, a time-consuming but important step in the development process. Dye hopes to have working prototypes for both devices ready for testing in 2020.

The first step is the hardest

During a memorable conversation with one of the inventors he met at Mayo Clinic, Dye says he was assured that his ideas had merit.

"This patient and noted inventor gave me the courage to step out and take the most difficult step, which was the first step," he says.

With several other technologies in the works, Dye is driven by his belief that safety is paramount and an obligation to patients. His advice for aspiring innovators is to focus not on how things currently work or appear, but how they should appear.

"It's important to realize that your invention is alive so to speak and will change as your thoughts, perspectives and observations change," Dye says. "Through innovation, a change in technology can benefit patients beyond our own backyard. With the potential to touch patients all around the world, that is transformational medicine."

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Tags: anesthesiology, artificial heart, biotechnology, cardiology, Innovations, Kenneth Dye, medical innovation, Neil Feinglass, News, patient safety, People, surgery, surgical outcomes

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