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March 11, 2021 | Tom Ballard

NE Tennessee Nephrologist develops device to address dialysis line disconnection

By Tom Ballard, Chief Alliance Officer, PYA

Terrence (TJ) O’Neil says an observation he made during a routine shopping trip to Walmart provided the inspiration for a potentially lifesaving solution to a problem that many dialysis patients experience.

He’s an Emeritus Nephrologist with the Veterans Administration (VA) who spent the last 11 years of his career at the James H. Quillen VA Medical Center in Johnson City and, before that, served for three decades in the U.S. Air Force. During both careers, O’Neil says he got “sick and tired” of telling people on dialysis that they had incurred an infection in their heart valves resulting from contamination of the central venous catheter (CVC) line connection or having to transfuse blood because of bleeding due to an unintentional line disconnection during treatment.

“The most common means of reducing venous line disconnect risk currently is taping across the  connections, leaving sticky adhesive residue that attracts debris and bacteria despite disinfection,” he explains. “I’ve developed a device to virtually eliminate disconnects and infections.”

The inspiration for the design came during that visit with his wife to Walmart as they prepared for a trip, and exactly what inspired O’Neil is truly surprising. It was something that many individuals have bought and used – a snap-on cover to keep toothbrush bristles clean and dry. As soon as O’Neil saw the cover, he thought, “This is the answer.”

Now, after several years of fine-tuning the idea and tapping a number of resources, he’s ready to raise outside capital. O’Neil has a 3D-printed prototype, but recognizes the need to manufacturer the cover for a larger market, meaning an injection molding process. He’s also drawn on expertise at East Tennessee State University’s Innovation Lab and BioTN’s Mentor Network that is funded in part by Launch Tennessee.

To say O’Neil is passionate about his work would be an understatement.

“Today, at any one time, there are 100,000 patients in the U.S. alone using central venous catheters for hemodialysis treatments,” he explains. “Each of these patients dialyzes three times a week or 156 treatments a year. Sticky tape is the current standard of care. There is currently no product on the market mitigating both catheter disconnect risk as well as providing a way to reduce CVC/line connection-point contamination that can result in sepsis.”

How pervasive are these two issues? O’Neil says there are an estimated 700 disconnects annually, usually because the nurses are in a hurry and don’t get it done correctly. There’s also the fact that the connections can fail as a result of too many uses. In addition, O’Neil says about 20,000 infections annually can be attributed to contamination from the tape.

“I was sick and tired of telling families there’s nothing more we can do,” he says in reference to the infection of heart valves that frequently results in death. About a year after leaving the VA in 2017, O’Neil started working on the idea, withdrawing $30,000 from his retirement account to self-fund the effort.

“Four design patents are secured, and a utility patent is pending,” he says for the company that he founded named HD Clean LLC (i.e., Hemodialysis Clean). “My device is compatible with the standard dialysis tubing used on Baxter, Fresenius, NxStage, B Braun and TABLO hemodialysis machines.  Because it is compatible with the NxStage machine, it would protect patients on continuous renal replacement therapies (CCRRT) used in acute ICU settings as well as standard hemodialysis.”

O’Neil describes the device as “an oval transparent polymer bivalve with snap closure transparently securing and protecting the critical bloodline-hub connection with wings to allow easy staff opening after completion of treatment.” The initial target market is extremely high-risk environments like in-patient hospital and nursing home dialysis and continuous renal replacement treatment settings. From there, HD Clean would expand to chronic outpatient dialysis units and home use for catheter-dependent patients.

His initial fundraising goal is $100,000 for what O’Neil believes would qualify for U.S. Food and Drug Administration designation as a Class 1 device.

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