MORGANTOWN – Joint replacements can become infected, and detecting the infection can be a matter of luck.
Traditional methods can miss mild infections up to 40 percent of the time, leading to delays in treatment and more frequent complications, said Dr. Ali Oliashirazi, professor and chair of orthopedic surgery at the Joan C. Edwards School of Medicine at Marshall University.
This is where Kneedle and Morgantown-based Intermed Labs come into play.
Dr. Tom McClellan is CEO of Morgantown-based Intermed Labs; Justin Chambers is Intermed’s chief technical officer. Intermed is a medical device startup studio dedicated to finding West Virginia-based solutions to national and global problems.
McClellan said he and Chambers were in Huntington and discussed the problem with Oliashirazi — his nickname is Dr. Oli — and Dr. Oli’s colleague, Dr. Alisina Shahi, an orthopedic surgeon at the University of Texas Health Science Center in Houston.
Oli and Shahi had a vision for a solution, McClellan said, but didn’t know how to implement it.
An infected knee fills with fluid and swells, he said. To detect infection, the doctor inserts a needle into the fluid around the artificial joint – called a component – and withdraws some fluid and sends it for culture or PCR testing for DNA strands.
However, the sample result may be false negative, delaying detection and identification of the infection and treatment.
Oli and Shahi had an idea, McClellan said, based on the way a component becomes infected. The component forms a biofilm – a film of bacteria around the component that creates a nearly impenetrable barrier. So while extracting fluid might not give an accurate result, rubbing something against the biofilm would destroy it.
The two doctors imagined running a wire through a needle, which would rub against the component. But they still had to turn the idea into a functional device.
“This is a big problem,” McClellan said. “There is no good non-surgical solution.” You have to open the knee and take a swab.
After McClellan and Chambers spoke with the two orthopedic surgeons, “our team started working on it. Last fall, we had a breakthrough.”
The name “Kneedle” comes from the fact that the original inspiration was knee replacement, he said, but it can be used for much more: hip replacements, reconstructive breast implants, pacemakers and so on.
For business reasons we cannot provide a photo or detailed description of this, but imagine a large syringe tube with a removable smaller tube on top. The large tube would withdraw liquid in the traditional way, while the top tube would hold the wire.
By moving a slider on the upper tube, a knurled flexible wire is pushed into the joint space, where the knurling picks up a biofilm sample. (Knurled means that instead of a smooth wire, small protrusions or grooves are etched into it to break up and hold the biofilm.)
With a single test, the physician can obtain fluid and biofilm for culture or PCR testing to detect and identify the infection. It is a non-surgical solution that can be performed quickly in the clinic and provides faster results.
“We are really excited about this because the idea is very simple, the implementation is very inexpensive and the impact is big,” said McClellan.
Dr. Oli was at a speaking event and could not be reached for comment, but in a press release announcing the Kneedle, he said, “The Kneedle device could be a game-changer for both patients and healthcare providers. Our goal is to increase the accuracy of infection detection, reduce the number of false negatives, and ultimately improve the quality of care for patients undergoing joint replacement surgery.”
Since December, they’ve gone through a series of revisions to get to a market-ready version, McClellan said. The wire had to be both flexible and stiff, and feature a proprietary knurling design at the end.
They will begin lab testing next week to obtain lab data for their FDA submission. Lab testing ensures that a medical device is safe and effective before it moves on to clinical testing.
The finished kneedle is manufactured using an injection molding process. They are currently waiting for offers for it. They want to build around 1,000 units for clinical testing.
“We hope it will be on the market next year.”
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