MORGANTOWN — Joint replacements can get infected, and detecting the infection can be hit and miss.
Traditional methods can miss low-grade infections in up to 40% of cases, leading to delays in treatment and higher complications, said Dr. Ali Oliashirazi, professor and chair of orthopaedic surgery at the Marshall University Joan C. Edwards School of Medicine.
Enter the Kneedle, and Morgantown-based Intermed Labs.
Dr. Tom McClellan is CEO of Morgantown-based Intermed Labs; Justin Chambers is Intermed’s head of engineering. Intermed is a medical device startup studio devoted to finding West Virginia-originated solutions to national and global problems.
McClellan said he and Chambers were in Huntington, talking with Oliashirazi – he’s called Dr. Oli – and Dr. Oli’s colleague, Dr. Alisina Shahi, an orthopaedic surgeon at the University of Texas Health Science Center at Houston, about the problem.
Oli and Shahi had a vision for a solution, McClellan said, but didn’t know how to create it.
And infected knee will fill with fluid and swell up, he said. To verify an infection, the doctor will insert a needle into the fluid around the prosthetic joint – called a component – withdraw some fluid and send it off for a culture or PCR testing for DNA strands.
But the sample may come back with a false negative, delaying detection and identification of the infection and treatment.
Oli and Shahi had an idea, McClellan said, built on the how a component gets infected. The component forms a biofilm – a film of bacteria around the component that creates a nearly impenetrable barrier. So while extracting fluid may not yield an accurate result, rubbing something against the biofilm would disrupt it.
So the two doctors envisioned passing a wire through a needle to rub up against the component. But they needed to turn the idea into a functional device.
“It’s a major problem,” McClellan said. “There’s no good non-operative solution.” You have to open up the knee and take a swab.
So after McClellan and Chambers talked to the two orthopaedists, “our team started working on it. We had a breakthrough last fall.”
It’s called the Kneedle because its original inspiration was knee replacements, he said, but it can be used for much more: hip replacements, reconstructive breast implants, pacemakers, on and on.
For business reasons, we can’t provide a photograph or a precise description of it. But roughly, picture a large syringe tube topped with a detachable smaller tube. The big tube would withdraw fluid in the traditional manner, while the top tube holds the wire.
Sliding a slider on the top tube slides a knurled flexible wire into the joint space where the knurls collect a biofilm sample. (Knurled means that instead of a smooth wire it has small projections or ridges eteched onto it to disrupt and hold the biofilm.)
With a single stick, the doctor and obtain fluid and biofilm for a culture or PCR exam to ascertain and identify the infection. It’s a non-operative solution that can be done quickly in clinic and yield faster results.
“We’re really excited about this because it’s a very simple idea, it’s very cheap to make, it’s impactful,” McClellan said.
Dr. Oli was at a speaking engagement and couldn’t be reached for comment, but he said in a release announcing the Kneedle, “The Kneedle device may be a game-changer for both patients and health care 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 surgeries.”
Since December, they’ve gone through a series of revisions to reach a version ready to take to market, McClellan said. The wire had to be both flexible and stiff, with a proprietary knurl design on the end of the wire.
They will start bench testing in the next week or so to get bench data for their FDA submission. Bench testing ensures a medical device is safe and effective before proceeding to clinical trials.
The finished Kneedle will be manufactured via injection molding, and they are awaiting quotes on that now. They look to build about 1,000 units for clinical trials.
“Our hope is that this would be on the market next year.”
Email: dbeard@dominiopost.com
