CT Company Enters Cranial Implant Market

Aug 2, 2011

A tiny Connecticut company that’s making innovative skull implants for trauma victims has just shipped its first product.  Kelyniam says its rapid-response device is different than anything else on the market. As WNPR’s Harriet Jones reports, the company is employing skills and techniques usually associated with the aerospace industry.

In the lobby of Kelyniam Global’s small unit in a Canton business park several plastic skulls sit on glass shelves. The company’s CEO is James Ketner.

“This is the eye socket, and this is like a bullet hole wound, and we build this piece that goes in here. And it fits just like that.”

The old, traditional method of fixing cranial injuries is a titanium plate that would have to be fashioned to fit during surgery, making for a lengthy and sometimes risky process. But in recent years, different types of custom-made implants have started to emerge. Ketner’s background is in designing and making aircraft parts. He had the idea for a faster, closer-fitting cranial implant when he bought a rapid prototyping company from a friend. The company had a contract to create molds for a medical device company that was making implants.

“And I saw what they were doing and I thought, well, why would you make a mold when you’re only making a custom implant for one thing? Usually you make a mold if you’re going to do door handles on a car and make 900,000 or something – that’s why you make a mold. So if you’re going to make one of something, I would machine it.”

So Ketner went in search of a material that could used as an implant, and could be machined. He found a polymer commercially known as  PEEK.

“And since I can machine it, versus making a mold, instead of taking four to five weeks, I can do it in a couple of hours. So if you give us data by 9am in the morning, we can have you a part on your desk the next day by 9am.”

A hospital sends Kelyniam’s technicians a CT scan of the patient’s head, and using a computer aided design, or CAD program, the company can model and then mill an implant that conforms exactly to the void in the skull.

“The 24-hour turnaround time makes the part fit better. If you take a CT scan of a damaged area of your bone and it takes six weeks to get the implant, your bone has moved around. It’s re-growing, it’s morphing, it’s doing its thing. If it’s 24 hours before I give you the implant, it’s going to fit better.”

Kelyniam won approval for its process and its device from the FDA in April, and in order to begin production, it had to move to new premises in Canton that meets strict federal government specifications – including high-level security.

“So this is basically what the patient data would look like. So you have all the slices from the CT, and then you can go over to 3D. So after you basically calculate the 3D, it takes all the images, it puts triangles and data around the images to create a 3D model.”

Nick Breault shows me on a computer screen how the virtual, CAD part of the process is carried out.

“Part of the way that we validate that the implant we’re making is the correct one, is we make a model of the outside area of the skull. So that way after we have our physical model, we take our implant, set it on the model and check the fit.”

That’s done here, in the stereolithography room, where the model of the outside part of the skull is created by laser-curing a liquid polymer resin.

“The laser comes through, it’s directed onto the machine, it’s focused and then it takes a layer by layer slice, cures the material on the platform, the platform moves down, cures more and moves down, until you get a solid model.”

Next door, Tommy Ziolkowski is working at a CNC machine much like any you might see on an industrial shop floor. He used to operate something very similar when he was a contractor for Sikorsky making helicopter parts, but how he’s machining the first version of a cranial implant.

“We’ll make the first go-around on the implant. So we check that, after milling here. Once it’s passed here, it goes into the clean room and we mill it there out of the PEEK product. This is a delron plastic that we make it out of – it’s less costly than the PEEK.”

Several companies, including some very big medical device players are now getting into the market for custom implants. Kelyniam believes that its 24-hour process will give it the edge. CEO James Ketner says it’s a little nerve-wracking seeing his product going out the door for the first time.

“Building an airplane part and doing the nose wheel well on a Boeing 777 – that was interesting, but this is different. This person’s going to put this in their head and it’s going to reshape the way they look and they’re going to have it for the rest of their life – it’s pretty important stuff.”

Kelyniam hopes to expand its innovative process to make new types of bone implants, and it’s already planning new application to the FDA for more product launches.

For WNPR, I'm Harriet Jones.