Clean manufacturing keys 'chilling' advance in neurosurgery practice
BY CHRIS ANDERSON
PORTSMOUTH, N.H.—Medical device innovator Seacoast Technologies Inc. (www.seacoasttechnologies.com) has announced the first human application of its ChillerStrip product used to create localized profound hypothermia during brain aneurysm surgery.
The surgery, performed at Rush University Medical Center in Chicago, kicked off the clinical testing period for the first of what Seacoast hopes will be a trio of separate cooling devices aimed at the neurosurgery profession.
The technology works by applying the ChillerStrip directly to the cortex of the patient's brain. Chilled saline is then continuously pumped through the strip to produce a deeper cooling in the local area while the rest of the body remains at normal temperature. While the strip itself is quite small—about 20 by 50 millimeters—it will cool an area larger than its surface.
Manufactured in a Class 10,000 cleanroom, the ChillerStrip creates localized brain hypothermia that can aid in successful aneurysm surgery.
"Cooler is theorized to be better because you can preserve the tissue better," says Tim Robinson, director of R&D for Seacoast.
The company turned to contract manufacturer NT Medical (Wilmington, Mass.), a division of NuTool Design Inc. (www.neu-tool.com). Bill Stanhope, marketing manager for NT Medical, says the two companies began working together last July to create enough product that should last through the clinical trials.
Manufaucturing was conducted in three small batches using NT's Class 10,000 cleanroom to produce both the disposable strip itself and the tubes used to circulate the chilled saline solution. Once packaged, the products are sterilized with Ethylene Oxide before delivery to hospitals for the ongoing trials.
"We helped develop the assembly and production methods for the ChillerStrip, though right now, it is a highly labor intensive," says Stanhope.
The induction of mild hypothermia has been used by doctors for years in a number of different operative settings to slow down the body's metabolism and protect vital organs. But previous methods involved cooling the entire body, and it is here that Seacoast officials feel they have an advantage.
Localized chilling technology
"When you chill the whole body, you can't really go below 32 or 33 degrees Celsius because if you go cooler than that, there are a lot of complications," says Seacoast Technologies' Robinson. "The Chiller Strip allows for more profound chilling, down to 15 degrees Celsius, and only a localized area."
While Robinson wouldn't speculate when the clinical trials would end or even when the company would seek FDA approval for ChillerStrip, it's apparent that the first-ever use on a human was a significant step to bringing Seacoast's products to market. "This is a major milestone," says founder, president and chief executive officer Donald Larnard. "Seacoast has overcome enormous engineering and clinical challenges to bring this technology to the marketplace."
Meanwhile, NT Medical is also manufacturing two other products for Seacoast Technologies: The ChillerPad and ChillerButton, both of which are entering pre-clinical trials.