In partnership with University of Colorado Cancer Center investigator Wilbur Franklin, MD, five mechanical engineering seniors from CU-Boulder’s Design Center Colorado filed a patent for a medical device that lets researchers quickly, easily and inexpensively isolate a patient’s cancer cells for the genetic tests that allow doctors to target the disease.
“Believe it or not, there’s not a good way to do this. Existing techniques are either technical and expensive, or low-tech like using a manual pipette to transfer cells,” Franklin said.
The group’s device includes a handheld grip the size of an electric toothbrush that holds a commercial pipette connected to a highly precise pump that can aspirate cells into the pipette and then expel them into a test tube. Working under a microscope, a user manipulates the thin tip of the pipette into the center of tumor cells on a slide. Then, the push of a button sucks cells into the pipette and another push expels them. The pump can be set to pull cells from the alcohol, saline or formaldehyde solutions that are commonly used to mobilize cells in thin tissue slices on slides.
“It doesn’t sound like rocket science, but it was surprisingly complex,” said Aaron Lieberman, a senior in the CU-Boulder mechanical engineering department. For example, the team found that pushing the button to suck cells into the system created a pulling pressure that didn’t naturally end with the release of the button but instead pulled cells further into the pipette. To troubleshoot, the team added a solenoid valve to vent the backpressure built up in the system. Likewise, the group worked closely with Franklin to troubleshoot issues of usability so important to a device that lab techs could use for hours at a time.
“The movement at the end of pipette has to be so precise. Not only did we have to take great care with the mechanics of the system, but design elements like ergonomics and control turned out to be just as important,” said CU-Boulder senior Mark Palmer. The mechanical engineering senior design team also included Andrew Hanuszek, Willem Berglund and Stephen DeMars.
“More and more genetic tests are coming online every month,” Franklin said. “For example, the American Academy of Thoracic Surgeons now recommends that every patient’s lung cancer be tested for the genetic abnormalities known as EGFR and ALK mutations. And we’re working to develop a 48-gene panel that could help match patients to treatments that target mutations in these genes. But all these tests start with cells in a tube. Now we have a very promising way to get them there.”
The collaboration between Franklin and the student design team was part of the CU-Boulder mechanical engineering department’s senior design class in which firms ranging from Boeing to independent inventors collaborate with student teams to solve real-world design challenges. First, firms submit descriptions of their design needs. Then, working in teams of about five, CU-Boulder engineering seniors bid and are matched with projects. Finally, student teams work closely with industry representatives who bring their vision and training to bear on these real-world challenges. Every year, of the 25-or-so teams involved in the senior design class, a very few projects lead to patents. In this case, Franklin had built and patented a rough prototype, but knew additional design expertise was needed to bring the device to fruition.
“The collaboration has worked well and has been a lot of fun,” Franklin said. “We started in September with the prototype I’d built in my basement, and now with the help of these talented students, we’ve patented a device that could be useful in thousands of labs around the country.”
The work included not only realizing Franklin’s vision but managing user surveys to discover additional design goals and constraints. The team also worked with suppliers of widely used components to make the design compatible with eventual mass production. Now with patent in hand for the upgrades that make the device usable, Franklin and his team will present the device at medical and scientific industry trade shows and plan to pursue additional funding.
“This is an immediately usable product. Maybe we replace the coat hooks we’re using as a handgrip stand with something a little more aesthetic, but I’ve already been using it in my lab and it’s a huge improvement,” Franklin said.
Franklin is still deciding whether to start a company that would produce the device, or to pursue licensing the device to an existing medical and scientific tools company.
“The future of cancer treatment is these targeted agents that act against a tumor’s genetic mutations,” Franklin said. “This device could make it possible for even small hospitals and labs to isolate patients’ cells for the genetic testing needed to prescribe the best treatments.”