WCU engineering program partners with healthcare provider for sinus device patent
By Julia Duvall
What started as a project concept ended up coming full circle for one Western Carolina University alumna.
Arlynn Baker, a Charlotte native and 2018 graduate of WCU鈥檚 College of Engineering and Technology, had worked with engineering professor Martin Tanaka since she was a freshman on various research projects including one about finite element analysis of the heart.
鈥淚 was doing biomedical work and Arlynn was interested in biomedicine, so it worked out for her to be able to conduct research with me during her first year in the program,鈥� Tanaka said. 鈥淭hen by coincidence she ended up being on my capstone team her senior year.鈥�
When it was time for Baker to embark on her senior capstone project, she and fellow mechanical engineering students Sean Biette, Tiffany Branch and Tyler Zaroff, were tasked with a project that would take her back to her early days of biomedical research at WCU.
鈥淒r. Kashif Mazhar, Raleigh-based ENT surgeon and CEO of excelENT, contacted WCU looking for us to do a capstone project to develop a new medical device for sinus surgery that utilized medical balloons. These are also used in angioplasty where a tiny balloon is blown up to stretch a blood vessel in the heart to relieve a blockage,鈥� Tanaka said. 鈥淪o, for the sinus procedures, it is a similar concept where it stretches the nasal passages to open the sinuses so the doctor can go in and irrigate. The surgeon might want to be pushing antibiotics as well. Instead of going up and down through the maze of tubes each time, the student team invented a device that combined the balloon and irrigation into a singular device enabling the surgeon to do all the work in an area without needing to change instruments.鈥�
The student team developed the device with guidance from Tanaka and Mazhar.
鈥淭he existing technology is very commonly used for sinus surgeries; so this new prototype is a useful device to not only make surgeries more efficient but make the surgery itself more comfortable to perform,鈥� Baker said. 鈥淒r. Mazhar shared that fellow doctors had carpal tunnel issues from doing these types of procedures all day long and it was really taking a toll on them physically. Not only would this device be more economical and make surgery more efficient, but it would also make these types of surgeries less strenuous on the doctors鈥� hands and wrists that perform them.鈥�
The students worked with Tanaka to develop the initial prototype and then Mazhar and the capstone team applied for a provisional patent.
A provisional patent protects your idea for one year giving you time to further develop it, get investors, etc.,鈥� Tanaka said. 鈥淎fter the students completed their project, Kashif began working with WCU鈥檚 Brett Banther in the Rapid Center to further develop and refine the idea.鈥�
Banther and Shawn Lyvers, engineers with the Rapid Center, were instrumental in carrying the design into its present form. At the end of the second year, Mazhar applied for a full patent.
鈥淥nce the process for the full patent begins, the US Patent and Trademark Office has 18 months to review the submission and respond, then you can start addressing their concerns,鈥� Tanaka said. 鈥淪o, it can take several years before a patent is finally awarded and it could also be denied. We got ours in January 2022.鈥�
Once the patent was awarded, Mazhar submitted the device to the US Food and Drug Administration (FDA) and was cleared as a 510k. 鈥淭he FDA needs to evaluate the safety and efficacy of new medical devices before they can be legally sold in the USA,鈥� said Tanaka, who has worked as a Scholar in Residence at the FDA.
鈥淲e have been able to develop a device that has currently been FDA-approved for balloon sinus dilation and is helping patients in real life,鈥� Mazhar said. 鈥淭he second device is a novel intranasal fluid and drug delivery device and one of the products based on this platform will be commercially launched in April or May of 2025. I have thoroughly enjoyed working with this team and I would recommend every medical entrepreneur to work with WCU."
Prior to the FDA approval, Baker graduated from WCU in 2018 and through connections Tanaka helped her make, went on to graduate school at the University of Virginia.
After finishing her master's degree, Baker applied for a research and development engineer position at Medical Murray in Charlotte, North Carolina.
This is where her past work at WCU gave her the experience the organization was looking for.
鈥淒uring the interview I was talking about my capstone project and the interviewer said he knew exactly what project I was talking about, and that Medical Murray was working with Dr. Mazhar to manufacture the device,鈥� Baker said. 鈥淚 was hired and this ended up being my first project while working there. I worked on the project for around two years along with others.鈥�
Baker was thrilled to know that the project she worked on both in college and early in her career would live on as her name was listed on the patent as one of the co-inventors.
鈥淎s an engineer it is really cool to be able to say you are listed on a patent,鈥� she said. 鈥淲CU has been impactful in all areas of my life, from my college career to engineering career and I even met my husband at WCU.鈥�
As for Mazhar, he has enjoyed working with WCU in multiple capacities.
鈥淚 have worked with WCU both as a capstone sponsor and as a client through their Rapid Center. In all my interactions with the teams, I have been impressed by the level of professionalism and the knowledge they have.鈥�
