Bioengineering students identify a need, design a prototype, build it and begin testing — all in a single year.
The powder-blue backpack looks like the kind of bag a kindergartener might use to carry lunch to school, but unzipping a flap reveals something more.
A medication pump is tucked inside.
The RX Bag was designed so that children with cancer would be able to stay mobile instead of remaining tethered to an IV pole while undergoing chemotherapy. They would be able to fidget, roam the halls with their parents or visit the playroom.
It’s the creation of a team of four seniors majoring in bioengineering, who dubbed their team Tyke Medical, and is just one example of the many biomedical devices that students and faculty are creating at Clemson University.
Tyke Medical unveiled its creation to the public for the first time at the Clemson Bioengineering Design Symposium, held each year in Greenville, South Carolina.
In few places is the culture of innovation and entrepreneurship more evident. Forty-one teams gathered in May for the most recent installment. They came with new devices to help treat cancer, remove tonsils and put broken bones back together, just to name a few examples. Several students said they saw opportunities to market their devices not only in the United States but globally.
The symposium gave all the students a chance to show their work to faculty, alumni and potential collaborators. But at the center of the event were 22 teams of seniors. Each team worked with clinicians to identify a need, design a prototype, build it and begin testing, all in a single academic year. All seniors who major in bioengineering participate.
Martine LaBerge, chair of the Department of Bioengineering, said the real-world experience is the “capstone” on their undergraduate education. “It’s clinically driven to assure that patient and health care needs are met,” LaBerge said. “The bioengineering curriculum at Clemson is focused on educating students to meet the current and future needs of health care practitioners so they can better serve patients.”
Ideas for the devices came from medical care practitioners across South Carolina, including some from Prisma Health, Medical University of South Carolina and Roper St. Francis Healthcare. Physicians suggest ideas in some cases. In others, students themselves recognize the needs while working in hospitals as part of programs such as CU DeFINE, a six-week clinical and technology transfer immersion experience.
In addition to the RX Bag, other devices developed by the senior bioengineering students include:
Intrafix: A device to treat rib fractures that could help patients heal faster with more mobility during recovery.
Need: Doctors often face a hard choice when deciding how to treat rib fractures. They can perform major surgery, making a large incision to screw a plate onto the rib. Or patients can be sent home to heal on their own, which can mean weeks of bedrest and pain medicine. IntraFix aims to treat patients who would be sent home without surgery by helping them heal faster and giving them more mobility in the process.
How it works: The surgeon would make a small incision in the patient, drill a hole 30 millimeters from the fracture, clean out the inside of the bone and align the fracture. The IntraFix would be placed into the hole, across the fracture, and expand inside the rib. Barbed tips would help hold the device in place. The surgeon would then drill another hole to insert a screw into a plate that would also help hold the IntraFix in place. A handle that would be included could be attached to a suture loop, allowing the surgeon to pull until satisfied with device engagement.
HIFree: A low-cost breast pump with a filter designed to deactivate HIV.
Need: Deciding between HIV and malnutrition is a choice no mother should have to make, but it’s a stark reality in many parts of the world, including Tanzania, where students got the idea for the device. About 40 percent of babies with HIV get it through breast feeding, the team says. And it’s a stigmatized disease. One of the big challenges the team faces is making the HIV filter as inconspicuous as possible to avoid identifying its users as HIV-positive.
How it works: The team’s name, Kifua Pampu, means breast pump in Swahili, which is exactly what the team created. The pump features a filter made out of a special material designed to deactivate HIV. The filter can also kill some of the bacteria in milk that causes it to spoil. HIFree could allow a mother to pump milk and store it for longer than is currently possible — a crucial issue in areas where refrigeration may be limited. Also, the pump can be used manually or electrically, making it ideal for rural areas where power availability can be limited.
Biopsy PolyGuide: A device to be used in breast cancer biopsies to mark the spot of the mass.
Need: The Biopsy PolyGuide would eliminate one of the procedures currently involved in all lumpectomy surgeries. Patients arrive at the hospital hours before their surgeries so that a guide wire can be inserted into the breast, a procedure called localization. It can be painful, and patients are often left waiting hours for surgery with a wire sticking out of their breasts. Students said that 12.4 percent of American women will get breast cancer, and that 60 percent of all breast cancer patients will opt for lumpectomy.
How it works: The Biopsy PolyGuide would go to work during the biopsy, which is performed to determine whether a mass is benign or cancerous. As part of the biopsy, a thin tube called a cannula is inserted into the breast to help extract a tissue sample. Once the sample has been taken, the syringe-like Biopsy PolyGuide would be inserted into the mass through the cannula. The doctor would use the device’s plunger to push a polymer insert into the mass. The Biopsy PolyGuide would be removed from the breast, leaving behind the polymer insert. The doctor would then cut the polymer insert at the surface of the skin. If the mass turns out to be cancerous, the surgeon who performs the lumpectomy could use the polymer insert as a guide to find the mass. The polymer insert would not need to be removed, whether the mass is cancerous or not, because it is bio-absorbable and would degrade until fully dissipated.
The Apollo: A device to assist surgeons in treating femoral fractures.
Need: The number of femoral fractures worldwide is expected to grow to 8.2 million in 2050 (in 2010, the number was 1.7 million); this increase is driven in part by aging populations, students said. While current methods of cable application take 5 to 15 minutes per pass, the Apollo can help a surgeon complete a single pass in 3 to 5 minutes. OrthoJAMZ, the students’ team name, estimates that their design could save 40 hours of surgical time per year, significantly reducing the risk of blood loss and infection.
How it works: The surgeon would use the Apollo to feed a cable around the bone. The cable would then be tightened to bring the fractured bone back together so that a metal plate, screw or other medical device could be affixed. Devices currently in use travel only part way around the fractured bone. Surgeons then have to use their fingers to locate the device in the patient’s flesh to secure the cable. A big part of what makes the Apollo unique is that a U-shaped “passer” goes through the flesh, and the tip emerges on the other side of the bone. The surgeon would then press a lever-like “pusher” to extend a proboscis from the passer. The tapered end of the cable would be fed into the proboscis and through the passer to enclose the fracture. Then the proboscis would be retracted and the passer would be removed, leaving the cable in place.
The AdjustaBite: An adjustable tool for holding open the mouth and depressing the tongue during tonsillectomies.
Need: About 600,000 tonsillectomies are performed in the United States each year, students said. The tonsillectomy treatment market is valued at $3 million per year and is expected to grow. The AdjustaBite would result in quicker procedures, safer experiences for patients and reduced costs for hospitals.
How it works: The AdjustaBite would be the first fully adjustable tool for holding open the mouth and depressing the tongue during tonsillectomies. The device would not only allow surgeons to better see the tonsils but would also help prevent damage to soft tissue, which could result in less postoperative pain for the patient. The device is made of stainless steel and has silicon pads to protect the molars. Pressing a button would allow for vertical adjustment, while a pin and series of notches would allow for horizontal adjustment. The AdjustaBite is capable of making the tonsils at least 90 percent visible.