Biomedical engineers from Case Western Reserve University and the University of Chicago are ready to test an implantable device that could restore the sense of feeling for breast cancer patients who have had reconstructive surgery.
The device, called a C-FINE, sends touch signals to the nervous system. The same technology has been used to provide a sense of touch to prosthetic devices after a limb is amputated, but this study is the first for intercostal nerves, which communicate signals from the breast.
Emily Graczyk, a biomedical engineer who is leading the team at CWRU, said patients who have mastectomies lose more than just breast tissue. The muscles and nerves are also often removed from the chest, which can lead to lifelong numbness or chronic pain.
"While it's wonderful that they have survived the cancer and are survivors, they have to deal with these lifelong effects," Graczyk said. "And so we're hoping that with this technology, we might be able to offer them better quality of life and a more normal experience after their fight against breast cancer."
Graczyk said the project has been ongoing for years, started by Stacy Tessler Lindau, a professor of obstetrics and gynecology at the University of Chicago. The device recently received U.S. Food and Drug Administration approval for testing, meaning researchers will begin recruiting patients once regulatory approvals are in place.
Testing will begin with patients who are scheduled for a bilateral mastectomy for breast cancer in the Chicago area. Graczyk and her team will combine their expertise with University of Chicago experts. Graczyk said their hope is to begin clinical testing in 2024.
"We hope that by summer or maybe early fall, we'll be able to implant our first patient. Our study will run for about five years in total, though each patient's involvement will be between 12 and 20 weeks. The timing is based on their clinical surgeries they already have as part of their personal secondary care," Graczyk said.
The C-FINE device, which is made of silicon and platinum, will be implanted during the first phase of breast reconstruction in trial patients. Once the device is implanted, researchers can determine how to stimulate the nerves to create the sense of touch. The C-FINE device wraps around the intercostal nerve branches. Thin, flexible wires will exit the skin under the arm to connect to an external neurostimulation system.
Graczyk noted the devices could be implanted for patients even if they had a mastectomy years ago.
Researchers will test the system in labs by sending small electrical signals to the implanted electrodes around the nerves. The electrical signals activate the nerves to create touch sensation. Patients will then describe the sensations, their location, intensity and how natural they feel.
Research for the project was started by Dustin Tyler, a professor of biomedical engineering at CWRU and consultant on the project, which is funded by a $3.99 million grant from the National Institutes of Health.
