Published April 2, 2019
A medical device under development aims to reduce the number of joint replacement infections by using electrical stimulation.
While widely successful, not all joint replacements go as planned. Infections are a serious problem, often requiring costly and painful follow-up surgery.
But this could become much less common thanks to the efforts of a multidisciplinary research team at the University at Buffalo that has developed and patented a new infection control strategy that delivers low magnitude, voltage-controlled electrical stimulation to a joint replacement or any metal inserted into the body.
The electric signal modifies the interfacial electrochemical processes at the metal implant surface to create an antibacterial environment that stops infections before they become problematic.
The initial groundwork for this innovative therapy was generated through a multidisciplinary collaboration between Mark Ehrensberger, PhD, associate professor of biomedical engineering and director of the Kenneth A. Krackow, MD, Orthopaedic Research Laboratory, and Anthony A. Campagnari, PhD, professor of microbiology and immunology and senior associate dean for research and graduate education.
The team showed that the electrical stimulation can prevent and eradicate problematic infections and importantly that the technology was synergistic with traditional antibiotic therapy.
Garwood Medical Devices, LLC, the Buffalo-based startup company that licensed the technology from UB, is developing the Biofilm Disruption Device™ (BDD™) to apply this therapeutic electrical stimulation in a clinical setting.
The BDD™ system includes two electrode skin patches, a machine that generates the electrical stimulation, and a small percutaneous probe that delivers the stimulation directly to the joint replacement.
The probe is inserted into the body until it reaches the implant or metal hardware. The electric simulation then modulates electrochemical processes at the surface of implant, which produces a surrounding microenvironment that promotes the killing of bacteria.
The advancement is important, says Wayne D. Bacon, president and chief executive officer of Garwood, because infections affect roughly one of every 100 knee replacements and there is no simple and effective way to treat them.
Often infections prompt the need for replacement surgeries, which cost at a minimum tens of thousands of dollars. And some studies suggest the rate of infections following joint replacements will increase.
“Biofilm Disruption Device™ is an elegant and minimally invasive solution to a growing problem that causes pain and suffering in hospitals across the nation. It also could save the health care system billions of dollars,” says Ehrensberger.
Garwood is developing the technology with assistance from UB’s Buffalo Institute for Genomics and Data Analytics.
Garwood also has been working with UB’s New York State Center of Excellence in Materials Informatics, the UB Center for Advanced Technology in Big Data and Health Sciences and the UB Center for Computational Research.
Additional testing of BDD™ is underway, with the goal of providing the necessary information to win approval from the U.S. Food and Drug Administration when Garwood files its formal application in 2020, Bacon says.
In parallel with the commercialization efforts, Ehrensberger and Campagnari are continuing to work with Albert H. Titus, PhD, professor and chair of biomedical engineering, and Thomas R. Duquin, MD, clinical associate professor of orthopaedics, on a project funded by the Office of Naval Research that seeks to further optimize the electrical stimulation parameters for preventing and treating orthopaedic implant-related infections.